Public Policy

The PRIM&R Public Policy Committee provides expert guidance and input on emerging policy issues that merit PRIM&R’s response and attention. PRIM&R's most recent comments are listed below. Read about PRIM&R's other policy initiatives.


September 2019

On August 1, the Food and Drug Administration (FDA), as part of their work with the International Conference of Harmonization (ICH), released the revised “E8 (R1) General Considerations for Clinical Studies” guideline for comment by US stakeholders. The ICH was set up to expedite the development of new treatments and allow for the transference of clinical trial data between different countries by harmonizing regulatory requirements. The FDA was one of the ICH’s founding members. On September 16, PRIM&R submitted comments by way of the FDA approving of the ICH’s efforts 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. If stakeholders do not understand the broad ethical principles that justify human subject protection requirements such as selecting appropriate subject populations and providing opportunities for informed consent, they are more likely to see them as merely operational tasks. PRIM&R suggests the ICH could do a better job of providing additional discussion on the following ethical issues: respect for persons, fair distribution of burdens and benefits, special protections for the vulnerable, and risk-benefit evaluation. We also recommend that the ICH consider reorganizing some of its guidelines to make it easier for those conducting research to learn more about the fundamental ethical principles and related best practices.

(For more about the ICH’s role and how to submit your own comments by September 30, see our blog post.)

July 2019

On June 7, the Food and Drug Administration (FDA) published a draft guidance on "Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs." In our July 2019 response, PRIM&R thanks the FDA for issuing the draft guidance as part of their recent significant efforts to enhance diversity in clinical trial participation. The guidance offers many practical strategies that sponsors and other parties can adopt to advance the important goal of ensuring that clinical trial enrollment better reflects the populations that will ultimately be taking a newly approved therapy. At the same time, PRIM&R believes the draft guidance needs a more robust discussion of the ethics of enhancing clinical trial diversity. We ask the FDA to include a discussion of the Belmont Report’s principle of justice. Those most likely to receive the benefits of a newly approved therapy ought also to share the burdens of participating in the clinical trial testing that therapy. The ethical issue of fair distribution of benefits and burdens of research participation also raises questions about relevant populations’ access to novel therapies post approval such as whether or not new therapies will reach all communities where there is need. PRIM&R also argues that the draft guidance needs to better address the fact that exclusion of those of with concomitant chronic conditions has often served specifically as protection from the increased risks these individuals may face and include more discussion of the safeguards that may need to be in place to facilitate inclusion. The guidance should include broad recommendation that as sponsors work to include historically underrepresented groups, they must consider and make plans to address the full range of risks participants might face.

June 2019

On April 2, the Food and Drug Administration (FDA) published a Discussion Paper: "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).” In our June 2019 response, PRIM&R expresses appreciation to the FDA for rethinking its regulatory framework for devices as the use of adaptive AI/ML-based technologies become increasingly prevalent in the health and wellness space. At the same time, PRIM&R asks the FDA, as it determines appropriate oversight of adaptive AI/ML-based technologies, 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. PRIM&R raises these concerns in light of the tech sector’s increasing use of algorithms that may be based on human subject research to develop health and wellness products. PRIM&R believes that the FDA’s review of these issues is especially important given the lack of federal oversight of private sector software and social media companies that depend on not just observing, but at times perturbing, human beings’ engagement with software to develop their products and services. Increasingly, these observations are taking place in real time on an almost continuous basis with companies frequently pulling source material not only from the user but also from those they are in contact with such as friends and acquaintances. PRIM&R also outlines four human research protection issues the FDA should consider as they craft a new regulatory framework for AI/ML-Based Software as a Medical Device, which the organization believes should begin to extend to certain health products produced that are not currently considered as medical devices.

May 2019

On March 13, the Food and Drug Administration (FDA) published a draft guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients." In our May 2019 response, PRIM&R applauds the FDA for their ongoing work to enhance clinical trial access for younger patients and for the level of detail in the guidance. The FDA specifies the types of evidence that could support including pediatric patients in adult clinical trials, and we note that such information will be invaluable to sponsors, investigators, and IRBs as they make the required determination whether enrollment in the study provides the prospect of direct clinical benefit to pediatric subjects. PRIM&R suggests that the FDA clarify what is meant by their suggestion that one reason to include pediatric patients in adult oncology trials is that separate pediatric trials may be “infeasible because the disease occurs so rarely in pediatric patients,” given the potential for different interpretations of "infeasible" in this context. We also recommend that the agency encourage sponsors pursuing adult oncology clinical trials that include pediatric patients to describe in protocols how the pediatric data obtained will be used to support pediatric labeling, whether by itself or in combination with other data. This information will be especially useful for IRBs as they review protocols involving adults and pediatric patients.

