Types of Review
Submissions Requiring Review
As IRB members, you will be asked to review different types of submissions:
New Studies (Initial Submissions)
- Definition: First-time submissions of research protocols for IRB review and approval.
- IRB Role: Evaluate whether the study meets regulatory criteria for approval, including risk-benefit analysis, informed consent, and safeguards for research subjects.
- Member Expectation: Carefully review the protocol, consent documents, and supporting materials to determine level of risk and whether the study is approvable under federal regulations. Contact the investigator, when necessary to provide counsel and ask additional clarification.
Expedited Review
- Definition: Minimal-risk research eligible for review through one of nine federal expedited categories.
- IRB Role: Reviewed by the IRB Chair or a designated experienced reviewer; no full board review required.
- Member Expectation: Assigned to at least one member with the appropriate expertise, using the reviewer’s checklists. Feedback is due within 10 business days.
Full Board Review
- Definition: Research involving greater than minimal risk, vulnerable populations, or sensitive or complex new topics.
- IRB Role: Reviewed at convened meetings with quorum; discussion and formal vote required.
- Member Expectation: Review and provide feedback on all studies listed on the agenda before the meeting. Participate actively in meetings, contribute disciplinary expertise, and vote on study determinations.
Modifications (Amendments)
- Definition: Proposed changes to previously approved studies, such as procedures, study team members, or consent forms.
- IRB Role: Assessed to determine whether the change is still in line with the approved study objectives, affects risk, consent, or participant protections.
- Member Expectation: Review and assess the impact of proposed changes, comparing the approved study to the proposed changes; determine whether re-consent is needed or if the proposal needs to be submitted as a new study.
Continuing Review
- Definition: Periodic review of ongoing research (at least annually for full board studies or as required).
- IRB Role: Ensure research continues to meet approval criteria and that no new risks have emerged.
- Member Expectation: Start with the working presumption that the research, as previously approved, does satisfy all criteria for approval.
- Focus on whether there is any new information provided by the investigator, or otherwise available to the IRB, that would alter the IRB’s prior determinations, particularly with respect to the IRB’s prior evaluation of the potential benefits or risks to the subjects.
- Assess whether there is any new information that would necessitate revision of the protocol and/or the informed consent document.
- If you determine that the protocol no longer meets criteria for approval, provide feedback on changes that would result in research satisfying these criteria, table, or disapprove the research.
Reportable Events
- Definition: Includes unanticipated problems, serious or continuing noncompliance, or protocol deviations.
- IRB Role: Assess whether corrective actions or reporting to federal agencies is required.
- Member Expectation: Evaluate the nature and seriousness of the event and recommend appropriate follow-up.
Levels of Review
Research submissions are reviewed as Exempt, Expedited, or Full Board, depending on the level of risk involved. The review level is determined by comparing the study’s risk to the federal definition of minimal risk.
Exempt Review
University policy require researchers to submit their studies for IRB review and final determination by the IRB. Key information about exempt research studies:
- Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations.
- Studies that qualify for exemption must be submitted to the IRB for review before starting the research.
- Investigators do not make their own determination as to whether a research study qualifies for an exemption — the IRB issues exemption determinations.
- The application in OneAegis uses smart logic for exempt studies; there is no separate application.
- Although there are eight HHS exempt category regulations, BYU has opted to implement six of those categories at this time.
- Studies that qualify for an exemption do not undergo continuing review and are processed by trained HRPP staff.
- Exemptions do not apply to research with prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners. [45 CFR 46.104(b)(2)].
- Exemption 2(iii) and Exemption 3 do not apply to research with children.
Expedited Review
Federal regulations (45 CFR 46.110) authorize the use of an expedited review process for:
- Minimal risk human subjects research that meets one or more of the OHRP Expedited Review Categories
- Minor IRB Amendments approved by the full board
- Applications qualifying for expedited review are accepted and reviewed on a continuing basis.
Expediting reviewers are experienced IRB members appointed to the role by the IRB Chair or designee. The expediting reviewer has the authority to make a determination or to refer a submission for full board review for multiple purposes (e.g., clarification, expertise), including in cases of disapproval. Only the full board has the authority to disapprove a study.
Note: Categories one (1) through seven (7) pertain to both initial and continuing IRB review. Categories eight (8) and nine (9) pertain only to continuing IRB review.
