Possible Mechanisms for Scientific Review
Academic-based research: A separate, internal committee with requisite expertise (such as departmental or GCRC [General Clinical Research Center] unit); a subcommittee of the Research ERB, perhaps augmented with others from the institution with appropriate expertise; external committees of experts (i.e., federal peer review mechanisms). Outside expert consultants should always be considered as a resource to remove the perception or the reality of conflicts of interest and to ensure a sound scientific review. Funding for scientific review should be assumed by the academic institution, which should also include auditing of the scientific review process within its overall quality assurance (QA) activities. Written assurance of the scientific review should be provided to the Research ERB.
Industry-sponsored research (for FDA-regulated products): Company Protocol Review Committee independent of the author(s) of the research protocol; applicable FDA Review Division. Both should provide written assurances to the Research ERB.
Privately sponsored research (not for FDA-regulated products): Protocol Review Committee (e.g., leaders in the applicable field) independent of the author of the research protocol and external to the research sponsor. The committee should provide written assurance to the Research ERB. May be funded by the research sponsor, but should operate at arm’s length and according to a charter.
Federally funded research (NIH or equivalent): Protocol Review Committee independent of the author of the research protocol. Written assurance to the Research ERB should be provided (such as grant “pink sheets”). May be funded by the research sponsor, but should operate at arm’s length and according to a charter. NIH or equivalent agency should have an audit mechanism to verify adequacy of the scientific review process.
Locally sponsored research (e.g., a university department using unrestricted grants): Departmental Protocol Review Committee independent of the author of the research protocol. Written assurance should be provided to the Research ERB. Should be subject to audit by institutional-level body.