Basic Criteria of IRB Review

In assessing the adequacy of human subjects’ protections in research, the IRB considers a number of basic criteria – specifically whether:

• risks to subjects are minimized;
• risks to subjects are reasonable in relation to anticipated benefits;
• selection of subjects is equitable;
• informed consent is sought from each prospective participant or legally authorized representative, and properly documented;
• adequate preparation is taken to protect the privacy and confidentiality of subjects; and
• adequate provisions are made for the ongoing monitoring of the subjects' welfare.

The assessment also includes additional factors important in the context of the individual proposal.

Note that once a study has been reviewed initially by a particular panel, every effort is made to send all subsequent correspondence and requests regarding that study back to the same panel, and even the same reviewer, for review. The original panel is most familiar with the research and can best assess new information in the context of the study as a whole.

Scientific Merit

In general, it is not the charge of the IRB to comment upon the scientific merit of proposals submitted for review except where merit cannot be established by another entity.

The exception, however, is where the scientific merit of the research, or lack thereof, increases either the risks to the subject (directly or indirectly) or the research burden to be borne by the subject. In such cases, the investigator may be referred to his/her advisor (in the case of a student) or to institutional experts for further guidance.