April 27, 2023

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Secretary’s Advisory Committee on Human Research Protections (SACHRP) Responds to Recommendation to Improve Approaches to Measuring IRB Effectiveness

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Biomedical Research Awareness Day (BRAD) and the Journey From Research Using Animals to Research Involving Humans (free recording included!)

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Member Spotlight: A Conversation With Dawn Prospect

This past month we chatted with PRIM&R Member Dawn Prospect, consultant for HRP Consulting Group. Dawn shared her thoughts with us about the harmonization of FDA regulations, getting started in human research protections, research compliance, and more. A member since 2006, she currently serves on PRIM&R’s Membership Committee. In her free time Dawn enjoys crocheting, reading, playing racquetball, and traveling with her husband and two daughters.

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Call to Action: Public Policy

Visit PRIM&R Public Policy webpage to keep abreast of relevant open comment periods and to get information on how to submit comments. The listed items are open for comment.

For questions, feedback, or to let us know about a policy item not listed, please contact us.

FDA Draft Guidance on Considerations for Design and Conduct of Externally Controlled Trials for Drugs and Biological Products

Response due by May 2, 2023

Request for Information (RFI) on Update to NOT-OD-05-034 Guidance on Prompt Reporting of Noncompliance to OLAW

Response due by May 5, 2023

USDA ANPRM on Environmental Enrichment for Regulated Species

Response due by May 5, 2023

FDA Framework for the Use of DHTs in Drug Development

Response due by May 23, 2023

Research with Children not Approvable by IRB-Guidance on Process for Referral to FDA and OHRP

Response due by May 30, 2023

Free Program Recordings

Diversity, Equity, Inclusion, and Justice Resources

The IRB's Role in Achieving Diversity in Research (1.25 CEs)

Embedding a Racial Justice Lens into Research and IRB Review With Human Subjects—How to Be an Anti-Racist at Work Every Day

Eligible for Continuing Education Credits (CEs)

Nurturing a Healthy Post-approval Monitoring Program: A Case-Based Approach (1.25 CEs)

Un-Common Rules: Navigating FDA-Regulated Research and the IRB (1.5 CEs)

Introducing PRIM&R's New Mentoring Program

We’re excited to announce a major update to our longstanding Mentoring Program, which began in 2005 to enable research ethics professionals at various stages of their careers to connect and learn from one another. The Mentoring Program is now part of the PRIM&R Online Community, and is member-driven! This updated program gives you better control over your participation status, match criteria, and mentoring relationships, making it easier than ever to make meaningful connections and advance your career.

Learn More About Mentoring

Enroll as a Mentor or Mentee

May is Member Appreciation Month!

To thank our members for helping PRIM&R advance the highest ethical standards in the conduct of research, we're offering special perks and free content all month long! Click below to learn more.

Connect with your colleagues to discuss challenges, successes, regulation, and more with our Online Communities!

Latest Discussions

IACUC Channel: OLAW Animal Welfare Assurance Renewal Delays

IRB Forum: Criteria for Requiring Amendments for Exempt Research

SBER Network: SBER IRBs that are Using Digital Document Submission Systems

Post your resume, apply for open positions, and receive job alerts from over 300 postings through PRIM&R’s Career Center. Hiring? PRIM&R members receive discounts on job postings.

Career Center Postings

Research IRB Protocol Analyst 2 | The Ohio State University

Research Conflict of Interest Administrator | Oregon State University

IACUC Administrator | University of North Texas Health Science Center at Fort Worth

Upcoming Events and Dates

5/12: Call for 2023 PRIM&R Annual Conference Posters are due!

5/25 Webinar: Implementing New National Science Foundation Responsible Conduct of Research Requirements: Key Considerations for Institutions. This webinar is free to all!

6/16 Workshop: Exploring the Common Rule: A Guide for Beginners

6/25 Webinar: Diversity, Equity, Inclusion, and Justice Tools for IRBs

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