VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

7.

CRITERIA FOR IRB APPROVAL The VCOM IRB strictly follows DHHS’ “Common Rule.” In order to approve research covered by this policy, the IRB will determine that all of the following requirements are satisfied: 7.1. Risks “Minimal risk” (for human subjects other than prisoners) means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45CFR46.102(j)]. Risks should be considered in terms of both severity and probability and should not be understood to include only physical risks. In reviewing a study, the IRB should also evaluate emotional and psychological risks, potential insurability, as well as risks to professional or community standing. As an example, participants taking a drug use survey could face severe penalties in the workplace or in the community if confidentiality were breached, even though the survey does not present a physical or psychological risk. Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risks. Whenever appropriate, procedures should be used that are already being performed on the subjects for diagnostic or treatment purposes. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects. Furthermore, risks are reasonable in relation to the importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research (distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The VCOM IRB will not consider possible long-range effects of applying knowledge gained in the research as among those research risks that fall within the purview of its responsibility. 7.2. Benefits In considering the possible benefit to be derived from a particular study, the IRB should examine both direct benefit to potential participants in the study as well as the long-term societal benefits. The IRB is also charged with evaluating the scholarly merit of a project. Such an evaluation entails a peer review of the research proposal and its likelihood of producing results that are both distinctive and significant in a given field of study. Researchers who submit proposals deemed lacking in scholarly merit should be given feedback that will help the researcher to better define the scholarly significance of his or her project before resubmitting the proposal to the IRB. 7.3. Selection of Subjects In accordance with the Belmont principles, both the burdens and benefits of research should be distributed equally. Selection of subjects is one important means of ensuring this equity. In making this assessment, the IRB should consider the purposes of the research and the setting in which the research will be conducted. This includes reviewing any advertisements or other recruitment materials to ensure that they are not misleading to subjects. The IRB should be particularly cognizant of the special problems of research involving vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged children (see Section 17. Vulnerable Subjects ).

VCOM Institutional Review Board Policies and Procedures

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