Public Policy

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The PRIM&R Public Policy Committee provides expert guidance and input on emerging policy issues that merit PRIM&R’s response and attention. PRIM&R's most recent comments are listed below.

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.

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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

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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.

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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).

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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.

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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.

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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."

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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.

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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.”

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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)."

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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.

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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.

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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.

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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.
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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.

March 2017

In March 2017, PRIM&R's Public Policy Committee held a day-long Ethics of Data Access, Use, and Sharing for Human Subjects Research Workshop in partnership with the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard University (MRCT Center).
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October 2016

In August 2016, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.”

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April 2016

In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed new requirements for sharing clinical trial data.

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April 2016

In December 2015, the New England Journal of Medicine published a Perspectives article by Zeke Emanuel that defended the process and content of the NPRM to change the Common Rule.

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February 2016

In November 2015, the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations.

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January 2016

In December 2015, The New York Times published an opinion piece written by Rebecca Skloot, author of The Immortal Life of Henrietta Lacks. In this piece, Skloot highlights some of the sweeping changes in the Department of Health and Human Services’ 2015 Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule. Three members of PRIM&R’s leadership, Alexander M. Capron, LLB, Elisa A. Hurley, PhD, and David H. Strauss, MD, responded in a letter to the editor that the NPRM’s proposed regulations fall short of the government’s stated goals.

December 2015

In a December 2015 letter to the New England Journal of Medicine, PRIM&R responded to an editorial on the SUPPORT study and argued much of the debate about informed consent engendered by the SUPPORT study was productive, intelligent, and important. Three members of PRIM&R’s leadership, Alexander M. Capron, LLB, Elisa A. Hurley, PhD, and David H. Strauss, MD, stated "We believe that meaningful informed consent in research comparing standard-of-care treatments, like all consent in intervention research, must rest on a clear explanation to the patient of the differences between treatment that is provided in the context of research and treatment that is not."

December 2015

In September 2015, the Department of Health and Human Services (DHHS) solicited feedback on a notice of proposed rulemaking (NPRM), which proposed substantive changes to the Federal Policy for the Protection of Human Subjects for the first time since 1981.

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September 2015

On September 8, the Office for Human Research Protections issued a notice of proposed rulemaking (NPRM), which proposed substantial changes to the Federal Policy for the Protection of Human Subjects. In this brief letter, PRIM&R requests that the comment period be extended to 120 days to allow all interested parties sufficient opportunity to craft thoughtful comments that will assist the Federal government in the rulemaking process. Visit PRIM&R's NPRM Resource page below for everything you need to know about the proposed changes to the Common Rule.

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August 2015

In July 2015, the National Institutes of Health (NIH) released a draft framework for a five-year NIH-wide Strategic Plan.

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July 2015

In April 2015, the Presidential Commission for the Study of Bioethical Issues issued a "Request for Comments on Deliberation and Bioethics Education." In July 2015, Elisa A. Hurley, PhD, responded, in her capacity as Executive Director of PRIM&R, and highlighted the importance of research ethics education in the context of continuing professional education, as well as the role of professional certification programs.

May 2015

On February 24, 2015, a proposed rule titled "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators" was submitted to the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA).

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January 2015

In October 2014, the Office for Human Research Protections released "Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care." PRIM&R responded in January 2015 and expressed concern about the narrowness of the draft guidance’s scope. PRIM&R urges the OHRP to rewrite the document to provide clearer guidance to investigators, IRBs, and sponsors and puts forward several recommendations for future guidance.

January 2015

In December 2014, the National Institutes of Health issued a "Draft Policy on the Use of a Single Institutional Review Board for Multi-Site Research." In January 2015, PRIM&R responded to the draft and acknowledged that the use of a single IRB can be a beneficial approach for some multi-site studies, but cautioned that it is premature and perhaps inappropriate to mandate single IRB review for all NIH-funded and conducted studies. PRIM&R encouraged the NIH to pursue additional empirical research on the use of single IRBs and offered recommendations regarding activities that the NIH can take to support the wider use of the single IRB model.

November 2014

In October 2014, the Office for Human Research Protections issued a request comment on a document titled "Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care." In this brief letter, PRIM&R requests that the comment period for the draft guidance be extended to 120 days to allow all interested parties sufficient opportunity to craft thoughtful comments that will assist the Federal government in the rulemaking process.