Public Policy

Objections to HHS Proposal for Retrospective Review

Agency: US Department of Health and Human Services (HHS)
Submitted: December 3, 2020

PRIM&R responded to a notice of proposed rulemaking, Securing Updated and Necessary Statutory Evaluations Timely, that mandates regular retrospective review by HHS of its regulations. Though retrospective review is a worthy goal, the plan laid out by HHS in this proposed rule is an overly blunt and rigid tool for a process that demands nuance and flexibility.

PRIM&R Supports Proposed Changes to AWA Facility Registration Rules

Agency: USDA Animal and Plant Health Inspection Service (APHIS)
Submitted: November 13, 2020

PRIM&R submitted comments in support of the changes to AWA Facility Registration Rules proposed by USDA’s Animal and Plant Health Inspection Service, agreeing that the changes would reduce duplicative requirements and administrative burden.

Serious Concerns About EPA Transparency Supplement

Agency: Environmental Protection Agency (EPA)
Submitted: May 15, 2020

PRIM&R responded to the EPA supplemental notice of proposed rulemaking adding to the previously issued Strengthening Transparency in Regulatory Science rule, joining other science and health groups in voicing serious concern about the supplement, which expands the scope of the original rule.

NIH-Wide Strategic Plan For FYs 2021-2025

Agency: National Institutes of Health (NIH)
Submitted: March 30, 2020

PRIM&R responded to the NIH Framework for the NIH-Wide Strategic Plan for FYs 2021-2025 expressing support for the breadth and aims of the framework and suggesting ways that NIH can refine, including the clarification of language around “stewardship,” explicit recognition of the value of participant-submitted data, acknowledgment of rigor and reproducibility efforts in research involving animals, and a broad vision for the range of stakeholders included in the “[promotion] of collaborative science.”

Desirable Characteristics of Data Repositories.

Agency: White House Office of Science and Technology Policy (OSTP)
Submitted: March 2, 2020

PRIM&R responded to OSTP's Draft Desirable Characteristics of Repositories for Managing and Sharing Data Resulting From Federally Funded Research welcoming this step toward harmonizing policies and enhancing responsible research and presenting some recommendations to enhance the outlined desirable characteristics of data repositories.

Ensuring Public Access to Government Funded/Conducted Research

Agency: National Institutes of Health (NIH)
Submitted: January 10, 2020

PRIM&R responded to the NIH "Draft NIH Policy for Data Management and Sharing and Supplement Draft Guidance" applauding the NIH for proactively taking steps to accelerate data sharing efforts, while also offering a few constructive suggestions centered primarily around privacy, informed consent, and oversight funding issues.

Considerations for Clinical Studies

Agency: Food and Drug Administration (FDA)
Submitted: September 16, 2019

PRIM&R responded to the FDA revised “E8 (R1) General Considerations for Clinical Studies” guideline approving of the the  FDA's work with the International Conference of Harmonization (ICH) to modernize their guidelines, but also suggesting that the document could benefit from a better discussion of the broad ethical principles that underlie many of the human subject protections the document details.

Enhancing the Diversity of Clinical Trial Populations

Agency: Food and Drug Administration (FDA)
Submitted: July 30, 2019

PRIM&R responded to the FDA draft guidance on "Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs," thanking the FDA for issuing the draft guidance as part of their recent significant efforts to enhance diversity in clinical trial participation, but calling for more robust discussion of the ethics of enhancing clinical trial diversity and broad recommendation for sponsors to plan for the full range of risks historically underrepresented groups might face.

Artificial Intelligence/Machine Learning-Based Software as a Medical Device

Agency: Food and Drug Administration (FDA)
Submitted: June 3, 2019

PRIM&R responded to the FDA Discussion Paper: "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” expressing appreciation to the FDA for rethinking its regulatory framework for devices as the use of adaptive AI/ML-based technologies become increasingly prevalent and asking the FDA to consider the ethical impact of generating training data and optimizing algorithmic models through data that comes from interactions with human beings in real time.

