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# Current Bibliographies in Medicine 99-3

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# Ethical Issues in Research Involving Human Participants

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January 1989 through November 1998

4650 Citations

Prepared byCynthia B. Love, M.L.S., National Library of MedicineElizabeth J. Thomson, M.S., R.N., National Human Genome Research InstituteCharmaine D. Royal, Ph.D., National Human Genome Research Institute; Howard University

1999 May

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESPublic Health ServiceNational Institutes of Health

National Library of MedicineReference Section8600 Rockville PikeBethesda, Maryland 20894

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      - Series Note
      - Table of Contents
      - Introduction
      - Sample Citations

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**Series Note**

Each bibliography in the Current Bibliographies in Medicine (CBM) series covers a distinct subject area of biomedicine and is intended to fulfill a current awareness function. Citations are usually derived from searching a variety of online databases. NLM databases utilized include MEDLINE®, LocatorPlus, BIOETHICSLINE®, HEALTHSTARtm, POPLINEtm, and TOXLINE®. The only criterion for the inclusion of a particular published work is its relevance to the topic being presented; the format, ownership, or location of the material is not considered.

Other publications in the *Current Bibliographies in Medicine* series are available at no cost to anyone with Internet access through the Library's World Wide Web site at http://www.nlm.nih.gov/pubs/resources.html.

Comments and suggestions on this series may be addressed to:

Karen Patrias, EditorCurrent Bibliographies in MedicineReference SectionNational Library of MedicineBethesda, MD 20894Phone: 301-496-6097Fax: 301-402-1384Internet: ref@nlm.nih.gov

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## Table of Contents

### Series Note

### Introduction

### Sample Citations

## Part I: Bibliography

### 1. Overview of the ethics of research involving human participants:Journal Articles; Books

### 2. Historical perspectives on research involving human participants:Journal Articles; Books

### 3. Informed consent:Journal Articles; Books

### 4. Community consent:Journal Articles; Books

### 5. Privacy and confidentiality:Journal Articles; Books

### 6. Clinical trials:Journal Articles; Books

### 7. Special or vulnerable populations

### a. Women:Journal Articles; Books

### b. Minorities and cross-cultural issues:Journal Articles; Books

### c. Children and adolescents:Journal Articles; Books

### d. Cognitively impaired:Journal Articles; Books

### e. Elderly:Journal Articles

### f. Prisoners:Journal Articles; Books

### g. Military personnel:Journal Articles; Books

### h. Teaching and research using newly deceased patients:Journal Articles

### i. Self-experimentation by researchers:Journal Articles; Books

### 8. Special Research Topics

### a. Genetic research:Journal Articles; Books

### b. Gamete, embryo and fetal research:Journal Articles; Books

### c. Human cloning:Journal Articles; Books

### d. Research using human biological materials including fetal tissue:Journal Articles; Books

### e. Xenotransplantation:Journal Articles; Books

### f. AIDS/HIV research:Journal Articles; Books

### g. Cancer research:Journal Articles; Books

### h. Emergency medicine, acute care and critical care research:Journal Articles

### i. Drug and medical device research and development:Journal Articles; Books

### j. Institutional review boards and ethics committees:Journal Articles; Books

## Part II: Resources

### 1. Bioethics education:Journal Articles; Books

### 2. Case studies:Journal Articles; Books

### 3. Audiovisual materials for teaching the ethics of research involving human participants.

### 4. Bioethics journals

### 5. Bioethics databases

### 6. Source materials

### a. U.S. federal government laws, regulations, and guides concerning the protection of human research participants:Journal Articles; Books

### b. Guidelines for the protection of human research participants published by U.S. non-government organizations:Journal Articles; Books

### c. Guidelines for the protection of human research participants published by non-U.S. government and other organizations:Journal Articles; Books

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**Introduction**

ETHICAL ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS

On May 16, 1997, President Clinton apologized to the survivors and families of hundreds of men used in a research project to study the progression of untreated syphilis. These men were mainly sharecroppers from Macon County, Alabama (the area surrounding Tuskegee). They were poor, African American, and had few resources available to them. In 1932, when they were offered free medical care by physicians and researchers involved with the United States Public Health Service, they believed they had found treatment for what they had been told was "bad blood." Instead, they were enrolled in an observational research study, without their knowledge or consent. In exchange for their participation (which included agreeing to an autopsy at death), the men received free medical examinations (primarily to provide data for the study), transportation and hot meals on the days of their examinations, and $50 for burial expenses. Even though some rudimentary remedies for syphilis were available in the early years of the study, they were not offered to these men, so that the study of the natural history of the untreated disease would not be jeopardized. 1

The study (the Tuskegee Study of Untreated Syphilis in the Male Negro 2) did not end until 1972, forty years after it had begun, and twenty years after penicillin had been identified as an effective treatment for syphilis. The *New York Times* headline exposing the experiment read, "Syphilis victims in U.S. study went untreated for 40 years." 3 The article revealed the details of the study and called it "the longest nontherapeutic experiment on human beings in medical history." According to the Report of the Tuskegee Syphilis Study Legacy Committee, "In the almost 25 years since its disclosure, the Study has moved from a singular historical event to a powerful metaphor. It has come to symbolize racism in medicine, ethical misconduct in human research, paternalism by physicians, and government abuse of vulnerable people." 4

According to President Clinton, "The legacy of the study at Tuskegee has reached far and deep, in ways that hurt our progress and divide our nation. We cannot be one America when a whole segment of our nation has no trust in America. An apology is the first step, and we take it with a commitment to rebuild that broken trust. We can begin by making sure there is never again another episode like this one. We need to do more to ensure that medical research practices are sound and ethical, and that researchers work more closely with communities." 5

In his remarks, the President promised that several steps would be taken to assure that such research tragedies would not happen again. The plan, laid out by the President, contained five elements and was designed to begin the process of restoring the public trust that had been severely damaged, particularly in the African American community. The first step was to award a planning grant to Tuskegee University so that the University could establish a Center for Bioethics in Research and Health Care. This Center will serve as a museum of the Tuskegee Syphilis Study and support the University's efforts to strengthen bioethics training. The second element was to increase community involvement in research, so that the lost trust of some segments of society could begin to be restored. A third element of the plan was to strengthen researchers' training in bioethics to help increase their understanding of the core ethical principles of respect for individuals, beneficence, and justice, as set forth in the Belmont Report. 6 Fourth, a commitment was made to provide post-graduate fellowships to train more bioethicists, especially among African Americans and other minority groups. Finally, by executive order, the President extended the charter of the National Bioethics Advisory Commission to October of 1999. 7

Following the apology, the Department of Health and Human Services charged several of its agencies with implementing the President's plan. In support of the first two elements, funds have been awarded to Tuskegee University for the establishment of a Center for Bioethics, and several meetings have been held to explore how communities, especially minority communities, can be involved in the planning and implementation of research. In response to the third and fourth elements, interagency Program Announcements soliciting research and training grant applications have been developed, issued, and are ongoing. They are designed to: support research to examine ethical issues surrounding research involving human participants; 8 provide training opportunities in the form of mentored scientist awards in research ethics; 9 and develop short term courses in research ethics. 10

Although regulatory safeguards for protecting research participants have improved significantly in recent years, 11 historical cases such as the Tuskegee Syphilis Study stand as examples of the potential for ethical problems in research involving human participants, and of the need for vigilance in protecting the rights and welfare of these individuals. Contemporary safeguards such as requirements that federally funded research protocols be submitted to an institutional review board (IRB) are important, but by themselves are insufficient. Educating researchers and the public about research ethics is critical for the full protection of research participants.

To facilitate the identification and dissemination of materials to support the education of researchers on the ethics of research involving human participants, an interagency working group (the Bioethics Education Materials and Resources Subcommittee) was established. It included representatives from five Department of Health and Human Services (DHHS) agencies. The agencies co-leading this effort, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) were joined by the Food and Drug Administration (FDA), Health Resources Services Administration (HRSA), and Substance Abuse and Mental Health Services Administration (SAMHSA). This working group was charged with identifying existing bioethics educational materials and resources and making these materials more accessible to the entire research and research training community. In addition, the working group was asked to identify gaps in these resources and make recommendations about how to fill them.

In response to this charge, the members of the Bioethics Education Materials and Resources Subcommittee have identified and drawn together this extensive bibliography of books, audiovisuals, and journal article citations. The focus of these materials is the inclusion and protection of human participants from diverse populations in biomedical research, and not on other areas of research ethics and scientific integrity. It provides information about topics critical to understanding ethical issues surrounding research involving human participants and provides resources to support the further integration of these topics into research and research training settings. These materials have been compiled and are now available in this two-part publication which will be disseminated to all DHHS-funded research and training sites. To ensure that this document is widely accessible, it is available on the Internet at the National Library of Medicine at: http://www.nlm.nih.gov/pubs/cbm/hum_exp.html.

The first part of this publication is a citation bibliography, consisting of more than 4000 journal and book entries on topics relevant to the involvement and protection of human participants in research. The first section provides a comprehensive overview of this topic. Next is a section on historical perspectives on research ethics, which includes references to some of the most striking lapses in research ethics (e.g. the Tuskegee Syphilis Study, the Willowbrook experiment, the human radiation experiments, etc.). This section also includes a number of citations regarding the egregious Nazi "experiments," the subsequent Nuremberg Trial, the resulting Nuremberg Code, and their role in the development of protections for research participants. This is followed by sections on the fundamental research ethics topics of informed consent, including community consent, privacy and confidentiality, and clinical trials. Next, the bibliography focuses on selected populations that may be recruited for research, including: women; minorities; children; the elderly; the cognitively impaired (including those who have mental disorders and whose capacity to consent may be diminished or questionable); prisoners; military personnel; newly deceased individuals; and researchers involved in self-experimentation. The final section focuses on special research topics, including: genetics research; research on gametes, embryos, and fetuses; cloning; research involving human biological materials (including fetal tissue research); xenotransplantation; AIDS/HIV research; cancer research; emergency, acute and critical care research; drug and device development; and finally, institutional review boards and ethics committees.

The second part of this publication provides bibliographic and other information and resources that can be used to enhance bioethics education in research and other settings. It includes over 500 journal and book citations on bioethics education, case study citations that may be useful for discussion in educational settings, and a list of audiovisual materials. It also includes a list of bioethics journals and bioethics databases, as well as relevant government and non-government documents on laws, regulations and guidelines for research.

The journal article citations selected for this bibliography were published between 1989 and 1998 in English-language journals from around the world, in the fields of biomedicine, ethics and history. Also included, especially in the History section, are some earlier references considered to be seminal articles in the field. Books published and audiovisuals produced in English in the last 10 years were selected from the National Library of Medicine catalog (LocatorPlus). Some earlier, particularly significant, books are cited as well. Journal articles and books listed in the Source Materials sections may also be listed under another subject. Materials citing both Women and Minorities as keywords are listed under both subject headings. All other citations are listed under only one topic. Thus, if the subject of interest is, for example, HIV research involving women, it would be useful to look both in the AIDS/HIV Research section and the section on Women. Items included in the bibliography were selected solely on the basis of relevance to the subject.

The documents cited in this bibliography provide a rich source of history as well as practical guidance for those who are involved in teaching and mentoring research trainees. They may also be of use to those who are planning or conducting research. It is our hope that this bibliography will be useful to researchers throughout the global community and to all individuals interested in teaching or learning about the ethical conduct of research.

Members of the working group would especially like to acknowledge the leadership of Ms. Cynthia Love of the National Library of Medicine in developing this bibliography. We would also like to acknowledge the patience and support of the parent committee, the Tuskegee Follow-Up Steering Committee, especially its co-chairs Dr. Dixie E. Snider, Jr. (CDC) and Dr. Wendy Baldwin (NIH).

The compilers of this bibliography would further like to express their gratitude to those who provided direct assistance in the production of this publication: Dr. Peggie Tillman, Ms. Twann Dailey, Ms. Karen Patrias, Mr. Adam Glazer and Ms. Jennie Hunt of the National Library of Medicine, and Ms. Susan Saylor and Ms. Leizle Talangbayan of the National Human Genome Research Institute.

To search this web document for a particular author or keyword, begin at the top of the document. Type **CTRL F** or use your browser's **EDIT-FIND** function, type in the last name of the author or the keyword you wish to locate, hit **ENTER**, and the first citation that you wish to find will be located. You can then hit **FIND AGAIN** to search the entire document for the author or keyword of interest. To begin a new search, you must first return to the begining of the document.

Any reproduction of this bibliography, in whole or in part, must include all credits. If you wish to cite this bibliography, the correct format is: Love, Cynthia B; Thomson, Elizabeth J.; Royal, Charmaine D., compilers. Ethical issues in research involving human participants [bibliography on the Internet]. Bethesda (MD): National Library of Medicine; 1999 April. (Current bibliographies in medicine; no. 99-3). 4621 citations from January 1989 through November 1998. Available from: http://www.nlm.nih.gov/pubs/resources.html

Bioethics Education Materials and Resources Subcommittee

Lead agencies and staff:
      - National Institutes of Health
      - Ms. Elizabeth Thomson, Subcommittee Chair, National Human Genome Research Institute
      - Ms. Cynthia Love, National Library of Medicine
      - Dr. Charmaine Royal, National Human Genome Research Institute; Howard University
      - Ms. Joy Boyer, National Human Genome Research Institute
      - Dr. Christine Grady, Department of Clinical Bioethics, Clinical Center
      - Dr. Ruth Fischbach, Office of the Director, NIH
      - Centers for Disease Control and Prevention
      - Dr. Steven Coughlin, National Center for Chronic Disease Prevention and Health Promotion
      - Dr. Andrew Dannenberg, Division of Applied Public Health Training

Participating agencies and staff:
      - Food and Drug Administration
      - Dr. Glen Drew, Office of Health Affairs
      - Dr. Stuart Nightingale, Office of Health Affairs
      - Health Resources Services Administration
      - Dr. Louis Mahoney, Center for Quality
      - Substance Abuse and Mental Health Services Administration
      - Dr. Dorita Sewell, Division of Extramural Activities, Policy, and Review

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**References**

1. Jones JH, Bad Blood: The Tuskegee Syphilis Experiment, new and expanded ed., New York: Free Press, 1993.

2. Vonderlehr RA, Clark T, Wenger OC, Heller JR Jr. Untreated syphilis in male Negro; comparative study of treated and untreated cases. Ven Dis Inform 1936 Sep;17(9):260-5. Also J Am Med Assoc 1936 Sep 12;107:856-60.

3. Heller J. Syphilis victims in U.S. study went untreated for 40 years. New York Times 1972 Jul 26;1, 8.

4. Report of the Tuskegee Syphilis Study Legacy Committee Final Report--May 20, 1996 [report on the Internet]. [place unknown]: The Committee; 1996 [cited 1999 April 29]. [8 p.]. Available from: http://www.med.virginia.edu/hs-library/historical/apology/report.html.

5. Remarks by President Clinton in apology for study done in Tuskegee [speech on the Internet]. Clinton WJ. Washington: The White House; 1997 May 16 [cited 1999 April 29]. [3 p.]. Available from: http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi://oma.eop.gov.us/1997/5/16/11.text.1.

6. The Belmont report: ethical principles and guidelines for the protections of human subjects. Bethesda (MD): U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; 1978. 8 p. Also available on the Internet from: http://www.nih.gov:80/grants/oprr/humansubjects/guidance/belmont.htm.

7. Executive Order 13046. Further Amendment To Executive Order 12975, Extension Of The National Bioethics Advisory Commission. [file on the Internet]. Washington: The White House. Office of the Press Secretary; 1997 May 16 [cited 1999 May 10]. [1 p.]. Available from: http://bioethics.gov/about/further.htm. Also available from: http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi://oma.eop.gov.us/1997/5/16/7.text.2

8. Research on ethical issues in human studies. PA [Program Announcement]-99-079 [announcement on the Internet]. Bethesda,(MD): National Institutes of Health; 1999 Mar 31 [cited 1999 April 29]. [15 p.] Available from: http://www.nih.gov/grants/guide/pa-files/PA-99-079.html.

9. Mentored scientist development award in research ethics. PA-99-050 [announcement on the Internet] Bethesda (MD): National Institutes of Health; 1999 Jan 22 [cited 1999 April 29]. [10 p.]. Available from: http://www.nih.gov/grants/guide/pa-files/PA-99-050.html.

10. Short-term courses in research ethics. PA-99-051 [announcement on the Internet]. Bethesda (MD): National Institutes of Health; 1999 Jan 22 [cited 1999 April 29]. [6 p.]. Available from: http://www.nih.gov/grants/guide/pa-files/PA-99-051.html.

11. Protection of Human Subjects-Title 45 Code of Federal Regulations Part 46, Revised June 18, 1991. Available from: http://www.nih.gov:80/grants/oprr/humansubjects/45cfr46.htm.
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**Sample Citations**

Citations are formatted according to the rules established for *Index Medicus* ®. Sample journal and monograph citations appear below. For journal articles written in a foreign language, the English translation of the title is placed in brackets; for monographs, the title is given in the original language. In both cases the language of publication is shown by a three letter abbreviation appearing at the end of the citation.

**Journal Article:**

*Example:*Appelbaum PS. Examining the ethics of human subjects research. Kennedy Inst Ethics J 1996 Sep;6(3):283-7.

*Order, with separating punctuation:*Authors. Article Title. Abbreviated Journal Title Date;Volume(Issue):Pages.

**Monograph:**

*Example:*McNeill PM. The ethics and politics of human experimentation. New York: Cambridge University Press; 1993. 315 p.

*Order, with separating punctuation:*Authors/Editors. Title. Place of Publication: Publisher; Date. Total No. of Pages.

For details of the formats used for references, see the following publication:Patrias, Karen. *National Library of Medicine recommended formats for bibliographic citation*. Bethesda (MD): The Library; 1991 Apr. Available from: NTIS, Springfield, VA; PB91-182030.
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## Overview of the ethics of research involving human participants - Journal Articles

Aarons D. Research ethics. West Indian Med J 1995 Dec;44(4):115-8.

Abbott A. European vote raises bioethics stakes [news]. Nature 1996 Jun 13;381(6583):545.

Ackerman TF. Balancing moral principles in federal regulations on human research. IRB Rev Hum Subj Res 1992;14(1):1-6.

Ackerman TF. An ethical framework for the practice of paying research subjects. IRB Rev Hum Subj Res 1989 Jul-Aug;11(4):1-4.

Alderson P. A national research ethics committee? Bull Med Ethics 1995 Apr;107:13-6.

Aldhous P. Medical research. UK ethics guidelines [news]. Nature 1991 Aug 29;352(6338):746.

Alecrim M das G. Ethics on malaria seroepidemiology. Rev Inst Med Trop Sao Paulo 1992 Apr;34 Suppl 9:S31-2.

Alhous P. Ethics and research: sex, hearts and brains; animal rights; genetic engineering [news]. Nature 1990 Jan 4;343(6253):8-9.

American Academy of Neurology Code of Professional Conduct. Neurology 1993 Jun;43(6):1257-60.

American Hospital Association. A patient's bill of rights [monograph on the Internet]. Chicago: The Association; c1992 [cited 1998 Sep 28]. [141 lines]. Available from: http://www.aha.org/resource/pbillofrights.html.

Anderson JR, Jameton A, Reitemeier PJ, Prentice E. The case of two devices: disclosure to subjects following Phase IV ("post-marketing") research. IRB Rev Hum Subj Res 1995 May-Jun;17(3):6-9.

Annas GJ. Experimentation and research. J Calif Alliance Ment Ill 1994;5(1):9-11.

Annas GJ. Questing for grails: duplicity, betrayal and self-deception in postmodern medical research. J Contemp Health Law Policy 1996 Spring;12(2):297-324.

Annas GJ. Will the real bioethics (commission) please stand up? Hastings Cent Rep 1994 Jan-Feb;24(1):19-21.

Annotated bibliography and appendices: international codes of ethics. Bull Pan Am Health Org 1990;24(4):582-629.

Appelbaum PS. Examining the ethics of human subjects research. Kennedy Inst Ethics J 1996 Sep;6(3):283-7.

Ashby D, Machin D. Stopping rules, interim analyses and data monitoring committees. Br J Cancer 1993 Dec;68(6):1047-50.

Baer N. New draft code for research involving humans proved a major challenge. CMAJ 1996 Aug 15;155(4):442-4.

Bailey RR. New Zealanders--why let this medical experiment proceed? [letter]. N Z Med J 1992 Jul 8;105(937):270.

Balk DE. Bereavement research using control groups: ethical obligations and questions. Death Stud 1995 Mar-Apr;19(2):123-38.

Bamberg M, Budwig N. Therapeutic misconceptions: when the voices of caring and research are misconstrued as the voice of curing. Ethics Behav 1992;2(3):165-84.

Beauchamp TL, Cook RR, Fayerweather WE, Raabe GK, Thar WE, Cowles SR, Spivey GH. Ethical guidelines for epidemiologists. J Clin Epidemiol 1990;44(1 Suppl):S151-S69.

Beauvais F. The politicizing of science: when protection of subjects' rights leads to a wrong. Subst Use Misuse 1997 Jan;32(1):77-82.

Bebeau MJ, Davis EL. Survey of ethical issues in dental research. J Dent Res 1996 Feb;75(2):845-55.

Bebeau MJ, Holt SC, American Association for Dental Research Ethics Committee. The role of the AADR in promoting research integrity: perspectives and consensus statements. J Dent Res 1996 Feb;75(2):856-60.

Beeson D. Nuance, complexity, and context: qualitative methods in genetic counseling research. J Genet Couns 1997 Mar;6(1):21-43.

Behi R, Nolan M. Ethical issues in research. Br J Nurs 1995 Jun 22-Jul 12;4(12):712-6.

Bell R. MRC [Medical Research Council] faces negligence claims over growth hormone victims [news]. Nature 1996 Apr 25;380(6576):661.

Benatar SR, Keet MP, Prozesky OW. Guidelines to ethics of medical research. S Afr Med J 1994 Feb;84(2):62.

Benrubi GI. Medical ethics: what we couldn't possibly learn at our mother's knee [editorial]. Obstet Gynecol Surv 1995 Mar;50(3):163-4.

Benster R, Pollock A, Pelerin M, Hall SM, Drury M. Ethics and multicentre research projects [letters]. BMJ 1992 Jun 27;304(6843):1696.

Bernard J. Bioethics and knowledge. Nouv Rev Fr Hematol 1990;32(6):377-85.

Bernard J. Ethics and haematology. Haematologia (Budap) 1991;24(4):221-7.

Bernat JL, Beresford HR, American Academy of Neurology. The American Academy of Neurology Code of Professional Conduct. Neurology 1993 Jun;43(6):1257-60.

Biesecker LG, DeRenzo EG. Internet solicitation of research subjects for genetics studies [letter]. Am J Hum Genet 1995 Nov;57(5):1255-6.

Bioethics panel [news]. Science 1996 Aug 2;273(5275):583.

Bjune G, Gedde-Dahl TW. Some problems related to risk-benefit assessments in clinical testing of new vaccines. IRB Rev Hum Subj Res 1993;15(1):1-5.

Black KJ, Hodge MH. Protecting subjects' identity in test-retest experiments. IRB Rev Hum Subj Res 1987 Mar-Apr;9(2):10-1.

Blanck PD, Bellack AS, Rosnow RL, Rotheram-Borus MJ, Schooler NR. Scientific rewards and conflicts of ethical choices in human subjects research. Am Psychol 1992 Jul;47(7):959-65.

Bleich JD. Utilization of scientific data obtained through immoral experimentation--survey of recent halakhic literature. Tradition J Orthodox Jew Thought 1991 Fall;26(1):65-79.

Blinded by science [editorial]. Lancet 1994 Mar 5;343(8897):553-4.

Blustein J. What bioethics needs to learn about families. Theor Med Bioeth 1998 Apr;19(2):101-15.

Bok S. The ethics of giving placebos. Sci Am 1974 Nov;231(5):17-23.

Botkin JR. Ethics and evidence [commentary]. J Clin Ethics 1992 Spring;3(1):63-4.

Bracken MB, Nicholas JA, O'Leary PF, Ragnarsson KT. Offering a celebrity experimental treatment [letter and response]. N Engl J Med 1993 Apr 22;328(16):1202-3.

Brett A, Grodin M. Ethical aspects of human experimentation in health services research. JAMA 1991 Apr 10;265(14):1854-7.

Brewer TF, Heymann SJ. Two-tiered health care: the root of ethical problems in recent clinical trials [editorial]. Int J Infect Dis 1998 Jan-Mar;2(3):123-6.

Brewin T, Thornton H, Bradley C, McPherson K, Gore SM, Silverman WA, Altman DG. Patients' preferences and randomised trials [letters and response]. Lancet 1996 Apr 20;347(9008):1118-9.

Brezinova V, Shaw AB. Ethical issues in randomised prevention trials [letters]. BMJ 1992 Mar 20;306(6880):790.

Brink PJ. Writing a research grant for AFNR ethical clearance. AARN News Lett 1992 Jul-Aug;48(7):36.

Bristol study continues to cause debate [news]. Bull Med Ethics 1995 May;108:3-5.

British Psychological Society. Ethical research in psychology: revised ethical principles for conducting research with human participants. Bull Med Ethics 1991 May;68:8-11.

Brodie DA, Stopani K. Experimental ethics in sports medicine research. Sports Med 1990 Mar;9(3):143-50.

Brody BA. Research ethics: international perspectives. Camb Q Healthc Ethics 1997 Fall;6(4):376-84.

Brody BA. When physicians go wrong. J Health Polit Policy Law 1995 Summer;20(2):503-9.

Browner WS. Ethics, statistics, and technology assessment: the use of a stopping rule and an independent policy and data monitoring board in a cohort study of perioperative cardiac morbidity. Clin Res 1991 Feb;39(1):7-12.

Buchanan RN. Problems related to the use of human subjects in clinical evaluation/responsibility for follow-up care. J Dent Educ 1991 Dec;55(12):797-801.

Bulger RE. Toward a statement of the principles underlying responsible conduct in biomedical research. Acad Med 1994 Feb;69(2):102-7.

Busch DB, Bryan GT, Easterling D, Leventhal H, Messing E M, Cummings KB. Follow-up: recontacting subjects in mutagen exposure monitoring studies [letter]. IRB Rev Hum Subj Res 1988 Sep-Oct;10(5):9-11.

Butler D. 'Bioethics needs better input from public' [news]. Nature 1997 Oct 23;389(6653):775.

Butler D. Europe plans convention on social impacts of biomedical technologies [news]. Nature 1994 Jul 7;370(6484):3.

Byk C. The European Convention on bioethics. J Med Ethics 1993 Mar;19(1):13-6. Comment in: J Med Ethics 1993 Mar;19(1):3-4.

Byk C. The European Convention on Bioethics. Med Law 1993;12(6-8):507-19.

Byk C. Medical and biological progress and the European Convention on Human Rights. Med Law 1992;11(3-4):187-219.

Canadian Medical Association. Code of Ethics of the Canadian Medical Association (approved by General Council, August 1996). CMAJ 1996 Oct 15;155(8):1176A-1176B. Comment in: Can Med Assoc J 1996 Oct 15;155(8):1063-5.

Capron AM. An egg takes flight: the once and future life of the National Bioethics Advisory Commission. Kennedy Inst Ethics J 1997 Mar;7(1):63-80.

Capron AM. Protection of research subjects: do special rules apply in epidemiology? Law Med Health Care 1991 Fall-Winter;19(3-4):184-90.

Carico JM, Harrison ER. Ethical considerations for nurses in biomedical research. J Neurosci Nurs 1990 Jun;22(3):160-3.

Carriero A, Spinazzi A, Bonomo L. Ethics and research. Eur Radiol 1996;6 Suppl 1:S11-5.

Cassidy V. Ethical responsibilities in nursing: research findings and issues. J Prof Nurs 1991 Mar-Apr;7(2):112-8.

Cattorini P, Mordacci R. The physician as caregiver and researcher. Thyroidology 1993 Dec;5(3):73-6.

Chalmers I. Ethics, clinical research, and clinical practice in obstetric anaesthesia [letter]. Lancet 1992 Feb 22;339(8791):498.

Chalmers I. What do I want from health research and researchers when I am a patient? BMJ 1995 May 20;310(6990):1315-8.

Chao TC. The three dimensions in medicine: science, art and ethics. Ann Acad Med Singapore 1995 Nov;24(6):919-20.

Charlton E. Ethical guidelines for pain research in humans. Committee on Ethical Issues of the International Association for the Study of Pain [editorial]. Pain 1995 Dec;63(3):277-8.

Chaudhary SK, Chaudhary K. Unethical experimental studies on humans [letter]. J Indian Med Assoc 1994 Jul;92(7):241-2.

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## Overview of the ethics of research involving human participants - Books

American Hospital Association. Directory of biomedical ethics organizations. Chicago: Hospital Ethics; 1989. 165 p.

Annas GJ. The rights of patients: the basic ACLU guide to patient rights. Carbondale (IL): Southern Illinois University Press; 1989.

Annas GJ. Standard of care: the law of American bioethics. New York: Oxford University Press; 1993. 291 p.

Annual Report of the National Council on Bioethics in Human Research, Jan 1990. Ottawa: NCBHR; 1990 Jan. 60 p.

Annual Report of the National Council on Bioethics in Human Research, Jan 1991. Ottawa: NCBHR; 1991 Jan. 53 p.

Arras J, Steinbock B. Ethical issues in modern medicine. 4th ed. Mountain View (CA): Mayfield Pub. Co; c1995. 681 p.

Bankowski Z, Bryant JH, Last JM, editors. Ethics and epidemiology: international guidelines: proceedings of the 25th Council for International Organization of Medical Sciences Conference; 1990 Nov 7-9; Geneva, Switzerland. Switzerland: CIOMS; 1991.

Bankowski Z, Levine RJ. Ethics and research on human subjects: international guidelines: proceedings of the 26th Council for International Organization of Medical Sciences Conference; 1992 Feb 5-7; Geneva, Switzerland. Switzerland: CIOMS; 1993. 63 p.

Beach D. The responsible conduct of research. New York: VCH Publishers; 1996. 161 p.

Beauchamp TL, Childress JF. Principles of biomedical ethics. 3rd ed. New York: Oxford University Press; 1989. 470 p.

Beauchamp TL, Childress JF. Principles of biomedical ethics. 4th ed. New York: Oxford University Press; 1994. 546 p.

Beauchamp TL, Walters L, editors. Contemporary issues in bioethics. 3rd ed. Belmont (CA): Wadsworth Pub. Co.; 1989. 655 p.

Beauchamp TL, Walters L, editors. Contemporary issues in bioethics. 4th ed. Belmont (CA): Wadsworth Pub. Co; c1994. 752 p.

Bebeau MJ, Pimple KD, Muskavitch KMT, Smith DH, Borden SL. Moral reasoning in scientific research: cases for teaching and assessment. Bloomington (IN): Indiana University-Bloomington, Poynter Center for the Study of Ethics and American Institutions; c1998. 100 p.

Beecher HK. Research and the individual; human studies. 1st ed. Boston: Little, Brown; c1970. 358 p.

Bernard C, Nassiry L, Knoppers BM. Legal aspects of research and clinical practice with human beings: selected Canadian legal bibliography, 1980-1992. Ottawa: National Council on Bioethics in Human Research; 1992. 35 p.

Bioethics and clinical practice: examining research outcomes and methods: a workshop sponsored by the National Center for Nursing Research. Bethesda (MD): National Institutes of Health, National Center for Nursing Research; 1990 Apr. 25 p.

Bioethics and human rights: final report and recommendations of the International Meeting on Bioethics and the Social Consequences of Biomedical Research, 1991 May 13-15, Moscow, USSR. Paris: UNESCO; 1992. 32 p.

Biomedical ethics in U.S. public policy. Washington: Congress of the United States, Office of Technology Assessment; 1993. 92 p. (Background paper).

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## Historical perspectives on research involving human participants - Journal Articles

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Ernst E. 50 years ago: the Nuremberg Doctors' Tribunal. Part 3: The failure of coming to terms with the past. Wien Med Wochenschr 1997;147(2):53-4.

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Weissmann G. Origins of the Pernkopf anatomy atlas [letter]. JAMA 1997 Apr 9;277(14):1122; discussion 1123-4.

Weissmann G, Cutler DS, Israel HA, Seidelman WE, Panush RS, Ebenbauer A, Schutz W. Origins of the Pernkopf Anatomy atlas. [letters and responses]. JAMA 1997 Apr 9;277(14):1122-4.

Weitzman M. The ethics of using Nazi medical data: a Jewish perspective. Second Opin 1990 Jul;14:27-38.

White BC. Ethical issues surrounding informed consent. Part I. A brief history and ethical foundations surrounding informed consent. Urol Nurs 1989 Jan-Mar;9(3):11-4.

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Whymant R. The Butchers of Harbin. Experimentation on POWs--Japan, World War II. Conn Med 1983 Mar;47(3):163-5.

Wikler D, Barondess J. Bioethics and anti-bioethics in light of Nazi medicine: what must we remember? Kennedy Inst Ethics J 1993 Mar;3(1):39-55.

Williamson F. Man against insect. 3. Walter Reed v yellow fever. Nurs Times 1974 Aug 1;70(31):1202-3.

Wilson W. Old ethics: new dilemmas. Ulster Med J 1982;51(1):23-34.

Yankauer A. The neglected lesson of the Tuskegee study [letter]. Am J Public Health 1998 Sep;88(9):1406.

Young EW. When critical illness interferes with informed consent. Prog Clin Biol Res 1989;299:235-9.

Zinn C. Australian orphans were used as guinea pigs [news]. BMJ 1997 Jun 21;314(7097):1783.

Ziporyn T. What the Nazis called 'medical research' haunts the scientific community to this day [news]. JAMA 1990 Feb 9;263(6):791.
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## Historical perspectives on research involving human participants - Books

A report on the use of radioactive materials in human subject research that involved residents of state-operated facilities within the Commonwealth of Massachusetts from 1943 through 1973. Boston: Massachusetts Department of Mental Retardation; 1994 Apr. 290+ p.

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Advisory Committee on Human Radiation Experiments. The human radiation experiments: final report of the Advisory Committee. New York: Oxford University Press; 1996. 620 p.

Advisory Committee on Human Radiation Experiments. Interim report of the Advisory Committee on Human Radiation Experiments: October 21, 1994. Washington: U.S. Government Printing Office; 1994.

Aly G, Chroust P, Pross C. Cleansing the fatherland: Nazi medicine and racial hygiene. Cooper B, translator. Baltimore: Johns Hopkins University Press; 1994. 295 p. Consists primarily of edited translations of articles which originally appeared in German in the journal: Beitrage zur nationalsozialistischen Gesundheits- und Sozialpolitik.

Annas GJ, Grodin MA, editors. The Nazi doctors and the Nuremberg Code: human rights in human experimentation. New York: Oxford University Press; 1992. 371 p.

Beecher H. Research and the individual: human studies. Boston: Little, Brown. 1970.

Caplan AL. When medicine went mad: bioethics and the Holocaust. Papers from a conference; 1989 May 17-19; University of Minnesota. Totowa (NJ): Humana Press; 1992. 359 p. (Contemporary issues in biomedicine, ethics, and society).

Cold War Era Human Subject Experimentation: Hearing Before the Legislation and National Security Subcomm. of the House Comm. on Government Operations, 103rd Cong., 2nd Sess. (1994 Sep 28) [microform]. Washington: U.S. Government Printing Office; 1994. 213 p.

Cole LA. Clouds of secrecy: the Army's germ warfare tests over populated areas. Totowa (NJ): Rowman and Littlefield; 1988. 188 p.

Committee of Inquiry into Allegations Concerning the Treatment of Cervical Cancer at National Women's Hospital (New Zealand). Report of the Cervical Cancer Inquiry (Cartwright report). Auckland: Government Printing Office; 1988 Jul. 288 p.

Coney S. The unfortunate experiment. New York: Penguin Books; 1988. 287 p.

Deichmann U. Biologists under Hitler. Cambridge (MA): Harvard University Press; 1996. 468 p.

Dell'Oro R, Viafora C. History of bioethics: international perspectives. San Francisco: International Scholars Publications; 1996. 313 p.

Department of Defense Mustard Gas Testing: Hearing (1993 Mar 10). Washington: U.S. Government Printing Office; 1993. 117 p.

Documents on origin and development of the Tuskegee syphilis study, 1973. 4 manuscript boxes (12 v.). Bethesda (MD): National Library of Medicine, History of Medicine Division.

Feldshuh D. Miss Evers' boys. New York: Dramatists Play Service; 1995. 101 p.

Final report of the Advisory Committee on Human Radiation Experiments. Supplemental vol. 1: Ancillary materials. Washington: U.S. Government Printing Office; 1995 Oct. 840 p.

Final report of the Advisory Committee on Human Radiation Experiments. Supplemental vol. 2: Sources and documentation, Supplemental vol. 2a: Sources and documentation -- Appendices. Washington: U.S. Government Printing Office; 1995 Oct.

Friedlander H. The origins of Nazi genocide: from euthanasia to the final solution. Chapel Hill: University of North Carolina Press; 1995. 421 p.

Gallagher HG, editor. By trust betrayed: patients, physicians, and the license to kill in the Third Reich. Rev. ed. Arlington (VA): Vandamere Press; 1995. 318 p.

Geiger HJ, Rush D. Dead reckoning: a critical review of the Department of Energy's epidemiologic research. Washington: Physicians for Social Responsibility, Physicians Task Force on the Health Risks of Nuclear Weapons Production; 1992. 96 p.

Geison GL. The private science of Louis Pasteur. Princeton (NJ): Princeton University Press; 1995. 378 p.

Glass JM. "Life unworthy of life": racial phobia and mass murder in Hitler's Germany. New York: Basic Books; 1997. 252 p.

Government-Sponsored Testing on Humans: Hearing (1994 Feb 3). Washington: U.S. Government Printing Office; 1994. 289 p.

Gray FD. The Tuskegee Syphilis Study: the real story and beyond. Montgomery (AL): Black Belt Press, c1998. 175 p.

Hamilton D. The monkey gland affair. London: Chatto & Windus; 1986. 155 p.

Harris SH. Factories of death: Japanese biological warfare 1932-45 and the American cover-up. New York: Routledge; 1994. 297 p.

Hoedeman P, translation from Dutch by Ralph de Rijke. Hitler or Hippocrates: medical experiments and euthanasia in the Third Reich. Sussex (England): Book Guild; 1991. 260 p.

Human Radiation and other Scientific Experiments: the Federal Government's Role: Hearing Before the Senate Committee on Governmental Affairs, 103rd Cong. 2nd Sess. (1994 Jan 25) [microform]. Washington: U.S. Government Printing Office; 1995. 176 p.

Human Radiation Experimentation, Ethics, and Gene Therapy: Hearing (1994 Feb 10). Washington: U.S. Government Printing Office; 1994. 145 p.

Human radiation experiments associated with the U.S. Department of Energy and its predecessors [microform]. Washington: Department of Energy, Assistant Secretary for Environment, Safety, and Health; 1995. 213 p.

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Hunt L, editor. Secret agenda: the United States government, Nazi scientists, and Project Paperclip, 1945 to 1990. 1st ed. New York: St. Martin's Press; 1991. 340 p.

International Auschwitz Committee. Nazi medicine: doctors, victims, and medicine in Auschwitz. New York: Howard Fertig; 1986. 227 p. Reproduced from an original copy in the YIVO Institute for Jewish Research Library.

Jones JH. Bad blood: the Tuskegee syphilis experiment. New and expanded ed. New York: Free Press; c1993. 297 p.

Jones S. Race, prejudice and health care: the lessons of the Tuskegee Syphilis Experiment, and Critical condition: African Americans in the health care system -- a dual conference report. Minneapolis (MN): Illusion Theater; 1992. 51 p.

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Lederer SM. Human experimentation and antivivisection in turn-of-the-century America [photocopy]. Ann Arbor (MI): U.M.I. Dissertation Information Service; 187. 268 p.

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Lindee MS. Suffering made real: American science and the survivors at Hiroshima. Chicago: University of Chicago Press; 1994. 287 p.

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McCullough LB. John Gregory and the invention of professional medical ethics and the profession of medicine. Boston: Kluwer Academic; c1998. 347 p. (Philosophy and medicine; 56).

Michalczyk JJ, editor. Medicine, ethics, and the Third Reich: historical and contemporary issues. Kansas City: Sheed & Ward; c1994. 258 p.

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Shelley L. Criminal experiments on human beings in Auschwitz and war research laboratories: twenty women prisoners' accounts. San Francisco: Mellen Research University Press; c1991. 402 p.

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The thyroid studies: a follow-up report on the use of radioactive materials in human subject research that involved residents of state-operated facilities within the Commonwealth of Massachusetts from 1943 through 1973. Boston: Massachusetts Department of Mental Retardation; 1994 Jun. 23 p.

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Weindling P. Health, race, and German politics between National Unification and Nazism, 1870-1945. New York: Cambridge University Press; 1989. 641 p.

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Wright S. Molecular politics: developing American and British regulatory policy for genetic engineering, 1972-1982. Chicago: University of Chicago Press; 1994. 591 p.
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## Informed consent - Journal Articles

Aaronson NK, Visser-Pol E, Leenhouts GH, Muller MJ, van der Schot AC, van Dam FS, Keus RB, Koning CC, ten Bokkel Huinink WW, van Dongen JA, Dubbelman R. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol 1996 Mar;14(3):984-96.

Abrams FR. Commentary on ACOG Committee Opinion #108, May 1992; ethical dimensions of informed consent. Womens Health Issues 1993 Spring;3(1):27-8.

Adedeji OA. Informed consent in clinical trials. Raise public awareness... [letter]. BMJ 1993 Dec 4;307(6917):1495-6. Comment on: BMJ 1993 Nov 6;307(6913):1199-201.

Agencies look to improve informed consent [news]. Science 1996 Aug 2;273(5275):567.

Alderson P. Nursing ethics. Consent to research: the role of the nurse. Nurs Stand 1995 May 31-Jun 6;9(36):28-31.

American Public Health Association. Worker notification and institutional review for privately funded research in occupational health and safety. [Policy statement 9503]. Am J Public Health 1996 Mar;86(3):432-3.

American Society of Human Genetics. ASHG report: statement on informed consent for genetic research. Am J Hum Genet 1996 Aug;59(2):471-4.

Ana JN. Informed consent in medical research. South African study raises the ghosts of Nuremberg and apartheid [letter]. BMJ 1997 May 17;314(7092):1479-80. Comment on: BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4.

Anderson WF. Big changes at the RAC [editorial]. Hum Gene Ther 1994 Nov;5(11):1309-10.

Andrews LB. Genetics and informed consent [letter]. Science 1996 Mar 8;271(5254):1346-7. Comment on: Science 1996 Jan 26;271(5248):440. Comment in: Science 1996 May 31;272(5266):1248-9.

Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Cent Rep 1987 Apr;17(2):20-4.

Ashcroft R, Toth B. Informed consent. Research suffers if patients suspect that their rights may be breached [letter]. BMJ 1997 Jul 26;315(7102):252. Comment on: BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7; BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4.

Bagley G. Informed consent: the FDA's perspective. Food Drug Law J 1993;48(2):181-6.

Bang O. EC proposal for directive can destroy the possibilities of cancer research. Eur J Cancer 1992;28A(6-7):1012-3.

Barer D. Informed consent. Respect for autonomy may conflict with principle of beneficence [letter]. BMJ 1997 Jul 26;315(7102):254. Comment on: BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7; BMJ 1997 Apr 12;314(7087):1107-11.

Barker EM. Informed consent in medical research: the ethics committee's view [letter]. BMJ 1998 Jan 31;316(7128):392-3.

Bartolo [pseud]. Tales of informed consent: four years on an institutional review board. Health Matrix 1992 Summer;2(2):193-245.

Baum M. Clinical trials--a brave new partnership: a response to Mrs. Thornton. J Med Ethics 1994 Mar;20(1):23-5.

Baum M. Informed consent in medical research. The whole population must be mobilised in the war against cancer [letter]. BMJ 1997 May 17;314(7092):1482. Comment on: BMJ 1997 Apr 12;314(7087):1107-11; BMJ 1997 Apr 12;314(7087):1111-4.

Baum M. Informed consent. Reactionary approach inhibits progress [letter]. BMJ 1994 Jan 22;308(6923):271.

Bebout RR, Becker DR, Drake RE. A research induction group for clients entering a mental health research project: a replication study. Community Ment Health J 1998 Jun;34(3):289-95.

Belizan JM, Carroli G. Eclampsia studies in developing countries [letter]. Lancet 1998 Sep 26;352(9133):1067.

Benatar D, Benatar SR. Informed consent and research. BMJ 1998 Mar 28;316(7136):1008.

Benatar SR. Informed consent in Africa [editorial]. S Afr Med J 1992 May 16;81(10):489-90.

Benoit G, Spira A, Nicoulet I, Moukarzel M. Presumed consent law: results of its application/outcome from an epidemiologic survey. Transplant Proc 1990 Apr;22(2):320-2.

Bergmann JF, Chassany O, Gandiol J, Deblois P, Kanis JA, Segrestaa JM, Caulin C, Dahan R. A randomised clinical trial of the effect of informed consent on the analgesic activity of placebo and naproxen in cancer pain. Clin Trials Metaanal 1994 Apr;29(1):41-7.

Bernhardt BA, Geller G, Strauss M, Helzlsouer KJ, Stefanek M, Wilcox PM, Holtzman NA. Toward a model informed consent process for BRCA1 testing: a qualitative assessment of women's attitudes. J Genet Couns 1997 Jun;6(2):207-22.

Berry DL, Dodd MJ, Hinds PS, Ferrell BR. Informed consent: process and clinical issues. Oncol Nurs Forum 1996 Apr;23(3):507-12.

Birley JL. Informed consent in clinical trials [letter]. Lancet 1991 Jun 1;337(8753):1353.

Bland M. Informed consent in medical research. Let readers judge for themselves [letter]. BMJ 1997 May 17;314(7092):1477-8. Comment on: BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7; BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4.

Blichert-Toft M, Mouridsen H, Andersen KW. Clinical trials. Semin Surg Oncol 1996 Jan-Feb;12(1):32-8.

Bok S. Informed consent in tests of patient reliability [editorial]. JAMA 1992 Feb 26;267(8):1118-9. Comment on: JAMA 1992 Feb 26;267(8):1106-8. Comment in: JAMA 1992 Aug 12;268(6):790-1; JAMA 1992 Nov 4;268(17):2373-4; discussion 2375-6.

Bok S. Shading the truth in seeking informed consent for research purposes. Kennedy Inst Ethics J 1995 Mar;5(1):1-17.

Bracken MB, Shepard MJ. Informed consent [letter]. J Neurosurg 1997 Aug;87(2):336.

Bratt DE. Informed consent in medical research. Doctors are arrogant to think they need to debate issue of patient consent [letter]. BMJ 1997 May 17;314(7092):1477. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

Breast cancer: research without consent [news]. J Med Ethics 1997 Dec;23(6):372.

Brent NJ. Legal issues in research: informed consent. J Neurosci Nurs 1990 Jun;22(3):189-91.

Brewin T. Informed consent. Blanket consent to trials would be a good idea [letter]. BMJ 1997 Jul 26;315(7102):253. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

Brodeur D. Considering experimentation and elusive truth: informed consent made difficult. Issues Crit Exam Contemp Ethical Issues Health Care 1992 Mar-Apr;7(2):1-8.

Bromhead HJ, Goodman NW. CONSORT statement on the reporting standards of clinical trials. Reporting of refusal of consent to take part in clinical trials is still poor [letter]. BMJ 1997 Apr 12;314(7087):1126-7. Comment on: BMJ 1996 Sep 7;313(7057):570-1.

Brushwood DB. Hospital's independent responsibility to obtain informed consent. Am J Hosp Pharm 1994 Sep 1;51(17):2176-8.

Butler DJ. Informed consent for videotaping [letter]. Acad Med 1996 Dec;71(12):1276-7. Comment on: Acad Med 1996 Jul;71(7):744-8.

Cacciatore G. Tailoring consent for innovative therapies. Am J Health Syst Pharm 1995 Mar 15;52(6):600-1.

Campbell H, Boyd KM, Surry SA. Informed consent. Journals should require routine reporting of consent rates [letter]. BMJ 1997 Jul 26;315(7102):247. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

Cardinal BJ, Martin JJ, Sachs ML. Readability of written informed consent forms used in exercise and sport psychology research. Res Q Exerc Sport 1996 Sep;67(3):360-2.

Castronovo FP Jr. An attempt to standardize the radiodiagnostic risk statement in an institutional review board consent form. Invest Radiol 1993 Jun;28(6):533-8.

Chanter DO. Informed consent in medical research. Risk of bias may be another reason not to seek consent [letter]. BMJ 1997 May 17;314(7092):1478. Comment on: BMJ 1997 Apr 12;314(7087):1107-11.

Clarke H. Nursing research and patients' rights. Nurs BC 1992 Jul-Aug;24(4):19-20.

Cocking D, Oakley J. Medical experimentation, informed consent and using people. Bioethics 1994 Oct;8(4):293-311.

Counsell CE, Sandercock PA. Informed consent in medical research. Failure to publish completed randomised controlled trials is unethical in itself [letter]. BMJ 1997 May 17;314(7092):1481. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

Cowell HR. Ethics of medical authorship [editorial]. J Bone Joint Surg Am 1998 Feb;80(2):151-3. Comment on: J Bone Joint Surg Am 1998 Feb;80(2):198-206.

Cox C, Macpherson CNL. Modified informed consent in a viral seroprevalence study in the Caribbean. Bioethics 1996 Jul;10(3):222-32.

Cox NH, Wells F. Informed consent to postmarketing research [letters]. BMJ 1995 Sep 9;311(7006):692.

Culliton BJ. Illuminating informed consent [editorial]. Nat Med 1995 Nov;1(11):1099.

Dal-Re R. Elements of informed consent in clinical research with drugs: a survey of Spanish clinical investigators. J Intern Med 1992 Apr;231(4):375-9.

