Public Policy

Comments to ORI on 2005 PHS Policies on Research Misconduct

Agency: Office of Research Integrity
Submitted: October 31, 2022

PRIM&R responded to the Office of Research Integrity (ORI) Request for Information and Comments on the 2005 Public Health Service Policies on Research Misconduct. Given that the research landscape is radically different from when this policy was issued, PRIM&R endorsed the long-overdue revision. In it’s comments, PRIM&R also urged ORI to undertake a broader and more wholistic assessment of the current research landscape, so as to be better positioned to guide the community on emerging issues in research integrity.

Download a pdf of PRIM&R's full comments

Comments to FTC on ANPR Commercial Surveillance and Data Security

Agency: Federal Trade Commission (FTC)
Submitted: October 21, 2022
 

PRIM&R submitted comments to the Federal Trade Commission (FTC) on the Advance Notice of Proposed Rulemaking (ANPR) on Commercial Surveillance and Data Security. PRIM&R strongly supported the FTC effort to establish a federal oversight mechanism for the digital technology sector, specifically to protect consumers from harms that may result from commercial use of their personal data. PRIM&R also highlighted the importance of responsible data stewardship, especially given the ubiquity of digital technologies in everyday life and the blurring of lines between research and commerce.

Download a pdf of PRIM&R's full comments

Comment on the OHRP Use of Single Institutional Review Board for Cooperative Research Draft Guidance

Agency: Office for Human Research Protections (OHRP) 
Submitted: August 30, 2022

PRIM&R submitted comments to the Office for Human Research Protections (OHRP) on its Draft guidance for the use of single institutional review board (sIRB) for cooperative research. While PRIM&R appreciated OHRP’s efforts to assist, PRIM&R noted that the draft guidance falls short of its stated intent, of providing clarity and reducing regulatory burden. PRIM&R recommended ways in which OHRP can provide clearer guidance on how to comply with the regulatory requirements for sIRB oversight of cooperative research in the US effectively and efficiently.

Download a pdf of PRIM&R's full comments.

Input to NAM Committee on a Framework for Emerging Science, Technology, and Innovation in Health and Medicine

Agency: National Academy of Medicine (NAM)
Submitted: August 10, 2022

PRIM&R submitted comments to the National Academy of Medicine (NAM) Committee on Creating a Framework for Emerging Science, Technology, and Innovation in Health and Medicine. PRIM&R endorsed the Committee’s intent to develop a framework that is founded on the ethical principles of justice, equity, and fairness. PRIM&R also recommended that the Committee take into consideration the impact of evolving social norms on research ethics, the need for enhanced and expanded training in scientific ethics. Lastly, PRIM&R highlighted various shortcomings of the current governance systems for oversight of science, technology, and innovation, and provided suggestions for reform.

Download a PDF of PRIM&R's full comments.

Comments to NIH on Protecting Privacy When Sharing Human Research Participant Data

Agency: National Institutes of Health (NIH)
Submitted: June 20, 2022

PRIM&R submitted comments on the Draft Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data. In its comments, PRIM&R noted that vague and perfunctory language of the diminishes its usefulness to the research. Thus, PRIM&R recommended that NIH consider re-drafting the guidance by more clearly elaborating on the sections on best practices and points to consider, so that NIH-funded researchers and institutions have a clear understanding of how to meet the NIH standards for protecting the privacy of research participants while following the agency’s DMS Policy. 

Download a PDF of PRIM&R's full comments.

PRIM&R Comments on FDA Draft Guidance on Diversity Plans

Agency: Food and Drug Administration (FDA)
Submitted: June 6, 2022

PRIM&R submitted comments to the FDA in response to their "Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials." PRIM&R believes the FDA’s draft guidance represents a significant and welcome step forward in enhancing diversity in clinical trial participation and we applaud the agency’s deliberate efforts to assist industry in advancing this important societal goal by recommending concrete strategies. PRIM&R also provided additional recommendations that we believe will not only enhance diversity in clinical trial participation but will also bolster public trust and confidence in scientific research.

Download a PDF of PRIM&R's full comments.

Letter to OSTP endorsing recommendation to reinstate a Presidential Commission on Bioethics

Agency: White House Office of Science and Technology Policy
Submitted: March 30, 2022

PRIM&R sent a letter to the White House Office of Science and Technology Policy endorsing a recommendation from the Presidents of the National Academies of Science and Medicine to reinstate a Presidential Commission on Bioethics. PRIM&R noted that wide-ranging advances in science and medicine and in the ubiquitous use of digital technologies in medicine, research, as well as in everyday life had transformed the research landscape. In addition, the emergence and widespread adoption of these advances and technologies have far outpaced societal deliberations on their ethical dimensions and implications – a task that warranted the sustained attention of an entity with the stature a Presidential commission.

Download a PDF of the full letter.

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.”