Miller, FG; Brody, H. “What Makes Placebo-Controlled Trial Unethical?” American Journal of Bioethics 2.2 (2002): 3-9. 9 September 2013. Temple, R; Ellenberg, SS. “Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues.” Annals of Internal Medicine 133.6 (2000): 455-463. 9 September 2013. World Medical Association (WMA). “Declaration of Helsinki.” WMA. 9 September 2013. ←Essential Element 2: → Standard of Care London, AJ. “The Ambiguity and the Exigency: Clarifying ‘Standard of Care’ Arguments in International Research.” Journal of Medicine and Philosophy 25.4 (2000): 379–397. 9 September 2013. Wendler, D; Emanuel, EJ; and Lie, RK. “The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries’ Health Needs?” American Journal of Public Health 94.6 (2004): 923-928. 9 September 2013. Gu, S. “The Ethics of Placebo-Controlled Studies on Perinatal HIV Transmission and Its Treatment in the Developing World.” Penn Bioethics Journal 2.2 (2006): 21-24. 9 September 2013. ←Essential Element 2: → Essential Element 3: Choice of Study Design Examples Statements indicating that the ethical impact of the chosen study design has been considered: The ethics section should not repeat what is discussed in other sections of the protocol. The details of the design and the scientific rationale for the choice of each of the design elements should have been well explained elsewhere. However, because of the central importance of scientific validity as the basis for ethical soundness, it may be useful to introduce the ethical section with a statement summarizing and recognizing that the authors believe it is scientifically valid. The following examples in an ethical section acknowledge what should be completely supported in the rest of the protocol. “The study has been carefully designed to collect the data needed to reach its objective while enrolling the lowest possible number of subjects.”
The procedures in many studies will involve only minimal risks such as drawing blood. Taking large volumes of blood or blood sampling in children will need justification in the protocol and mention of why this is acceptable in the ethics section. Other procedures may be more invasive such as tissue biopsies, lumbar punctures, or excessive exposure to multiple x-rays or CAT scans. These should be appropriate and acceptable. ←Essential Element 5: → Non-physical harm: Risks can also involve non-physical harm, such as breach of confidentiality and privacy, damage to reputation, monetary harm, legal risk, loss of insurance coverage, emotional stress, genetics issues such as paternity, and discrimination. Information might be published that could stigmatize a group or expose its members to discrimination. For example, the information gained from a study could indicate, rightly or wrongly, that the group has a higher than average prevalence of alcoholism, mental illness or sexually transmitted disease, or is particularly susceptible to certain genetic disorders. There may be risks to family members from knowledge gained in genetics studies. Benefits Potential benefits to the individual subject: Ethically, considerations for the well-being of the subject should take precedence over the interests of science and society (CIOMS 2002, Declaration of Helsinki 2000, para 5). If there is lack of potential benefit, this should be stated. Benefits to subjects might include positive response to the study intervention (both products and procedures), additional medical care and oversight, possibility of life-style modifications (e.g., programs for diabetes or obesity), coverage of costs of additional medical care, payment for participation, or post-study continued access to study interventions. Potential benefits to others including the community and society: Knowledge: The knowledge that results from a study and the application of that knowledge may benefit society. The kinds of knowledge may be the resolution of a safety issue or the proof that a new mechanism of action is relevant in a hard-to-treat disease. In spite of societal benefit, there may be some risks to the individual that are too great to support conducting the study, so how the balance is achieved is properly discussed in the ethical section.
←Essential Element 11: → Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (2011) See p. 56-70 9 September 2013 Presidential Commission for the of Bioethical Issues, “Appendix III: US Treatment/Compensation for Treatment Methods” in Moral Science: Protecting Participants in Human Subjects Research (2011): Web 9 September 2013 Presidential Commission for the Study of Bioethical Issues, “Appendix IV: International and Transnational Requirements for Treatment and Compensation for Research Injuries” in Moral Science: Protecting Participants in Human Subjects Research (2011): 186-190 9 September 2013 President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Compensating for Research Injuries. (1982) 9 September 2013 South African Department of Health, Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa. (2000) See Section 4.11 (Second Edition, 2006) 5 November 2014. Medical Association (WMA). “Declaration of Helsinki.” WMA. 9 September 2013 Additional Resources Beh, Hazel. “Compensation for Research Injuries.” IRB: Ethics & Human Research 27.3 (2005): 11-15 9 September 2013. Capron, Alexander M. “When Experiments Go Wrong: The US Perspective.” Journal of Clinical Ethics 15.1 (2004): 22-29. 9 September 2013. Guest, Stephen. “Compensation for Subjects of Medical Research: The Moral Rights of Patients and the Power of Research Ethics Committees.” Journal of Medical Ethics 23.3 (1997): 181-185. 9 September 2013. Mariner, Wendy K., “Compensation for Research Injuries,” in Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. Vol. 2 (Anna C. Mastroianni et al. eds., 1994). 5 November 2014.
←Essential Element 11: → Paasche-Orlow, Michael K, Brancati, Frederick L. “Assessment of Medical School Institutional Review Board Policies Regarding Compensation of Subjects for Research-Related Injury.” 118.2 American Journal of Medicine (2005): 178-180. 9 September 2013. Pike, Elizabeth. “Recovering from Research: A Proposal to Compensate Injured Research Participants.” American Journal of Law and Medicine 38.1 (2012): 7-62. 9 September 2013. Resnik, David B. “Compensation for Research-Related Injuries, Ethical and Legal Issues.” Journal of Legal Medicine 27.3 (2006): 263-287. 9 September 2013. Scott, Larry D. “Research-Related Injury: Problems and Solutions.” Journal of Law, Medicine, and Ethics 31.3 (2003): 419-428. 9 September 2013. Steinbrook, Robert. “Compensation for Injured Research Subjects.” New England Journal of Medicine 354.18 (2006): 1871-1873. 5 November 2014. ←Essential Element 11: →