Source: http://www.newschool.edu/leadership/provost/irb/policies/
Timestamp: 2014-07-24 03:48:43
Document Index: 278501569

Matched Legal Cases: ['art 46', '§46', '§46', '§46', '§46', '§46', '§46', '§46']

Leadership :: Provost's Office :: For Faculty :: Institutional Review Board :: Policies & Procedures on Research Involving Human Subjects
New School > Leadership > Provost's Office > For Faculty > Institutional Review Board > Policies & Procedures on Research Involving Human Subjects
Application to Human Subjects Review Committee PDF
Abbreviated Application (Short Form) PDF
The New School Institutional Review Board Frequently Asked Questions
The New School Institutional Review Board Frequently Asked Questions for Class Projects
Sample 4 PDF Human Subjects [+]
Statement of Ethical Responsibility for Research Involving Human Subjects
New School faculty and staff engaged in research or supervising student research projects must be aware of their responsibilities for ethical conduct in any project involving the use of human subjects. Faculty and staff are responsible for research done by students under their supervision with respect to these matters. Each research design must be examined for possible risk to subjects. If even minor risk of physical, psychological, sociological or other harm may be involved, the faculty or staff member must consult with the University Institutional Review Board (IRB) to determine that:
Legally effective informed consent will be obtained by adequate and appropriate methods in accordance with the provisions of this part; and
The conduct of the activity will be reviewed at timely intervals and no less than once per year.
In addition to questions of risk and informed consent, the subjects rights of privacy must be protected.
If a faculty or staff member has any doubts regarding the ethics of a project or steps taken to protect human subjects, he/she should refer them to the IRB. In any case, the IRB should be informed of all research projects involving human subjects.
The New School University Institutional Review Board (IRB) is the official oversight committee for the protection of human subjects in research. It functions under a Multiple Project Assurance (MPA-1445) granted by the Office for Protection from Research Risks (OPRR) of the Department of Health and Human Services (DHHS).
The IRB reviews each applicable research proposal and related materials, including informed consent documents. The IRB has the responsibility and authority to approve, require modification of, or disapprove any research activity involving human subjects. Research protocols will be reviewed not less than every 12 months and perhaps more frequently if required by the IRB on the basis of degree of risk to subjects, amendments made to the protocol, or adverse events reported.
IRB review and approval are independent of the initial endorsement by the institutional official of the extramural research proposal.
Dr. Marcel Kinsbourne is the IRB Chair. Students should contact IRB@newschool.edu with their applications.
Consent Procedures [+]
General Requirements For Informed Consent*
(45 CFR ß46.116)
Except as provided elsewhere in 45 CFR 46, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subjects' legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subjects' legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
(8) a statement that participation is voluntary, refusal to participate will involve no penalty of loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
(2) anticipated circumstances under which the subjects' participation may be terminated by the investigator without regard to the subject's consent;
(4) the consequences of a subjects' decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) a statement that significant new findings developed during the course of the research which may relate to the subjects' willingness to continue participation will be provided to the subject; and
(6) the approximate number of subjects involved in the study. Documentation of Informed Consent (45 CFR ß46.117)
(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subjects' legally authorized representative. A copy shall be given to the person signing the form.
(1) A written document that embodies the elements of informed consent required by ß46.116. This form may be read to the subject or the subjects' legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
(2) A short form written consent document stating that the elements of informed consent required by ß46.116 have been presented orally to the subject or the subjects' legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
Modification of Informed Consent Procedures [+]
Modifications of any of the informed consent procedures must be approved by the IRB in the minutes signed by the Chair. Granting of permission to use modified procedures imposes additional responsibility upon the IRB and the University to establish that the risk to any subject is minimal, that use of either of the informed consent procedures would invalidate objectives of considerable immediate importance, and that any reasonable alternative means for attaining these objectives would be less advantageous to the subject.Guidelines for Preparing an Informed Consent Form [+]
An informed consent form requires a fair and proper explanation of all of the basic elements of informed consent listed in (a)(1)-(a)(8) above. When appropriate, elements from (b)(1)-(b)(6) should also be included. The order of explanations or the use of words should be adapted to the nature of each study and subject.
