Public Policy

Reducing Administrative Burden

February 15, 2019

PRIM&R responded to OLAW's proposed provisions and asks the agencies to implement a process for following up on their proposed changes.

Modifying HIPAA Rules to Improve Care

February 11, 2019

PRIM&R suggests that as the OCR evaluates how to modify the HIPAA Rules to reduce regulatory burdens and facilitate more efficient care coordination

IRB Waiver or Alteration of Consent

February 5, 2019

PRIM&R applauds the FDA for taking steps to harmonize their human subject regulations with the Common Rule; however, PRIM&R raises two areas of consideration for the FDA.

January 2019

In October 2018, the New England Journal of Medicine published a Perspective article by the Director of the National Institutes of Health, Dr. Francis S. Collins, and the Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb, which argued for a new role for the Recombinant DNA Advisory Committee (RAC).

December 2018

On October 10, the National Institutes of Health (NIH) published a Request for Information (RFI) from the public on Proposed Provisions for a Draft Data Management and Sharing Policy for NIH Funded or Supported Research. In our December 2018 response to the RFI, PRIM&R stated that we fully support data sharing initiatives as they allow for the optimization of scarce research resources, accelerate science, maximize the value of research subjects’ contributions, and can minimize risks to subjects.

October 2018

In August 2018, the National Institutes of Health issued a proposal to amend its Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to both reduce redundant reporting requirements and modify the Recombinant DNA Advisory Committee (RAC)’s role in oversight of such research.

August 2018

In April 2018, the Environmental Protection Agency (EPA) put forth a proposed rule"Strengthening Transparency in Regulatory Science," that would prohibit the agency from basing regulatory action on scientific research for which the underlying raw models and data are not available to the public "in a manner sufficient for validation and analysis."

July 2018

In June 2018, the Food and Drug Administration (FDA) released draft guidance on "Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.

June 2018

In April 2018, the Food and Drug Administration (FDA) released draft guidance on “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.”

May 2018

On March 14, 2018, the National Institutes of Health, in coordination with the Department of Agriculture and the Food and Drug Administration, published a 90-day request for comments "seeking information to improve the coordination of regulations and policies with respect to research with laboratory animals as required by the 21st Century Cures Act, Section 2034(d)."

May 2018

In April 2018, the Department of Health and Human Services and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) proposing to delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects, or "Common Rule," six more months to January 21, 2019.

April 2018

In an opinion article for The Hill published April 13, 2018, PRIM&R’s Executive Director, Elisa A. Hurley and PRIM&R Board members, F. Claire Hankenson and David H. Strauss, take the position that Congress should support the lab animal oversight community given its vital role in ensuring the ethical conduct of research with animals.

April 2018

On April 4, 2018, PRIM&R's Executive Director, Elisa A. Hurley, argued in a STAT First Opinion article that as the government works to review and revise laboratory animal research policies and regulations.

June 2017

In June 2017, Science published an article by Jocelyn Kaiser detailing how President Trump’s budget proposes to cut the National Institutes of Health budget by $4.6 billion without affecting spending on science by substantially reducing payments for indirect costs.

June 2017

In April 2017, the National Institutes of Health issued a "Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the Lifespan."

PRIM&R responded in June 2017 that we endorse the NIH’s efforts to promote research involving pediatric and elderly populations, but emphasize and provide examples of the ethical complexities that must be considered when including such groups in research.