Other Policy Initiatives

The PRIM&R Public Policy Committee oversees special initiatives that it determines are relevant to PRIM&R's mission and warrant PRIM&R's input. Information on PRIM&R's most recent public policy initiatives are listed below.

2011

April 2011

The Boundaries Between Research and Practice was a meeting held on April 27, 2011, in order to develop guidance for persons making decisions regarding the need for ethical review or oversight of health-related activities conducted along the boundary between research and practice. The result of this effort is reflected in PRIM&R’s white paper titled Health-Related Activities Along the Boundary Between Research and Practice: When to Take Alternate Approaches to Providing Ethical Oversight. Learn more about this project here

April 2011

Strategies for Returning IRBs for their Subject Protection Roots was a meeting held on April 26, 2011 to develop strategies that will help IRBs identify the essential responsibilities and tasks that are necessary for assessing and managing the ethical issues that IRBs were intended to consider. For more information please view the meeting agenda and attendee list.

2007

March 2007

The establishment of the PRIM&R Human Tissue/Specimen Banking Working Group and the development of a 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 (IRB) 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 part 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 the form of educational materials, discussions of relevant issues, and points to consider.