Dal-Re R. Informed consent in clinical research with drugs in Spain: perspective of clinical trials committee members. Eur J Clin Pharmacol 1990;38(4):319-24.

Daly MB. Informed consent. Research studies in diving medicine are considered by Ministry of Defence research ethics committee [letter]. BMJ 1997 Jul 26;315(7102):248. Comment on: BMJ 1997 May 17;314(7092):1481.

Daniels RW. For nonscientists and subjects, consent forms are too technical [letter]. IRB Rev Hum Subj Res 1990;12(4):7.

Daugherty CK, Ratain MJ, Minami H, Banik DM, Vogelzang NJ, Stadler WM, Siegler M. Study of cohort-specific consent and patient control in phase I cancer trials. J Clin Oncol 1998 Jul;16(7):2305-12.

Daugherty CK, Ratain MJ, Siegler M. Pushing the envelope: informed consent in phase I trials [editorial]. Ann Oncol 1995 Apr;6(4):321-3. Comment on: Ann Oncol 1995 Apr;6(4):363-9.

Daugherty CK, Siegler M, Ratain MJ, Zimmer G. Learning from our patients: one participant's impact on clinical trial research and informed consent. Ann Intern Med 1997 Jun 1;126(11):892-7.

Davis AJ. Informed consent process in research protocols: dilemmas for clinical nurses. West J Nurs Res 1989 Aug;11(4):448-57.

Davis TC, Holcombe RF, Berkel HJ, Pramanik S, Divers SG. Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst 1998 May 6;90(9):668-74. Comment in: J Natl Cancer Inst 1998 May 6;90(9):644-5.

DeCherney GS. Actionable medical ethics: informed consent (Part II--Research subjects). Del Med J 1993 Nov;65(11):727-9.

DeLuca SA, Korcuska LA, Oberstar BH, Rosenthal ML, Welsh PA, Topol EJ. Are we promoting true informed consent in cardiovascular clinical trials? J Cardiovasc Nurs 1995 Apr;9(3):54-61.

Dicker BG, Kent DL. Physician consent and researchers' access to patients. Epidemiology 1990 Mar;1(2):160-3.

Douglas S, Briones J, Chronister C. The incidence of reporting consent rates in nursing research articles. Image J Nurs Sch 1994 Spring;26(1):35-40.

Dowd SB, Wilson B. Informed patient consent: a historical perspective. Radiol Technol 1995 Nov-Dec;67(2):119-24.

Doyal L. Informed consent -- a response to recent correspondence. BMJ 1998 Mar 28;316(7136):1000-1.

Doyal L. Informed consent in medical research. Journals should not publish research to which patients have not given fully informed consent--with three exceptions. BMJ 1997 Apr 12;314(7087):1107-11. Comment in: BMJ 1997 Apr 12;314(7087):1059-60; BMJ 1997 May 17;314(7092):1477; BMJ 1997 May 17;314(7092);1478; BMJ 1997 May 17;314(7092):1480; BMJ 1997 May 17;314(7092);1480-1; BMJ 1997 May 17;314(7092):1481; BMJ 1997 May 17;314(7092):1482; BMJ 1997 Jul 26;315(7102):247; BMJ 1997 Jul 26;315(7102):248; BMJ 1997 Jul 26;315(7102):250; BMJ 1997 Jul 26;315(7102):253; BMJ 1997 Jul 26;315(7102):254

Doyal L, Tobias JS, Warnock M, Power L, Goodare H. Informed consent in medical research. BMJ 1998 Mar 28;316(7136):1000-5. Comment in: BMJ 1998 Mar 28;316(7136):949-51.

Dudley HA. Informed consent--issues for the 1990s. Br J Urol 1991 Dec;68(6):561-4.

Edmond MB, Wenzel RP. Ethical considerations in the use of subliminal stimulation to improve handwashing compliance: scientific utility versus autonomy of the individual. Infect Control Hosp Epidemiol 1993 Feb;14(2):107-9.

Elbourne D, Snowdon C, Garcia J. Informed consent. Subjects may not understand concept of clinical trials [letter]. BMJ 1997 Jul 26;315(7102):248-9. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

Ellenberg SS. Informed consent: protection or obstacle? Some emerging issues. Control Clin Trials 1997 Dec;18(6):628-36; discussion 661-6.

Ellenberg SS. Randomized consent designs for clinical trials: an update [letter]. Stat Med 1992 Jan 15;11(1):131-2. Comment on: Stat Med 1990 Jun;9(6):645-56.

Emberton M, Wood C, Meredith P. Informed consent in clinical trials. Should be comprehensive...[letter]. BMJ 1993 Dec 4;307(6917):1494. Comment on: BMJ 1993 Nov 6;307(6913):1199-201.

Emberton M, Wood C, Meredith P, Gerlis L, Wong JG, Walsworth-Bell JP, Modi N, Adedeji OA, Thornton H, Chinnery P, Asimakopoulos G, Kenny RA, McIntosh N, Keatinge R, Kanis JA, Bergmann JF. Informed consent in clinical trials [letters]. BMJ 1993 Dec 4;307(6917):1494-7.

Epstein K, Sloat B. Informed consent. Informed consent is not always obtained in United States [letter]. BMJ 1997 Jul 26;315(7102):249. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

Ethical dimensions of informed consent ACOG Committee Opinion: Committee on Ethics Number 108--May 1992. Int J Gynaecol Obstet 1992 Dec;39(4):346-55.

Euretig JG. Legal and ethical aspects of deliberate G-induced loss of consciousness experiments. Aviat Space Environ Med 1991 Jul;62(7):628-31.

Faden R. Informed consent and clinical research. Kennedy Inst Ethics J 1996 Dec;6(4):356-9.

Finkel MJ. Should informed consent include information on how research is funded? IRB Rev Hum Subj Res 1991;13(5):1-3.

Flegel KM. Physicians, finder's fees and free, informed consent [editorial]. CMAJ 1997 Nov 15;157(10):1373-4.

Fligner DJ, Spivey WH, Runge JW. Informed consent and the regulation of research (SAEM position paper). Acad Emerg Med 1994 Nov-Dec;1(6):561-2.

Food and Drug Administration (US). Informed consent for human drugs and biologics; determination that informed consent is not feasible; interim rule and opportunity for public comment. Fed Regist 1990 Dec 21;55(246):52814-7.

Food and Drug Administration (US). Protection of human subjects; informed consent; proposed rule. Fed Regist 1995 Sep 21;60(183):49086-103.

Foster C. Commentary: ethics of clinical research without patients' consent. BMJ 1996 Mar 30;312(7034):817.

Freedman B. Cohort-specific consent: an honest approach to phase 1 clinical cancer studies. IRB Rev Hum Subj Res 1990 Jan-Feb;12(1):5-7.

Freeman JM, Weil W, Berris RF, Veatch RM. Abandoning informed consent? [letters and response]. Hastings Cent Rep 1996 Jan-Feb;26(1):2-4.

Friedlander WJ. The evolution of informed consent in American medicine. Perspect Biol Med 1995 Spring;38(3):498-510.

Fumes from the spleen [letter]. Paediatr Perinat Epidemiol 1998 Jan;12(1):2-4.

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Thar WE. The epidemiologist's responsibilities to research subjects in the occupational setting. J Clin Epidemiol 1991;44 Suppl 1:91-4S.

Thong YH, Harth SC. The social filter effect of informed consent in clinical research. Pediatrics 1991 Apr;87(4):568-9.

Thornton H. Clinical trials--a brave new partnership? J Med Ethics 1994 Mar;20(1):19-22; discussion 23-5. Comment in: J Med Ethics 1994 Mar;20(1):3-4.

Thornton H. Informed consent in medical research. We all have a responsibility to contribute to research [letter]. BMJ 1997 May 17;314(7092):1479. Comment on: BMJ 1997 Apr 12;314(7087):1111-4.

Thornton H. Understanding informed consent. Lancet 1995 Oct 21;346(8982):1047-8. Comment on: Lancet 1995 Oct 21;346(8982):1060-4.

Tindall B, Forde S, Ross MW, Goldstein D, Barker S, Cooper DA. Effects of two formats of informed consent on knowledge amongst persons with advanced HIV disease in a clinical trial of didanosine. Patient Educ Couns 1994 Dec;24(3):261-6.

Titus SL, Keane MA. Do you understand?: an ethical assessment of researchers' description of the consenting process. J Clin Ethics 1996 Spring;7(1):60-8.

Tobias JS. BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 1997 Apr 12;314(7087):1111-4. Comment in: BMJ 1997 Apr 12;314(7087):1059-60; BMJ 1997 May 17;314(7092):1477; BMJ 1997 May 17;314(7092);1479; BMJ 1997 May 17;314(7092):1480-1; BMJ 1997 May 17;314(7092);1481; BMJ 1997 May 17;314(7092);1482; BMJ 1997 Jul 26;315(7102):247; BMJ 1997 Jul 26;315(7102):253.

Tobias JS. Changing the BMJ's position on informed consent would be counterproductive. BMJ 1998 Mar 28;316(7136):1001-2.

Tobias JS, Houghton J. Is informed consent essential for all chemotherapy studies? [editorial]. Eur J Cancer 1994;30A(7):897-9.

Tognoni G, Geraci E. Approaches to informed consent. Control Clin Trials 1997 Dec;18(6):621-7; discussion 661-6.

Tomamichel M, Sessa C, Herzig S, de Jong J, Pagani O, Willems Y, Cavalli F. Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients. Ann Oncol 1995 Apr;6(4):363-9. Comment in: Ann Oncol 1995 Apr;6(4):321-3.

Tooley PJ. Informed consent: the law [letter]. Med Sci Law 1992 Jul;32(3):272. Comment on: Med Sci Law 1992 Jan;32(1):35-42.

Tregillus EV. Informed consent for trial of elective ventilation will not be forthcoming [letter]. BMJ 1995 Dec 2;311(7018):1502. Comment on: BMJ 1995 Oct 7;311(7010):950.

Tuthill KA. Human experimentation. Protecting patient autonomy through informed consent. J Leg Med 1997 Jun;18(2):221-50.

Vansweevelt T. Medical experimentation and informed consent [editorial]. Acta Clin Belg 1995;50(1):1-3.

Verdun-Jones S, Weisstub DN. Consent to human experimentation in Quebec: the application of the Civil Law principle of personal inviolability to protect special populations. Int J Law Psychiatry 1995 Spring;18(2):163-82.

Verheggen FW, Jonkers R, Kok G. Patients' perceptions on informed consent and the quality of information disclosure in clinical trials. Patient Educ Couns 1996 Nov;29(2):137-53.

Verheggen FW, van Wijmen FC. Myth and reality of informed consent in clinical trials. Med Law 1997;16(1):53-69.

Vollmann J, Helmchen H. Publishing information about patients. Obtaining consent to publication may be unethical in some cases [letter]. BMJ 1996 Mar 2;312(7030):578.

Voluntary consent goes down [editorial]. Lancet 1996 Nov 16;348(9038):1323. Comment in: Lancet 1997 Feb 8;349(9049):436-7.

Wager E, Tooley PJ, Emanuel MB, Wood SF. How to do it. Get patients' consent to enter clinical trials. BMJ 1995 Sep 16;311(7007):734-7. Comments in: BMJ 1996 Jan 20;312(7024):185-6; BMJ 1996 Jan 20;312(7024):186; BMJ 1996 Mar 30;312(7034):847.

Wager E, Tooley PJH, Emanuel MB, Wood SF. Get patients' consent to enter clinical trials. BMJ 1995 Sep 16;311(7007):734-37.

Waggoner WC, Mayo DM. Who understands? A survey of 25 words or phrases commonly used in proposed clinical research consent forms. IRB Rev Hum Subj Res 1995 Jan-Feb;17(1):6-9.

Waggoner WC, Sherman BB. Who understands? II: a survey of 27 words, phrases, or symbols used in proposed clinical research consent forms. IRB Rev Hum Subj Res 1996;18(3):8-10.

Warnock M. Informed consent -- a publisher's duty. BMJ 1998 Mar 28;316(7136):1002-3.

Watson R, Wilson P. Informed consent. Rigorous studies are needed to determine values of interventions [letter]. BMJ 1997 Jul 26;315(7102):250-1. Comment on: BMJ 1997 Apr 12;314(7087):1059-60; BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7.

Weiss AH. Asking about asking: informed consent in organ donation research. IRB Rev Hum Subj Res 1996;18(1):6-10.

Wendler D. Deception in medical and behavioral research: is it ever acceptable? Milbank Q 1996;74(1):87-114.

Wenger NS, Shapiro MF. Consent and discontent. CMAJ 1997 Dec 15;157(12):1691-2.

Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns 1997 Mar;30(3):239-45.

White LJ, Jones JS, Felton CW, Pool LC. Informed consent for medical research: common discrepancies and readability. Acad Emerg Med 1996 Aug;3(8):745-50.

Whitney J. Notes on methodology. Participation of human subjects in studies. J Wound Ostomy Continence Nurs 1997 May;24(3):165. Comment on: J Wound Ostomy Continence Nurs 1997 May;24(3):163-71.

Williams BF, French JK, White HD. Is our method of obtaining consent appropriate for randomised controlled trials in acute myocardial infarction? N Z Med J 1997 Aug 8;110(1049):298-9.

Williams CJ, Zwitter M. Informed consent in European multicentre randomised clinical trials -- are patients really informed? Eur J Cancer 1994;30A(7):907-10.

Williamson C. Not gaining patients' consent in trials is deceitful [letter]. BMJ 1996 Jun 8;312(7044):1479. Comment on: BMJ 1996 Feb 24;312(7029):508-9; discussion 509-10. Comment in: BMJ 1996 Aug 10;313(7053):362-3.

Wilmshurst P. Informed consent in medical research. Subjects may be coerced into participating in studies [letter]. BMJ 1997 May 17;314(7092):1481. Comment on: BMJ 1997 Apr 12;314(7087):1059-60. Comment in: BMJ 1997 Jul 26;315(7102):248.

Wiltshire C. Informed consent in medical research. Communication with potential subjects needs to be effective [letter]. BMJ 1997 May 17;314(7092):1482. Comment on: BMJ 1997 Apr 12;314(7087):1107-11; BMJ 1997 Apr 12;314(7087):1111-4.

Winkens RA, Knottnerus JA, Kester AD, Grol RP, Pop P. Fitting a routine health-care activity into a randomized trial: an experiment possible without informed consent? J Clin Epidemiol 1997 Apr;50(4):435-9.

Wirshing DA, Wirshing WC, Marder SR, Liberman RP, Mintz J. Informed consent: assessment of comprehension. Am J Psychiatry 1998 Nov;155(11):1508-11.

Wise J. Patients do not read consent forms [news]. BMJ 1996 Dec 7;313(7070):1421.

Wollin DA, Avanzato J. Informed consent: a primer for health care practitioners. Med Health R I 1996 Apr;79(4):155-7.

Woodcock T, Norman J. Informed consent. Explicit guidance is required on valid exemptions for need for ethical review [letter]. BMJ 1997 Jul 26;315(7102):250. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

Young DR, Hooker DT, Freeberg FE. Informed consent documents: increasing comprehension by reducing reading level. IRB Rev Hum Subj Res 1990;12(3):1-5.

Zelen M. Randomised consent trials [letter]. Lancet 1992 Aug 8;340(8815):375. Comment on: Lancet 1992 Jun 27;339(8809):1574-5.

Zelen M. Randomized consent designs for clinical trials: an update. Stat Med 1990 Jun;9(6):645-56. Comment in: Stat Med 1992 Jan 15;11(1):131-2.
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## Informed consent - Books

Alderson P. Consent to health treatment and research: differing perspectives. London: University of London, Institute of Education, Social Science Research Unit, 1992. 56 p.

Brazier M. Protecting the vulnerable: autonomy and consent in health care. New York: Routledge; 1991. 183 p. (Social ethics and policy series).

Buchanan AE, Brock DW. Deciding for others: the ethics of surrogate decision making. New York: Cambridge University Press; 1989. 422 p. (Studies in philosophy and health policy).

Close B, editor. Volunteers in research and testing. Bristol (PA): Taylor & Francis; c1997. 198 p.

Faden RR, Beauchamp TL, King NMP. A history and theory of informed consent. New York: Oxford University Press; 1986. 392 p.

Hirsch SR, Harris J, editors. Consent and the incompetent patient: ethics, law, and medicine. Proceedings of a meeting held at the Royal Society of Medicine; 1986 Dec 9. London: Gaskell; 1988. 101 p. (Gaskell psychiatry series).

Palmer RN. Consent and confidentiality. London: Medical Protection Society; 1991. 26 p.

Rowland HF, Rowland AB. Hospital consents manual. Gaithersburg (MD): Aspen Publishers; 1992.

Rozovsky LE. The Canadian law of consent to treatment. 2nd ed. Toronto: Butterworths; c1997. 166 p.

Tomes JP. Informed consent: a guide for the healthcare professional. Chicago: Probus Pub. Co.; c1993. 164 p.

Van Oosten F, editor. The doctrine of informed consent in medical law. New York: P. Lang; c1991. 495 p. (Recht & Medizin; 23).

Wear S. Informed consent: patient autonomy and clinician beneficence within health care. 2nd ed. Washington: Georgetown University Press; 1998.

White BC. Competence to consent. Washington: Georgetown University Press; c1994. 209 p.
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## Community consent - Journal Articles

Abbott K, Blair F, Duncan S. Participatory research. Can Nurse 1993 Jan;89(1):25-7.

Abeliovich D, Quint A, Weinberg N, Verchezon G, Lerer I, Ekstein J, Rubinstein E. Cystic fibrosis heterozygote screening in the Orthodox Community of Ashkenazi Jews: the Dor Yesharim approach and heterozygote frequency. Eur J Hum Genet 1996;4(6):338-41.

Alderete E. The formulation of a health research agenda by and for indigenous peoples: contesting the Western scientific paradigm. J Altern Complement Med 1996 Fall;2(3):377-85.

Banner RO, DeCambra H, Enos R, Gotay C, Hammond OW, Hedlung N, Issell BF, Matsunaga DS, Tsark JA. A breast and cervical cancer project in a native Hawaiian community: Wai'anae cancer research project. Prev Med 1995 Sep;24(5):447-53.

Boston P, Jordan S, MacNamara E, Kozolanka K, Bobbish-Rondeau E, Iserhoff H, Mianscum S , Mianscum-Trapper R, Mistacheesick I, Petawabano B, Sheshamush-Masty M, Wapachee R, Weapenicappo J. Using participatory action research to understand the meanings aboriginal Canadians attribute to the rising incidence of diabetes. Chronic Dis Can 1997;18(1):5-12.

Burnett L, Proos AL, Chesher D, Howell VM, Longo L, Tedeschi V, Yang VA, Siafakas N, Turner G. The Tay-Sachs disease prevention program in Australia: Sydney pilot study. Med J Aust 1995 Sep 18;163(6):298-300.

Cadwell K, White E. Global participatory action research (GLOPAR) [letter]. J Hum Lact 1995 Dec;11(4):262.

Chen AM, Wismer BA, Lew R, Kang SH, Min K, Moskowitz JM, Tager IB. Health is strength: a research collaboration involving Korean Americans in Alameda County. Am J Prev Med 1997 Nov-Dec;13(6 Suppl):93-100.

Chesler MA. Participatory action research with self-help groups: an alternative paradigm for inquiry and action. Am J Community Psychol 1991 Oct;19(5):757-68.

Coggan C, Disley B, Patterson P. Community based intervention on adolescent risk taking: using research for community action. Inj Prev 1998 Mar;4(1):58-61.

Colen BD. Proceedings of the Workshop on Inherited Breast Cancer in Jewish Women: Ethical, Legal, and Social Implications. LawMed News 1996 Summer;2(1):1-4.

Corcega TF. Participatory research: getting the community involved in health development. Int Nurs Rev 1992 Nov-Dec;39(6):185-8.

Cornwall A, Jewkes R. What is participatory research? Soc Sci Med 1995 Dec;41(12):1667-76.

Dorff EN. Jewish theological and moral reflections on genetic screening: the case of BRCA1. Health Matrix 1997 Winter;7(1):65-96.

Drevdahl D. Coming to voice: the power of emancipatory community interventions. ANS Adv Nurs Sci 1995 Dec;18(2):13-24.

Enquselassie F, Nokes J, Cutts F. Ethics committees. Communities' confidentiality should be maintained and community consent sought [letter]. BMJ 1996 Jan 6;312(7022):54-5. Comment on: BMJ 1995 Sep 9;311(7006):639-40.

Foster MW, Bernsten D, Carter TH. A model agreement for genetic research in socially identifiable populations. Am J Hum Genet 1998 Sep;63(3):696-702.

Foster MW, Eisenbraun AJ, Carter TH. Communal discourse as a supplement to informed consent for genetic research. Nat Genet 1997 Nov;17(3):277-9.

Gallagher EM, Scott VJ. The STEPS Project: participatory action research to reduce falls in public places among seniors and persons with disabilities. Can J Public Health 1997 Mar-Apr;88(2):129-33.

Geller G, Bernhardt BA, Helzlsouer K, Holtzman NA, Stefanek M, Wilcox PM. Informed consent and BRCA1 testing [letter]. Nat Genet 1995 Dec;11(4):364.

Gibson RS, Yeudall F, Drost N, Mtitimuni B, Cullinan T. Dietary interventions to prevent zinc deficiency. Am J Clin Nutr 1998 Aug;68(2 Suppl):484S-487S.

Grams GD, Herbert C, Heffernan C, Calam B, Wilson MA, Grzybowski S, Brown D. Haida perspectives on living with non-insulin-dependent diabetes. CMAJ 1996 Dec 1;155(11):1563-8.

Green LW, O'Neill M, Westphal M, Morisky D. The challenges of participatory action research for health promotion [editorial]. Promot Educ 1996 Dec;3(4):3-5.

Hagey RS. The use and abuse of participatory action research [editorial]. Chronic Dis Can 1997;18(1):1-4.

Hamet P, Petrasovits A. How to translate science into community action. J Hum Hypertens 1996 Feb;10 Suppl 1:S89-92.

Hecker R. Participatory action research as a strategy for empowering aboriginal health workers. Aust N Z J Public Health 1997 Dec;21(7):784-8.

Henderson DJ. Consciousness raising in participatory research: method and methodology for emancipatory nursing inquiry. ANS Adv Nurs Sci 1995 Mar;17(3):58-69.

Herbert CP. Community-based research as a tool for empowerment: the Haida Gwaii Diabetes Project example. Can J Public Health 1996 Mar-Apr;87(2):109-12.

Juengst ET. Groups as gatekeepers to genomic research: conceptually confusing, morally hazardous, and practically useless. Kennedy Inst Ethics J 1998 June;8(2):183-200.

Kirkpatrick SM. Participatory nursing research. A promising methodology in Third World countries. West J Nurs Res 1990 Jun;12(3):282-92.

Kirkwood M, Simmons D, Weblemoe T, Voyle J, Richards D. Perceptions of diabetes among rural Maori elders and spokespersons. N Z Med J 1997 Nov 14;110(1055):415-7.

Labonte R, Robertson A. Delivering the goods, showing our stuff: the case for a constructivist paradigm for health promotion research and practice. Health Educ Q 1996 Nov;23(4):431-47.

Laurell AC, Noriega M, Martinez S, Villegas J. Participatory research on workers' health. Soc Sci Med 1992 Mar;34(6):603-13.

Lehrman S. Jewish leaders seek genetic guidelines...[news]. Nature 1997 Sep 25;389(6649):322.

Liberati A. Consumer participation in research and health care [editorial]. BMJ 1997 Aug 30;315(7107):499. Comment in: BMJ 1998 Jan 10;316(7125):148.

Lindsey E, Stajduhar K. From rhetoric to action: establishing community participation in AIDS-related research. Can J Nurs Res 1998 Spring;30(1):137-52.

Macaulay AC, Delormier T, McComber AM, Cross EJ, Potvin LP, Paradis G, Kirby RL, Saad-Haddad C, Desrosiers S. Participatory research with native community of Kahnawake creates innovative Code of Research Ethics. Can J Public Health 1998 Mar-Apr;89(2):105-8.

Macaulay AC, Paradis G, Potvin L, Cross EJ, Saad-Haddad C, McComber A, Desrosiers S, Kirby R, Montour LT , Lamping DL, Leduc N, Rivard M. The Kahnawake Schools Diabetes Prevention Project: intervention, evaluation, and baseline results of a diabetes primary prevention program with a native community in Canada. Prev Med 1997 Nov-Dec;26(6):779-90.

Macilwain C. Tribal groups attack ethics of genome diversity project [news]. Nature 1996 Sep 19;383(6597):208.

Macleod C. Research as intervention within community mental health. Curationis 1997 Jul;20(2):53-6.

Matsunaga DS, Enos R, Gotay CC, Banner RO, DeCambra H, Hammond OW, Hedlund N, Ilaban EK, Issell BF, Tsark JA. Participatory research in a Native Hawaiian community. The Wai'anae Cancer Research Project. Cancer 1996 Oct 1;78(7 Suppl):1582-6.

Nelson NJ. Ashkenazi community is not unwilling to participate in genetic research [news]. J Natl Cancer Inst 1998 Jun 17;90(12):884-5.

Nkozo-Mtembu LL. Participatory research in psychiatric nursing. Curationis 1996 Sep;19(3):57-9.

Oliver S. The progress of lay involvement in the NHS Research and Development Programme. J Eval Clin Pract 1996 Nov;2(4):273-80.

Piercy FP, Thomas V. Participatory evaluation research: an introduction for family therapists. J Marital Fam Ther 1998 Apr;24(2):165-76.

Rains JW, Ray DW. Participatory action research for community health promotion. Public Health Nurs 1995 Aug;12(4):256-61.

Richardson M. Participatory research methods: people with learning difficulties. Br J Nurs 1997 Oct 23-Nov 12;6(19):1114-21.

Robinson A. Transformative 'cultural shifts' in nursing: participatory action research and the 'project of possibility'. Nurs Inq 1995 Jun;2(2):65-74.

Rothenberg KH. Breast cancer, the genetic quick fix, and the Jewish community: ethical, legal, and social challenges. Health Matrix 1997 Winter;7(1):97-124.

Schell LM, Tarbell AM. A partnership study of PCBs and the health of Mohawk youth: lessons from our past and guidelines for our future. Environ Health Perspect 1998 Jun;106 Suppl 3:833-40.

Scott K, Receveur O. Ethics for working with communities of Indigenous Peoples. Can J Physiol Pharmacol 1995 Jun;73(6):751-3.

Seeley JA, Kengeya-Kayondo JF, Mulder DW. Community-based HIV/AIDS research--whither community participation? Unsolved problems in a research programme in rural Uganda. Soc Sci Med 1992 May;34(10):1089-95.

Seng JS. Praxis as a conceptual framework for participatory research in nursing. ANS Adv Nurs Sci 1998 Jun;20(4):37-48.

Setton GC, Garvican L, Wilson R. Informed consent. Ethical principles may need to be adapted when research subject is not an individual subject [letter]. BMJ 1997 Jul 26;315(7102):251.

Smith SE, Pyrch T, Lizardi AO. Participatory action-research for health. World Health Forum 1993;14(3):319-24.

Soltis-Jarrett V. The facilitator in participatory action research: les raisons d'etre. ANS Adv Nurs Sci 1997 Dec;20(2):45-54.

Sperber AD, Henkin Y, Shany S. Methodological issues in conducting a community-based clinical drug trial. Fam Pract Res J 1993 Dec;13(4):311-21.

Spiers HR. Community consultation and AIDS clinical trials: I. IRB Rev Hum Subj Res 1991 May-Jun;13(3):7-10.

Spiers HR. Community consultation and AIDS clinical trials: II. IRB Rev Hum Subj Res 1991 Jul-Aug;13(4):1-6.

Spiers HR. Community consultation and AIDS clinical trials: III. IRB Rev Hum Subj Res 1991 Sep-Oct;13(5):3-7.

Thompson JL. Exploring gender and culture with Khmer refugee women: reflections on participatory feminist research. ANS Adv Nurs Sci 1991 Mar;13(3):30-48.

Travers KD. Reducing inequities through participatory research and community empowerment. Health Educ Behav 1997 Jun;24(3):344-56.

Travers KD. The social organization of nutritional inequities. Soc Sci Med 1996 Aug;43(4):543-53.

Wadman M. 'Group debate' urged for gene studies [news]. Nature 1998 Jan 22;391(6665):314. Comment in: Nature 1998 Mar 5;392(6671):14; Nature 1998 Apr 16;392(6677):646.

Wadman M. Jewish leaders meet NIH chiefs on genetic stigmatization fears [news]. Nature 1998 Apr 30;392(6679):851.

Westphal MF, da Silva NN, Maciel MG. Participatory research as social mobilization for health. Promot Educ 1996 Dec;3(4):21-4.

Willms D, Bhatia R, Lowe J, Niemi F, Stewart D, Westmoreland-Traore J. Five conversations: reflections of stakeholders on the impact of the ethnocultural communities facing AIDS study. Can J Public Health 1996 May-Jun;87 Suppl 1:S44-8, S49-53.

Willms D, Singer SM, Adrien A, Godin G, Maticka-Tyndale E, Cappon P. Participatory aspects in the qualitative research design of phase II of the ethnocultural communities facing AIDS study. Can J Public Health 1996 May-Jun;87 Suppl 1:S15-25, S16-27.

Wismer BA, Moskowitz JM, Chen AM, Kang SH, Novotny TE, Min K, Lew R, Tager IB. Rates and independent correlates of Pap smear testing among Korean-American women. Am J Public Health 1998 Apr;88(4):656-60.
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## Community consent - Books

De Koning K, Martin M. Participatory research in health: issues and experiences. Johannesburg: Zed Books; 1996. 242 p.
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## Privacy and confidentiality - Journal Articles

American Psychiatric Association resource document on preserving patient confidentiality in the era of information technology. J Am Acad Psychiatry Law 1997;25(4):551-9.

American Public Health Association. Protecting confidential data in disease registries. [Policy statement 9515]. Am J Public Health 1996 Mar;86(3):443-4.

Andrews G, Wittchen HU. Clinical practice, measurement and information technology [editorial]. Psychol Med 1995 May;25(3):443-6.

Annas GJ. Genetic prophecy and genetic privacy--can we prevent the dream from becoming a nightmare? [editorial]. Am J Public Health 1995 Sep;85(9):1196-7. Comment on: Am J Public Health 1995 Sep;85(9):1280-4.

Annas GJ. A national bill of patients' rights. N Engl J Med 1998 Mar 5;338(10):695-9.

ASHG statement. Professional disclosure of familial genetic information. The American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure. Am J Hum Genet 1998 Feb;62(2):474-83.

Avins AL, Woods WJ, Lo B, Hulley SB. A novel use of the link-file system for longitudinal studies of HIV infection: a practical solution to an ethical dilemma. AIDS 1993 Jan;7(1):109-13.

Bain MR, Chalmers JW, Brewster DH. Routinely collected data in national and regional databases--an under-used resource. J Public Health Med 1997 Dec;19(4):413-8.

Bakker AR, Barber B, Pellikka RT. Overall observations, conclusions and recommendations. Int J Biomed Comput 1996 Oct;43(1-2):149-52.

Baram M. The laws of genetics. Environ Health Perspect 1997 May;105(5):488-91.

Barratt K. Reviewing gag clauses in managed care contracts. Wis Med J 1996 Apr;95(4):249-50.

Bellach B, Schon D. Legislation to protect individual confidentiality: the case of cancer registration in Germany. Sci Total Environ 1996 May 17;184(1-2):33-6.

Bentley-Cooper JE. Protecting human research from an invasion of privacy: the unintended results of the Commonwealth Privacy Act 1988. Aust J Public Health 1991 Sep;15(3):228-34.

Berry RM. The genetic revolution and the physician's duty of confidentiality. The role of the old Hippocratic virtues in the regulation of the new genetic intimacy. J Leg Med 1997 Dec;18(4):401-41.

Beto JA, Geraci MC, Marshall PA, Bansal VK. Pharmacy computer prescription databases: methodologic issues of access and confidentiality. Ann Pharmacother 1992 May;26(5):686-91.

Bharucha-Reid R, Schork MA, Schwartz SA. Data linkage and subject anonymity for HIV testing. AIDS Public Policy J 1990 Winter;5(4):189-90.

Birkett N. Confidentiality and research [letter]. CMAJ 1993 Feb 15;148(4):486-7.

Black B. Subpoenas and science--when lawyers force their way into the laboratory. N Engl J Med 1997 Mar 6;336(10):725-7. Comments in: N Engl J Med 1997 Jul 24;337(4):282-3; N Engl J Med 1997 Jul 24;337(4):283.

Black D. Access to records for epidemiological research [letter]. BMJ 1992 Apr 11;304(6832):987.

Black D. Personal health records [editorial]. J Med Ethics 1992 Mar;18(1):5-6.

Blandino DA. Adolescents and confidentiality. J Fam Pract 1998 Jan;46(1):15-6.

Botkin JR, McMahon WM, Smith KR, Nash JE. Privacy and confidentiality in the publication of pedigrees: a survey of investigators and biomedical journals. JAMA 1998 Jun 10;279(22):1808-12.

Bracken MB. Alarums false, alarums real: challenges and threats to the future of epidemiology. Ann Epidemiol 1998 Feb;8(2):79-82.

Brahams D. Who owns patients' data? [news]. Lancet 1990 Jan 6;335(8680):39-40.

Brase T. Privacy and medical-records research [letter]. N Engl J Med 1998 Apr 9;338(15):1076-7; discussion 1077-8. Comment on: N Engl J Med 1997 Nov 13;337(20):1466-70.

Brennan TA. Ethics of confidentiality: the special case of quality assurance research. Clin Res 1990 Oct;38(3):551-7.

Brenner H, Schmidtmann I, Stegmaier C. Effects of record linkage errors on registry-based follow-up studies. Stat Med 1997 Dec 15;16(23):2633-43.

Buchan H, Paul C. When important social interests compete with privacy. N Z Med J 1992 Dec 9;105(947):492-3.

Bullimore D. Publication of pictures of patient on BMJ's website was mistake [letter]. BMJ 1998 Mar 28;316(7136):1022.

Butler D. BSE researchers bemoan 'ministry secrecy' [news]. Nature 1996 Oct 10;383(6600):467-8.

Byers PH, Ashkenas J. Pedigrees-publish? or perish the thought? Am J Hum Genet 1998 Sep;63(3):678-81.

Chamberlayne R, Green B, Barer ML, Hertzman C, Lawrence WJ, Sheps SB. Creating a population-based linked health database: a new resource for health services research. Can J Public Health 1998 Jul-Aug;89(4):270-3.

Clarke EA, Darlington G, Holowaty EJ, Kreiger N, Marrett LD, McLaughlin J, Parkes R, Sloan M, Theis E. Confidentiality and research [letter]. CMAJ 1993 Sep 15;149(6):792-3.

Clarke J. Moral dilemmas in nursing research. Nurs Pract 1991;4(4):22-5.

Clough J. The Disability Discrimination Act 1995--an OHP challenge. Occup Health (Lond) 1997 Feb;49(2):62-3.

Cole D, Graf HP. Database consultation for phase I studies in Europe. Eur J Med 1993 Jun-Jul;2(6):358-62.

Coleman MP, Muir CS, Menegoz F. Confidentiality in the cancer registry. Br J Cancer 1992 Dec;66(6):1138-49.

Conference of Medical Royal Colleges and Their Faculties in the United Kingdom Audit Working Group. Access to medical records for the purposes of medical audit [statement]. BMJ 1993 Apr 3;306(6882):896-7.

Cooper JE. Balancing the scales of public interest: medical research and privacy. Med J Aust 1991 Oct 21;155(8):556-60.

Cuatrecasas P. Industry-university alliances in biomedical research. J Clin Pharmacol 1992 Feb;32(2):100-6.

Cushman R. Serious technology assessment for health care information technology. J Am Med Inform Assoc 1997 Jul-Aug;4(4):259-65.

Dahl R. The right to the research. Environ Health Perspect 1997 Dec;105(12):1306-8.

Dannenberg AL, Vernick JS, Kirk GD. AIDS and confidentiality: making exemptions to encourage research [letter]. JAMA 1993 Jan 6;269(1):47-8.

Davis T, King KM. Accessing patients, patient records, and patient databases: the confidentiality-access maze, Part I. Can J Cardiovasc Nurs 1997;8(2):35-8.

Detmer DE. Improving health and reducing costs through information technology. Acad Med 1998 Mar;73(3):286-7.

Detmer DE, Steen EB. The computer-based record: patient moving from concept toward reality. Int J Biomed Comput 1996 Jul;42(1-2):9-19.

Dierks C. Medical confidentiality and data protection as influenced by modern technology. Med Law 1993;12(6-8):547-51.

Donaldson MS, Lohr KN, Bulger RJ. From the Institute of Medicine. JAMA 1994 May 4;271(17):1308.

Donaldson MS, Lohr KN, Bulger RJ. From the Institute of Medicine. JAMA 1994 May 11;271(18):1392.

Dovey SM, Tilyard MW. The computer research network of the Royal New Zealand College of General Practitioners: an approach to general practice research in New Zealand. Br J Gen Pract 1996 Dec;46(413):749-52.

Doyal L. Data from patient records [letter]. Br Dent J 1995 Jun 24;178(12):448. Comment on: Br Dent J 1995 Apr 22;178(8):286.

Earley CL, Strong LC. Certificates of confidentiality: a valuable tool for protecting genetic data. Am J Hum Genet 1995 Sep;57(3):727-31. Comment in: Am J Hum Genet 1996 Feb;58(2):436-8.

Edouard L, Rawson NS. Use of personal records for research purposes. Identification numbers help maintain confidentiality [letter]. BMJ 1995 Jan 28;310(6974):257-8. Comment on: BMJ 1994 Nov 26;309(6966):1422-4.

Elwood JM. Scientific and ethical issues of computer-linked records [letter]. Int J Cancer 1996 Aug 7;67(4):586-7. Comment on: Int J Cancer 1995 May 16;61(4):485-90.

Emson HE. Guidelines on ethical and legal considerations in anonymous unlinked HIV seroprevalence research [letter]. CMAJ 1991 Dec 1;145(11):1418-9. Comment on: CMAJ 1991 Jun 15;144(12):1603-4.

Emson HE. Minimal breaches of confidentiality in health care research: a Canadian perspective. J Med Ethics 1994 Sep;20(3):165-8. Comment in: J Med Ethics 1995 Apr;21(2):117.

Erlen JA. The inadvertent breach of confidentiality. Orthop Nurs 1998 Mar-Apr;17(2):47-50.

Fisher CB, Higgins-D'Alessandro A, Rau JM, Kuther TL, Belanger S. Referring and reporting research participants at risk: views from urban adolescents. Child Dev 1996 Oct;67(5):2086-100.

Fitzgerald J, Hamilton M. The consequences of knowing: ethical and legal liabilities in illicit drug research. Soc Sci Med 1996 Dec;43(11):1591-600.

Fitzgerald JL, Hamilton M. Confidentiality, disseminated regulation and ethico-legal liabilities in research with hidden populations of illicit drug users. Addiction 1997 Sep;92(9):1099-107.

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Foster MW, Freeman WL. Naming names in human genetic variation research.[editorial]. Genome Res 1998 Aug;8(8):755-7.

Frisch SR, Fowler-Graham D, Shannon V, Dembeck P. Maintaining the anonymity of vulnerable subjects. Can J Nurs Res 1990 Winter;22(4):51-60.

Furnell SM, Sanders PW. Security management in the healthcare environment. Medinfo 1995;8 (Pt 1):675-8.

Gabbard GO. Case histories and confidentiality [letter]. Int J Psychoanal 1997 Aug;78 ( Pt 4):820-1. Published erratum appears in 1997 Oct;78(Pt 5):1020. Comment on: Int J Psychoanal 1997 Jun;78( Pt 3):435-8.

Gabriel SE. Threats to population-based research [editorial]. Curr Opin Rheumatol 1997 Mar;9(2):87-9. Comment on: Curr Opin Rheumatol 1997 Mar;9(2):90-4; Curr Opin Rheumatol 1997 Mar;9(2):95-101; Curr Opin Rheumatol 1997 Mar;9(2):102-5; Curr Opin Rheumatol 1997 Mar;9(2):106-11; Curr Opin Rheumatol 1997 Mar;9(2):118-25; Curr Opin Rheumatol 1997 Mar;9(2):126-32.

Galbraith RA, Sobel BE. Patient information and confidentiality: a compelling conundrum [editorial]. Coron Artery Dis 1997 Jan;8(1):59-60.

Garber JE, Patenaude AF. Ethical, social and counselling issues in hereditary cancer susceptibility. Cancer Surv 1995;25:381-97.

Genetic(al) correctness [editorial]. Nat Genet 1997 Dec;17(4):363-4.

Genetic testing and insurance. The Ad Hoc Committee on Genetic Testing/Insurance Issues. Am J Hum Genet 1995 Jan;56(1):327-31.

Goldberg A. Ethics and drugs. Ir J Med Sci 1990 Aug;159(8):242-3.

Goldberg A. Writing case histories [editorial]. Int J Psychoanal 1997 Jun;78(Pt 3):435-8. Comment in: Int J Psychoanal 1997 Aug;78( Pt 4):820-1.

Goodman KW. Critical care computing: outcomes, confidentiality, and appropriate use. Crit Care Clin 1996 Jan;12(1):109-22.

Goodman KW. Ethics, genomics, and information retrieval. Comput Biol Med 1996 May;26(3):223-9.

Goodman NW. Secrecy in research [letter]. N Engl J Med 1996 Jul 11;335(2):134-5; discussion 135-6. Comment on: N Engl J Med 1996 Feb 8;334(6):392-4.

Goodwin C. Personal privacy vs. public health. New Sci 1993 Dec 11;140(1903):25-7.

Gordis L. Ethical and professional issues in the changing practice of epidemiology. J Clin Epidemiol 1991;44 Suppl 1:9S-13S.

Gorelick DA. Subpoenas and science [letter]. N Engl J Med 1997 Jul 24;337(4):282-3. Comment on: N Engl J Med 1997 Mar 6;336(10):725-7.

Gostin LO, Lazzarini Z, Neslund VS, Osterholm MT. The public health information infrastructure. A national review of the law on health information privacy. JAMA 1996 Jun 26;275(24):1921-7.

Guenin LM. Confidentiality [letter]. Science 1996 Mar 29;271(5257):1790.

Haddow JE, Palomaki GE. Use of personal records for research purposes. Restrictions unnecessary and obstructive [letter]. BMJ 1995 Jan 28;310(6974):258. Comment on: BMJ 1994 Nov 26;309(6966):1422-4.

Hancock B. Research: your secrets are safe with us. Nurs Stand 1994 Aug 31-Sep 6;8(49):44-5.

Hawkins MM, Craft AW. Use of personal records for research purposes. Records prematurely destroyed [letter]. BMJ 1995 Jan 28;310(6974):258. Comment on: BMJ 1994 Nov 26;309(6966):1422-4.

Hertz-Picciotto I, Lee LW, Hoyo C. HIV test-seeking before and after the restriction of anonymous testing in North Carolina. Am J Public Health 1996 Oct;86(10):1446-50. Comment in: Am J Public Health 1998 Apr;88(4):683.

Hoge SK. Proposed federal legislation jeopardizes patient privacy. Bull Am Acad Psychiatry Law 1995;23(4):495-500.

Holder AR. Research records and subpoenas: a continuing issue. IRB Rev Hum Subj Res 1993 Jan-Feb;15(1):6-7.

Holder AR. Researchers and subpoenas: the troubling precedent of the Selikoff case. IRB Rev Hum Subj Res 1989 Nov-Dec;11(6):8-10.

Horner JS. Research, ethics and privacy: the limits of knowledge. Public Health 1998 Jul;112(4):217-20.

Human genome--any questions? Med Leg J 1991;59(Pt 1):41-9.

Independent ethical review of studies involving personal medical records. Report of a working group to the Royal College of Physicians Committee on Ethical Issues in Medicine. J R Coll Physicians Lond 1994 Sep-Oct;28(5):439-43. Comment in: J R Coll Physicians Lond 1995 Sep-Oct;29(5):446.

International Committee of Medical Journal Editors. Protection of patients' rights to privacy [guidelines]. BMJ 1995 Nov 11;311(7015):1272.

Isaacs P, Anand JK, Myles JW. Pictures in the "BMJ" [letters and editor's response]. BMJ 1993 Apr 17;306(6884):1067-8.

Iversen KR, Grotan TO. Socio-technical aspects of the use of health related personal information for management and research. Int J Biomed Comput 1996 Oct;43(1-2):83-91.

Iversen T. Health registries. Ethics and security. Acta Obstet Gynecol Scand 1996 Nov;75(10):875-6.

Jaillon P. Healthy volunteers data bank: where and how? Fundam Clin Pharmacol 1990;4(2 Suppl):177S-81S.

Jones TL, George T. Private matters. Will electronic medical records doom confidentiality? Tex Med 1996 May;92(5):46-50.

Kaiser J. Privacy rules set no new research curbs [news]. Science 1997 Sep 19;277(5333):1757.

Keppel S. Use of personal health information by third parties for research purposes. Auckland Univ Law Rev 1992 Aug;7(1):1-26.

Kern DG. Confidentiality agreements and scientific independence [letter]. Med Decis Making 1998 Apr-Jun;18(2):239.

King KM, Davis T. Accessing patients, patient records, and patient databases: the confidentiality-access maze. Part II. Can J Cardiovasc Nurs 1997;8(3):31-5.

Kottow MH. Confidentiality as fair agreement [letter]. J Med Ethics 1995 Apr;21(2):117. Comment on: J Med Ethics 1994 Sep;20(3):165-8.

Lane MJ. Privacy protection: implications for public health researchers. Med J Aust 1991 Dec 2-16;155(11-12):831-3.

Lane MJ. Privacy protection: implications for public health researchers [letter]. Med J Aust 1992 Mar 16;156(6):438.

Lehrman S. University blocks efforts to reveal researchers' identity [news]. Nature 1995 Mar 9;374(6518):109.

Leigh WA. Participant protection with the use of records: ethical issues and recommendations. Ethic Behav 1998;8(4):305-19.

Lincoln TL. Privacy: a real-world problem with fuzzy boundaries [editorial]. Methods Inf Med 1993 Apr;32(2):104-7. Comment on: Methods Inf Med 1993 Apr;32(2):95-103.

Lowden JA. Certificates of confidentiality [letter]. Am J Hum Genet 1996 Feb;58(2):436-8. Comment on: Am J Hum Genet 1995 Sep;57(3):727-31.

Loxley W, Hawks D, Bevan J. Protecting the interests of participants in research into illicit drug use: two case studies. Addiction 1997 Sep;92(9):1081-5.

Lynge E. European directive on confidential data: a threat to epidemiology [editorial]. BMJ 1994 Feb 19;308(6927):490. Comment on: BMJ 1994 Feb 19;308(6927):522-3.

Lynge E. New draft on European directive on confidential data [editorial]. BMJ 1995 Apr 22;310(6986):1024.

Maloney DM. Institutional review boards, genetic research, and privacy. Hum Res Rep 1996 Sep;11(9):6.

Mann RD. Selling patients' data [letter]. Lancet 1990 Feb 24;335(8687):478.

Marshall E. Publishing sensitive data: who calls the shots? Secretiveness found widespread in life sciences [news]. Science 1997 Apr 25;276(5312):525.

McCarthy CR, Porter JP. Confidentiality: the protection of personal data in epidemiological and clinical research trials. Law Med Health Care 1991 Fall-Winter;19(3-4):238-41.

McClintock T, Friendship C. Ethics committees. Information that can be given to researchers over the telephone needs to be clarified [letter]. BMJ 1996 Jan 6;312(7022):54. Comment on: BMJ 1995 Sep 9;311(7006):659-60.

McCormick WC. Impact of a change in confidentiality law on enrollment of persons with AIDS in a clinical research study. Clin Res 1990 Oct;38(3):545-50.

McLean SA. Mapping the human genome--friend or foe? Soc Sci Med 1994 Nov;39(9):1221-7.

Melton GB. Certificates of confidentiality under the Public Health Service Act: strong protection but not enough. Violence Vict 1990 Spring;5(1):67-71.

Melton LJ 3rd. The threat to medical-records research. N Engl J Med 1997 Nov 13;337(20):1466-70. Comments in: N Engl J Med 1998 Apr 9;338(15):1076; discussion 1077-8; N Engl J Med 1998 Apr 9;338(15):1076-7; discussion 1077-8; N Engl J Med 1998 Apr 9;338(15):1077; discussion 1077-8.

Meux E. Encrypting personal identifiers. Health Serv Res 1994 Jun;29(2):247-56.

Michaelis J, Miller M, Pommerening K, Schmidtmann I. A new concept to ensure data privacy and data security in cancer registries. Medinfo 1995;8 (Pt 1):661-5.

Milholland DK. Privacy and confidentiality of patient information. Challenges for nursing. J Nurs Adm 1994 Feb;24(2):19-24.

Miller SK. Genetic privacy makes strange bedfellows [news]. Science 1990 Sep 21;249(4975):1368.

Mills ME. Data privacy and confidentiality in the public arena. Proc AMIA Annu Fall Symp 1997:42-5

Monahan J, Appelbaum PS, Mulvey EP, Robbins PC, Lidz CW. Ethical and legal duties in conducting research on violence: lessons from the MacArthur Risk Assessment Study. Violence Vict 1993 Winter;8(4):387-96.

New bills seek to prevent misuse of medical data [news]. Nat Biotechnol 1997 May;15(5):398.

Newcombe HB. When privacy threatens public health. Can J Public Health 1995 May-Jun;86(3):188-92.

Newcombe HB, Cavoukian A. Cohorts and privacy [article and response]. Cancer Causes Control 1994 May;5(3):287-92.

Nicholl D, Winters G, Davies D. Publishing information about patients: GMC's guidelines should be followed before information is put on Internet [letter]. BMJ 1996 Mar 2;312(7030):578-9.

