Public Policy
Guided by our Public Policy Committee, PRIM&R provides expert guidance and input on emerging policy issues. Browse PRIM&R's public policy work below or use the dropdown to sort by year.
2024
PRIM&R Comments to FDA and OHRP on Guidance for Key Information and Facilitating Understand of Informed Consent
Agency: Food and Drug Administration
Date submitted: April 29, 2024
PRIM&R, in partnership with, the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) and Public Responsibility in Medicine and Research (PRIM&R) submitted combined comments on the proposed joint guidance entitled “Key Information and Facilitating Understanding in Informed Consent” published in the Federal Register on March 1, 2024. The joint comments for FDA/OHRP consideration included (1) Providing additional guidance on what constitutes reasonably foreseeable risks; (2) incorporating data on information that participants consider important; (3) Providing additional guidance on the informed consent process, not just the document; and, (4) acknowledge the challenges presented by variation in individual participants’ perspectives on what constitutes key information.
2023
PRIM&R Comments to FDA on Draft Guidance on external controls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PRIM&R submitted comments on FDA’s Draft Guidance for Industry, on “Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products,” published in the Federal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 In its comments, PRIM&R noted that while the draft guidance was well-crafted, it does not address ethical issues in studies involving external controls.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.
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.
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.
2022
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.
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.
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.
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.
Comments to FTC on ANPR Commercial Surveillance and Data Security
Agency: Federal Trade Commission (FTC)
Submitted: October 21, 2022
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.
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.
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.
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.
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.
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.
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:
- 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,
- 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
- 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: NIHSubmitted: 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.
2021
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.
2020
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.
2019
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.
2018
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.
2017
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.
2016
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
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."
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.
2015
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."
December 2015
In September 2015, the Department of Health and Human Services (DHHS) solicited feedback on a notice of proposed rulemaking (NPRM), which proposed substantive changes to the Federal Policy for the Protection of Human Subjects for the first time since 1981.
September 2015
On September 8, the Office for Human Research Protections issued a notice of proposed rulemaking (NPRM), which proposed substantial changes to the Federal Policy for the Protection of Human Subjects. In this brief letter, PRIM&R requests that the comment period be extended to 120 days to allow all interested parties sufficient opportunity to craft thoughtful comments that will assist the Federal government in the rulemaking process. Visit PRIM&R's NPRM Resource page below for everything you need to know about the proposed changes to the Common Rule.
August 2015
In July 2015, the National Institutes of Health (NIH) released a draft framework for a five-year NIH-wide Strategic Plan.
July 2015
In April 2015, the Presidential Commission for the Study of Bioethical Issues issued a "Request for Comments on Deliberation and Bioethics Education." In July 2015, Elisa A. Hurley, PhD, responded, in her capacity as Executive Director of PRIM&R, and highlighted the importance of research ethics education in the context of continuing professional education, as well as the role of professional certification programs.
May 2015
On February 24, 2015, a proposed rule titled "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators" was submitted to the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA).
January 2015
In October 2014, the Office for Human Research Protections released "Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care." PRIM&R responded in January 2015 and expressed concern about the narrowness of the draft guidance’s scope. PRIM&R urges the OHRP to rewrite the document to provide clearer guidance to investigators, IRBs, and sponsors and puts forward several recommendations for future guidance.
January 2015
In December 2014, the National Institutes of Health issued a "Draft Policy on the Use of a Single Institutional Review Board for Multi-Site Research." In January 2015, PRIM&R responded to the draft and acknowledged that the use of a single IRB can be a beneficial approach for some multi-site studies, but cautioned that it is premature and perhaps inappropriate to mandate single IRB review for all NIH-funded and conducted studies. PRIM&R encouraged the NIH to pursue additional empirical research on the use of single IRBs and offered recommendations regarding activities that the NIH can take to support the wider use of the single IRB model.
January 2015
In December 2014, the National Institutes of Health issued a "Draft Policy on the Use of a Single Institutional Review Board for Multi-Site Research." In January 2015, PRIM&R responded to the draft and acknowledged that the use of a single IRB can be a beneficial approach for some multi-site studies, but cautioned that it is premature and perhaps inappropriate to mandate single IRB review for all NIH-funded and conducted studies. PRIM&R encouraged the NIH to pursue additional empirical research on the use of single IRBs and offered recommendations regarding activities that the NIH can take to support the wider use of the single IRB model.
