November Newsletter

Wanted to attend our recent workshop “Beyond Altruism - Exploring Payment for Research Participation” but had a conflict? Fear not! OHRP has got you covered

This year’s Exploratory Workshop (EW) attracted an audience from around the world to learn more about the ethics and utility of payment for research participation. The event covered multiple perspectives and discussions included the impacts, considerations, and challenges for including payment in research.

Check out our EW page to read the summary report, watch the video recordings, and get the workshop slides. Make sure to share this information with your colleagues. Click here for more information.

Join OHRP for the PreCon Workshop of the NIH Grants Conference on December 6, from 12 to 2 pm ET!

Save the date to watch these presentations:

How Do I Know If a Research Study Is Human Subjects Research and What Does That Even Mean?

This presentation will explain what makes a study “human subjects research” under the Common Rule, what responsibilities that entail, and what flexibilities may be available to simplify review for human research protections.

What You Need to Know About FWAs and IRBs to Get Your Grant Money

The presentation will answer questions such as: what is an FWA? What IRB needs to review the study? Is my institution even engaged if our investigators are only responsible for part of the research?

For more information on how to register and access the event, click here.

Start getting your colleagues together to attend OHRP’s in-person Research Community Forum in Knoxville, Tennessee next Spring!

Join OHRP and Oak Ridge Associated Universities, East Tennessee State University, and the University of Tennessee on March 29-30 for our next Research Community Forum titled “Research in the Age of Technology – The impact of innovative and emerging technologies on human subjects research”.

This event will focus on how we can move forward with using, developing, and researching innovative and emerging technologies, while ensuring that the rights and welfare of human research participants in studies utilizing these technologies are protected. Experts and leaders from academia, federal agencies, and national organizations will share their views on these overall topics, as well as specific areas of research, such as Artificial Intelligence (AI), Big Data and Biometric Research, Mobile Health Research, Online and Social Media Research, and much more!

Click here for more information!

Not familiar with OHRP’s Luminaries Lecture Series? Get to know this great educational resource!

Check out our Luminaries Lectures Series, which features videos by esteemed individuals with thought- provoking insights on diverse aspects of human research protections.

Here’s a list of some recently added videos covering the challenges of research during public health emergencies and research studying usual care practices, as well as thoughts from representatives in the research community on how to promote diversity and engagement in research participation:

• “The Covid Drug Wars” – What We Learned from the Front Lines
• “Unusual Practices Masquerading as Usual Care”
• “Vulnerability, Justice, Equity, and Engagement: A Conversation About Public Health and Human Subjects Research”

Use these videos to support educational effort for researchers, HRPP administrators, and others interested in or involved in protecting human participants in research. The videos are eligible for CIP credits.

Click here and start watching!

OHRP’s Guidelines for Reporting Incidents to OHRP Updated!

OHRP is happy to announce release of updated incident reporting guidelines on OHRP’s webpage “Reporting Incidents to OHRP (2022).” The information has been updated to reflect changes to the incident reporting process including the following:

• Updates to the flow diagram to explain what incidents should be reported to OHRP
• Updates to the submission process via the Incident Report Online Form
• Adding a new section explaining how OHRP processes incident reports
• Other changes for clarity

HHS regulations at 45 CFR part 46 require that organizations engaged in or reviewing nonexempt HHS- conducted or supported human subjects research establish and follow written procedures for ensuring prompt reporting to OHRP of incidents such as unanticipated problems involving risk to subjects or others, serious or continuing noncompliance with 45 CFR 46, or suspension or termination of IRB approval to OHRP.

The new reporting guidelines may be found at the following link: www.hhs.gov/ohrp/compliance-and-reporting/guidance-on-reporting-incident/index.html

Belmont Report now available in Spanish!

Did you know that the Belmont Report is the most popular item on OHRP’s website? This oldie but goodie is now also available in Spanish! Visit this page to access the Spanish-translated Belmont Report.

Newsletter Archives!

Missed out on one of OHRP’s monthly newsletters? Remember an event that happened back in March but can’t find the link to it? Now you can access all OHRP’s monthly newsletters at the click of a button on our News and Events page! Bookmark this page for your records!