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 HSR Office.
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 in Cayuse IRB. 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 via our post-monitoring program (PMP). 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 HSR 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 Human Subjects Research Office (HSR) via email to the Principal Investigator (PI) and Faculty Sponsor (if the PI is a student). HSR staff will work with the PI to establish a monitoring visit usually within thirty (30) days of notification.
During the visit, HSR staff’s review and evaluation will include (but is not limited to) the following areas:
- IRB records and documentation
- Compliance to IRB approved protocol
- Participant recruitment, selection, and payment procedures
- Participant enrollment and corresponding records
- Informed consent procedures and corresponding records
- Participant payment and corresponding records
- Data storage / retention practices
- Confidentiality and privacy practices and process
Once the PI and research team is notified of the PMP visit, they are encouraged to contact the HSR Office with any questions or concerns.
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 Closure in Cayuse IRB 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.
If a study’s approval expires before a Renewal application is submitted 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 Renewal application has been reviewed and approved by the IRB / HSR Office.
If a study’s approval expires and remains lapsed for 30 days (with no Renewal application submitted), the study will be administratively closed by the HSR Office. Once a study has been administratively closed, a new Initial application form must be submitted via Cayuse to resume the research activities.