Continuing rapid developments in the life sciences offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances also bring with them new social, ethical, legal, and security challenges. Governance questions form an increasingly important part of the discussions about these advances--whether the particular issue under debate is the development of ethical principles for human genome editing, how to establish regulatory systems for (...) the safe conduct of field trials of gene drive-modified organisms, or many others. However there are continuing concerns that the knowledge, tools, and techniques resulting from life sciences research could also enable the development of bioweapons or facilitate bioterrorism. Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, in Zagreb, Croatia. Hosted by the Croatian Academy of Sciences and Arts, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine. This publication summarizes the presentations and discussions from the workshop."--Publisher's description. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.2 (2002) 215-224 [Access article in PDF] Bioethics Inside the Beltway Expanding Human Research Oversight Ellen Holt [Table]Overwhelmed by all the changes and proposed changes in the system to ensure human subject protection? It is an important subject and one in which everyone is interested. Being for human subject protection is like being for Mom. However, we all know that Mom sometimes (...) can be a handful! So I shall quickly review how we got to where we are, what is being done, and who is doing it. The table at the end of this article provides an additional summary of the current state of human subject protections. How We Got Here The current system of human subject protection was built 30 years ago with Institutional Review Boards (IRBs) as the cornerstone. Some well-publicized system failures in the last decade prompted evaluations that identified increasing volume and research complexity as primary threats to the system's effectiveness. In response, the Department of Health and Human Services (DHHS) Office of Inspector General (OIG 1998), and the National Bioethics Advisory Commission (NBAC 2001) issued recommendations calling for education and reform. Since then, initiatives in pursuit of these objectives have been rolling out non-stop. What Is Being Done The Office of Human Research Protections (OHRP) is leading the effort for DHHS, holding noncompliant research organizations accountable, while expanding the government's capacity for oversight, monitoring, and educating the research community. OHRP already has leveraged resources by: (1) implementing a unified federal registration system for all IRBs that identifies where IRBs are, how they are constituted, what kinds of research they are reviewing, and what volume of work they handle; (2) implementing a streamlined assurance process allowing all federal agencies to recognize a single, common assurance and avoid redundancy. The assurance is a commitment from any entity that receives federal funds for research to follow federal rules for protection of research subjects; and (3) redeploying resources from the process of negotiating assurances to supporting [End Page 215] quality improvement, including increasing the number site visits and providing IRBs with tools for self assessment and guidance for improvement.The goal is to prevent problems before they occur, and positive reinforcement and supportive training are the preferred themes. OHRP does wield a big stick and can shut down clinical studies in response to lax oversight, but it also has developed a big carrot by creating a national awards program to recognize excellence in protection of human research subjects—e.g., best practices, innovations in protecting research volunteers, and lifetime achievement for outstanding protection activities.Dr. Greg Koski, Director of OHRP, also is working with other government agencies to consolidate and build a comprehensive program. OHRP has four goals for a new oversight framework: Simplicity, Uniformity, Efficiency and Effectiveness. Selecting representatives from throughout the federal government, Dr. Koski has created the "SUEE" task force to identify and eliminate inefficiencies between the various agencies' human testing regulatory approaches. In addition, the SUEE task force will suggest improvements to current OHRP practices that can be achieved relatively quickly and easily.OHRP is working in concert with the Food and Drug Administration (FDA), which in October 2001, established the Office of Good Clinical Practice (OGCP) to improve the conduct and oversight of clinical research and to promote the protection of participants in FDA-regulated clinical research. Congressional Developments Although Dr. Koski is leading an aggressive charge to consolidate oversight across the federal government, many feel that reform will require legislation to succeed.Action on Capitol Hill is encouraging Bush administration efforts to reform oversight of clinical research. The House International Relations Committee has approved a measure that protects individuals in clinical trials overseas. A six-part Washington Post series (17-22 December 2000), "The Body Hunters," prompted an amendment to the Export Administration Act that, if finalized, will require drug companies to show that a U.S. ethics committee has approved the clinical trial as part of the application for authorization to export the investigational product.Members of Congress also are considering legislation to expand federal oversight of... (shrink)

