The PRIM&R Public Policy Committee oversees the development of oral or written comments on particular policies that it determines are relevant to PRIM&R's mission and warrant PRIM&R's input. PRIM&R's most recent comments are listed below. Read about PRIM&R's other policy initiatives.
In August 2016, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.”
PRIM&R responded in October 2016 that the draft guidance’s checklist format may be particularly useful to institutions that currently have little in the way of written procedures in place and are looking to strengthen their research oversight infrastructure.
However, PRIM&R recommended the agencies provide specific examples of responsive answers to certain checklist prompts. We warned that without examples of acceptable practices that will “help regulators understand how the IRB operates,” the prompts may do little more than result in documentation that merely reiterates the prompt itself.
We also requested that the guidance clarify exactly who the guidance is for, and ensure that the content matches the intended audience. Without this clarification, the checklist could perpetuate IRB “mission creep,” threatening to divert IRB resources and attention from the core of its work of protecting human subjects.
In December 2015, the New England Journal of Medicine published a Perspectives article by Zeke Emanuel that defended the process and content of the NPRM to change the Common Rule. Three members of PRIM&R’s leadership, Alexander M. Capron, LLB, Elisa A. Hurley, PhD, and David H. Strauss, MD, responded in a letter to the editor. Consistent with PRIM&R's submitted comments on the NPRM, they disagreed with Emanuel, concluding that: "Without question, an improved and modernized system of human-subjects protection will better serve both research participants and good science. Contrary to Emanuel's contention that some change is better than none, we believe that neither the scientific community nor the public can be confident that improved practices will emerge from the regulatory changes mandated by the NPRM. The shortcomings apparent in this attempt at comprehensive reformulation suggest a better approach: careful, step-by-step revisions of individual Common Rule provisions with input along the way from the public, biomedical researchers, the research protections community, and appropriate advisory bodies."
In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed new requirements for sharing clinical trial data. ICMJE asked the public to respond to five questions about their new requirements. PRIM&R responded in April 2016 that we fully support initiatives to promote data sharing. The public availability of patient-level data can optimize the use of existing data sets, enhance accountability, and reduce research redundancy. As a culture, we ask individuals to assume risks associated with being research subjects for the benefit of science and data sharing honors subjects’ contributions to research. But the value of data sharing is not without risk. PRIM&R points out several practical and policy issues that will need to be addressed if data sharing mandates are put in place, including guidance for IRBs on reviewing of data sharing plans and ethical standards for the conduct of secondary analyses on shared data.
In November 2015, the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. This is the first time the agencies have jointly issued specific guidance on IRB meeting minutes.
PRIM&R responded in February 2016 that we agree with OHRP and FDA that additional guidance about the required content and emphasis of IRB meeting minutes could benefit the research community. PRIM&R also agrees that documentation requirements can support human subjects protections by fostering appropriate deliberations around matters most critical to protocol review and approval. However, documentation requirements represent a double-edged sword. While broad requirements can constructively drive substantive discussion of key subject protection issues and actions, an excessive focus on “detailed” documentation will have unwanted consequences and lead to wasted effort and less meaningful written records of IRB activity.
In December 2015, The New York Times published an opinion piece written by Rebecca Skloot, author of The Immortal Life of Henrietta Lacks. In this piece, Skloot highlights some of the sweeping changes in the Department of Health and Human Services’ 2015 Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule. Three members of PRIM&R’s leadership, Alexander M. Capron, LLB, Elisa A. Hurley, PhD, and David H. Strauss, MD, responded in a letter to the editor that the NPRM’s proposed regulations fall short of the government’s stated goals.
Back to top
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."
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. PRIM&R responded in December 2015 that the proposals in the NPRM have a number of serious shortcomings and that efforts to finalize the proposed rule as is should not move ahead. Rather, PRIM&R encourages DHHS to pursue thoughtful, incremental revisions of individual Common Rule provisions that reflect careful study and input along the way from the research community and public. PRIM&R also offers specific recommendations on topics put forward in the notice, including the proposal to redefine research with biospecimens, the mandate for the use of a single-IRB for multisite research, the creation of a new category of excluded research and the expansion of the existing category of exempt research, and the strengthening of the informed consent process.
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 webpage for everything you need to know about the proposed changes to the Common Rule.
In July 2015, the National Institutes of Health (NIH) released a draft framework for a five-year NIH-wide Strategic Plan. PRIM&R responded to the draft in August 2015 and applauded the agency for its long-standing commitment to human subjects protections, the ethical conduct of science, and scientific integrity in its stewardship of the research enterprise. PRIM&R encouraged the NIH to ensure that its new strategic plan emphasizes the centrality that ethics plays in the research enterprise by elevating ethics to a unifying element within its framework.
In August 2015, The Boston Globe published an opinion piece written by Steven Pinker, PhD, a psychology professor at Harvard University. In the piece, Pinker argued that bioethicists need to “get out of the way” of science. Three members of PRIM&R’s leadership, Alexander M. Capron, Elisa A. Hurley, PhD, and David H. Strauss, MD, responded that “science unfettered by ethics is bad science” in a letter to the editor.
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.
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). On May 19, 2015, PRIM&R met with representatives from OIRA to discuss the proposed rule. During the meeting, PRIM&R highlighted four central points: (1) the need for harmonization among regulatory requirements; (2) objections to requiring institutions to register with OHRP protections that go beyond those required by the regulations; (3) concerns about mandating a single IRB of record for all multi-site studies; and (4) the need to provide a framework for delineating the types of activities subject to IRB review.
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.
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.
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.
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.
In January 2014, the Presidential Commission for the Study of Bioethical Issues announced they were seeking public comment on "the ethical considerations of neuroscience research and the application of neuroscience research findings." PRIM&R responded in March 2014 and cautioned the Bioethics Commission against developing a set of guiding ethical principles for neuroscience research that is distinct from the principles of research ethics generally. PRIM&R also encouraged the group to revisit scholarship from past advisory groups, which speaks to how existing ethical and regulatory framework can be applied to at least a subset of neuroscience research.
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.
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.
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. The RFI sought input from principal investigator's on Federal policies and institutional requirements that increase the administrative workload of investigators.
In their response, PRIM&R advocated that any attempts to reduce administrative workload should remain directed at protecting research subjects.
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.
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.
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.
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.
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.
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.
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.
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.
Similarly, PRIM&R commented on OHRP's Draft Guidance on IRB Continuing Review of Research. PRIM&R asserted that the draft guidance was helpful in clarifying ambiguities and had several suggestions to make the document clearer.
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.
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. However the comments state that "PRIM&R would not however, support a regulatory change primarily promulgated to reduce institutional administrative burdens, if they might diminish protections for human subjects. Cooperative review agreements should not be used to waive, transfer or weaken the responsibility of the institution or investigators conducting the research to protect human subjects and to comply with the federal regulations and ethical principles that govern human subjects research."
OHRP invited public comment on a draft guidance document entitled, "Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.'' This draft guidance is intended to explain how to interpret the terms "participation" and "discontinuation of participation" in research. The guidance would also clarify that investigators may continue to analyze already collected individually identifiable private information about a subject even when the subject's participation has been discontinued, and that research may continue to involve human subjects even when the participation of all subjects has been completed or discontinued.
PRIM&R's Public Policy Committee developed comments that request further clarification about the ongoing responsibilities of the investigator and IRB toward subjects who's participation in a study has terminated. Please review PRIM&R's comments.
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.
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.
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.
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.
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.
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.
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.
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.