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Sheet 12 — NIH INSTITUTIONAL REVIEW BOARD ADMINISTRATIVE PROCEDURES
- ESTABLISHMENT AND COMPOSITION OF NIH'S INSTITUTIONAL REVIEW BOARDS (IRBS)
All NIH IRBs are established and function in accord with the NIH Standard Operating Procedures for IRBs and NIH Manual Chapter 3014 titled “NIH Human Research Protection Program”.
Each IRB must be sufficiently qualified through the experience and expertise of its members, and the diversity of the members' backgrounds, to foster respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review and approve specific research activities, the IRB must be able to ascertain the acceptability of proposed research in light of
- ethical principles set forth in The Belmont Report,
- requirements of Federal regulations for the protection of human subjects (45 CFR 46),
- applicable Federal, state and local law, and
- standards of professional conduct and practice. (See OHSR Information Sheet #3 for a discussion of the criteria for IRB approval of research involving human subjects.)
IRB members and Chairs are appointed by the NIH Deputy Director for Intramural Research for one to three-year renewable terms, after having been nominated by their IC Clinical Director in consultation with the IC Scientific Director. Each Board must have at least five members, at least one of whom must not be affiliated with the Public Health Service and at least one whose primary interests are nonscientific. These two attributes may be combined in the same member. Each Board must also have a member with expertise as a statistician. NIH IRBs include a bioethicist from the Clinical Center Bioethics Program, and a representative from other Clinical Center Departments. An IRB may also utilize ad hoc reviewers in cases where additional or specialized expertise in protocol review would be of value to the Board in its deliberations. Ad hoc reviewers are not IRB members and do not vote on protocols.
- IRB MEETINGS
Each IRB Chair is responsible for setting agendas and calling convened meetings as often as required to accomplish the business of the IRB. The meetings are open to the public except for those discussions which the Chair determines deal with private or confidential information. Full Board actions require the presence of a quorum of the voting members, defined as a majority of the membership (i.e., fifty per cent plus one) including at least one member whose primary concerns are in nonscientific areas.
Principal Investigators (PIs) are expected to present new protocols at IRB meetings and to respond to questions from IRB members. PIs are excused from the meeting prior to the vote of the IRB. PIs are not necessarily expected to be present for the continuing review of protocols, although their presence may be required by the IRB Chair.
IRB meetings are conducted in accordance with Roberts Rules of Order. That is, at a minimum, the Chair conducts the meeting, there is a predetermined agenda, the minutes of the prior meeting are voted upon, and all actions and resolutions require the voice or show-of-hands vote of the members present following discussion and the making and seconding of a motion.
- IRB ACTIONS ON RESEARCH PROTOCOLS
An IRB may vote to approve, disapprove, or table a research protocol. These actions require the vote of a majority of the members present at the meeting (see 2. above). The Chair does not vote, except to break a tie. If the vote is not unanimous, the minority opinion must be recorded in or attached to the minutes when forwarded for final institutional review and approval. An IRB member may abstain from voting for any reason, without explanation. A member may change his/her vote until the time the vote is finally announced by the Chair. After that, a member's vote may be changed only by permission of the Board which may be given by general consent (see Roberts Rules of Order, Article VIII, Section 46).
An IRB may require that stipulations must be met before a protocol is approved. When the stipulations are minor in nature, i.e., they only require simple concurrence from the PI and do not require substantive judgment by the reviewer, the IRB may vote to authorize the IRB Chair (or a subcommittee) to approve the response to the stipulations. The IRB may also offer non-binding recommendations with its action to approve or table a protocol. PIs must respond in writing to IRB stipulations and recommendations on new protocols and continuing reviews within 30 days.
The Chair of an IRB, or a member(s) designated by the Chair may review and approve research which involves no more than minimal risk to subjects and in which the only involvement of human subjects will be in one or more of the categories in 45 CFR 46110 and in the NIH Standard Operating Procedures for IRBs, Attachment 5-8, found on the OHSR website at http://ohsr.od.nih.gov/. This expedited review procedure may also be used to review and approve minor changes in previously approved research during the period for which approval is authorized. In either event, the IRB Chair or member(s) conducting the review must inform the full IRB of research which has been approved by this procedure, and this information should be documented in the minutes.
Protocol changes or amendments may receive either expedited or full IRB review and approval depending on the nature of the amendment. Implementation of the amendment at the Clinical Center occurs only after an approval memorandum from the IRB Chair and IC Clinical Director has been included in the protocol file maintained by the Clinical Center Medical Record Department.
The Chair of an IRB may also be called upon to review and approve either the Premature Entry, Single Patient Exception, Compassionate Exception, or Emergency use IND application of an IRB-approved research protocol or drug for a single patient. Such actions, called Exceptions, are requested by the PI and must also be approved by the PI's Branch Chief, the IC Clinical Director, and the Associate Director for Quality Assurance and Hospital Epidemiology of the Clinical Center. Criteria for use of Exceptions are found in the Clinical Center's Medical Administrative Series issuance MAS 93-1. The full IRB must subsequently be informed of these Exceptions, which should also be documented in the minutes.
IRBs are authorized to modify, suspend or terminate approval of research that has been associated with unexpected serious harm to subjects, or is not being conducted in accordance with 45 CFR 46 or the IRB's decisions, conditions and requirements.
- FINALITY OF IRB ACTIONS
By Federal regulation, institutional officials may not approve research that has not been approved by an IRB. Consequently, NIH does not have an appeal procedure if a protocol is not approved by an IRB. PIs may request an IRB to reconsider a decision regarding a human subject research activity. However investigators do not have the option to seek the reversal of an IRB decision by submitting the same protocol to another NIH IRB.
- IRB MINUTES AND RECORDS (SEE ALSO OHSR INFORMATION SHEET #16)
The minutes of IRB meetings must be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining, including the reasons for any opposing vote (see 3. above); the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
Each IRB must maintain copies of protocols and consent documents that it has reviewed including continuing reviews; scientific evaluations, if any, that accompany protocols; minutes of its meetings; a current approved membership list; progress reports submitted by investigators; reports of injuries to subjects; copies of all correspondence between the IRB and investigators; statements of significant new findings provided to subjects; and documentation of collaborative and cooperative research activities occurring at other institutions with Federal Wide 0041ssurances, including documentation of protocol and consent form approval by the IRBs at these sites. Records and documents must be retained for at least three years after completion of the research.
Revised: 12/05/06
