The IRB applies federal regulations, its own IRB Policy Guide, and diligent reasoning to its proposal determinations. On some matters — such as the use of children as research subjects — existing policies are extensive and clear. Other matters require more proposal-specific analysis.
Every proposal is reviewed comprehensively and individually. For example, identical proposals might be submitted by a faculty member and a student. The faculty member’s proposal might be approved and the student’s proposal might be disapproved. In such a case, the IRB likely would have considered the experience and skills of the faculty researcher to be adequate and the student’s experience and skills to be inadequate.
Typically, a researcher will be informed about the reasons for not approving a proposal. Not approving a proposal could be made in several forms including: (1) returning the proposal for more information, (2) approving the proposal “with conditions” that must be met prior to final approval, and (3) disapproval. Any action disapproving a proposal should provide the researcher with written reasons for the proposal’s disapproval. Typically the board will vote on one of the above actions and direct the Chair to provide the written notice of action to the researcher. The Chair cannot — by federal regulation — use the expedited process to disapprove a proposal.
Only the full board can disapprove any research proposal. As stated in §46.110, “Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in §46.108(b).”