Once approved, any changes to the protocol (regardless of the scope of the change) may not be implemented by the research team until they have been reviewed and approved by the IRB Office / IRB Committee.
Expedited / Full Board Studies: Proposed modifications must be submitted to the IRB Specialist via email using the Modification Request (MOD) form. The modification request must include a completed MOD form (signed by the PI and Faculty Sponsor, as appropriate), an amended protocol application form, and any of the study documents that need to be updated to reflect the changes.
Minimal Review / Class Projects: The modification request must be submitted through the OAR electronic portal. A copy of any study documents that need to be updated must be uploaded in OAR and submitted with the MOD request. For additional information on the OAR electronic portal watch this tutorial video.
Effective January 21, 2019, the Revised Common Rule removes the requirement to conduct annual continuing reviews (CR) of ongoing research for studies approved through the expedited review process. Most studies approved through the expedited review process on or after January 21, 2019 will not automatically undergo CR by the IRB. If the IRB determines continuing review is not required, investigators will still be required to complete a short annual status check-in report. The IRB may require CR for special circumstances, to be determined on a study-by-study basis. The research team will be notified at the time of initial approval whether or not a CR will be required.
Notification of Expiration Dates
The PI must submit a CR application or annual status check-in report prior to the study’s expiration of IRB approval. As a courtesy, the IRB Office will send reminder notices for each active study. Notices are sent 30 and 7 days before the expiration date and on the due date. An expiration notice is also sent on the expiration date.
If IRB approval expires before a CR or annual status check-in report is submitted by the PI and/or approved, all human subjects research activities (interaction with participants and analysis of their data) must cease. No recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of data is allowed.
Investigators may resume research activities only once the CR (or annual status check-in report) has been reviewed and approved by the IRB / IRB Office.
If a study’s IRB approval expires and remains lapsed for 30 days, the study will be administratively closed by the IRB Office. Once a study has been administratively closed, a new application form must be submitted to continue the research activities.
The IRB requires PI to promptly report (within 5 days) a summary of reportable events (including unanticipated problems and deviations) using the Reportable Events Report. Examples of events that require reporting to the IRB include but are not limited to the following:
- Information that indicates a new or increased risk, or a new safety issue.
- Harm experienced by a subject or other individual, which in the opinion of the investigator are unexpected and probably related to the research procedures.
- Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB or the institution, or an allegation of such non-compliance.
- Audit, inspection, or inquiry by a federal agency or any other outside entity and any resulting reports.
- Failure to follow the protocol whether planned or unplanned (deviations).
- Breach of confidentiality.
- Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.
- Incarceration of a subject in a study not approved by the IRB to involve prisoners.
- Complaint of a subject that cannot be resolved by the research team.
- Premature suspension or termination of the protocol by the sponsor, investigator, or institution.
- Unanticipated adverse device effect.
Any active study is subject to a post-approval review. The purpose of the PMP is to assess the research activities conducted under the University’s Federal Wide Assurance Agreement with the Office of Human Research Protections (OHRP). This program assures human subject safety in research, provides education to research professionals, and identifies strengths and areas for improvement.
PMP reviews may be initiated for the following reasons:
- A protocol is randomly selected form a list of currently approved studies;
- The PI or PI’s department may wish to have research studies reviewed proactively;
- The IRB may request IRB staff conduct an observational visit for a specific protocol because the study is very complex or involves unusual levels or types of risks to participants; or
- Other reasons primarily related to subjects’ risk and safety.
Notification of a PMP visit is sent by the IRB via email to the Principal Investigator (PI) and Faculty Sponsor (if the PI is a student). IRB staff will work with the PI to establish a monitoring visit usually within thirty (30) days of notification.
A study may be closed when all of the following apply:
- All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing).
- All subject specimens, records, or data have been obtained (no further collection of data/information from or about living individuals will be obtained).
- No further contact with subjects is necessary (all interactions or interventions are complete).
- Analysis of subject identifiable data, records, specimens are complete (use or access to subject identifiable data is no longer necessary. Note: this includes review of source documents by study sponsors, if appropriate).
In order for a PI to close an IRB protocol, submission of a Final Report Form is required. Once the closing report has been received by the IRB Office, a confirming e-mail will be sent to the PI and the Faculty Sponsor (if applicable) to document protocol closure.
Administrative Closures: in cases where a PI does not submit a CR or a Final Report within 30 days of the expiration of IRB approval, these studies will be administratively closed by the IRB Office and recorded as non-compliant.