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