In addition, the agreement of consent, written or oral, should include no exculpatory language through which the subject is made to waive or appear to waive his/her legal rights or release the institution or appear to release the institution or its agents from liability for negligence.
The name and telephone number of the project director should be clearly indicated on the consent form as should the name and telephone number of Dr. Marcel Kinsbourne, Chair, Human Subjects Committee, 212-229-5727 Ext. 3103, for questions about research subjects' rights and for research-related injuries and complaints.
A statement that the subject has been given a copy of the consent form to keep should also be included. The form should include an authorization section, for example:
I, the undersigned, have understood the above explanation and give consent to my voluntary participation in
(Dr./Mr./Ms.)_______________________________ research project.
Date________________ Location_____________
________________________________________Signature of subject
________________________________________Signature of legal representative (if applicable)
________________________________________Signature of person obtaining consent
________________________________________Signature of witness (if applicable) * Source: Protection of Human Subjects,
Title 45, Code of Federal Regualtions, Part 46. Revised June
IRB Submission [+]
Instructions and Application for Submitting Research Proposals to the Institutional Review Board
The IRB is chaired by Dr. Marcel Kinsbourne, Professor, Psychology at The New School for Social Research. Please contact him with any questions and to submit the IRB Application.
Professor, Psychology Chair,
New School Institutional Review Board
80 Fifth Avenue, Room 731
212-229-5727 Ext. 3103kinsboum@newschool.edu
Informed Consent Checklist to HRP [+]
An explanation of the purposes of the research The expected duration of the subject's participation
A description of the procedures to be followed Identification of any procedures which are experimental
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
( ) Research Questions
( ) Rights Questions
( ) Injury Questions
A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject The approximate number of subjects involved in the study
§46.117
Documentation of Informed Consent Checklist a. Except as provided in paragraph "c" of this section, informed consent shall be documented by the use of a written consent form approved by the IRB, and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
1. A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.
2. A short form written consent document, stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
WAIVER of req't for signed formc.
The IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405. Where research is covered by §46.406 and §46.407, and permission is to be obtained from parents, both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
OHRP Tips on Informed Consent OHRP [+]
Use of the first person (e.g., "I understand that ...") can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject. Use of scientific jargon and legalese is not appropriate. Think of the document primarily as a teaching tool not as a legal instrument. Describe the overall experience that will be encountered. Explain the research activity, how it is experimental (e.g., a new drug, extra tests, separate research records, or nonstandard means of management, such as flipping a coin for random assignment or other design issues). Inform the human subjects of the reasonably foreseeable harms, discomforts, inconvenience and risks that are associated with the research activity. If additional risks are identified during the course of the research, the consent process and documentation will require revisions to inform subjects as they are re-contacted or newly contacted.
The regulations provide for the identification of contact persons who would be knowledgeable to answer questions of subjects about the research, rights as a research subject, and research-related injuries. These three areas must be explicitly stated and addressed in the consent process and documentation.
Furthermore, a single person is not likely to be appropriate to answer questions in all areas. This is because of potential conflicts of interest or the appearance of such. Questions about the research are frequently best answered by the investigator(s). However, questions about the rights of research subjects or research-related injuries (where applicable) may best be referred to those not on the research team. These questions could be addressed to the IRB, an ombudsman, an ethics committee, or other informed administrative body. Therefore, each consent document can be expected to have at least two names with local telephone numbers for contacts to answer questions in these specified areas.
Don't forget to ensure provision for appropriate additional requirements which concern consent. Some of these requirements can be found in sections 46.116(b), 46.205(a)(2), 46.207(b), 46.208(b), 46.209(d), 46.305(a)(5-6), 46.408(c), and 46.409(b). The IRB may impose additional requirements that are not specifically listed in the regulations to ensure that adequate information is presented in accordance with institutional policy and local law. Revised 3/16/93