HRPP policies & procedures manual

409: Reporting requirements

1. Purpose

This policy describes the reporting requirements for reporting:

  • Unanticipated problems involving risks to subjects and others,
  • Serious and continuing non-compliance and/or
  • Termination or suspension of a study by the IRB.

2. Policy

One or more of the following, as appropriate, will be notified within 15 days of any serious and continuing noncompliance, unanticipated problem involving risks to subjects or others, and/or suspension or termination of IRB approval of a study.

  • Institutional Review Board
  • Principal investigator
  • Sponsor, if the study is sponsored
  • Contract research organization , if study is overseen by one
  • Department chair or supervisor of principal investigator
  • Head or appropriate designee of the funding department or agency
  • Appropriate designee of the sponsoring company or organization
  • Vice president for research
  • FDA, when the research is FDA-regulated
  • OHRP, in all cases
  • Other federal agencies when the research is overseen by those agencies, and they require reporting separate from that to OHRP
  • Local agencies as required by institutional officials

3. Specific policies

All serious and continuing non-compliance, serious adverse events, suspensions, terminations, or unanticipated problems involving risks to subjects or others will be reported within 15 days to OHRP and/or FDA.  The ORA director will draft a letter that outlines:

  • Nature of the event
  • Name of institution conducting the research
  • Title of the research project and/or grant proposal in which the problem occurred
  • Name of principal investigator
  • Number assigned by the IRB and number of applicable federal awards
  • Detailed findings of the IRB
  • Actions taken by the IRB
  • Reasons for the IRB’s action
  • Plans for continued investigation or action
  • Plans, if any, to send a follow-up report or final report

The letter is sent to the institutional official for review, approval, and signature and to other appropriate persons as outlined in section 2 of this policy.

All unanticipated problems involving risks to subjects or others need to be reported to the FDA by the investigator when the research is FDA-regulated. Copies of the reports must be sent to the IRB.

4. Applicable regulations and guidelines

21 CFR 56.108(b)(1), 56.108(b)(2), 56.108(b)(3)

5. Forms


6. Procedures employed to implement this policy & assignment of responsibility

ORA director, IRB coordinator Report to appropriate internal and external agencies.
Institutional official (IO)Review, approve and sign letter.