Institutional Review Boards are responsible for continuing review of ongoing research to ensure that the rights and welfare of human subjects are protected. FDA regulations require that continuing review of research be conducted at intervals appropriate to the degree of risk, but not less than once per year[21 CFR 56.108(a)(1) and 56.190(f)]. The frequency and extent of continuing review for each study will be adequate to ensure the rights and welfare of research subjects, and will be documented in the initial approval letter.
A letter of notification will be sent 45 days via receipt mail prior to the review being due if the board has not received your report 30 days prior another reminder will be sent out. “Failure to comply may result in suspension of IRB approval.”
The factors considered in setting the frequency of continuing review for any given study may include, but are not limited to:
- The nature of the study;
- The degree of risk involved;
- The vulnerability of the study subject population.
The purpose of continuing review is to review the progress of the entire study, not just changes in it. Continuing review of a study may not be conducted through an expedited review process.
CONTINUING REVIEW REQUIREMENTS:
The following documentation is required, when reporting to the IRB using the continuing review process.
- A copy of the informed consent document currently in use
- A written progress report from the clinical investigator, which includes the following information (see continuing review form included with this sheet).
- Number of subjects entered into the study;
- A summary description of subject experiences (benefits, adverse reactions);
- Numbers of withdrawals from the study;
- Reasons for withdrawals;
- The research results obtained thus far;
- A current risk-benefit assessment based on study results;
- Any new information since the IRB’s last review
When to report:
The following are the three instances when it is required and/or appropriate to report to the IRB using the continuing review process.
1.End of approval period: You will receive a reminder letter approximately one month prior to the end of the study’s approval period. You are required to submit a continuing review form along with the appropriate documentation to the IRB for review at their next meeting. For studies on the second or greater review, a $500.00 continuing review fee payable to International Cellular Medicine Society (ICMS). Failure to comply will result in expiration of IRB approval and closure of the study file for International Cellular Medicine Society.
2.Study completion: Upon completion of the study, you will be required to submit a final report to the IRB for review. The continuing review form may be used for this purpose.
3.Minor changes/update: The continuing review form may be used to inform the IRB of minor changes in ongoing previously approved research during the period for which approval is authorized.
The continuation of research after expiration of IRB approval is a violation of the regulations [21 CFR 56.103(a)]. If the IRB has not reviewed and approved a research study by the study’s current expiration date, i.e. IRB approval has expired research activities should stop. No new subjects may be enrolled in the study. By regulation, an IRB has the authority and the responsibility to take appropriate steps such as terminating or suspending approval of research that is not being conducted in accordance with the IRB’s requirements.
In the event of termination of the study the sponsor will also be notified.