Nicholson RH. Divide and rule [news]. Hastings Cent Rep 1992 Jul-Aug;22(4):5.

Olsen J, Breart G, Feskens E, Grabauskas V, Noah N, Olsen J, Porta M, Saracci R. Directive of the European Parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data. The International Epidemiological Association-IEA European Epidemiological Group [letter]. Int J Epidemiol 1995 Apr;24(2):462-3.

Paddison J. Ethical issues in qualitative studies. Mod Midwife 1995 May;5(5):23-5.

Pejovich RJ. Critical aspects of conducting and auditing GLP studies--the practical perspective. Qual Assur 1995 Mar;4(1):87-90.

Pommerening K, Miller M, Schmidtmann I, Michaelis J. Pseudonyms for cancer registries. Methods Inf Med 1996 Jun;35(2):112-21.

Prentnieks M, Qual S. Protecting the privacy of computerized health information. The Kassabaum-Kennedy Act. Minn Med 1996 Nov;79(11):47-51.

Reilly P. ASHG statement on genetics and privacy: testimony to United States Congress. Am J Hum Genet 1992 Mar;50(3):640-2.

Robinson I. Confidentiality for whom? Soc Sci Med 1991;32(3):279-86.

Rosenberg SA. Secrecy in medical research. N Engl J Med 1996 Feb 8;334(6):392-4. Comments in: N Engl J Med 1996 Jul 11;335(2):134-5; discussion 135-6: N Engl J Med 1996 Jul 11;335(2):135; discussion 135-6.

Rosenberg SA. Secrecy in research: cooperation and costimulation in immunology [editorial]. Curr Opin Immunol 1996 Oct;8(5):611-2.

Rossiter BJ, Caskey CT. The human genome project. Clin Obstet Gynecol 1993 Sep;36(3):466-75.

Roush W. Publishing sensitive data: who calls the shots? Secrecy dispute pits Brown researcher against company [news]. Science 1997 Apr 25;276(5312):523-4.

Royal College of Physicians Committee on Ethical Issues in Medicine. Independent ethical review of studies involving personal medical records. J R Coll Physicians Lond 1994 Sep-Oct;28(5):439-43.

Ruffin M. Developing and using a data repository for quality improvement: the genesis of IRIS. Jt Comm J Qual Improv 1995 Oct;21(10):512-20.

Schulte PA. Biomarkers in epidemiology: scientific issues and ethical implications. Environ Health Perspect 1992 Nov;98:143-7.

Schulte PA, Hunter D, Rothman N. Ethical and social issues in the use of biomarkers in epidemiological research. IARC Sci Publ 1997;(142):313-8.

Sieber JE. Sharing scientific data: I. New problems for IRBs. IRB Rev Hum Subj Res 1989 Nov-Dec;11(6):4-7.

Slack WV. Private information in the hands of strangers. MD Comput 1997 Mar-Apr;14(2):83-6.

Smee PH. Should insurance companies have access to patients' medical records? Denying access would do more harm than good. BMJ 1996 Aug 3;313(7052):287. Comment on: BMJ 1996 Aug 3;313(7052):286-7. Comments in: BMJ 1996 Nov 16;313(7067):1261; BMJ 1996 Nov 16;313(7067):1261-2.

Smith GP. Accessing genomic information or safeguarding genetic privacy. J Law Health 1994-5;9(1):121-34.

Smith J. Keeping confidences in published papers [editorial]. BMJ 1991 May 18;302(6786):1168. Comment on: BMJ 1991 May 18;302(6786):1182.

Smith MF. Data protection, health care, and the new European directive: extension of data protection to paper records is logical but problematic [editorial]. BMJ 1996 Jan 27;312(7025):197-8.

Stark AN. Use of personal records for research purposes. Guidelines may affect audit [letter]. BMJ 1995 Jan 28;310(6974):258. Comment on: BMJ 1994 Nov 26;309(6966):1422-4.

Statements from the International Committee of Medical Journal Editors. JAMA 1991 May 22-29;265(20):2697-8. Comment in: JAMA 1991 May 22-29;265(20):2720.

Statements from the International Committee of Medical Journal Editors [editorial]. Ann Intern Med 1991 Jun 1;114(11):989.

Stern SB. Privileged communication: an ethical and legal right of psychiatric clients. Perspect Psychiatr Care 1990;26(4):22-5.

Stevens S. Patients' rights and publication [letter]. J Med Ethics 1993 Mar;19(1):50-1.

Stiller CA. Cancer registration: its uses in research, and confidentiality in the EC. J Epidemiol Community Health 1993 Oct;47(5):342-4.

Sweeney L. Privacy and medical-records research [letter]. N Engl J Med 1998 Apr 9;338(15):1077; discussion 1077-8. Comment on: N Engl J Med 1997 Nov 13;337(20):1466-70.

Taube DO, Burkhardt S. Ethical and legal risks associated with archival research. Ethics Behav 1997;7(1):59-67.

Thacker SB, Stroup DF. Future directions for comprehensive public health surveillance and health information systems in the United States. Am J Epidemiol 1994 Sep 1;140(5):383-97.

The hazards of government data [editorial]. Nature 1996 Oct 10;383(6600):463.

Thomas SP. Issues in data management and storage. J Neurosci Nurs 1993 Aug;25(4):243-5.

Users and uses of patient records. Report of the Council on Scientific Affairs. Council on Scientific Affairs, American Medical Association. Arch Fam Med 1993 Jun;2(6):678-81.

Vanchieri C. New EC privacy directive worries European epidemiologists [news]. J Natl Cancer Inst 1993 Jul 7;85(13):1022-3.

Vandenbroucke JP. Privacy, confidentiality and epidemiology: the Dutch ordeal [letter]. Int J Epidemiol 1992 Aug; 21(4):825-6.

Vehvilainen-Julkunen K. Ethical considerations in qualitative nursing research. Vard Nord Utveckl Forsk 1993 Summer;13(2):23-5.

vonKoss Krowchuk H, Moore ML, Richardson L. Using health care records as sources of data for research. J Nurs Meas 1995 Summer;3(1):3-12.

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Wald N, Law M, Meade T, Miller G, Alberman E, Dickinson J. Use of personal medical records for research purposes. BMJ 1994 Nov 26;309(6966):1422-4. Comment in: BMJ 1995 Jan 28;310(6974):257-8; BMJ 1995 Jan 38;310(6974):258.

Whitaker VB, Whitaker R Jr. Ethics: issues of concern. Insight 1991 Dec;16(6):30-1.

Whose right to genetic knowledge? [editorial]. Nature 1996 Feb 1;379(6564):379.

Wolffers I. Confidentiality in research [letter]. Lancet 1996 Mar 2;347(9001):620. Comment on: Lancet 1995 Nov 11;346(8985):1303.

Woodward B. Privacy and medical-records research [letter]. N Engl J Med 1998 Apr 9;338(15):1076; discussion 1077-8. Comment on: N Engl J Med 1997 Nov 13;337(20):1466-70.

Zimmerli WC. Who has the right to know the genetic constitution of a particular person? Ciba Found Symp 1990;149:93-102; discussion 102-10.
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## Privacy and confidentiality - Books

Bruce JAC. Privacy and confidentiality of health care information. 2nd ed. Chicago: American Hospital Publishing; 1988. 209 p.

Confidentiality: a guide to the federal law and regulations. New York: Legal Action Center; 1995.

Confidentiality, use, and disclosure of personal health information. London: Great Britain, Department of Health; 1994 Aug 10. 23 p. Draft guidance.

CPRI Work Group on Confidentiality, Privacy, and Security. Sample confidentiality statements and agreements for organizations using computer-based patient record systems. Schaumburg (IL): Computer-Based Patient Record Institute; c1996. 29 p.

Donaldson MS. Regional health databases, health services research, and confidentiality: summary of an invitational workshop at the Institute of Medicine, national implications of the development of regional health database organizations, January 31-February 1, 1994. Washington: Institute of Medicine; 1994.

Donaldson MS, Lohr KN, editors. Health data in the information age: use, disclosure, and privacy. Washington: National Academy Press; 1994. 257 p.

Goldman J, Mulligan D. Privacy and health information systems: a guide to protecting patient confidentiality. Washington: Center for Democracy & Technology; c1996. 46 p.

Lowrance WW. Privacy and health research: a report. Washington: Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation; 1997. 80 p.

Saunders JM. Patient confidentiality. 4th ed. Salt Lake City: Medicode, Inc.; 1998. 107 p.

Tomes JP. Healthcare privacy and confidentiality: the complete legal guide. Chicago: Probus; 1994. 236 p.
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## Clinical trials - Journal Articles

Ahmad I. Clinical trials in surgery. JPMA J Pak Med Assoc 1991 Sep;41(9):235-8.

Alderson P. Equipoise as a means of managing uncertainty: personal, communal and proxy. J Med Ethics 1996 Jun;22(3):135-9.

Alibhai SM. The placebo effect [letter]. CMAJ 1997 Oct 15;157(8):1020, 1022. Comment on: CMAJ 1997 Apr 15;156(8):1153-7.

Allen ME. Good Clinical Practice: current state of the art for clinical trial documentation. Med Leg J 1998;66(Pt 2):61-4.

Altman DG, Whitehead J, Parmar MK, Stenning SP, Fayers PM, Machin D. Randomised consent designs in cancer clinical trials. Eur J Cancer 1995 Nov;31A(12):1934-44.

Alves WA, Macciocchi SN. Ethical considerations in clinical neuroscience. Current concepts in neuroclinical trials. Stroke 1996 Oct;27(10):1903-9.

Ashcroft RE, Chadwick DW, Clark SR, Edwards RH, Frith L, Hutton JL. Implications of socio-cultural contexts for the ethics of clinical trials. Health Technol Assess 1997;1(9):1-65.

Barer D, Finch E, Gossop M, Hankinson L, Taylor C, Farrell M, Strang J, Thornton H. Patients' preferences and randomised trials. Lancet 1994 Sep 3;344(8923):688-9.

Bartelink H, Jassem J. Early presentation of results in clinical trials: an ethical dilemma for medicine and science. Eur J Cancer 1990 Apr;26(4):419-20.

Barton JM, Macmillan MS, Sawyer L. The compensation of patients injured in clinical trials. J Med Ethics 1995 Jun;21(3):166-9.

Basch PF. Antischistosomal vaccines: beyond the laboratory. Trans R Soc Trop Med Hyg 1993 Sep-Oct;87(5):589-92.

Baum M. The ethics of clinical trials. Isr J Med Sci 1995 Feb-Mar;31(2-3):197-200. Comment in: Isr J Med Sci 1995 Sep;31(9):580-2.

Baum M. The ethics of randomized controlled trials. Eur J Surg Oncol 1995 Apr;21(2):136-7.

Beran RG, Tilley M. Clinical trials of antiepileptic drugs performed in the private practice setting. Epilepsia 1994 Jan-Feb;35(1):101-6.

Bleich HL. The science and ethics of the randomized clinical trial [editorial]. MD Comput 1995 Jan-Feb;12(1):5-6. Comment on: MD Comput 1995 Jan-Feb;12(1):36-44.

Boissel JP, Haugh MC. Clinical trial registries and ethics review boards: the results of a survey by the FICHTRE project. Fundam Clin Pharmacol 1997;11(3):281-4.

Bolton WK. The nature of clinical trials in nephrology [editorial]. Kidney Int 1992 Nov;42(5):1061-9.

Bone HG, Chavkin W, Fox H, Chalmers TC. Ethical implications of rejecting patients for clinical trials [letters and response]. JAMA 1990 Aug 22;264(8):973-4.

Bornman PC. The clinical researcher--present and future prospective. S Afr J Surg 1992 Sep;30(3):118-23.

Brandon S. Ethics, economics and science [editorial]. J R Soc Med 1991 Oct;84(10):575-7.

Buck BA. Ethical issues of randomized clinical trials. Radiol Technol 1990 Jan-Feb;61(3):202-5.

Burchell HB. Vicissitudes in clinical trial research. Subjects, participants, patients. Control Clin Trials 1992 Jun;13(3):185-9.

Cappelleri JC, Trochim WM. Ethical and scientific features of cutoff-based designs of clinical trials: a simulation study. Med Decis Making 1995 Oct-Dec;15(4):387-94.

Chalmers TC. Ethical implications of rejecting patients for clinical trials [editorial]. JAMA 1990 Feb 9;263(6):865. Comment on: JAMA 1990 Feb 9;263(6):825-30. Comment in: JAMA1990 Aug 22-29;264(8):973-4.

Chen MJ, Scarth BJ, Slack CJ. Good clinical research practice in Canada. CMAJ 1994 Nov 1;151(9):1255-7.

Citron ML. Placebos and principles: a trial of ondansetron [editorial]. Ann Intern Med 1993 Mar 15;118(6):470-1. Comment on: Ann Intern Med 1993 Mar 15;118(6):407-13.

Claessens MT, Bernat JL, Baron JA. Ethical issues in clinical trials. Br J Urol 1995 Nov;76 Suppl 2:29-36.

Clark PI, Leaverton PE. Scientific and ethical issues in the use of placebo controls in clinical trials. Annu Rev Public Health 1994;15:19-38.

Cleophas TJ. Clinical trials: specific problems associated with the use of a placebo-control group. J Mol Med 1995 Aug;73(8):421-4.

Cleophas TJ. Is selective reporting of well-designed clinical research unethical as well as unscientific? [letter]. Ned Tijdschr Geneeskd 1996 Mar 2;140(9):509-10. Comment on: Ned Tijdschr Geneeskd 1996 Jan 27;140(4):220-1.

Cohen-Haguenauer O. Safety and regulation at the leading edge of biomedical biotechnology. Curr Opin Biotechnol 1996 Jun;7(3):265-72.

Cohen J. Clinical trial monitoring: hit or miss? [news]. Science 1994 Jun 10;264(5165):1534-7.

Collier J. Confusion over use of placebos in clinical trials [editorial]. BMJ 1995 Sep 30;311(7009):821-2. Comment on: BMJ 1995 Sep 30;311(7009):844-6.

Connolly CK, Trewby PN. Per capita payments for clinical trials [letter]. J R Coll Physicians Lond 1992 Oct;26(4):457.

Corbett F, Oldham J, Lilford R. Offering patients entry in clinical trials: preliminary study of the views of prospective participants. J Med Ethics 1996 Aug;22(4):227-31.

CQ sources. Camb Q Healthc Ethics 1994 Fall;3(4):574-7.

CQ sources/bibliography. Camb Q Healthc Ethics 1996 Summer;5(3):422-4.

Cramer JA. Ethical issues in the planning and conduct of clinical trials of anti-epileptic drugs. Med Law 1997;16(2):209-14.

Dahlqvist G. Epidemiological and ethical considerations on trials with immunotherapy in pre-type 1 (insulin-dependent) diabetes mellitus [letter]. Diabetologia 1991 Jul;34(7):536. Comment on: Diabetologia 1990 Dec;33(12):741.

De Deyn PP, D'Hooge R. Placebos in clinical practice and research. J Med Ethics 1996 Jun;22(3):140-6.

de Zoysa I, Elias CJ, Bentley ME. Ethical challenges in efficacy trials of vaginal microbicides for HIV prevention. Am J Public Health 1998 Apr;88(4):571-5.

DeMets DL , Fleming TR, Whitley RJ, Childress JF, Ellenberg SS, Foulkes M, Mayer KH, O'Fallon J, Pollard RB, Rahal JJ, et al. The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. Control Clin Trials 1995 Dec;16(6):408-21.

Dennison DK. Components of a randomized clinical trial. J Periodontal Res 1997 Jul;32(5):430-8.

Deo MG. Leprosy vaccines [letter]. Natl Med J India 1992 May-Jun;5(3):143-4.

Deutsch E, von Eickstedt KW, Frolich JC, Schneider B. Monitors and European Community guideline on clinical trials [letter]. Lancet 1991 Nov 2;338(8775):1151.

Devlin HB. Clinical trials and clinical practice [letter]. Lancet 1993 Nov 27;342(8883):1367-8.

Downs FS. Clinical trials revisited [editorial]. Nurs Res 1994 May-Jun;43(3):132.

Durant JR. Overview. Current status of clinical trials. Cancer 1990 May 15;65(10 Suppl):2371-5.

Early termination of clinical trials: causes, consequences and control. With special reference to trials in the field of arrhythmias and sudden death. Task Force of the Working Group on Arrhythmias of the European Society of Cardiology. Eur Heart J 1994 Jun;15(6):721-38.

Easterbrook P, Houghton J. Informing patients about clinical trials [letter]. BMJ 1993 Jan 23;306(6872):273.

Edwards SJ, Lilford RJ, Braunholtz D, Jackson J. Why underpowered trials are not necessarily unethical. Lancet 1997 Sep 13;350(9080):804-7.

Einhorn LH. Curable neoplasms and the ethics of clinical trials [editorial]. J Clin Oncol 1993 Apr;11(4):593-5. Comment on: J Clin Oncol 1993 Apr;11(4):598-606.

Elander G, Hermeren G. Placebo effect and randomized clinical trials. Theor Med 1995 Jun;16(2):171-82.

Ellis PM, Coates AS. Ethics of randomized clinical trials [letter]. J Clin Oncol 1998 Jul;16(7):2570. Comment on: J Clin Oncol 1998 Jan;16(1):365-6; discussion 366-71.

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Emerson SS, Fleming TR. Interim analyses in clinical trials. Oncology (Huntingt) 1990 Mar;4(3):126-33; discussion 134, 136.

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## Clinical trials - Books

Clinical Research: Hearing Before a Subcomm. of the Senate Comm. on Appropriations. 104th Cong. 2nd Sess. [microfiche]. Washington: U.S. Government Printing Office; 1996. 59 p. (Senate hrg; 104-559).

Current issues in human subject protection: an FDA perspective: proceedings of a meeting, 1996 Sep 13, National Institutes of Health. Bethesda MD. Rockville (MD): Food and Drug Administration; 1996. 1 vol.

Friedman LM, Furberg C, DeMets DL. Fundamentals of clinical trials. 3rd ed. St. Louis: Mosby; c1996. 361 p.

Friedman LM, Furberg C, DeMets DL. Fundamentals of clinical trials. 4th ed. New York: Springer; c1998.

Giffels JJ. Clinical trials: what you should know before volunteering to be a research subject. New York: Demos Vermande; c1996. 48 p.

Kadane JB, editor. Bayesian methods and ethics in a clinical trial design. New York: J. Wiley & Sons; c1996. 318 p. (Wiley series in probability and statistics. Applied probability and statistics).

Mann RD. Risk and consent to risk in medicine: the proceedings of a conference. Park Ridge (NJ): Parthenon Pub. Group; 1989. 224 p.

Perman JA, Rey J. Clinical trials in infant nutrition: methodology, statistics, and ethicial issues. Philadelphia: Lippincott-Raven; c1998. 281 p. (Nestle Nutrition Workshop series; vol. 40).

Spilker B, Cramer JA. Patient recruitment in clinical trials. New York: Raven Press; c1992. 346 p.

Walker SR, Lumley CE, McAuslane JAN. The relevance of ethnic factors in the clinical evaluation of medicines. Boston: Kluwer Academic; c1994. 262 p. (CMR workshop series).
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## Special or vulnerable populations - Women - Journal Articles

Aldhous P. Boost for women's health [news]. Nature 1991 Jul 18;352(6332):180.

Allen A, Ross RL, Payer L, Angell M. Women's health [letters and response]. N Engl J Med 1993 Dec 9;329(24):1816-7.

American College of Clinical Pharmacy Task Force on Women's Health and Research Issues. Women as research subjects. [ACCP white paper]. Pharmacotherapy 1993 Sep-Oct;13(5):534-42.

Anderson C. Clinical research: panel backs pregnant women in trials [news]. Science 1994 Mar 4;263(5151):1216.

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Women as research subjects. American College of Clinical Pharmacy. Pharmacotherapy 1993 Sep-Oct;13(5):534-42.

Women promoting women's health. J Am Med Womens Assoc 1993 Jan-Feb;48(1):12-3, 18.

Women's health research at NIEHS [news]. Environ Health Perspect 1993 Jun;101(2):110.

Woods NF. The United States women's health research agenda analysis and critique. West J Nurs Res 1994 Oct;16(5):467-79.

Wysocki S. Women's health care: equality for the 90s. Nurse Pract Forum 1991 Mar;2(1):8-10.

Yi JK. Are Asian/Pacific Islander American women represented in women's health research? [letter]. Womens Health Issues 1996 Jul-Aug;6(4):237-8.

Yonkers KA, Harrison W. The inclusion of women in psychopharmacologic trials [editorial]. J Clin Psychopharmacol 1993 Dec;13(6):380-2. Comment in: J Clin Psychopharmacol 1994 Aug;14(4):288.

Zahm SH, Pottern LM, Lewis DR, Ward MH, White DW. Inclusion of women and minorities in occupational cancer epidemiologic research. J Occup Med 1994 Aug;36(8):842-7.

Zinn C. Australia launches major study of women's health [news]. BMJ 1995 Apr 22;310(6986):1026.
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## Special or vulnerable populations - Women - Books

Beauregard L, Haseltine F, Jacobson BG. Women's health research: a medical and policy primer. 1st ed. Washington: Health Press International; c1997. 364 p.

Clinical research and products liability issues: use of women of childbearing potential in drug trials. Meeting, 1995 Oct 30, New York City. Albany: New York State Bar Association; 1995. 122 p.

Comprehensive report of the Office of Research on Women's Health: fiscal year 1991-1992. Bethesda (MD): National Institutes of Health, Office of the Director; 1993? 127 p. (NIH publication; no.93-3455).

Implementation of the NIH guidelines on the inclusion of women and minorities as subjects in clinical research, FY 1995-1996: advisory council reports certifying compliance. Bethesda (MD): National Institutes of Health, Office of Research on Women's Health, NIH Tracking/Inclusion Committee; 1997.

Institute of Medicine, Board on Health Sciences Policy. Inclusion of women in clinical trials: policies for population subgroups. Washington: National Academy Press; 1993. 11 p.

Komesaroff PA. Troubled bodies: critical perspectives on postmodernism, medical ethics, and the body. Durham: Duke University Press; 1995. 241 p.

Laurence L, Weinhouse B. Outrageous practices: the alarming truth about how medicine mistreats women. New York: Fawcett Columbine; 1994. 434 p.

Mastroianni AC, Faden R, Federman D. Women and health research: ethical and legal issues of including women in clinical studies. Vol. 2, Workshop and commissioned papers. Washington: National Academy Press; 1994. 247 p.

Mastroianni AC, Faden R, Federman D. Women and health research: ethical and legal issues of including women in clinical studies. Vol. 1. Washington: National Academy Press; 1994. 271 p.

Moss KL. Man-made medicine: women's health, public policy, and reform. Durham (NC): Duke University Press; 1996. 288 p.

National Institutes of Health, NIH Advisory Committee on Women's Health Issues. NIH support for research on women's and men's health issues. Bethesda (MD): National Institutes of Health; 1991-.

Nechas E, Foley D. Unequal teatment: what you don't know about how women are mistreated by the medical community. New York: Simon and Schuster; 1994. 272 p.

Outreach notebook for the NIH guidelines on inclusion of women and minorities as subjects in clinical research. Bethesda (MD): National Institutes of Health, 1994. 37 p.

Ragavan VV. Drug development for women. New York: J. Wiley; 1998. 480 p.

Recruitment and Retention of Women in Clinical Studies. Bethesda (MD): National Institutes of Health, Office of the Director, Office of Research on Women's Health; 1994. 104 p. (NIH publication; no. 95-3756).

Research to improve women's health: an agenda for equity: a preliminary report, presented to Ruth Kirschstein, Acting Deputy Director, Office of Research on Women's Health, National Institutes of Health. [Washington?]: National Women's Health Network; 1990. 18 p.

Rosser SV. Women's health-- missing from U.S. medicine. Bloomington: Indiana University Press; c1994. 213 p. (Race, gender, and science).

Sechzer JA, Griffin A, Pfafflin SM. Forging a women's health research agenda: policy issues for the 1990s. New York: New York Academy of Sciences; 1994. 223 p.

Smith JM. Women and doctors: a physician's explosive account of women's medical treatment -- and mistreatment -- in America today and what you can do about it. New York: Atlantic Monthly Press; 1992. 241 p.

Treichler PA, Cartwright L, Penley C, editors. The visible woman: imaging technologies, gender, and science. New York: New York University Press; 1998. 400 p.

Wolf SM. Feminism and bioethics: beyond reproduction. New York: Oxford University Press; 1996. 398 p.

Women Health Care Consumers: Short-Changed on Medical Research and Treatment: Hearing Before the Subcomm. on Housing and Consumer Interests of the Select Committee on Aging, 101st Cong., 2nd Sess. (1990 July 24). Washington: U.S. Government Printing Office; 1991. 174 p.
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## Special or vulnerable populations - Minorities and cross-cultural issues - Journal Articles

Adebimpe VR. Race, racism, and epidemiological surveys. Hosp Community Psychiatry 1994 Jan;45(1):27-31.

Agosti V, Nunes E, Ocepeck-Welikson K. Patient factors related to early attrition from an outpatient cocaine research clinic. Am J Drug Alcohol Abuse 1996 Feb;22(1):29-39.

Allen M. The dilemma for women of color in clinical trials. J Am Med Womens Assoc 1994 Jul-Aug;49(4):105-9.

Alvidrez J, Azocar F, Miranda J. Demystifying the concept of ethnicity for psychotherapy researchers. J Consult Clin Psychol 1996 Oct;64(5):903-8.

Anderson MR, Moscou S. Race and ethnicity in research on infant mortality. Fam Med 1998 Mar;30(3):224-7.

Andrews MM, Krouse SA. Research on excess deaths among American Indians and Alaska Natives: a critical review. J Cult Divers 1995 Winter;2(1):8-15.

Arean PA, Gallagher-Thompson D. Issues and recommendations for the recruitment and retention of older ethnic minority adults into clinical research. J Consult Clin Psychol 1996 Oct;64(5):875-80.

Azuonye IO. Describing race, ethnicity, and culture in medical research. Guidelines will encourage the thinking that underpins racism in medicine [letter]. BMJ 1996 Aug 17;313(7054):426. Comment on: BMJ 1996 Apr 27;312(7038):1054; BMJ 1996 Apr 27;312(7038):1094.

Bagley C. A plea for ignoring race and including insured status in American research reports on social science and medicine [editorial]. Soc Sci Med 1995 Apr;40(8):1017-9.

Ballard EL, Nash F, Raiford K, Harrell LE. Recruitment of black elderly for clinical research studies of dementia: the CERAD experience. Gerontologist 1993 Aug;33(4):561-5.

Barry M, Molyneux M. Ethical dilemmas in malaria drug and vaccine trials: a bioethical perspective. J Med Ethics 1992 Dec;18(4):189-92.

Bauer BA. Race and ethnicity: a compelling research agenda [letter]. Ann Intern Med 1997 Feb 1;126(3):252. Comment on: Ann Intern Med 1996 Aug 1;125(3):237-9.

Bauman LJ, Adair EG. The use of ethnographic interviewing to inform questionnaire construction. Health Educ Q 1992 Spring;19(1):9-23.

Bayer R. The debate over maternal-fetal HIV transmission prevention trials in Africa, Asia, and the Caribbean: racist exploitation or exploitation of racism? Am J Public Health 1998 Apr;88(4):567-70.

Beatty LA. Issues in drug abuse prevention intervention research with African Americans. NIDA Res Monogr 1994;139:171-201.

Bedolla MA. The principles of medical ethics and their application to Mexican-American elderly patients. Clin Geriatr Med 1995 Feb;11(1):131-7.

Bell CC. Race as a variable in research: being specific and fair [editorial]. Hosp Community Psychiatry 1994 Jan;45(1):5. Comment in: Hosp Community Psychiatry 1994 May;45(5):498-9; Psychiatr Serv 1995 Jul;46(7):731.

Bennett T, Bhopal R. US health journal editors' opinions and policies on research in race, ethnicity, and health. J Natl Med Assoc 1998 Jul;90(7):401-8.

Bhopal R. Is research into ethnicity and health racist, unsound, or important science? BMJ 1997 Jun 14;314(7096):1751-6. Comment in: BMJ 1997 Jun 14;314(7096):1703-4; BMJ 1997 Nov 15;315(7118):1309.

Bhopal R, Donaldson L. White, European, Western, Caucasian, or what? Inappropriate labeling in research on race, ethnicity, and health. Am J Public Health 1998 Sep;88(9):1303-7. Comment in: Am J Public Health 1998 Sep;88(9):1297-8.

Bhopal R, Kohli H, Rankin J. Editors' practice and views on terminology in ethnicity and health research. Ethn Health 1997 Aug;2(3):223-7.

Bhopal RS, Phillimore P, Kohli HS. Inappropriate use of the term 'Asian': an obstacle to ethnicity and health research. J Public Health Med 1991 Nov;13(4):244-6.

Biggins DR. Ethics of health research [letter]. Aust J Public Health 1992 Mar;16(1):107-8.

Bleyer WA. Re: recruiting minorities into clinical trials: toward a participant-friendly system [letter]. J Natl Cancer Inst 1996 Mar 20;88(6):377. Comment on: J Natl Cancer Inst 1995 Dec 6;87(23):1747-59.

Bleyer WA, Tejeda HA, Murphy SB, Brawley OW, Smith MA, Ungerleider RS. Equal participation of minority patients in U.S. national pediatric cancer clinical trials. J Pediatr Hematol Oncol 1997 Sep-Oct;19(5):423-7.

Blumenthal DS, Sung J, Coates R, Williams J, Liff J. Recruitment and retention of subjects for a longitudinal cancer prevention study in an inner-city black community. Health Serv Res 1995 Apr;30(1 Pt 2):197-205.

Bonner GJ, Miles TP. Participation of African Americans in clinical research. Neuroepidemiology 1997;16(6):281-4.

Brawley OW, Tejeda H. Minority inclusion in clinical trials issues and potential strategies. J Natl Cancer Inst Monogr 1995;(17):55-7.

Brown LS Jr. Enrollment of drug abusers in HIV clinical trials: a public health imperative for communities of color. J Psychoact Drugs 1993 Jan-Mar;25(1):45-52.

Burish TG. Behavioral and psychosocial cancer research. Building on the past, preparing for the future. Cancer 1991 Feb 1;67 Suppl 3:865-7.

Butler D. Genetic diversity proposal fails to impress international ethics panel [news]. Nature 1995 Oct 5;377(6548):373. Comment in: Nature 1996 Jan 4;379(6560):11.

Byman B. Out from the shadow of Tuskegee. Fighting racism in medicine. Minn Med 1991 Aug;74(8):15-20.

Caban CE. Hispanic research: implications of the National Institutes of Health guidelines on inclusion of women and minorities in clinical research. J Natl Cancer Inst Monogr 1995;(18):165-9.

Campbell A. Ethics in a bicultural context -- a report from New Zealand. Bioethics 1995 Apr;9(2):149-54.

Cancer research in Hispanic populations in the United States. J Natl Cancer Inst Monogr 1995;(18):1-169.

Cassidy CM. Walk a mile in my shoes: culturally sensitive food-habit research. Am J Clin Nutr 1994 Jan;59(1 Suppl):190S-197S.

Castaneda DM. A research agenda for Mexican-American adolescent mental health. Adolescence 1994 Spring;29(113):225-39.

Castro FG, Harmon MP, Coe K, Tafoya-Barraza HM. Drug prevention research with Hispanic populations: theoretical and methodological issues and a generic structural model. NIDA Res Monogr 1994;139:203-33.

Chavez EL, Oetting ER. A critical incident model for considering issues in cross-cultural research. Failures in cultural sensitivity. Int J Addict 1995 May;30(7):863-74.

Cheung YW. Ethnicity and alcohol/drug use revisited: a framework for future research. Int J Addict 1990-91;25(5A-6A):581-605.

Chiodo GT, Tolle SW. Informed consent across cultures. Gen Dent 1997 Sep-Oct;45(5):421-4.

Christakis NA. Ethics are local: engaging cross-cultural variation in the ethics for clinical research. Soc Sci Med 1992 Nov;35(9):1079-91.

Coghlan A. Gene treaty promises rewards for unique peoples [news]. New Sci 1996 Nov 2;152(2054):8.

Cohen GD. African American issues in geriatric psychiatry: a perspective on research opportunities. J Geriatr Psychiatry Neurol 1993 Oct-Dec;6(4):195-9.

Coleman EA, Tyll L, LaCroix AZ, Allen C, Leveille SG, Wallace JI, Buchner DM, Grothaus LC, Wagner EH. Recruiting African-American older adults for a community-based health promotion intervention: which strategies are effective? Am J Prev Med 1997 Nov-Dec;13(6 Suppl):51-6.

Coreil J, Losikoff P, Pincu R, Mayard G, Ruff AJ, Hausler HP, Desormeau J, Davis H, Boulos R, Halsey NA. Cultural feasibility studies in preparation for clinical trials to reduce maternal-infant HIV transmission in Haiti. AIDS Educ Prev 1998 Feb;10(1):46-62.

Crews DE, Bindon JR. Ethnicity as a taxonomic tool in biomedical and biosocial research. Ethn Dis 1991 Winter;1(1):42-9.

De Bono D. Describing race, ethnicity, and culture in medical research. White populations also need to be accurately described [letter]. BMJ 1996 Aug 17;313(7054):425; discussion 426. Comment on: BMJ 1996 Apr 27;312(7038):1054.

Delgado JL, Johnson CL, Roy I, Trevino FM. Hispanic Health and Nutrition Examination Survey: methodological considerations. Am J Public Health 1990 Dec;Suppl 80:6-10.

Des Jarlais DC, Stepherson B. History, ethics, and politics in AIDS prevention research [editorial]. Am J Public Health 1991 Nov;81(11):1393-4. Comment on: Am J Public Health 1991 Nov;81(11):1498-505; Am J Public Health 1991 Nov;81(11):1506-17.

Donovan RJ, Spark R. Towards guidelines for survey research in remote Aboriginal communities. Aust N Z J Public Health 1997 Feb;21(1):89-95. Comment in: Aust N Z J Public Health 1997 Feb;21(1):96-7.

Dula A. African American suspicion of the healthcare system is justified: what do we do about it? Camb Q Healthc Ethics 1994 Summer;3(3):347-57.

Edgar H. Twenty years after. The legacy of the Tuskegee Syphilis Study. Outside the community. Hastings Cent Rep 1992 Nov-Dec;22(6):32-5.

Edwards NC. Important considerations in the use of ethnicity as a study variable. Can J Public Health 1992 Jan-Feb;83(1):31-3.

el-Sadr W, Capps L. The challenge of minority recruitment in clinical trials for AIDS. JAMA 1992 Feb 19;267(7):954-7.

Ellison GT, de Wet T, IJsselmuiden CB, Richter LM. Desegregating health statistics and health research in South Africa. S Afr Med J 1996 Oct;86(10):1257-62. Comment in: S Afr Med J 1996 Dec;86(12):1559; S Afr Med J 1997 Mar;87(3):329-31.

Ethnicity, race and culture guidelines for research audit and publication. BMJ 1996 Apr 27;312(7038):1094. Comment in: BMJ 1996 Apr 27;312(7038):1054; BMJ 1996 Aug 17;313(7054):425-6; BMJ 1996 Aug 17;313(7054):426; discussion 426; BMJ 1996 Aug 17;313(7054):426.

Feinleib M, Hancoff LD, Phillips M, Osborne NG, Feit MD. The use of race in medical research [letters and response]. JAMA 1992 Jun 17;267(23):3150-1.

Fernando S. Racial stereotypes [letter]. Br J Psychiatry 1991 Feb;158:289-90. Comment on: Br J Psychiatry 1990 Sep;157:410-5.

Francis CK. Research in coronary heart disease in blacks: issues and challenges. J Health Care Poor Underserved 1997 Aug;8(3):250-69.

Freeman HP. The impact of clinical trial protocols on patient care systems in a large city hospital. Access for the socially disadvantaged. Cancer 1993 Nov 1;72(9 Suppl):2834-8.

Freeman HP. The meaning of race in science--considerations for cancer research: concerns of special populations in the National Cancer Program. Cancer 1998 Jan 1;82(1):219-25.

Fulwood R. Setting the agenda for research and education on coronary heart disease. J Health Care Poor Underserved 1997 Aug;8(3):247-9.

Gamble VN. A legacy of distrust: African Americans and medical research. Am J Prev Med 1993 Nov-Dec;9(6 Suppl):35-8.

Gamble VN. The Tuskegee Syphilis Study and women's health. J Am Med Womens Assoc 1997 Fall;52(4):195-6.

Gamble VN. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health 1997 Nov;87(11):1773-8. Comment in: Am J Public Health 1997 Nov;87(11):1765-6.

Gavaghan H. Clinical trials face lack of minority group volunteers [news]. Nature 1995 Jan 19;373(6511):178.

Geis SB, Fuller RL. Inadvertent discrimination in medical research. J Relig Health 1990 Fall;29(3):207-17.

Gibson RC. The age-by-race gap in health and mortality in the older population: a social science research agenda. Gerontologist 1994 Aug;34(4):454-62.

Gore SM. Inclusion of women and minorities in clinical trials. Control Clin Trials 1995 Oct;16(5):290-2.

Gorelick PB, Harris Y, Burnett B, Bonecutter FJ. The recruitment triangle: reasons why African Americans enroll, refuse to enroll, or voluntarily withdraw from a clinical trial. An interim report from the African-American Antiplatelet Stroke Prevention Study (AAASPS). J Natl Med Assoc 1998 Mar;90(3):141-5.

Gorelick PB, Richardson D, Hudson E, Perry C, Robinson D, Brown N, Harris Y. Establishing a community network for recruitment of African Americans into a clinical trial. The African-American antiplatelet stroke Prevention Study (AAASPS) experience [editorial]. J Natl Med Assoc 1996 Nov;88(11):701-4.

Grunbaum JA, Labarthe DR, Ayars C, Harrist R, Nichaman MZ. Recruitment and enrollment for Project HeartBeat. Achieving the goals of minority inclusion. Ethn Dis 1996 Autumn;6(3-4):203-12.

Guralnik JM, Leveille SG. Race, ethnicity, and health outcomes--unraveling the mediating role of socioeconomic status. Am J Public Health 1997 May;87(5):728-30. Comment on: Am J Public Health 1997 May;87(5):805-10.

Hardy K. Clinical trials need more ethnic balance [news]. J Natl Cancer Inst 1997 May 21;89(10):686.

Harris Y, Gorelick PB, Samuels P, Bempong I. Why African Americans may not be participating in clinical trials. J Natl Med Assoc 1996 Oct;88(10):630-4.

Haynes MA, Bernard LJ. Drew/Meharry/Morehouse Consortium Cancer Center: an approach to targeted research in minority institutions. J Natl Med Assoc 1992 Jun;84(6):505-11.

Hohmann AA, Parron DL. How the new NIH Guidelines on Inclusion of Women and Minorities apply: efficacy trials, effectiveness trials, and validity. J Consult Clin Psychol 1996 Oct;64(5):851-5.

Holder B, Turner-Musa J, Kimmel PL, Alleyne S, Kobrin S, Simmens S, Cruz I, Reiss D. Engagement of African American families in research on chronic illness: a multisystem recruitment approach. Fam Process 1998 Summer;37(2):127-51.

Houston S, Legge D. Aboriginal health research and the National Aboriginal Health Strategy [editorial]. Aust J Public Health 1992 Jun;16(2):114-5.

Hughes AO, Fenton S, Hine CE, Pilgrim S, Tibbs N. Strategies for sampling black and ethnic minority populations. J Public Health Med 1995 Jun;17(2):187-92. Published erratum appears in J Public Health Med 1995 Sep;17(3):375.

Huttlinger K, Drevdahl D. Increasing minority participation in biomedical and nursing research. J Prof Nurs 1994 Jan-Feb;10(1):13-21.

Jones JH. The Tuskegee legacy. AIDS and the black community. Hastings Cent Rep 1992 Nov-Dec;22(6):38-40.

Kaluzny A, Brawley O, Garson-Angert D, Shaw J, Godley P, Warnecke R, Ford L. Assuring access to state-of-the-art care for U.S. minority populations: the first 2 years of the Minority-Based Community Clinical Oncology Program. J Natl Cancer Inst 1993 Dec 1;85(23):1945-50.

Kaufert JM, O'Neil JD, Koolage WW. The cultural and political context of informed consent for Native Canadians. Arctic Med Res 1991;Suppl:181-4.

King PA. The dangers of difference. [The legacy of the Tuskegee Syphilis Study]. Hastings Cent Rep 1992 Nov-Dec;22(6):35-8.

Kitler ME. Clinical trials and transethnic pharmacology. Drug Saf 1994 Nov;11(5):378-91.

Krieger N, Sidney S, Coakley E. Racial discrimination and skin color in the CARDIA study: implications for public health research. Coronary Artery Risk Development in Young Adults. Am J Public Health 1998 Sep;88(9):1308-13.

Kristal AR, Feng Z, Coates RJ, Oberman A, George V. Associations of race/ethnicity, education, and dietary intervention with the validity and reliability of a food frequency questionnaire: the Women's Health Trial Feasibility Study in Minority Populations. Am J Epidemiol 1997 Nov 15;146(10):856-69.

Kuramoto FH. Drug abuse prevention research concerns in Asian and Pacific Islander populations. NIDA Res Monogr 1994;139:249-72.

Lakhani ZM. Racism, sexism and trials. Ann R Coll Physicians Surg Can 1990 Dec;23(7):509-10.

Landrine H, Klonoff EA. Conclusions: the future of research on black women's health. Womens Health 1997 Fall-Winter;3(3-4):367-81.

Lehrman S. Coalition to pursue ethnic concerns over gene research [news]. Nature 1998 Apr 2;392(6675):428. Comment in: Nature 1998 Jun 18;393(6686):618.

Lenfant C. Enhancing minority participation in research. The NHLBI experience [news]. Circulation 1995 Aug 1;92(3):279-80.

Lewis MA, Rachelefsky G, Lewis CE, Leake B, Richards W. The termination of a randomized clinical trial for poor Hispanic children. Arch Pediatr Adolesc Med 1994 Apr;148(4):364-7.

Lin KM. Ethical aspects of psychopharmacological studies in different ethnic groups. Clin Neuropharmacol 1992 1992;15 (Suppl 1 Pt A):483A-484A.

Macaulay AC. Ethics of research in Native communities [editorial]. Can Fam Physician 1994 Nov;40:1888-90, 1894-7.

Maddocks I. Ethics in aboriginal research. A model for minorities or for all? Med J Aust 1992 Oct 19;157(8):553-5. Comment in: Med J Aust 1993 Apr 5;158(7):508.

Marin G, Amaro H, Eisenberg C, Opava-Stitzer S. The development of a relevant and comprehensive research agenda to improve Hispanic health. Public Health Rep 1993 Sep-Oct;108(5):546-50.

Marshall SL, While AE. Interviewing respondents who have English as a second language: challenges encountered and suggestions for other researchers. J Adv Nurs 1994 Mar;19(3):566-71.

Mathews J, Currie B. Ethics in aboriginal research [letter]. Med J Aust 1993 Apr 5;158(7):508. Comment on: Med J Aust 1992 Oct 19;157(8):553-5.

Mathews J, Currie B, Maddocks I. Ethics in Aboriginal research [letter and response]. Med J Aust 1993 Apr 5;158(7):508.

McAuley J, De Souza L, Sharma V, Robinson I, Main CJ, Frank AO. Describing race, ethnicity, and culture in medical research. Self defined ethnicity is unhelpful [letter]. BMJ 1996 Aug 17;313(7054):425-6. Comment on: BMJ 1996 Apr 27;312(7038):1054; BMJ 1996 Apr 27;312(7038):1094.

McGinnis JM, Ballard-Barbash RM. Obesity in minority populations: policy implications of research. Am J Clin Nutr 1991 Jun;53(6 Suppl):1512S-1514S.

McGraw SA, McKinlay JB, Crawford SA, Costa LA, Cohen DL. Health survey methods with minority populations: some lessons from recent experience. Ethn Dis 1992 Summer;2(3):273-87.

McKenzie K, Crowcroft NS. Describing race, ethnicity, and culture in medical research [editorial]. BMJ 1996 Apr 27;312(7038):1054. Comment on: BMJ 1996 Apr 27;312(7038):1080-2; BMJ 1996 Apr 27;312(7038):1094. Comment in: BMJ 1996 Aug 17;313(7054):425; discussion 426; BMJ 1996 Aug 17;313(7054):425-6; BMJ 1996 Aug 17;313(7054):426; discussion 426; BMJ 1996 Aug 17;313(7054):426.

McLaughlin LA, Braun KL. Asian and Pacific Islander cultural values: considerations for health care decision making. Health Soc Work 1998 May;23(2):116-26.

McMasters A. Research from an aboriginal health worker's point of view. Aust N Z J Public Health 1996 Jun;20(3):319-20. Comment in: Aust N Z J Public Health 1996 Jun;20(3):227-9.

Mhlongo SW, Mdingi GV. Informed consent. Informed consent is light years away for black African patients [letter]. BMJ 1997 Jul 26;315(7102):252. Comment on: BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4.

Miller P, Rainow S. Commentary: don't forget the plumber: research in remote Aboriginal communities. Aust N Z J Public Health 1997 Feb;21(1):96-7. Comment on: Aust N Z J Public Health 1997 Feb;21(1):89-95.

Millon-Underwood S, Sanders E, Davis M. Determinants of participation in state-of-the-art cancer prevention, early detection/screening, and treatment trials among African-Americans. Cancer Nurs 1993 Feb;16(1):25-33.

Minority health research [news]. Environ Health Perspect 1993 Jun;101(2):112-3.

Modan B, Kovar MG, Weeks JA. Health policy for the aged. We don't study the right people. Aging (Milano) 1998 Feb;10(1):1-4.

Modiano MR, Villar-Werstler P, Meister J, Figueroa-Valles N. Cancer in Hispanics: issues of concern. J Natl Cancer Inst Monogr 1995;(18):35-9.

Mohiuddin SM, Hilleman DE. Gender and racial bias in clinical pharmacology trials [editorial]. Ann Pharmacother 1993 Jul-Aug;27(7-8):972-3. Comment on: Ann Pharmacother 1993 Jul-Aug;27(7-8):904-11.

Moody LE, Gregory SJ, Bocanegra T, Vasey F. Factors influencing post-menopausal African-American women's participation in a clinical trial. J Am Acad Nurse Pract 1995 Oct;7(10):483-8.

Morris RD, Munasinghe RL. Aggregation of existing geographic regions to diminish spurious variability of disease rates. Stat Med 1993 Oct;12(19-20):1915-29.

Mosby JA. Relevance of race or ethnic group in case reports [letter]. Am Fam Physician 1996 Apr;53(5):1530.

Moulton LH, Wolff MC, Brenneman G, Santosham M. Case-cohort analysis of case-coverage studies of vaccine effectiveness. Am J Epidemiol 1995 Nov 1;142(9):1000-6.

Mouton CP, Harris S, Rovi S, Solorzano P, Johnson MS. Barriers to black women's participation in cancer clinical trials. J Natl Med Assoc 1997 Nov;89(11):721-7.

Nacif de Brey V, Gonzalez VM. Recruiting for arthritis studies in hard-to-reach populations: a comparison of methods used in an urban Spanish-speaking community. Arthritis Care Res 1997 Feb;10(1):64-71.

Naranjo LE, Dirksen SR. The recruitment and participation of Hispanic women in nursing research: a learning process. Public Health Nurs 1998 Feb;15(1):25-9.

Nelson C. Cancer screening, clinical trials for African Americans still problematic [news]. J Natl Cancer Inst 1994 Dec 7;86(23):1753-4.

Ness RB, Nelson DB, Kumanyika SK, Grisso JA. Evaluating minority recruitment into clinical studies: how good are the data? Ann Epidemiol 1997 Oct;7(7):472-8.

Norton IM, Manson SM. Research in American Indian and Alaska Native communities: navigating the cultural universe of values and process. J Consult Clin Psychol 1996 Oct;64(5):856-60.

Novick A. One small ethical issue arising in ethnographic research. AIDS Public Policy J 1996 Fall;11(3):115-7.

Olivier S. Informed consent and transcultural research [editorial]. S Afr Med J 1995 Oct;85(10):984-5.

Osborne NG, Feit Marvin D. The use of race in medical research. JAMA 1992 Jan 8;267(2):275-9.

Padgett DK. Consideration of the ethnic factor in aging research--the time has never been better [editorial]. Gerontologist 1990 Dec;30(6):723-4.

Paskett ED, DeGraffinreid C, Tatum CM, Margitic SE. The recruitment of African-Americans to cancer prevention and control studies. Prev Med 1996 Sep-Oct;25(5):547-53.

Pavlik VN, Hyman DJ, Vallbona C, Dunn JK , Louis K, Dewey CM, Wieck L, Toronjo C. Response rates to random digit dialing for recruiting participants to an onsite health study. Public Health Rep 1996 Sep-Oct;111(5):444-50.

Payne-Johnson JC. Communications and aging. A case for understanding African Americans who are elderly. ASHA 1992 Jan;34(1):41-4. Published erratum appears in ASHA 1992 Apr;34(4):15.

Pettiway LE. Identifying, gaining access to, and collecting data on African-American drug addicts. NIDA Res Monogr 1993;130:258-79.

Phillips JM. Research for improving the health and well-being of the black community: implications for shaping a research agenda. J Natl Black Nurses Assoc 1994 Fall-Winter;7(2):21-8.

Pinn VW. The status of women's health research: where are African American women? J Natl Black Nurses Assoc 1996 Spring-Summer;8(1):8-19.

Pollard RQ. Cross-cultural ethics in the conduct of deafness research. Rehabil Psychol 1992 Summer;37(2):87-101.

Porter TL. The use of race in case presentations [letter]. Am J Psychiatry 1993 Jul;150(7):1129.

Powless Sage G. Drug prevention research with Native-American populations: some considerations. NIDA Res Monogr 1994;139:235-48.