A subcommittee of the American Association of University Professors has published a report, “Research on Human Subjects: Academic Freedom and the Institutional Review Board” , which argues that institutional review board oversight may pose a threat to academic freedom, and that a different oversight model based on departmental review would both maintain subject protection and eliminate the threat. But the report does not demonstrate that IRBs pose a threat to academic freedom, and using departmental oversight may (...) not sufficiently protect human subjects of research, could introduce other problems, and would itself pose threats to academic freedom. Instead, some alternative methods of streamlining IRB oversight for certain types of research would better address the practical problems currently encountered. (shrink)

Background The ethical use both of human and non-human animals in research is predicated on the assumption that it is of a high quality and its projected benefits are more significant than the risks and harms imposed on subjects. Yet questions remain about whether and how IRBs and IACUCs should consider the scientific value of proposed research studies.Methods We draw upon 45 interviews with IRB and IACUC members and researchers with oversight experience about their perceptions of their (...) own roles in reviewing the quality and value of scientific protocols. Interview transcripts were memoed to highlight specific findings, which were then used to identify key themes through an iterative process.Results IRB and IACUC members expressed broad trust in the need for and value of research, and they often assumed that protocols had social value or that prior review, especially when associated with funding, affirmed both the rigor and merit of those protocols. Some oversight members also took an explicit stance against scientific review by stating that such review is not within the regulatory mandates governing their parts in the oversight system. Yet other interviewees expressed uneasiness about the current paradigm for evaluating the quality and overall value of science, suggesting that IRB and IACUC members perceive gaps in the oversight systems.Conclusions These findings reveal many similarities in how IRB and IACUC members understand the roles and limitations of their respective oversight committees. We conclude with a discussion of how the lack of a clear mandate regarding scientific review within US federal regulations may undermine ethical engagement of whether human and animal research is scientifically justified, resulting in a “mission lapse” wherein no organizational body is clearly responsible for ensuring that the research being conducted has the potential to advance science and benefit society. (shrink)

The understanding of appropriate ethical protections for participants of biomedical research has not been static. It has evolved over time, with the evolution of biomedical research as well as social values. Since World War II, there have been four major paradigms of research and research oversight operative in the United States. These paradigms incorporate different values and provide different approaches to research oversight and the protection of research participants.

Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because (...) these assessments often involve value judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call “deliberative pathologies,” or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research. (shrink)

The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review-and-comment, to the current review-and-approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

Volume 20, Issue 4, May 2020, Page 104-105.

One of the concerns that citizen science shares with the evolving practice of precision medicine is how to approach oversight for N-of-1 or N-of-many-1’s research. In their target article, Wiggins...

Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal (...) of Medicine. The oversight system is based on a foundation, first implemented by the U.S. Public Health Service in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report. (shrink)

To address the ethical challenges in big data health research we propose the concept of systemic oversight. This approach is based on six defining features and aims at creating a common ground across the oversight pipeline of biomedical big data research. Current trends towards enhancing granularity of informed consent and specifying legal provisions to address informational privacy and discrimination concerns in data-driven health research are laudable. However, these solutions alone cannot have the desired impact unless (...) oversight activities by different stakeholders acquire a common substantive orientation. (shrink)

Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR (...) is governed by the same oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration. (shrink)

