April Newsletter

April 2023

The wait is over! Slides and recordings from our popular Common Rule webinar series are now available!

OHRP’s recent webinar series on the Common Rule was a great success and attended by over 3,600 individuals! Click here to access the slides and recordings for the following presentations:

1. Doing Research with Data and Biospecimens under the Common Rule Part 1 – What Researchers Should Know
2. Doing Research with Data and Biospecimens under the Common Rule Part 2 – How Does that Work with Repositories and Future Use?
3. Before Saying “I Do” to the Common Rule: Figuring out “Engagement”
4. Respecting Persons – From Basic Requirements to Embracing Participant-Centered Informed Consent

Save the date! OHRP’s next Research Community Forum (RCF) will be held in beautiful Ann Arbor, Michigan on Sept 26-27th

Join OHRP and the University of Michigan for our next RCF: “Making a difference in human subjects research: Empowering participants, engaging communities, and protecting data.” This two-day, in-person event is targeted at all those involved in conducting and protecting participants in biomedical and socio-behavioral human subjects research. Day one will offer an interactive workshop with staff from OHRP on how to apply the regulations at 45 CFR 46. Day two will include presentations from esteemed subject matter experts in the field.

Click here for more information!

Coming soon - OHRP’s 6th Annual Exploratory Workshop (EW)! Livestreamed for free on Thursday, Sept 14th!

Save the date and be on the lookout for more information about this exciting event in the coming months!

In the meantime, be sure to check out our Exploratory Workshop page to view videos and slides from past workshops, such as the 2022 EW on the ethics and utility of providing payment for research participation.

Have you visited our Luminaries Lecture Series page? No better time than now to stop by and view the content!

Click here to access our series of videos from experts in the field examining a variety of topics on human subjects protections. This content meets the Certified IRB Professional (CIP) recertification guidelines.

Highlights of the month:

“Finding the 'Key' in 'Key Information'”

This presentation discussed approaches for how to develop and communicate "key information" to prospective research participants.

“The Changing Regulatory Landscape and Genetic Research”

This presentation discussed revisions to the Common Rule and examined what these changes might mean for genetic and genomic research in the future.

Draft Guidance on Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections

March 31, 2023

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) have announced draft guidance, “Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections.” Notice of this draft guidance is included in the March 31 issue of the Federal Register (88 FR 19310) and can be accessed at https://www.federalregister.gov/documents/2023/03/31/2023-06649/research-involving-children-as-subjects-and-not-otherwise-approvable-by-an-institutional-review.

This guidance is intended to assist institutional review boards (IRBs), institutions, investigators, and sponsors in understanding the processes used for review of research involving children as subjects that is not otherwise approvable by an IRB and has been referred to the FDA under 21 CFR 50.54, OHRP under 45 CFR 46.407, or both, for review.

The text of the draft guidance document appears on OHRP’s website (https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-research-involving-children-as-subjects/index.html) and is also available on the FDA website (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/research-involving-children-subjects-and-not-otherwise-approvable-institutional-review-board-process).

This draft guidance has a public comment period of 60 days, closing on May 30, 2023. See the Federal Register Notice for details regarding how to submit public comment. Thank you.