Prince CS. Research on Indian reserves--an Indian perspective. Arctic Med Res 1991;Suppl:185-7.

Raine CS. What's in a name? [letter]. Can J Neurol Sci 1995 Aug;22(3):247.

Ramirez AG, McAlister A, Gallion KJ, Villarreal R. Targeting Hispanic populations: future research and prevention strategies. Environ Health Perspect 1995 Nov;103 Suppl 8:S287-90.

Recruiting black men to a clinical trial to evaluate prostate cancer screening--Detroit Michigan 1998. MMWR Morb Mortal Wkly Rep 1998 Aug 28;47(33):694-6.

Reynolds T. Panel grapples with the legacy of race medicine in research [news]. J Natl Cancer Inst 1997 Jun 4;89(11):758-61.

Reynolds T. Screening and prevention trials step up minority recruitment [news]. J Natl Cancer Inst 1996 Sep 18;88(18):1265-7.

Roberson NL. Clinical trial participation. Viewpoints from racial/ethnic groups. Cancer 1994 Nov 1;74(9 Suppl):2687-91.

Robinson SB, Ashley M, Haynes MA. Attitude of African-Americans regarding prostate cancer clinical trials. J Community Health 1996 Apr;21(2):77-87.

Rosenberg L, Adams-Campbell L, Palmer JR. The Black Women's Health Study: a follow-up study for causes and preventions of illness. J Am Med Womens Assoc 1995 Mar-Apr;50(2):56-8.

Rosenbloom AL, House DV, Winter WE. Non-insulin dependent diabetes mellitus (NIDDM) in minority youth: research priorities and needs. Clin Pediatr (Phila) 1998 Feb;37(2):143-52.

Sano M, Mackell JA, Ponton M, Ferreira P, Wilson J, Pawluczyk S, Pfeiffer E, Thomas RG, Jin S, Schafer K , Schittini M, Grundman M, Ferris SH , Thal LJ. The Spanish Instrument Protocol: design and implementation of a study to evaluate treatment efficacy Instruments for Spanish-speaking patients with Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord 1997;11 Suppl 2:S57-64.

Sasao T, Sue S. Toward a culturally anchored ecological framework of research in ethnic-cultural communities. Am J Community Psychol 1993 Dec;21(6):705-27.

Saunders E. Recruitment of African-American patients for clinical trials--the Allhat challenges. Antihypertensive and Lipid-lowering Trial to Prevent Heart Attack. J Natl Med Assoc 1995 Aug;87(8 Suppl):627-9.

Savage PJ, Harlan WR. Racial and ethnic diversity in obesity and other risk factors for cardiovascular disease: implications for studies and treatment. Ethn Dis 1991 Spring;1(2):200-11.

Sawyer L, Regev H, Proctor S, Nelson M, Messias D, Barnes D, Meleis AI. Matching versus cultural competence in research: methodological considerations. Res Nurs Health 1995 Dec;18(6):557-67.

Sayers S, Powers J. Missing values ignored [letter]. J Paediatr Child Health 1997 Apr;33(2):174; discussion 174-5. Comment on: J Paediatr Child Health 1996 Apr;32(2):99-102.

Scrimgeour D. Ethics are local: engaging cross-cultural variation in the ethics for clinical research [letter]. Soc Sci Med 1993 Oct;37(7):957-8. Comment on: Soc Sci Med 1992 Nov;35(9):1079-91.

Serrano LaVertu D, Linares AM. Ethical principles of biomedical research on human subjects: their application and limitations in Latin America and the Caribbean. Bull Pan Am Health Organ 1990;24(4):469-79.

Shavers-Hornaday VL, Lynch CF, Burmeister LF, Torner JC. Why are African Americans under-represented in medical research studies? Impediments to participation. Ethn Health 1997 Mar-Jun;2(1-2):31-45.

Sheldon TA, Parker H. Race and ethnicity in health research. J Public Health Med 1992 Jun;14(2):104-10.

Silva MC. The ethics of cultural diversity and culturally competent nursing education, practice, and research. NursingConnections 1994 Summer;7(2):52-6.

Singer M. Knowledge for use: anthropology and community-centered substance abuse research. Soc Sci Med 1993 Jul;37(1):15-25.

Smith R. Deception in research, and racial discrimination in medicine [editorial]. BMJ 1993 Mar 13;306(6879):668-9.

Snowden LR. Ethnic minority populations and mental health outcomes. New Dir Ment Health Serv 1996 Fall;(71):79-87.

Swanson GM, Ward AJ. Recruiting minorities into clinical trials: toward a participant-friendly system. J Natl Cancer Inst 1995 Dec 6;87(23):1747-59. Comment in: J Natl Cancer Inst 1996 Mar 20;88(6):377.

Tejeda HA, Green SB, Trimble EL, Ford L, High JL, Ungerleider RS, Friedman MA, Brawley OW. Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials. J Natl Cancer Inst 1996 Jun 19;88(12):812-6.

Thomas CR Jr, Pinto HA, Roach M 3rd, Vaughn CB. Participation in clinical trials: is it state-of-the-art treatment for African Americans and other people of color? [editorial]. J Natl Med Assoc 1994 Mar;86(3):177-82.

Thompson EE, Neighbors HW, Munday C, Jackson JS. Recruitment and retention of African American patients for clinical research: an exploration of response rates in an urban psychiatric hospital. J Consult Clin Psychol 1996 Oct;64(5):861-7.

Torzillo PJ. Politicised Aborigine health research [letter]. Med J Aust 1997 Nov 17;167(10):555-6.

Trimble JE. Ethnic specification, validation prospects, and the future of drug use research. Int J Addict 1990-91;25(2A):149-68; discussion 168-70.

Tseng AL. Anonymous HIV testing in the Canadian aboriginal population. Can Fam Physician 1996 Sep;42:1734-40. Comment in: Can Fam Physician 1996 Dec;42:2341-2, 2344.

Turbott J. Who should do cross-cultural research? [letter]. Aust N Z J Psychiatry 1998 Apr;32(2):302-3. Comment on: Aust N Z J Psychiatry 1997 Aug;31(4):496-503.

Centers for Disease Control and Prevention (US), Agency for Toxic Substances and Disease Registry. Policy on the inclusion of women and racial and ethnic minorities in externally awarded research; notice. Fed Regist 1995 Sep 15;60(179):47947-51.

van Wissen K, Williams C, Siebers R, Maling T. Maori health research. N Z Med J 1994 Apr 13;107(975):134-6.

Wagener DK. Ethical considerations in the design and execution of the National and Hispanic Health and Nutrition Examination Survey (HANES). Environ Health Perspect 1995 Apr;103 Suppl 3:75-80.

Walker AR. Desegregating health statistics: what should be done? [news]. Natl Med J India 1998 May-Jun;11(3):146-7.

Walker AR. Race, ethnicity, and health: how can greater understanding be attained? [letter]. Am J Clin Nutr 1997 Dec;66(6):1481-3. Comment on: Am J Clin Nutr 1997 Mar;65(3):831-6; Am J Clin Nutr 1997 Mar;65(3):887-8.

Walker AR, Sitas F, Cleaton-Jones PE, Vorster HH, Whittaker DE. Desegregating health statistics and health research in South Africa [letter]. S Afr Med J 1997 Mar;87(3):329-31 Published erratum appears in S Afr Med J 1997 Apr;87(4):478. Comment on: S Afr Med J 1996 Oct;86(10):1257-62. Comment in: S Afr Med J 1997 Dec;87(12):1701-4.

Walker AR, Sitas P, Cleaton-Jones PE, Vorster HH, Whittaker DE, Segal I. Desgregrating health statistics and health research in South Africa [letter]. S Afr Med J 1997 Dec;87(12):1701-4. Comment on: S Afr Med J 1997 Mar;87(3):329-31.

Wallace RW. The Human Genome Diversity Project: medical benefits versus ethical concerns. Mol Med Today 1998 Feb;4(2):59-62.

Warnecke RB, Johnson TP, Chavez N, Sudman S, O'Rourke DP, Lacey L, Horm J. Improving question wording in surveys of culturally diverse populations. Ann Epidemiol 1997 Jul;7(5):334-42.

Watson T. Affirmative action for clinical trials [news]. Science 1993 May 7;260(5109):746.

Wax ML. The ethics of research in American Indian communities. Am Indian Q 1991 Fall;15(4):431-56.

Weissman A. Race and phobia [letter]. J Nerv Ment Dis 1991 May;179(5):305. Comment on: J Nerv Ment Dis 1990 Jul;178(7):434-41.

Welsh KA, Ballard E, Nash F, Raiford K, Harrell L. Issues affecting minority participation in research studies of Alzheimer disease. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:38-48.

Wermeling DP, Selwitz AS. Current issues surrounding women and minorities in drug trials. Ann Pharmacother 1993 Jul-Aug;27(7-8):904-11. Comment in: Ann Pharmacother 1993 Jul-Aug;27(7-8):972-3.

Whelton PK, Lee JY, Kusek JW, Charleston J, DeBruge J, Douglas M, Faulkner M, Greene PG, Jones CA, Kiefer S , Kirk KA, Levell B, Norris K, Powers SN, Retta TM, Smith DE, Ward H. Recruitment experience in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study. Control Clin Trials 1996 Aug;17(4 Suppl):17S-33S.

White LL, Goldberg HI, Gilbert TJ, Ballew C, Mendlein JM, Peter DG, Percy CA, Mokdad AH. Rationale, design and methodology for the Navajo Health and Nutrition Survey. J Nutr 1997 Oct;127(10 Suppl):2078S-2084S.

Williams DR. The concept of race in Health Services Research: 1966 to 1990. Health Serv Res 1994 Aug;29(3):261-74.

Williams DR. Race/ethnicity and socioeconomic status: measurement and methodological issues. Int J Health Serv 1996;26(3):483-505.

Williams LM. Ethics and nursing research: meeting the needs of indigenous peoples. Nurs Inq 1998 Mar;5(1):25-31.

Wolinsky H. Steps still being taken to undo damage of America's Nuremberg [news]. Ann Intern Med 1997 Aug 15;127(4):I43-4.

Yeo G. Ethical considerations in Asian and Pacific Island elders. Clin Geriatr Med 1995 Feb;11(1):139-52.

Young TK. Ethical issues in health research among circumpolar indigenous populations [editorial]. Arctic Med Res 1995 Jul;54(3):114-5.

Yu ES, Liu WT. US National Health Data on Asian Americans and Pacific Islanders: a research agenda for the 1990s. Am J Public Health 1992 Dec;82(12):1645-52.

Zahm SH, Pottern LM, Lewis DR, Ward MH, White DW. Inclusion of women and minorities in occupational cancer epidemiologic research. J Occup Med 1994 Aug;36(8):842-7.

Zambrana RE. The role of Latino/Hispanic communities in health services research: strategies for a meaningful partnership. J Med Syst 1996 Oct;20(5):317-28.
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## Special or vulnerable populations - Minorities and cross-cultural issues - Books

A partnership for health. Minorities and biomedical research. Bethesda (MD): National Institutes of Health, National Institute of Allergy and Infectious Diseases; 1992. 25 p.

Duster T. Backdoor to eugenics. New York: Routledge; 1990. 201 p.

Flack H, Pellegrino ED, editors. African-American perspectives on biomedical ethics. Washington: Georgetown University Press; c1992. 203 p.

Implementation of the NIH guidelines on the inclusion of women and minorities as subjects in clinical research, FY 1995-1996: advisory council reports certifying compliance. Bethesda (MD): National Institutes of Health, Office of Research on Women's Health, NIH Tracking/Inclusion Committee; 1997. 1 vol.

Kirmayer LJ. Emerging trends in research on mental health among Canadian aboriginal peoples: a report prepared for the Royal Commission on Aboriginal Peoples. Rev. final version. Montreal: Sir Mortimer B. Davis-Jewish General Hospital, Institute of Community & Family Psychiatry, Culture & Mental Health Research Unit; 1994? 119 p. (Report. Culture & Mental Health Research Unit; no. 2).

Outreach notebook for the NIH guidelines on inclusion of women and minorities as subjects in clinical research. Bethesda (MD): National Institutes of Health, 1994. 37 p.

Pellegrino ED, Mazzarella P, Corsi P, editors. Transcultural dimensions in medical ethics. Papers based on proceedings of the Transcultural Dimensions in Medical Ethics Symposium held at the National Academy of Sciences; 1990 Apr 26-27; Washington, DC. Frederick (MD): University Pub Group; 1992. 221 p.

Pletsch PK. Cultural values and health research: a methods conference. Milwaukee: University of Wisconsin; 1994.

Tucker WH. The science and politics of racial research. Urbana: University of Illinois Press; 1994. 371 p.

Walker SR, Lumley CE, McAuslane JAN. The relevance of ethnic factors in the clinical evaluation of medicines. Boston: Kluwer Academic; c1994. 262 p. (CMR workshop series).
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## Special or vulnerable populations - Children and adolescents - Journal Articles

Abramovitch R, Freedman JL, Henry K, Van Brunschot M. Children's capacity to agree to psychological research: knowledge of risks and benefits and voluntariness. Ethics Behav 1995;5(1):25-48.

Ackerman TF. The ethics of phase I pediatric oncology trials. IRB Rev Hum Subj Res 1995 Jan-Feb;17(1):1-5.

Ackerman TF. Nontherapeutic research procedures involving children with cancer. J Pediatr Oncol Nurs 1994 Jul;11(3):134-6.

Ackerman TF. Phase I pediatric oncology trials. J Pediatr Oncol Nurs 1995 Jul;12(3):143-5.

Ackerman TF. Protectionism and the new research imperative in pediatric AIDS. IRB Rev Hum Subj Res 1990 Sep-Oct;12(5):1-5.

Akers JA, Bell SK. Should children be used as research subjects? Nurs Forum 1994 Jul-Sep;29(3):28-33.

Alcaraz R, Klonoff EA, Landrine H. The effects on children of participating in studies of minors' access to tobacco. Prev Med 1997 Mar-Apr;26(2):236-40.

Alderson P. Did children change, or the guidelines? Bull Med Ethics 1992 Aug:21-8.

Alderson P. 'Will you help us with our research?'. Arch Dis Child 1995 Jun;72(6):541-2.

Aman MG, Wolford PL. Consumer satisfaction with involvement in drug research: a social validity study. J Am Acad Child Adolesc Psychiatry 1995 Jul;34(7):940-5.

American Academy of Pediatrics, Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995 Feb;95(2):286-94.

Anderson B, Hall B. Parents' perceptions of decision making for children. J Law Med Ethics 1995 Spring;23(1):15-9.

Arnold LE, Stoff DM, Cook E Jr, Cohen DJ, Kruesi M, Wright C, Hattab J, Graham P, Zametkin A, Castellanos FX, et al. Ethical issues in biological psychiatric research with children and adolescents. J Am Acad Child Adolesc Psychiatry 1995 Jul;34(7):929-39.

Autret E, Dutertre JP, Barbier P, Jonville AP, Pierre F, Berger C. Parental opinions about biomedical research in children in Tours, France. Dev Pharmacol Ther 1993;20(1-2):64-71.

Beardsmore CS. Ethical aspects of respiratory research in infancy and early childhood. Pediatr Pulmonol 1998 Jul;26(1):64-8.

Belzer EG, McIntyre L, Simpson C, Officer S, Stadey N. A method to increase informed consent in school health research. J Sch Health 1993 Sep;63(7):316-7.

Berglund CA. Children in medical research: Australian ethical standards. Child Care Health Dev 1995 Mar;21(2):149-59.

Bjune G, Arnesen O. Problems related to informed consent from young teenagers participating in efficacy testing of a new vaccine. IRB Rev Hum Subj Res 1992;14(5):6-9.

Brooks-Gunn J, Rotheram-Borus MJ. Rights to privacy in research: adolescents versus parents. Ethics Behav 1994;4(2):109-21.

Bulford R. Children have rights too. BMJ 1997 May 10;314(7091):1421-2.

Butler D. French suspend child research pending review [news]. Nature 1993 Feb 11;361(6412):481.

Capron C. Consent laws [letter]. Nature 1993 Mar 11;362(6416):102. Comment on: Nature 1993 Jan 14;361(6408):102.

Chan KW, Gajewski JL, Supkis D Jr, Pentz R, Champlin R, Bleyer WA. Use of minors as bone marrow donors: current attitude and management. A survey of 56 pediatric transplantation centers. J Pediatr 1996 May;128(5 Pt 1):644-8.

Choudhry S. Review of legal instruments and codes on medical experimentation with children. Camb Q Healthc Ethics 1994 Fall;3(4):560-72.

Consent form for paediatric research [news]. Bull Med Ethics 1992 Nov;93:6.

Crigger BJ. You read it first here. IRB Rev Hum Subj Res 1992;14(5):10-1.

Cunningham N, Hutchinson S. Neonatal nurses and issues in research ethics. Neonatal Netw 1990 Apr;8(5):29-48.

de Martino M, Galli L, Guarino Amato A, Vierucci A. Human immunodeficiency virus type 1 infection, clinical trials and ethics in paediatrics. Acta Paediatr Suppl 1997 Jun;421:78-85.

Dogramaci I. Ethics in pediatric research. Turk J Pediatr 1993 Oct-Dec;35(4):245-7.

Evans D. The investigation of life-threatening child abuse and Munchausen syndrome by proxy. J Med Ethics 1995 Feb;21(1):9-13. Comment in: J Med Ethics 1995 Jun;21(3):131-2.

Evans M. Conflicts of interest in research on children. Camb Q Healthc Ethics 1994 Fall;3(4):549-59.

Field D. Ethics of consent for babies in randomised clinical trials. The Steering Committee of the Collaborative UK ECMO Trial [letter]. Lancet 1995 May 27;345(8961):1370. Comment on: Lancet 1995 Apr 1;345(8953):805-6.

Fisher CB. Integrating science and ethics in research with high-risk children and youth. Soc Policy Rep Soc Res Child Dev 1993 Winter;7(4):1-27.

Freedman B, Fuks A, Weijer C. In loco parentis. Minimal risk as an ethical threshold for research upon children. Hastings Cent Rep 1993 Mar-Apr;23(2):13-9.

Freeman WL. Research with radiation and healthy children: greater than minimal risk. IRB Rev Hum Subj Res 1994;16(5):1-5.

Friman PC. Take away their hammer: logical and ethical problems in Range and Cotton's Reports of assent and permission in research with children: illustrations and suggestions. Ethics Behav 1995;5(4):349-53.

Gamble SA. The ethics of research in the neonatal intensive care unit. Nurs Prax N Z 1996 Nov;11(3):47-9.

Gans JE, Brindis CD. Choice of research setting in understanding adolescent health problems. J Adolesc Health 1995 Nov;17(5):306-13.

Garralda E. Venepuncture distress and research in childhood [letter]. Lancet 1993 Mar 27;341(8848):832.

Gidding SS, Camp D, Flanagan MH, Kowalski JA, Lingl LL, Silverman BL, Langman CB. A policy regarding research in healthy children. J Pediatr 1993 Dec;123(6):852-5.

Gillon R. Covert surveillance by doctors for life-threatening Munchausen's syndrome by proxy [editorial]. J Med Ethics 1995 Jun;21(3):131-2. Comment on: J Med Ethics 1995 Feb;21(1):9-13; J Med Ethics 1995 Apr;21(2):104-5, 115.

Glantz LH. Conducting research with children: legal and ethical issues. J Am Acad Child Adolesc Psychiatry 1996 Oct;35(10):1283-91.

Glantz LH. Research with children. Am J Law Med. 1998;24(2-3):213-44

Goodman GS, Tobey AE. Ethical issues in child witness research [letter]. Child Abuse Negl 1994 Mar;18(3):290-3.

Gordon B, Prentice E, Reitemeier P. The use of normal children as participants in research on therapy. IRB Rev Hum Subj Res 1996;18(3):5-8.

Gordon VM, Bonkovsky FO. Family dynamics and children in medical research. J Clin Ethics 1996 Winter;7(4):349-54; discussion 362-4. Comment in: J Clin Ethics 1996 Winter;7(4):355-61.

Grodin MA, Sassower R. Whose patient is this, anyway? [case study]. IRB Rev Hum Subj Res 1987 Mar-Apr;9(2):6-7.

Guidelines for adolescent health research. Society for Adolescent Medicine. J Adolesc Health 1995 Nov;17(5):264-9. Comment in: J Adolesc Health 1995 Nov;17(5):259.

Guidelines for the ethical conduct of medical research involving children. BPA Ethics Advisory Committee. Bull Med Ethics 1992 Aug:13-20.

Hall D. Reviewing research involving children: the practice of British research ethics committees. IRB Rev Hum Subj Res 1988 Mar-Apr;10(2):1-5.

Harth SC, Johnstone RR, Thong YH. The psychological profile of parents who volunteer their children for clinical research: a controlled study. J Med Ethics 1992 Jun;18(2):86-93.

Harth SC, Thong YH. Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med 1995 Jun;40(11):1573-7.

Harth SC, Thong YH. Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med 1995 Dec;41(12):1647-51.

Harth SC, Thong YH. Sociodemographic and motivational characteristics of parents who volunteer their children for clinical research: a controlled study. BMJ 1990 May 26;300(6736):1372-5.

Hoagwood K. The certificate of confidentiality at the National Institute of Mental Health: discretionary considerations in its applicability in research on child and adolescent mental disorders. Ethics Behav 1994;4(2):123-31.

Jacqz-Aigrain E. Ethical aspects of pediatric therapeutic clinical trials. Acta Gastroenterol Belg 1998 Apr-Jun;61(2):243-4.

Kachoyeanos MK. Ethical perspectives on research involving healthy children. MCN Am J Matern Child Nurs 1995 Sep-Oct;20(5):285.

Kauffman RE. Drug trials in children: ethical, legal, and practical issues. J Clin Pharmacol 1994 Apr;34(4):296-9.

Kauffman RE, Kearns GL. Pharmacokinetic studies in paediatric patients. Clinical and ethical considerations. Clin Pharmacokinet 1992 Jul;23(1):10-29. Comment in: Clin Pharmacokinet 1992 Jul;23(1):1-9.

Keens TG, Oki GSF, Gilsanz V, Roe TF, Goodman W, Tsang RC, Specker BL, Saenger EL. Does radiation research in healthy children pose greater than minimal risk? IRB Rev Hum Subj Res 1994;16(5):5-10. Commentaries on W.L. Freeman, p. 1-5.

Kent G. Volunteering children for bone marrow donation. Studies show large discrepancies between views of surrogate decision makers and patients [letter]. BMJ 1996 Jul 6;313(7048):49-50.

Kodish ED, Pentz RD, Noll RB, Ruccione K, Buckley J, Lange BJ. Informed consent in the Childrens Cancer Group: results of preliminary research. Cancer 1998 Jun 15;82(12):2467-81.

Koren G. Ethical boundaries of medical research in infants and children in the 80s: analysis of rejected protocols and a new solution for drug studies. Dev Pharmacol Ther 1990;15(3-4):130-41.

Koren G. The eutectic mixture of local anesthetics: changing the risk-benefit ratio in pediatric research. IRB Rev Hum Subj Res 1992 Mar-Apr;14(2):4-6.

Koren G, Carmeli DB, Carmeli YS, Haslam R. Maturity of children to consent to medical research: the babysitter test. J Med Ethics 1993 Sep;19(3):142-7.

Koren G, Pastuszak A. Medical research in infants and children in the eighties: analysis of rejected protocols. Pediatr Res 1990 May;27(5):432-5.

Lantos JD. Was the UK collaborative ECMO trial ethical? Paediatr Perinat Epidemiol 1997 Jul;11(3):264-8.

Lantos JD, Frader J. Extracorporeal membrane oxygenation and the ethics of clinical research in pediatrics. N Engl J Med 1990 Aug 9;323(6):409-13.

Lau YL, Yeung CY. Parental perception of the effect of venepuncture in preschool children in non-therapeutic research. J Paediatr Child Health 1992 Aug 4;28(4):294-6.

Laughren TP. Regulatory issues in pediatric psychopharmacology. J Am Acad Child Adolesc Psychiatry 1996 Oct;35(10):1276-82.

Lee L. Ethical issues related to research involving children. J Pediatr Oncol Nurs 1991 Jan;8(1):24-9.

Leikin S. Minors' assent, consent, or dissent to medical research. IRB Rev Hum Subj Res 1993 Mar-Apr;15(2):1-7.

Leikin S. The role of adolescents in decisions concerning their cancer therapy. Cancer 1993 May 15;71(10 Suppl):3342-6.

Levene M, Wright I, Griffiths G. Is informed consent in neonatal randomised controlled trials ritual? [letter]. Lancet 1996 Feb 17;347(8999):475.

Levine C. Children in HIV/AIDS clinical trials: still vulnerable after all these years. Law Med Health Care 1991 Fall-Winter;19(3-4):231-7.

Levine RJ. Adolescents as research subjects without permission of their parents or guardians: ethical considerations. J Adolesc Health 1995 Nov;17(5):287-97.

Lilleyman JS. Informed consent: how informed and consent to what? [editorial]. Pediatr Hematol Oncol 1995 Nov-Dec;12(6):xiii-xvi.

Liss MB. Child abuse: is there a mandate for researchers to report? Ethics Behav 1994;4(2):133-46.

Litt IF. Ethics and research on adolescents [editorial]. J Adolesc Health 1992 Dec;13(8):640. Comment in: J Adolesc Health 1995 Nov;17(5):259.

Lowes L. Paediatric nursing and research ethics: is there a conflict? J Clin Nurs 1996 Mar;5(2):91-7.

Lynch A. Ethics of research involving children. Ann R Coll Physicians Surg Can 1992 Oct;25(6):371-2.

Maloney DM. Bill requires express written consent, not passive consent [news]. Hum Res Rep 1995 Jul;10(7):6.

Maloney DM. Law would remove ability of institutional review boards to waive written consent [news]. Hum Res Rep 1996 Aug;11(8):1-2.

Mammel KA, Kaplan DW. Research consent by adolescent minors and institutional review boards. J Adolesc Health 1995 Nov;17(5):323-30.

Mason S. Obtaining informed consent for neonatal randomised controlled trials--an elaborate ritual? Arch Dis Child Fetal Neonatal Ed 1997 May;76(3):F143-5. Comment in: Arch Dis Child Fetal Neonatal Ed 1998 Mar;78(2):F156-7.

Mason S, Brown J, Levene M. What is this thing called randomise? Lancet 1997 Nov 15;350(9089):1416. Comment in: Lancet 1998 Feb 14;351(9101):530.

McCormick MC. Ethics of consent for babies in randomised clinical trials [letter]. Lancet 1995 May 27;345(8961):1370-1. Comment on: Lancet 1995 Apr 1;345(8953):805-6.

McLean S. Medical experimentation with children. Int J Law Fam 1992 Apr;6(1):173-91.

McNutt B. The under-enrollment of HIV-infected foster children in clinical trials and protocols and the need for corrective state action. Am J Law Med 1994;20(3):231-49.

Medical Research Council (Great Britain). MRC guidance on research ethics. Bull Med Ethics 1992 Mar;76:8-10.

Medical Research Council (Great Britain). MRC guidance on research ethics: children and the mentally incapacitated. Int J Bioethics 1992 Sep;3(3):185-6.

Meran JG. Ethics of consent for babies in randomised clinical trials [letter]. Lancet 1995 May 27;345(8961):1370. Comment on: Lancet 1995 Apr 1;345(8953):805-6.

Miller SK. Ethics lobby forces rethink on growth hormones [news]. New Sci 1992 Aug 15;135(1834):9.

Modi N. Clinical trials and neonatal intensive care [letter]. Arch Dis Child Fetal Neonatal Ed 1994 May;70(3):F231-2. Comment in: Arch Dis Child Fetal Neonatal Ed 1995 Jan;72(1):F79.

Modi N. Informed consent in clinical trials. Informed consent difficult in paediatric intensive care [letter]. BMJ 1993 Dec 4;307(6917):1495. Comment on: BMJ 1993 Nov 6;307(6913):1199-201.

Modi N. Neonatal research [letter]. Lancet 1998 Feb 14;351(9101):530. Comment on: Lancet 1997 Nov 15;350(9089):1416.

Modi N, Carr R. Informed consent for observational research in children [letter]. Lancet 1996 Jul 6;348(9019):68. Comment on: Lancet 1996 May 25;347(9013):1423.

Morton CT. Is research in normal and ill children involving radiation exposure ethical? [letter]. Arch Gen Psychiatry 1996 Nov;53(11):1059-61. Comment on: Arch Gen Psychiatry 1993 May;50(5):333-40.

Mott MG, Chambers TL. Distress due to venepuncture [letter]. Lancet 1993 Feb 6;341(8841):373.

Munir K, Earls F. Ethical principles governing research in child and adolescent psychiatry. J Am Acad Child Adolesc Psychiatry 1992 May;31(3):408-14. Comment in: J Am Acad Child Adolesc Psychiatry 1993 Mar;32(2):471-2.

Nahata MC. Conducting pediatric research. Ann Pharmacother 1994 Sep;28(9):1105-8. Comment in: Ann Pharmacother 1995 Oct;29(10):1052.

Nassiry L. Health science research ethics and the law: research involving children. NCBHR Commun 1993 Nov-Dec;4(2):11-3.

National Council on Bioethics in Human Research (Canada). Ethics of research involving children: proceedings of a national workshop. NCBHR Commun 1993 Apr-May;4(1):12-41.

National Council on Bioethics in Human Research (Canada). Revised recommendations of the NCBHR "Report on Research Involving Children". NCBHR Commun 1993 Apr-May;4(1):8-11.

Neargarder T. Informed consent and use of artificial baby milk [letter]. J Hum Lact 1993 Mar;9(1):6-7. Comment on: J Hum Lact 1992 Jun;8(2):61-2; J Hum Lact 1992 Jun;8(2):67-72.

Oberman M. Minor rights and wrongs. J Law Med Ethics 1996 Summer;24(2):127-38.

Oesterheld JR, Fogas B, Rutten S. Ethical standards for research on children [letter]. J Am Acad Child Adolesc Psychiatry 1998 Jul;37(7):684-5.

Olds RS, Symons CW. Recommendations for obtaining cooperation to conduct school-based research. J Sch Health 1990 Mar;60(3):96-8.

Orr RD, Perkin RM. Clinical ethics consultations with children. J Clin Ethics 1994 Winter;5(4):323-8.

Osmun WE. Volunteering children for bone marrow donation. Children's views should have been represented in discussion [letter]. BMJ 1996 Jul 6;313(7048):50.

Paavilainen E, Astedt-Kurki P, Paunonen M. Ethical problems in research on families who are abusing children. Nurs Ethics 1998 May;5(3):200-5.

Paul M. Informed consent in medical research. Children from the age of 5 should be presumed competent [letter]. BMJ 1997 May 17;314(7092):1480. Comment on: BMJ 1997 Apr 12;314(7087):1107-11.

Pellegrino ED. Commentary. Clinical judgment, scientific data, and ethics: antidepressant therapy in adolescents and children. J Nerv Ment Dis 1996 Feb;184(2):106-8.

Phillips SR. Asking the sensitive question: the ethics of survey research and teen sex. IRB Rev Hum Subj Res 1994 Nov-Dec;16(6):1-7.

Pierro A, Spitz L. Informed consent in clinical research: the crisis in paediatrics [letter]. Lancet 1997 Jun 7;349(9066):1703.

Pilpel D, Leavitt FJ, Elizur-Leiberman E. Ethical and cross cultural questions concerning pediatric clinical trials. Control Clin Trials 1996 Jun;17(3):201-8.

Postlethwaite RJ, Reynolds JM, Wood AJ, Eminson DM. Recruiting patients to clinical trials: lessons from studies of growth hormone treatment in renal failure [letter]. Arch Dis Child 1996 Jan;74(1):91. Comment on: Arch Dis Child 1995 Jul;73(1):30-5.

Postlethwaite RJ, Reynolds JM, Wood AJ, Evans JH, Lewis MA, Eminson DM. Recruiting patients to clinical trials: lessons from studies of growth hormone treatment in renal failure. Arch Dis Child 1995 Jul;73(1):30-5. Comment in: Arch Dis Child 1996 Jan;74(1):91.

Pratt CB. The conduct of phase I-II clinical trials in children with cancer. Med Pediatr Oncol 1991;19(4):304-9.

Prentice ED, Antonson DL, Jameton A, Graber B, Sears T. Can children be enrolled in a placebo-controlled randomized clinical trial of synthetic growth hormone? IRB Rev Hum Subj Res 1989 Jan-Feb;11(1):6-10.

Proposed regulations would mandate pediatric testing for many drugs [news]. Am J Health Syst Pharm 1997 Oct 1;54(19):2152.

Prows CA, McCain GC. Parental consent for bone marrow transplantation in the case of genetic disorders. J Soc Pediatr Nurs 1997 Jan-Mar;2(1):9-18; quiz 19-20.

Puskar KR, Weaver PL, DeBlassio K. Nursing research in a school setting. J Sch Nurs 1994 Dec;10(4):8, 10-4.

Range LM, Cotton CR. Assent and permission rejoinder. Ethics Behav 1995;5(4):345-7. Comment on: Ethics Behav 1995;5(4):333-4.

Range LM, Cotton CR. Reports of assent and permission in research with children: illustrations and suggestions. Ethics Behav 1995;5(1):49-66.

Rhodes AM. Curran v. Bosze: bone marrow donation. MCN Am J Matern Child Nurs 1992 Mar-Apr;17(2):67.

Roberts MC, Buckloh LM. Five points and a lament about Range and Cotton's Reports of assent and permission in research with children: illustrations and suggestions. Ethics Behav 1995;5(4):333-44.

Robinson W. Commentary on family dynamics and children in medical research. J Clin Ethics 1996 Winter;7(4):362-4. Comment on: J Clin Ethics 1996 Winter;7(4);349-54.

Rogers AS, D'Angelo L, Futterman D. Guidelines for adolescent participation in research: current realities and possible resolutions. IRB Rev Hum Subj Res 1994 Jul-Aug;16(4):1-6.

Rowell M, Zlotkin S. The ethical boundaries of drug research in pediatrics. Pediatr Clin North Am 1997 Feb;44(1):27-40.

Salva P, Aguado MA. Clinical trials in paediatrics [letter]. Lancet 1990 Dec 15;336(8729):1513.

Santelli J. Human subjects protection and parental permission in adolescent health research. J Adolesc Health 1997 Dec;21(6):384-7. Comment on: J Adolesc Health 1997 Dec;21(6):376-83.

Santelli JS, Rosenfeld WD, DuRant RH, Dubler N, Morreale M, English A, Rogers AS. Guidelines for adolescent health research: a position paper of the Society for Adolescent Medicine. J Adolesc Health 1995 Nov;17(5):270-6.

Scarr S. Ethical problems in research on risky behaviors and risky populations. Ethics Behav 1994;4(2):147-55.

Scott-Jones D. Ethical issues in reporting and referring in research with low-income minority children. Ethics Behav 1994;4(2):97-108.

Sheldon M. Adolescent medicine: introduction [to a set of articles by S.E. Zinner, R.E. Ladd and E.N. Forman, and R.F. Weir and J.R. Horton]. Theor Med 1995 Dec;16(4):321-22.

Should deaths of neonates in trial have been more openly reported? [news]. Bull Med Ethics 1993;93:3-5.

Sieber JE. Issues presented by mandatory reporting requirements to researchers of child abuse and neglect. Ethics Behav 1994;4(1):1-22.

Sikand A, Schubiner H, Simpson PM. Parent and adolescent perceived need for parental consent involving research with minors. Arch Pediatr Adolesc Med 1997 Jun;151(6):603-7.

Silverman WA. The future of clinical experimentation in neonatal medicine. Pediatrics 1994 Dec;94(6 Pt 1):932-8.

Snowdon C, Garcia J, Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med 1997 Nov;45(9):1337-55.

Stephenson T, Walker DA. Gaining patients' consent. Telling parents all relevant details might reduce recruitment of children to trials [letter]. BMJ 1996 Aug 10;313(7053):362-3. Comment on: BMJ 1996 Jun 8;312(7044);1479. Comment in: BMJ 1997 Jan 4;314(7073):74-5.

Stone R. Clinical research: NIH adds an extra layer of review for sensitive grants [news]. Science 1993 Mar 26;259(5103):1820-1.

Strasburger VC. Parental permission in adolescent health research [letter]. J Adolesc Health 1998 May;22(5):362. Comment on: J Adolesc Health 1997 Dec;21(6):376-83; J Adolesc Health 1997 Dec;21(6):384-7.

Susman EJ, Dorn LD, Fletcher JC. Participation in biomedical research: the consent process as viewed by children, adolescents, young adults, and physicians. J Pediatr 1992 Oct;121(4):547-52.

Tait AR, Voepel-Lewis T, Siewert M, Malviya S. Factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research. Anesth Analg 1998 Jan;86(1):50-3.

Tarnowski KJ, Allen DM, Mayhall C, Kelly PA. Readability of pediatric biomedical research informed consent forms. Pediatrics 1990 Jan;85(1):58-62.

Tauer CA. The NIH trials of growth hormone for short stature. IRB Rev Hum Subj Res 1994 May-Jun;16(3):1-9.

Thompson RA. Behavioral research involving children: a developmental perspective on risk. IRB Rev Hum Subj Res 1990 Mar-Apr;12(2):1-6.

Thompson RA. Vulnerability in research: a developmental perspective on research risk. Child Dev 1990 Feb;61(1):1-16.

Thurber FW, Deatrick JA, Grey M. Children's participation in research: their right to consent. J Pediatr Nurs 1992 Jun;7(3):165-70.

Truog RD. Randomized controlled trials: lessons from ECMO. Clin Res 1992;40(3):519-27.

Visser HK. Paediatrics in The Netherlands: challenges for today and tomorrow. Arch Dis Child 1993 Aug;69(2):251-5.

Walterspiel JN. Informed consent: influence on patient selection among critically ill premature infants. Pediatrics 1990 Jan;85(1):119-21.

Weimer D. Beyond parens patriae: assuring timely, informed, compassionate decisionmaking for HIV-positive children in foster care. Univ Miami Law Rev 1991 Nov;46(2):379-402.

Weir RF, Horton JR. Genetic research, adolescents, and informed consent. Theor Med 1995 Dec;16(4):347-73.

Weisz V, Robbennolt JK. Risks and benefits of pediatric bone marrow donation: a critical need for research. Behav Sci Law 1996 Autumn;14(4):375-91.

Westcott HL. On sensitivity and ethical issues in child witness research [letter]. Child Abuse Negl 1994 Mar;18(3):287-90. Comment on: Child Abuse Negl 1992 Nov-Dec;16(6):779-96.

White GB. Human growth hormone: the dilemma of expanded use in children. Kennedy Inst Ethics J 1993 Dec;3(4):401-9.

White RJ. Ethical issues in pediatric surgical research. America 1997 Feb 8;176(4):17-20.

Williams PC. Ethical principles in federal regulations: the case of children and research risks. J Med Philos 1996 Apr;21(2):169-86.

Your baby is in a trial [editorial]. Lancet 1995 Apr 1;345(8953):805-6.

Zinner SE. The elusive goal of informed consent by adolescents. Theor Med 1995 Dec;16(4):323-31.
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## Special or vulnerable populations - Children and adolescents - Books

Alderson P, Mayall B. Children's decisions in health care and research. London: University of London, Institute of Education, Social Science Research Unit; 1994 Jul. 63 p.

Bernard C. Legal aspects of research and clinical practice with children. Questions de droit touchant la recherche et la pratique clinique aupres des enfants. Canada: The National Council on Bioethics in Human Research; 1992. 15 p.

Burgess MM, Woodrow BE. Contemporary issues in paediatric ethics. Lewiston (NY): E. Mellen Press; 1991. 109 p.

English A. State minor consent statutes: a summary. Cincinnati: Children's Hospital Medical Center, Division of Adolescent Medicine, National Center for Youth Law for the Center for Continuing Education in Adolescent Health; 1995. 197 p.

Grodin MA, Glantz LH, editors. Children as research subjects: science, ethics, and law. New York: Oxford University Press; 1994. 258 p.

Guidelines for the ethical conduct of medical research involving children. London: British Paediatric Association, Ethics Advisory Committee; 1992 Aug. 18 p.

Hoagwood K, Jensen PS, Fisher CB, editors. Ethical issues in mental health research with children and adolescents. Mahwah (NJ): Erlbaum Associates; 1996. 313 p.

Koren G, editor. Textbook of ethics in pediatric research. Ethics in pediatric research. Original ed. Malabar (FL): Krieger Pub. Co.; 1993. 336 p.

Miller JN. Reflections on research involving children. Ottawa (Canada): The Council on Bioethics in Human Research; 1993.

Report on research involving children. Ottawa: National Council on Bioethics in Human Research; 1992. 64 p. Prepared by the Consent Panel Task Force of the National Council on Bioethics in Human Research with the support of the Canadian Paediatric Society.

Stanley B, Sieber JE. Social research on children and adolescents: ethical issues. Newbury Park (CA): Sage Publications; 1992. 205 p.

The ethical conduct of research on children. London: Medical Research Council, Working Party on Research on Children; 1991 Dec. 21 p.
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## Special or vulnerable populations - Cognitively impaired - Journal Articles

Abbing HDCR. Medical research involving incapacitated persons: what are the standards? Eur J Health Law 1994;1(2):147-60.

Addington D, Williams R, Lapierre Y, el-Guebaly N. Placebos in clinical trials of psychotropic medication. Can J Psychiatry 1997 Apr;42(3):6.

Adelman LS. The ethics of research in incurable disease. R I Med 1992 Mar;75(3):133-5.

Adler MW. Human subject issues in drug abuse research. College on Problems of Drug Dependence. Drug Alcohol Depend 1995 Feb;37(2):167-75.

Angrist B. Ethical issues regarding prospective studies of amphetamine psychosis. J Calif Alliance Ment Ill 1994;5(1):32-5.

Appelbaum PS. Consent and coercion: research with involuntarily treated persons with mental illness or substance abuse. Account Res 1995;4(1):69-79.

Appelbaum PS. Drug-free research in schizophrenia: an overview of the controversy. IRB Rev Hum Subj Res 1996;18(1):1-5.

Appelbaum PS. Patients' competence to consent to neurobiological research. Account Res 1996;4(3-4):241-51.

Appelbaum PS. Psychiatric research and the incompetent subject. Psychiatr Serv 1997 Jul;48(7):873-4.

Appelbaum PS. Rethinking the conduct of psychiatric research. Arch Gen Psychiatry 1997 Feb;54(2):117-20. Comment on: Arch Gen Psychiatry 1997 Feb;54(2):105-11; Arch Gen Psychiatry 1997 Feb;54(2):113-6; Arch Gen Psychiatry 1997 Feb;54(2):121-3. Comment in: Arch Gen Psychiatry 1997 Feb;54(2):121-3.

Arboleda-Florez J, Weisstub DN. Ethical research with the mentally disordered. Can J Psychiatry 1997 Jun;42(5):485-91.

Armstrong E. Safety of patients participating in drug trials. Use of placebo in trials of drugs for mental illness should be debated [letter]. BMJ 1998 Sep 19;317(7161):818.

Backlar P. Advance directives for subjects of research who have fluctuating cognitive impairments due to psychotic disorders (such as schizophrenia). Community Ment Health J 1998 Jun;34(3):229-40.

Baskin SA, Morris J, Ahronheim JC, Meier DE, Morrison RS. Barriers to obtaining consent in dementia research: implications for surrogate decision-making. J Am Geriatr Soc 1998 Mar;46(3):287-90.

Baudouin JL. Biomedical experimentation on the mentally handicapped: ethical and legal dilemmas. Med Law 1990;9(4):1052-61.

Becker D, Kahana Z. Informed consent in demented patients: a question of hours. Med Law 1993;12(3-5):271-6.

Becker JC. A mother's testimony. J Calif Alliance Ment Ill 1994;5(1):17.

Bein PM. Surrogate consent and the incompetent experimental subject. Food Drug Cosmet Law J 1991 Sep;46(5):739-71.

Beltran JE. Response to special section: ethical decision making and persons with mental retardation (CQ vol 3, no 2). Camb Q Healthc Ethics 1995 Winter;4(1):100-2.

Berg JW. Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines. J Law Med Ethics 1996 Spring;24(1):18-35.

Berghmans RL. Advance directives for non-therapeutic dementia research: some ethical and policy considerations. J Med Ethics 1998 Feb;24(1):32-7.

Berghmans RLP, ter Meulen RHJ. Ethical issues in research with dementia patients. Int J Geriatr Psychiatry 1995 Aug;10(8):647-51.

Bergsma J. Response to ethical concerns about relapse studies by Adil E Shamoo and Timothy J Keay (CQ Vol 5, No 3). Research with vulnerable subjects [letter]. Camb Q Healthc Ethics 1997 Spring;6(2):233-4. Comment on: Camb Q Healthc Ethics 1996 Summer;5(3):373-86.

Birenbaum R. Doctor proposes new ethics protocol for Alzheimer's research. CMAJ 1991 Feb 1;144(3):335, 338.

Bonkovsky FO. Helping Ken and Marie Pines. J Clin Ethics 1994 Summer;5(2):126; discussion 127-8. Comment in: J Clin Ethics 1994 Summer;5(2):129-31.

Bonnie RJ. Research with cognitively impaired subjects. Unfinished business in the regulation of human research. Arch Gen Psychiatry 1997 Feb;54(2):105-11. Comments in: Arch Gen Psychiatry 1997 Feb;54(2):117-20; Arch Gen Psychiatry 1997 Feb;54(2):121-3.

Candilis PJ, Wesley RW, Wichman A. A survey of researchers using a consent policy for cognitively impaired human research subjects. IRB Rev Hum Subj Res 1993;15(6):1-4.

Caplan AL. Are existing safeguards adequate? J Calif Alliance Ment Ill 1994;5(1):36-8.

Capron AM. Incapacitated research. Hastings Cent Rep 1997 Mar-Apr;27(2):25-7.

Carpenter WT Jr. The risk of medication-free research. Schizophr Bull 1997;23(1):11-8.

Carpenter WT Jr, Schooler NR, Kane JM. The rationale and ethics of medication-free research in schizophrenia. Arch Gen Psychiatry 1997 May;54(5):401-7. Comment in: Arch Gen Psychiatry 1997 May;54(5):412-3; Arch Gen Psychiatry 1997 May;54(5):415-6; Arch Gen Psychiatry 1998 Mar;55(3):280-1; discussion 283; Arch Gen Psychiatry 1998 Mar;55(3):281-3.

Chinnery P, Asimakopoulos G, Kenny RA. Informed consent in clinical trials. Consent may not be possible [letter]. BMJ 1993 Dec 4;307(6917):1496. Comment on: BMJ 1993 Nov 6;307(6913):1199-201.

Clinical development of atypical antipsychotics: research design and evaluation. Collaborative Working Group on Clinical Trial Evaluations. J Clin Psychiatry 1998;59(Suppl 12):10-6.

Cognitively impaired subjects. American College of Physicians. Ann Int Med 1989 Nov 15;111(10):843-8.

College on Problems of Drug Dependence. Policy on Administering Drugs with Abuse Potential in Human Research [news]. Drug Alcohol Depend 1996 Dec 2;43(1-2):115-7.

Convit A, Levine S, Berns S, Evangelista C. Type of symptomatology as a form of volunteer bias. Bull Am Acad Psychiatry Law 1991;19(2):185-91.

Corrigan PW, Garman AN. Considerations for research on consumer empowerment and psychosocial interventions. Psychiatr Serv 1997 Mar;48(3):347-52.

Cusveller BS, Jochemsen H. The new Dutch 'medical experimentation bill' and incompetent patients. Ethics Med 1993 Summer;9(2):18-20.

Cutler NR, Sramek JJ. Scientific and ethical concerns in clinical trials in Alzheimer's patients: the bridging study. Eur J Clin Pharmacol 1995;48(6):421-8. Comment in: Eur J Clin Pharmacol 1996;50(3):245-6.

De Deyn PP. On the ethical acceptability of placebo application in neuropsychiatric research. Acta Neurol Belg 1995;95(1):8-17.

Delano SJ, Zucker JL. Protecting mental health research subjects without prohibiting progress. Hosp Community Psychiatry 1994 Jun;45(6):601-3.

DeRenzo E. Surrogate decision making for severely cognitively impaired research subjects: the continuing debate. Camb Q Healthc Ethics 1994 Fall;3(4):539-48.

DeRenzo EG. The ethics of involving psychiatrically impaired persons in research. IRB Rev Hum Subj Res 1994;16(6):7-9, 11.

Dilonardo JD, Kendrick KA, Vivaldi KB. Chronic or long-term psychiatric patients: potential subjects for longitudinal research. Issues Ment Health Nurs 1993 Apr-Jun;14(2):109-18.

Dolinsky ZS, Babor TF. Ethical, scientific and clinical issues in ethanol administration research involving alcoholics as human subjects. Addiction 1997 Sep;92(9):1087-97.

Dresser R. Mentally disabled research subjects. The enduring policy issues. JAMA 1996 Jul 3;276(1):67-72.

du Plessis AD, van Heerden FJ, Oosthuizen H. Informed consent: research and the psychotic patient. Med Law 1996;15(3):493-7.

Dukoff R, Sunderland T. Durable power of attorney and informed consent with Alzheimer's disease patients: a clinical study. Am J Psychiatry 1997 Aug;154(8):1070-5.

Elliott C. Caring about risks. Are severely depressed patients competent to consent to research? Arch Gen Psychiatry 1997 Feb;54(2):113-6. Comments in: Arch Gen Psychiatry 1997 Feb;54(2):117-20; Arch Gen Psychiatry 1997 Feb;54(2):121-3.

Ethical issues concerning research in patients with dementia. Societa Italiana di Neurologia (SIN)--Working Group Bioethics and Neurology. Ital J Neurol Sci 1996 Oct;17(5):371-5. Published erratum appears in Ital J Neurol Sci 1997 Feb;18(1):68.

Fins JJ, Miller FG. The call of the sirens. Navigating the ethics of medication-free research in schizophrenia. Arch Gen Psychiatry 1997 May;54(5):415-6. Comment on: Arch Gen Psychiatry 1997 May;54(5):401-7.

