Brief Overview of Regulatory Basis of IRB Authority and Review Responsibilities
IRB Member Fact Sheet--Version Date: 4-9-2007
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.
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.
- Approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.
- Observe or have a third party observe the consent process and the research.
- Suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
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.
- Risks to subjects are minimized
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result
- Selection of subjects is equitable
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative, except in certain circumstances
- Informed consent will be appropriately documented, except in certain circumstances
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, the IRB must ensure that additional safeguards have been included in the study to protect the rights and welfare of these subjects
In addition, the VA regulations require IRBs to:
- review and approve the consent form and ensure the HIPAA Privacy Rule language is within the VA consent forms
- ensure that steps to manage, reduce or eliminate potential or real conflicts of interest (financial, role (investigator/patient relationships), and/or institutional) have been taken
- determine that the principal investigator and all other investigators of the proposed research activity have met all current educational requirements for the protection of human research subjects outlined in the VA regulations
- determine that the investigator(s) is qualified through education, training, and experience to conduct the research
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.