Feasibility Guidance & Scientific Review

Feasibility Analysis

The purpose of Feasibility Analysis is to evaluate studies involving human subjects for feasibility. If required by your Division, Department, or Organization, PIs, Sub-Investigators, or Study Coordinators may conduct a Feasibility Analysis using the this Clinical Trial Feasibility Checklist (courtesy of UCLA) tool. For industry trials, you may complete the “Sponsor Expectations” section of the checklist and include any additional information as appropriate.

Scientific Review

Scientific or scholarly review is required before an Institutional Review Board (IRB) can approve a human research study, to ensure that the following regulatory criteria for approval of research are met. Regulations 45 CFR 46.111(a) and 21 CFR 56.111(a) are quoted below:

  1. “Risks to participants are minimized (i) By using procedures consistent with sound research design and which do not unnecessarily expose participants to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  2. Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.

In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies that subjects would receive even if not participating in the research.) The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall with the purview of this responsibility.”

For studies conducted at the Moores Cancer Center please refer to the Moores Cancer Center (MCC) Internal Protocol Review & Monitoring Committee (PRMC).

Last updated: 4 Mar 2019