January Newsletter

January 2023

Announcing the retirement of Dr. Jerry Menikoff, Director of the Office for Human Research Protections (OHRP)

Dr. Menikoff’s substantial contributions focused on protecting the rights, welfare, and well-being of subjects involved in research conducted or supported by HHS. As the Director of OHRP, Dr. Menikoff had a direct impact on providing leadership in the protection of subjects by offering clarification and guidance, developing educational programs and materials, and maintaining regulatory oversight. Among his many achievements during his tenure at OHRP was his leadership of the revisions to the Common Rule. Dr. Menikoff’s efforts led to regulatory changes that strengthen informed consent and promote the trustworthiness of the research enterprise.

Prior to joining OHRP, Dr. Menikoff also served as the director of the National Institutes of Health (NIH) Office of Human Subjects Research, responsible for day-to-day oversight of the NIH intramural research program's human research protection program, including policy development and educational activities.

Dr. Menikoff held several academic positions prior to his government service. He served for nine years as the chair of the human subjects committee and the hospital ethics committee at the University of Kansas Medical Center. He was also on the faculty of schools of law at the University of Chicago and other esteemed universities. Most recently, before coming to the federal government, he was Associate Professor of Law, Ethics and Medicine at the University of Kansas.

Dr. Menikoff's research interests have concentrated on bioethics in general, and more particularly on the ethics of research with human subjects. Dr. Menikoff is the author of Law and Bioethics: An Introduction (Georgetown University Press) and What the Doctor Didn’t Say: The Hidden Truth about Medical Research (Oxford University Press).

OHRP wishes Dr. Menikoff well in his future endeavors, and thanks him for his exemplary and meaningful leadership.

Those wishing to reach Dr. Menikoff can contact him at jamzz8@gmail.com.

Julie Kaneshiro will be serving as the Acting Director of OHRP starting January 1, 2023.

Check out the latest addition to our interactive IRB scenarios on reviewing human subjects research!

Our newest addition to the series, “Balancing Risks and Benefits”, covers what IRBs may consider as potential benefits of research and if the benefits are reasonable against the research risks participants may face. Join IRB professional CK and researcher Dr. Bazzi as they walk you through a study and assess this review criterion. Click here to access!

While you’re at it, don’t forget to review our popular existing scenarios on “Equitable Selection of Subjects” and “Minimizing Risks in Research”, now with completion certificates for your records! Visit this page to access all our offerings.

Join us for a Research Community Forum (RCF) in Knoxville, Tennessee this spring!

Ready to get back to in-person events? Eager to see your colleagues and collaborate face-to-face? 

Register now for our upcoming in-person RCF – Research in the Age of Technology, March 29-30th in Knoxville, TN! 

Day one will include opportunities for attendees to interact with OHRP staff and fellow colleagues in the field of human research protections. The agenda will address a variety of issues and current challenges, including, but not limited to, IRB reviews of complex studies and writing readable and understandable informed consent documents.  

Day two kicks off with a keynote address from Renee Cummings on the use of AI and other novel technologies for research into existing and innovative crime prevention strategies and the special considerations for conducting this type of research with human participants and private identifiable information. Later sessions will highlight current developments with the NIH “All of Us” research program, examine regulatory considerations for “Big Data” research, and a lot more! 

Click here for the agenda and other event details! Certified IRB Professional (CIP) credits available.

Save the dates! OHRP’s Basics of the Common Rule webinar series is back!

Mark your calendars for OHRP’s upcoming, free virtual presentations and be on the lookout for emails announcing registration information in the very near future!

1. Doing Research with Data and Biospecimens under the Common Rule Part 1 – What Researchers Should Know (75 mins, Yvonne Lau), February 22, 2023, 12-1:15 pm EST
2. Doing Research with Data and Biospecimens under the Common Rule Part 2 – How Does that Work with Repositories and Future Use? (75 mins, Yvonne Lau), March 1, 2023, 12-1:15 pm EST
3. Before Saying “I Do” to the Common Rule: Figuring out “Engagement” (60 mins, Michael Grippaldi), March 8, 2023, 12-1 pm EST
4. Respecting Persons – From Basic Requirements to Embracing Participant-Centered Informed Consent (60 mins, Marianna Azar), March 15, 2023, 12-1 pm EST

NIH Virtual Pre-Conference on Human Subjects Research: Policies, Clinical Trials & Inclusion – Video Recordings Now Available!

Missed the live event? Now you can watch recordings of the two-day virtual conference and learn about the basic HHS regulations and NIH policies that apply to research involving human subjects, how to prepare a research proposal for review that addresses the regulatory requirements, and strategies for developing realistic and scientifically acceptable inclusion plans. Visit this page for event slides and links to the session recordings.