Fitten LJ. The ethics of conducting research with older psychiatric patients. Int J Geriatr Psychiatry 1993 Jan;8(1):33-9.

Fletcher JC. Ethical aspect of research involving elderly subjects [commentary]. J Clin Ethics 1990 Winter;1(4):285-6.

Frese FJ. Informed consent and the right to refuse or participate. J Calif Alliance Ment Ill 1994;5(1):56-7.

Fulford KW, Howse K. Ethics of research with psychiatric patients: principles, problems and the primary responsibilities of researchers. J Med Ethics 1993 Jun;19(2):85-91.

Gallant D. Ethical considerations of alcohol administration in human research studies. Alcohol Clin Exp Res 1993 Dec;17(6):1345-6.

Gaughwin PC. The ACT heroin trial proposal: an overview [letter]. Med J Aust 1997 Feb 17;166(4):221-2. Comment on: Med J Aust 1996 Jun 3;164(11):690-2.

Geiselmann B, Helmchen H. Demented subjects' competence to consent to participate in field studies: the Berlin Ageing Study. Med Law 1994;13(1-2):177-84.

Ghaemi SN, Hundert EM. The ethics of research in mental illness. J Calif Alliance Ment Ill 1994;5(1):47-9.

Gift AG. Informed consent and vulnerable subjects. Clin Nurse Spec 1993 Jul;7(4):183.

Glass KC, Speyer-Ofenberg M. Incompetent persons as research subjects and the ethics of minimal risk. Camb Q Healthc Ethics 1996 Summer;5(3):362-72.

Goodwin FK. Questions and answers [about National Institute of Mental Health-funded studies]. J Calif Alliance Ment Ill 1994;5(1):45-7.

Green RM, Pascual LA, Wasserman EM. Ethical guidelines for rTMS research. IRB Rev Hum Subj Res 1997 Mar-Apr;19(2):1-7.

Haimowitz S, Delano SJ, Oldham JM. Uninformed decision making: the case of surrogate research consent. Hastings Cent Rep 1997 Nov-Dec;27(6):9-16.

Hale B. Mentally incapacitated adults and decision-making: the English perspective. Int J Law Psychiatry 1997 Winter;20(1):59-75.

Hassner V. What is ethical? What is not? Where do you draw the line? J Calif Alliance Ment Ill 1994;5(1):4-5.

Helmchen H. The problem of informed consent in dementia research. Med Law 1990;9(6):1206-13.

Henn FA, Lader M. Medication-free research with schizophrenic patients. A European perspective. Arch Gen Psychiatry 1997 May;54(5):412-3. Comment on: Arch Gen Psychiatry 1997 May;54(5):401-7.

High DM. Advancing research with Alzheimer disease subjects: investigators' perceptions and ethical issues. Alzheimer Dis Assoc Disord 1993 Fall;7(3):165-78.

High DM. Research with Alzheimer's disease subjects: informed consent and proxy decision making. J Am Geriatr Soc 1992 Sep;40(9):950-7.

High DM, Post SG, Whitehouse PJ. Ethical and legal issues in Alzheimer disease research. Introduction. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:1-4.

High DM, Whitehouse PJ, Post SG, Berg L. Guidelines for addressing ethical and legal issues in Alzheimer disease research: a position paper. National Institute on Aging. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:66-74.

Hope T. Aging, research and families [editorial]. J Med Ethics 1997 Oct;23(5):267-8.

Hoppe SK. Institutional review boards and research on individuals with mental disorders. Account Res 1996;4(3-4):187-95.

Howe EG. Deceiving patients for their own good. J Clin Ethics 1997 Fall;8(3):211-6.

Irving DN. Psychiatric research: reality check. J Calif Alliance Ment Ill 1994;5(1):42-4.

Jonas C, Soutoul JH. Biomedical research on incapacitated people according to French law. Med Law 1993;12(6-8):567-72.

Kaminski R. The importance of maintaining patient's continued and informed consent. J Calif Alliance Ment Ill 1994;5(1):57-8.

Kane JM. Enormous ethical challenges. J Calif Alliance Ment Ill 1994;5(1):28-9.

Kane JM. Obstacles to clinical research and new drug development in schizophrenia. Schizophr Bull 1991;17(2):353-6.

Kapp MB. Proxy decision making in Alzheimer disease research: durable powers of attorney, guardianship, and other alternatives. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:28-37.

Katz J. Ethics in neurobiological research with human subjects -- final reflections. Account Res 1996;4(3-4):277-83.

Kay B. Grasping the research nettle in learning disabilities nursing. Br J Nurs 1995 Jan 28-Feb 8;4(2):96-8.

Keyserlingk EW, Glass K, Kogan S, Gauthier S. Proposed guidelines for the participation of persons with dementia as research subjects. Perspect Biol Med 1995 Winter;38(2):319-61.

King EM, Smith A, Jobst KA. Autopsy: consent, completion and communication in Alzheimer's disease research. Age Ageing 1993 May;22(3):209-14.

Kristjanson LJ, Hanson EJ, Balneaves L. Research in palliative care populations: ethical issues. J Palliat Care 1994 Autumn;10(3):10-5.

Kunjukrishnan R. RE: The need for research and ethical safeguards in special populations [letter]. Can J Psychiatry 1995 Mar;40(2):110. Comment on: Can J Psychiatry 1993 Dec;38(10):681-90.

Lazarus J. Critical ethical issues and conflicts. J Calif Alliance Ment Ill 1994;5(1):20-1.

Lehrman NS, Sharav VH. Ethical problems in psychiatric research. J Ment Health Adm 1997 Spring;24(2):227-50.

Levine RH. A researcher's concern with ethics in human research. J Calif Alliance Ment Ill 1994;5(1):6-8.

Levine RJ. Proposed regulations for research involving those institutionalized as mentally infirm: a consideration of their relevance in 1995. Account Res 1996;4(3-4):177-86.

Lieberman Jeffrey A, Sloan Judith. The moral imperatives of medical research in human subjects. J Calif Alliance Ment Ill 1994;5(1):40-42.

Lynn J. Ethical concerns about research on incompetent persons [letter]. J Am Geriatr Soc 1998 May;46(5):660. Comment on: J Am Geriatr Soc 1997 Aug;45(8):929-33.

Maciunas KA, Moss AH. Learning the patient's narrative to determine decision-making capacity: the role of ethics consultation. J Clin Ethics 1992 Winter;3(4):287-9.

Marshall E. NIH examines standards for consent [news]. Science 1998 Jun 12;280(5370):1688.

Marson DC, Schmitt FA, Ingram KK, Harrell LE. Determining the competency of Alzheimer patients to consent to treatment and research. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:5-18.

Marwick C. Bioethics Commission examines informed consent from subjects who are 'decisionally incapable' [news]. JAMA 1997 Aug 27;278(8):618-9.

McGee G. Subject to payment? JAMA 1997 Jul 16;278(3):199-200.

McGovern TF. Vulnerability: reflection on its ethical implications for the protection of participants in SAMHSA programs. Ethic Behav 1998;8(4):293-304.

Medical Research Council (Great Britain). MRC guidance on research ethics. Bull Med Ethics 1992 Mar;76:8-10.

Medical Research Council (Great Britain). MRC guidance on research ethics: children and the mentally incapacitated. Int J Bioethics 1992 Sep;3(3):185-6.

Meier DE. Voiceless and vulnerable: dementia patients without surrogates in an era of capitation [editorial]. J Am Geriatr Soc 1997 Mar;45(3):375-7. Comment on: J Am Geriatr Soc 1997 Mar;45(3):369-74.

Miller FG, Rosenstein DL. Psychiatric symptom-provoking studies: an ethical appraisal. Biol Psychiatry 1997 Sep 1;42(5):403-9.

Milliken AD. The need for research and ethical safeguards in special populations. Can J Psychiatry 1993 Dec;38(10):681-90. Comment in: Can J Psychiatry 1995 Mar;40(2):110.

Modell JG, Glaser FB, Mountz JM. The ethics and safety of alcohol administration in the experimental setting to individuals who have chronic, severe alcohol problems. Alcohol Alcohol 1993 Mar;28(2):189-97.

Moline ML, Aisen MW. Perspectives of protocol reviewers. J Calif Alliance Ment Ill 1994;5(1):59-60.

Morris JC. Conflicts of interest: research and clinical care. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:49-57.

Nahas GG. The experimental use of cocaine in human subjects. Bull Narc 1990;42(1):57-62.

NAMI outlines national standards for protecting research subjects with serious mental illness [news]. Psychiatr Serv 1995 Apr;46(4):419-20.

National Bioethics Advisory Commission. Research involving persons with mental disorders that may affect decisionmaking capacity [monograph on the Internet]. [place unknown]: The Commission; 1998 Dec [cited 1999 May 18]. Available from: http://bioethics.gov/capacity/TOC.htm

Neylan TC, Wright BA, Shelton MD, van Kammen DP. More on ethics of drug discontinuation studies in schizophrenia [letter]. Arch Gen Psychiatry 1990 Feb;47(2):192.

Oosthuizen H, Fick G, Els C. Legal status of the mentally disabled person in South African law. Med Law 1995;14(7-8):601-9.

Ostini R, Bammer G, Dance PR, Goodin RE. The ethics of experimental heroin maintenance. J Med Ethics 1993 Sep;19(3):175-82.

Pellegrino ED. Emerging ethical issues in palliative care. JAMA 1998 May 20;279(19):1521-2.

Pinals DA, Malhotra AK, Breier A, Pickar D. Informed consent in schizophrenia research [letter]. Psychiatr Serv 1998 Feb;49(2):244.

Post SG, Ripich DN, Whitehouse PJ. Discourse ethics: research, dementia, and communication. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:58-65.

Prentice ED, Antonson DL, Leibrock LG, Prabhu VC, Kelso TK, Sears TD. An update on the PEG-SOD study involving incompetent subjects: FDA permits an exception to informed consent requirements. IRB Rev Hum Subj Res 1994;16(1-2):16-8.

Puglisi JT, Ellis GB. Neurobiological research involving human subjects: perspectives from the Office for Protection from Research Risks. Account Res 1996;4(3-4):261-5.

Ryan AJ. True protection for persons with severe mental disabilities, such as schizophrenia, involved as subjects in research? A look and consideration of the Protection of Human Subjects. J Law Health 1994-5;9(2):349-76.

Sachs GA. Advance consent for dementia research. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:19-27.

Sachs GA, Stocking CB, Stern R, Cox DM, Hougham G, Sachs RS. Ethical aspects of dementia research: informed consent and proxy consent. Clin Res 1994 Oct;42(3):403-12.

Shamoo AE. Human rights in reference to persons with mental illness. Account Res 1996;4(3-4):207-16.

Shamoo AE. Our responsibilities toward persons with mental illness as human subjects. J Calif Alliance Ment Ill 1994;5(1):14-6.

Shamoo AE, Irving DN. Accountability in research using persons with mental illness. Account Res 1993;3:1-17.

Shamoo AE, Keay TJ. Ethical concerns about relapse studies. Camb Q Healthc Ethics 1996 Summer;5(3):373-86. Comment in: Camb Q Healthc Ethics 1997 Spring;6(2):233-4.

Shore D, Berg K, Mullican C. Ethical issues in clinical neurological research. J Calif Alliance Ment Ill 1994;5(1):61-2.

Sigmon ST. Ethical practices and beliefs of psychopathology researchers. Ethics Behav 1995;5(4):295-309.

Skolnick AA. Evaluating estrogen for Alzheimer disease poses ethical and logistical challenges [news]. JAMA 1997 Jun 18;277(23):1831-3.

Smith L. Ethical issues in interviewing. J Adv Nurs 1992 Jan;17(1):98-103.

Stricker G. Ethical concerns in alcohol research. J Consult Clin Psychol 1991 Apr;59(2):256-7. Comment on: J Consult Clin Psychol 1991 Feb;59(1):176-81; discussion 183.

Sunderland T, Dukoff R. Informed consent with cognitively impaired patients: an NIMH perspective on the durable power of attorney. Account Res 1996;4(3-4):217-26.

Swartz MS, Burns BJ, George LK, Swanson J, Hiday VA, Borum R, Wagner HR. The ethical challenges of a randomized controlled trial of involuntary outpatient commitment. J Ment Health Admin 1997 Winter;24(1):35-43.

Thomasma DC. A communal model for presumed consent for research on the neurologically vulnerable. Account Res 1996;4(3-4):227-39.

Thomasma DC. Obtaining consent for research in the neurobiologically impaired. J Calif Alliance Ment Ill 1994;5(1):54-5.

Tomossy GF, Weisstub DN. The reform of adult guardianship laws: the case of non-therapeutic experimentation. Int J Law Psychiatry 1997 Winter;20(1):113-39.

Trickett EJ. Prevention ethics: explicating the context of prevention activities. Ethics Behav 1992;2(2):91-100.

Wadman M. Ethical protection for subjects 'could stifle psychiatric research' [news]. Nature 1998 Aug 20;394(6695):713.

Wadman M. Mentally disabled research subjects 'need protection' [news]. Nature 1997 Oct 16;389(6652):652.

Walsh JH. The substance-abusing family: consideration for nursing research. J Pediatr Nurs 1991 Feb;6(1):49-56.

Warren CAB, Karner TX. Permissions and the social context. Am Sociol 1990 Summer;21(2):116-35.

Watson R. Practical ethical issues related to the care of elderly people with dementia. Nurs Ethics 1994 Sep;1(3):151-62.

Weijer C, Appelbaum P. Placebo controls are not good science [letter and response]. IRB Rev Hum Subj Res 1996;18(5):8-10.

Weisstub DN, Arboleda-Florez J. Ethical research with the developmentally disabled. Can J Psychiatry 1997 Jun;42(5):492-6.

Wichman A, Sandler AL. Research involving subjects with dementia and other cognitive impairments: experience at the NIH, and some unresolved ethical considerations. Neurology 1995 Sep;45(9):1777-8.

Willwerth James. How to tell if the men in white coats are lying to you (investigative journalism and research abuse). Account Res 1997;5(1-3):51-8.

Wilson JR. Source data verification in clinical trials involving the temporarily incapacitated subject: is there a missing link in the notion of proxy consent? IRB Rev Hum Subj Res 1992 Jul-Aug;14(4):8-10.

Wyatt RJ. Research in schizophrenia and the discontinuation of antipsychotic medications. Schizophr Bull 1997;23(1):3-9.

Young SN, Annable L, Canadian College of Neuropsychopharmacology. The use of placebos in psychiatry: a response to the draft document prepared by the Tri-Council Working Group. J Psychiatry Neurosci 1996 Jul;21(4):235-8.

Zeph LA. Are we allowing our science to interfere with our ethics? A response to Mulick and Kedesdy. Ment Retard 1990 Apr;28(2):122-3. Comment on: Ment Retard 1988 Aug;26(4):223-9. Comment in: Ment Retard 1990 Aug;28(4):245.

Zipursky RB. Re: The use of placebos in clinical trials for acute schizophrenia [letter]. Can J Psychiatry 1995 Sep;40(7):425-6. Comment on: Can J Psychiatry 1995 May;40(4):171-6.
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## Special or vulnerable populations - Cognitively impaired - Books

Alderson P. Disabled people and consent to medical treatment and research. London: University of London, Institute of Education, Social Science Research Unit, 1993 Mar. 62 p.

Berg JM, Karlinsky H, Lowy FH. Alzheimer's disease research: ethical and legal issues. Toronto: Carswell; 1991. 366 p.

Colloquy in research ethics: issues in biomedical research involving cognitively impaired subjects. Washington: U.S. Government Printing Office; 1995. 47 p. Edited transcript of the proceedings of a meeting held in August 1993.

Hertzman M, Feltner DE. The handbook of psychopharmacology trials: an overview of scientific, political, and ethical concerns. New York: New York University Press; c1997. 454 p.

Mentally incapacitated adults and decision-making: medical treatment and research. London: Her Majesty's Stationery Office; 1993. 139 p.

Moorhouse JA. Autonomy and beneficence: striking a balance in Alzheimer's Disease research. 2 vol. Ann Arbor (MI): University Microfilms International; 1991. 513 p.

Prien RF, Robinson DS. Clinical evaluation of psychotropic drugs: principles and guidelines. New York: Raven Press; c1994. 728 p.

Roth J, editor. The disturbed subject: epistemological and ethical implications of reactivity in videotape research. New York: Peter Lang; c1990. 134 p. (American university studies. Series 8, Psychology; 20).

Sramek JJ. Optimizing the development of antipsychotic drugs. New York: John Wiley & Sons; 1997. 204 p.

The ethical conduct of research on the mentally incapacitated. London: Medical Research Council, Working Party on Research on the Mentally Incapacitated; 1991 Dec. 23 p.
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## Special or vulnerable populations - Elderly - Journal Articles

Alt-White AC. Obtaining informed consent from the elderly. West J Nurs Res 1995 Dec;17(6):700-5.

Applegate WB, Curb JD. Designing and executing randomized clinical trials involving elderly persons. J Am Geriatr Soc 1990 Aug;38(8):943-50.

Avorn J. Including elderly people in clinical trials: better information could improve the effectiveness and safety of drug use [editorial]. BMJ 1997 Oct 25;315(7115):1033-4.

Brod MS, Feinbloom RI. Feasibility and efficacy of verbal consents. Res Aging 1990 Sep;12(3):364-72.

Christensen K, Haroun A, Schneiderman LJ, Jeste DV. Decision-making capacity for informed consent in the older population. Bull Am Acad Psychiatr Law 1995;23(3):353-65.

Good BA, Rodrigues-Fisher L. Vulnerability: an ethical consideration in research with older adults. West J Nurs Res 1993 Dec;15(6):780-3.

Kaye JM, Lawton P, Kaye D. Attitudes of elderly people about clinical research on aging. Gerontologist 1990 Feb;30(1):100-6.

Lane LW, Cassel CK, Bennett W. Ethical aspects of research involving elderly subjects: are we doing more than we say? J Clin Ethics 1990 Winter;1(4):278-85; discussion 285-6. Published erratum appears in J Clin Ethics 1991 Spring;2(1):4.

McNeely EA, Clements SD. Recruitment and retention of the older adult into research studies. J Neurosci Nurs 1994 Feb;26(1):57-61.

Miller J, Evans T. Some reflections on ethical dilemmas in nursing home research. West J Nurs Res 1991 Jun;13(3):375-81.

Patriarca PA. A randomized controlled trial of influenza vaccine in the elderly: scientific scrutiny and ethical responsibility [editorial]. JAMA 1994 Dec 7;272(21):1700-1.

Rapp CG, Topps-Uriri J, Beck C. Obtaining and maintaining a research sample with cognitively impaired nursing home residents. Geriatr Nurs 1994 Jul-Aug;15(4):193-6.

Rikkert MG, van den Bercken JH, ten Have HA, Hoefnagels WH. Experienced consent in geriatrics research: a new method to optimize the capacity to consent in frail elderly subjects. J Med Ethics 1997 Oct;23(5):271-6.

Sachs GA, Cassel CK. Biomedical research involving older human subjects. Law Med Health Care 1990 Fall;18(3):234-43.

Sachs GA, Rhymes J, Cassel CK. Biomedical and behavioral research in nursing homes: guidelines for ethical investigations. J Am Geriatr Soc 1993 Jul;41(7):771-7.

Sugarman J, McCrory DC, Hubal RC. Getting meaningful informed consent from older adults: a structured literature review of empirical research. J Am Geriatr Soc 1998 Apr;46(4):517-24.

Tymchuk AJ. An alternative conceptualization of informed consent with people who are elderly. Educ Gerontol 1992 Mar;18(2):135-47.

Uman GC, Urman HN. The challenges of conducting clinical nursing research with elderly populations. AORN J 1990 Aug;52(2):400-6.

Williams SG. Research considerations: family opinions about elderly relatives in research. J Gerontol Nurs 1992 Dec;18(12):3-8.
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## Special or vulnerable populations - Prisoners - Journal Articles

Arboleda-Florez J. Ethical issues regarding research on prisoners [editorial]. Int J Offender Ther Comp Criminol 1991 Mar;35(1):1-5.

Bailey RC, Berg D. The Behavioral and Attitudinal Modification Project (BAM): a failed experiment using a classical experimental research design in a closed institutional setting for drug addicts. Int J Addict 1994 Aug;29(10):1315-45.

Behrendt C, Kendig N, Dambita C, Horman J, Lawlor J, Vlahov D. Voluntary testing for human immunodeficiency virus (HIV) in a prison population with a high prevalence of HIV. Am J Epidemiol 1994 May 1;139(9):918-26.

Bellin E. Non-placebo controlled HIV experimental trials in prisoners [letter]. J Acquir Immune Defic Syndr Hum Retrovirol 1995 Jul 1;9(3):315-6. Comment on: J Acquir Immune Defic Syndr 1994 Oct;7(10):1086-94.

Boudreau D. A question of ethics? International medical community condemns death row donations in China. Nephrol News Issues 1995 Aug;9(8):29.

Brakel SJ. Considering behavioral and biomedical research on detainees in the mental health unit of an urban mega-jail. N Engl J Crim Civil Confine 1996 Winter;22(1):1-27.

Briggs JD. The use of organs from executed prisoners in China [editorial]. Nephrol Dial Transplant 1996 Feb;11(2):238-40.

Callender CO, Kelly BS, Rivadeneira DA. Medical utility versus legal justice: a proposal for the ethical use of prisoner-donated organs. Transplant Proc 1996 Feb;28(1):374.

Campbell KA. Knots in the fabric: Richard Pearson Strong and the Bilibid Prison vaccine trials, 1905-1906. Bull Hist Med 1994 Winter;68(4):600-38.

Collins A, Baumgartner D, Henry K. US prisoners' access to experimental HIV therapies. Minn Med 1995 Nov;78(11):45-8.

Fletcher BW, Tims FM. Methodological issues: drug abuse treatment research in prisons and jails. NIDA Res Monogr 1992;118:246-60.

Gore SM, Basson J, Bird AG, Goldberg DJ. Uptake of confidential, named HIV testing in Scottish prisons [letter]. Lancet 1992 Oct 10;340(8824):907-8.

Gore SM, Jolliffe DW, Bird AG. Prisoners' uptake of confidential, named HIV testing [letter]. Lancet 1992 Jun 13;339(8807):1491-2.

Harkness JM. Prisoners and pellagra. Public Health Rep 1996 Sep-Oct;111(5):463-7.

Hornblum AM. They were cheap and available: prisoners as research subjects in twentieth century America. BMJ 1997 Nov 29;315(7120):1437-41.

Hsieh H, Yu TJ, Yang WC, Chu SS, Lai MK. The gift of life from prisoners sentenced to death: preliminary report. Transplant Proc 1992 Aug;24(4):1335-6.

Human rights begin at home [editorial]. BMJ 1997 Nov 29;315(7120):1387.

In the name of consent [editorial]. New Sci 1994 Feb 19;141(1913):3.

Kuvin SF. AIDS and malaria experiments [letter]. Nature 1992 Jan 23;355(6358):305. Comment on: Nature 1991 Nov 28;354(6351):262.

Leukefeld CG, Tims FM. Directions for practice and research. NIDA Res Monogr 1992;118:279-93.

Liebling A, Ward T. Prison doctors and prison suicide research. Clio Med 1995;34:118-29; discussion 130-3.

Mason JK. Recording HIV status on police computers [editorial]. BMJ 1992 Apr 18;304(6833):995-6. Comment in: BMJ 1992 May 9;304(6836):1243; BMJ 1992 Jun 20;304(6842):1635-6.

Moore J. Informed consent with prisoners in research: issues, dilemmas and regulations. Correctcare 1995 Jun-Jul;9(2):14-5, 18.

New rule for vulnerable research subjects has some special provisions [news]. Hum Res Rep 1994 Jun;9(6):1-2.

Potler C, Sharp VL, Remick S. Prisoners' access to HIV experimental trials: legal, ethical, and practical considerations. J Acquir Immune Defic Syndr 1994 Oct;7(10):1086-94. Comment in: J Acquir Immune Defic Syndr Hum Retrovirol 1995 Jul 1;9(3):315-6.

Siegal HA, Carlson RG, Falck R, Reece RD, Perlin T. Conducting HIV outreach and research among incarcerated drug abusers: a case study of ethical concerns and dilemmas. J Subst Abuse Treat 1993 Jan-Feb;10(1):71-5.

Stein GL, Headley LD. Forum on prisoners' access to clinical trials: summary of recommendations. AIDS Public Policy J 1996 Spring;11(1):3-20.
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## Special or vulnerable populations - Prisoners - Books

Gordner RL. Prison health care: January 1986 through September 1990: 1132 citations. Bethesda (MD): National Library of Medicine, Reference Section; 1990. 77 p. (Current bibliographies in medicine; no. 90-12).

Hornblum AM. Acres of skin: human experiments at Holmesburg Prison: a true story of abuse and exploitation in the name of medical science. New York: Routledge; 1998. 297 p.
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## Special or vulnerable populations - Military personnel - Journal Articles

Annas GJ. Changing the consent rules for Desert Storm. N Engl J Med 1992 Mar 12;326(11):770-3. Comments in: N Engl J Med 1992 Oct 8;327(15):1096; discussion 1098; N Engl J Med 1992 Oct 8;327(15):1096-7; N Engl J Med 1992 Oct 8;327(15):1097; discussion 1098; N Engl J Med 1992 Oct 8;327(15):1097-8; N Engl J Med 1992 Oct 8;327(15):1098.

Annas GJ. Protecting soldiers from friendly fire: the consent requirement for using investigational drugs and vaccines in combat. Am J Law Med 1998;24(2-3):245-60

Berezuk GP, McCarty GE. Investigational drugs and vaccines fielded in support of Operation Desert Storm. Mil Med 1992 Aug;157(8):404-6. Comment in: Mil Med 1992 Dec;157(12):A8.

Birmingham K. Pentagon breaks FDA rules [news]. Nat Med 1998 Mar;4(3):255.

Butler D. Admission on Gulf War vaccines spurs debate on medical records [news]. Nature 1997 Nov 6;390(6655):3-4.

Cooper RM. Military medical research: proving the safety and effectiveness of a nerve gas antidote -- a legal view. IRB Rev Hum Subj Res 1989 Jul-Aug;11(4):7-9.

Cotton P. Veterans seeking answers to syndrome suspect they were goats in Gulf War [news]. JAMA 1994 May 25;271(20):1559-61.

Dudley HA. Research ethics committees and military defence. J R Coll Physicians Lond 1994 May-Jun;28(3):237-41.

FDA seeks public comment on informed consent rules in combat situations [news]. Hastings Cent Rep 1997 Sep-Oct;27(5):43.

Gunby P. Informing troops of investigational drugs, devices [news]. JAMA 1995 Jan 25;273(4):276.

Hickman JR. Panel [on deliberate G-LOC] summary: from Zen riddle to the razor's edge. Aviat Space Environ Med 1991 Jul;62(7):632-7.

Howe EG, Martin ED. Treating the troops. Hastings Cent Rep 1991 Mar-Apr;21(2):21-4; discussion 24-9.

Levine C. Military medical research: are there ethical exceptions? IRB Rev Hum Subj Res 1989 Jul-Aug;11(4):5-7.

Milner CA. Gulf War guinea pigs: is informed consent optional during war? J Contemp Health Law Policy 1996 Fall;13(1):199-232.

Moran PJ. A military exception to informed consent: "Doe v. Sullivan" [comment]. St.Johns Law Rev 1993 Fall-Winter;66(3):847-63.

Morris CE, Briggs J, Popper SE. Human subject research at Armstrong Laboratory, 1973-93: medical and musculoskeletal disqualifications. Aviat Space Environ Med 1997 May;68(5):378-83.

Pearson GS. Experiments and volunteers [letter]. Nature 1994 Feb 24;367(6465):676.

Poikonen J, McCart GM, Veatch RM. Waivers for military use of investigational agents. Am J Hosp Pharm 1991 Jul;48(7):1525; discussion 1525-9.

Rall DP, Pechura CM. Effects on health of mustard gas [letter]. Nature 1993 Dec 2;366(6454):398-9.

Schuchardt EJ. Walking a thin line: distinguishing between research and medical practice during Operation Desert Storm. Columbia J Law Soc Probl 1992 Autumn;26(1):77-115.

Soldiers as experimental animals [editorial]. Nature 1993 Feb 11;361(6412):479.

Summers C. Militarism, human welfare, and the APA Ethical Principles of Psychologists. Ethics Behav 1992;2(4):287-310.

Tiedt TN. The Nuremberg Code, informed consent, and involuntary treatment [letter]. JAMA 1997 Mar 5;277(9):712-3; discussion 713-4. Comment on: JAMA 1996 Nov 27;276(20):1682-3.

Vander Hamm DG. Human subjects research [letter]. Science 1997 Apr 4;276(5309):17.

Vlassov V. Experimenting on the vulnerable [letter]. Nature 1994 Oct 27;371(6500):734.
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## Special or vulnerable populations - Military personnel - Books

Is Military Research Hazardous to Veterans' Health? Lessons from World War II, the Persian Gulf, and Today: Hearing (1994 May 6). Washington: U.S. Government Printing Office; 1995. 474 p.

Pechura CM, Rall DP. Veterans at risk: the health effects of mustard gas and lewisite. Washington: National Academy Press; 1993. 427 p.
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## Teaching and research using newly deceased patients - Journal Articles

Ardagh M. May we practise endotracheal intubation on the newly dead? J Med Ethics 1997 Oct;23(5):289-94.

Ashby R. Teaching resuscitation on the newly deceased: do we want to know? [editorial]. Med J Aust 1996 Oct 21;165(8):412-3. Comment on: Med J Aust 1996 Oct 21;165(8):445-7.

Benfield DG, Flaksman RJ, Lin TH, Kantak AD, Kokomoor FW, Vollman JH. Teaching intubation skills using newly deceased infants. JAMA 1991 May 8;265(18):2360-3. Comment in: JAMA 1991 Sep 25;266(12):1649-51.

Brattebo G, Wisborg T. Consent for invasive procedures in the newly deceased [letter]. JAMA 1995 Jul 12;274(2):128-9. Comment on: JAMA 1995 Jan 25;273(4):310-2.

Brattebo G, Wisborg T. Teaching and training of emergencies on 'newly dead' patients: national experiences from Norway [letter]. Arch Emerg Med 1990 Sep;7(3):237-8.

Brattebo G, Wisborg T. Teaching procedures on the newly dead [letter]. Ann Emerg Med 1995 Aug;26(2):242. Comment on: Ann Emerg Med 1995 Jan;25(1):86-90; Ann Emerg Med 1995 Jan;25(1):91-4; Ann Emerg Med 1995 Jan;25(1):99-100.

Brattebo G, Wisborg T, Oyen N. Using newly deceased patients in teaching procedures [letter]. N Engl J Med 1995 May 25;332(21):1445; discussion 1446-7. Comment on: N Engl J Med 1994 Dec 15;331(24):1652-5.

Brattebo G, Wisborg T, Solheim K, Oyen N. Public opinion on different approaches to teaching intubation techniques. BMJ 1993 Nov 13;307(6914):1256-7.

Burns JP, Reardon FE, Truog RD. Using newly deceased patients to teach resuscitation procedures. N Engl J Med 1994 Dec 15;331(24):1652-5. Comments in: N Engl J Med 1995 May 25;332(21):1445; discussion 1446-7; N Engl J Med 1995 May 25;332(21):1445-6; discussion 1446-7; N Engl J Med 1995 May 25;332(21):1446; discussion 1446-7.

Catalano JT. The ethics of cadaver experimentation. Crit Care Nurse 1994 Dec;14(6):82-5.

Fernandes CM. Practice of procedures on the newly dead [letter]. Ann Emerg Med 1995 Jul;26(1):106-7. Comment on: Ann Emerg Med 1995 Jan;25(1):86-90; Ann Emerg Med 1995 Jan;25(1):91-4.

Ginifer C, Kelly AM. Teaching resuscitation skills using the newly deceased. Med J Aust 1996 Oct 21;165(8):445-7. Comment in: Med J Aust 1996 Oct 21;165(8):412-2.

Goldblatt AD. Don't ask, don't tell: practicing minimally invasive resuscitation techniques on the newly dead. Ann Emerg Med 1995 Jan;25(1):86-90. Comment on: Ann Emerg Med 1995 Jan;25(1):91-4. Comments in: Ann Emerg Med 1995 Jan;25(1):99-100; Ann Emerg Med 1995 Jul;26(1):106-7; Ann Emerg Med 1995 Aug;26(2):242.

Hayes GJ. Issues of consent: the use of the recently deceased for endotracheal intubation training. J Clin Ethics 1994 Fall;5(3):211-6. Comments in: J Clin Ethics 1994 Fall;5(3):256-60; J Clin Ethics 1994 Fall;5(3):261-40; J Clin Ethics 1994 Fall;5(3):264-6.

Intubation training: an ethical practice? Nurs Stand 1993 Jul 21-27;7(44):38-9.

Iserson KV. Law versus life: the ethical imperative to practice and teach using the newly dead emergency department patient. Ann Emerg Med 1995 Jan;25(1):91-4. Comments in: Ann Emerg Med 1995 Jan;25(1):86-90; Ann Emerg Med 1995 Jan;25(1):99-100; Ann Emerg Med 1995 Jul;26(1):106-7; Ann Emerg Med 1995 Aug;26(2):242.

Iserson KV. Life versus death: exposing a misapplication of ethical reasoning [editorial]. J Clin Ethics 1994 Fall;5(3):261-4. Comment on: J Clin Ethics 1994 Fall;5(3):211-6.

Iserson KV. Postmortem procedures in the emergency department: using the recently dead to practise and teach. J Med Ethics 1993 Jun;19(2):92-8.

Iserson KV. Requiring consent to practice and teach using the recently dead [editorial]. J Emerg Med 1991 Nov-Dec;9(6):509-10. Comment on: J Emerg Med 1991 Nov-Dec;9(6):515-8.

Kerns AF. Better to lay it out on the table rather than do it behind the curtain: hospitals need to obtain consent before using newly deceased patients to teach resuscitation procedures. J Contemp Health Law Policy 1997 Spring;13(2):581-612.

King AI, Viano DC, Mizeres N, States JD. Humanitarian benefits of cadaver research on injury prevention. J Trauma 1995 Apr;38(4):564-9.

Knopp R. Bioethics and health policy section: practicing procedures on the newly dead [editorial]. Ann Emerg Med 1995 Jan;25(1):99-100. Comment on: Ann Emerg Med 1995 Jan;25(1):86-90; Ann Emerg Med 1995 Jan;25(1):91-4. Comment in: Ann Emerg Med 1995 Aug;26(2):242.

Knopp RK. Practicing cricothyrotomy on the newly dead [editorial]. Ann Emerg Med 1995 May;25(5):694-5. Published erratum appears in Ann Emerg Med 1995 Jul;26(1):109. Comment on: Ann Emerg Med 1995 May;25(5):660-5.

Lurie KG, Benditt D. Regulated to death: the matter of informed consent for human experimentation in emergency resuscitation research. Pacing Clin Electrophysiol 1995 Jul;18(7):1443-7.

McNamara RM, Monti S, Kelly JJ. Requesting consent for an invasive procedure in newly deceased adults. JAMA 1995 Jan 25;273(4):310-2. Comment in: JAMA 1995 Jul 12;274(2):128-9.

Morhaim DK, Heller MB. The practice of teaching endotracheal intubation on recently deceased patients. J Emerg Med 1991 Nov-Dec;9(6):515-8. Comment in: J Emerg Med 1991 Nov-Dec;9(6):509-8.

Nelson MS. Models for teaching emergency medicine skills. Ann Emerg Med 1990 Mar;19(3):333-5.

Olsen J, Spilger S, Windisch T. Feasibility of obtaining family consent for teaching cricothyrotomy on the newly dead in the emergency department. Ann Emerg Med 1995 May;25(5):660-5. Comment in: Ann Emerg Med 1995 May;25(5):694-5.

Olsen JC, Buenefe ML, Falco WD. Death in the emergency department. Ann Emerg Med 1998 Jun;31(6):758-65.

Orlowski JP. Politically correct ethical thinking and intubation practice on cadavers [editorial]. J Clin Ethics 1994 Fall;5(3):256-60. Comment on: J Clin Ethics 1994 Fall;5(3):211-6.

Orlowski JP, Kanoti GA, Mehlman MJ. The ethical dilemma of permitting the teaching and perfecting of resuscitation techniques on recently expired patients. J Clin Ethics 1990 Fall;1(3):201-5.

Perkins HS, Gordon AM. Should hospital policy require consent for practicing invasive procedures on cadavers? The arguments, conclusions, and lessons from one ethics committee's deliberations. J Clin Ethics 1994 Fall;5(3):204-10.

Rosner F. Research and/or training on the newly dead: the Jewish perspective. Mt Sinai J Med 1997 Mar;64(2):120-4.

Rosner F. Research and training on the newly dead [letter]. Arch Pathol Lab Med 1997 Oct;121(10):1029.

Teaching intubation skills using newly deceased infants [letter]. JAMA 1991 Sep 25;266(12):1649-51. Comment on: JAMA 1991 May 8;265(18):2360-3.

Tonks A. Intubation practice on cadavers should stop [news]. BMJ 1992 Aug 8;305(6849):332.
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## Special or vulnerable populations - Self-experimentation by researchers - Journal Articles

Altman LK. Auto-experimentation. An unappreciated tradition in medical science. N Engl J Med 1972 Feb 17;286(7):346-52.

Batchelor JA, Briggs C. Subject, project or self? Thoughts on ethical dilemmas for social and medical researchers. Soc Sci Med 1994;39(7):949-54.

Burchell HB. The investigator as volunteer subject. Mayo Clin Proc 1982 Jul;57 Suppl:28-33.

Fontenot C, O'Leary JP. Dr. Werner Forssman's self-experimentation. Am Surg 1996 Jun;62(6):514-5.

Forrester JM. Using oneself as one's only experimental subject. Lancet 1990 Sep 29;336(8718):798-9. Comments in: Lancet 1990 Nov 10;336(8724):1200; Lancet 1990 Dec 8;336(8728):1448.

Frayn KN. Nutritionists as guinea-pigs [editorial]. Br J Nutr 1996 Aug;76(2):157-9.

Garcia-Caceres U, Garcia FU. Bartonellosis. An immunodepressive disease and the life of Daniel Alcides Carrion. Am J Clin Pathol 1991 Apr;95(4 Suppl 1):S58-66.

Goldman L. History of self-experimentation in dermatology: should we go first--sometimes? Cutis 1991 Oct;48(4):338-41.

Josefson D. Doctors volunteer to be guinea pigs for AIDS vaccine [news]. BMJ 1997 Oct 4;315(7112):833.

London NL, London WT. A case of self-experimentation [editorial]. Cancer Epidemiol Biomarkers Prev 1997 Jul;6(7):475-6.

Marino D. Doctors plan to inject themselves with live AIDS vaccine [news]. Dent Today 1997 Nov;16(11):27, 29.

Murley R. Guilty of perpetuating the myth that John Hunter suffered from syphilis after inoculating himself from a chancre [letter]. World J Surg 1994 Mar-Apr;18(2):290. Comment on: World J Surg 1993 Jul-Aug;17(4):563-5.

van Everdingen JJ, Cohen AF. Self-experimentation by doctors [letter]. Lancet 1990 Dec 8;336(8728):1448. Comment on: Lancet 1990 Sep 29;336(8718):798-9.

Wright AJ. Self-experimentation in anesthesia. A preliminary inventory. Middle East J Anesthesiol 1994 Jun;12(5):431-42.

Zorgniott AW. Self-experimentation [letter]. Lancet 1990 Nov 10;336(8724):1200. Comment on: Lancet 1990 Sep 29;336(8718):798-9.
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## Special or vulnerable populations - Self-experimentation by researchers - Books

Altman LK. Who goes first? the story of self-experimentation in medicine. Berkeley: University of California Press; 1998. Originally published: New York: Random House; 1987.

Franklin J, Sutherland J. Guinea pig doctors: the drama of medical research through self-experimentation. New York: Morrow; 1984. 317 p.
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## Genetic Research - Journal Articles

Abbott A. German physicians warn of genetics risks [news]. Nature 1996 Nov 7;384(6604):5.

Agarwal S, Khardori R, Khardori N. Gene therapy: a status report. J Assoc Physicians India 1992 Feb;40(2):95-8. Comment in: J Assoc Physicians India 1992 Oct;40(10):706-7.

Alcolado JC, Rees JA, Owens DR. Selection of control subjects in genetic studies of diabetes mellitus [letter]. Diabetologia 1994 Jun;37(6):639-40. Comment on: Diabetologia 1993 Nov;36(11):1208-9.

Alexander JR, Lerer B, Baron M. Ethical issues in genetic linkage studies of psychiatric disorders. Br J Psychiatry 1992 Jan;160:98-102.

Anderson C. Gene therapy: a speeding ticket for NIH's controversial cancer star [news]. Science 1993 Mar 5;259(5100):1391-2.

Anderson FW. Reflections: of hope and of concern [editorial]. Hum Gene Ther 1991 Fall;2(3):193-4.

Anderson WF. Compassionate exemptions [editorial]. Hum Gene Ther 1993 Apr;4(2):125-6.

Anderson WF. Genetic engineering and our humanness. Hum Gene Ther 1994 Jun;5(6):755-9; discussion 759-60.

Anderson WF. Genetics and human malleability. Hastings Cent Rep 1990 Jan-Feb;20(1):21-4.

Anderson WF. Human gene therapy. Science 1992 May 8;256(5058):808-13.

Anderson WF. Human gene therapy. Nature 1998 Apr 30;392(6679 Suppl):25-30.

Anderson WF. RAC approves accelerated review [editorial]. Hum Gene Ther 1994 Jun;5(6):665-6.

Anderson WF. September 14, 1990: the beginning [editorial]. Hum Gene Ther 1990 Winter;1(4):371-2.

Anderson WF. Uses and abuses of human gene transfer [editorial]. Hum Gene Ther 1992 Feb;3(1):1-2.

Anderson WF, Blaese RM, Culver K. The ADA human gene therapy clinical protocol: Points to Consider response with clinical protocol, July 6, 1990. Hum Gene Ther 1990 Fall;1(3):331-62.

Areen J, King P. Legal regulation of human gene therapy. Hum Gene Ther 1990 Summer;1(2):151-61.

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## Genetic Research - Books

Agius E. Germ-line intervention and our responsibilities to future generations. Boston: Kluwer Academic Publishers; c1998. 174 p. (Philosophy and medicine; 55).

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Macer DRJ. Shaping genes: ethics, law and science of using genetic technology in medicine and agriculture. Christchurch (New Zealand): Eubios Ethics Institute; 1990. 421 p.

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Muller S, Simon JW, Vesting JW. Interdisciplinary approaches to gene therapy: legal, ethical, and scientific aspects. New York: Springer; c1997. 292 p. Collection of papers from the Luneburg Symposium on Interdisciplinary Approaches to Gene Therapy, University of Luneburg, Germany, held Mar. 25-6, 1996.

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## Gamete, embryo and fetal research - Journal Articles

Abbot A. European convention allows use of human embryos [news]. Nature 1996 Nov 28;384(6607):298.

Aldhous P. Pressure stepped up on embryo research [news]. Nature 1990 Apr 19;344(6268):691.

American College of Obstetricians and Gynecologists, Committee on Ethics. Preembryo research: history, scientific background, and ethical considerations. ACOG Committee Opinion 136, Apr 1994. Int J Gynaecol Obstet 1994 Jun;45(3):291-301.

American Medical Association, Board of Trustees. Frozen pre-embryos [report]. JAMA 1990 May 9;263(18):2484-7.

Andrews L, Elster N. Embryo research in the US. Hum Reprod 1998 Jan;13(1):1-4.

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Appleton T. Ethical issues in assisted reproductive medicine: a pragmatic approach. Br J Urol 1995 Nov;76 Suppl 2:85-92.

Bahadur G, Steele SJ. Ovarian tissue cryopreservation for patients. Hum Reprod 1996 Oct;11(10):2215-6.

Baird P. Proceed with care: new reproductive technologies and the need for boundaries. J Assist Reprod Genet 1995 Sep;12(8):491-8.

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Benzie RJ, Hughes-Benzie RM. Fetal therapy. Baillieres Clin Obstet Gynaecol 1991 Sep;5(3):715-29.

Berkowitz JM. Mummy was a fetus: motherhood and fetal ovarian transplantation. J Med Ethics 1995 Oct;21(5):298-304. Published erratum appears in J Med Ethics 1996 Apr;22(2):77.

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Brennan SR. Black looks at when life begins [letter]. J R Coll Physicians Lond 1990 Jul;24(3):250. Comment on: J R Coll Physicians Lond 1990 Jan;24(1):8-9.

Bromham DR. Attitudes toward embryo research. J Assist Reprod Genet 1992 Apr;9(2):90-3.

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Butler D. Ethics bill prompts second thoughts among scientists [news]. Nature 1994 Jan 20;367(6460):209.

Butler D. France is urged to loosen ban on embryo research [news]. Nature 1997 May 15;387(6630):218.

Byk JC. A proposed draft protocol for the European Convention on Biomedicine relating to research on the human embryo and fetus. J Med Ethics 1997 Feb;23(1):32-7.

Callahan D. The puzzle of profound respect. Hastings Cent Rep 1995 Jan-Feb;25(1):39-40.

Campbell CS. Awe diminished. Hastings Cent Rep 1995 Jan-Feb;25(1):44-6.

Centre For Bioethics and Public Policy (London). Response to the Human Fertilisation and Embryology Authority's consultation document on research and fertility treatment using human ova and ovarian tissue obtained from live women, cadavers or fetuses. Ethics Med 1995;11(2):33-6.

Cole AP, Duddington AJ, Duddington JG, Sayer GS. Human embryo research [letter]. Lancet 1990 Apr 28;335(8696):1040.

Corrigan E, Mumford SE, Hull MG. Posthumous storage and use of sperm and embryos: survey of opinion of treatment centres. BMJ 1996 Jul 6;313(7048):24. Comment in: BMJ 1996 Jul 6;313(7048):1-2.

Craft I, Shapland D, Fincham E, al-Shawaf T. Research on human embryos, cryopreservation, and the HFEA [letter]. Lancet 1991 Oct 5;338(8771):888.

Culliton BJ, Ivinson AJ. Expect more from embryos [editorial]. Nat Med 1996 Sep;2(9):947. Comment in: Nat Med 1996 Dec;2(12):1280.

Dalton R. Researchers 'duped' over use of embryos without consent [news]. Nature 1996 Feb 29;379(6568):756.

Davis JH. Frozen pre-embryos [letters and responses]. JAMA 1990 Nov 14;264(18):2382-3.

Dawson KJ. The storage of human embryos. Hum Reprod 1997 Jan;12(1):6.

Deutsch E. Fetus in Germany: the Fetus Protection Law of 12.13.1990. Int J Bioethics 1992 Jun;3(2):85-93.

Dickenson DL. Procuring gametes for research and therapy: the argument for unisex altruism--a response to Donald Evans. J Med Ethics 1997 Apr;23(2):93-5. Comment on: J Med Ethics 1995 Oct;21(5):261-4. Comment in: J Med Ethics 1997 Apr;23(2):67-8.

Dickman S. Embryo research: Germany turns clock back [news]. Nature 1990 Nov 1;348(6296):8.

Dickson D. UK parliament passes surprise ban on fetal embryos in IVF [news]. Nature 1994 Apr 21;368(6473):676.

Dickson D. Use of fetal eggs in research to be debated [news]. Nature 1993 Jul 29;364(6436):372.

Dijon X. Abortion and genetic manipulation: breaking with reasoning founded on disrespect for life and human dignity. Med Law 1993;12(1-2):85-92.

Donated ovarian tissue in embryo research and assisted conception: public consultation document. UK Human Fertilisation and Embryo Authority. Hum Reprod 1994 May;9(5):931-5.

Edwards JH, Benham JD. Views on donated ovarian tissue [letter]. Lancet 1994 Sep 17;344(8925):824. Comment on: Lancet 1994 Jul 16;344(8916):204.

Edwards RG, Beard HK. Destruction of cryopreserved embryos. UK law dictated the destruction of 3000 cryopreserved human embryos. Hum Reprod 1997 Jan;12(1):3-5; discussions 5-6.

Eisenberg VH, Schenker JG. Preembryo research: medical aspects and ethical considerations. Obstet Gynecol Surv 1997 Sep;52(9):565-74.

Embryo research [editorial]. Nature 1990 Apr 19;344(6268):690.

Eser A. The legal status of the embryo in comparative perspective. Med Law 1992;11(7-8):579-90.

Ewing C. Australian perspectives on embryo experimentation: an update. Issues Reprod Genet Eng J Int Feminist Anal 1990;3(2):119-23.

Fackelmann KA. Embryo research panel ignites debate [news]. Sci News 1994 Oct 1;146(14):212.

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Ferguson-Smith ME. Ethical and legal implications in IVF and prenatal diagnosis in the UK. Prenat Diagn 1991 Aug;11(8):661-70.

Fletcher JC. Women's and fetal rights and interests: ethical aspects. Food Drug Law J 1993;48(2):213-21.

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Franco JG Jr. Frozen embryos in Brazil. Hum Reprod 1995 Dec;10(12):3082-3.

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Handyside A. Sex and the single cell [news]. New Sci 1990 Apr 21;126(1713):34-5.

Hersey J. Enigma of the unborn mother: legal and ethical considerations of aborted fetal ovarian tissue and ova transplantations. UCLA Law Rev 1995 Oct;43(1):159-207.

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Holzgreve W, Garritsen HS, Tercanli S, Miny P, Nippert I, Ganshirt D. Noninvasive prenatal diagnosis. Strategy for a clinical trial. Ann N Y Acad Sci 1994 Sep 7;731:253-6.

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Kazem R, Thompson LA, Hamilton MP, Templeton A. Current attitudes towards egg donation among men and women. Hum Reprod 1995 Jun;10(6):1543-8.

