FULL BOARD CATEGORY REVIEW
At UNTHSC ALL research projects involving human subjects require a priori review by the Office for the Protection of Human Subjects (OPHS), and if required, by the Institutional Review Board (IRB). Note that this review process may involve several stages or levels of review, depending on the various features of the research project and the potential risk to the subjects.
What is Full Board Category Review?
All other studies that cannot be reviewed and approved at an EXEMPT or EXPEDITED level, must be reviewed by a convened meeting of the IRB (so-called "Full Board review"). For such reviews, each member of the IRB must have the appropriate amount of time available to review all relevant information needed for an effective review in accordance with federal regulations. Thus, a Full Board review requires additional time and resources for review.
As with other categories, a Full Board review is initially conducted by an OPHS staff member and then verified by the IRB Chair who then presents the pre-reviewed protocol to the Board at a convened meeting. In addition, Board members receive a copy of all relevant protocol materials (synopsis, consent forms, associated recruiting materials, questionnaires, case report forms, etc.) well before the convened meeting in order for them to preview materials for a more efficient use of time at the meeting.
Although not required, it is recommended that investigators contact OPHS well before submitting a protocol for full Board review. If time is available, OPHS staff can provide a "pre-review" of the protocol to identify any issues or concerns that might come up during a Board meeting, especially with complex, unusual or higher risk research projects. Again, this assistance is often helpful to new investigators, or researchers expanding into a new area, but is only effective if enough advance time is provided.
In all cases, whether a project may be thought of as Exempt, Expedited or Full Board category, investigators are advised to contact an OPHS staff member, or consult with the website, for guidance and assistance in developing protocols for submission and review.
What are the Criteria for Full Board Review?
The following are some conditions that define studies under Full Board level of review.
1. Studies that cannot be reviewed and approved at an EXEMPT or EXPEDITED REVIEW level
Some studies that are "minimal risk" may qualify for EXEMPT category status. These studies have features and procedures that are specifically described by the federal regulations as "exempt" from IRB review. [Click here for descriptions and definitions of what research qualifies as an "exempt" category project].
Recall that, at UNTHSC, all research projects involving human subjects must be reviewed by the OPHS to determine if they are truly "exempt" or if they must be reviewed by the IRB. This EXEMPT category of review is conducted by OPHS staff and verified by the Director of OPHS.
Other studies that are "minimal risk", but that do not meet the strict criteria for EXEMPT category must be reviewed by the IRB.
However, the regulations allow for such minimal-risk studies to be reviewed at an "expedited" level, in which only the IRB Chair, or an IRB member designated by the Chair, may review and approve the project. Federal regulations allow for such reviews for a wide-range of specifically defined studies with certain features. [Click here for descriptions and definitions of what research can be reviewed at an "Expedited" level].
As with Exempt category projects, an Expedited review is initially conducted by an OPHS staff member and then verified by the Director of OPHS. However, at this level, the IRB Chair (or IRB member designee) must also review and approve the project.
2. Studies which have been determined by IRB Chairperson to be MORE THAN MINIMAL RISK
Federal regulations define "minimal risk" as:
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
45 CFR 46. 102 (i)
Therefore, determination of "more than minimal risk" becomes a judgment call for the IRB who must carefully assess study procedures and its effects on subject risk. At UNTHSC, risk to subject assessment is initially evaluated by OPHS Director and staff. If the OPHS Director decides that a project is "more than minimal risk", it is then sent to the IRB chairperson for further assessment and prepared for Full Board Review for final determination.
3. Studies involving elements, procedures or interventions that require additional provisions or safeguards, as stated by federal regulations and guidance.
- Vulnerable or certain Special Subject Populations (e.g., children, prisoners, incapacitated subjects, etc.)
- Studies taking place in foreign countries particularly those with little or no provisions for protection of human subjects in which the procedures pose more than minimal risk to subjects
- Studies where information may be disclosed that could require reporting, e.g., child or elder abuse, illegal activities, etc.
