Public Policy

PRIM&R Asks OSTP for Extension of Deadline to Comment on the Development of a Federal Scientific Integrity Policy Framework

Agency: White House Office of Science and Technology Policy
Submitted: March 8, 2022

On March 3, 2022, the White House Office of Science and Technology Policy (OSTP) published a Request for Information on the Development of a Federal Scientific Integrity Policy Framework. Noting the complexity of the four substantive areas in which OSTP is seeking input, PRIM&R submitted a request to OSTP asking that the 30-day deadline for comments be extended to at least another 60 days.

Download a PDF of the PRIM&R request here.

Response to NIH RFI on Genomic Data Sharing Policy

Agency: NIH Office of Science Policy 
Submitted: February 3, 2022 

In November 2021, the National Institutes of Health (NIH) Office of Science Policy (OSP) published a Request for Information (RFI) concerning their Genomic Data Sharing Policy. NIH is seeking public input on potential updates to the original Policy, issued in 2014. Last week, PRIM&R submitted comments welcoming revisions to the policy in the face of evolving technologies and encouraging NIH enhance its public engagement efforts.

In our comments, PRIM&R urged NIH to:

1. Embrace the revision of the original Genomic Data Sharing Policy as an opportunity to undertake a more substantive and meaningful process of public engagement around genomic data sharing,
2. Review and assess the full range of safeguards available for genomic data sharing beyond deidentification of data, which can no longer carry the entire burden ofprotection, and
3. Seriously consider methods and policies for sanctioning parties who misuse the data to which they have been granted access.

Comments for NIH RFI on Consent Language for Future Data and Biospecimen Use

Agency: NIH Office of Science Policy 
Submitted: September 8, 2021 

PRIM&R submitted comments to the National Institutes of Health Office of Science Policy in response to their Request for Information: Developing Consent Language for Future Use of Data and Biospecimens, published July 1, 2021. The document provides sample consent language to include in research where data and biospecimen sharing might occur, which addresses issues including the voluntariness of participating in data sharing, participant discontinuation or withdrawal, risk/benefit ratios of participation, and others. PRIM&R believes that the resource would be more useful to relevant stakeholders if it was clearer in its scope and force, and if it provided additional language explaining the broad context for data sharing.

Letter to ILAR regarding Guide revisions

Agency: National Academies, Institute for Laboratory Animal Research  
Submitted: June 21, 2021 

PRIM&R submitted a letter to the Institute for Laboratory Animal Research at the National Academies in support of a group of colleague organizations who requested that the ninth revisions to the Guide for the Care and Use of Laboratory Animals be made in a collaborative, inclusive manner and with consideration to feedback from the community of animal care institutions and professionals who rely on the Guide in their work. 

Download a PDF of the full letter.

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.