HRP Consulting Group

The World Medical Association’s Declaration of Helsinki was recently revised to enhance the commitment to protections of research involving human participants. Read more below.

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

Join National Telecommunications and Information Administration (NTIA)’s virtual listening session today from 3:30–5 PM ET. The session will gather feedback from the public, researchers, civil society, and industry on "Ethical Research with Online/Pervasive Data.

📣 Calling All STEM Students 🔬🧪 FDA's Office of Science and Engineering Labs Summer Research Program Projects for 2025 are now open! Submit your application by Feb. 1, 2025. Go here for a list of all the current summer research opportunities offered. https://lnkd.in/eehpYz5w

I had the pleasure of having a great discussion at PRIM&R's annual conference with Christopher Quarles from NTIA about a planned Request for Comments (RFC) about potential ethical guidelines for research with "pervasive data" - which is defined in the RFC as data about people that is gathered through online services. Christopher reached out to me yesterday to let me know that the RFC had been posted and provided me with permission to share his email to help spread the word. Please see his message copied and pasted below. The RFC can be found here: https://lnkd.in/dmvCwGYX Hi Karen, It was great talking with you at PRIM&R. You had expressed interest in NTIA’s upcoming request for comments. That RFC opened today, and I wanted to make sure you had it. Feel free to share with any individuals or organizations who you think might be interested. NTIA is seeking public comments on potential ethical guidelines for research with “pervasive data” - data about people gathered through online services. This includes, for instance, data from social media platforms, online marketplaces, cell phones, the Internet of Things, wearable devices, and AI systems. This type of research is important for understanding human behavior, public health, the impact of technology, and many other topics. However, it also poses tricky ethical questions around things like privacy, consent, and societal-level effects. We hope to get a wide range of feedback on these potential ethical guidelines. The RFC can be found here, and comments can be submitted through regulations.gov. Comments are due January 15, 2025. Note that commenters don’t need to respond to every question in the RFC. They can also provide relevant input on the topic even if there is no related question.  In addition, we will be hosting a public online listening session on the same topic on December 17, 3:30-5:00 Eastern Standard Time. This is an opportunity for members of the public to share their thoughts verbally with the government. I am happy to answer any questions you or others have. We would like the submission process to be clear and accessible, including for people who have never submitted to an RFC before. _______________________________________________ Christopher Quarles, Ph.D. Information Policy Specialist National Telecommunications and Information Administration [email protected]

I had the pleasure of having a great discussion at PRIM&R's annual conference with Christopher Quarles from NTIA about a planned Request for Comments (RFC) about potential ethical guidelines for research with "pervasive data" - which is defined in the RFC as data about people that is gathered through online services. Christopher reached out to me yesterday to let me know that the RFC had been posted and provided me with permission to share his email to help spread the word. Please see his message copied and pasted below. The RFC can be found here: https://lnkd.in/dmvCwGYX Hi Karen, It was great talking with you at PRIM&R. You had expressed interest in NTIA’s upcoming request for comments. That RFC opened today, and I wanted to make sure you had it. Feel free to share with any individuals or organizations who you think might be interested. NTIA is seeking public comments on potential ethical guidelines for research with “pervasive data” - data about people gathered through online services. This includes, for instance, data from social media platforms, online marketplaces, cell phones, the Internet of Things, wearable devices, and AI systems. This type of research is important for understanding human behavior, public health, the impact of technology, and many other topics. However, it also poses tricky ethical questions around things like privacy, consent, and societal-level effects. We hope to get a wide range of feedback on these potential ethical guidelines. The RFC can be found here, and comments can be submitted through regulations.gov. Comments are due January 15, 2025. Note that commenters don’t need to respond to every question in the RFC. They can also provide relevant input on the topic even if there is no related question.  In addition, we will be hosting a public online listening session on the same topic on December 17, 3:30-5:00 Eastern Standard Time. This is an opportunity for members of the public to share their thoughts verbally with the government. I am happy to answer any questions you or others have. We would like the submission process to be clear and accessible, including for people who have never submitted to an RFC before. _______________________________________________ Christopher Quarles, Ph.D. Information Policy Specialist National Telecommunications and Information Administration [email protected]

Listen now! On Research Podcast Episode 10: The Role of Pharmacy in Research This episode welcomes special guest Adam Samson, Head of Clinical Delivery Operations at Walgreens, and discusses the evolution of pharmacy in clinical research. What topics do you want the On Research Podcast to explore? Let us know in the comments. https://lnkd.in/eBF6yjNQ #Pharmacy #ClinicalResearch

We’re here at #PRIMR24. Stop by our booth to get your carabiners and chocolates!

#PRIMR24 is only a few days away! You can find us in the mornings at registration handing out complimentary water bottles and at our booth. And, if you didn't already know, our very own Karen Christianson will be presenting Tuesday night (IRB Review of Research Involving Politicized Topics and Populations). We're looking forward to seeing everyone!