July Newsletter

July 2023

Making a Difference in Human Subjects Research: Empowering Participants, Engaging Communities, and Protecting Data in Ann Arbor, Michigan on Sep 26-27th

Join OHRP for this 2-day event co-sponsored with the University of Michigan. Conference highlights include the ethical challenges and opportunities presented by AI technologies, innovations in informed consent, and best practices for data sharing in the area of social and behavioral research.

Click here to register!

OHRP’s 6th Annual Exploratory Workshop (EW), Old Trips, New Destinations: Exploring the Ethical and Practical Considerations of Psychedelics Research, will be livestreamed on Thursday, Sept 14th!

This free event will be streamed live around the world on Thursday, September 14, 2023, from 9:45 a.m. to 4:15 p.m. EDT. No registration is required.

Experts will deliberate on the ethical, practical, and legal questions pertaining to psychedelics research, including unique risk considerations, issues pertaining to informed consent, study design and integrity, inclusion of vulnerable groups, as well as the importance of preserving public trust. This is a timely and important discussion that responds to tremendous interest in this topic from diverse stakeholders, including patients, researchers, funders, regulators, and policymakers at both the state and federal levels.

Visit the event website for details and tell your colleagues about it.

Join OHRP’s Policy Team!

OHRP is hiring a Public Health Advisor at the GS-11/12 level in the Division of Policy and Assurances (DPA). The incumbent will carry out a wide variety of assignments related to DPA’s policy and guidance initiatives to support OHRP's mission. This is a career ladder position with growth potential to the GS-13 grade level.

The position will be open to applicants from June 29, 2023, to July 27, 2023, but will close to applications when 500 applications have been received. 

Please note that there are multiple job announcements for this position that differ regarding the location of the position and who is eligible to apply.  For specific eligibility requirements and more information on how to apply for this position, please visit the links below:

https://www.usajobs.gov/job/734055100

https://www.usajobs.gov/job/734057200

https://www.usajobs.gov/job/734062000

https://www.usajobs.gov/job/734066900

Reminder: OHRP’s Common Rule Basics Webinar Series

Thank you to those who registered for our upcoming webinar series! – please make sure to mark your calendars – we look forward to seeing you.

1. Unlocking the Mysteries of the §46.111 Criteria for IRB Approval of Research

Date: Tuesday, July 11, 2023, 12:00 PM EDT

Description: This presentation will explain the criteria for IRB approval of research and include case studies and interactive quizzes to demonstrate the way the criteria can be applied.

2. The Who, What, Why, and Where of IRB Meetings and Membership

Date: Tuesday, July 18, 2023, 12:00 PM EDT

Description: This presentation will provide an overview of the requirements for IRB meetings and membership, including quorum, minutes, records, and more.  

3. How Do I Review Thee? Let Me Count the Ways: The Types and Manners of IRB Review

Date: Tuesday, June 25, 2023, 12:00 PM EDT

Description: In this presentation, attendees will learn about the different types and manners of IRB review, including full board, limited review, expedited review, and for various lifecycle actions like, initial review, review of amendments, and continuing review applications.

New Additions to the Luminaries Lecture Series

The NIH All of Us Research Program and the Role of Technology in Advancing Health Research

This video detailed NIH’s “All of Us” efforts to foster relationships with participants, community partners, researchers, and providers across the United States to engage and involve populations traditionally left out of medical research. Dr. Karriem Watson addressed how the “All of Us” research aims to overcome the recruitment and inclusion challenges it has faced since its launch and highlight how it is leveraging technology to recruit traditionally underrepresented people and populations in research.

Regulations and the Secrets of Big Data: Public, Private, or What?

This video presented by Ivor A. Pritchard, Ph.D., Senior Advisor to the Director, Office for Human Research Protections, examined how the history of technology has transformed the meaning of “privacy” and discussed how information could be considered public or private based on legal and regulatory interpretations and definitions of these terms.

Filtered Research and Field Trips to Our Imagination, Research in the Age of AI

This video presented by Professor Renee Cummings, Data Science Professor OTP, AI Ethicist, Data Activist in Residence, and Criminologist at the University of Virginia, addressed the topic of using artificial intelligence and other novel technologies for research into existing and innovative crime prevention strategies. Dr. Cummings also explored the special considerations for conducting this type of research with human participants and private identifiable data.

Promoting Research Representation and Engagement Opportunities under the Common Rule – Slides and Recording now Available

The slides and recording for OHRP’s webinar on Promoting Research Representation and Engagement Opportunities under the Common Rule are now available on our website! This webinar covered the Belmont Report principle of justice in human research ethics and discussed how the interpretation of justice has changed over time. The webinar explored what opportunities exist under the Common Rule to promote research representation and engagement in research and research participation.

Click here to access!

Draft Guidance on Limited Institutional Review Board Review and Related Exemptions – Open for Public Comment

OHRP recently announced a new draft guidance document, “Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions.” The draft guidance document applies to human subjects research that is conducted or supported by HHS. It is intended primarily to help entities implement the requirement for limited review of research by an institutional review board (IRB) to meet the conditions of four exemptions found at 45 CFR 46.104(d). When finalized, this will provide OHRP’s first formal guidance on this topic.

The draft guidance can be viewed on OHRP’s website here: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-frequently-asked-questions-limited-institutional-review-board-review-related-exemptions/index.html

Notice of this draft guidance appeared in the June 16, 2023 issue of the Federal Register (88 FR 39438), which can be accessed at: https://www.federalregister.gov/d/2023-12924

This draft guidance has a public comment period of 60 days, which closes on August 15, 2023.  Details about how to submit public comments are in the Federal Register notice or on OHRP’s website here: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/frequently-asked-questions-limited-institutional-review-board-review-related-exemptions/index.html

Save the date for SACHRP’s next meeting!

• Wednesday, July 19
• Thursday, July 20

Click here for more information!