The following description of the IRB review process reflects the various ethical principles and regulatory requirements that each investigator should consider during the design phase of their project. In order to approve a research project involving human subjects, the IRB must assure itself that (1) the prospective subject population is appropriate in terms of characteristics and number, (2) the recruitment of subjects is free of coercion, (3) the experimental design of the study is sound, (4) any risks associated with the research project are minimized to the greatest extent possible, (5) the potential benefits are maximized to the greatest extent possible, (6) the risks to the subject are outweighed or balanced by the potential benefits, (7) the level of subject compensation (if any) is fair and non-coercive, (8) the degree to which confidentiality is maintained is acceptable, (9) the method used to obtain informed consent is ethically and legally acceptable, and (10) the investigator has the appropriate qualifications, experience and facilities to conduct the research.
The IRB review process is not particularly concerned with the nature of a research topic. Providing the rights and welfare of the subjects are adequately protected and the protocol will be conducted in full compliance with HHS regulations, it does not matter what the research topic is or how controversial it is perceived to be. However, after IRB review and approval is obtained, it is possible that a research project could require an additional level of review. As per 45 CFR 46:112, research that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. Those officials cannot, however, approve any research project unless it is first approved by the IRB.
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