Promptly Reportable Information
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.
The OHRE Standard Operating Procedures (SOP) serve to fulfill the requirements of these regulations and to protect the rights, safety, and welfare of research participants. The SOPs can be accessed via: http://ohresop.web.unc.edu/
New Safety Information is reported through IRBIS.
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)