Klein RD. IVF research: a question of feminist ethics. Issues Reprod Genet Eng J Int Feminist Anal 1990;3(3):243-51.

Krimsky S, Hubbard R. The business of research. Hastings Cent Rep 1995 Jan-Feb;25(1):41-3. Published erratum appears in Hastings Cent Rep 1995 May-Jun;25(3):2.

Lappert PW. Scarless fetal skin repair: unborn patients and fetal material [letter]. Plast Reconstr Surg 1996 Nov;98(6):1125.

Laruelle C, Englert Y. Psychological study of in vitro fertilization-embryo transfer participants' attitudes toward the destiny of their supernumerary embryos. Fertil Steril 1995 May;63(5):1047-50. Comment in: Fertil Steril 1996 Jan;65(1):205-6.

Lornage J, Chorier H, Boulieu D, Mathieu C, Czyba JC. Six year follow-up of cryopreserved human embryos. Hum Reprod 1995 Oct;10(10):2610-6.

Lyall H, Murray E, Glasier A, Baird DT. Donated ovarian tissue in embryo research and assisted conception--the view of women of reproductive age. Hum Reprod 1995 May;10(5):1242-5.

Marshall E. Embryologists dismayed by sanctions against geneticist [news]. Science 1997 Jan 24;275(5299):472.

Martin PA, Lagod ML. The human preembryo, the progenitors, and the state: toward a dynamic theory of status, rights, and research policy. High Technol Law J 1990 Fall;5(2):257-310.

McCormick RA. The preembryo as potential: a reply to John A. Robertson. Kennedy Inst Ethics J 1991 Dec;1(4):303-5.

Minkoff HL, Moreno JD. Paternal consent for fetal research [letter]. N Engl J Med 1993 Jul 22;329(4):278.

More fuss about genetics and embryos [editorial]. Nature 1994 Jan 13;367(6459):99-100.

Mulkay M. Women in the parliamentary debate over embryo research. Sci Tech Hum Values 1994 Winter;19(1):5-22.

Multhaupt S, Kloth K. In-vitro fertilization and embryo research: the necessity of statutory regulations. Med Law 1991;10(6):565-73.

Nathanson B. Of pre-embryos and Bourbon kings. Ethics Med 1992 Spring;8(1):1-3.

Ohlendorf-Moffat P. Surgery before birth. Discover 1991 Feb;12(2):58-65.

Penn ZJ, Steer PJ. Reasons for declining participation in a prospective randomized trial to determine the optimum mode of delivery of the preterm breech. Control Clin Trials 1990 Aug;11(4):226-31.

Quintavalle J. Case for reforming Human Fertilisation and Embryology Authority [letter]. Lancet 1996 Sep 14;348(9029):758.

Quintavalle J. What to do with spare embryos [letter]. Lancet 1996 May 25;347(9013):1489. Comment on: Lancet 1996 Apr 13;347(9007):983.

Robertson JA. Legal and ethical issues arising with preimplantation human embryos. Arch Pathol Lab Med 1992 Apr;116(4):430-5.

Robertson JA. What we may do with preembryos: a response to Richard A. McCormick. Kennedy Inst Ethics J 1991 Dec;1(4):293-302.

Rogers A. European data protection to give unborn children rights? [news]. Lancet 1997 Feb 22;349(9051):550.

Rosenwaks Z, Davis OK. On the disposition of cryopreserved human embryos: an opinion. Hum Reprod 1997 Jun;12(6):1121.

Sams L. Ethical dilemmas in maternal-fetal research. MCN Am J Matern Child Nurs 1997 Mar-Apr;22(2):67-71.

Samuels A, Barrister JP. Embryo research: the significance of the new law. Med Sci Law 1991 Apr;31(2):115-8.

Saunders DM, Bowman MC, Grierson A, Garner F. Frozen embryos: too cold to touch? The dilemma ten years on. Hum Reprod 1995 Dec;10(12):3081-2.

Schafer D, Kettner M. Moral concern over cryopreserved human embryos: too much or too little? Hum Reprod 1997 Jan;12(1):10-1.

Schenker JG. Research on human embryos. Eur J Obstet Gynecol Reprod Biol 1990 Sep;36(3):267-73.

Sperber GH. The ethics of embryo experimentation [editorial]. Cleft Palate Craniofac J 1995 Jul;32(4):269-70.

Sullivan L. Embryo experimentation and the murder prohibition: a casuistic examination of the utilitarian and pro-life positions on the moral status of the embryo. Med Law 1995;14(5-6):369-86.

Tauer CA. Embryo research and public policy: a philosopher's appraisal. J Med Philos 1997 Oct;22(5):423-39.

Thomas AK. Human embryo experimentation and surrogacy. Med J Aust 1990 Oct 1;153(7):369-71.

Waldschmidt A. The embryo as a legal entity -- woman as a fetal environment: the new German laws on reproductive engineering and embryo research. Issues Reprod Genet Eng J Int Feminist Anal 1991;4(3):209-22.

Warnock M. Ethical challenges in embryo manipulation. BMJ 1992 Apr 18;304(6833):1045-9.

Warnock M. Green College Lecture. Ethical challenges in embryo manipulation. BMJ 1992 Apr 18;304(6833):1045-9. Comment in: BMJ 1992 May 30;304(6839):1446.

Warren MA. Embryo manipulation and experimentation. Baillieres Clin Obstet Gynaecol 1991 Sep;5(3):591-609.

Yding AC, Westergaard LG, Grinsted J, Petersen K, Nyboe AA. Frozen embryos: too cold to touch? Frozen pre-embryos in Denmark. Hum Reprod 1996 Apr;11(4):703.
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## Gamete, embryo and fetal research - Books

Annual Report 1989 and 1990. The Hague: Health Council of the Netherlands; 1991 Sep 2. 32 p.

Annual Report 1992. London: The Human Fertilisation and Embryology Authority; 1992. 36 p.

Bertazzoni U, et al., editors. Human embryos and research: proceedings of the European Bioethics Conference; 1988 Nov 7-9; Mainz. New York: Campus Verlag; 1990. 258 p. (Gentechnologie; 25).

Code of practice: consultation document. London: Human Fertilisation and Embryology Authority; 1991. 37 p.

Ethics and mapping of the human genome: protection of sensitive personal information, genetic screening, and genetic testing in appointments, etc.: Reports [and] fifth annual report. 1992. Copenhagen: Danish Council of Ethics; 1993. 115 p.

Evans D. Conceiving the embryo: ethics, law and practice in human embryology. Boston: Martinus Nijhoff; 1996. 358 p.

Evans MI, editor. Fetal diagnosis and therapy: science, ethics, and the law. Philadelphia: Lippincott; c1989. 592 p.

Fetal diagnosis and ethics: a report [and] third annual report, 1990. Copenhagen: Danish Council of Ethics; 1991. 82 p.

Human Fertilisation and Embryology Authority (Great Britain). Statutory storage period for embryos. London: Department of Health; 1995 Jul. 13 p. Report by the Human Fertilisation and Embryology Authority to the Health Ministers of the United Kingdom.

Humber JM, Almeder RF. Biomedical ethics reviews, 1991. Bioethics and the fetus: medical, moral and legal issues. Totowa (NJ): Humana Press; 1991. 190 p.

Kolata G. The baby doctors: probing the limits of fetal medicine. New York: Delacorte Press; 1990. 213 p.

Manual for centres. London: The Human Fertilisation and Embryology Authority; 1991 Jun. 1 vol. Looseleaf.

Mulkay MJ. The embryo research debate: science and the politics of reproduction. New York: Cambridge University Press; 1997. 212 p. (Cambridge cultural social studies).

Nimrod C, Griener G. Biomedical ethics and fetal therapy. Waterloo (Ontario): Wilfred Laurier University Press; 1988. 122 p. Published for the Calgary Institute for the Humanities.

Protection of human gametes, fertilized ova, embryos and fetuses: a report [and] second annual report, 1989. Copenhagen: Danish Council of Ethics; 1990. 147 p.

Rini SM, editor. Beyond abortion: a chronicle of fetal experimentation. Avon-by-the-Sea (NJ): Magnificat Press; c1988. 186 p.

Singer P, editor. Embryo experimentation. New York: Cambridge University Press; 1990. 263 p.

Steinberg DL. Bodies in glass: genetics, eugenics, embryo ethics. Manchester (England): Manchester University Press; 1997. 224 p.

Steinbock B. Life before birth: the moral and legal status of embryos and fetuses. New York: Oxford University Press; 1992. 256 p.

Swedish act concerning use of gene technology on human beings and experiments with fertilised ova. Stockholm: Ministry of Health and Social Affairs; 1991. 17 p.

Washington M, editor. Fetal research: a survey of state law. Washington: Library of Congress; 1988. 15 p. (CRS report for Congress; 88-198 A).
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## Human cloning - Journal Articles

Adult cloning marches on [editorial]. Nature 1998 Jul 23;394(6691):303. Comment on: Nature 1998 Jul 23;394(6691):315-6; Nature 1998 Jul 23;394(6691):329-30; Nature 1998 Jul 23;394(6691):369-74.

Andrews LB. Mom, dad, clone: implications for reproductive privacy. Camb Q Healthc Ethics 1998 Spring;7(2):176-86.

Andrews LB, Rothstein MA, Latham SR, Garfinkel MD, Charo RA. The clone age. ABA J Lawyers Mag 1997 Jul;83:68-73.

Annas GJ. Regulatory models for human embryo cloning: the free market, professional guidelines, and government restrictions. Kennedy Inst Ethics J 1994 Sep;4(3):235-49.

Annas GJ. Why we should ban human cloning. N Engl J Med 1998 Jul 9;339(2):122-5.

Annas GJ, Robertson JA. Human cloning: should the United States legislate against it? Yes, individual dignity demands nothing less; No the potential for good is too compelling. ABA J Lawyers Mag 997 May;1(83):80-1.

Benatar D. Cloning and ethics. QJM 1998 Feb;91(2):165-6.

Blacksher E. Cloning human beings. Responding to the National Bioethics Advisory Commission's Report. Hastings Cent Rep 1997 Sep-Oct;27(5):6-9.

Bloom FE. Breakthroughs 1997 [editorial]. Science 1997 Dec 19;278(5346):2029.

Bower H. Public consultation on human cloning launched [news]. BMJ 1998 Feb 7;316(7129):411.

Boyd KM. Little lamb, who made thee? A letter from Edinburgh [letter]. Camb Q Healthc Ethics 1998 Spring;7(2):199-202.

Buck G. An open letter to Dr. Seed [satire]. JAMA 1998 Apr 1;279(10):977.

Buehler DA. CQ sources/bibliography. Camb Q Healthc Ethics 1998 Spring;7(2):203-5.

Bulfield G, Campbell K, James R, Wilmut I. Voices from Roslin: the creators of Dolly discuss science, ethics, and social responsibility [interview by Arlene Judith Klotzko]. Camb Q Healthc Ethics 1998 Spring;7(2):121-40.

Burke MB. NABER on embryo splitting [letter]. Kennedy Inst Ethics J 1996 Jun;6(2):210-1.

Butler D. Calls for human cloning ban 'stem from ignorance' [news]. Nature 1997 May 22;387(6631):324. Comment in: Nature 1997 Jul 24;388(6640):320.

Butler D. Europe brings in first international ban [news]. Nature 1998 Jan 15;391(6664):219.

Butler D. European ethics advisers back cloning ban [news]. Nature 1997 Jun 5;387(6633):536.

Butler D, Schiermeier Q. Ruttgers and Chirac seek cloning ban [news]. Nature 1997 May 8;387(6629):111.

Butler D, Wadman M. Calls for cloning ban sell science short [news]. Nature 1997 Mar 6;386(6620):8-9.

Cahill LS. The status of the embryo and policy discourse. J Med Philos 1997 Oct;22(5):407-14.

Callahan D. Cloning: the work not done. Hastings Cent Rep 1997 Sep-Oct;27(5):18-20.

Callahan D. Cloning: then and now. Camb Q Healthc Ethics 1998 Spring;7(2):141-4.

Campbell CS. Prophecy and policy. Hastings Cent Rep 1997 Sep-Oct;27(5):15-7.

Caplan A, Venter C. Using one's head [letter]. Science 1997 Nov 28;278(5343):1547-8. Comment on: Science 1997 Oct 31;278(5339):798.

Capron AM. Inside the Beltway again: a sheep of a different feather. Kennedy Inst Ethics J 1997 Jun;7(2):171-9.

Capron AM. Is it time to clone a bioethics commission? Hastings Cent Rep 1994 Jan-Feb;24(1):29-30.

Childress JF. The challenges of public ethics: reflections on NBAC's report. Hastings Cent Rep 1997 Sep-Oct;27(5):9-11.

Cimons M. Cloning research a possibility [news]. Nat Med 1997 Jul;3(7):710.

Clone encounters [editorial]. Nat Genet 1997 Apr;15(4):323-4.

Cloning: realising the benefits while minimising the risks [news]. Vet Rec 1997 Mar 29;140(13):323-4.

Coghlan A. One small step for a sheep [news]. New Sci 1997 Mar 1;153(2071):4.

Coghlan A. Will cloned cows rise from the dead? [news]. New Sci 1997 Mar 8;153(2072):5.

Cohen CB. Future directions for human cloning by embryo splitting: after the hullabaloo. Kennedy Inst Ethics J 1994 Sep;4(3):187-92.

Cohen J, Tomkin G. The science, fiction, and reality of embryo cloning. Kennedy Inst Ethics J 1994 Sep;4(3):193-203.

Cole-Turner R. Human cloning research [letter]. N Engl J Med 1998 Jun 11;338(24):1770-1. Comment on: N Engl J Med 1998 Mar 26;338(13):905-6.

Conley JJ. Narcissus cloned. America 1994 Feb 12;170(5):15-7.

Cooling down over cloning [editorial]. Lancet 1998 Jan 17;351(9097):151.

Council for Responsible Genetics. Position statement on cloning. Bull Med Ethics 1997 Sep;131:10-1.

de Grouchy J. The ethician's puzzle. Biomed Pharmacother 1997;51(9):365-6.

Dickson D. UK consults public on clones for research [news]. Nature 1998 Feb 5;391(6667):523.

Double trouble [editorial]. Nature 1997 Aug 7;388(6642):501. Comment on: Nature 1997 Aug 7;388(6642):508.

Drury KC. Viable offsprings derived from fetal and adult mammalian cells. J Womens Health 1998 May;7(4):475-6.

Ethical aspects of cloning techniques. Advisers to the President of the European Commission on the Ethical Implications of Biotechnology. J Med Ethics 1997 Dec;23(6):349-52.

Ethical aspects of cloning techniques: opinion of the Group of Advisers on the Ethical Implications of Biotechnology of the European Commission. Camb Q Healthc Ethics 1998 Spring;7(2):187-91; discussion 192-3.

Ethical aspects of genetic modification of animals: opinion of the Group of Advisers on the Ethical Implications of Biotechnology of the European Commission. Camb Q Healthc Ethics 1998 Spring;7(2):194-6; discussion 196-8.

European Parliament. Cloning animals and human beings. [Resolution of 12 March 1997]. Bull Med Ethics 1997 May;128:10-1.

Fainzilber M. Advantage of knowing nature's secrets [letter]. Nature 1997 Apr 3;386(6624):431. Comment on: Nature 1997 Feb 27;385(6619):757. Comment in: Nature 1997 May 8;387(6629):119.

Fielding EW. Fear of cloning. Hum Life Rev 1997 Spring;23(2):15-22.

FitzGerald KT. Human cloning: analysis and evaluation. Camb Q Healthc Ethics 1998 Spring;7(2):218-22.

Fox JL. Bioethicists ruminate separately on clones, gene 'enhancements' [news]. Nat Biotechnol 1997 May;15(5):406-7.

Fox JL. US bioethicists say continue human cloning moratorium [news]. Nat Biotechnol 1997 Jul;15(7):609.

French Academy split on cloning policy [news]. Nature 1997 Jul 3;388(6637):11.

Galton DJ, Kay A, Cavanna JS. Human cloning: safety is the issue [letter]. Nat Med 1998 Jun;4(6):644.

Greenberg DS. Much ado about mutton? Lancet 1997 Jun 21;349(9068):1850.

Greenberger P. Research funding and cloning: top recent policy agenda [news]. J Womens Health 1998 Jun;7(5):501-3.

Griffin H, Wilmut I. Seven days that shook the world. New Sci 1997 Mar 22;153(2074):49.

Group of Advisers to the President of the European Commission on the Ethical Implications of Biotechnology. Ethical aspects of cloning techniques. J Med Ethics 1997 Dec;23(6):349-52.

Haglund K. Ninety-day wonder [editorial]. J NIH Res 1997 Jul;9(7):10.

Harris J. Cloning and bioethical thinking [letter]. Nature 1997 Oct 2;389(6650):433. Comment on: Nature 1997 Jul 24;388(6640):320.

Harris J. Cloning and human dignity. Camb Q Healthc Ethics 1998 Spring;7(2):163-7.

Harris J. Goodbye Dolly? The ethics of human cloning. J Med Ethics 1997 Dec;23(6):353-60.

Harris J. Is cloning an attack on human dignity? [letter]. Nature 1997 Jun 19;387(6635):754. Comment on: Nature 1997 Feb 27;385(6619):810-3; Nature 1997 Mar 13;386(6621):119. Comment in: Nature 1997 Jul 3;388(6637):15; Nature 1997 Jul 24;388(6640):320.

Healy BP. The asexual revolution of Dolly the lamb [editorial]. J Womens Health 1998 Feb;7(1):1-2.

Hodgson J. Dolly opens a farm full of possibilities [news]. Nat Biotechnol 1997 Apr;15(4):306.

Holden C. Scholars' group defends cloning [news]. Science 1997 May 30;276(5317):1341.

Holden C. UN weighs in on cloning [news]. Science 1997 Nov 21;278(5342):1407.

Holm S. A life in the shadow: one reason why we should not clone humans. Camb Q Healthc Ethics 1998 Spring;7(2):160-2.

Hopkins PD. Bad copies. How popular media represent cloning as an ethical problem. Hastings Cent Rep 1998 Mar-Apr;28(2):6-13.

Hoyle R. Arrogance on human cloning may pose a threat to biotechnology. Nat Biotechnol 1998 Jan;16(1):6.

Hubris, benefits and minefields of human cloning. Editorial. Nature 1998 Jan 15;391(6664):211.

Husted GL, Husted JH. An ethical defense against the plague of cloning. Adv Pract Nurs Q 1997 Fall;3(2):82-4.

Husted GL, Husted JH. An ethical examination of cloning. AORN J 1997 Jun;65(6):1112-3.

Husted GL, Husted JH. Is cloning moral? N HC Perspect Community 1997 May-Jun;18(3):168-9.

Jones HW. Reflections on the usefulness of embryo cloning. Kennedy Inst Ethics J 1994 Sep;4(3):205-7.

Jones HW, Edwards RG, Seidel GE. On attempts at cloning in the human [editorial]. Fertil Steril 1994 Mar;61(3):423-6.

Jones S. Send in the clones. Nurs Times 1997 Mar 19-25;93(12):24.

Josefson D. US scientist plans human cloning clinic [news]. BMJ 1998 Jan 17;316(7126):167.

Kahn A. Clone mammals... clone man? Nature 1997 Mar 13;386(6621):119. Comment on: Nature 1997 Feb 27;385(6619):810-3. Comment in: Nature 1997 Jun 19;387(6635):754.

Kahn A. Cloning, dignity and ethical revisionism [letter]. Nature 1997 Jul 24;388(6640):320. Comment on: Nature 1997 May 22;387(6631):321; Nature 1997 May 22;387(6631):324; Nature 1997 Jun 19;387(6635):754. Comment in: Nature 1997 Aug 7;388(6642):511; Nature 1997 Oct 2;389(6650):433.

Kassirer JP, Rosenthal NA. Should human cloning research be off limits? [editorial]. N Engl J Med 1998 Mar 26;338(13):905-6. Comment in: N Engl J Med 1998 Jun 11;338(24):1770; discussion 1771; N Engl J Med 1998 Jun 11;338(24):1770-1.

Kestenbaum D. Cloning plan spawns ethics debate [news]. Science 1998 Jan 16;279(5349):315.

Kim JH. Human cloning and the digital revolution. MD Comput 1998 Jul-Aug;15(4):215-6.

Kitcher P. Quality, not quantity. New Sci 1997 Mar 15;153(2073):47.

Klotzko AJ. The debate about Dolly. Bioethics 1997 Oct;11(5):427-38.

Klotzko AJ. Dolly, cloning, and the public misunderstanding of science: a challenge for us all [editorial]. Camb Q Healthc Ethics 1998 Spring;7(2):115-6.

Klotzko AJ. An embryonic dilemma. Nurs Times 1997 Oct 22-28;93(43):38-9.

Kolberg R. Human embryo cloning reported [news]. Science 1993 Oct 29;262(5134):652-3.

Kuhse H, Singer P. Cloning our way to Armageddon? [editorial]. Bioethics 1997 Oct;11(5):3-5.

Macilwain C. Cloning of human embryos draws fire from critics [news]. Nature 1993 Oct 28;365(6449):778.

Macklin R. Cloning without prior approval: a response to recent disclosures of noncompliance. Kennedy Inst Ethics J 1995 Mar;5(1):57-60.

Macklin R. Splitting embryos on the slippery slope: ethics and public policy. Kennedy Inst Ethics J 1994 Sep;4(3):209-25.

MacQuitty JJ. The real implications of Dolly. Nat Biotechnol 1997 Apr;15(4):294.

Marshall E. Biomedical groups derail fast-track anticloning bill [news]. Science 1998 Feb 20;279(5354):1123-4.

Marshall E. Clinton urges outlawing human cloning [news]. Science 1997 Jun 13;276(5319):1640.

Marshall E. Mammalian genome debate heats up [news]. Science 1997 Mar 21;275(5307):1733.

Marshall E. Panel weighs a law against cloning [news]. Science 1997 May 23;276(5316):1185-6.

Marwick C. Put human cloning on hold, say bioethicists [news]. JAMA 1997 Jul 2;278(1):13-4.

McClenahan JL. Anyone for cloning? Va Med Q 1998 Spring;125(2):110-1.

McCormick RA. Blastomere separation: some concerns. Hastings Cent Rep 1994 Mar-Apr;24(2):14-6.

Meyer JR. Cloning human embryos: why artificial human procreation is immoral. Linacre Q 1995 May;62(2):22-9.

Michael A. Europe/Japan face up to legal hurdles to cloning [news]. Nat Biotechnol 1997 Jul;15(7):609-10.

Miller FG, Caplan AL, Fletcher JC. Dealing with Dolly: inside the National Bioethics Advisory Commission. Health Aff (Millwood) 1998 May-Jun;17(3):264-7.

Miller SK, Vines G. Human clones split fertility experts [news]. New Sci 1993 Oct 30;140(1897):7.

More ado about cloning [news]. Nat Biotechnol 1998 Mar;16(3):219.

Morton O, Williams N. First Dolly, now headless tadpoles [news]. Science 1997 Oct 31;278(5339):798. Comment in: Science 1997 Nov 28;278(5343):1547-8.

National Advisory Board on Ethics in Reproduction (NABER). Report on human cloning through embryo splitting: an amber light. Kennedy Inst Ethics J 1994 Sep;4(3):251-82.

Nelkin D, Lindee MS. Cloning in the popular imagination. Camb Q Healthc Ethics 1998 Spring;7(2):145-9.

Nestle N. Cloning humans [letter]. Nature 1997 May 8;387(6629):119. Comment on: Nature 1997 Apr 3;386(6624):431.

Newman SA. Cloning our way to the next level. Nat Biotechnol 1997 Jun;15(6):488.

Newman SA. Human cloning and the family: reflections on cloning existing children. N Y Law Sch J Hum Rights 1997 Spring;13(3):523-30.

Nicholson R. Two of a kind--or none? [news]. Hastings Cent Rep 1997 May-Jun;27(3):5.

O'Brien C. Cloned sheep rekindles ethical debate [news]. Mol Med Today 1997 Apr;3(4):140.

O'Connor J. Human cloning: efficiency vs. ethics. Origins 1997 Apr 10;26(42):681, 683-4.

Opposition to human cloning [news]. JAMA 1997 Apr 9;277(14):1105.

Parens E. Tools from and for democratic deliberations. Hastings Cent Rep 1997 Sep-Oct;27(5):20-2.

Pennisi E. The lamb that roared [news]. Science 1997 Dec 19;278(5346):2038-9. Comment on: Science 1997 Dec 19;278(5346):2130-3.

Post SG. The Judeo-Christian case against human cloning. America 1997 Jun 21;176(21):19-22.

Report on cloning by the US Bioethics Advisory Commission: ethical considerations. Hum Reprod Update 1997 Nov-Dec;3(6):629-41.

Rhodes R. Clones, harms, and rights. Camb Q Healthc Ethics 1995 Summer;4(3):285-90.

Roberts MA. Human cloning: a case of no harm done? J Med Philos 1996 Oct;21(5):537-54.

Robertson JA. Human cloning and the challenge of regulation. N Engl J Med 1998 Jul 9;339(2):119-22.

Robertson JA. Liberty, identity, and human cloning. Texas Law Rev 1998 May;76(6):1371-456.

Robertson JA. The question of human cloning. Hastings Cent Rep 1994 Mar-Apr;24(2):6-14.

Rogers A. Britain denies prevarication over human-cloning ban [news]. Lancet 1997 Oct 18;350(9085):1151.

Rogers A. Europe takes steps to outlaw human cloning [news]. Lancet 1997 Oct 4;350(9083):1012.

Rovner J. USA to think again about ban on human cloning [news]. Lancet 1998 Feb 21;351(9102):578.

Saegusa A. Japan gears up to debate brake on human cloning [news]. Nature 1998 Jan 22;391(6665):313.

Saegusa A. Japanese fear that new publicity rules could hinder their research [news]. Nature 1998 Jul 30;394(6692):408.

Shapiro D. Cloning, dignity and ethical reasoning [letter]. Nature 1997 Aug 7;388(6642):511. Comment on: Nature 1997 Jul 24;388(6640):320.

Shapiro HT. Ethical and policy issues of human cloning. Science 1997 Jul 11;277(5323):195-6.

Short-circuit to be avoided by bioethics committees [editorial]. Nature 1997 May 22;387(6631):321.

Silberner J. Seeding the cloning debate. Hastings Cent Rep 1998 Mar-Apr;28(2):5.

Silva YJ. Cloning: the cataclysmic human challenge [news]. Natl Med J India 1998 Mar-Apr;11(2):92.

Silver LM. Cloning, ethics, and religion. Camb Q Healthc Ethics 1998 Spring;7(2):168-72.

Soldini M. Human cloning research [letter]. N Engl J Med 1998 Jun 11;338(24):1770; discussion 1771.

Solter D. Dolly is a clone--and no longer alone [news]. Nature 1998 Jul 23;394(6691):315-6. Comment on: Nature 1998 Jul 23;394(6691):329-30; Nature 1998 Jul 23;394(6691):369-74. Comment in: Nature 1998 Jul 23;394(6691):303.

SoRelle R. Legislation of human cloning in the United States [news]. Circulation 1998 May 19;97(19):1889.

Stephenson J. Threatened bans on human cloning research could hamper advances [news]. JAMA 1997 Apr 2;277(13):1023, 1025-6.

Strong C. Cloning and infertility. Camb Q Healthc Ethics 1998 Summer;7(3):279-93.

Sylvester R. No more cloning around [news]. Nurs Times 1997 Oct 22-28;93(43):24.

Taggart MJ. Advantage of knowing nature's secrets [letter]. Nature 1997 Apr 3;386(6624):431. Comment on: Nature 1997 Feb 27;385(6619):810-3.

Tanos V, Schenker JG. Reproductive health care policies around the world. Is human cloning justified? J Assist Reprod Genet 1998 Jan;15(1):1-9.

The point of no return [editorial]. New Sci 1997 Mar 1;153(2071):3.

Triumph of hope [editorial]. New Sci 1997 May 31;154(2084):3.

Trounson AO. Cloning: potential benefits for human medicine [editorial]. Med J Aust 1997 Dec 1-15;167(11-12):568-9.

van der Linde I. The gynaecologist who started all the fuss [news]. S Afr Med J 1998 Apr;88(4):420.

Verhey AD. Cloning: revisiting an old debate. Kennedy Inst Ethics J 1994 Sep;4(3):227-34.

Voelker R. Opposition to human cloning grows [news]. JAMA 1997 Jun 11;277(22):1750.

Vogel G. From science fiction to ethics quandary [news]. Science 1997 Sep 19;277(5333):1753-4.

Wadman M. Backing for anti-cloning bill reopens embryo debate [news]. Nature 1997 Aug 7;388(6642):505.

Wadman M. Cloned mice fail to rekindle ethics debate [news]. Nature 1998 Jul 30;394(6692):408-9.

Wadman M. Cloning for research 'should be allowed' [news]. Nature 1997 Jul 3;388(6637):6.

Wadman M. Seed sows further doubts on cloning [news]. Nature 1998 Jan 15;391(6664):218-9.

Wadman M. US biologists adopt cloning moratorium [news]. Nature 1997 Sep 25;389(6649):319.

Wadman M. US panel to back longer cloning ban, ducks thornier questions [news]. Nature 1997 May 15;387(6630):217-8.

Wadman M. US sees flurry of bills in bids to legislate [news]. Nature 1998 Feb 5;391(6667):523.

Wadman M. US Senate bills on cloning under fire from researchers [news]. Nature 1998 Feb 12;391(6668):623.

Wadman M. US senators urge caution on cloning ban [news]. Nature 1997 Mar 20;386(6622):204.

Wadman M. White House bill would ban human cloning [news]. Nature 1997 Jun 12;387(6634):644.

Warnock M. The regulation of technology. Camb Q Healthc Ethics 1998 Spring;7(2):173-5.

Watson R. European parliament wants world ban on human cloning [news]. BMJ 1997 Mar 22;314(7084):847.

Watson R. The [European] Union gets interested in ethics [news]. BMJ 1997 Jun 28;314(7098):1854.

Watt H. What moral status has a human clone? [letter]. Bull Med Ethics 1993 Nov;93 :2.

White RJ. Human cloning research [letter]. N Engl J Med 1998 Jun 11;338(24):1770; discussion 1771.

Wilkie T, Graham E. Power without responsibility: media portrayals of Dolly and science. Camb Q Healthc Ethics 1998 Spring;7(2):150-9.

Williams N. Cloning sparks calls for new laws [news]. Science 1997 Mar 7;275(5305):1415.

Winston R. The promise of cloning for human medicine [editorial]. BMJ 1997 Mar 29;314(7085):913-4. Comment in: BMJ 1997 Jul 26;315(7102):255.

Wolf DP, Meng L, Ely JJ, Stouffer RL. Recent progress in mammalian cloning. J Assist Reprod Genet 1998 May;15(5):235-9.

Wolf PL, Liggins G, Mercola D. The cloning debates and progress in biotechnology [editorial]. Clin Chem 1997 Nov;43(11):2019-20.

Wolf SM. Ban cloning? Why NBAC is wrong. Hastings Cent Rep 1997 Sep-Oct;27(5):12-5.
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## Human cloning - Books

Biotechnology and the Ethics of Cloning: How Far Should We Go? Hearing (1997 Mar 5). Washington: U.S. Government Printing Office; 1997. 59 p.

Cloning human beings: report and recommendations of the National Bioethics Advisory Commission. Rockville (MD): The Commission; 1997.

Harris J. Clones, genes, and immortality: ethics and the genetic revolution. New York: Oxford University Press; 1998. 328 p. Originally published as: Wonderwoman and superman. 1992.

Kass LR. Ethics of human cloning. Washington: American Enterprise Institute for Public Policy Research; 1998.

Kolata G. Clone: the road to Dolly, and the path ahead. New York: William Morrow; 1998. 276 p.

Nussbaum MC, Sunstein CR, editors. Clones and clones. Facts and fantasies about human cloning. New York: W. W. Norton & Co.; 1998. 288 p.

Pence GE. Flesh of my flesh: the ethics of cloning humans: a reader. Lanham (MD): Rowman and Littlefield; 1998. 154 p.

Scientific Discoveries in Cloning: Challenges for Public Policy: Hearing (1997 Mar 12). Washington: U.S. Government Printing Office; 1997. 87 p.

Silver LM. Remaking Eden: cloning and beyond in a brave new world. 1st ed. New York: Avon Books; c1997. 317 p.

Winters PA. Cloning. San Diego (CA): Greenhaven Press; c1998. 89 p.

World Health Organization, Fiftieth World Health Assembly. Cloning in human reproduction. Geneva: World Health Organization; 1997 May 14. 10 p.
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## Research using human biological materials including fetal tissue - Journal Articles

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Skett P, Tyson C, Guillouzo A, Maier P. Report on the international workshop on the use of human in vitro liver preparations to study drug metabolism in drug development. Held at Utrecht, The Netherlands, 6-8 September 1994. Biochem Pharmacol 1995 Jul 17;50(2):280-5.

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Sugarman J, Kaalund V, Kodish E, Marshall MF, Reisner EG, Wilfond BS, Wolpe PR. Ethical issues in umbilical cord blood banking. Working Group on Ethical Issues in Umbilical Cord Blood Banking. JAMA 1997 Sep 17;278(11):938-43.

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The rights of the many? [editorial]. New Sci 1994 Jan 15;141(1908):3.

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Vawter DE, Caplan A. Strange brew: the politics and ethics of fetal tissue transplant research in the United States. J Lab Clin Med 1992 Jul;120(1):30-4.

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## Research using human biological materials including fetal tissue - Books

Background and current practice of fetal tissue and embryo research in Canada. Ottawa: Royal Commission on New Reproductive Technologies; 1993. 288 p. (Research studies; 15).

Bauer AR. Legal and ethical aspects of fetal tissue transplantation. Austin (TX): R.G. Landes; 1994. 124 p.

Cataldo PJ, Moraczewski AS. The fetal tissue issue: medical and ethical aspects. Braintree (MA): Pope John XXIII Medical-Moral Research and Education Center, Task Force on Human Fetal Tissue Transplantation; 1994. 191 p.

College of American Pathologists. Minutes of the Board of Governors meeting; 1995 Aug 2. [Northfield (IL)]: The College; [1995]. Statement on the utilization of stored tissues.

Committee to Review the Guidance on the Research Use of Fetuses and Fetal Material (Great Britain). Review of the guidance on the research use of fetuses and fetal material. London: Her Majesty's Stationery Office; 1989 Jul. 30 p.

Council of Europe, Parliamentary Assembly. Recommendation 1100 (1989): On the use of human embryos and foetuses in scientific research. Strasbourg: The Council; 1989. 10 p.

Dickens BM. Legal issues in embryo and fetal tissue research and therapy. Ottawa: Royal Commission on New Reproductive Technologies; 1991 Dec. 11 p.

Donated ovarian tissue in embryo research and assisted conception: public consultation document. London: The Human Fertilisation and Embryology Authority; 1994. 12 p. Reprinted in Hum Reprod 1994 May;9(5):931-5.

Donated ovarian tissue in embryo research and assisted conception: report. London: The Human Fertilisation and Embryology Authority; 1994 Jul. 13 p.

Gold ER. Body parts: property rights and the ownership of human biological materials. Washington: Georgetown University Press; 1996. 223 p.

Gunning J. Human IVF, embryo research, fetal tissue for research and treatment, and abortion: international information. London: Her Majesty's Stationery Office; 1990 Feb. 44 p.

Human fetal tissue transplantation research: report of the Advisory Committee to the Director, National Institutes of Health. December 14, 1988, Bethesda, Maryland. Bethesda: The Institutes; 1988. 49 p.

Human tissue: ethical and legal issues. London: Nuffield Council on Bioethics; 1995 Apr. 153 p.

Institute of Medicine, Conference Committee on Fetal Research and Applications. Fetal research and applications: a conference summary. Washington: National Academy Press; 1994. 105 p. Based on the Conference on Fetal Research and Applications, held June 20-2, 1993 in Irvine, Calif.

Jones DG. Brain grafts: Parkinson's disease, fetuses and ethics. Bramcote (Nottingham, England): Grove Books; 1989. 27 p.

Langston JW, Palfreman J. The case of the frozen addicts: working at the edge of the mysteries of the human brain. New York: Vintage Books; 1996. 309 p.

Lehrman D. Fetal research and fetal tissue research: summary. Washington: The Association of American Medical Colleges; 1988 Jun. 34 p.

Maynard-Moody S. The dilemma of the fetus: fetal research, medical progress, and moral politics. 1st ed. New York: St. Martin's Press; 1995. 235 p.

Meetings of the Human Fetal Tissue Transplantation Research Panel. Bethesda (MD): National Institutes of Health, Human Fetal Tissue Transplantation Research Panel; 1988. 4 vol. 876 p. Transcript.

Morgan D, Lee RG. Blackstone's guide to the Human Fertilisation and Embryology Act 1990: abortion and embryo research -- the new law. London: Blackstone Press; 1991. 261 p.

Mullen MA. The use of human embryos and fetal tissues: a research architecture. Ottawa: Royal Commission on New Reproductive Technologies; 1992 Jan. 41 p.

National Bioethics Consultative Committee (Australia), Working Group on Embryo Experimentation. Embryo experimentation: report. Canberra: The Committee. 1991. 350 p.

NIH reauthorization: Hearings: 1991 Apr 15 -- Fetal tissue transplantation research (H.R. 1532), 1991 Apr 16 -- Health Sciences (H.R. 1161 and H.R. 1819). Washington: U.S. Government Printing Office; 1991. 643 p.

Report of the Human Embryo Research Panel, September 27, 1994. Bethesda (MD): National Institutes of Health, Human Embryo Research Panel; 1994 Sep 27. 111 p.

Report of the Human Fetal Tissue Transplantation Research Panel. 2 vol. Bethesda (MD): National Institutes of Health. Human Fetal Tissue Transplantation Research Panel; 1988 Dec.

Report, vol. 1. Bethesda (MD): National Institutes of Health, Human Embryo Research Panel; 1994 Sep. 145 p.

Report, vol. 2: Papers commissioned for the Human Embryo Research Panel. Bethesda (MD): National Institutes of Health, Human Embryo Research Panel; 1994 Sep. 407 p.

Research on fetuses. Oslo: National Committee for Medical Research Ethics; 1990 Nov. 29 p.

Sorsa M. Human biobanks: ethical and social issues. Copenhagen: Nordic Committee on Bioethics; c1997. 147 p.

Stith-Coleman I. Human fetal research and tissue transplantation. Washington: Library of Congress, Congressional Research Service; 1991. 14 p. (CRS issue brief).

The Genome Project: the Ethical Issues of Gene Patenting: Hearing Before the Subcomm. on Patents, Copyrights and Trademarks of the Senate Comm. on the Judiciary (1992 Sep 22). Washington: U.S. Government Printing Office; 1993. 240 p.

Vas CJ, de Souza EJ. Brain transplantation -- ethical concerns: report of a consultation workshop. Bombay: Mrs. P. Rodrigues for Rodrigo Enterprises; FIAMC Bio-Medical Ethics Centre; 1990. 86 p.

Vawter DE, et al, editors. The use of human fetal tissue: scientific, ethical, and policy concerns: a report of phase I of an interdisciplinary research project conducted by the Center for Biomedical Ethics. Minneapolis: University of Minnesota; c1990. 1 vol.
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## Xenotransplantation - Journal Articles

Advisory committee urges caution on xenotransplantation [news]. Vet Rec 1997 Jan 25;140(4):78-9.

Allan JS. Xenotransplantation at a crossroads: prevention versus progress. Nat Med 1996 Jan;2(1):18-21.

Andrews J. Animal donors. Nurs Stand 1996 Mar 6;10(24):16.

Arnold RM, Dresser R, Hefner P, Offner SK. Baboon-to-human transplants: should we proceed? Mak Rounds Health Faith Ethics 1995 Oct 9;1(3):1, 3-4, 8.

Auchincloss H. Literature update 1997, part 3. Xenotransplantation. 1998 May;5(2):164-7.

Baboon marrow transplant given OK [news]. Hastings Cent Rep 1995 Sep-Oct;25(5):47.

Bach FH. Xenotransplantation: problems and prospects. Annu Rev Med 1998;49:301-10.

Bach FH, Fineberg HV. Call for moratorium on xenotransplants [letter]. Nature 1998 Jan 22;391(6665):326. Comment in: Nature 1998 Mar 5;392(6671):11-2.

Bach FH, Fishman JA, Daniels N, Proimos J, Anderson B, Carpenter CB, Forrow L, Robson SC, Fineberg HV. Uncertainty in xenotransplantation: individual benefit versus collective risk. Nat Med 1998 Feb;4(2):141-4. Comment in: Nat Med 1998 Feb;4(2):131; Nat Med 1998 Feb;4(2):135-6; Nat Med 1998 Apr;4(4):372-3.

Bailey LL, Gundry SR. Evolving status of xenotransplantation: introduction. World J Surg 1997 Nov-Dec;21(9):899-900.

Bayever E. Xenotransplantation: a bold step forward [editorial]. Ann Allergy Asthma Immunol 1995 Dec;75(6 Pt 1):461-2.

Britain plays it cautious on animal-human transplants [news]. Nature 1997 Jan 23;385(6614):285.

Bronsther O. The dialectic nature of xenotransplantation. J Am Coll Surg 1998 Apr;186(4):397-401.

Brower V. Xenotransplantation under FDA spotlight [news]. Nat Med 1998 Feb;4(2):135-6. Comment on: Nat Med 1998 Feb;4(2):131; Nat Med 1998 Feb;4(2):141-4.

Butler D. Last chance to stop and think on risks of xenotransplants [news]. Nature 1998 Jan 22;391(6665):320-4. Comment in: Nature 1998 Mar 5;392(6671):11; Nature 1998 Mar 5;392(6671):12; Nature 1998 Apr 16;392(6677):646.

Calne R. Animal organ transplants [editorial]. Br J Hosp Med 1997 Feb 5-18;57(3):66-7.

Caplan AL. Is xenografting morally wrong? Transplant Proc 1992 Apr;24(2):722-7.

Chapman LE, Folks TM, Salomon DR, Patterson AP, Eggerman TE, Noguchi PD. Xenotransplantation and xenogeneic infections. N Engl J Med 1995 Nov 30;333 (22):1498-501.

Chiche L, Adam R, Caillat-Zucman S, Castaing D, Bach JF, Bismuth H. Xenotransplantation: baboons as potential liver donors? Scientific and ethical issues. Transplantation 1993 Jun;55(6):1418-21.

Coffman KL, Sher L, Hoffman A, Rojter S, Folk P, Cramer DV, Vierling J, Villamel F, Podesta L, Demetriou A, Makowka L. Survey results of transplant patients' attitudes on xenografting. Psychosomatics 1998 Jul-Aug;39(4):379-83.

Cooper DK. The safety of xenotransplantation. Transplant Proc 1998 Aug;30(5):2461-2.

Cooper DK. Xenotransplantation: benefits, risks and regulation. Ann R Coll Surg Engl 1996 Mar;78(2):92-6.

Cortesini R. Ethical aspects in xenotransplantation. Transplant Proc 1998 Aug;30(5):2463-4.

Culliton BJ. There's a xeno in your future [editorial]. Nat Med 1995 Sep;1(9):847.

Currie R. UK moves ahead on the xenotransplantation issue [news]. Nat Med 1998 Sep;4(9):988.

Daar AS. Ethics of xenotransplantation: animal issues, consent, and likely transformation of transplant ethics. World J Surg 1997 Nov-Dec;21(9):975-82.

Daar AS. Xenotransplants: proceed with caution [letter]. Nature 1998 Mar 5;392(6671):11. Comment on: Nature 1998 Jan 22;391(6665):320-4.

Dickson D. As ethics report clears xenografts. Nature 1996 Mar 7;380(6569):6.

Dickson D. Pig heart transplant 'breakthrough' stirs debate over timing of trials [news]. Nature 1995 Sep 21;377(6546):185-6.

Dillner L. Pig organs approved for human transplants [news]. BMJ 1996 Mar 16;312(7032):657. Comment in: BMJ 1996 Mar 16;312(7032):651-2.

Does biomedical research need another moratorium? [editorial]. Nat Med 1998 Feb;4(2):131. Comment on: Nat Med 1998 Feb;4(2):141-4. Comment in: Nat Med 1998 Feb;4(2):135-6.

Downie R. Xenotransplantation [editorial]. J Med Ethics 1997 Aug;23(4):205-6.

Duprez C, Duprez A. Are grafts of parts of human embryos resulting from requested legal abortions on to nude mice licit? Med Law 1993;12(6-8):657-61.

Eyskens E. Ethics in actual surgery. Ethics and organ transplantation. Acta Chir Belg 1994 May-Jun;94(3):185-8.

Federal guidelines needed to ensure safety in animal-human transplants [news]. Public Health Rep 1997 Jan-Feb;112(1):2-3.

First MR. Xenotransplantation: social, ethical, religious, and political issues. Kidney Int 1997 Mar;Suppl 58:S46-7.

Fox JL. Analyzing the science and ethics of xenografts. Biotechnology (NY) 1995 Aug;13(8):737, 739.

Fox JL. FDA seeks comfort factors before removing hold on porcine xenotransplantation trials [news]. Nat Biotechnol 1998 Mar;16(3):224.

Francione GL. Xenografts and animal rights. Transplant Proc 1990 Jun;22(3):1044-6.

Fullbrook SD, Wilkinson BM. Xenotransplantation and the law. Br J Theatre Nurs 1997 May;7(2):21-3.

Fullbrook SD, Wilkinson MB. Animal to human transplants: the ethics of xenotransplantation (1). Br J Theatre Nurs 1996 May;6(2):28-30, 32.

Fullbrook SD, Wilkinson MB. Animal to human transplants: the ethics of xenotransplantation (2). Br J Theatre Nurs 1996 Jun;6(3):13-5, 18.

Fung J. Xenotransplantation. Subhuman primates as donors. Pathol Biol (Paris) 1994 Mar;42(3):221-3.

Gurland HJ, Mujais SK. The future of artificial organs [editorial]. Int J Artif Organs 1995 Feb;18(2):64-8.

Halt the xeno-bandwagon [editorial]. Nature 1998 Jan 22;391(6665):309.

Hammer C, Molloy B. Ethical aspects in xenotransplantation. Transplant Proc 1993 Aug;25(4 Suppl 3):38-40.

Hanson MJ. Not just for breakfast anymore [news]. Hastings Cent Rep 1997 Jan-Feb;27(1):49.

Hanson MJ. The seductive sirens of medical progress. The case of xenotransplantation. Hastings Cent Rep 1995 Sep-Oct;25(5):5-6.

Hastillo A, Hess ML. Heart xenografting: a route not yet to trod [editorial]. J Heart Lung Transplant 1993 Jan-Feb;12(1 Pt 1):3-4. Comment in: J Heart Lung Transplant 1993 Sep-Oct;12(5):876-8; J Heart Lung Transplant 1993 Sep-Oct;12(5):878.

Have a pig's heart? [editorial]. Lancet 1997 Jan 25;349(9047):219. Comment in: Lancet 1997 Mar 8;349(9053):735-6; Lancet 1997 Apr 5;349(9057):1031.

Hobbs MN. US Public Health Service sets out plan for xenotransplantation [news]. Lancet 1998 Jan 31;351(9099):343.

Hughes J. Xenografting: ethical issues. J Med Ethics 1998 Feb;24(1):18-24.

Ildstad ST. Xenotransplantation for AIDS [letter]. Lancet 1996 Mar 16;347(9003):761. Comment on: Lancet 1995 Aug 5;346(8971):369-70.

Jayaraman KS. Pig heart transplant surgeon held in jail [news]. Nature 1997 Jan 30;385(6615):378.

Kaiser J. Xenotransplants. IOM backs cautious experimentation [news]. Science 1996 Jul 19;273(5273):305-6.

Kauffman HM JR, Ellison MD, Pierce GA, Graham WK, Daily OP. Increasing donor-recipient imbalance justifies xenograft research. Transplant Proc 1996 Apr;28(2):849-50.

Kennedy I. Xenotransplantation: ethical acceptability. Transplant Proc 1997 Sep;29(6):2729-30.

Kennedy I, Sewell H. Xenotransplantation moratorium [letter]. Nat Biotechnol 1998 Feb;16(2):120.

Kielstein R, Sass HM. From wooden limbs to biomaterial organs: the ethics of organ replacement and artificial organs. Artif Organs 1995 May;19(5):475-80.

Klotzko AJ. The beast inside. Nurs Times 1998 Aug 5-11;94(31):34-5.

Lehrman S. Trans-species transplants raise virus fears [news]. Nature 1995 Jul 6;376(6535):8. Comment in: Nature 1995 Sep 14;377(6545):98; Nature 1995 Nov 30;378(6556):434.

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Malouin R. Surgeons' quest for life: the history and the future of xenotransplantation. Perspect Biol Med 1994 Spring;37(3):416-28.

Mandel TE. Future directions in transplantation. Med J Aust 1993 Feb 15;158(4):269-73.

Marcelleti C. Bioethics and medicine. Med Law 1995;14(1-2):9-12.

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Xenotransplantation and the yuk factor [editorial]. Nat Biotechnol 1996 Apr;14(4):403-4.
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## Xenotransplantation - Books

Animal tissue into humans: a report by the Advisory Group on the Ethics of Xenotransplantation, 1996. London: Her Majesty's Stationery Office; 1997. 258 p.

Animal-to-human transplants: the ethics of xenotransplantation. London: Nuffield Council on Bioethics; 1996 Mar. 147 p.

Institute of Medicine, Committee on Xenograft Transplantation: Ethical Issues and Public Policy. Xenotransplantation: science, ethics, and public policy. Washington: National Academy Press; 1996. 126 p.
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## AIDS/HIV research - Journal Articles

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Gaskins S, Sowell R, Gueldner S. Overcoming methodological barriers to HIV/AIDS nursing research. J Assoc Nurses AIDS Care 1991;2(4):33-7.