February 2019

On December 7, the National Institutes of Health (NIH)’s Office of Laboratory Animal Welfare (OLAW) published a "Request for Information (RFI): Input on Draft Report from Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research." In our February 2019 response, PRIM&R thanks OLAW and its sister federal agencies for responding to the full range of comments submitted by the animal research community in response to an earlier RFI they issued on the topic. PRIM&R believes that changes such as streamlining technologies to facilitate report submissions and agency coordination for training will all be welcomed by the animal research community. At the same time, we also acknowledge that several recommendations made in response to the original RFI, including some of PRIM&R’s, would require statutory changes beyond the agencies’ purview; we express hope that the Working Group will include these suggestions—especially, amending the law to allow all vertebrate species to be brought under one harmonized regulatory framework—in any reports they plan to share with Congress. With respect to changes that agencies themselves have the power to implement, we note that very few of the proposals have definitive timelines attached. We ask the agencies to implement a process for following up on their proposed changes that will keep the research oversight community informed and involved in determining the final product.

February 2019

On December 14, the Office for Civil Rights (OCR) within the Department of Health and Human Services published a "Request for Information on Modifying HIPAA Rules to Improve Coordinated Care." In our February 2019 response, PRIM&R suggests 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. A combined reconsideration of HIPAA in the clinical and research settings would be particularly relevant today, as the lines between research and clinical care are increasingly blurred; e.g. in emerging "learning healthcare systems." PRIM&R also argues that this is an opportunity for the OCR to consider how the HIPAA Rules could be improved to better support the research enterprise in general. The application of HIPAA to covered entities involved in human subjects research is awkward and does not obviously provide additional privacy protections for individuals who take part in research, above and beyond those provided by the Common Rule. We provide several examples where the lack of harmonization between the HIPAA Rules and the Common Rule causes confusion for research participants and unnecessary burdens for research institutions.

February 2019

On November 15, the Food and Drug Administration (FDA) published a proposed rule "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations." In our February 2019 response, PRIM&R applauds the FDA for taking steps to harmonize their human subject regulations with the Common Rule; however, PRIM&R raises two areas of consideration for the FDA.

First, we ask the FDA to explain why it is not adopting the new fifth waiver criterion in the revised Common Rule, which says that an IRB may waive or alter informed consent if it finds and documents that, in addition to meeting the original four waiver criteria, “if the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.” Second, we urge the FDA to issue additional guidance on the standard of "practicability” as it pertains to the criteria for waiving or altering informed consent. We point out that current guidance does not adequately emphasize that IRBs’ waiver of consent decisions—and, in particular, determinations that getting consent would make the research impracticable— should take into account the importance of the research in question.

January 2019

In October 2018, the New England Journal of Medicine published a Perspective article by the Director of the National Institutes of Health, Dr. Francis S. Collins, and the Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb, which argued for a new role for the Recombinant DNA Advisory Committee (RAC). In their article, they state that the risks of many gene transfer procedures are well understood and that review at the level of the RAC is no longer necessary. Dr. Elisa A. Hurley, Darby Hull, and Dr. Sharon P. Shriver responded in a letter to the editor. They point out that maintaining many of the current features of the RAC is crucial to fostering public discussion about whether new technologies should be specially regulated, or even initiated. Local oversight bodies, such as IRBs and IBCs, are not in a position to make such high-level policy determinations. In a response to PRIM&R’s comments, Collins and Gottlieb emphasize that they plan to put in place a reconfigured RAC to review novel technologies such as germline gene editing.


December 2018

On October 10, the National Institutes of Health (NIH) published a Request for Information (RFI) from the public on Proposed Provisions for a Draft Data Management and Sharing Policy for NIH Funded or Supported Research. In our December 2018 response to the RFI, PRIM&R stated that we fully support data sharing initiatives as they allow for the optimization of scarce research resources, accelerate science, maximize the value of research subjects’ contributions, and can minimize risks to subjects.

