What happens after approval?
Once you have received IRB approval or an Exempt Determination you may begin conducting the research as approved.
Modifications to the Protocol
Sponsors may request or Investigators may decide to make changes to their study protocol. Such changes may not be implemented by the research team until they have been reviewed and approved by the HRPP/IRB.
However in the event that a modification is necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103b.4.iii), the change may be implemented without prior IRB approval and should be reported to the IRB as a Reportable New Information according to the timeline outlined in the Investigator Manual. This will be handled by the IRB accordingly
Proposed modifications must be submitted via iRIS. It is important to remember that in addition to submitting an Amendment/Modification form, the study application, protocol and/or any of the study documents already in iRIS may need to be updated to reflect those changes.
Reportable New Information
New safety, risk and compliance related information, including Unanticipated Problems, Adverse Events and deviation from the approved protocol require prompt reporting to the IRB using the Reportable New Information (RNI) form in iRIS. RNI includes but is not limited to:
- 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 (e.g. FDA Form 483.)
- Written reports of study monitors.
- 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.
Continuing Review of human research projects is required until the research team has completed all study activities, as described in the IRB-approved research protocol.
For Expedited and Full Board protocols continuing review is required at least annually. For studies determined to be exempt, the exempt determination is valid for 5 years at which point a new determination must be requested.
This review allows the IRB to monitor the progress of the study and ensures that the study continues to meet the requirements for approval.
When should I send my Continuing Review?
The Principal Investigator is responsible for submitting the Continuing Review in iRIS no later than 30 days before the study’s current expiration date to ensure adequate time for the IRB to review and approve it.
Will I be notified of upcoming expiration dates?
iRIS automatically generates continuing review reminder notices for each active study. The Principal Investigator and individuals listed as Study Contact will receive these notices. Notices are sent 60 days and 30 days before the due date and on the due date (which is 30 days before the study is set to expire). An expiration notice is also sent on the expiration date.
What if my study has expired?
If IRB approval expires all Human Research procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.
If the Principal Investigator believes it is necessary to continue a subject or subjects in a lapsed study for safety reasons or otherwise, contact the HRPP office.
The investigator may resume the research activity only once continuing review and approval by the IRB has occurred.
Post Approval Reviews
Any active study is subject to a post approval review. Most of these reviews are not for-cause; they are what we call “routine” reviews. The purpose of these reviews is to help investigators stay in compliance, to monitor compliance and to educate. Reviews may also be requested by the IRB, HRPP or Institutional Official to investigate allegations of non-compliance or other RNI. These would be “for cause” reviews.
To learn more about post-approval reviews, please see the Quality Assurance/Post Approval Monitoring Program page.
Closing the Study
If all research-related activities with human subjects have been completed, and data collection and analysis of identifiable private information described in the IRB-approved research plan are finished, then the study should be closed with the IRB.
Similarly, if the study was never initiated and the Investigators no longer have plans to pursue this project then the study should be closed with the IRB.