562. Continuing Reviews, Full Committee

Updated March 4, 2021

The University IRB uses a primary reviewer system for Full Committee Review (see reviewer assignment in the online Human Research Protection Policy (HRPP) Manual).

Continuing reviews for projects initially approved by Full Committee Review are also reviewed by the convened IRB unless the continuing review is eligible for review by expedited procedures. Research Integrity staff, a designated Expedited Reviewer, or the IRB Chair assess continuing review packages to determine eligibility for Expedited Review under categories 8(a), 8(b), 8(c), or 9 as specified by DHHS (see Categories of Research that May Be Reviewed Through an Expedited Review Procedure).

Continuing reviews must be approved before the expiration date; if not, all research activities (including participant enrollment) must cease unless the IRB determines continuation of a research intervention or interaction is in the best interest of enrolled participants.

Continuing Review Materials

As specified in the HRPP online Policy Manual (see submission requirements for continuing review by Full Committee Review), investigators requesting continuing review must submit a continuing review form and routine (or benign) safety reports not previously reported to the IRB.

The continuing review form asks for information about:

• The number of participants accrued.
• A summary since the last IRB review of:
  • Adverse events and adverse outcomes experienced by participants.
  • Unanticipated problems involving risks to participants or others.
  • Participant withdrawals.
  • The reasons for withdrawals.
  • Complaints about the research.
  • Amendments or modifications.
  • Any relevant recent literature.
  • Any interim findings.
  • Any relevant multi-center trial reports.
• The researcher’s current risk-potential benefit assessment based on study results.

The Primary Reviewer comprehensively reviews the materials submitted in the continuing review package, previous versions of any newly amended documents if necessary, and other relevant approved project documents in IRBNet (or those flagged by RI staff) and completes the relevant review worksheets. All other IRB members (including alternate members) voting during the meeting are expected to review the same materials as the primary reviewer.

The Primary Reviewer conducts a comprehensive review of the materials in the project/package in IRBNet and completes the relevant review worksheets. IRB members (including alternate members) attending the meeting are expected to review the same materials: 

• The full protocol, application, or a protocol summary containing the relevant information to determine whether the proposed research fulfills the criteria for approval.
• Current consent document.
• Continuing review form

See the online HRPP Policy Manual for more information about review materials and worksheets.

Considerations for Continuing Review

In addition to determining if the research continues to meet the regulatory criteria for approval and additional requirements under Subparts B, C, or D, or from other federal agencies, the IRB must determine if

• the current consent document is still accurate and complete;
• information from the continuing review suggests there may be changes to participants’ willingness to continue participation;
• any significant new findings that arise from the review process and that might relate to participants’ willingness to continue participation will be provided to participants;
• verification is required from sources other than the investigators that no material changes occurred since the previous IRB review (e.g., PI has previous IRB determinations of serious or continuing noncompliance, or information provided suggests unapproved changes may have occurred);
• enrollment numbers are consistent with the expected number of participants as noted in the Part II application or suggest enrollment-related matters may affect participant safety; or
• withdrawal numbers and reasons suggest there may be concerns associated with conduct of the research or the frequency or severity of risks.

Primary Reviewer Presentation

During the convened meeting, the Primary Reviewer summarizes the research and the materials provided in the continuing review package. The Primary Reviewer also presents salient factors, questions, and concerns about the project or status report. The reviewer’s comments may come from her/his review of materials submitted with the continuing review package, approved project documents, or both.

If the assigned Primary Reviewer is unexpectedly absent from the meeting, at the discretion of the Chair a written commentary from the Primary Reviewer may be submitted and presented for discussion, or another IRB member who is present at the meeting may assume the responsibilities of the Primary Reviewer if the Chair determines the member has the requisite knowledge and expertise and is sufficiently familiar with the materials submitted for review.

See the online HRPP Policy Manual for information about reviewer recommendations and documentation.

Possible IRB Actions for Continuing Review

The range of possible actions for continuing reviews include Approved, Approved with Conditions, or Deferred (as described in IRB policy IRB Actions).

When continuing reviews culminate in an action other than Approved, the possibility exists for IRB approval to expire before the requested revisions are reviewed and approved. In this case, the investigator would be required to cease all research activities until the IRB reviews and approves the study.

Determining Approval Periods at Continuing Review

In determining the approval period at continuing review, the IRB again considers the expected type, frequency, and severity of participant risks and the reasonableness of risks in relation to benefits, but also considers information presented during the continuing review. The IRB may determine the previously specified approval period should continue (whether one year or a shorter period), a shorter approval period is no longer necessary, or a shorter approval period is now warranted.

For research subject to FDA regulations:

• The IRB must determine which clinical investigations require review more than annually.
• The IRB must determine which clinical investigations need verification from sources other than the clinical investigator that no material changes in the research have occurred since the previous IRB review. The IRB should consider:
  1. The nature of and any risks posed by the clinical investigation.
  2. The degree of uncertainty regarding the risks involved.
  3. The vulnerability of the participants.
  4. The experience of the clinical investigator in conducting clinical research.
  5. The IRB’s previous experience with that researcher or sponsor (e.g., compliance history, previous problems with the researcher obtaining informed consent, prior complaints from participants about the researcher).
  6. The projected rate of enrollment.
  7. Whether the study involves novel therapies.

Actions that Must Occur if IRB Approval Expires

Continuing reviews must be approved before the expiration date; if not, all research activities (including participant enrollment) must cease unless it is determined that continuation of a research intervention or interaction is in the best interest of enrolled participants or the project.

If an investigator does not provide continuing review information to the IRB or the IRB has not approved a continuing review package by the expiration date, the IRB informs the researcher that all research activities must stop including but not limited to, enrollment of new participants and continuation of research interventions or interactions with currently enrolled participants, and data analysis.

If enrolled participants may be harmed by stopping study procedures, the PI must submit justification and explanation for which study procedures, some, or all, need to continue uninterrupted.