May Newsletter

Join OHRP on Friday, July 12, 2024, for the 50th anniversary of the National Research Act Commemoration Event

On Friday, July 12th, from 12 p.m. to 2:30 p.m. EDT, OHRP will be hosting a virtual event to commemorate the 50th anniversary of the National Research Act. Here are a few highlights:

• Patricia King, a commissioner in the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research that published the Belmont Report will reflect on the Commission’s work.
• A community research coordinator will talk about his work with youths and role in research studying gun violence.
• Laura Brosch of the Uniformed Services University of the Health Sciences will moderate a panel of distinguished speakers on the changing notion of human research protection amidst the scientific and technological advances coming our way and the challenges with preserving public trust in research.

We are at another significant moment in human research. Do not miss this opportunity for reflection.

Click here for more information. No registration required.

OHRP’s next RCF, Collaboration, Communication and Connection will be held on September 9-10!

This virtual Research Community Forum (RCF) co-hosted with the University of Pittsburgh, Penn State University, and the University of Pennsylvania, will include topics such as, implementation research, use of synthetic data, and engaging “hard-to-reach” communities in research. Staff from the HHS Office of Research Integrity (ORI) will join us for a presentation on research integrity.

Look out for more details here and register early!

The Evolving Landscape of Human Research with AI, Putting Ethics to Practice, OHRP Exploratory Workshop on Thursday, September 19

Yes – AI is undoubtedly the hottest topic of the year! We will be exploring some of the challenges in ethics, oversight, and governance in human research involving AI. Review our agenda and the list of diverse and distinguished speakers lined up for this year’s event.

Click here for details.

FWA/IRB Submission System Maintenance

We are making software updates to the electronic submission systems for Federalwide Assurances (FWAs) and Institutional Review Board (IRB) registration. This includes eFile and Search applications. The updates require scheduled downtime beginning May 15, 2024, at 7:30 PM EST, during which these systems will be unavailable. This will be followed by a post-launch maintenance window on May 16. We are requesting your assistance in minimizing use of the systems on May 16 during the post-launch maintenance window. We expect the systems to be fully functional on May 17.

If you are planning an initial, renewal, or update application for an FWA or IRB registration prior to May 15, we strongly encourage you to complete and submit the application as soon as possible, and no later than 5:00 PM EST on May 10. We encourage institutions to refrain from submitting update applications that are not required until May 17. For a reminder about when updates are required, please see the FWA FAQs and IRB Registration FAQs.

The system updates include changes to the user interface that we hope improve user experience. These updates do not include changes to the content of FWA or IRB registration applications.

Please contact OHRP’s Division of Policy and Assurances at IRBorFWA@hhs.gov if you have questions or need assistance. Thank you for your patience as we complete these updates.

The Belmont Principles and Human Research Ethics, presented by Dr. Ivor Pritchard slides and video now available!

Due to popular demand, Dr. Ivor Pritchard’s presentation on The Belmont Principles and Human Research Ethics slides and video are available now!

Click here to access.

Don’t forget you can find answers to many of your Common Rule questions by viewing our series of educational webinars here.