Human Research Protection Program

The purpose of this SOP is to set forth the procedures to be followed by the Brandeis University Institutional Review Board in determining at what interval approved human subjects research being conducted under the auspices of Brandeis University should be reviewed.

This SOP applies to human subjects research projects conducted under the auspices of Brandeis University.

It is the standard operating procedure of Brandeis University that when determining the appropriate interval for continuing review of human subjects research conducted under its auspices and reviewed by the fully convened Institutional Review Board, IRB members consider such things as the degree of risk to subjects, the vulnerability of the subject population and the nature and novelty of the intervention.

Full-committee reviewed research may be determined to require annual or more frequent than annual review. The determination to review a study more often than annually can be made at any time and as a response to such things as modifications in the research, noncompliance by the researcher(s) or an occurrence of an unanticipated problem or adverse event.

The U.S. Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46) contains the following requirements involving the determination of the review schedule for approved protocols:

1. An institutional review board shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than one per year, except as described in § ___109(f). [§46.109(e)]

2. Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances: [§46.109(f)(1)]

   1. Research eligible for expedited review in accordance with §___.110.

   2. Research reviewed by the IRB in accordance with the limited IRB review described in §___.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8).

   3. Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:

      • Data analysis, including analysis of identifiable private information or identifiable biospecimens.

      • Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.