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Publications

PRIM&R develops educational materials, publications, and resources on a wide range of topics, including centralized IRB review, HIPAA compliance, research administration, tissue banking, and ethical, legal, and procedural issues related to the conduct of human subjects research. Publications that are currently available are listed below.

Our Conference Proceedings have become standard references in the field, and are now available online and in a CD-ROM-based platform. Conferences from 2002 on are available in this format, and many prior years’ conference proceedings are still available as hard copy publications. Please visit our Conference Proceedings page to learn more.

>> PRIM&R Human Tissue/Specimen Banking White Paper
The establishment of the PRIM&R Human Tissue/Specimen Banking Working Group and the development of this White Paper was a collaborative effort between PRIM&R and Partners HealthCare Systems, Inc. with support from NIH Clinical Research Policy Analysis and Coordination Program and the NCI Cancer Diagnosis Program. The purpose of the Working Group was to identify current barriers to the collection, storage, distribution, and use of human specimens and data in research, and to develop strategies for overcoming those barriers while protecting subjects. The Working Group reflected the full range of stakeholders involved in specimen banking (see participant list in the Introduction) and included institutional review board members, lawyers, ethicists, researchers and repository managers, patient advocates, and representatives from industry, academia, and government.

The White Paper is organized into two parts. The first section includes a discussion of the challenges and recommendations to the federal regulatory and funding agencies. The second part provides tools for IRBs, repository managers and researchers in in the form of educational materials, discussions of relevant issues, and points to consider. Download a copy of the full report or the Toolkit excerpt.

>> PRIM&R Through the Years: Three Decades of Protecting Human Subjects
A compilation of nearly thirty years of key talks delivered at PRIM&R conferences, PRIM&R Through the Years is an essential reference tool for all those working in the human research subjects protections field. No person or institution involved in human subject protections should be without this anthology. PRIM&R Through the Years is an enduring chronicle of wise and thoughtful presentations given by the most respected and revered giants in the research ethics field. Many of these talks are as relevant today as they were when first delivered.

PRIM&R Through the Years is an essential companion for any person or program seeking to advance the highest ethical standards in the conduct of research. We cannot advance these standards without the history of the field in full focus. We are only able to honor human subjects if we learn—and apply—the lessons from the past. Order your copy today! 

>> The Art of Running a Successful IRB Meeting
Does your IRB/HRPP or IACUC meeting meander off-topic? Do some members drone on and on, bogging down discussion? Do some members hold back from participating? The memorable, fun, and practical tools presented in this self-study video CD-ROM will help members and chairs alike increase their meetings’ effectiveness. Based on Melissa Lewis’s highly acclaimed and entertaining program from previous PRIM&R conferences, this resource offers strategies to:

• Refocus the discussion when it has meandered off-topic;
• Get quiet members to speak up and contribute;
• Facilitate creative compromise when members are butting heads;
• Rescue an idea that has been “plopped”; and
• Recognize and cope with efficiency killers.

The CD-ROM contains video and PowerPoint slides from the program itself, along with an electronic library of articles, numerous practical examples, and other tools to make your IRB/HRPP or IACUC meeting more efficient and enjoyable for everyone.  Order your copy today!

>> Investigator 101
PRIM&R is proud to offer Investigator 101, a CD-ROM based on the successful IRB 101sm educational program for investigators. Divided into convenient ten-minute modules, the CD-ROM reviews the history and ethics of human subject research and the top ten responsibilities of investigators. Jeff Cooper, MD, and Ada Sue Selwitz, MA, two eminent teachers, writers, and leaders in the fields of research ethics and the regulation of research, have designed this course on CD-ROM so that research staff and investigators can easily and effectively learn the ethical and legal issues related to the conduct of research with human subjects.

Entities without Federal-wide Assurances (FWA) can order the Investigator 101 CD-ROM through PRIM&R today. Organizations that are non-FWA non-profits can purchase a master copy of the CD-ROM for $1,200 per copy. Non-FWA for-profits can purchase a master copy for $3,000 per copy.

The Office for Human Research Protections (OHRP) distributes the Investigator 101 CD-ROM to entities that hold an approved Department of Health and Human Services Assurance (FWA or MPA). Please contact OHRP at 301.496.7005 for more information.

>> Study Guide for Institutional Review Board: Management and Function
Developed by ARENA, PRIM&R's former membership division, this study guide companion to Institutional Review Board: Management and Function, Second Edition (2006) facilitates the application of knowledge acquired from the textbook. Written by IRB people for IRB people, this study guide is a useful resource that promotes the professional development of individuals working in the field of human subjects protection.

Purchasing Information:
The study guide is purchased directly from the publisher, Jones and Bartlett Publishers. You may order the study guide online.

>> OLAW IACUC Handbook
The OLAW IACUC Handbook, developed in collaboration with ARENA, PRIM&R's former membership division, was first published in 1992. The 2002 Second Edition continues to promote the fundamental principle of animal care and use programs: self-regulation with oversight. This comprehensive reference for IACUC professionals incorporates guidance and policies from a variety of critical resources. Practical advice for the IACUC practitioner is also offered. Visit the OLAW website to learn more and to obtain your copy of the Handbook.

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