Updated Policies

Current Policies and Guidance [HTML]

 

Select Updated or New ORI/IRB Policies or Guidance:

Not Human Research (NHR) Determination Form [HTML] Updated form available on REDCap. Submit for an official determination regarding need for IRB Review.
Re-consent Guidance [PDF] Updated guidance includes considerations for determining communication method (notification vs re-consent) for providing new information to future, current, and/or past participants.
Debriefing & Permission to Use Data Form [WORD] NEW: Sample template for a Debriefing Form for studies involving deception/incomplete disclosure.
FDA Flow Chart for Medical Device and Drug Trials [PDF] Reformatted to one-page flow chart with resource links, for applying FDA IRB regulations and FDA drug or device regulations to IRB protocols.
Mandated Reporting to External Agencies SOP [PDF] Updated to include additional AAHRPP reporting requirements including negative actions by government agency, lawsuits related to human research, or negative press coverage involving the human research protection program (HRPP).
Policy on Unanticipated Problem & Safety Reporting [PDF] Updated to include investigator reporting consistent with AAHRPP requirements.
Investigator Quick Guide to Reporting [PDF] Updated one-page guide to IRB reporting.