Background. Africa has seen an increase in the number of health research projects being conducted on the continent, particularly clinical trials. Ideally, this should be accompanied by a commensurate improvement in research ethics review capacity to competently provide the much-required research ethics oversight. Unfortunately, this is not the case in many African countries, which are still grappling with weak research ethics oversight capacity, not only at national level but also at institutional level. Objectives. To (...) describe the proposal by Kenya’s national research ethics regulatory authority, the National Commission for Science Technology and Innovation (NACOSTI), to build the capacity of its National Scientific and Ethics Committee (NSEC), tasked with providing the required research ethics oversight in the country. Methods. This is the proposal submitted by NACOSTI to the European and Developing Countries Clinical Trials Partnership for funding of a project entitled ‘Strengthening Research Ethics and Oversight in Kenya’ (STReK). It describes the activities involved to strengthen the NSEC to provide the required research ethics in the country, and to build the research ethics capacity of research ethics committees (RECs) it has accredited, through training and mentorship programmes, to enable them to efficiently review research proposals. Results. Proposed activities of the project are presented. Implementation of the activities described is ongoing. Conclusion. Lessons learnt in this regard may be of benefit to other research ethics regulatory authorities in resource-constrained countries aiming to strengthen their research ethics oversight capacity. (shrink)

Urban communities experiencing marginalization often disproportionately bear the risks and burdens of research and are left out of research ethics governance processes. To address this, many communities have created place-based and community-led research ethics governance initiatives to ensure that community voice is included in discussions surrounding research conduct. Place-based strategies in the Vancouver Downtown Eastside, the Bronx, and the Philadelphia Promise Zone successfully mobilize community perspectives in research ethics, filling in a significant gap in our (...) current system of institutional research ethics review and oversight. These cases demonstrate that place-based research ethics governance has the potential to account for the community-level risks posed by research projects and to ensure communities receive more felt benefits. Place-based communities sidestep simplistic notions of identity based on single shared features and make space for intersectional analyses and diverse community viewpoints to be considered. Such communities have a unique claim to expertise given their shared experience of place, which grants them the ability to see problematic assumptions embedded in scientific projects as well as community-level concerns within research. Despite this, many marginalized communities are excluded from current research ethics oversight processes. This exclusion demands critical examination and a way forward to facilitate the integration of place-based community oversight strategies within research ethics governance. (shrink)

The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring (...) central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void. (shrink)

Institutional review boards distinguish health care quality improvement and health care quality improvement research based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR.

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human‐nonhuman chimeric research. Led by bioethics researchers working closely (...) with an interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human‐nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics’ previous focus on human‐centered questions about the ethics of “humanization” and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less‐siloed governance and oversight and more‐comprehensive public communication. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and (...) regulated in the United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. Principal investigators should (...) build ‘true research teams’ where members of the team are meaningfully involved in decisions regarding the protocol and its implementation. There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions and look for means to negotiate appropriate protections for those willing to participate. In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

: Research involving the dead, especially heart-beating cadavers, may facilitate the testing of potentially revolutionary and life-saving medical treatments. However, to ensure that such research is conducted ethically, it is essential to: (1) identify appropriate standards for this research and (2) assign institutional responsibility and a mechanism for oversight. Protocols for research involving the dead should be reviewed by a special committee and assessed according to nine standards intended to ensure scientific merit, to protect deceased (...) patients and their families, and to promote institutional integrity and responsibility. Federal regulation of research involving the dead will foster appropriate standards and, equally importantly, help establish the acceptability of such research. (shrink)

In spite of many and varied concerns that the processes of institutional ethical review are flawed, cumbersome, and in need of reform, these processes do provide effective protection in certain sit...

The use of nonhuman animals in research has long been a source of bioethical and scientific debate. We consider the oversight and use of nonhuman animals in chimeric research. We conducted interviews with twelve members of embryonic stem cell research oversight committees, nine members of institutional animal care and use committees, and fourteen scientists involved in human–nonhuman‐animal chimeric research in different areas of the United States. Interviews addressed animal welfare and conceptual issues associated with (...) moral status and humanization of nonhuman animals that contain human cells. Our findings suggest that concepts of enhanced moral status and consciousness are not very useful in human–nonhuman‐animal chimeric research in part because their meanings are not easily defined, which presents challenges to applying the concepts in research. Instead, scientists and oversight committee members we interviewed seemed to rely on standard assessments of changes in animal welfare when focusing on the ethics of human‐animal chimeric research. (shrink)

