Federal regulations require an Institutional Review Board (IRB) to have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. At UNTHSC, the IRB has 14 members on the roster ensuring a committee that is sufficiently qualified through experience and expertise of its members. Also, the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, assists in advice and counsel for the safeguarding of rights and welfare of human subjects. In other words, IRB members are informational jugglers. IRB members must not only use their expertise when evaluating the scientific aspects of human subject research but also have the ability to “see” the study through the subject’s point of view, all the while being keenly aware of the federal regulations and guidelines as well as the ethical principles essential for such review.
There are two types of review, as specified in the federal regulations, that can be conducted by an IRB: Expedited and Full Board.
The first, Expedited, is a review that may be carried out by the IRB Chairperson (or by one or more experienced IRB members designated by the Chairperson) for research deemed by the IRB Chair as expedited and that involves no more than minimal risk. In addition, minor protocol modifications to an already approved protocol may be handled at this Expedited review level. Submission of this type of review for minor changes (minimal risk) and expedited protocols are managed on a “rolling admission” manner which can be handled as the projects come to the attention of the Board.
However, for those studies involving more than minimal risk, or which cannot be properly reviewed under Expedited procedures, such review must be conducted by a convened IRB (for a so-called Full Board review). Federal regulations require a convened Board to review “greater than minimal risk” protocols, protocol amendments, or modifications to such protocols. Further, the convened IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year. It is important to note that even minimal risk studies may be subject to full board review if regulations specify for more extensive review and monitoring (i.e. prisoner’s research) or if the chair deems it appropriate for that project.
The frequency of IRB meetings vary among institutions according to workload volume and availability of reviewers (Board members). At UNTHSC, the IRB meets the first Tuesday of every month in CBH 260 starting at 2:00 pm and continuing until all business is concluded for that meeting, usually 2 ½ – 3 hours later.
The protocol submission deadline (for complete application packet/kit) is the third Monday of the month (usually 2 weeks) prior to the meeting – see schedule. This allows sufficient time for OReC human research protection coordinators, who staff and support the functions of the IRB, to prepare the protocols for full board IRB review and for proper pre-review by IRB members. Prior to the IRB meeting, board members invest extensive time reviewing the protocols, consent forms, and research-related documents for careful consideration and to maximize efficiency during the convened meeting.
Regulations specify a majority of the registered board members (a quorum) must be present to conduct a legal meeting. At each meeting, the IRB Chair leads the discussion of the minutes from the previous meeting, followed by a summary report describing the previous month’s non-Full Board activities (i.e. exempt category reviews, expedited reviews, continuing reviews, minor modifications to protocols, serious adverse event management, outreach and educational activities, etc.). Then, the Board conducts new business: continuing review of full board protocols, final reports of closed studies, initial review (or re-review) of new protocols and amendments/modifications to protocol requiring a convened Board. When carrying out each review, IRB members consider:
- risk/benefit analysis,
- informed consent
- subject selection
- privacy and confidentiality
- costs to subject
- withdrawal from study
- scientific merit
- conflict of interest
- compliance with federal regulations, state laws and institutional policy
- risk determination
For each protocol or amendment reviewed, there is a Board determination resulting in a Board Action:
- Approval with no protocol modifications
- Approval contingent on Minor changes; protocol assigned to IRB chair for final review and determination
- Defer or “Tabled” (insufficient or inappropriate information to make a determination or approval)
- Disapprove (cannot be conducted as designed)
Notice of board determination is provided in writing to the principal investigator through a Board Action notice along with IRB guidance for modifications, if needed. It is the responsibility of the investigator to follow up and address board findings or stipulations. Investigators will not be able to initiate the research protocol until IRB requested modifications have been reviewed and IRB approval received.
In the event that the IRB disapproves or defers a protocol, the principal investigator may appeal the decision to the IRB by way of explanation or clarification of the disputed elements of the protocol. However, according to federal regulations (and UNTHSC policy and procedures), only the IRB can revisit or reconsider a disapproval or deferral. No other individual or office can alter an IRB non-approval of a research protocol involving human subjects.
If you have any questions regarding IRB review, please call 817-735-0409 for further assistance.