2014
November 2014
In October 2014, the Office for Human Research Protections issued a request comment on a document titled "Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care." In this brief letter, PRIM&R requests that the comment period for the draft guidance be extended to 120 days to allow all interested parties sufficient opportunity to craft thoughtful comments that will assist the Federal government in the rulemaking process.
September 2014
In July 2014, the US Food and Drug Administration (FDA) announced they were seeking comment on a draft guidance document titled "Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors." PRIM&R’s response, which was submitted in September 2014, commended the FDA for their efforts to further clarify the responsibilities of IRBs, clinical investigators, and sponsors with respect to informed consent, and made several broad recommendations related to the presentation of risks, the responsibilities of investigators, the use of understandable language, the enrollment of non-English-speaking subjects, and the delineation between consent form and the consent process.
2013
November 2013
In September 2013, the National Institutes of Health issued a request for public comments on a draft Genomic Data Sharing (GDS) Policy intended to promote sharing, for research purposes, of large-scale human and nonhuman genomic data generated from NIH-supported and NIH-conducted research. PRIM&R responded in November 2013 by urging NIH to utilize current data sharing possibilities as first and foremost opportunities to educate the public about genomic research. PRIM&R's comments provide some preliminary suggestions for how to create a model of disclosure around data sharing that has this broad educational goal at its core.
August 2013
In June 2013, the Department of Health and Human Services (DHHS) announced a public meeting and comment period to seek input on matters related to the protection of human subjects of research when studying standard of care interventions. PRIM&R responded in August 2013 with suggestions for institutional review board evaluations of standard-of-care comparisons. In their response, PRIM&R also urged DHHS to look ahead and establish appropriate oversight systems for the burgeoning field of research intended to compare the effectiveness of health interventions.
April 2013
In March 2013, the National Science Board, the policy and advisory board of the National Science Foundation, issued a request for information (RFI) titled Reducing Investigator's Administrative Workload for Federally Funded Research.
2012
October 2012
PRIM&R submitted comments to Congressman Edward Markey, (D-MA), on a bill titled "Trial and Experimental Studies Transparency (TEST) Act of 2012", which sought to increase transparency of clinical trials by expanding reporting and registration requirements for ClinicalTrials.gov. PRIM&R expressed support for increasing transparency of clinical trials, but cautioned that preliminary steps should be taken to analyze the efficacy of the current process before attempting to expand its requirements.
2011
April 2011
Strategies for Returning IRBs for their Subject Protection Roots was a meeting held on April 26, 2011 to develop strategies that will help IRBs identify the essential responsibilities and tasks that are necessary for assessing and managing the ethical issues that IRBs were intended to consider. For more information please view the meeting agenda and attendee list.
April 2011
PRIM&R drafted these comments in response to the Request for Comments on Human Subjects Protections in Scientific Studies by the Presidential Commission for the Study of Bioethical Issues. In their response, PRIM&R urges the Commission to consider, and address, the current regulatory requirements for obtaining and documenting informed consent.
April 2011
The Boundaries Between Research and Practice was a meeting held on April 27, 2011, in order to develop guidance for persons making decisions regarding the need for ethical review or oversight of health-related activities conducted along the boundary between research and practice. The result of this effort is reflected in PRIM&R’s white paper titled Health-Related Activities Along the Boundary Between Research and Practice: When to Take Alternate Approaches to Providing Ethical Oversight. Learn more about this project by reading more.
October 2011
Following the July 26, 2011 publication of the Advance Notice of Proposed Rulemaking on human subjects research protections, the OHRP solicited feedback on the questions posed in the notice. PRIM&R responded with specific recommendations on the broad spectrum of topics put forward in the notice, including informed consent, privacy, centralized review, calibrating level of review to level of risk, and post-IRB human subjects protections.
August 2011
PRIM&R submitted a request to the Department of Health and Human Services' Office of Human Research Protections (OHRP) that the comment period for the Advance Notice of Proposed Rulemaking proposing changes to the "Common Rule" published July 26, 2011, be extended from 60 days to 120 days.