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Harrison K, Vlahov D, Jones K, Charron K, Clements ML. Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. J Acquir Immune Defic Syndr Hum Retrovirol 1995 Nov 1;10(3):386-90.

Haynes BF. Scientific and social issues of human immunodeficiency virus vaccine development. Science 1993 May 28;260(5112):1279-86.

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IJsselmuiden CB, Faden RR. Research and informed consent in Africa--another look. N Engl J Med 1992 Mar 19;326(12):830-3. Comment in: N Engl J Med 1992 Oct 8;327(15):1101-2; discussion 1103.

Ivinson AJ. Hard-won consensus on AIDS vaccine trial guidelines [news]. Nat Med 1998 Aug;4(8):874.

Jenkins RA, Chinaworapong S, Morgan PA, Ruangyuttikarn C, Sontirat A, Chiu J, Michael RA, Nitayaphan S, Khamboonruang C. Motivation, recruitment, and screening of volunteers for a phase I/II HIV preventive vaccine trial in Thailand. J Acquir Immune Defic Syndr Hum Retrovirol 1998 Jun 1;18(2):171-7.

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Kaiser J. Flap on NEJM board over ethics articles [news]. Science 1997 Oct 10;278(5336):211.

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Wadman M. US dispute over live AIDS vaccine trials [news]. Nature 1997 Oct 2;389(6650):426.

Weber J. Trials and tribulations: ethical dilemmas in HIV therapy [editorial]. Curr Opin Immunol 1997 Oct;9(5):625-7.

Wehrwein P, Morris K. HIV-1-vaccine-trial go-ahead reawakens ethics debate [news]. Lancet 1998 Jun 13;351(9118):1789.

Wongchoosri S, Wera-arpachai M, Gulgolgarn V, Ketsararat W, Sittisombut N, Tovanabutra S. Studies in Thailand of the vertical transmission of HIV [letter]. N Engl J Med 1998 Mar 19;338(12):844. Comment on: N Engl J Med 1998 Mar 19;338(12):834-5.

Zion D. Can communities protect autonomy? Ethical dilemmas in HIV preventative drug trials. Camb Q Healthc Ethics 1995 Fall;4(4):516-23.

Zion D. Ethical considerations of clinical trials to prevent vertical transmission of HIV in developing countries. Nat Med 1998 Jan;4(1):11-2.

Wadman M. Controversy flares over AIDS prevention trials in third world [news]. Nature 1997 Oct 30;389(6654):894.

Zion D. The ethics of AIDS vaccine trials [letter]. Science 1998 May 29;280(5368):1329-30; discussion 1331-2. Comment on: Science 1998 Jan 9;279(5348):186-8.
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## AIDS/HIV research - Books

Adverse reactions to HIV vaccines: medical, ethical, and legal issues. Washington: Congress of the United States, Office of Technology Assessment; 1995. 197 p. (HIV-related issues. Background paper; 11).

AIDS Action Foundation, Working Group. HIV prevention vaccines: social, ethical, and political considerations for domestic efficacy trials. Washington: The Foundation; 1994 Jul. 54 p.

Dixon JE, editor. Catastrophic rights: experimental drugs & AIDS. Vancouver: New Star Book; 1990. 131 p.

Epstein S. Impure science: AIDS, activism, and the politics of knowledge. Berkeley: University of California Press; 1996. 466 p.

Fuenzalida-Puelma H, Linares Parada AM, LaVertu DS. Ethics and law in the study of AIDS. Washington: Pan American Health Organization; 1992. 273 p.

Gostin LO, Lazzarini Z. Human rights and public health in the AIDS pandemic. New York: Oxford University Press; 1997. 212 p.

Grady C. The search for an AIDS vaccine: ethical issues in the development and testing of a preventive HIV vaccine. Bloomington: Indiana University Press; c1995. 193 p. (Medical ethics series).

Grady C. Ethical issues in the development and testing of a preventive HIV vaccine. Ann Arbor (MI): University Microfilms International; 1993. 471 p.

Gray JN, Lyons PM, Melton GB. Ethical and legal issues in AIDS research. Baltimore: Johns Hopkins University Press; 1995. 199 p.

Kerns TA. Ethical issues in HIV vaccine trials. New York: St. Martin's Press; 1997. 249 p.

Kerns TA. Jenner on trial: an ethical examination of vaccine research in the age of smallpox and the age of AIDS. Lanham (MD): University Press of America; c1997. 98 p.

Kwitny J. Acceptable risks. New York: Poseidon Press; 1992. 466 p.

Loue S. Legal and ethical aspects of HIV-related research. New York: Plenum Press; c1995. 218 p. (The language of science).

Nichols EK. Expanding access to investigational therapies for HIV infection and AIDS: conference summary; 1990 Mar 12-13. Washington: National Academy Press; 1991. 73 p.

Nussbaum B. Good intentions: how big business and the medical establishment are corrupting the fight against AIDS. New York: Atlantic Monthly Press; 1990. 352 p.

Putney SD, Bolognesi D. AIDS vaccine research and clinical trials. New York: M. Dekker; c1990. 480 p.

The ethical conduct of AIDS vaccine trials: report of the Working Party on Ethical Aspects of AIDS Vaccine Trials. London: Medical Research Council; 1991. 40 p. (MRC ethics series).

Twomey JG. Clinical research ethics and pediatric HIV infection. Ann Arbor (MI): University Microfilms International; 1993. 236 p.

Women and HIV Disease: Falling Through the Cracks: Hearing (1991 Jun 6). Washington: U.S. Government Printing Office; 1992. 247 p.
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## Cancer research - Journal Articles

Anderson SJ, Costantino JP, Brown AM, Bryant JL, Cronin WM, Dignam JJ, Jones JM, Rockette HE, Wieand S. Breast cancer trials on trial: a case of conflicting ethical interests [letter]. Cancer 1995 Oct 1;76(7):1294-5. Comment on: Cancer 1995 May 15;75(10):2403-6.

Blumberg BS. Ethics and cancer therapy. Biomed Pharmacother 1993;47(9):393-5.

Cassidy J, Macfarlane DK. The role of the nurse in clinical cancer research. Cancer Nurs 1991 Jun;14(3):124-31.

Cheson BD. Cancer clinical trials. Clinical trials programs. Semin Oncol Nurs 1991 Nov;7(4):235-42.

Clinical trials: what cancer patients need to know. The British Association of Cancer United Patients (BACUP). Nurs Stand 1997 Sep 24;12(1):32-3.

Cockburn J, Redman S, Kricker A. Should women take part in clinical trials in breast cancer? Issues and some solutions. J Clin Oncol 1998 Jan;16(1):354-62.

Cox K, Avis M. Ethical and practical problems of early anti-cancer drug trials: a review of the literature. Eur J Cancer Care (Engl) 1996 Jun;5(2):90-5.

Cox K, Avis M. Psychosocial aspects of participation in early anticancer drug trials. Report of a pilot study. Cancer Nurs 1996 Jun;19(3):177-86.

Daugherty C, Ratain MJ, Grochowski E, Stocking C, Kodish E, Mick R, Siegler M. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 1995 May;13(5):1062-72. Published erratum appears in J Clin Oncol 1995 Sep;13(9):2476. Comment in: J Clin Oncol 1995 May;13(5):1049-51; J Clin Oncol 1995 Sep;13(9):2472.

Drury M. Developing new drugs for cancer [letter]. BMJ 1991 Nov 16;303(6812):1270. Comment on: BMJ 1991 Oct 26;303(6809):1005-6.

Eardley A, Cribb A, Pendleton L. Ethical issues in psychosocial research among patients with cancer. Eur J Cancer 1991;27(2):166-9.

Eastman P. Ready, set, go...stop: lessons learned from cancer prevention trials [news]. J Natl Cancer Inst 1998 Apr 1;90(7):494-6.

Faulder C. Better safe than sorry [the Tamoxifen Prevention Trial]. Bull Med Ethics 1992 Feb;75:29-33.

Harding M. Chemotherapy in non-small cell lung cancer. It may not be ethical to ask patients to participate in future trials [letter]. BMJ 1996 Jan 27;312(7025):249. Comment on: BMJ 1995 Oct 7;311(7010):889-90.

Henderson MM. Ethical issues: changing attitudes and practices. Cancer Detect Prev 1994;18(4):323-7.

Horton R. ICRF: from mayhem to meltdown. Lancet 1997 Oct 11;350(9084):1043-4.

Jensen AB, Madsen B, Andersen P, Rose C. Information for cancer patients entering a clinical trial--an evaluation of an information strategy. Eur J Cancer 1993;29A(16):2235-8.

Joslin CA. The patient's view of breast cancer trials [letter]. Lancet 1992 Feb 1;339(8788):314. Comment on: Lancet 1992 Jan 4;339(8784):44-5.

Kardinal CG. Ethical issues in cancer clinical trials. J La State Med Soc 1994 Aug;146(8):359-61.

Kaufman D. Cancer therapy and the randomized clinical trial: good medicine? CA Cancer J Clin 1994 Mar-Apr;44(2):109-14.

Lacombe D. Ethical issues in cancer clinical trials: a European perspective. Eur J Cancer 1997 Feb;33(2):184-5.

Lambird PA, Oneson RH. College of American Pathologists Foundation Conference VII: Ethical guidelines for biomedical technology development and application--the breast cancer paradigm: recommendations and summary. Arch Pathol Lab Med 1994 Nov;118(11):1093-5.

Mariani L. Experimental and nonexperimental studies: methodological, ethical, and practical implications in the context of hepatobiliary tumors. J Surg Oncol Suppl 1993;3:181-5.

Markman M. Ethical difficulties with randomized clinical trials involving cancer patients: examples from the field of gynecologic oncology. J Clin Ethics 1992 Fall;3(3):193-5.

Markman M. Ethical issues in clinical trials in oncology. Cleve Clin J Med 1997 May;64(5):275-7.

Markman M. The objective clinical scientist versus the advocate: a complex ethical and political dilemma facing cancer investigators and the public. Cancer Invest 1995;13(3):324-6.

McKenna RJ Sr, Laszlo J, Durant J, Hermann JF, Huguley C, Leventhal B, Roach E, Siegler M. Breakout I. Ethical considerations. Cancer 1990 May 15;65(10 Suppl):2407-8.

Much JK. Ethical issues and paclitaxel (TAXOL) administration. Semin Oncol Nurs 1993 Nov;9(4 Suppl2):16-20.

Mueller CB. Breast cancer trials on trial. A case of conflicting ethical interests. Cancer 1995 May 15;75(10):2403-6. Comments in: Cancer 1995 May 15;75(10):2407-9; discussion 2410-1; Cancer 1995 Oct 1;76(7):1294-5.

Mueller CB. The lumpectomy fraud. Poisson, the National Surgical Adjuvant Breast Project, and a crisis of ethics. Arch Surg 1994 Oct;129(10):1001-3.

Narasimhan P, Kalra J. Ethical questions on the testicular seminoma study [letter]. J Clin Oncol 1996 Feb;14(2):684. Comment on: J Clin Oncol 1995 Sep;13(9):2255-62.

Nayfield SG. Ethical and scientific considerations for chemoprevention research in cohorts at genetic risk for breast cancer. J Cell Biochem Suppl 1996;25:123-30.

Nyren O. Chemoprevention trials in cancer research--ethical considerations. Acta Oncol 1998;37(3):235-9. Comment in: Acta Oncol 1998 ;37(3):225.

Penson RT, Doyal L, Slevin ML. Ethical issues in cancer treatment. Br J Urol 1995 Nov;76 Suppl 2:37-40.

Pfeffer MR. Ethics and the oncologist. Med Law 1993;12(3-5):235-40.

Prestifilippo J, Antman K, Berkman BJ, Kaufman D, Lantos J, Lawrence W Jr, Levine RJ, McKenna RJ Sr. The ethical treatment of cancer. What is right for the patient? Cancer 1993 Nov 1;72(9 Suppl):2816-9.

Read C. Adjuvant treatment with tamoxifen. Local research ethics committees should review their approval of prevention trial [letter]. BMJ 1996 Apr 20;312(7037):1036. Comment on: BMJ 1996 Feb 17;312(7028):389-90.

Report of group A of the American Cancer Society Research Workshop on Cancer and Nutrition: panel on human studies. Cancer Res 1993 May 15;53(10 Suppl):2449s-2451s.

Slevin M, Mossman J, Bowling A, Leonard R, Steward W, Harper P, McIllmurray M, Thatcher N. Volunteers or victims: patients' views of randomised cancer clinical trials. Br J Cancer 1995 Jun;71(6):1270-4.

Sutherland HJ, da Cunha R, Lockwood GA, Till JE. What attitudes and beliefs underlie patients' decisions about participating in chemotherapy trials? Med Decis Making 1998 Jan-Mar;18(1):61-9.

Tabak N. Decision making in consenting to experimental cancer therapy. Cancer Nurs 1995 Apr;18(2):89-96.

Tabak N. Doctors' policy on explaining the implementation of novel experimental treatment to cancer patients. Med Law 1994;13(3-4):331-55.

Young FE. Ethical and financial considerations in third-party support of investigational cancer therapies. Cancer 1993 Nov 1;72(9 Suppl):2854-8.
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## Cancer research - Books

Cancer Patient Access to Unapproved Treatments: Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce. 104th Cong. 2nd Sess. (1996 Feb 29) [microfiche]. Washington: U.S. Government Printing Office; 1996. 71 p.

Oldham RK. Bioethics: opportunities, risks, and ethics -- the privatization of cancer research. Franklin (TN): Media America; 1992. 416 p.

Williams CJ, editor. Introducing new treatments for cancer: practical, ethical, and legal problems. New York: Wiley; 1992. 492 p.
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## Emergency medicine, acute care and critical care research - Journal Articles

American College of Emergency Physicians. Ethics manual. Ann Emerg Med 1991 Oct;20(10):1153-62.

Ault A. FDA may pull the plug on consent waiver [news]. Lancet 1997 Oct 11;350(9084):1084.

Barsan WG. Emergency medicine. JAMA 1991 Jun 19;265(23):3115-8.

Biros MH. Development of the multiorganizational document regarding emergency research consent [editorial]. Acad Emerg Med 1996 Feb;3(2):101-5.

Biros MH. Institutional review board approval: when and why? [editorial]. Acad Emerg Med 1998 Feb;5(2):91-2.

Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA 1995 Apr 26;273(16):1283-7. Comment in: JAMA 1995 Apr 26;273(16):1299-300; JAMA 1995 Apr 26;273(16):1300-2; JAMA 1995 Oct 18;274(15):1196.

Biros MH, Runge JW, Lewis RJ, Doherty C. Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances. Acad Emerg Med 1998 Apr;5(4):359-68.

Bradley K, Osborn HH, Tang M. College research associates: a program to increase emergency medicine clinical research productivity. Ann Emerg Med 1996 Sep;28(3):328-33.

Brody BA, Katz J, Dula A. In case of emergency: no need for consent. Hastings Cent Rep 1997 Jan-Feb;27(1):7; discussion 7-12.

Cline D, Henneman P, Van Ligten P, Spivey W, Olson J, Levitt A, Dire D, Zink B, Lowe R, Seaberg D, et al. A model research curriculum for emergency medicine. Ann Emerg Med 1992 Feb;21(2):184-92.

Cobaugh DJ, Spillane LL, Schneider SM. Research subject enroller program: a key to successful emergency medicine research. Acad Emerg Med 1997 Mar;4(3):231-3.

Dresser R, Whitehouse P. Emergency research and research involving subjects with cognitive impairment: ethical connections and contrasts [editorial]. J Am Geriatr Soc 1997 Apr;45(4):521-3. Comment on: J Am Geriatr Soc 1997 Apr;45(4):474-81.

Emergency Nurses Association. Code of Ethics for Emergency Nurses With Interpretive Statements. J Emerg Nurs 1990 Nov-Dec;16(6):22A-24A.

Ethical emergencies [editorial]. Lancet 1992 Feb 15;339(8790):399.

FDA proposes easing research consent requirements in life-threatening situations [news]. Am J Health Syst Pharm 1995 Nov 1;52(21):2379.

Firshein J. Informed consent rule in USA will require more money [news]. Lancet 1997 Jan 11;349(9045):111.

Food and Drug Administration (US). Protection of human subjects; informed consent and waiver of informed consent requirements in certain emergency research; final rules. Fed Regist 1996 Oct 2;61(192):51498-531

Fost N. Waived consent for emergency research. Am J Law Med 1998;24(2-3):163-83

Fraker LD, Orsay EM, Sloan EP, Bunney EB, Holden JA, Hart RG. A novel curriculum for teaching research methodology. J Emerg Med 1996 Jul-Aug;14(4):503-8.

Fresco C, Maggioni AP, Franzosi MG, Tognoni G. Ethical committees and noninformed consent [letter]. J Am Coll Cardiol 1994 Oct;24(4):1178. Comment on: J Am Coll Cardiol 1994 Jan;23(1):27-34.

Hallstrom Al. The case for randomization without consent in emergency care. IRB Rev Hum Subj Res 1990 Jul-Aug;12(4):5.

Hoekstra J. Randomized trials and common sense [editorial]. Ann Emerg Med 1997 Jan;29(1):164-6. Comment on: Ann Emerg Med 1997 Jan;29(1):1-12; Ann Emerg Med 1997 Jan;29(1):13-87.

Isaacman DJ, Reynolds EA. Effect of a research nurse on patient enrollment in a clinical study. Pediatr Emerg Care 1996 Oct;12(5):340-2.

Iserson KV. Research and barbaric medicine. Am J Emerg Med 1998 Mar;16(2):208.

Iserson KV, Lindsey D. Research on critically ill and injured patients: rules, reality, and ethics. J Emerg Med 1995 Jul-Aug;13(4):563-7.

Iserson KV, Mahowald MB. Acute care research: is it ethical? Crit Care Med 1992 Jul;20(7):1032-7.

Karlawish JH, Hall JB. The controversy over emergency research. A review of the issues and suggestions for a resolution. Am J Respir Crit Care Med 1996 Feb;153(2):499-506. Comment in: Am J Respir Crit Care Med 1996 Feb;153(2):507-8.

Karlawish JH, Sachs GA. Research on the cognitively impaired: lessons and warnings from the emergency research debate. J Am Geriatr Soc 1997 Apr;45(4):474-81. Comment in: J Am Geriatr Soc 1997 Apr;45(4):521-3.

Kiernan V. Emergency trials 'by popular consent.' [news]. New Sci 1995 Nov 4;148(2002):6.

Kim DT, Spivey WH. A retrospective analysis of institutional review board and informed consent practices in EMS research. Ann Emerg Med 1994 Jan;23(1):70-4. Comment in: Ann Emerg Med 1994 Oct;24(4):759-60.

Konigova R. Ethical problems in burn injury in the past decade. Acta Chir Plast 1992;34(3):178-81.

Lackner FX. Research in critically ill patients. Acta Anaesthesiol Scand Suppl 1997;111:160-2.

Lamiell JM, Grabenstein JD, Vander Hamm DG. Review of the 1995 Food and Drug Administration/National Institutes of Health Public Forum on informed consent in clinical research conducted in emergency circumstances. Mil Med 1995 Dec;160(12):599-603.

Levine RJ. Research in emergency situations. The role of deferred consent [editorial]. JAMA 1995 Apr 26;273(16):1300-2. Comment on: JAMA 1995 Apr 26;273(16):1261-8; JAMA 1995 Apr 26;273(16):1283-7.

Levine RJ, Abramson NS, Safar P. Deferred consent. Control Clin Trials 1991 Aug;12(4):546-52. Comment on: Control Clin Trials 1991 Aug;12(4):525-45.

Mader TJ, Playe SJ. Emergency medicine research consent form readability assessment. Ann Emerg Med 1997 Apr;29(4):534-9.

Manning JE. Research in emergency medicine. N C Med J 1997 Jul-Aug;58(4):296-9.

Mariner WK. Research in emergency care without consent: new proposed FDA rules. Lancet 1995 Dec 9;346(8989):1505-6.

Marwick C. Assessment of exception to informed consent [news]. JAMA 1997 Nov 5;278(17):1392-3.

Marwick C. FDA gets feedback on informed consent waiver [news]. JAMA 1996 Feb 7;275(5):347.

Marwick C. Informed consent waiver for emergency research [news]. JAMA 1995 Oct 18;274(15):1184-5.

Marwick C. Research in emergency circumstances [news]. JAMA 1995 Mar 1;273(9):687-8.

McCarthy CR. Ethical considerations of new guidelines for emergency research [editorial]. Am J Respir Crit Care Med 1996 Feb;153(2):507-8. Comment on: Am J Respir Crit Care Med 1996 Feb;153(2):499-506.

McCarthy CR. To be or not to be: waiving informed consent in emergency research. Kennedy Inst Ethics J 1995 Jun;5(2):155-62.

McCarthy CR. Update on waiving informed consent in emergency research [letter]. Kennedy Inst Ethics J 1995 Dec;5(4):385-6.

Menasche A, Levine RJ. FDA revises informed consent regulations for emergency research [article and comment on proposed rule]. IRB Rev Hum Subj Res 1995;17(5-6):19-22.

Merz JF, Caplan AL. Informed consent for emergency research [letter]. JAMA 1995 Oct 18;274(15):1196. Comment on: JAMA 1995 Apr 26;273(16):1283-7.

Miller BL. The ethics of cardiac arrest research. Ann Emerg Med 1993 Jan;22(1):118-24.

Miller BL. Informed consent to research on emergency care [editorial]. Ann Emerg Med 1991 Nov;20(11):1267-9. Comment on: Ann Emerg Med 1991 Nov;20(11):1251-65.

Morgan A. Informed consent: finding a path toward prudent policy. Pacing Clin Electrophysiol 1997 Mar;20(3 Pt 1):730-1.

Morley C. Informed consent in medical research. Consent is not always practical in emergency treatments [letter]. BMJ 1997 May 17;314(7092):1480. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

Nightingale SL. From the Food and Drug Administration: proposal for emergency use research. JAMA 1995 Nov 22;274(20):1578.

Olson CM. The letter or the spirit. Consent for research in CPR [editorial]. JAMA 1994 May 11;271(18):1445-7. Comment on: JM1994 May 11;271(18):1405-11. Comment in: JM1994 Nov 16;272(19):1477-8.

Olson CM, Jobe KA. Reporting approval by research ethics committees and subjects' consent in human resuscitation research. Resuscitation 1996 Jun;31(3):255-63.

Olson JE, Hamilton GC, Angelos MG, Singer JI, Eilers ME, Gaddis M. Objectives to direct the training of emergency medicine residents on off-service rotations: research. J Emerg Med 1992 Sep-Oct;10(5):631-6.

Orlowski JP. The impact of DNR orders on CPR research: educational and ethical implications. Clin Res 1993 Dec;41(4):595-600.

Panacek EA, Lewis RJ. Guidelines for clinical investigator involvement in industry-sponsored clinical trials. SAEM Research Committee. Acad Emerg Med 1995 Jan;2(1):43-5.

Paris PM. Relationship between academia and industry: ethical considerations. Ann Emerg Med 1996 Apr;27(4):416-7.

Passamani E. Clinical trials--are they ethical? N Engl J Med 1991 May 30;324(22):1589-92. Comment in: N Engl J Med 1991 Nov 21;325(21):1513-5.

Pinder M, Tshukutsoane S, Scribante J, Piccolo R, Lipman J. Critical care research and pre-emptive informed consent: a practical approach used in Chris Hani Baragwanath ICU. Intensive Care Med 1998 Apr;24(4):353-7.

Prentice E. An even safer safety net. Hastings Cent Rep 1997 May-Jun;27(3):46.

Prentice ED, Antonson DL, Leibrock LG, Kelso TK, et al. IRB review of a Phase II randommized clinical trial involving incompetent patients suffering from severe closed head injury. IRB Rev Hum Subj Res 1993 Sep-Oct;15(5):1-7.

Public Health Service (US). Action related to emergency research activity. Fed Regist 1995 Jul 26;60(143):38353-4.

Runge JW. Informed consent: an unresolved issue [letter]. Ann Emerg Med 1990 Jul;19(7):841. Comment on: Ann Emerg Med 1989 Jul;18(7):766-71.

Rydman RJ, Zalenski RJ, Fagan JK. An evaluation of research training in a large residency program. Acad Emerg Med 1994 Sep-Oct;1(5):448-53.

Sanders AB, Keim SM, Sklar D, Adams J, Society for Academic Emergency Medicine. Emergency physicians and the biomedical industry. Annals of Emergency Medicine 1992 May 1992;21(5):556-558.

Schou J. Ban prehospital randomized studies [letter]. Eur J Emerg Med 1997 Sep;4(3):174-5. Comment in: Eur J Emerg Med 1997 Sep;4(3):123-4.

Sklar DP. Ethical issues associated with pain research in emergency medicine. Ann Emerg Med 1996 Apr;27(4):418-20.

Smithline HA, Gerstle ML. Waiver of informed consent: a survey of emergency medicine patients. Am J Emerg Med 1998 Jan;16(1):90-1.

Somberg JC. Research in emergency care without consent: new proposed FDA rules [letter]. Lancet 1996 Feb 17;347(8999):475-6.

Spivey WH, Abramson NS, Iserson KV, MacKay CR, Cohen MP. Informed consent for biomedical research in acute care medicine. Ann Emerg Med 1991 Nov;20(11):1251-65. Comment in: Ann Emerg Med 1991 Nov;20(11):1267-9.

Waiver of informed consent requirements in certain emergency research. Fed Regist 1996 Oct 2;61(192):53531-3.

Watts DD. Informed consent in emergency research: what every emergency nurse should know. J Emerg Nurs 1997 Feb;23(1):70-4.

Whitley TW, Spivey WH, Abramson NS, Angelos MG, Barsan WG, Bradley K, Brown CG, Cordel WH, Dart RC, Krause GS, et al. A basic resource guide for emergency medicine research. Ann Emerg Med 1990 Nov;19(11):1306-9.

Wichman A. Ethics of proxy consent for research involving patients with adult respiratory distress syndrome [letter]. JAMA 1996 Sep 25;276(12):949-50. Comment on: JAMA 1996 Feb 7;275(5):383-9; JAMA 1996 Feb 7;275(5):404-5.

Wichman A, Sandler AL. Research involving critically ill subjects in emergency circumstances: new regulations, new challenges. Neurology 1997 May;48(5):1151-5.

Wolfgang L. Waivers proposed for emergency studies [news]. Science 1995 Oct 6;270(5233):25-6.

Yarborough M. What good are we doing? The role of clinical research in enhancing critical care medicine. J Crit Care 1993 Dec;8(4):228-36.
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## Drug and medical device research and development - Journal Articles

Abernethy DR, Azarnoff DL. Pharmacokinetic investigations in elderly patients. Clinical and ethical considerations. Clin Pharmacokinet 1990 Aug;19(2):89-93.

American College of Clinical Pharmacy Research Affairs Committee. Ethical issues related to clinical pharmacy research. [ACCP white paper]. Pharmacotherapy 1993 Sep-Oct;13(5):523-30.

Annas GJ. FDA's compassion for desperate drug companies. Hastings Cent Rep 1990 Jan-Feb;20(1):35-7.

Browne TR. Clinical trials performed for the new drug approval process in the United States: standard methods and alternative methods. Epilepsy Res Suppl 1993;10:31-44.

Canadian Medical Association. Physicians and the pharmaceutical industry (update 1994). Canadian Medical Association Journal 1994 Jan 15 1994;150(2):256A-256C.

Carroll P, Maher VF. Legal issues in experimental investigations of medications. Adv Clin Care 1990 May-Jun;5(3):6.

Dollow S. Safety of patients participating in drug trials. Glaxo's reply [letter]. BMJ 1998 Sep 19;317(7161):818.

Ebihara A, Takahashi K, Ikemoto F, Yamamoto K. Clinical pharmacology and clinical trials in Japan. J Mol Med 1996 Aug;74(8):479-86.

Edgar H, Rothman DJ. New rules for new drugs: the challenge of AIDS to the regulatory process. Milbank Q 1990;68 Suppl 1:111-42.

Ethical issues related to clinical pharmacy research. American College of Clinical Pharmacy. Pharmacotherapy 1993 Sep-Oct;13(5):523-30.

Fisher LD. The use of one-sided tests in drug trials: an FDA advisory committee member's perspective. J Biopharm Stat 1991;1(1):151-6.

French JA. Obstacles encountered in designing antiepileptic drug trials. Epilepsy Res Suppl 1993;10:81-9.

Gram L, Schmidt D. Innovative designs of controlled clinical trials in epilepsy. Epilepsia 1993;34 Suppl 7:S1-6.

Graves NM. The role of the pharmacist in investigational AED trials. Epilepsy Res Suppl 1993;10:201-9.

Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Committee on Drugs, American Academy of Pediatrics. Pediatrics 1995 Feb;95(2):286-94.

Haynes WG, Webb DJ. Ethics of volunteer research: the role of new EC guidelines. Br J Clin Pharmacol 1991 Dec;32(6):671-6.

Hillman AL, Eisenberg JM, Pauly MV. Avoiding bias in the conduct and reporting of cost-effectiveness research sponsored by pharmaceutical companies. N Engl J Med 1991 May 9;324(19):1362-5.

Hilton A, Dubbleman R. Oncology nursing: research protocols for drug regimens. Nurs Stand 1990 Jul 11-17;4(42):26-7.

Holdsworth MT. Ethical issues regarding study designs used in serotonin-antagonist drug development [editorial]. Ann Pharmacother 1996 Oct;30(10):1182-4.

Hubscher O. Ethics of drug trials in developing countries. World Health Forum 1993;14(1):25-7.

Idanpaan-Heikkila JE. WHO guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products: Responsibilities of the Investigator. Ann Med 1994 Apr;26(2):89-94.

Investigational device exemptions, 21 C.F.R. Sect. 812 (1998 revised).

Investigational new drug application, 21 C.F.R. Sect. 312 (1998 revised).

Kastrissios H, Blaschke TF. Medication compliance as a feature in drug development. Annu Rev Pharmacol Toxicol 1997;37:451-75.

Katz R. The domestic drug regulatory process: why time is of the essence. Epilepsy Res Suppl 1993;10:91-106.

Kellett JM. Drug trial ethics [letter]. J Med Ethics 1994 Dec;20(4):270.

Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, et al. Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute. J Cell Biochem Suppl 1994;20:55-62.

Kelloff GJ, Johnson JR, Crowell JA, Boone CW, DeGeorge JJ, Steele VE, Mehta MU, Temeck JW, Schmidt WJ , Burke G, et al. Guidance for development of chemopreventive agents. J Cell Biochem Suppl 1994;20:25-31.

Kessler DA. FDA's revitalization of medical device review and regulation. Biomed Instrum Technol 1994 May-Jun;28(3):220-6.

Kolff WJ. Delays by recalcitrant FDA, reluctant NIH, and fearful industry: the cost in human life, happiness, money, and loss of opportunity for American industry [editorial]. Artif Organs 1993 Sep;17(9):753-7.

La Puma J, Stocking CB, Rhoades WD, Darling CM, Ferner RE, Neuberger J, VandenBurg M, Dews I, Tobias JS. Financial ties as part of informed consent to postmarketing research. Attitudes of American doctors and patients. BMJ 1995 Jun 24;310(6995):1660-3. Published erratum appears in BMJ 1995 Aug 5;311(7001):373.

Lee PP, Yang JC. The nonapproved use of medications. Ophthalmology 1991 Jul;98(7):1071-4.

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Abbott K, Blair F, Duncan S. Participatory research. Can Nurse 1993 Jan;89(1):25-7.

Abeliovich D, Quint A, Weinberg N, Verchezon G, Lerer I, Ekstein J, Rubinstein E. Cystic fibrosis heterozygote screening in the Orthodox Community of Ashkenazi Jews: the Dor Yesharim approach and heterozygote frequency. Eur J Hum Genet 1996;4(6):338-41.

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Alderete E. The formulation of a health research agenda by and for indigenous peoples: contesting the Western scientific paradigm. J Altern Complement Med 1996 Fall;2(3):377-85.

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Blunt J, Savulescu J, Watson AJ. Meeting the challenges facing research ethics committees: some practical suggestions. BMJ 1998 Jan 3;316(7124):58-61.

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Boston P, Jordan S, MacNamara E, Kozolanka K, Bobbish-Rondeau E, Iserhoff H, Mianscum S , Mianscum-Trapper R, Mistacheesick I, Petawabano B, Sheshamush-Masty M, Wapachee R, Weapenicappo J. Using participatory action research to understand the meanings aboriginal Canadians attribute to the rising incidence of diabetes. Chronic Dis Can 1997;18(1):5-12.

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Cassidy VR, Oddi LF. Nurses on hospital IRBs: a critical voice in protecting human subjects. Nursingconnections 1993 Spring;6(1):31-8.

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Chalmers D, Pettit P. Towards a consensual culture in the ethical review of research. Australian Health Ethics Committee. Med J Aust 1998 Jan 19;168(2):79-82.

Charo RA. Principles and pragmatism. Kennedy Inst Ethics J 1996 Sep;6(3):319-22. Comment on: Kennedy Inst Ethics J 1996 Sep;6(3);289-311.

Chen AM, Wismer BA, Lew R, Kang SH, Min K, Moskowitz JM, Tager IB. Health is strength: a research collaboration involving Korean Americans in Alameda County. Am J Prev Med 1997 Nov-Dec;13(6 Suppl):93-100.

Chesapeake Research Review, Inc. Ellicott City MD. On being an IRB. IRB Rev Hum Subj Res 1995 Sep-Dec;17(5-6):12-6.

Chesler MA. Participatory action research with self-help groups: an alternative paradigm for inquiry and action. Am J Community Psychol 1991 Oct;19(5):757-68.

Cho MK, Billings P. Conflict of interest and institutional review boards. J Investig Med 1997 Apr;45(4):154-9.

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Clein P. Local research ethics committees in the UK. Palliat Med 1997 Jan;11(1):55-6.

Coggan C, Disley B, Patterson P. Community based intervention on adolescent risk taking: using research for community action. Inj Prev 1998 Mar;4(1):58-61.

Cohen M. Should there be an accredited ethics committee system for centralised review of multicentre clinical research? [letter]. Med J Aust 1998 May 18;168(10):528. Comment on: Med J Aust 1998 Feb 16;168(4):174-6.

Cohen M, Palafox PA. The legal liability of the institutional review board. Clin Rev Allergy 1994 Summer;12(2):211-8.

Colen BD. Proceedings of the Workshop on Inherited Breast Cancer in Jewish Women: Ethical, Legal, and Social Implications. LawMed News 1996 Summer;2(1):1-4.

Cookson JB. Auditing a research ethics committee. J R Coll Physicians Lond 1992 Apr;26(2):181-3.

Corcega TF. Participatory research: getting the community involved in health development. Int Nurs Rev 1992 Nov-Dec;39(6):185-8.

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Coughlin SS. Invited commentary: on the role of ethics committees in epidemiology professional societies. Am J Epidemiol 1997 Aug 1;146(3):209-13.

Creutzfeldt W. Function and duties of an ethics committee at a university faculty of medicine: 13 years of personal experience. Forensic Sci Int 1994 Dec 16;69(3):307-14.

Danis M. Should ethics committees study themselves? [editorial]. J Clin Ethics 1994 Summer;5(2):159-62. Comment on: J Clin Ethics 1994 Summer;5(2):121-5.

Danis M, Grady C. Institutional review board review and consent for research: what's behind the statistics? [editorial]. Crit Care Med 1998 Sep;26(9):1488-9. Comment on: Crit Care Med 1998 Sep;26(9):1596-602.

Danks DM. Ethics committees [letter]. Lancet 1991 Feb 9;3337(8737):369.

Darvall L. Increased review responsibilities for Australian institutional ethics committees. IRB Rev Hum Subj Res 1995;17(1):9.

Degnin FD. Max Weber on ethics case consultation: a methodological critique of the conference on evaluation of ethics consultation. J Clin Ethics 1997 Summer;8(2):181-92.

DeRenzo EG, Bonkovsky FO. Bioethics consultants to the National Institutes of Health's intramural IRB system: the continuing evolution. IRB Rev Hum Subj Res 1993;15(3):9-10.

DeRenzo EG, Wichman A. A pilot project: bioethics consultants as non-voting members of IRBs at the National Institutes of Health. IRB Rev Hum Subj Res 1990;12(6):6-8.

Deutsch E. The functions of ethical committees. Int J Bioethics 1990 Sep;1(3):177-82.

Diamond AL, Laurence DR. Better research ethics committees: comments on guidance from the Department of Health and the European Community. J R Coll Physicians Lond 1993 Apr;27(2):141-6.

Dickersin K, Min YI , Meinert CL. Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. JAMA 1992 Jan 15;267(3):374-8. Comment in: JAMA 1991 Jan 15;267(3):411-2.

Dickinson JA. Getting help for research: the RACGP research committees. Aust Fam Physician 1991 Nov;20(11):1659-62.

Dockerty JD, Elwood M. The difficulties and costs of ethical assessment of a national research project. N Z Med J 1992 Aug 12;105(939):311-3. Comment in: N Z Med J 1992 Sep 23;105(942):388.

Domen RE. A survey of ethics committees in national medical organizations in the United States. HEC Forum 1995 Nov;7(6):333-8.

Dorff EN. Jewish theological and moral reflections on genetic screening: the case of BRCA1. Health Matrix 1997 Winter;7(1):65-96.

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Douglass AJ, Jarvis A, Bloore S. Monitoring of health research by ethics committees. N Z Med J 1998 Mar 13;111(1061):79-81.

Doyal L. Towards a standard application form for LRECs. Bull Med Ethics 1994 Sep;101:15-28.

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Edgar H, Rothman DJ. The institutional review board and beyond: future challenges to the ethics of human experimentation. Milbank Q 1995;73(4):489-506.

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Ellis SJ. Ethics review and clinical trials [letter]. Lancet 1998 Apr 4;351(9108):1066. Comment on: Lancet 1998 Jan 24;351(9098):225.

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Ethics committees and health services research [letter]. J Public Health Med 1991 Aug;13(3):230-1. Comment on: J Public Health Med 1990;12(3-4):190-6.

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Feldman MK. Mode of inquiry. Minn Med 1996 Jun;79(6):18-23.

Fetters MD. Nemawashi essential for conducting research in Japan. Soc Sci Med 1995 Aug;41(3):375-81.

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Fleetwood J, Unger SS. Institutional ethics committees and the shield of immunity. Ann Intern Med 1994 Feb 15;120(4):320-5. Published erratum appears in Ann Intern Med 1994 Jul 15;121(2):154. Comments in: Ann Intern Med 1994 Feb 15;120(4):335-8; Ann Intern Med 1994 Sep 1;121(5):386; discussion 387; Ann Intern Med 1994 Sep 1;121(5):386-7; Ann Intern Med 1994 Nov 1;121(9).

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Fletcher JC, Hoffmann DE. Ethics committees: time to experiment with standards. Ann Intern Med 1994 Feb 15;120(4):335-8. Comment on: Ann Intern Med 1994 Feb 15;120(4):320-5. Comments in: Ann Intern Med 1994 Sep 1;121(5):386; discussion 387; Ann Intern Med 1994 Sep 1;121(5):386-7.

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Furler J, Burnell RH, Jamrozik K. Ethics committees: is the tail wagging the dog? [letters and response]. Med J Aust 1993 Jan 18;158(2):140-1.

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Wadman M. 'Group debate' urged for gene studies [news]. Nature 1998 Jan 22;391(6665):314. Comment in: Nature 1998 Mar 5;392(6671):14; Nature 1998 Apr 16;392(6677):646.

Wadman M. Jewish leaders meet NIH chiefs on genetic stigmatization fears [news]. Nature 1998 Apr 30;392(6679):851.

Waggoner WC. Institutional review boards. Clin Dermatol 1991 Oct-Dec;9(4):429-34.

Wald N, Peckham C. Independent ethical review of studies involving personal medical records [letter]. J R Coll Physicians Lond 1995 Sep-Oct;29(5):446.

Walshe JM. Ethical committees? [letter]. Lancet 1990 Dec 8;336(8728):1448-9. Comment on: Lancet 1990 Nov 10;336 (8724):194-5. Comment in: Lancet 1990 Dec 22-29; 336 (8730):1587.

Walters L. Data monitoring committees: the moral case for maximum feasible independence. Stat Med 1993 Mar;12(5-6):575-80.

Warnock M. Ethics committees. Baillieres Clin Obstet Gynaecol 1991 Sep;5(3):761-77.

Warren R, Allan J. Getting through ethics committees: partnerships between researchers and clinicians working with mentally ill clients. Aust N Z J Ment Health Nurs 1997 Mar;6(1):37-43.

Watling MI, Dewhurst JK. Local research ethics committees. Central ethics committee might have to face hostile locals [letter]. BMJ 1995 Dec 9;311(7019):1571. Comment on: BMJ 1995 Sep 9;311(7006):639-40; BMJ 1995 Sep 9;311(7006):659-60.

Watling MIL, Dewhurst JK. Current experience of central versus local ethics approval in multicentre studies. J R Coll Physicians Lond 1993 Oct;27(4):399-402.

Weeramanthri T, Currie BJ. Isn't one institutional ethics committee's approval enough? [letter]. Med J Aust 1994 Sep 19;161(6):398-9. Comment on: Med J Aust 1994 May 16;160(10):662.

Weinstein BD, McCurdy DB. Point and counterpoint: should expertise in bioethics be required for serving on a HEC? HEC Forum 1993 Nov;5(6):368-73.

Wells F. Ethics and journal publishing: taking the debate forward. A committee for scientific dishonesty--the way forward? [letter]. Addiction 1995 Oct;90(10):1316-7. Comment in: Addiction 1996 Jul;91(7):1063-4.

Westphal MF, da Silva NN, Maciel MG. Participatory research as social mobilization for health. Promot Educ 1996 Dec;3(4):21-4.

While AE. Ethics committees: impediments to research or guardians of ethical standards? BMJ 1995 Sep 9;311(7006):661. Published erratum appears in BMJ 1995 Sep 23;311(7008):792. Comments in: BMJ 1995 Sep 9;311(7006):639-40; BMJ 1995 Dec 9;311(7019):1571; BMJ 1995 Dec 9;311(7019):1572; BMJ 1996 Jan 6;312(7022):54.

While AE. Research ethics committees at work: the experience of one multi-location study. J Med Ethics 1996 Dec;22(6):352-5.

Wiesing U. Ethics committees in Germany. HEC Forum 1990;3(4):221-6.

Williams AM. Neuroscience nursing research: human subjects considerations. J Neurosci Nurs 1991 Apr;23(2):133-5.

Willms D, Bhatia R, Lowe J, Niemi F, Stewart D, Westmoreland-Traore J. Five conversations: reflections of stakeholders on the impact of the ethnocultural communities facing AIDS study. Can J Public Health 1996 May-Jun;87 Suppl 1:S44-8, S49-53.

Willms D, Singer SM, Adrien A, Godin G, Maticka-Tyndale E, Cappon P. Participatory aspects in the qualitative research design of phase II of the ethnocultural communities facing AIDS study. Can J Public Health 1996 May-Jun;87 Suppl 1:S15-25, S16-27.

Wise J. Royal College calls for central research ethics committee [news]. BMJ 1996 Aug 3;313(7052):251.

Wise P, Drury M. Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners. BMJ 1996 Nov 16;313(7067):1245-8.

Wismer BA, Moskowitz JM, Chen AM, Kang SH, Novotny TE, Min K, Lew R, Tager IB. Rates and independent correlates of Pap smear testing among Korean-American women. Am J Public Health 1998 Apr;88(4):656-60.

Wojtynek JE, Hutchinson RA, Thornton JP, O'Brien P. Institutional review boards and quality assurance activities [letter]. Am J Hosp Pharm 1991 Jan;48(1):72, 75.

Yealy DM, Paris PM, Vukmir RB. Prehospital IRBs and consent [letter]. Ann Emerg Med 1994 Oct;24(4):759-60. Comment on: Ann Emerg Med 1994 Jan;23(1):70-4.
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## Institutional review boards and ethics committees - Books

Christensen JO. Medical ethics committees: a selective bibliography of recent references. Monticello (IL): Vance Bibliographies; 1991. 23 p. (Public administration series, bibliography; P 3099).

Department of Health and Human Services (US), Office of Inspector General. Institutional review boards: their role in reviewing approved research [monograph on the Internet]. Boston: Office of Evaluations and Inspections, Boston Regional Office; June 1998. 190 p. Available from: http://www.dhhs.gov/progorg/oei.

Forming a moral community: a resource for healthcare ethics committees. Berkeley (CA): Bioethics Consultation Group Inc.; 1992. 161 p.

Foster CG. Manual for research ethics committees. London: King's College, Centre of Medical Law and Ethics; 1992. 1 vol.

Foster CG. Manual for research ethics committees. 2nd ed. London: King's College, Centre of Medical Law and Ethics; 1993. 1 vol. Looseleaf.

Fry-Revere S, editor. The accountability of bioethics committees and consultants. Frederick (MD): University Publishing Group; c1992. 141 p.

Guidelines on the practice of ethics committees in medical research involving human subjects: a report of the Royal College of Physicians. 2nd ed. London: Royal College of Physicians of London; 1990. 43 p.

Institutional review boards, a system in jeopardy. Hearing Before the Subcomm. on Human Resources Comm. on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, second session. (1998 Jun 11). Washington: U.S. Government Printing Office; 1999.

Kiger AF, compiler. Institutional ethics committees: January 1975 through December 1988 : 434 citations. Bethesda (MD): National Library of Medicine, Reference Section; 1988. 18 p. (Current bibliographies in medicine; 88-16).

Local research ethics committees. London: U.K. Department of Health; 1991 Aug 19. 26 p.

Melley CD. A philosophical investigation of health-care ethics committees, ethics consultation and the role of the philosopher in the health-care setting. Saarbrucken (Germany): Christopher Daniel Melley; 1991. 195 p.

Meslin EM. Protecting human subjects from harm in medical research: A proposal for improving risk judgements by institutional review boards. Ann Arbor (MI): University Microfilms International; 1989. 336 p.

Neuberger J, editor. Ethics and health care: the role of research ethics committees in the United Kingdom. London: King's Fund Institute; c1992. 48 p. (Research report (King's Fund Institute); 13).

Penslar RL. Protecting human research subjects: institutional review board guidebook [loose-leaf]. Rev., updated and expanded 2nd ed. Bethesda (MD): National Institutes of Health, Office of Protection from Research Risks; 1993. 1 vol.

Ross JW. Health care ethics committees: the next generation. Chicago: American Hospital Pub; c1993. 188 p.

Spicker SF, editor. Health care ethics committee experience: selected readings from HEC Forum. Malabar (FL): Krieger Pub; 1998.

The clinical trial notification scheme: draft guidelines for institutional ethics committees. Canberra: Australian Government Publishing Service; 1992. 14 p.

Toward a Canadian Advisory Council on Biomedical Ethics: study paper. Ottawa: Law Reform Commission; 1990. 119 p.

Whither IRB's in the 1990s?: new directions and new decisions, October 12-13, 1989. Boston: Public Responsibility in Medicine and Research; c1989. 138 p.
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## Bioethics education - Journal Articles

Aldridge D. Of ethics and education: strategies for curriculum development [editorial]. J R Soc Med 1992 Oct;85(10):594-7.

Ales KL, Charlson ME, Williams-Russo P, Allegrante JP. Using faculty consensus to develop and implement a medical ethics course. Acad Med 1992 Jun;67(6):406-8.

Andre J. Learning to see: moral growth during medical training. J Med Ethics 1992 Sep;18(3):148-52.

Andrews MD. Ethical and legal dilemmas in medicine: an introduction for medical students. J Okla State Med Assoc 1991 May;84(5):222-4.

Arda B, Ors Y. Teaching medical ethics with an ethics to teach. Bull Med Ethics 1996 Mar;116:19-22.

Asai A, Kishino M, Fukui T, Masano T. Postgraduate education in medical ethics in Japan. Med Educ 1998 Jan;32(1):100-4.

Babapulle CJ. Teaching of medical ethics in Sri Lanka. Med Educ 1992 May;26(3):185-9.

Barclay ML, Elkins TE. A computer conference format for teaching medical ethics. Acad Med 1991 Oct;66(10):592-4.

Baylis F, Downie J. Ethics education for Canadian medical students. Acad Med 1991 Jul;66(7):413-4.

Bebeau MJ, Thoma SJ. The impact of a dental ethics curriculum on moral reasoning. J Dent Educ 1994 Sep;58(9):684-92.

Benatar SR. Teaching medical ethics. QJM 1994 Dec;87(12):759-67.

Bickel J. Medical students' professional ethics: defining the problems and developing resources. Acad Med 1991 Dec;66(12):726-9.

Bickel J. Proceedings of the AAMC Conference on Students' and Residents' Ethical and Professional Development October 27-28, 1995. Introduction. Acad Med 1996 Jun;71(6):622-3.

Blasszauer B. Teaching medical ethics [letter]. J Med Ethics 1995 Apr;21(2):118. Comment on: J Med Ethics 1994 Dec;20(4):239-43.

Blechner BB, Hager CL, Williams NR. The Jay Healey technique: teaching law and ethics to medical and dental students. Am J Law Med 1994;20(4):439-55.

Branch WT, Pels RT. Add professors and stir [letter]. Hastings Cent Rep 1995 Jan-Feb;25(1):49.

Bryant JH. Educating tomorrow's doctors. World Health Forum 1993;14(3):217-30; discussion 231-52.

Bryson-Brockmann W, Roll D. Single-case experimental designs in medical education: an innovative research method. Acad Med 1996 Jan;71(1):78-85.

Bulger RE, Reiser SJ. Studying science in the context of ethics. Acad Med 1993 Sep;68(9 Suppl):S5-9.

Burack JH. Response to Further exploration of the relationship between medical education and moral development by Donnie J Self, DeWitt C Baldwin, Jr, and Frederic D Wolinsky (CQ Vol 5, No 3). Deriving ought from p: methodological and theoretical pitfalls in quantitative ethics [letter]. Camb Q Healthc Ethics 1997 Spring;6(2):226-32. Comment on: Camb Q Healthc Ethics 1996 Summer;5(3):444-9.

