Public Policy

PRIM&R’s Public Policy Committee (PPC) promotes public policies that reflect the highest ethical standards and best practices in research involving human and animal subjects. The PPC tracks policy initiatives and changes issued by government agencies and policy organizations. The Committee also oversees the development of oral and written comments on particular policies that it determines are relevant to PRIM&R's mission and warrant PRIM&R's input. Periodically, PRIM&R will appoint a task force to draft comments in response to a particular policy initiative. Members interested in participating in a policy task force should monitor our monthly Newsletter to learn about new policy initiatives. 

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 (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. Download a copy of the full report or the Toolkit excerpt.

Questions?
Please contact us via e-mail or telephone at 617.423.4112, ext. 15.  Thank you!