Continuing Review / Progress Report

Regulation:

Office for Human Research Protections: An IRB shall conduct continuing review of research “at intervals appropriate to the degree of risk, but NOT LESS THAN ONCE PER YEAR.” 45 Code of Federal Regulation 46.109(e) [emphasis added]

Regulatory Interpretation Issued by OHRP:

“The regulations make no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval. . . .

If the IRB does not re-approve research by the specified expiration date, subject accrual should be suspended pending re-approval of the research by the IRB, (Enrollment of new subjects cannot ordinarily occur after the expiration of IRB approval.) Continuation of research interventions or interactions in already enrolled subjects should only continue where the IRB finds that it is in the best interests of individual subjects to do so.” [emphasis added]

Source: OHRP Compliance Activities: Common Findings and Guidance – 9/1/2000 (Compliance Oversight Branch Division of Human Subjects Protection, OHRP)

Further interpretation appeared in a letter to the University of Oklahoma Health Sciences Center, Michael Carome, M.D., OHRP Director, Division of Compliance Oversight in a letter dated October 19, 2000:

“Please note that when continuing review does not occur by the date specified by the IRB, IRB approval expires automatically.” [emphasis in original]

Food and Drug Administration: An IRB shall conduct continuing review of research “at intervals appropriate to the degree of risk, but NOT LESS THAN ONCE PER YEAR.” 21 Code of Federal Regulations 56.109(e) [emphasis added]

Regulatory Interpretation Issued by FDA:

“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. However, if the investigator is actively pursuing renewal with the IRB and the IRB believes that an over-riding safety concern or ethical issue is involved, the IRB may permit the study to continue for the brief time required to complete the review process.
When study approval is terminated by the IRB, in addition to stopping all research activities, any subjects currently participating should be notified that the study has been terminated. Procedures for withdrawal of enrolled subjects should consider the rights and welfare of subjects. If follow-up of subjects for safety reasons is permitted/required by the IRB, the subjects should be so informed and any adverse events/outcomes should be reported to the IRB and the sponsor.“ [emphasis added]
Source: Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators (1998 Update, Food and Drug Administration)

 


 

Primary teaching affiliate
of BU School of Medicine