Public Policy

PRIM&R Critical of EPA Transparency Rule

May 15, 2020
PRIM&R submitted comments to the EPA in response to their recent supplemental notice of proposed rulemaking on Strengthening Transparency in Regulatory Science joining other science and health groups in voicing serious concern about the rule.

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.

PRIM&R Comments on Desirable Characteristics of Data Repositories

March 3, 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.

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.

Animal Rehoming and Euthanasia, Sex Bias in Research, and more at IACUC20

February 20, 2020
PRIM&R's 2020 Institutional Animal Care and Use Committee Conference will take place April 5-7 at the Renaissance Orlando at SeaWorld® in Orlando, FL. Complimentary registration is available for credentialed journalists from health, medical, science, and policy outlets or beats.

PRIM&R Comments on Draft NIH Policy for Data Management and Sharing

January 16, 2020
PRIM&R responded to the NIH "Draft NIH Policy for Data Management and Sharing and Supplement Draft Guidance" applauding the proactive step to accelerate data sharing efforts and offering a few constructive suggestions centered primarily around privacy, informed consent, and oversight funding issues.

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.

PRIM&R Responds to FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations

August 2, 2019
PRIM&R responded to the FDA draft guidance on "Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs," 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.

PRIM&R Responds to FDA, "Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device”

June 10, 2019
PRIM&R responded to the FDA Discussion Paper: "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device” 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.

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.