The purpose of an oversight structure or institution is to protect human subjects from research that would pose unacceptable dangers or deny human rights. Review boards provide an independent assessment of research proposals. This additional level of scrutiny is meant to provide an additional level of protection for human subjects. However, oversight of human subject research, as currently carried out in the bureaucratic, rule‐based, clinically‐biased American system, is too cumbersome with regard to online research. (...) In addition, it is not conducive to the training of ethical Internet researchers. Internet research differs from traditional human subject research in many ways, and the oversight rules governing traditional research do not easily relate to the complexities of conducting research online. Online researchers do not oppose the foundational principles of non‐maleficence and autonomy, nor do they reject the ideals of informed consent and confidentiality, nevertheless, they face practical dilemmas in attempting to follow these principles and apply these ideals in the various Internet domains. The current oversight system is ill‐equipped to assist. A conservative response to this problem of fit might entail adjustments to the oversight system that, in the case of the American system, would entail modifications to the Common Rule and Institutional Review Boards. I will argue in this paper, instead, that re‐structuring is needed to allow more oversight authority for Internet researchers. I will utilize Consequentialism and Virtue Ethics in making this case. (shrink)

We examine whether the current regulatory regime instituted in South Korea and the United States would have prevented Hwang’s potential transgressions in oocyte procurement for somatic cell nuclear transfer, we compare the general aspects and oversight framework of the Bioethics and Biosafety Act in South Korea and the US National Academies’ Guidelines for Human Embryonic Stem Cell Research, and apply the relevant provisions and recommendations to each transgression. We conclude that the Act would institute centralized oversight under (...) governmental auspices while the Guidelines recommend politically-independent, decentralized oversight bodies including a special review body for human embryonic stem cell research at an institutional level and that the Guidelines would have provided more vigorous protection for the women who had undergone oocyte procurement for Hwang’s research than the Act. We also suggest additional regulations to protect those who provide oocytes for research in South Korea. (shrink)

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research (...) regulatory structures, arranging a site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide. (shrink)

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in (...) IRB processes. (shrink)

