What is the purpose of the Oversight & Outreach Program
The purpose of the Oversight & Outreach Program (O&O) is to improve the quality of the human subjects’ protection program through education, training, and post approval monitoring of research studies. This program is intended to be proactive, not punitive, and focuses on educating investigators and research staff about their ethical and regulatory responsibilities in the conduct of research.
What is the relationship between the IRB and the Oversight & Outreach Program (O&O)?
The IRB and O&O are both components of the HRPP. The O&O is charged with evaluating and enhancing human research protections through education, training, and monitoring. The IRB is charged with reviewing and overseeing human research to ensure protection of research participants. The feedback received from Oversight & Outreach reviews provides a way for the IRB to improve these activities.
What activities comprise the Oversight & Outreach Program?
The Oversight & Outreach Program (O&O) is responsible for reviewing activities associated with human research protections and for providing related education and monitoring. Examples include, but are not limited to:
- Routine, random reviews
- For Cause reviews
- Investigator-initiated reviews (post approval monitoring of research studies requested by the investigator or study team)
- Conflict of interest reviews
- Pre-study site or investigator assistance
How are individuals notified when their studies are selected for routine Oversight & Outreach review?
The Principal Investigator is notified electronically via e-mail or in writing that a particular study has been selected for a review. (Note: Individuals listed as study team members in e-IRB may also be copied on the notification.) The study team and Oversight & Outreach will arrange a date/time for the review, typically within 2-4 weeks of notification.
What can an investigator or research staff member do to prepare for a routine QI review?
Organizing study related records (even without an Oversight & Outreach review) can help to track your study’s progress. Some helpful tips include:
- Conducting your own internal monitoring review and including notes to file in research records where discrepancies are found or clarification is needed.
- Performing inventories of items that require accountability (e.g., drugs, devices).
- Ensuring that documents are organized and can be made available for review.
- Using the helpful tools on the O&O website to review your files for the appropriate contents.
What is a “For Cause” review?
A “For Cause” review is an in-depth examination of a research study to determine if the safety, rights, and welfare of research subjects are being upheld according to federal regulatory, IRB, and institutional requirements. For Cause reviews are conducted in response to:
- Requests from the IRB
- Subject Complaints
- Sponsor Complaints
- Requests from institutional officials or other institutional contacts
- Requests/concerns from government agencies (e.g. FDA, NIH, OHRP, etc.)
What is a “Random” review?
A “Random” review is conducted as a normal part of the Oversight & Outreach program to ensure that the safety, rights and welfare of research subjects are properly protected and to identify any educational and/or training needs the study team might have as related to the research. This type of review includes, but is not limited to, all research records and documents, observations of processes, and interviews with research team members
How are protocols randomly selected for a review?
Protocols are randomly selected for a review by performing a query of the IRB database.
What studies can be reviewed?
Any study that has WFUHS IRB approval can be reviewed.
Do I need to be present for the entire review?
No, you do not need to be present during the entire review. The research team, however, should be readily available to answer any questions that may arise during the review.
How long will the review take?
The length of time a review takes depends on many factors such as:
- The complexity of the study
- The number of subjects enrolled
- The length of time the study has been active
- The organization of the research records and regulatory files
How many research records are reviewed?
The number of records reviewed depends on the type of review (random vs. for cause) and the number of subjects enrolled. Generally, all signed consent forms are reviewed along with a random sampling of 10% of the research records/source documents. If deficiencies are identified, then additional research records may be reviewed.
What materials should I have available for the review?
The following items should be available for review:
- The regulatory binder
- All signed consent forms
- Source documentation and research records for all enrolled subjects.
What is a regulatory binder?
A regulatory binder contains all the essential documents for the conduct of the study and demonstrates compliance with the standards of good clinical practice and all applicable regulatory requirements. All investigators are expected to maintain regulatory binders that contain all vital study documentation.
What are the most frequently identified issues found during a review?
- Utilization of an outdated informed consent
- Incomplete regulatory files
- Failure to document the consent process
- Failure of subjects to initial optional procedures on consent form
- Failure to follow protocol as written
- Consent obtained by individuals not IRB approved and/or CITI certified
- Inadequate documentation to verify study eligibility
- Site responsibility/delegation log not maintained
Who receives a copy of the Oversight & Outreach report?
A copy of the Oversight & Outreach report is shared with the Assistant Dean for Research, the IRB Director, and the IRB Executive Chair. A follow-up letter is sent to the principal investigator and study coordinator outlining all findings as well as any corrective actions required by the study team. The investigator should provide a written response to the follow-up letter within 30 days documenting the corrective actions taken and study revisions made in order to eliminate future recurrences of the problem.
In cases where major deficiencies are identified, a meeting with the Principal Investigator, study coordinator, IRB Director, IRB Executive Chair, and Oversight & Outreach may be scheduled to clarify discrepancies/deficiencies and to develop a corrective action plan to prevent further recurrences.