- Deception studies/studies that are more than minimal risk
What are some examples of studies that would receive Full Board Review?
- All sponsored and non-sponsored-driven Clinical Trials (investigational drug or device) subject to FDA regulations.
- A study investigating the usefulness (observational validity) of a survey developed by the Principal Investigator in detecting the effects of drug X on multiple features of hot flashes.
- Research involves collecting brain tissue to study neurodegenerative disorders such as Alzheimer's disease (AD).
- A study investigating the prevalence of depressive symptoms among pregnant adolescent women.
- A study examining the association between exposure to contaminated flood waters, massive crowding, and lack of potable water and H. pylori infection in children who evacuated a Hurricane zone.
How do I submit a new Full Board Review Research Project? Investigators seeking Full Board review complete and sign an IRB Application Form, and attach all appropriate documents relevant to that particular protocol well in time for review at the next meeting. IRB meeting schedule and deadline dates are listed elsewhere on this website. Please submit all protocols to the Office for the Protection of Human Subjects located in CBH Suite 160 during business hours (8 am - 5 pm). Note that investigators must submit the appropriate amount of hard-copies for proper IRB review. No E-versions of research-related documents will be accepted.
New IRB Full Board Protocol: (1) Signed Original of the IRB New Protocol Application (2) Twenty (20) Copies of the following documents: (3) Four (4) Copies of the following documents: (4) One (1) Copy of the following documents: How (and When) Will I know that a Protocol or Amendment has been Approved?
Once a protocol has been reviewed and approved, a formal written notice of approval will be sent to the Principal Investigator. A written "Board Action" will be sent to the Principal, Investigator as soon as possible after the convened IRB meeting, describing the Board's findings and determination, along with description of the needed changes (if any). In most cases, this notice will be sent within 48 hrs of the convened meeting. If the protocol is APPROVED "as is": If the protocol was APPROVED "as is", the Principal Investigator will receive a Board Action notice from the IRB Chair specifying the terms and conditions of the approval, as well as the continuing review period (6 months, 12 months). The project is then ready for initiation. If the protocol was Approved (but contingent on minor modifications): In some cases, the Board, during its review, may require changes or clarifications to elements of a protocol, consent document, or other project related materials. This happens when the protocol is APPROVED contingent on specific minor modifications. The Principal Investigator makes the necessary changes and re-submits the revised protocol for subsequent review by the IRB Chair. If all changes are appropriate, the IRB Chair may then Approve the protocol as previously authorized by the convened Board that had contingently approved the protocol. If the protocol was DEFERRED (requiring substantive modifications): In other cases, the Board, during its review, may require significant or numerous changes or clarifications to elements of a protocol, consent document, or other project related materials. Under these circumstances, the protocol cannot be approved, even on a contingent basis. The protocol is "tabled" or Deferred for major revision and re- submission to the Full Board. This happens when significant or numerous changes are required for the consent form, or the protocol itself, to address issues of risk, scientific merit, safety and clarity for the subjects likely to be involved in a project. For DEFERRED protocols, the Principal Investigator makes the necessary changes and re-submits the revised protocol for subsequent review. In this case, however, the review must be conducted by a convened IRB, and not only the IRB Chair. For that reason, investigators are strongly encouraged to appropriately respond to the Board Action notice specifying needed changes, and be able to submit a properly corrected protocol application in time for the next IRB meeting deadline. Investigators are also encouraged to seek additional guidance from the OPHS staff managing that protocol to assist them in preparation of an appropriate and timely re-submission to avoid subsequent deferrals or delays.
Who receives these IRB Board Action Notices / Letters of Approval?
The Principal Investigator of record is responsible for all aspects of a research protocol involving human subjects, and is the person who will receive formal correspondence from OPHS and/or the IRB.
The principal investigator may designate, in writing, other project personnel to receive copies of such notices or correspondence, and such designation should be sent directly to the IRB for inclusion in the protocol folder. However, the principal investigator is still fully responsible for acting on such correspondence from OPHS and/or the IRB.