New discoveries are improving the odds of human cells surviving in host animals, prompting regulatory and funding agencies to issue calls for additional layers of ethical oversight for certain types of human–animal chimeras. Of interest are research proposals involving chimeric animals with humanized brains. But what is motivating the demand for additional oversight? I locate two, not obviously compatible, motivations, each of which provides the justificatory basis for paying special attention to different sets of human–animal chimeras. Surprisingly, (...) the sets of animals that actually get flagged for special scrutiny by research and funding guidelines do not correlate with either of the sets of animals that arise when we think about what is motivating additional oversight. What this shows is that existing research policies and funding guidelines are disconnected from their motivation: the rationale for flagging certain types of human–animal chimeras as requiring special oversight is ignored in execution. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Future Directions for Oversight of Stem Cell Research in the United States: An UpdateMary A. Majumder (bio) and Cynthia B. Cohen (bio)On 9 March 2009, President Barack Obama (2009a) signed an executive order revoking the statement issued by President George W. Bush during a televised speech in August 2001, in which the latter had sharply restricted the scope of federally funded human embryonic stem cell (hESC) (...) class='Hi'>research to cell lines derived (without federal funding) prior to 9:00 P.M. EDT on 9 August 2001. Action by President Obama to remove the cut-off date had been expected. It came as a surprise, however, that he gave authority to determine the scope of eligible research to the Director of the National Institutes of Health (NIH), referencing only general concerns of responsibility, scientific worth, and legality.1 This contrasted not only with the approach of former President Bush, but also with that of former President Clinton, who had expressed personal opposition to the creation of embryos for research and had a distinction between hESCs derived from embryos created for research and those derived from spare embryos enshrined in NIH policy.President Obama’s remarks upon signing the executive order give some insight into the thinking behind his approach. Implicit in them are the views that earlystage human embryos outside the womb do not have full moral status and that the destruction of human embryos in the effort to care for and ease the suffering of human beings who do have full moral status does not devalue human life. The President also stressed that the decision to pursue hESC research reflected not only his opinion, but also a broad social consensus. He concluded with strong ethical commitments on two fronts:We will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse. And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society.(Obama 2009b)The specific guarantee that President Obama gave against government support for the development of cloning techniques for human reproductive purposes made his silence on the use of cloning for research seem significant. Comments he had made in the course of the campaign (Obama 2008) suggested that he would affirm [End Page 195] the Clinton-era policy of limiting federal funding to hESCs derived from spare embryos. Did this silence mean that President Obama was opening the door to federal funding of research cloning when and if scientists might manage that feat?2009 NIH GuidelinesThe answer to this question and several others came on 17 April, when Raynard Kington, the acting director of NIH, released Draft NIH Guidelines for Human Stem Cell Research (NIH 2009), developed by an NIH Stem Cell Task Force, along with a request for public comment within 30 days of their publication in the Federal Register.2 The 2009 Draft Guidelines exclude from federal funding the derivation of hESCs, a restriction mandated by the reenactment of the Dickey-Wicker Amendment as part of the 2009 Omnibus Appropriations Act (Public Law 111-8, Division F, Title V, § 509). The 2009 Draft Guidelines also exclude the use of hESCs derived from embryos created for research purposes, and so represent a refusal to open the funding door as broadly as the NIH interpretation of the Dickey-Wicker Amendment might allow, at least for the time being.It appears that the drafters used as their starting point the 2000 NIH Guidelines for Research Using Human Pluripotent Stem Cells (NIH 2000) dating from the Clinton Administration, rather than more recent guidelines from the National Academy of Sciences (National Research Council 2005; 2007; 2008) and other private bodies. Both the format and content of the 2000 and 2009 NIH efforts are similar, making the departures in the latter stand out in high relief. We highlight departures related to informed consent to embryo donation, creation of human-nonhuman chimeras, and the role of an NIH task force, updating our original comment (Cohen and Majumder 2009).Informed Consent to Embryo DonationThe 2009 NIH Draft Guidelines require that certain statements... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Future Directions for Oversight of Stem Cell Research in the United StatesCynthia B. Cohen (bio) and Mary A. Majumder (bio)Human pluripotent stem cell research, meaning research into cells that can multiply indefinitely and differentiate into almost all the cells of the body, has become a minefield in which science, ethics, and politics have collided over the last decade in the United States. President Barack Obama (...) entered this highly charged territory when he indicated during his campaign that once in office he would issue an executive order expanding federally funded human embryonic stem cell (hESC) research and introduce rigorous oversight of it (Obama 2008a & b). Candidate Obama stated that he would require that the hESC lines involved were derived with donor consent from early embryos that otherwise would be discarded following in vitro fertilization (IVF) treatment. However, in contrast with the policy of President George W. Bush, he would do so without regard to the date of their derivation. He added that he would call upon the director of the National Institutes of Health (NIH) to develop guidelines for federally funded hESC and other pluripotent stem cell research that would draw from the guidelines developed in 2005 by the National Academies of Science (NAS) for privately funded research (National Research Council 2005).A similar policy was written into the 2008 version of the Stem Cell Research Enhancement Act, which reiterates the policy enunciated in earlier versions of this bill, passed twice by the Congress but vetoed by President Bush each time (House of Representatives, 110th Congress 2008).1 Depending on how one reads the 2008 version of the act, it could also apply in certain respects to hESC research that is not federally funded. We proceed on the assumption that the act applies at least to federally funded stem cell research. Therefore, it appears that the president or the Congress, or both, will approve of an expanded policy of federal funding of hESC research, as well as other forms of human pluripotent stem cell research. [End Page 79]This policy would make the guidelines developed by a committee appointed by NAS, a prestigious private body of American scientists and related experts, the primary basis for the development of new federal guidelines for oversight of hESC research in the United States. This would have certain advantages in that those familiar with the relevant scientific issues are likely to address them accurately and stem cell investigators are apt to accept restrictions on their research written by fellow scientists and ethics and policy experts whom they perceive as strong supporters of stem cell research. However, it also would have certain disadvantages. Chief among these is that the NAS committee appointed to write guidelines for this research, in its concern to see stem cell science move forward after a period in which many scientists and others maintained that it had been unduly restricted, might have overlooked or deferred consideration of some pressing ethical and policy issues. We maintain that this is the case—although we also maintain that the NAS guidelines provide a responsible foundation for developing NIH guidelines for stem cell research. Consequently, we propose that an NIH task force charged by the director of NIH with writing new guidelines for hESC and other stem cell research should revise and expand the NAS guidelines in ways that we propose below, as well as others that it considers necessary, and make it obligatory for those seeking federal funding of such research to follow these new guidelines.We highlight certain areas in which an ethical case can be made for strengthening the existing NAS guidelines and certain areas in which more fundamental ethical reflection—and building on that, additional guideline/policy development—seems warranted. Among the sections of the NAS guidelines that need clarification and reworking, we include those regarding consent to embryo donation, which provide one of their central focuses, and the development of human-nonhuman chimeras, which they address relatively briefly. In addition, we maintain that new guidelines need to be written to address the nascent ethical and policy issues raised by the possibility that human gametes will be induced from pluripotent stem cells in the next few years and that... (shrink)