July 2011
The American Psychological Association put out a request for comments regarding the revised Guidelines for Ethical Conduct in the Care and Use of Nonhuman Animals in Research. PRIM&R responded by commending the APA for their commitment to ethical conduct and making a suggestion for the further clarification of the Guidelines.
June 2011
In response to a request for comments on the revised International Guiding Principles for Biomedical Research Involving Animals, PRIM&R submitted comments to CIOMS/ICLAS. PRIM&R supports the guidelines, which they describe a morally comprehensive, but would like to see explicit requirements for education for research personnel.
2010
March 2010
PRIM&R developed these comments in response to the FDA's proposed rule on informed consent. PRIM&R supports efforts to fully inform potential research subjects of the risks, benefits, and alternatives potentially encountered as a result of participating in research. However, PRIM&R has two serious concerns with this proposed rule.
January 2010
PRIM&R filed comments in response to OHRP's Draft Guidance on IRB Approval of Research with Conditions. PRIM&R believes this draft guidance document is helpful, but has a few questions to further clarify the guidance.
2009
July 2009
The Association for the Accreditation of Human Research Protection Programs (AAHRPP), of which PRIM&R is a founding member, issued a request for public comment on its "Proposed Revised Accreditation Standards". PRIM&R issued comments, along with those submitted by La Cesta Consultants, LLC, and HRP Associates, LLP.
June 2009
PRIM&R filed comments in response to OHRP's request for public comment on IRB accountability. PRIM&R expressed support of the general proposal to hold institutional review boards (IRBs) and the institutions or organizations operating the IRBs, directly accountable for meeting regulatory requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects.
January 2009
OHRP invited public comment on a draft guidance document entitled, "Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued"
2008
September 2008
PRIM&R's board chair in 2008, Leonard Glantz, JD, responded to a request for information from the Office for Human Research Protections (OHRP) on Human Subjects Protection Training and Education. In his comments, Mr. Glantz stated that it is not necessary for an education requirement to "prescribe in detail the process, content, or evaluation" of an educational program. He instead proposed a framework for education regulation based on institutional discretion.
2007
June 2007
In June 2007, the Food and Drug Administration (FDA) issued a guidance document titled Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting. The guidance document was based on the agency's request for information on adverse event reporting in March 2005, upon which PRIM&R commented. In this response, PRIM&R urges the FDA to provide addition guidance as outlined in their previous set of comments.
April 2007
PRIM&R board chair in 2007, Pearl O'Rourke, MD, responded to an article titled "As Ethics Panels Expand Grip, No Field is Off Limits," that was published in the New York Times. In her response, Dr. O'Rouke stressed the need for and value of the work of institutional review boards (IRBs) in justifying and minimizing risk whenever possible.
January 2007
In January 2007, the Office for Human Research Protections (OHRP) released Draft Guidance on Engagement of Institutes in Human Subjects Research. In their comments, PRIM&R commended OHRP for their efforts to clarify the current policy and suggested two points of clarification.
March 2007
The establishment of the PRIM&R Human Tissue/Specimen Banking Working Group and the development of a White Paper was a collaborative effort between PRIM&R and Partners HealthCare Systems, Inc. with support from NIH Clinical Research Policy Analysis and Coordination Program and the NCI Cancer Diagnosis Program. The purpose of the Working Group was to identify current barriers to the collection, storage, distribution, and use of human specimens and data in research, and to develop strategies for overcoming those barriers while protecting
2006
November 2006
In response to the release of the Food and Drug Administration's (FDA's) Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research, PRIM&R proposed several sections that could use further clarification, including the study design and IRB requirement sections.
January 2006
PRIM&R responded to the Office for Human Research Protections (OHRP) Draft Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others in January 2006 by providing recommendations in three general categories: harmonization of Food and Drug Administration (FDA) and OHRP/National Institutes of Health (NIH) guidance, reporting requirements, and reformatting of the draft guidance.
2005
April 2005
The Applied Research Ethics National Association (ARENA), PRIM&R's former membership arm, responded to the Food and Drug Administration's (FDA's) request for comments on adverse events. The topic of institutional review board (IRB) review of data and safety monitoring plans was also addressed.
May 2005
The Applied Research Ethics National Association (ARENA), PRIM&R's former membership arm, responded to questions put forth by the Office for Human Research Protections (OHRP) on the Proposed Criteria for Determination of Equivalent Protections, drafted in May 2005.