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The Organization requires compliance with DHHS 45 CFR 46.111(a)(1) and FDA 21 CFR 56.111(a)(1) regarding determinations that must be made by an IRB. The IRBs are required to consider whether risks to participants are minimized, in part, by using procedures consistent with sound research design. The JHM IRB review process will include an assessment of whether the research question asked in a proposed human participants research project is valid and whether the research design is sound and could yield the expected knowledge. Documentation of the determinations will be recorded for the record on the JHM IRB review sheet. The review requirement does not mean that the IRBs will perform a level of review comparable to the NIH peer review process.
The IRB will note in the review process whether outside scientific review has or has not been done. When the PI has a copy of the outside scientific review outcome, it is to be uploaded into the eIRB application. The meeting minutes shall state the entity that conducted an outside scientific review; and the minutes will document when the reviewing IRB members have the expertise required to perform the required review.
If an outside scientific review has not been performed and the reviewing IRB believes it does not have the expertise required to make the required determinations, the IRB will request outside scientific review by a consultant pursuant to Organization Policy 107.2.