Burling SJ, Lumley JS, McCarthy LS, Mytton JA, Nolan JA, Sissou P, Williams DG, Wright LJ. Review of the teaching of medical ethics in London medical schools. J Med Ethics 1990 Dec;16(4):206-9.

Cain JM, Elkins T, Bernard PF. The status of ethics education in obstetrics and gynecology. Obstet Gynecol 1994 Feb;83(2):315-20.

Calman K. The profession of medicine. BMJ 1994 Oct 29;309(6962):1140-3. Comments in: BMJ 1994 Oct 29;309(6962):1099-100; BMJ 1994 Dec 17;309(6969):1657; BMJ 1994 Dec 17;309(6969):1657-8; BMJ 1994 Dec 17;309(6969):1658; BMJ 1994 Dec 17;309(6969):1658-9.

Campbell AV. Ethics after Cartwright. N Z Med J 1991 Feb 13;104(905):36-7. Comments in: N Z Med J 1991 Apr 10;104(909):146-7; N Z Med J 1991 Jun 12;104(913):235.

Caplan RM. CME ethics, continued. Iowa Med 1990 Mar;80(3):135.

Carse AL. The 'voice of care': implications for bioethical education. J Med Philos 1991 Feb;16(1):5-28.

Chamberlain JE, Nisker JA. Residents' attitudes to training in ethics in Canadian obstetrics and gynecology programs. Obstet Gynecol 1995 May;85(5 Pt 1):783-6.

Charon R, Banks JT, Connelly JE, Hawkins AH, Hunter KM, Jones AH, Montello M, Poirer S. Literature and medicine: contributions to clinical practice. Ann Intern Med 1995 Apr 15;122(8):599-606. Comments in: Ann Intern Med 1995 Apr 15;122(8):618-9; Ann Thorac Surg 1995 Dec 15;123(12):965; discussion 966; Ann Thorac Surg 1995 Dec 15;123(12):965-6.

Charon R, Fox RC. Critiques and remedies: medical students call for change in ethics teaching. JAMA 1995 Sep 6;274(9):767, 771.

Churchill LR. AIDS and 'dirt': reflections on the ethics of ritual cleanliness. Theor Med 1990 Sep;11(3):185-92. Comment in: Theor Med 1991 Jun;12(2):151-6.

Classe JG. Ethics redux [editorial]. J Am Optom Assoc 1996 Sep;67(9):509-11.

Cohen JJ. An awesome responsibility for medical educators. Acad Med 1996 Jan;71(1):56.

Coles R. The moral education of medical students. Acad Med 1998 Jan;73(1):55-7.

Coughlin SS. Model curricula in public health ethics. Am J Prev Med 1996 Jul-Aug;12(4):247-51.

Coughlin SS, Etheredge GD. On the need for ethics curricula in epidemiology. Epidemiology 1995 Sep;6(5):566-7.

Coutts MC. Teaching ethics in the health care setting, part I: survey of the literature [bibliography]. Kennedy Inst Ethics J 1991 Jun;1(2):171-85.

Coutts MC. Teaching ethics in the health care setting, part II: sample syllabus. Kennedy Inst Ethics J 1991 Sep;1(3):263-73.

Coverdale JH. The status of ethics education in Australasian psychiatry. Aust N Z J Psychiatry 1996 Dec;30(6):813-8.

Currie C, Green J, Davies S, Morgan C. Cost effectiveness of medical ethics training [letter]. J Med Ethics 1997 Oct;23(5):328.

Derse AR. Ethics emergent [editorial]. Ann Emerg Med 1990 Feb;19(2):210-2.

Desjardins J, Kenny NP, Lynch A, Crelinsten GL, Grunberg F, Watts J, Ruedy J. Teaching of biomedical ethics in postgraduate training programs. Ann R Coll Physicians Surg Can 1992 Aug;25(5):308-12.

Dibbern DA Jr, Wold E. Workshop-based learning: a model for teaching ethics. JAMA 1995 Sep 6;274(9):770-1.

Diekema DS, Shugerman RP. An ethics curriculum for the pediatric residency program. Confronting barriers to implementation. Arch Pediatr Adolesc Med 1997 Jun;151(6):609-14.

Dorsch JL. BIOETHICSLINE use by medical students: curriculum-integrated instruction and collection development implications. Bull Med Libr Assoc 1997 Apr;85(2):147-53.

Douglas-Steele D, Hundert EM. Accounting for context: future directions in bioethics theory and research. Theor Med 1996 Jun;17(2):101-19.

Downing MT, Way DP, Caniano DA. Results of a national survey on ethics education in general surgery residency programs. Am J Surg 1997 Sep;174(3):364-8.

Doyal L, Gillon R. Medical ethics and law as a core subject in medical education. A core curriculum offers flexibility in how it is taught-but not that it is taught [editorial]. BMJ 1998 May 30;316(7145):1623-4.

Dressel R, Christ G, Reiter-Theil S. Training ethics teachers in Germany. Bull Med Ethics 1995 Jun;109:13-5.

Elliott D. Case studies for teaching research ethics. Prof Ethics 1995 Spring-Summer;4(3-4):179-98.

Erde EL. The inadequacy of role models for educating medical students in ethics with some reflections on virtue theory. Theor Med 1997 Mar-Jun;18(1-2):31-45.

Finocchio LJ, Bailiff PJ, Grant RW, O'Neil EH. Professional competencies in the changing health care system: physicians' views on the importance and adequacy of formal training in medical school. Acad Med 1995 Nov;70(11):1023-8.

Forrow L, Wolf ML. Ideals in action: the U.S. Schweitzer Fellows Programs. Acad Med 1998 Jun;73(6):658-61.

Fox E, Arnold RM, Brody B. Medical ethics education: past, present, and future. Acad Med 1995 Sep;70(9):761-9.

Frank RR, Becker MJ. Ethics/human values curricula in US medical schools: results of a recent survey. Health Care Anal 1994 Feb;2(1):80.

Friedman PJ. Research ethics: a teaching agenda for academic medicine. Acad Med 1990 Jan;65(1):32-3.

Fulford KW, Yates A, Hope T. Ethics and the GMC core curriculum: a survey of resources in UK medical schools. J Med Ethics 1997 Apr;23(2):82-7.

Gauthier CC. Teaching the virtues: justifications and recommendations. Camb Q Healthc Ethics 1997 Summer;6(3):339-46.

Gilbert J, Jeffrey D. How much ethics is needed to make a good doctor? [letters]. Lancet 1993 Feb 20;341(8843):498-9.

Gillon R. Thinking about a medical school core curriculum for medical ethics and law [editorial]. J Med Ethics 1996 Dec;22(6):323-4. Comment on: J Med Ethics 1996 Dec;22(6):325-6.

Goals of medicine. Setting new priorities. Hastings Cent Rep 1996 Nov-Dec;26(6):S1-27.

Goldbort RC. How dare you sport thus with life?: Frankensteinian fictions as case studies in scientific ethics. J Med Humanit 1995 Summer;16(2):79-91.

Green B, Miller PD, Routh CP. Teaching ethics in psychiatry: a one-day workshop for clinical students. J Med Ethics 1995 Aug;21(4):234-8.

Green MJ, Mitchell G, Stocking CB, Cassel CK, Siegler M. Do actions reported by physicians in training conflict with consensus guidelines on ethics? Arch Intern Med 1996 Feb 12;156(3):298-304.

Greene D. The use of service learning in client environments to enhance ethical reasoning in students. Am J Occup Ther 1997 Nov-Dec;51(10):844-52.

Grundstein-Amado R. Values education: a new direction for medical education. J Med Ethics 1995 Jun;21(3):174-8.

Hanson MJ. Do as I do [bioethics education]. Hastings Cent Rep 1992 Sep-Oct;22(5):3.

Hart CW. From innocence to experience: teaching medical ethics to medical students. J Relig Health 1995 Spring;34(1):55-60.

Healey MA. Lies students tell [letter]. CMAJ 1997 May 1;156(9):1266; discussion 1267. Comment on: CMAJ 1997 Jan 15;156(2):219-22.

Hensel WA, Rasco TL. Storytelling as a method for teaching values and attitudes. Acad Med 1992 Aug;67(8):500-4.

Holm S, Nielsen GH, Norup M, Vegner A, Guldmann F, Andreasen PH. Changes in moral reasoning and the teaching of medical ethics. Med Educ 1995 Nov;29(6):420-3.

Homenko DF, Kohn M, Rickel T, Wilkinson ML. Student identification of ethical issues in a primary care setting. Med Educ 1997 Jan;31(1):41-4.

Hope T. Ethics and law for medical students: the core curriculum [editorial]. J Med Ethics 1998 Jun;24(3):147-8.

Hope T. Teaching medical ethics: healthy variety, but are we learning from each other? Bull Med Ethics 1991 Aug;70:22-3.

Hughes J. Ultimate justification: Wittgenstein and medical ethics. J Med Ethics 1995 Feb;21(1):25-30.

Hundert EM, Douglas-Steele D, Bickel J. Context in medical education: the informal ethics curriculum. Med Educ 1996 Sep;30(5):353-64.

Hundert EM, Hafferty F, Christakis D. Characteristics of the informal curriculum and trainees' ethical choices. Acad Med 1996 Jun;71(6):624-42.

Jones AH. Literature and medicine: narrative ethics. Lancet 1997 Apr 26;349(9060):1243-6.

Kane GC, Leone FT, Rowane J, Fish JE. Nationwide perspective on the use of a formal ethics curriculum during critical care fellowship training [letter]. Acad Med 1998 Jan;73(1):103.

Kent H. Medical, health-science students bring different perspectives to interdisciplinary ethics course. CMAJ 1997 May 1;156(9):1317-8.

Kinsella D, Lockyer J, Brownell K. Ethics training for residents [abstract]. Acad Med 1994 May;69(5):432.

Knight JA. Moral growth in medical students. Theor Med 1995 Sep;16(3):265-80; discussion 281-9.

Komesaroff PA. Review essay: the nature of medicine and the teaching of medical ethics. Bioethics 1990 Jan;4 (1):66-77.

Kopelman LM. Philosophy and medical education. Acad Med 1995 Sep;70(9):795-805.

Krulwich TA, Friedman PJ. Integrity in the education of researchers. Acad Med 1993 Sep;68(9 Suppl):S14-S18.

Kuczewski M, Wicclair MR, Arnold RM, Pinkus RL, Aumann GM. Make my case: ethics teaching and case presentations. J Clin Ethics 1994 Winter;5(4):310-5. Comment in: J Clin Ethics 1994 Winter;5(4):347-8.

Layman E. Ethics education: curricular considerations for the allied health disciplines. J Allied Health 1996 Spring;25(2):149-60.

Levine RJ. Some reflections on postgraduate medical ethics education. Ethics Behav 1997;7(1):15-26.

Loudon I. The Hippocratic oath [letter]. BMJ 1994 Aug 6;309(6951):414.

Lynch A, Gourdeau R. Medical ethics 101 [editorial]. Ann R Coll Physicians Surg Can 1990 Jan;23(1):13-5.

Macrina FL, Munro CL. The case study approach to teaching scientific integrity in nursing and the biomedical sciences. J Prof Nurs 1995 Jan-Feb;11(1):40-4.

Macrina FL, Munro CL. Graduate teaching in principles of scientific integrity [and] Resource materials on scientific integrity issues. Acad Med 1993 Dec;68(12):879-86.

Makoul G, Curry RH. Patient, physician & society: Northwestern University Medical School. Acad Med 1998 Jan;73(1):14-24.

McGee G. Phronesis in clinical ethics. Theor Med 1996 Dec;17(4):317-28.

Methodologies of teaching. The Ethics Committee of the American Academy of Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg 1996 Sep;115(3):258-61.

Michels R. Ethics education or moral persuasion? [commentary on H.S. Moffic, J. Coverdale, and T. Bayer, Ethics education for psychiatry]. J Clin Ethics 1991 Fall;2(3):166.

Miner RD. Academy helps budding colleagues through ethics program. Ann Dent 1997 Oct:2, 5, 8

Morton KR, Lamberton HH, Testerman JK, Worthley JS, Loo LK. Why does moral reasoning plateau during medical school? [letter]. Acad Med 1996 Jan;71(1):5-6.

Napper SA, Hale PN. Teaching of ethics in biomedical engineering. IEEE Eng Med Biol Mag 1993 Dec;12(4):100-5.

Nicholas B, Gillett G. Doctors' stories, patients' stories: a narrative approach to teaching medical ethics. J Med Ethics 1997 Oct;23(5):295-9.

Nolan PW, Smith J. Ethical awareness among first year medical, dental and nursing students. Int J Nurs Stud 1995 Oct;32(5):506-17.

O'Toole J. The story of ethics: narrative as a means for ethical understanding and action. JAMA 1995 May 3;273(17):1387, 1390.

Ors Y. Teaching medical ethics in the subjunctive mood. Bull Med Ethics 1993 Nov;93:31-6.

Parker M. Autonomy, problem-based learning, and the teaching of medical ethics. J Med Ethics 1995 Oct;21(5):305-10.

Parker MH, Price DA, Harris PG. Teaching of medical ethics: implications for an integrated curriculum. Med Educ 1997 May;31(3):181-7.

Pearlman RA. The value of an oath of professional conduct: process, content, or both? [commentary on H.S. Moffic, et al., The Hippocratic Oath and clinical ethics]. J Clin Ethics 1990 Winter;1(4):292-3.

Pellegrino ED. The Hippocratic Oath and clinical ethics [commentary on H.S. Moffic, et al., The Hippocratic Oath and clinical ethics]. J Clin Ethics 1990 Winter;1(4):290-1.

Poker AM. Making optimal use of information technology [letter]. Acad Med 1997 Jun;72(6):471-2. Comment on: Acad Med 1997 Jan;72(1):36-41.

Pruitt R, Young EWD, Ross JW, Gross ML, Schwartz R. Facing fallibility and feelings: can medical ethics education play a role? Mak Rounds Health Faith Ethics 1996 Feb 12;1(11):4-8.

Quinn CA. A conceptual approach to the identification of essential ethics content for the undergraduate nursing curriculum. J Adv Nurs 1990 Jun ;15(6):726-31.

Ralston HJ 3rd, Beattie DS, Berns KI, Goode LD, Kelley WN, Lennarz WJ, Marton LJ, Prange AJ Jr, Shipp AC. Capturing the promise of science in medical schools. Acad Med 1996 Dec;71(12):1314-23.

Reiser SJ, Heitman E. Creating a course on ethics in the biological sciences. Acad Med 1993 Dec;68(12):876-9.

Roberts A, Fincher RM. Teaching third-year medical students how to handle ethical dilemmas. J Med Assoc Ga 1997 Nov;86(4):327-9.

Rosnow RL. Teaching research ethics through role-play and discussion. Teach Psychol 1990 Oct;17(3):179-81.

Rossignol AM, Goodmonson S. Are ethical topics in epidemiology included in the graduate epidemiology curricula? Am J Epidemiol 1995 Dec 15;142(12):1265-8.

Ruckdeschel JC, Albrecht TL, Blanchard C, Hemmick RM. Communication, accrual to clinical trials, and the physician-patient relationship: implications for training programs. J Cancer Educ 1996 Summer;11(2):73-9.

Sanders M. The forgotten curriculum: an argument for medical ethics education. JAMA 1995 Sep 6;274(9):768-9.

Schatz IJ. Empathy and medical education. Hawaii Med J 1995 Apr;54(4):495-7.

Schubert-Lehnhardt V. Teaching medical ethics in Germany. Bull Med Ethics 1992 Feb;75:13-5.

Seedhouse D. Against medical ethics: a response to Cassell. J Med Ethics 1998 Feb;24(1):13-7.

Self DJ, Baldwin DC Jr, Wolinsky FD. Further exploration of the relationship between medical education and moral development. Camb Q Healthc Ethics 1996 Summer;5(3):444-9. Comment in: Camb Q Healthc Ethics 1997 Spring;6(2):226-32.

Self DJ, Davenport E. Measurement of moral development in medicine. Camb Q Healthc Ethics 1996 Spring;5(2):269-77.

Self DJ, Gopalakrishnan G, Kiser WR, Olivarez M. The relationship of empathy to moral reasoning in first-year medical students. Camb Q Healthc Ethics 1995 Fall;4(4):448-53.

Self DJ, Olivarez M. Retention of moral reasoning skills over the four years of medical education. Teach Learn Med 1996;8(4):195-9.

Self DJ, Olivarez M, Baldwin DC Jr. Clarifying the relationship of medical education and moral development. Acad Med 1998 May;73(5):517-20.

Self DJ, Olivarez M, Baldwin DCJr. The amount of small-group case-study discussion needed to improve moral reasoning skills of medical students. Acad Med 1998 May;73(5):521-3.

Self DJ, Skeel JD, Jecker NS. A comparison of the moral reasoning of physicians and clinical medical ethicists. Acad Med 1993 Nov;68(11):852-5.

Self DJ, Skeel JD, Jecker NS. The influence of philosophical versus theological education on the moral development of clinical medical ethicists. Acad Med 1993 Nov;68(11):848-52.

Shotton L. The ethics of teaching nursing ethics. Health Care Anal 1997 Sep;5(3):259-63.

Sidorov JJ. Education in medical ethics [article and discussion]. Gastroenterol Jpn 1993 Jul;28(Suppl 6):3-10.

Silverman DR. Narrowing the gap between rhetoric and the reality of medical ethics. Acad Med 1996 Mar;71(3):227-37.

Singer PA. Bioethics for clinicians [editorial]. CMAJ 1996 Jul 15;155(2):189-90. Comment on: CMAJ 1996 Jul 15;155(2):177-80.

Singer PA, Robb A, Cohen R, Norman G, Turnbull J. Performance-based assessment of clinical ethics using an objective structured clinical examination. Acad Med 1996 May;71(5):495-8.

Sofaer B. Enhancing humanistic skills: an experiential approach to learning about ethical issues in health care. J Med Ethics 1995 Feb;21(1):31-4.

Sonis J, Gorenflo DW, Jha P, Williams C. Teaching of human rights in US medical schools. JAMA 1996 Nov 27;276(20):1676-8. Comment in: JAMA 1996 Nov 27;276(20):1679-81.

Spafford MM, Strong G. Design elements of professional ethics courses. Optom Vis Sci 1995 Oct;72(10):741-52.

St Onge J. Medical education must make room for student-specific ethical dilemmas. CMAJ 1997 Apr 15;156(8):1175-7.

Strohmetz DB, Skleder AA. The use of role-play in teaching research ethics: a validation study. Teach Psychol 1992 Apr;19(2):106-8.

Strong C, Miller BE, Photopulos GJ, Smiley LM. An approach to teaching ethical, legal, and psychosocial aspects of gynecologic oncology in a residency program. Obstet Gynecol 1997 Jan;89(1):142-4.

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Sulmasy DP, Dwyer M, Marx E. Knowledge, confidence, and attitudes regarding medical ethics: how do faculty and housestaff compare? Acad Med 1995 Nov;70(11):1038-40.

Sulmasy DP, Geller G, Levine DM, Faden R. Medical house officers' knowledge, attitudes, and confidence regarding medical ethics. Arch Intern Med 1990 Dec;150(12):2509-13.

Sulmasy DP, Marx ES. Ethics education for medical house officers: long-term improvements in knowledge and confidence. J Med Ethics 1997 Apr;23(2):88-92.

Swazey JP, Bird SJ. Teaching and learning research ethics. Prof Ethics 1995 Spring-Summer;4(3-4):155-78.

Swenson SL, Rothstein JA. Navigating the wards: teaching medical students to use their moral compasses. Acad Med 1996 Jun;71(6):591-4.

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Taubes G. Indiana: wrong answers--but no right ones. Science 1995 Jun 23;268(5218):1707. Published erratum appears in Science 1995 Sep 22;269(5231):1657.

Taubes G. Pittsburgh: interwoven with the fabric of learning. Science 1995 Jun 23;268(5218):1709.

Teaching ethics: right to refuse? [letter]. Hastings Cent Rep 1991 May-Jun;21(3):39-40.

Teaching medical ethics and law within medical education: a model for the UK core curriculum. J Med Ethics 1998 Jun;24(3):188-92.

Tealdi JC. Teaching bioethics as a new paradigm for health professionals. Bioethics 1993 Apr;7(2-3):188-99.

ten Have H. Teaching ethics within the medical curriculum. Health Care Anal 1994 May;2(2):173-7.

Thompson JN. Moral imperatives for academic medicine. Acad Med 1997 Dec;72(12):1037-42.

Thornton BC, Callahan D, Nelson JL. Bioethics education. Expanding the circle of participants. Hastings Cent Rep 1993 Jan-Feb;23(1):25-9.

Thornton H. Learning about randomised controlled trials. Bull Med Ethics 1993 Apr;87:21-3.

Tokuda Y. Teaching ethics in Japan [letter]. Lancet 1995 Jun 17;345(8964):1574. Comment on: Lancet 1995 Apr 15;345(8955):980; Lancet 1995 Apr 15;345(8955):980-1; Lancet 1995 Jun 3;345(8962):1446; Lancet 1995 Jun 3;345(8962):1446-7.

Triana JE. Humanistic and social education for physicians: the experience of the Colombian School of Medicine. J Med Philos 1996 Dec;21(6):651-7.

Tysinger JW, Klonis LK, Sadler JZ, Wagner JM. Teaching ethics using small-group, problem-based learning. J Med Ethics 1997 Oct;23(5):315-8.

Valiathan MS. Training doctors for tomorrow. Indian Pediatr 1996 Jun;33(6):481-92.

Veatch RM. Should we study the Hippocratic Oath? [commentary on H.S. Moffic, et al., The Hippocratic Oath and clinical ethics]. J Clin Ethics 1990 Winter;1(4):291-2.

Waz WR, Henkind J. The adequacy of medical ethics education in a pediatrics training program. Acad Med 1995 Nov;70(11):1041-3.

Weatherall DJ. Teaching ethics to medical students [editorial]. J Med Ethics 1995 Jun;21(3):133-4.

Weiner R. Ethics rounds. Fla Nurse 1995 Jan;43(1):2, 16.

Weisberg M, Duffin J. Evoking the moral imagination: using stories to teach ethics and professionalism to nursing, medical, and law students. J Med Humanit 1995 Winter;16(4):247-63.

White BD, Zaner RM. Clinical ethics training for staff physicians: designing and evaluating a model program. J Clin Ethics 1993 Fall;4(3):229-35. Comment in: J Clin Ethics 1993 Fall;4(3):273-5.

White R. Lead by example [letter]. Br J Anaesth 1997 May;78(5):628-9.

Wichman A, Foa R. Ethics education in neurology residency programs: results of a survey. Neurology 1996 May;46(5):1481-3.

Williamson B. Medical ethics, teaching and the new genetics [editorial]. J Med Ethics 1996 Dec;22(6):325-6. Comment in: J Med Ethics 1996 Dec;22(6):323-4.

Williamson C, Wilkie P. Teaching medical students in general practice: respecting patients' rights [editorial]. BMJ 1997 Nov 1;315(7116):1108-9. Comment on: BMJ 1997 Nov 1;315(7116):1142.

Wurzbach ME. Teaching nursing ethics on interactive television: fostering interactivity. J Nurs Educ 1993 Jan;32(1):37-9.
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## Bioethics education - Books

Baylis F, Downie J, et al. Undergraduate medical ethics education: a survey of Canadian medical schools. Canada: Westminster Institute for Ethics and Human Values; 1990. 142 p.

Grafius LC. Ethics for everyone: a practical guide to interdisciplinary biomedical ethics education. Chicago: American Hospital Pub; c1995. 223 p.

Nelson HL. Stories and their limits: narrative approaches to bioethics. New York: Routledge; 1997. 284 p. (Reflective bioethics).

Thornton BC, Callahan D. Bioethics education: expanding the circle of participants. Briarcliff Manor (NY): The Hastings Center; 1993. 35 p.
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## Case studies - Journal Articles

Casebook in psychiatric ethics. Introduction. Rep Group Adv Psychiatry 1990;(129):1-9.

Cassidy VR. Literary works as case studies for teaching human experimentation ethics. J Nurs Educ 1996 Mar;35(3):142-4.

Coope CM. Does teaching by cases mislead us about morality? J Med Ethics 1996 Feb;22(1):46-52. Comment in: J Med Ethics 1996 Feb;22(1):3-4.

Durbin PT, Engel JD, Blacklow RS, Wellenbach BL. Sensitizing residents to moral issues by case discussions. Acad Med 1991 Oct;66(10):588.

Gillon R. Case studies and medical education [editorial]. J Med Ethics 1996 Feb;22(1):3-4. Comment on: J Med Ethics 1996 Feb;22(1):46-52.

Jonsen AR. Case analysis in clinical ethics. J Clin Ethics 1990 Spring;1(1):63-5.

Tannsjo T. The morality of clinical research--a case study. J Med Philos 1994 Feb;19(1):7-21.
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## Case studies - Books

Ackerman TF, Strong C. A casebook of medical ethics. New York: Oxford University Press; 1989. 240 p.

Coughlin SS, Soskolne CL, Goodman KW. Case studies in public health ethics. Washington: American Public Health Association; 1997. 180 p.

Crigger BJ, editor. Cases in bioethics: selections from the Hastings Center report. 2nd ed. New York: St. Martin's Press; c1993. 297 p.

Forman EN, Ladd RE, editors. Ethical dilemmas in pediatrics: a case study approach. New York: Springer-Verlag; c1991. 142 p.

Group for the Advancement of Psychiatry, Committee on Medical Education. A casebook in psychiatric ethics. New York: Brunner Mazel; 1990. 113 p. (Report; 129).

Horn P. Clinical ethics casebook. Belmont (CA): Wadsworth Pub. Co.; 1998.

Korenman SG, Shipp AC. Teaching the responsible conduct of research through a case study approach: a handbook for instructors. Washington: Association of American Medical Colleges; c1994. 226 p.

Levine C, editor. Cases in bioethics: selections from the Hastings Center report. New York: St. Martin's Press; 1989. 291 p.

Penslar RL. Research ethics: cases and materials. Bloomington: Indiana University Press; 1995.

Thomas JE, Waluchow WJ, editors. Well and good: case studies in biomedical ethics. Rev. ed. Peterborough (Ont): Broadview Press; c1990. 218 p.
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## Audiovisual materials for teaching the ethics of research involving human participants

Atomic guinea pigs. Sacrifice zone [videorecording]. Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1998. 1 videocassette: 40 min., sound, color with black and white, 1/2 in.

Addressing the dil[e]mmas of medical ethics [audiocassette]. Blake, Mary Beth. Teach'em, Inc. producer. Chicago: Foundation of the American College of Healthcare Executives; 1987. 1 sound cassette: 1 7/8 ips.

An approach to ethical dilemmas: case studies & policies [audiocassette]. Cohen, Elliott G. Teach'em, Inc., producer. Chicago: Foundation of the American College of Healthcare Executives; 1987. 2 sound cassettes: 1 7/8 ips.

Balancing society's mandates: I.R.B. review criteria [videorecording]. National Institutes of Health (US); Food and Drug Administration (US). National Library of Medicine, producer. Bethesda (MD): National Institutes of Health; 1986. 1 videocassette: 38 min., sound, color, 3/4 in. Available also from National Institutes of Health, Office of Extramural Research under title Protecting Human Subjects. Three Instructional Films. Evolving Concern. Balancing Society's Mandates. The Belmont Report; 1/2 in.

The Belmont report: basic ethical principles and their applications [videorecording]. National Institutes of Health (US); Food and Drug Administration (US). National Library of Medicine, producer. Bethesda (MD): National Institutes of Health; 1986. 1 videocassette: 34 min., sound, color with black and white, 3/4 in. Available also from National Institutes of Health, Office of Extramural Research under title Protecting Human Subjects. Three Instructional Films. Evolving Concern. Balancing Society's Mandates. The Belmont Report; 1/2 in.

Bioethics for health professionals [computer program]. Version 1.0. Rorden, Judith Waring. Orlando (FL): Computerized Educational Systems; 1996. 1 computer disk: 3 1/2 in. Accompanied by 1 manual. System requirements: Any IBM PC/XT/AT/PS-2 or compatible; 512 RAM; DOS 3.0 or greater; col. monitor preferred; optional record keeping requires an IBM or compatible 80 column dot matrix printer.

Bioethics vs. clinical ethics: practical applications in hospital administration [audiocassette]. LaPuma, John. Chicago: Foundation of the American College of Healthcare Executives; 1989. 1 sound cassette: 1 7/8 ips.

The birth of bioethics [videorecording]. Jonsen, Albert R; Scribner, Belding H. University of Washington, School of Medicine, Dept. of Medical History and Ethics, producer. Seattle: University of Washington, Health Sciences Center for Educational Resources; 1993. 14 videocassettes: 14 hr., 40 min., 49 sec., sound, color, with black and white, 1/2 in. Conference held Sept. 23-24, 1993 in Seattle, Wash.

Confidentiality and privacy [videorecording]. Reeter, Alan K. Medfilms, Inc., producer. Tucson (AZ): Medfilms; 1997. 1 videocassette: 10 min., sound, color with black and white, 1/2 in. Accompanied by 1 guide, 9 p.

Confidentiality, ethical and legal considerations [videorecording]. Blenkhorn Phyllis; Calfee Barbara E; Rolince Pat. Cleveland: Fairview Audio-Visuals; 1989. 1 videocassette: 18 min., sound, color, 3/4 in. Issued also as a 1/2 in. videocassette.

Conflicts in caring: medical, ethical, and legal perspectives in bioethical decision-making [videorecording]. Bradley, Lou; Glaser, Jack. Sight & Sound, Inc., producer. Kansas City: Sheed & Ward; 1988. 1 videocassette: 30 min., sound, color, 1/2 in.

The deadly deception [videorecording]. Films for the Humanities; WGBH (Television station: Boston, Mass.), producers. Boston: WGBH Educational Foundation; 1993. 1 videocassette: 60 min., sound, color, 1/2 in.

Doctors, nurses, and informed consent [videorecording]. Blenkhorn, Phyllis; Irwin, John R. Cleveland: Fairview Audio-Visuals; 1988. 1 videocassette:18 min., sound, color, 3/4 in. Issued also as a 1/2 in. videocassette.

Ethics committees: necessary invention of modern health care [videorecording]. Glaser, Jack. Mount Carmel Mercy Hospital, Audiovisual Services, producer. Kansas City (MO): Sheed & Ward; 1988. 1 videocassette: 23 min., sound, color, 1/2 in.

The ethics of cloning [videorecording]. Films for the Humanities. New River Media, producer. Princeton (NJ): Films for the Humanities & Sciences; 1997. 1 videocassette: 29 min., sound, color, 1/2 in.

Evolving concern: protection for human subjects [videorecording]. National Institutes of Health (US); Food and Drug Administration (US). National Library of Medicine, producer. Bethesda (MD): National Institutes of Health; 1986. 1 videocassette: 23 min., sound, black and white with color, 3/4 in. Available also from National Institutes of Health, Office of Extramural Research under title Protecting Human Subjects. Three Instructional Films. Evolving Concern. Balancing Society's Mandates. The Belmont Report; 1/2 in.

Fetal surgery and tissue implant: right or wrong? [videorecording]// . Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1998. 1 videocassette: 58 min., sound, color, 1/2 in.

Gene research: promises and dilemmas [videorecording]. Rose, Steven P. R. Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1998. 1 videocassette: 33 min., sound, color, 1/2 in.

The human experiment [videorecording]. Columbia University Seminars on Media & Society. WNET (Television station: New York, N.Y.), producer. New York: Trustees of Columbia University in the City of New York; 1989. 1 videocassette: 60 min., sound, color, 1/2 in. Issued also as a 3/4 in. videocassette.

Informed consent: what every physician should know [videorecording]. Webb, M. Sharon. Rob Cooper Creative Production Services, producer. United States: SEAK, Inc.; 1995. 1 videocassette: 55 min., sound, color, 1/2 in.

Integrity in scientific research: five video vignettes [videorecording]. Amram Nowak Associates, producer. Washington: American Association for the Advancement of Science; 1996. 5 videocassettes: 43 min., sound, color, 1/2 in. Accompanied by: 1 guide, 50 p. Produced for the American Association for the Advancement of Science in cooperation with the Medical College of Georgia, Division of Health Communication.

The JCAHO patient rights standards: implications for assessing patients' competence [videorecording]. Hixon, Thomas J. University of Arizona, National Center for Neurogenic Communication Disorders, producer. Tucson (AZ): Arizona Board of Regents; 1992. 1 videocassette: sound, color, 1/2 in. Accompanied by 1 guide, 6 leaves. (Telerounds; 5).

The man-made man [videorecording]. Sheen, Martin; narrator. Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1998. 1 videocassette: 60 min., sound, color, 1/2 in.

The man who believes in body transplants [videorecording]. Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1997. 1 videocassette: 30 min., sound, color, 1/2 in.

On 'doubling' in Nazi doctors: the psychological uncovering of evil [audiocassette]. Lifton, Robert Jay. American Psychoanalytic Association, producer. Chicago: Teach'em; 1987? 1 sound cassette: analog. Recorded at the American Psychoanalytic Association's Fall Meeting, held at the Waldorf Astoria in New York City, Dec. 16-20, 1987.

Practical considerations [videorecording]. Wivel, Nelson. Bethesda (MD): BioConferences International Inc.; 1993. 1 videocassette: sound, color, 1/2 in. Recorded at BioEast '93, held in Washington, D.C.

Protecting human subjects. Three instructional films. Evolving concern. Balancing society's mandates. The Belmont Report [videorecording]. National Institutes of Health (US); Food and Drug Administration (US). National Library of Medicine, producer. Bethesda (MD): National Institutes of Health, Office of Extramural Research; 1986. 1/2 in.

Protection of human research subjects. Computer-based training for researchers [computer program on the Internet]. Bethesda (MD): National Institutes of Health, Office of Human Subjects Research; [cited 1999 Feb 23]. Available from: http://helix.nih.gov:8001/ohsr/newcbt/. Program may be downloaded or used online. System Requirements for Downloading: Macintosh PowerPC running System 7.5.1 or higher; Macintosh 68k PC running System 7.1.2 or higher; Windows PC running Microsoft Windows 95/98/NT/3.1 or higher. This training course is an educational requirement for all National Institutes of Health employees who conduct research.

The science of cloning [videorecording]. Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1997. 1 videocassette: 25 min., sound, color, 1/2 in.

We all have our reasons: community perceptions of HIV vaccine research [videorecording]. Kanter, Ron. Video/Film Associates, producer. Philadelphia: University of Pennsylvania, School of Medicine, Dept. of Psychiatry; 1997? 1 videocassette: 25 min., sound, color, 1/2 in. Accompanied by: 1 guide, 21 p.
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## Bioethics journals

Bioethics. Oxford: Blackwell Publishers Ltd. 1987- .

Bulletin of Medical Ethics. London: Royal Society of Medicine Press Ltd. No. 53, 1989- .

Cambridge Quarterly of Healthcare Ethics. New York: Cambridge University Press. 1992- .

Ethics and Behavior. Mahwah (NJ): Lawrence Erlbaum Associates, Inc. 1991- .

Hastings Center Report. Garrison (NY): The Hastings Center. 1971- .

Human Research Report: Protecting Researchers and Research Subjects. Omaha (NE): Deem-Corporation. 1986- .

IRB: A Review of Human Subjects Research. Garrison (NY): The Hastings Center. 1979- .

Journal of Clinical Ethics. Frederick (MD): The Journal of Clinical Ethics, Inc. 1990- .

Journal of Law, Medicine & Ethics. Boston (MA): American Society of Law, Medicine & Ethics. 1973- .

Journal of Medical Ethics. London: BMJ Publishing Group. 1975- .

Journal of Medicine and Philosophy. Lisse (Netherlands): Swets & Zeitlinger. 1976- .

Kennedy Institute of Ethics Journal. Baltimore (MD): Johns Hopkins University Press. 1991- .

Nursing Ethics: An International Journal for Health Care Professionals. London: Arnold. 1994- .

Science and Engineering Ethics. Guildford, Surrey (UK): Opragen Publications. 1995- .

Theoretical Medicine and Bioethics: Philosophy of Medical Research and Practice. Dordrecht (Netherlands): Kluwer Academic Publishers. 1977- .
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## Bioethics databases

BIOETHICSLINE [database on the Internet]. Washington: Georgetown University, Kennedy Institute of Ethics, National Reference Center for Bioethics Literature; 1974- . Updated bimonthly. Available free from: National Library of Medicine, http://www.nlm.nih.gov; National Reference Center for Bioethics Literature, http://bioethics.georgetown.edu/bioline.htm. Index of bioethics literature.

CINAHL (Cumulative Index to Nursing and Allied Health Literature) [database on the Internet]. Glendale (CA): Cinahl Information Systems. 1982- . Updated monthly. Available from: Cinahl Information Systems, http://www.cinahl.com/; Aries Systems Corp., North Andover, MA; Data-Star, Philadelphia, PA; EBSCO Publishing, Peabody, MA; Healthgate Data Corp., Malden, MA; OCLC First Search, Dublin, OH; Ovid Technologies, New York; SilverPlatter Information, Norwood, MA; Paper*Chase*, Boston, MA; Synthesys Technologies, Austin, TX. Index of nursing and allied health literature.

HISTLINE [database on the Internet]. Bethesda (MD): National Library of Medicine; 1964- . Updated monthly. Available free from: National Library of Medicine, http://www.nlm.nih.gov. Index of history of medicine literature.

LEXIS [databases on the Internet]. Dayton (OH): Mead Data Central. Available from: http://www.lexis-nexis.com/lncc/. Source of numerous legal databases.

LocatorPlus [library catalog on the Internet]. Bethesda (MD): National Library of Medicine. Updated daily. Available free from: National Library of Medicine, http://www.nlm.nih.gov. National Library of Medicine catalog of books, journals, and audiovisuals.

MEDLINE [database on the Internet]. Bethesda (MD): National Library of Medicine; 1960- . Updated weekly. Available from: National Library of Medicine (free), http://www.nlm.nih.gov; Ovid Technologies, New York; Knight-Ridder, Detroit, MI; CompuServe, Columbus, OH; Paper*Chase*, Boston, MA; LEXIS-NEXIS, Dayton, OH. Index of nearly 4000 medical journals.

WESTLAW [databases on the Internet]. St. Paul (MN): West Group. Available from: http://www.westgroup.com/. Source of numerous legal databases.
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## Source materials - U.S. federal government laws, regulations, and guides concerning the protection of human subjects - Journal Articles

Berg JW. Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines. J Law Med Ethics 1996 Spring;24(1):18-35.

Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA 1995 Apr 26;273(16):1283-7. Comment in: JAMA 1995 Apr 26;273(16):1299-300; JAMA 1995 Apr 26;273(16):1300-2; JAMA 1995 Oct 18;274(15):1196.

Biros MH, Runge JW, Lewis RJ, Doherty C. Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances. Acad Emerg Med 1998 Apr;5(4):359-68.

Centers for Disease Control and Prevention (US), Agency for Toxic Substances and Disease Registry. Policy on the inclusion of women and racial and ethnic minorities in externally awarded research; notice. Fed Regist 1995 Sep 15;60(179):47947-51.

de Jong J, Reatig N. SAMHSA philosophy and statement of ethical principles. Ethic Behav 1998;8(4):339-43.

Food and Drug Administration (US). Addendum to the Points to Consider in Human Somatic Cell and Gene Therapy (1991). Hum Gene Ther 1996 Jun 10;7(9):1181-90.

Food and Drug Administration (US). Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs; notice. Fed Regist 1993 Jul 22;58(139):39406-16.

Food and Drug Administration (US). Information sheets: guidance for Institutional Review Boards and clinical investigators. 1998 update [monograph on the Internet]. Rockville (MD): The Administration; 1998 Sep [cited 1999 May 10]. [12 web p.]. Available from: http://www.fda.gov/oc/oha/IRB/toc.html.

Food and Drug Administration (US). Informed consent for human drugs and biologics; determination that informed consent is not feasible; interim rule and opportunity for public comment. Fed Regist 1990 Dec 21;55(246):52814-7.

Food and Drug Administration (US). Protection of human subjects: categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure. Fed Regist 1998 Nov 9;63(216);60353-6.

Food and Drug Administration (US). Protection of human subjects; informed consent and waiver of informed consent requirements in certain emergency research; final rules. Fed Regist 1996 Oct 2;61(192):51498-531

Food and Drug Administration (US). Protection of human subjects; informed consent; proposed rule. Fed Regist 1995 Sep 21;60(183):49086-103.

Institutional review boards, 21 C.F.R. Sect. 56 (1998 revised).

Investigational device exemptions, 21 C.F.R. Sect. 812 (1998 revised).

Investigational new drug application, 21 C.F.R. Sect. 312 (1998 revised).

National Human Genome Research Institute (US). The use of human subjects in large-scale DNA sequencing [monograph on the Internet]. [Bethesda (MD)]: The Institute. [date unknown; cited 1998 Sep 28]. NHGRI-DOE guidance on human subjects issues in large-scale DNA sequencing: August 17, 1996; [7 p.]. Available from: http://www.nhgri.nih.gov/Grant_info/Funding/Statements/RFA/human_subjects.html.

National Institutes of Health. Recombinant DNA research; actions under guidelines; notice. Fed Regist 1990 Sep 12;55(177):37565-7.

National Institutes of Health. Recombinant DNA research; actions under guidelines; notice -- E. Points to consider for protocols for the transfer of recombinant DNA into the genome of human subjects. Fed Regist 1990 Mar 1;55(41):7443-7.

National Institutes of Health. Recombinant DNA research: notice of intent to propose amendments to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) regarding enhanced mechanisms for NIH oversight of recombinant DNA activities. Fed Regist 1996 Jul 8;61(131):35774-7.

National Institutes of Health. Recombinant DNA research: proposed actions under the guidelines; notice. Fed Regist 1996 Nov 22;61(227):59726-42.

National Institutes of Health. Recombinant DNA research: proposed actions under the guidelines; notice. Fed Regist 1997 Feb 14;62(31):7108-23.

Office of Science and Technology Policy (US). Federal policy for the protection of human subjects; final rule. Fed Regist 1991 Jun 18;56(117):28003-23.

Protection of human subjects, 21 C.F.R. Sect. 50 (1998 revised).

Public Health Service (US). Action related to emergency research activity. Fed Regist 1995 Jul 26;60(143):38353-4.

Public Health Service (US). Draft Public Health Service guideline on infectious disease. Issues in xenotransplantation (August 1996); notice. Fed Regist 1996 Sep 23;61(185):49919-32.

Waiver of informed consent requirements in certain emergency research. Fed Regist 1996 Oct 2;61(192):53531-3.

Wilson DJ. NIH guidelines for research involving recombinant DNA molecules. Accountability Res 1993;3(2-3):177-85.
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## Source materials - U.S. federal government laws, regulations, and guides concerning the protection of human subjects - Books

The Belmont report: ethical principles and guidelines for the protections of human subjects. Bethesda (MD): U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; l979. 8 p. Reprinted in numerous books and Internet web sites.

Department of Energy (US), Office of Energy Research. Protecting human research subjects at the Department of Energy: human subjects handbook [loose-leaf]. Washington: Department of Energy, Assistant Secretary for Environment, Safety, and Health, Office of Energy Research, Office of Health and Environmental Research; 1992-. 1 vol.

DOE human subjects research handbook: protecting human research subjects [microform]. 2nd ed. Washington: Department of Energy, Office of Health and Environmental Research; 1996. Rev. ed. of: Protecting human research subjects at the Department of Energy. 1992.

English A. State minor consent statutes: a summary. Cincinnati: Children's Hospital Medical Center, Division of Adolescent Medicine, National Center for Youth Law for the Center for Continuing Education in Adolescent Health; 1995. 197 p.

Guidelines for the conduct of research at the National Institutes of Health. Bethesda (MD): National Institutes of Health; 1990 Mar 21. 15 p.

Guidelines for the conduct of research involving human subjects at the National Institutes of Health. Bethesda (MD): National Institutes of Health; 1995 Apr. 21 p.

Outreach notebook for the NIH guidelines on inclusion of women and minorities as subjects in clinical research. Bethesda (MD): National Institutes of Health, 1994. 37 p.

Penslar RL. Protecting human research subjects: institutional review board guidebook [loose-leaf]. Rev., updated and expanded 2nd ed. Bethesda (MD): National Institutes of Health, Office of Protection from Research Risks; 1993. 1 vol.

Washington M, editor. Fetal research: a survey of state law. Washington: Library of Congress; 1988. 15 p. (CRS report for Congress; 88-198 A).
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## Source materials - guidelines for the protection of human subjects published by U.S. non-government organizations - Journal Articles

American Academy of Pediatrics. Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995 Feb;95(2):286-94.

American College of Clinical Pharmacy Research Affairs Committee. Subcommittee. Ethical issues related to clinical pharmacy research. [ACCP white paper]. Pharmacotherapy 1993 Sep-Oct;13(5):523-30.

American College of Clinical Pharmacy Task Force on Women's Health and Research Issues. Women as research subjects. [ACCP white paper]. Pharmacotherapy 1993 Sep-Oct;13(5):534-42.

American College of Emergency Physicians. Ethics manual. Ann Emerg Med 1991 Oct;20(10):1153-62.

American College of Obstetricians and Gynecologists. Committee on Ethics. Preembryo research: history, scientific background, and ethical considerations. ACOG Committee Opinion 136, Apr 1994. Int J Gynaecol Obstet 1994 Jun;45(3):291-301.

American Hospital Association. A patient's bill of rights [monograph on the Internet]. Chicago: The Association; c1992 [cited 1998 Sep 28]. [141 lines]. Available from: http://www.aha.org/resource/pbillofrights.html.

American Medical Association. Board of Trustees. Frozen pre-embryos [report]. JAMA 1990 May 9;263(18):2484-7.

American Medical Association, Council on Scientific Affairs and Council on Ethical and Judicial Affairs. Medical applications of fetal tissue transplantation. JAMA 1990 Jan 26;263(4):565-70.

American Public Health Association. Protecting confidential data in disease registries. [Policy statement 9515]. Am J Public Health 1996 Mar;86(3):443-4.

American Society of Human Genetics. ASHG report: statement on informed consent for genetic research. Am J Hum Genet 1996 Aug;59(2):471-4.

Beauchamp TL, Cook RR, Fayerweather WE, Raabe GK, Thar WE, Cowles SR, Spivey GH. Ethical guidelines for epidemiologists. J Clin Epidemiol 1990;44(1 Suppl):S151-S69.

Bernat JL, Beresford HR, American Academy of Neurology. The American Academy of Neurology Code of Professional Conduct. Neurology 1993 Jun;43(6):1257-60.

College on Problems of Drug Dependence. College on Problems of Drug Dependence policy on administering drugs with abuse potential in human research. IRB Rev Hum Subj Res 1996 Sep-Oct;18(5):5-7.

Emergency Nurses Association. Code of Ethics for Emergency Nurses With Interpretive Statements. J Emerg Nurs 1990 Nov-Dec;16(6):22A-4A.

Ethics manual. Fourth edition. American College of Physicians. Ann Intern Med 1998 Apr 1;128(7):576-94

Gidding SS, Camp D, Flanagan MH, Kowalski JA, Lingl LL, Silverman BL, Langman CB. A policy regarding research in healthy children. J Pediatr 1993 Dec;123(6):852-5.

International Committee of Medical Journal Editors. Protection of patients' rights to privacy [guidelines]. BMJ 1995 Nov 11;311(7015):1272.

National Council for Hospice and Specialist Palliative Care Services (Great Britain). Guidelines on research in palliative care [official statement]. Bull Med Ethics 1995 Aug;(110):19-20.

Nuremberg Military Tribunal. The Nuremberg code [reprint]. JAMA 1996 Nov 27;276(20):1691.
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## Source materials - guidelines for the protection of human subjects published by U.S. non-government organizations - Books

Addendum to the 1995 edition of the Principles of medical ethics: with annotations especially applicable to psychiatry. Washington: American Psychiatric Association; 1995. 11 p.

American College of Physicians, Ad Hoc Committee on Medical Ethics. American College of Physicians ethics manual. 2nd ed. Philadelphia: The College; 1989. Reprinted from Annals of Internal Medicine 1989; 111:245-52; 327-35.

American Medical Association, Council on Ethical and Judicial Affairs. Code of medical ethics, current opinions. Current opinions: including the principles of medical ethics, fundamental elements of the patient-physician relationship and rules of the Council on Ethical and Judicial Affairs. Chicago: American Medical Association; 1992.

American Medical Association, Council on Ethical and Judicial Affairs. Code of medical ethics. Reports of the Council on Ethical and Judicial Affairs of the American Medical Association. Chicago: The Association; 1992-.

American Medical Association, Council on Ethical and Judicial Affairs. Reports. Chicago: The Association; 1990. 1 vol. Loose-leaf binder; revised Jan 1990.

American Medical Association, Council on Ethical and Judicial Affairs, Southern Illinois University at Carbondale, School of Medicine, Southern Illinois University at Carbondale, School of Law. Code of medical ethics, current opinions with annotations. Current opinions with annotations: including the principles of medical ethics, fundamental elements of the patient-physician relationship and rules of the Council on Ethical and Judicial Affairs. Chicago: American Medical Association; 1994.

American Nurses' Association. Code for nurses: with interpretative statements. Kansas City (MO): The Association; 1985. 16 p.

Annas GJ. The rights of patients: the basic ACLU guide to patient rights. Carbondale (IL): Southern Illinois University Press; 1989.

Bird LP, Barlow J, editors. Codes of medical ethics, oaths, and prayers: an anthology. Richardson (TX): Christian Medical & Dental Society; 1989. 103 p.

Canter MB. Ethics for psychologists: a commentary on the APA ethics code. Washington: American Psychological Association; c1994. 254 p.

Code of medical ethics: current opinions with annotations. 1996-1997 edition. Chicago: American Medical Association, Council on Ethical and Judicial Affairs; 1996. 191 p.

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