Chapter 47

IRB Reporting Requirements

Submit promptly reportable information via ClinSphere® eReview Manager or IRBNet. Promptly reportable information should be submitted within five days of becoming aware of the event (calendar days). If there is a delay, please include an explanation for the delayed reporting.

The following are reported by a submission of a promptly reportable information submission:

  1. New or increased risk.
  2. Protocol deviation that harmed a participant or placed a participant at risk of harm. This includes any site monitoring report that directly and materially affects subject safety or their willingness to continue participation.
  3. Protocol deviation made without prior IRB approval to eliminate an immediate hazard to a participant.
  4. Audit, inspection, or inquiry by a federal agency.
  5. Written reports of federal agencies (e.g., FDA Form 483).
  6. Allegation of Noncompliance or Finding of Noncompliance.
  7. Breach of confidentiality.
  8. Unresolved participant complaint.
  9. Suspension or premature termination by the sponsor, investigator, or institution.
  10. Incarceration of a participant in a research study not approved to involve prisoners.
  11. All IND safety reports. Any adverse events or SUSARs that require a change to the protocol or consent.
  12. State medical Board actions.
  13. Unanticipated adverse device effect.
  14. Information where the sponsor requires prompt reporting to the IRB.

The following are reported by submission of a change in research:

  1. Change in financial interest disclosure.
  2. Any findings from closed research when those findings materially affect the safety and medical care of past subjects. Findings will be reported for two years after the closure of the research.

Sponsors no longer planning or able to provide financial support for conduct of the study: When a site learns that sponsor is no longer able to fulfill their financial support for conduct of the study due to financial concerns, bankruptcy, or a general business decision, the site should promptly submit a PRI report (category 9 above) or administrative letter as a change in research with this information. This submission would include information regarding the status of the study overall and at the site, including any enrolled participants, and their plan for those participants.

Information not listed above does not require prompt reporting to WCG IRB.  

Please note, only adverse events or SUSARs that prompt a change to the protocol or consent document are required to be reported to the IRB. We have based our guidance on the most current FDA recommendations, and it is our goal to try and encourage the submission only of the items required and to avoid submission of non-reportable events, which causes delays in review and detracts from our mission of human participant protection.

When new information is submitted to WCG, if additional action/information is required, you will be contacted within 30 days. Otherwise, please consider this information filed only with no additional formal acknowledgment or confirmation. 

Note: consistent with AAHRPP’s requirements in connection with its accreditation of IRBs, the individual and/or organization submitting research for review shall promptly communicate or provide, and where necessary cause each investigator to promptly communicate or provide, the following information relevant to the protection of human participants to WCG IRB in a timely manner:

  • Upon request, a copy of the written plan between Client and Site that addresses whether expenses for medical care incurred by Human Research participants who experience research related injury will be reimbursed, and if so, who is responsible in order to determine consistency with the language in the consent document. 
  • Any site monitoring report that directly and materially affects participant safety or their willingness to continue participation. Such reports will be provided to the Review Board within five days. 
  • Reports from any data monitoring committee, data and safety monitoring Board, or data and safety monitoring committee in accordance with the timeframe specified in the study protocol.
  • Any findings from a closed study when those findings materially affect the safety and medical care of past participants. Findings will be reported for two years after the closure of the study.

To safeguard participant privacy, wherever possible provide records relating to participants in de-identified form.