All changes to an approved research protocol (including changes to consent forms, recruitment scripts / flyers, study measures, personnel, protocol procedures / activities, etc.) must be reviewed and approved prior to the changes taking effect, except when necessary to eliminate immediate hazards to subjects. 

Modifications must be submitted through Cayuse. All changes must be outlined and explained in enough detail for Reviewers to understand the intent and purpose for all changes. If the needed modification affects protocol documents, such as recruitment scripts, consent forms, study measures, the updated or new versions must be uploaded to replace the previous versions (as appropriate).

Once submitted, the Office of Human Subjects Protections (OHSP) will conduct a pre-review of the modification application and work with the PI to ensure the submission is complete and all required documentation has been uploaded. Once the pre-review process has concluded, the OHSP will initiate the appropriate review.

Effective January 21, 2019, the Revised Common Rule removes the requirement to conduct annual continuing reviews (Renewal applications) of ongoing research for studies approved through the expedited review process.  The requirement for annual renewal applications for studies approved under the Revised Common Rule is determined by the IRB on a study-by-study basis.

If the IRB determines an annual renewal application is not required, the study will be approved for a 2-year period. Investigators are required to complete the renewal application in order to continue the research every 2 years.

To allow adequate time for IRB review and to avoid any unnecessary delays, it is recommended that the PI submit a Renewal application through Cayuse 30 – 45 days prior to the study’s expiration date. The Renewal includes a status report on the progress of the research, including confirmation of or an explanation relating to the following (as appropriate):

• Current status of enrollment
• Number of participants consented to date
• Number of participants consented since the previous IRB Renewal
• Signed consent documents are on file and available for inspection
• Changes, reportable events, participant complaints, etc. were processed / reported consistent with UTD OHSP Policy and procedures
• Detailed description of the progress of the study, including summary of any interim findings and plans for the next approval period
• Any other relevant information, especially that may impact the risk / benefit ratio

Per current OHSP Policy, once a study is closed to enrollment (as indicated on the Renewal submission), it cannot be reopened for additional enrollment. To ensure that the research follows current UTD / OHSP Policies and Procedures regarding the protection of participants, a new Initial application must be submitted to conduct any new data collection procedures. There are no exceptions to this process.

If a study is approved for data collection and no enrollment has been conducted over the past four (4) years, the research activities should be limited to data analysis only (as indicated on the Renewal submission) as the study materials may not reflect current UTD / OHSP Policies and Procedures at that time. A new Initial application can be submitted when the study team is ready to proceed with enrollment / data collection procedures to ensure that the research follows the required guidelines to conduct human subjects research (Policies / Procedures, Regulations, State Laws, etc.).

Exception Request

An exception to this process may be requested by submitting the IRB Renewal Enrollment Exception Request. Please note that the exception requires a reasonable justification indicating why the study should remain open to enrollment when no enrollment has been conducted over the past four (4) years.

Once the Renewal Enrollment Exception Request has been submitted, the IRB will review and determine if an exception may be granted. If an exception is granted, the Renewal approval will be released with stipulations that a Modification must be submitted to address the stipulations outlined on the Renewal approval letter. These stipulations could include requiring updates to the application and study materials based on recent updates to UTD / OHSP Policies and Procedures, Federal Regulations, State Laws, etc.

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.

Federal regulations do not make provisions for any grace period extending research beyond the expiration date, which occurs at midnight on the date specified in the approval letter. If a study’s approval expires before a Renewal application is submitted and/or approved, all human subjects research activities—including interactions with participants and data analysis—must be paused (except when pausing would jeopardize the welfare of human subjects). This includes recruitment, screening, enrollment, consent, and data collection or analysis. Any lapse in approval could negatively impact funding.

Research activities may only resume once the Renewal application has been reviewed and approved by the IRB/OHSP.

Administrative Closures: If a Renewal or Closure is not submitted within 30 days of the expiration date, the research study will be administratively closed by the OHSP. Once a study is administratively closed, a new Initial application must be submitted via Cayuse to resume research activities.

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 data, records, specimens are complete (use or access to subject 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 via Cayuse is required. Once the Closure has been received by the OHSP, a confirmation e-mail will be sent to the PI and the Faculty Sponsor (if applicable) via Cayuse to document protocol closure.

Administrative Closures: If a Renewal or Closure is not submitted within 30 days of the expiration date, the research study will be administratively closed by the OHSP. Once a study is administratively closed, a new Initial application must be submitted via Cayuse to resume research activities.

Any active study is subject to a post-approval review via our post-monitoring program (PMP). The PMP assesses 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. Additional information regarding the PMP can be found here.