INTRODUCTION TO CATEGORIES OF IRB REVIEW
| Exempt Review |
| Expedited Review |
| Full Board Review |
| Continuing Review |
| Protocol Amendments |
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.
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.
By providing complete and accurate information along with the Exempt Category Review form, investigator's can obtain effective review and approval within a few days (often sooner).
All EXEMPT category projects are then reported to the full IRB at their next convened meeting for their acceptance and approval as Exempt category projects.
Note that EXEMPT category projects do not need continuing IRB review and do not need any annual reporting (see below for brief overview of Continuing Review).
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. By providing complete and accurate information along with the Expedited Category Review form, investigators can obtain an effective and timely review and approval within a few days, depending on the complexity of the project and proper documentation provided by the investigator. An incomplete application or protocol with concerns that need to be addressed will extend the time period before final approval can be authorized.
All EXPEDITED category projects are then reported to the full IRB at their next convened meeting for their acceptance and approval as Expedited category projects. However, because of the increased level of risk and complexity that might be involved with such projects, any IRB member, at any time, can ask that a protocol which was approved on an Expedited basis be brought back to the full IRB for further review and consideration at the next convened meeting.
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 pre-review 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.
Investigators seeking Full Board review complete and sign an IRB Application Form, and attach all appropriate documents relevant to that particular protocol (see Application for specific guidance and instructions) well in time for review at the next meeting. IRB meeting schedule and deadline dates are listed elsewhere on this website.
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.
CONTINUING REVIEW (Progress Reports)
Ongoing Project
Once an Expedited or Full Board protocol is approved, the approval period extends for not more than one year (as specified by federal regulations). Some projects may be approved for a shorter time period, perhaps 6 or 9 months, depending upon risks or procedures associated with the study. In any case, the approval period will be stated on the initial approval letter and investigators are encouraged to mark this date. Although OPHS will send out courtesy reminder letters several weeks in advance of the expiration date, it is the investigator's responsibility to file a Progress Report for continuing review of the project in a timely manner (click here for the appropriate form and instructions).
If a Progress Report is not filed with OPHS for IRB continuing review, the approval period will expire, the protocol will be suspended, and the lapse in approval caused by the investigator's non-compliance will need to be reported to the sponsor/funding agency as well as appropriate federal authorities.
The continuing review process follows a format similar to initial review. Expedited Review have their continuing review conducted on an Expedited basis; Full Board protocols needs to have continuing review conducted by the Full Board. As with initial review, allow plenty of time to prepare a Progress Report for an effective review before the protocol approval period expires.
Completed Project
If the project is essentially complete, and all subject interactions and follow-ups are done during the approval period, then the Progress Report becomes a "Final Report". Using the same form (check the box for Final Report), investigators submit the same information as for a continuing review, with some minor exceptions.
For more details and instructions on Progress reports / Final reports, see the guidance section on "Continuing Review".
EXEMPT category projects do not need continuing IRB review and do not need any annual reporting.
AMENDMENTS to a Research Project
IRB review and approval only applies to those project documents and procedures that were reviewed and approved. Any change in any document or procedure must have IRB review and approval before it can be implemented. The exception: when a change is immediately essential for the safety of subjects. And even in those cases, it must still be reported as soon as possible afterwards to the IRB for a needed change in protocol and/or consent form.
Many modifications entail minimal risk adjustments to a protocol and/or consent form and can be made on an Expedited basis (via the IRB Chair). Some examples are format changes, correcting spelling errors, adding key personnel, minor changes to questionnaires, recruiting ad changes, and so forth. Other, more substantive changes, especially those that alter the risk-benefit ratio, may require Full Board review and approval. In all cases, except where noted above regarding subject safety, any changes to any protocol document or procedure must first be approved by the IRB before they can be implemented. For more details on protocol amendment procedures, click here.
Note that these modification requirements also apply to EXEMPT category projects. Any change in a project approved as Exempt category must be reviewed beforehand by OPHS staff.
This review is essential to determine if the change has altered the level of review and whether or not IRB review might be involved as a result of the modification. As usual, contact OPHS personnel if you have any questions.