Post-Approval
Responsibilities After IRB Approval
Obtaining approval or exemption from the IRB is an important milestone in conducting human subjects research. IRB approval does not end the researcher’s responsibilities. Throughout the duration of a study, researchers are responsible for conducting the research in accordance with the approved protocol and for keeping the HRPP informed of changes, events, and other information that may affect the rights, safety, or welfare of research participants.
This page provides an overview of key responsibilities researchers have after IRB approval and throughout the life of the study. Researchers should review the requirements that apply to their study and complete all required submissions within the applicable timeframes.
Administrative Check-ins
ETSU HRPP requires all studies to submit annual progress reports unless the study has an expiration date and requires Continuing Review (see below). The progress report is called an Adminsitrative Check-in because it does not require IRB review and serves as an administrative report for the HRPP study record. All IRB Exempt studies have an administrative check-in due date, and many minimal risk IRB-approved studies do as well. Refer to the study approval letter or OneAegis study page.
Learn more about Administrative Check-in.
Continuing Reviews
Some studies require periodic IRB review after initial approval either for compliance with regulatory criteria or as established by the IRB. Researchers are responsible for knowing whether continuing review is required and for submitting the required materials by the IRB-established deadline in advance of the expiration date. If a study expires, all research activities must halt.
Learn more about Continuing Reviews.
Changes to Approved Research (Modifications)
If researchers plan to change an IRB-approved study, the proposed changes generally must be submitted to and approved by the IRB before implementation. This may include changes to the protocol, study personnel, consent documents, recruitment materials, data collection procedures, or other approved study materials. IRB Exempt research may also require submission of some modifications to ensure compliance ETSU policy, HRPP SOPs, and verify exemption eligibility.
Learn more about Modifications.
Researcher Monitoring and Reporting
Researchers must have appropriate mechanisms in place to monitor, identify, and assess any adverse events, problems, complaints, or other issues that occur during the research. Research must promptly report certain events or information to the HRPP for review and potential IRB action. Reportable events may include unexpected problems involving risks to participants or others, serious or unanticipated events, noncompliance, privacy or confidentiality breaches, or other information that may affect the conduct of the study or the rights, safety, or welfare of participants.
Learn more about Reportable Events (UPIRTSOs).
Closing Studies
When a study has met the applicable criteria for closure, researchers are responsible for submitting a study closure in OneAegis within a reasonable timeframe. Before closing a study, researchers should ensure that all required study activities are complete and that records are retained in accordance with institutional, regulatory, and sponsor requirements. ETSU record retention begins upon approval of the study closure submission.
Learn more about Study Closure.
Audits, Inspections, and Compliance Reviews
Research involving human subjects may be subject to post-approval monitoring to assess whether the study is being conducted in accordance with the approved protocol, applicable requirements, and institutional policies. These post-approval monitoring visits may be IRB-directed audits, Regulatory Inspections (e.g., FDA inspections), or Not-For-Cause Compliance Reviews. Researchers must cooperate with requests for audit, inspection, or compliance review whether by sponsors, regulatory agencies, or institutional compliance officials.
Researchers should maintain complete and accurate study records and be prepared to provide documentation related to the conduct of the study if selected for monitoring. If researchers are notified of an audit or inspection by an agency or organization other than the ETSU HRPP Office, it is considered a reportable event and the HRPP must be notified promptly along with follow-up reports of the outcome of the audit or inspection.
Learn more about Not-for-Cause Compliance Reviews.