Brief Overview of Regulatory Basis of IRB Authority and Review Responsibilities

IRB Member Fact Sheet--Version Date: 4-9-2007

Introduction
Any institutions that receive federal support are required to provide a written assurance to the Office for Human Research Protections that describes how the institution will protect the rights and welfare of human subjects.  These assurances also include an agreement to follow the Common Rule.  In 1991, many federal agencies adopted Subpart A of 45 CFR Part 46, at which time the term “Common Rule” came into use.  The Department of Health and Human Services (DHHS) adopted requirements above and beyond Subpart A of the Common Rule to provide additional protections for fetuses, neonates and pregnant women (Subpart B, 45 CFR Part 46), prisoners (Subpart C, 45 CFR Part 46), and children (Subpart D, 45 CFR Part 46). 

Any institution that conducts human subjects research involving products regulated by the US Food and Drug Administration (FDA) also must follow the FDA regulations governing human subjects research.  Because the Health Sciences IRBs at the University of Wisconsin-Madison serve as the IRBs of record for research conducted at the Madison Veteran’s Administration (VA) hospital or by Madison VA researchers, the VA human subjects regulations also must be applied when research is conducted at VA or VA-approved facilities and/or conducted by VA researchers while on official VA duty time. 

These three sets of regulations – Common Rule, FDA, and VA – outline the authority and responsibilities of IRBs and are generally consistent in their descriptions.  The most detail is provided within the Common Rule, which is summarized below.  Special or additional requirements outlined in the VA regulations are also noted.

IRB Authority
The regulations describe the basis of IRB authority, which includes the authority to:
Under the VA regulations, the IRB also has the authority to conduct audits of recurring processes to be sure that all written procedures are followed, review research records and research case histories for compliance with written procedures and regulations contained in the VA Handbook; consider results of audits conducted by other entities within the institution.

Approval of Human Subjects Research
In order for an IRB to approve research under these regulations, the committee must determine that the following requirements are satisfied (outlined in more detail in a separate fact sheet), otherwise the research cannot be approved:
An IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB.

In addition, the VA regulations require IRBs to:
Continuing Review
IRBs are required to conduct continuing review of research at least once per year.
The IRB can require more frequent review appropriate to the degree of risk the protocol presents to subjects.

Communication with Researchers
The IRB is required to notify investigators and the institution in writing of its decision to approve or disapprove a proposed research activity, or of modifications required to obtain IRB approval of the research activity.  If the IRB disapproves a research activity, it is required to include in its written notification to the investigator a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.