Public Policy

PRIM&R Comments to FDA on Draft Guidance on external controls

Agency: Food and Drug Administration

Date submitted: April 30, 2023

PRIM&R submitted comments on FDA’s Draft Guidance for Industry, on “Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products,” published in the Federal Register on February 1, 2023. In its comments, PRIM&R noted that while the draft guidance was well-crafted, it does not address ethical issues in studies involving external controls. Specifically, the guidance is silent on respecting individuals’ consent for the use of their data that were collected for other purposes. PRIM&R recommended that the guidance include a section that both specifies factors that the IRB should take into consideration when evaluating the appropriateness of a proposed external control and advises investigator on the type of information they should include in their IRB protocols to describe the control selected and the rationale for selecting it. 
Download a PDF of the full letter
 

PRIM&R Comments to USDA APHIS on the ANPRM on Environmental Enrichment for Regulated Species

Agency: USDA  Animal & Plant Health Inspection Service (APHIS)

Date submitted: April 10, 2023

PRIM&R focused its comments to USDA, on the ANPRM published in the Federal Register on January 9, 2023, exclusively on the section on environmental enrichment of all covered species. In its comments, PRIM&R stated that similar to existing requirements for nonhuman primates and marine mammals, environmental enrichment standards for other species should be evidence-based, rather than based on non-scientific approaches, such as anthropomorphism and/or colloquial experience. In addition, given the dearth of information on and understanding of the needs of many of the other species that are covered under the AWA, PRIM&R recommended that, before establishing environmental enrichment standards for all other AWA covered, species, USDA support research in areas such as animal behavior, comparative psychology, and ethology to better elucidate environmental needs that sustain the wellbeing of different species.
Download a PDF of the full letter

PRIM&R Comments on OSTP RFI on Clinical Research Infrastructure and Emergency Clinical Trials

Agency: Office of Science and Technology Policy
Submitted: January 26, 2023

PRIM&R responded to the OSTP Request for Information on Clinical Research Infrastructure and Emergency Clinical Trials. Based on the lessons learned from the flexibility, creativity and ingenuity demonstrated by the research community in the early days of the COVID-19 pandemic, PRIM&R comments focused on three specific: 1) Streamlining institutional review board (IRB) review for research during emergencies; 2) Utilization of public health surveillance during emergencies ; and, 3) Tension between clinical care and research during public health emergencies.

Download a PDF of the full letter

PRIM&R Comments to FDA on Harmonization

Agency: Food and Drug Administration
Submitted: December 23, 2022

PRIM&R submitted comments to the FDA endorsing the proposed rule to harmonize FDA regulations for institutional review boards (IRBs) and human subjects protections with the revised Common Rule. PRIM&R believes that harmonization will indeed achieve its intended goal of streamlining the review of research and reducing regulatory burden, especially in cases where both sets of regulations apply.

Download a PDF of the full letter.

PRIM&R Comments to FDA on Draft Guidance for Ethical Considerations for Research with Children

Agency: Food and Drug Administration
Submitted: December 23, 2022

PRIM&R submitted comments on the FDA’s Draft Guidance for Industry, Sponsors, and Institutional Review Boards on “Ethical Considerations for Clinical Investigations of Medical Products Involving Children, In its comments, PRIM&R applauded FDA’s efforts and provided additional that PRIM&R believes will not only enhance the utility of the guidance but also bolster public trust and confidence in biomedical research with children.

Download a PDF of the full letter.

PRIM&R Comments to FDA on sIRB

Agency: Food and Drug Administration
Submitted: December 23, 2022

PRIM&R submitted comments to the FDA on its proposed rule harmonizing FDA regulations with the provisions of the revised Common Rule regarding the use of a single IRB (sIRB) for multi-site or cooperative research studies. While PRIM&R applauded FDA efforts to reduce regulatory burden on the research community PRIM&R believed that it is premature for FDA to mandate the use of a sIRB and recommended a more thorough evaluation of the impact of the rule on the regulated community, before it is finalized. 

Download a PDF of the full letter.

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.

PRIM&R Responded to the NIH RFI on a Framework for the NIH-wide Strategic Plan for Diversity, Equity, Inclusion, and Accessibility

Agency: NIH
Submitted: March 11, 2022

PRIM&R responded to the NIH Request for Information Inviting Comments and Suggestions on a Framework for the NIH-wide Strategic Plan for Diversity, Equity, Inclusion, and Accessibility. In its comments, PRIM&R noted that the published framework was extremely spares and insufficient in allowing interested parties to provide substantive feedback. Thus, PRIM&R recommended that NIH publish a more well-developed draft framework to ensure more thoughtful and detailed comments and suggestions from the research community.

Download a PDF of the full letter.

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.

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.