The IRB Process

Meetings

The IRB meets regularly on the third Tuesday of each month at 2:30 p.m. Called meetings may occur at any time in response to needs as determined by the chair. Special meetings may be called if the number of protocols to be reviewed exceeds the time and ability of the Board to evaluate them at regularly scheduled meetings. Meetings may also be called by the chair because of issues related to timeliness of reviews, patient safety concerns, compliance issues, request from a board member, etc.

For a meeting 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.

The Board will be 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.

In the event of special protocols involving prisoners and other protected groups, opinions will be sought from knowledgeable representatives and/or spokesperson for that group as to the appropriateness of the proposed study.

Members, including the chair, are appointed by the chancellor of the University of Tennessee Health Sciences Center based in Memphis. As indicated in the preamble to these guidelines, the IRB is intended to assist the investigator in the task of providing appropriate safety to human participants. Therefore if the investigator has concerns regarding any aspect of the IRB approval procedure the investigator is encouraged to discuss the protocol with the IRB chair prior to submission, and thus receive guidance in the application preparation.

Protocol Submission

Protocols for review should be submitted to the IRB office 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.

The IRB operates in a primary reviewer mode, which means one or two Board members are provided the full protocol for review. Reviewers are expected to provide a written critique of the proposal, which is presented to the Board at the meeting after which the protocol is open to discussion.

Members who are not given primary review responsibilities are provided at least with a summary of the proposed research in sufficient detail to allow evaluation of the study. A complete copy of the informed consent is provided to all Board members. Vote: For a protocol to be approved a majority of Board members present and eligible to vote most vote approval.

Conflict of Interest

Members of the IRB may not participate in the vote of any protocol in which they are principal or co-investigators. In addition, because of the for-profit nature of the in-house clinical trials programs, board members who would normally share in any program profits are required to forego any such profits.

Board Action

Within ten business days following each meeting, investigators are informed of the results of the Boards review. The following actions are possible:

Approved

This indicates the Board has no concerns regarding the proposed study, and the investigator may commence the study.

Approved with Administrative Proviso

This indicates that the Board has no significant concerns requiring the proposed study, but does require some slight modification. If the investigator accepts the modification, e.g. wording in the informed consent, additional routing signature, etc., the chair is authorized to accept the modification. The investigator may not commence the study until the chair has accepted the response, and issued a letter of full approval.

Deferred

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.

Disapproved

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 even present additional clarifying information.

Investigators are not generally invited to attend Board meetings to present their position, because of the finite amount of time available for the Board to complete its agenda. Since this is a local guideline, and not a rule, 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.

Duration of Approval

In no instance may a study be approved for more than 12 months. In select instances, the Board may choose to approve a study for less than 12 months. Examples of issues leading to such a decision would be: Boards unfamiliarity with off-campus site to administer research program, concern over safety issues prompting early review at a specified time, or after a limited number of participants have been enrolled, etc.

All studies terminate 12 months after Board approval, unless renewed.

Continuing Review

Although the IRB office generally sends out reminders to investigators of impending anniversaries for approved protocols, it is the exclusive responsibility of the investigator to submit applications for continuing review.

Approval for projects is limited to one year, unless a more limited approval is specified in the original review. The renewal form is available and must be completed by the investigator petitioning for continued approval. The completed form must be accompanied by a copy of the current informed consent for the project in question.

Amendments and Revisions

Frequently in the course of a research study, new information will become available which requires modifications in an approved research protocol. Such amendments, including the informed consent document must be submitted to the IRB for review and approval prior to implementation. An exception to this requirement would be a modification designed to prevent harmful effects to participants. In this instance, change may be immediately implemented and the IRB notified promptly thereafter.

Termination of a Study

At the completion of a study, the investigator is required to submit a form to the IRB informing that body of the action, and any significant findings.

Special Sub-committees

It is possible that from time to time 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.

Research Involving Radioactive Agents or X-rays

This IRB is authorized by the State of Tennessee to review for the purposes of approval research at this center, which involves exposure of humans to radioactive agents or x-rays.

In virtually all instances, 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 are encouraged to 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 require submission of an IDE to the FDA.

Additional Approvals

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 UT Hospital of the proposed study.

Many studies may also require significant levels of support or collaboration from other staff and departments in order fully to execute the proposed study. Two such departments, which may be impacted, are the Departments of Pathology and Nursing Service. Investigators are encouraged to secure agreement for support from these departments prior to submitting to the IRB. Forms are available to facilitate documentation of support.