Office for Human Research Protections (OHRP), United States Department of Health and Human Services

Announcing OHRP Fact Sheet on SACHRP’s Recommendations for the Ethical Review and Inclusion of LGBTQI+ Participants in Human Subjects Research. The Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) has issued a fact sheet summarizing recommendations from the Secretary’s Advisory Committee on Human Research Protections (SACHRP), “SACHRP’s Recommendations for the Ethical Review and Inclusion of LGBTQI+ Participants in Human Subjects Research.” The SACHRP fact sheet does not represent OHRP’s guidance, but is an overview of SACHRP’s recommendations. The fact sheet can be found on OHRP’s website here: https://lnkd.in/gnkjM4aN

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Interagency Announcement: Seeking public comments on the ethical guidelines for the use of “pervasive data” in research The Department of Commerce’s National Telecommunications and Information Administration (NTIA) is seeking public input on potential ethical guidelines for the use of “pervasive data” in research. Pervasive data are data about people gathered through online services, which can include a wide range of technologies from wearable devices to social media platforms and AI systems. Research with pervasive data can inform an understanding of online behavior, technology’s effects on children, the digital economy, and more. NTIA’s Request for Comments “considers ethical issues and risks to privacy and other rights, and mitigation strategies throughout the lifecycle of a research project, from research design, data acquisition, and access, data processing, and analysis to dissemination.” The deadline for comments is January 15th. NTIA’s Request for Comments: https://lnkd.in/gk_eeXDK Comment Submission Site: https://lnkd.in/gaxgNtEQ Listening Session Information: https://lnkd.in/gTzcbVYB

Read OHRP’s Recent Publication in the National Council of University Research Administrators (NCURA) Magazine! On July 12, 2024, OHRP hosted a webinar to commemorate the 50th anniversary of the passage of the National Research Act (https://lnkd.in/gAeahDKx). In the Oct/Nov 2024 NCURA Magazine, Dr. Yvonne Lau reflects on the webinar and the fruitful discussion of event panelists (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://lnkd.in/gCAAiXdC) For more articles published by OHRP in NCURA and other outlets, click here - https://lnkd.in/gXctjqks

On Differing Approaches to Measuring and Ensuring IRB Effectiveness - Webinar Recording, Now Available! This webinar marked the culmination of collaborative efforts between OHRP and the FDA to bring together key stakeholders and explore strategies for assessing the effectiveness of Institutional Review Boards (IRBs) in protecting human subjects, as outlined in the Government Accountability Office’s (GAO) 2023 report. Experts in the field shared their insights on four key approaches for evaluating IRB effectiveness. Interested in learning more? Click here to watch the recording. The summary report and slides are coming soon - https://lnkd.in/gFyk6ise The presentations and panel discussion for this webinar meet the CIP recertification guidelines and are eligible for continuing education units.

Advancing Research Participation for LGBTQI+ Individuals - Webinar Recording, Slides, and Summary Report Now Posted! This recent webinar, co-sponsored by OHRP and the Sexual & Gender Minority Research Office (SGMRO) at the NIH, highlighted the importance of fostering diversity, inclusivity, and representation in biomedical and socio-behavioral research to enhance health outcomes for all. A key focus of the webinar was advancing these efforts for LGBTQI+ communities. Event speakers addressed several critical topics, including the evolving concepts of sex and gender, ethical challenges in conducting research with LGBTQI+ populations, as well as SACHRP recommendations on this topic. Click here to access the recording, slides and summary report of the event proceedings - https://lnkd.in/gWdA_PXf The presentations and panel discussion for this webinar meet the CIP recertification guidelines and are eligible for continuing education units.

The Evolving Landscape of Human Research with AI - 2024 Exploratory Workshop Summary Report, Slides, and Event Recording Available on OHRP’s Website OHRP’s 7th annual Exploratory Workshop on AI in human research drew over 3,000 viewers from around the world. The workshop explored the potential applications of AI in research, how to use it, what risks AI may pose, how we can prepare for and control these risks, and how this might inform future policy developments. The summary report, event slides, and recording are available now on OHRP’s website - https://lnkd.in/giyrpM5V All Exploratory Workshop sessions meet the CIP recertification guidelines and are eligible for continuing education units.

Check Out the Recently Released 2024 Edition of the International Compilation of Human Research Standards! The OHRP International Compilation of Human Research Standards is an essential tool for conducting international research. IRBs, HRPPs, and others interested in learning more about international research laws, regulations, and ethical guidelines are encouraged to consult this document. With the help of our international partners, we have updated this compilation to offer information for over 100 countries. Click here to access the 2024 edition - https://lnkd.in/g25wNam

Interested in Co-Sponsoring a Research Community Forum (RCF) with OHRP? OHRP co-sponsors two to three RCFs each year at locations across the United States to promote the protection of human subjects in research. RCFs bring together two educational events: a 1-day interactive workshop focusing on the interpretation and application of HHS regulations and policies for human research protections and a 1-day conference focusing on ethical and regulatory issues related to current topics in human research protections. OHRP provides a small co-sponsoring financial contribution to support the event. If you’re interested in co-hosting an RCF with OHRP in fiscal year 2026 (which starts in October 2025) or beyond, email us at [email protected] to let us know!

The Next Research Community Forum (RCF) is Rapidly Approaching! Join OHRP on February 19 & 20th, 2025 in North Augusta, SC! Now is the perfect time to tap into those year-end budgets and register for what will be OHRP’s only in-person RCF in 2025! Join us in North Augusta, SC as we co-host the next RCF, Maintaining Public Trust in the Face of Emerging Trends in Research, with Augusta University, Georgia State University, Georgia Southern University, University of Georgia, and Emory University. Day 1 of the RCF will feature OHRP-led interactive sessions that will guide audience members through real-time applications of the regulations at 45 CFR 46. Attendees with a working knowledge of the regulations will find these sessions particularly helpful. Day 2 will begin with a keynote address from Dr. Carl Elliott titled Blowing the Whistle on Abuses to Human Subjects followed by plenaries and breakout sessions focused on building trust in the community and navigating the ever-changing field of artificial intelligence in human research. All the presentations at this event meet the criteria in the Certified IRB Professional (CIP) recertification guidelines.   Review the agenda and register now to save your spot! - https://lnkd.in/gJvhH_3T