Cancer Clinical Trial Eligibility Criteria and Pediatric Patients

Agency: Food and Drug Administration (FDA)
Submitted: May 13, 2019

PRIM&R responded to FDA draft guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients, applauding the FDA for their ongoing work to enhance clinical trial access for younger patients and for the level of detail in the guidance and suggesting that the FDA clarify what is meant by “infeasible" and recommending that the agency encourage sponsors to describe in protocols how the pediatric data obtained will be used to support pediatric labeling.

Reducing Administrative Burden

Agency: Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH)
Submitted: February 15, 2019

PRIM&R responded to OLAW's "RFI: Input on Draft Report from Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research" welcoming changes from an earlier RFI and asking the agencies to implement a process for keeping the research oversight community informed and involved in determining the final product.

Modifying HIPAA Rules to Improve Care

Agency: Office for Civil Rights (OCR), Department of Health and Human Services (HHS)
Submitted: February 11, 2019

PRIM&R responded to the OCR "Request for Information on Modifying HIPAA Rules to Improve Coordinated Care" suggesting that as the OCR evaluates how to modify the HIPAA Rules to reduce regulatory burdens and facilitate more efficient care coordination, they could also conduct a parallel evaluation of the HIPAA Rules as they are applied to research.

IRB Waiver or Alteration of Consent

Agency: Food and Drug Administration (FDA)
Submitted: February 5, 2019

PRIM&R responded to the FDA proposed rule "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations" applauding the FDA for taking steps to harmonize their human subject regulations with the Common Rule, but raising two areas of consideration for the FDA.

The Next Phase of Human Gene-Therapy Oversight

Publication: New England Journal of Medicine
Published: January 24, 2019

PRIM&R responded to an article in the New England Journal of Medicine, stressing the importance of the Recombinant DNA Advisory Committee (RAC) in fostering public discussion about whether new technologies should be specially regulated, or even initiated. 

Data Management and Sharing Policy

Agency: National Institutes of Health (NIH)
Submitted: December 3, 2018

PRIM&R responded to the NIH Request for Information on "Proposed Provisions for a Draft Data Management and Sharing Policy for NIH Funded or Supported Research," expressing support for data sharing initiativess, but also pointing to data sharing risks and seeking clarification and further guidance from the agency. 

Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Agency: National Institutes of Health (NIH)
Submitted: October 16, 2018

PRIM&R responded to an NIH proposal to amend its "Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules," agreeing with the overall need to reduce duplicative oversight, but expressing serious concerns about scaling back the Recombinant DNA Advisory Committee (RAC).

Including Pregnant Women in Clinical Trials

Agency: Food and Drug Administration (FDA)
Submitted: June 8, 2018

PRIM&R responded to FDA draft guidance on “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials,” applauding the FDA for taking this important step to fill regulatory gaps around the inclusion of pregnant women in FDA-regulated clinical trials so they may share the benefits of clinical trials (namely, access to safe and effective medication).

Coordination of Regulations as Required by 21st Century Cures Act

Agencies: National Institutes of Health (NIH), US Department of Agriculture (USDA), and the Food and Drug Administration (FDA)
Submitted: May 23, 2018

PRIM&R responded to the NIH, USDA, and FDA 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)," advocating that any new regulatory policy better support the work of IACUCs and the research oversight community and reduce bureaucratically intensive regulations that do not necessarily translate to better animal welfare.

New Notice of Proposed Rulemaking Delaying Compliance Date for the "Common Rule"

Agency: Department of Health and Human Services (HHS)
Submitted: May 14, 2018

PRIM&R responded to the HHS (16 other federal agencies) new Notice of Proposed Rulemaking (NPRM) proposing to delay the general compliance date for the "Common Rule" to January 21, 2019, endorsing the proposal predicated on an understanding that during the delay the agencies produce much-needed guidance and make it available to the regulated community in advance of the compliance date.

