563. Continuing Reviews, Expedited

Updated March 4, 2021

Continuing review of research must occur at intervals appropriate to the degree of risk, but not less than once a year. A qualified IRB member is assigned to complete continuing reviews using expedited procedures. Research Integrity staff may assign additional reviewers or a consultant if additional expertise is required (for more information, see reviewer assignment in the online HRPP Policy Manual).

Protocols that require ongoing continuing reviews must be approved before the approval 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.

Studies initially approved by Expedited or Full Committee Review under the pre-2018 Requirements

Continuing reviews for projects initially approved by expedited procedures are also completed by Expedited Review. Continuing reviews for projects initially approved by Full Committee Review may be completed by expedited procedures under specific circumstances (see Categories of Research that May Be Reviewed through an Expedited Review Procedure, categories 8(a), 8(b), 8(c) or 9).

Studies initially approved by Expedited Review under the 2018 Requirements

Studies initially approved by Expedited Review will receive continuing review by expedited procedures if

• The project is regulated by the Food & Drug Administration (FDA) or another sponsor that requires continuing review; or
• The IRB reviewer requests and justifies a need for ongoing expedited review.

Some circumstances that may trigger the continuing review requirement include:

• The research targets vulnerable populations, including those with a mental health diagnosis or self-reported suicidal ideation or past suicide attempts;
• The study populations are deemed to be at risk of physical or mental harm, or breach of confidentiality;
• The research involves collection of sensitive information such as substance abuse, criminal behavior, or mental health data;
• The project involves additional regulatory oversight, such as conflict of interest management;
• The investigator has had previous serious noncompliance or a pattern of non-serious noncompliance.

For studies initially approved by Expedited Review that do not require continuing review, investigators must submit an annual progress report. The initial IRB protocol approval letter will specify whether the project requires a continuing review by expedited procedures or an annual progress report. Progress reports are administratively reviewed by Research Integrity staff to monitor project status.

Studies initially approved by Full Committee Review under the 2018 Requirements

Under specific circumstances, studies initially approved by Full Committee Review may receive continuing review by expedited procedures (see Categories of Research that May Be Reviewed through an Expedited Review Procedure, categories, 8(b) or 9).

When projects initially approved by Full Committee Review reach the stage of data analysis, including analysis of identifiable private information or identifiable biospecimens, or accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care, researchers will submit the continuing review/progress report form with the applicable project status. These projects will no longer receive expedited continuing review but will receive administrative review. The IRB will confirm the type of report (continuing review or progress report) and level of review going forward in the outcome letter based upon the research status reported in the continuing review/progress report form.

Continuing Review Materials

As specified in the IRB policy for submission requirements for continuing review by expedited procedures, 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 current status of the project; information about recent literature, interim findings, serious adverse events, problems, complaints, and amendments that occurred during the approval period; participant enrollment and withdrawal numbers; and a current assessment of risks and benefits based on study results.

Considerations for Continuing Review

In addition to determining whether the research continues to meet the regulatory criteria for approval and additional requirements under Subparts B, C, and D, or from other federal agencies, the Expedited Reviewer 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 serious or continuing noncompliance or information provided suggest 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; and
• withdrawal numbers and reasons suggest there may be concerns associated with conduct of the research or the frequency or severity of risks.

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

Possible Expedited Review Actions for Continuing Reviews

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 for Expedited Continuing Reviews

During the continuing review, the Expedited Reviewer assesses the approved project documents and information in the status report. The reviewer determines the established approval period continues to be reasonable or should be adjusted and documents her/his decision in IRBNet.

For research subject to FDA regulations:

• The reviewer must determine which clinical investigations require review more than annually.
• The reviewer 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 reviewer 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.