2022 PRIM&R Annual Conference

All Virtual - December 12 - 15, 2022
Over 100 sessions for both human subjects and animal research, their administrators, and leaders. 
Learn strategies for day-to-day oversight work. Attend networking events. Add a half-day workshop to your registration!
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Learn Something New

PRIM&R programs offer opportunities to share information and strategies with experts and colleagues from around the globe.

FDA long awaited proposed rules for IRBs

FDA long awaited proposed rules for IRBs

Wednesday, September 28, 2022, the FDA issued proposed rules for the long-awaited harmonization of FDA regulations for IRBs and human subject protections with the revised Common Rule.

One proposed rule amends sections of 21 CFR 50 and 56 to harmonize language, requirements for informed consent, and provisions for continuing review and recordkeeping.

The other amends 21 CFR 56 to adopt the 2018 Common Rule’s single IRB requirement for cooperative research in the US, with additional exceptions. The comment period for both proposed rules close 11/28/2022.

FDA Draft Guidance for Including and Protecting Children in Trials

FDA Draft Guidance for Including and Protecting Children in Trials

Monday, September 27, 2022 the FDA issued a draft guidance to help industry, sponsors, and IRBs when considering enrolling children in clinical investigations of drugs, biological products, and medical devices. The comment period closes 12/27/2022.

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Comments to OHRP

Comments to OHRP

Agency: Office for Human Research Protections (OHRP) 
Submitted: August 30, 2022

PRIM&R submitted comments to the Office for Human Research Protections (OHRP) on its draft guidance for the use of single institutional review board (sIRB) for cooperative research. While PRIM&R appreciated OHRP’s efforts to assist, PRIM&R noted that the draft guidance falls short of its stated intent, of providing clarity and reducing regulatory burden. PRIM&R recommended ways in which OHRP can provide clearer guidance on how to comply with the regulatory requirements for sIRB oversight of cooperative research in the US effectively and efficiently.

Download a pdf of PRIM&R's full comments.

Resources You Can Access Anytime, Anywhere

Research Ethics Timeline

This timeline summarizes key events in research ethics from 1900 to 2020. It highlights pivotal points that have shaped the current research ethics oversight environment.

Webinar Recordings & Bundles

Recordings of past webinars are available to view on demand! PRIM&R members have complimentary access to over 100 recordings and to webinar bundles.

Conference Archives

Packages of materials and recordings from past PRIM&R programs are available for purchase. PRIM&R members also have complimentary access to conference archives more than a year old.

AROC & EROC

Our Animal Research Oversight Course and Ethical Research Oversight Course are engaging, interactive online course that equip research ethics and oversight professionals for their roles. Individual and institutional licenses available.

PRIM&R On Demand

Access live or recorded programs for groups at your institution. Provide customized, comprehensive education in an effective, economical way. Courses include Exploring Hot Topics in SBER, Introduction to the IRB, Essentials of IACUC Administration, and many more.

Upcoming Dates and Deadlines

Mark your calendar.

Ongoing

Call for Webinar Proposals

We are soliciting proposals for basic, intermediate, and advanced webinars on topics of interest to individuals working in the fields of human subjects protections and animal care and use. 

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Ongoing

Visit PRIM&R's Career Center

The Career Center is an active source for employment opportunities in the research ethics field, with new openings added regularly. Employers can post jobs easily and search resumes. Job seekers can find opportunities at all experience levels from all around the country.

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