The IRB meets on the third Tuesday of each month at noon.
To conduct official business a quorum of members must be present including at least one member whose expertise is in a non-scientific area. A quorum is a majority of the membership. If the quorum is not maintained throughout the meeting, e.g. because of departure of a member, then official action must be suspended until the quorum is re-established.
Membership is composed of sufficient members to provide for competent review of proposed research protocols. Ad hoc reviewers may be utilized to provide guidance to the Board in the event the necessary expertise for a particular study is not present in the membership. The ad hoc reviewer however, may not vote for, or against a study. All efforts will be made to establish appropriate racial and gender representation on the Board.
Members, including the Chair, are appointed by the Assistant Dean of Research of the UTGSM.
Protocols for review should be submitted through iMedRIS according to the posted deadlines in order to be placed on the agenda. This is to allow sufficient time for distribution to Board members, and for their review.
For a protocol to be approved, a majority of Board members must be present and eligible to vote.
Members of the IRB may not participate in the vote of any protocol in which they have a Confict of Interest.
Investigators are informed of the results of the Boards review. The following actions are possible:
This indicates the Board has no concerns regarding the proposed study, and the investigator may commence the study.
This indicates that the Board has no significant concerns requiring the proposed study, but does require slight modification. The investigator may not commence the study until the Chair has approved the changes, and issued a letter of full approval.
This action indicates the Board has more substantive issues regarding the proposed study. The study may not be commenced until the investigator has responded to the Board's issues, and the Board, in a convened meeting approves the protocol as amended and/or clarified.
This action indicates the Board has significant concerns regarding the proposed study, generally involving patient safety. The investigator will be given an explanation of the reasons behind the Board's action. The investigator may resubmit the proposal for another review if the investigator can modify the study, or present additional clarifying information.
Investigators may be invited on special occasion to attend a Board meeting, and thus assist in clarifying Board issues. The investigator must leave the room before the final Board discussion and vote. The study cannot commence until all issues have been resolved, and a letter of full approval issued.
More complex protocols may require direct and possibly extended interaction between investigator and the Board in order to facilitate protocol evaluation. In these instances, a sub-committee of Board members and possibly ad hoc experts may be convened to facilitate resolution of issues. Sub-committee action and/or recommendations are not final until voted and approved by the full Board. A sub-committee may also be called to review adverse events, non-compliance or other issues of importance to maintaining research subject safety.
The Board will rely upon the expertise of the radiation safety officer for the medical center, and in the case of radiopharmaceuticals upon the recommendation of the radioactive drug research committee.
Investigators must consult with these two resources before submitting protocols in this category to the IRB. In general, x-ray exposure of individuals must be performed under a physician's supervision, and by a technician trained and licensed to perform such procedures. It should be noted that x-ray exposure of children, even in trace levels such as is encountered with a DEXA machine requires submission of an IDE to the FDA.
Although administrative leaders may not approve a research protocol not approved by the IRB, administrative approval may be required in addition to IRB approval. An example of such a study would be one involving an approved pharmaceutical for its designated indications. Such studies have been considered "seeding studies." The IRB will review protocols which fall into this category, but will notify the VP of Clinical Affairs for the University of Tennessee Medical Center of the proposed study.
Many studies may also require significant levels of support from other staff and departments in order fully to execute the proposed study. Investigators must obtain collaboration forms from these supporting departments prior to submitting to the IRB.Top
Kimberly C Mason, PharmD
Kenneth M Bielak, MD
Vice Chair, IRB
Becky West, MS, CIP
Cindy Langley, RN, CIP
IRB Regulatory Specialist
The Institutional Review Board (IRB)
UTHSC Graduate School of Medicine
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1924 Alcoa Highway
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The University of Tennessee Graduate School of Medicine
1924 Alcoa Highway
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