However, we note that data sharing also involves risks, particularly in the areas of privacy and confidentiality, and urge the agency to provide more guidance on the ways to minimize these risks and enhance public trust in the data sharing enterprise. The NIH should also be prepared to encourage grantees to request the appropriate amount of resources to facilitate data sharing in a safe and ethical manner. We also seek clarification from the agency on its current definition of “scientific data” and request further guidance on how to implement the proposed requirement that data sharing plans be consistent with informed consent in retrospective studies.

October 2018

In August 2018, the National Institutes of Health issued a proposal to amend its Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to both reduce redundant reporting requirements and modify the Recombinant DNA Advisory Committee (RAC)’s role in oversight of such research. In our October 2018 response to the proposal, PRIM&R agrees that there is an overall need to reduce duplicative oversight as gene therapy research becomes more routine. However, we express serious concerns about the agency’s proposal to scale back the scope and function of the RAC. We argue that the proposed Guidelines fail to recognize how the RAC‘s independence, special expertise, and transparency make it uniquely positioned to identify, consider, and address ethical and social implications of the newest genetic technologies and foster public trust in emerging genetic science. We also object to the proposal to remove the RAC’s protocol review authority, arguing that discussions in the abstract, removed from actual protocols, may be inadequate for addressing the complex and as-yet-unresolved ethical challenges raised by rapidly evolving technologies. In addition, we express concern about the lack of detail provided regarding the RAC’s future role, given the NIH’s proposal to remove all references to the RAC from the Guidelines. As human gene therapy technology continues to evolve, some applications—such as the ability to affect the germline—are raising new and even thornier ethical issues. It is therefore crucial to maintain the RAC’s current features as an open and transparent forum that engages the public in deliberations on research with important social implications.

August 2018

In April 2018, the Environmental Protection Agency (EPA) put forth a proposed rule "Strengthening Transparency in Regulatory Science," that would prohibit the agency from basing regulatory action on scientific research for which the underlying raw models and data are not available to the public "in a manner sufficient for validation and analysis." In our August 2018 response to the proposed rule, PRIM&R urges the EPA to withdraw the rule immediately because of two major concerns. First, far from enhancing transparency, the proposed rule arbitrarily restricts access to and use of rigorous, peer-reviewed science in environmental policymaking, to the detriment of the public’s health and trust in the regulatory process. Second, we argue that the proposed rule fails to respect the contributions of human research participants who agree to participate in research, sometimes after disasters.

July 2018

In June 2018, the Food and Drug Administration (FDA) released draft guidance on "Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials." The guidance "recommends the inclusion of adolescents in disease- and target-appropriate adult oncology trials to enable earlier access to investigational and approved drugs for adolescent patients with cancer." In our July 2018 response to the draft guidance, PRIM&R agrees with FDA that inclusion of certain adolescent patients in adult oncology research will result in data about safe and effective treatments more quickly given that currently, adolescent subjects need to wait until after the completion of a late-phase adult trial, and the start of a pediatric trial to enroll. However, PRIM&R believes that the guidance document should recommend that the sponsor’s evaluation of the relevant safety data be provided in a format that the investigator can share with an IRB to inform its determination regarding whether offering adolescents the opportunity to enroll in such research is ethically appropriate.

June 2018

In April 2018, the Food and Drug Administration (FDA) released draft guidance on “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” The guidance “supports an informed and balanced approach to gathering data on the use of drugs and biological products during pregnancy through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk.” In our June 2018 response to the draft guidance, PRIM&R points out that ethical considerations of justice, respect, and beneficence demand that pregnant women who are or may become sick, or sick women who may become pregnant, share in the benefits of clinical trials, namely, access to safe and effective medication, and thus applauds the FDA for taking this important step to fill regulatory gaps around the inclusion of pregnant women in FDA-regulated clinical trials. The guidance also appropriately acknowledges the tension between the need for more information about how to appropriately treat pregnant women and the ethical and scientific complexity involved in including women who are pregnant in clinical trials.

PRIM&R also put forth several suggestions on areas that could be clarified including: conditions under which it is ethically justifiable to include pregnant women with a disease or medical condition in premarketing studies of investigational drugs and what ought to happen when women become pregnant during the course of a clinical trial.