Congress Should Support the Lab Animal Oversight Community

Publication: The Hill
Published: April 13, 2018 

In an opinion article for The Hill, 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.

Simplifying Lab Animal Regulations Without Weakening Welfare Standards

Publication: STAT
Published: April 4, 2018

PRIM&R's Executive Director, Elisa A. Hurley, PhD, argues in a STAT First Opinion article that as the government works to review and revise laboratory animal research policies and regulations, as mandated by the 21st Century Cures Act, federal decision-makers should not let legitimate and important concerns about administrative burdens obscure the crucial role that regulations can play in promoting the ethical and humane use of lab research animals.

Research Cuts Threaten Public Trust

Publication: Science
Published: June 30, 2017

David H. Strauss, Darby G. Hull, and Elisa A. Hurley (on behalf of PRIM&R's Public Policy Committee) responded in a letter to the editor to a Science article by Jocelyn Kaiser detailing how President Trump’s budget proposes to cut the National Institutes of Health budget by $4.6 billion by substantially reducing payments for indirect costs, pointing out that such indirect cost payments cover processes that serve to protect the safety and rights of those who participate in research.

Including Pediatric and Elderly Populations in Clinical Research

Agency: National Institutes of Health (NIH)
Submitted: June 30, 2017

PRIM&R responded to the NIH "Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the Lifespan" endorsing the NIH’s efforts to promote research involving pediatric and elderly populations, but emphasizing and providing examples of the ethical complexities that must be considered when including such groups in research.

Ethics of Data Access, Use, and Sharing

March 1, 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). Thirty-nine leaders in the field participated in the day's roundtable and discussed the ethics of data access and sharing as a component of a range of current and emerging human subjects research activities. Summary and video of the day can be found here.

IRB Written Procedures

Agencies: Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA)
Submitted: October 3, 2016

PRIM&R responded to the OHRP and FDA draft guidance on IRB written procedures, noting that the checklist format may be particularly useful to institutions that currently have little in the way of written procedures and are looking to strengthen their research oversight infrastructure, but recommending that the agencies provide specific examples and clarify the target audiences for the guidance to prevent "mission creep."

Reform of Clinical Research Regulations

Publication: New England Journal of Medicine
Published: April 28, 2016

Three members of PRIM&R’s leadership, Alexander M. Capron, LLB, Elisa A. Hurley, PhD, and David H. Strauss, MD, responded to the New England Journal of Medicine Perspectives article by Zeke Emanuel, disagreeing with Emanuel and concluding that, while an improved and modernized system of human subjects protections will better serve both research participants and good science, the regulatory changes mandated by the NPRM do not instill confidence and need further work.

Sharing Clinical Trial Data

Group: International Committee of Medical Journal Editors (ICMJE)
Submitted: April 18, 2016

PRIM&R responded to the the ICMJE proposed new requirements for sharing clinical trial data, voicing support for initiatives to promote data sharing and pointing out  out several practical and policy issues that will need to be addressed if data sharing mandates are put in place.

IRB Meeting Minutes

Agencies: Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA)
Submitted: February 3, 2016

PRIM&R responded to the OHRP and FDA draft guidance on meeting minutes for IRBs who oversee human subjects research under the FDA and/or DHHS regulations, agreeing that additional guidance about the required content and emphasis of IRB meeting minutes could benefit the research community and that documentation requirements can support human subjects protections, but noting that documentation requirements represent a double-edged sword. 

Common Rule Revisions Fall Short

Publication: The New York Times
Published: January 11, 2016

Three members of PRIM&R’s leadership, Alexander M. Capron, LLB, Elisa A. Hurley, PhD, and David H. Strauss, MD, responded to a New York Times opinion piece written by Rebecca Skloot, contending that the proposed regulations in the Department of Health and Human Services’ 2015 Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule 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."