HRPP policies & procedures manual

403: Continuing review

1. Purpose

The purpose of this policy is to describe the procedure for the renewal of approved research at the expiration of the IRB approval period.

2. Policy

The IRB conducts continuing review (renewal) of research taking place within its jurisdiction at intervals appropriate to the degree of risk, but not less than once per year including:

  • Research that remains active for long-term follow-up of subjects, even when research is permanently closed to enrollment of new subjects and all subjects have completed all research-related interventions.
  • The remaining research activities include collection or analysis of private identifiable data.

3. Specific policies

3.1 Interval for review for continuing review

The IRB reviews all active expedited and full-board applications at least annually. The IRB may determine the frequency of the review based on the nature and/or risk of the research. In general, continuing reviews are conducted at the level of the initial review, but the review level can be changed as necessary to conform to the risk level, law and policy. In order to ensure continuing reviews are substantive and meaningful, the IRB members designated as the primary and/or secondary (and tertiary) reviewers will receive the continuing review form, consent form, as well as the full application (background material containing previously approved protocol and/or activities) and any additional information that is necessary. Any IRB member who is not a designated reviewer can receive a complete application packet upon request. All material is available to all members via SharePoint.

Approved applications determined to present more than minimal risk category can be reviewed under expedited review category where:

  • The research is permanently closed to the enrollment of new subjects; and
  • All subjects have completed all research-related interventions; and
  • The research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis.

Research activities that were originally reviewed using expedited criteria may receive continuing review on an expedited basis, unless the research activities no longer meet the expedited criteria for review and approval (e.g., risk has changed to be greater than minimal).

3.4 Possible outcomes of continuing review

As an outcome of continuing review, the IRB may authorize continuation of the research, require that the research be modified, or that it be suspended or terminated.

Appropriate continuing review intervals are addressed with each review conducted by the IRB. Factors taken into consideration when determining the appropriate review interval include, but are not limited to, the following:

  • Involvement of vulnerable populations
  • Involvement of recombinant DNA or other types of gene transfer protocols
  • Use of waiver of informed consent procedures
  • Classified research
  • Research for which subjects would be exposed to additional risks, e.g., breach of confidentiality, phase I studies, disproportionate number or severity of adverse events
  • Previous suspensions of the research due to compliance, record-keeping, or other concerns

Any changes required to obtain continued renewal approval shall be provided to the investigators by the IRB staff.

3.5 Date of continuing review approval

The expiration date of the protocol will be determined by the date the protocol is approved by the convened IRB.  If the study is reviewed by expedited review, the expiration date will be determined by the date the study is approved.

3.6 Expiration and extensions of approval period

Generally there is no grace period extending the conduct of the research beyond the expiration date of IRB approval. Extensions beyond the expiration date will not be granted. However, if there is a lapse due to an investigator error or IRB office, the IRB office may consider options on how to proceed with the continuing review. The investigators will be informed to stop the study completely till the decision has been taken.  Otherwise, if a continuing review form is not received as scheduled, the IRB approval will expire and the investigator must stop all research procedures, screening, recruitment, enrollment, interventions, advertisements, consent, interactions, and collection of private identifiable data.

Investigators who believe that currently enrolled subjects will be at risk if the research project is discontinued must immediately submit to the IRB chair a list of subjects for whom suspension of the research would cause harm.  The IRB chair, or an experienced IRB member designated by the chair, will determine whether it is in the best interest of individual subjects to continue to take part in the research interventions or interactions.

At the discretion of the reviewers, the matter might be brought to a convened meeting. However, new subjects CANNOT be enrolled. Prospective research data cannot be collected, and no procedures that are only being performed for the purpose of the protocol may be performed.

Research activity that is carried out after failure to obtain renewal of an approved study in the required time frame may be considered serious non-compliance, and may be reported to the appropriate institutional officials and regulatory authorities when applicable.

4. Applicable regulations and guidelines

21 CFR 56.108, 56.111

45 CFR 46.111

Office for Human Research Protections (OHRP) Guidance on Continuing Review, 2010

5. Forms

Continuing review request

6. Procedures employed to implement this policy & assignment of responsibility

IRB coordinator Generate and e-mails correspondence notification letters and continuing review forms.

Review the report and associated materials to determine the status of continuation of the study. Full-board studies will be put on the next meeting agenda.

Assign expedited studies to reviewers. Notify the investigator of the outcome of the review.
Member(s)Review continuations.