April 2008 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 study design appears to be appropriate. This regulatory requirement does not mean that the IRBs will perform a level of review comparable to the NIH peer review process. Many applications sent to the JHM IRBs have had prior scientific review by one of the following entities: - NIH Study Section
- FDA Review Committee
- Company Protocol Review Committee, independent of the investigators, for industry-sponsored protocols
- Protocol Review Subcommittee of the GCRC
- Clinical Research Committee of the Sidney Kimmel Comprehensive Cancer Center
- JHUSOM Clinician Scientist Award Review Committee
- JHUSOM Institutional Grants Review Projects Committee
- Departmental Review Committee
The JHM IRBs may consider such prior reviews to affirm in the review process that the research design is sound. If outside scientific review has not been done and the reviewing IRB members have the expertise required to review a study, the IRB will be responsible for the scientific review. If outside scientific review has not been done and the reviewing IRB believes it does not have the expertise required to understand the background, aims, and research methods proposed, the IRB will request outside scientific review by a consultant prior to taking action on a project. The consultant shall be outside the IRB but may be within the Institution. Prospective consultants may not have any conflicts of interest, personal or financial, with the study, investigator, or sponsor. (See JHM IRB Policy 107.2). The consultant’s response will be available to the IRB during final deliberations on the study. The IRB’s determination of scientific merit will be documented on the review sheet.
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