May 2018

On March 14, 2018, the National Institutes of Health, in coordination with the Department of Agriculture and the Food and Drug Administration, published a 90-day 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)."

PRIM&R responded in May 2018 to the questions listed in the request for information but encouraged the agencies to be open, in the spirit of the mandate in the Cures Act, to the wide range of recommendations that the regulated community has put forth to reduce administrative burden associated with federally funded laboratory animal research while protecting the welfare of research animals and maintaining the integrity of science. PRIM&R made clear that any new regulatory policy should 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.

May 2018

In April 2018, the Department of Health and Human Services and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) proposing to delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects, or "Common Rule," six more months to January 21, 2019. The NPRM also proposes to allow institutions to implement three "burden-reducing provisions" during the delay period.

PRIM&R responded in May 2018 that we endorse the proposal, but our support is predicated on an understanding that the delay will give the agencies time to produce much-needed guidance and make it available to the regulated community far enough in advance of the compliance date to be useful in guiding institutions’ implementation plans, ideally at least three months in advance. PRIM&R also highlighted four areas that should be prioritized for guidance.

April 2018

In an opinion article for The Hill published April 13, 2018, 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. This is particularly important given Congress’ interest in streamlining the oversight of research with animals as evidenced by recent language in the 21st Century Cures Act. They highlight how the welfare of research animals is monitored and how related regulations and laws have evolved over the years. For federal and institutional animal oversight to keep apace of new developments in research and adhere to rigorous ethical standards, public, administrative, and federal support must remain in place, and regulations must be re-worked to eliminate those that are inconsistent, redundant, or do not meaningfully contribute to animal welfare.

April 2018

On April 4, 2018, PRIM&R's Executive Director, Elisa A. Hurley, argued 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. She highlights four things policymakers should consider to ensure policy changes do not weaken animal welfare standards: 1) A new consolidated federal body for animal research oversight could both reduce redundant regulations while simultaneously ensuring that more research animals receive federal oversight protections 2) New policies should support the important role that Institutional Animal Care and Use Committees and attending veterinarians play in the oversight of animal research 3) New federal advisory bodies should solicit a diversity of perspectives and 4) Any new federal oversight body should have the independence, legal authority, and resources from Congress to effectively encourage and enforce compliance with animal welfare policies.


June 2017

In June 2017, Science published an article by Jocelyn Kaiser detailing how President Trump’s budget proposes to cut the National Institutes of Health budget by $4.6 billion without affecting spending on science by substantially reducing payments for indirect costs. David H. Strauss, Darby G. Hull, and Elisa A. Hurley responded on behalf of PRIM&R’s Public Policy Committee in a letter to the editor. They pointed out that such indirect cost payments cover processes that serve to protect the safety and rights of those who participate in research, and that such processes were put in place after severe instances of research misconduct in the US. Any large reductions in indirect cost payments will result in funding cuts for institutional oversight activities, including IRBs’ work, that protect research participants. This will undoubtedly threaten research participant's welfare and their trust in the ethical foundation upon which the US human research program rests.

June 2017

In April 2017, the National Institutes of Health issued a "Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the Lifespan."

PRIM&R responded in June 2017 that we endorse the NIH’s efforts to promote research involving pediatric and elderly populations, but emphasize and provide examples of the ethical complexities that must be considered when including such groups in research.

March 2017

In March 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, representing a range of stakeholders in the data sharing, access, and use landscape, 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, including individual-patient level data sharing in clinical trials, the All of Us Research Program, patient-centered outcomes research (PCOR), NIH requirements around genomics and clinical trials, and the learning healthcare system.

The wide-ranging discussion highlighted the current potential but also the ethical and regulatory challenges for research, healthcare, and policy as the movement toward greater data access and data transparency alters the research landscape.

The proceedings including a summary and video of the day can be found here.


October 2016

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.

April 2016

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."

April 2016

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.

February 2016

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.

January 2016

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.

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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. 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.

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 webpage 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. 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.

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). 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.

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 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.

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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.

March 2014

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.

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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. 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.

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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 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.

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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.

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. 

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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.

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. 

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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. 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."

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.'' 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.

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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.

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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.

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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.

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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.

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.