Approval is not the end of our relationship. Once a project has been approved by an IRB, there is a continued obligation to that IRB until the end of the study. This obligation includes stipulations built into the approval letter that are designed to ensure subject safety during the course of the study, and sometimes extending beyond study close-out. This information is reviewed at the time of continuing review.
Failure to adhere to the stipulations of approval may result in the suspension or termination of enrollment and/or IRB approval for conduct of the study.
E&I’s Stipulations of Approval – found at the end of approval letters – reads:
- No subjects may be involved in any study procedure prior to the IRB approval date or after the expiration date. Investigators and sponsors are responsible for initiating Continuing Review proceedings.
- All protocol modifications must be IRB approved prior to implementation. This includes any addition or change of recruitment materials, change of investigator, or performance site address. (Exception: If necessary to eliminate apparent immediate hazard to subjects.)
- Report to E&I within five working days of learning if any of the following occur: – Unanticipated problems involving risk to human subjects or others; – Unanticipated Serious Adverse Events and Safety Reports; – Protocol deviations, violations, and exceptions that impact subject welfare or safety or study integrity including changes intended to reduce immediate risk to subjects; – Use of an investigational product in an emergency situation; and – Claims for compensation or for medical care for research-related injury.
- Advertising and recruitment materials must be approved by E&I prior to use or publication.
Following completion of the study, all promises made to subjects and to the IRB continue to reamin in effect.