Purpose of the IRB
- Will the risks be outweighed by the benefits to the subject and the knowledge to be gained from the study?
- Will the rights and welfare of subjects be adequately protected?
- Will legally effective, informed consent be secured from subjects?
- Will ethically appropriate, informed consent be secured from subjects?
- Will the protocol meet all standards established by the federal government and University guidelines, including those pertaining to special populations such as minors, pregnant women, and prisoners?
NOTE: In reviewing proposals, the IRB will utilize federal statutes contained in 45 CFR 46.111, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 (Criteria for IRB approval of research). If procedures included in a proposal are deemed to be inconsistent with sound research design or if a proposal appears to be so scientifically flawed that no valid conclusions can be reached, then the IRB will consider rejection of the proposal based on poor risk/benefit ratio for the potential subjects and the academic institution.