The Office for Human Research Protections (OHRP) and the 2018 Boston OHRP Research Community Forum Planning Committee May 1-2, presented a two day symposium at Harvard Medical School to address “issues of Informed Consent and discuss how we can move forward as a community to address issues of content, communications, and emerging technologies.”
At the forefront of the discussion and presentations were the changes to informed consent contained in the revised Common Rule. OHRP Director Jerry Menikoff, MD, JD, discussed the Common Rule’s new requirements and flexibilities in the informed consent process and stated that OHRP is currently working on guidance documents and templates which he expects will be issued shortly.
Dr. Menikoff also discussed the proposed delay to the revised regulation’s general compliance dates [see Washington Highlights, Jan. 19], and asserted that that June 21, 2017, joint letter from the AAMC and other higher education associations requesting a one year extension to the compliance date [see Washington Highlights, June 23, 2017] played a significant role in the decision to delay the Common Rule’s implementation. Dr. Menikoff agreed with community concerns that regulated entities need additional time and official guidance from the Common Rule agencies to make the necessary preparations to implement the revised regulations. He also recognized the importance of the harmonization of the Food and Drug Administration (FDA) human subjects protections regulations with the Common Rule.
For more information on OHRP’s Research Community Forums and other education opportunities with research institutions across the U.S., visit OHRP's Educational Collaboration website. The AAMC posts updates, resources, and links to guidance documents on our Common Rule webpage as soon as they are available.