IRB Guidelines

Section IV: Criteria for IRB Approval of Research

In order to consider approval of applications for human subjects research, the IRB must determine that all of the following requirements are satisfied:

A. Risks to subjects must be minimized by:

• Using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk.
• Using procedures already being performed on the subjects for other purposes, whenever this opportunity exists.

B. Risks to subjects must be reasonable in relation to potential benefits to subjects and to the importance of the knowledge that may reasonably be expected to result. In this regard, evaluation shall include only those risks and benefits, which may result from the research itself, and not to risks and benefits, which subjects would receive even if not participating in the research.

C. Selection of subjects must be equitable, and take into account the purposes of the research, the setting in which it will be conducted, and the population from which subjects will be recruited.

D. Appropriate measures must be taken to obtain and document the informed prior consent of the subject, or the subject's legally authorized representative, to participate in the research. See Section VIII.

E. Where appropriate, the research plan must include adequate provisions for monitoring data collection to ensure safety of the subjects.

F. Adequate provisions must be made for monitoring data collection to ensure safety of subjects and to protect their privacy by maintaining anonymity or confidentiality of the data.

• In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the researcher obtains the express permission of the subject to do otherwise. All instruments and procedures must be carefully designed to limit personal information to only that which is essential for the research. Data that could reveal a subject's identity should be stored in files which are accessible only to the project researcher and authorized staff.
• The data on subjects should be coded to remove all personal identifying information.
• When research protocols use audio and video taping of research subjects, subjects should always be told that taping will occur. Explicit consent must be obtained for any public use of the tapes such as use in the classroom or as part of a public presentation of the research results, since this constitutes a waiver of the normal confidentiality of research data.
• There have been instances in which the identities of subjects or research data have been sought by law enforcement agencies. This includes some studies, which involve collection of data on sensitive matters such as sexual behavior or criminal activities. Under federal law, researchers can obtain a Certificate of Confidentiality that will provide some protection against subpoenas of research data.

G. Where subjects are potentially vulnerable to coercion or undue influence, appropriate additional safeguards must be included in the study to protect the rights and welfare of these subjects. Such subjects include persons with acute or severe physical or mental illness, and persons who are economically or educationally disadvantaged.