Full Board Review
Federal regulations and institutional policy require an IRB Full Board Review for applications where the research involves more than minimal risk to human subjects or has been referred to the committee by an expedited reviewer or the Chair. Regardless of risk level, BYU IRB may require full board review when the research involves:
- Vulnerable populations, particularly prisoners
- Sensitive topics, including illegal behaviors which may require an NIH Certificate of Confidentiality [CoC] to protect subject data from compelled disclosure
- Research involving genetic testing
- A complex research design requiring the expertise of multiple board members to evaluate
Applications requiring full board review are required to submit by the 10th of the month to be reviewed for the next month’s meeting, the first Thursday of the month. Please refer to the IRB calendar.
IRB Administrator assigns submissions to a primary and secondary IRB reviewer for presentation at the full board meeting. At the conclusion of the meeting, the board votes and issues a determination.
Overview of IRB Review Process
Screening: The IRB assigns an analyst to follow each individual submission from initial submission to final approval. This analyst conducts an administrative pre-review screening to ensure the submission is complete before forwarding it to IRB reviewers. When the submission is complete and meets basic submission standards (inclusion of recruitment and consent documents and correct sections of the application completed, applicable pre-submission approvals like SRC, student committee reviews), the analyst will assign the submission to IRB reviewer(s). Although the analyst may try to clarify major issues with the PI before the meeting, the analyst does not conduct an initial review for expedited and full board studies.
IRB Administrator triage: The IRB Administrator categorizes submissions as Exempt, Expedited, and Full board review.
Exempt
a. Review is complete in the HRPP office, rarely sent to IRB members for review.
b. Turnaround time 3-5 days.Expedited
a. Assigned to one to two IRB members that are experts in the area.
b. Reviewers are given 10 business days to complete their assignments in OneAegis.Full Board
a. Every 1st Thursdays of the month 3-6 pm.
b. Turnaround time is 4-6 weeks.
c. We are required to meet quorum--which is at least half the total full members plus 1—in order to hold a meeting.
d. Research involving special groups [children (required), prisoners (required), pregnant women, special minority groups, institutionalized etc.] should consult with an advocate.
e. You may be asked to serve on a subcommittee for studies that require post-meeting consultation.
Notes for Reviewers
- If there is a conflict of interest (family, academic review committee, your own student) please let the office know ASAP so we can reassign the protocol.
- If you leave town for a period of time AND cannot complete reviews via electronic submission, please let the office know so we can reassign the protocol.
- Problems with an application: If you feel that the research cannot be approved, contact the IRB administrator—the protocol will need to be discussed at the full board meeting. It takes only one reviewer to send it to full board meeting.
- Community rep and Non-Scientist should be part of the meeting.
- Non-Scientist must be a part of the quorum or forfeit meeting.
IRB Member Review Process: Review assigned studies in depth according to information in the IRB Reviewer’s Checklist and the IRB Member Reviewer’s Guide. Specifically, members should:
- Apply the criteria required by federal regulations for IRB approval of a human research study and the appropriate regulatory determinations (i.e., for inclusion of children in research, the inclusion of pregnant women, neonates and fetuses in research, the inclusion of prisoners in research, criteria for waiving and/or altering consent.
- If possible, contact investigator before a meeting to clarify major issues that could result in a return if left unanswered.
- Put comments in OneAegis Note Section. See below for details about this process.
When reviewing the study, the IRB reviewers will be asked to identify any outstanding issues that must be addressed by the PI prior to approval. IRB requests for changes or additional information should be clearly related to one or more of the federal criteria for approval of human research studies or to achieve compliance with State regulations and/or University policies. If there are no outstanding issues, the reviewers should indicate that the submission can be approved.
Post-Review Stipulations: If the IRB reviewers identify issues that need to be addressed prior to approval, the HRPP staff will draft post-review stipulations and send them to the PI. (Note: The staff may forward the stipulations to the IRB Chair or other reviewer(s) before sending them to the PI to ensure accuracy.)
After the PI responds and the response is complete, the HRPP staff will forward the response to either the full committee or the designated IRB reviewer(s), as applicable. If the reviewer(s) find the response acceptable, and the study meets the federal criteria required for IRB approval of a human research study, the IRB will approve the submission. If the response is not adequate, the HRPP staff will send additional stipulations to the PI and approve the submission only after the response is deemed acceptable by the reviewer(s).