HRPO Seminar: Guidance for the New Regulatory Requirement for Key Information in Consent Documents

August 14, 2018 -

12:00pm to 1:00pm

SLIDES

Join Judy and Nena to learn about the Key Information required by the 2018 Common Rule.  This session will present Guidance on Key Information that was developed by the HRPO working group and provide examples of Key Information for several types of studies as well as present results of a survey of prospective research participants on their expectations of Key Information. 

The revised final rule to update the regulations at 45 CFR 46 include important changes to the requirements for informed consent intended to “better protect human subjects involved in research, facilitate research, remove ambiguity, and reduce regulatory burden.”  The revised rule requires that the informed consent process begin with a concise and focused presentation of the “key information” that is likely to assist a prospective subject in deciding whether or not to participate in the research.  This new requirement makes sense as a possible remedy to the current state of informed consent documents, but is problematic in that clearly, the “key information” required about one type of research study may be significantly different from the “key information” required for a different type of research study. 

To address these ambiguities, the University of Pittsburgh Human Research Protection Office formed a working group composed of IRB staff, board members including community (unaffiliated) members and research investigators and coordinators. The results will be presented here.

No pre-registration is required and all are welcome to attend. For more information or to submit advance questions, contact Melissa Miklos by email at mgm12@pitt.edu.

Speaker

Judith Navratil, MA, CIP - HRPO Research Review Specialist, Faculty Research Liaison
Nena Ansari, BA - HRPO Research Review Analyst

Location and Address

Biomedical Science Tower South, Room S120
220 Darragh Street
Pittsburgh, PA 15213