Per federal regulations, institutions engaged in human subjects research are required to have written procedures in place for ensuring prompt reporting of (i) Unanticipated Problems Involving Risk to Subjects or Others, (ii) Serious or Continuing Non-compliance, and (iii) suspension or a termination of IRB approval to the IRB, appropriate institutional officials, and applicable federal agencies.

SOP 1401, 1402, and 1403 (effective June 2, 2017) serve to fulfill the requirements of these regulations and to protect the rights, safety, and welfare of research participants. Link to the SOPs and key points of each SOP are included below.

SOP 1401: Reporting New Safety Information:

  • What type of information is promptly reportable to the IRB: TABLE 1, New Safety Information
  • Promptly reportable = 7 calendar days
  • What constitutes increased risk
  • Root Cause Analysis (RCA)
  • Corrective and Preventative Action (CAPA) Plans
  • Examples of New Safety Information (SUPPLEMENT 1).

SOP 1402: IRB Management of New Safety Information:

  • Pre-review by the Safety and Welfare Analysis Group (SWAG)
  • Safety Committee Review
  • Determinations and Considerations by the Safety Committee
  • Reporting to federal agencies

SOP 1403: Questions, Concerns, or Complaints from Research Participants or Third Parties

  • Requirement to include the contact information of the investigator (or designee) and the IRB in the UNC consent document.
  • Procedures for managing complaints from participants or third parties.
  • Procedures for IRB review and resolution of complaints from participants or third parties.

New Safety Information is reported through IRBIS 

Relevant Links:

OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (January 15, 2007)

FDA Guidance for Clinical Investigators, Sponsors, and IRBs. Adverse Event Reporting to IRBs — Improving Human Subject Protection (January 2009)

FDA Guidance for Industry and Investigators. Safety Reporting Requirements for INDs and BA/BE Studies (December 2012)