In this set of contributions to the Kennedy Institute of Ethics Journal celebrating the significant work and contributions of LeRoy Walters, we aim to bring new perspectives to topics that Dr. Walters helped to pioneer and continue his tradition of bringing moral insights and arguments to bear on the development of practical public and professional policies. Dr. Walters is well known for his invaluable service as member and chair of the Recombinant DNA Advisory Committee at the National Institutes of Health. (...) He also made major contributions to a variety of other committees responsible for the oversight of research and science, and to the development and implementation of influential... (shrink)

In their target article, “The Rise of Citizen Science in Health and Biomedical Research,” Andrea Wiggins and John Wilbanks (2019) summarize some of the emerging ethical issues related to citizen sc...

We provide additional information relevant to our previous publication on the quality of reports of investigations of research integrity by academic institutions. Despite concerns being raised about ethical oversight of research published by a group of researchers, each of the four institutional investigations failed to determine and/or report whether ethics committee approval was obtained for the majority of publications assessed.

In lieu of an abstract, here is a brief excerpt of the content:Future Directions for Oversight of Stem Cell Research in the United StatesCynthia B. Cohen (bio) and Mary A. Majumder (bio)Human pluripotent stem cell research, meaning research into cells that can multiply indefinitely and differentiate into almost all the cells of the body, has become a minefield in which science, ethics, and politics have collided over the last decade in the United States. President Barack Obama (...) entered this highly charged territory when he indicated during his campaign that once in office he would issue an executive order expanding federally funded human embryonic stem cell (hESC) research and introduce rigorous oversight of it (Obama 2008a & b). Candidate Obama stated that he would require that the hESC lines involved were derived with donor consent from early embryos that otherwise would be discarded following in vitro fertilization (IVF) treatment. However, in contrast with the policy of President George W. Bush, he would do so without regard to the date of their derivation. He added that he would call upon the director of the National Institutes of Health (NIH) to develop guidelines for federally funded hESC and other pluripotent stem cell research that would draw from the guidelines developed in 2005 by the National Academies of Science (NAS) for privately funded research (National Research Council 2005).A similar policy was written into the 2008 version of the Stem Cell Research Enhancement Act, which reiterates the policy enunciated in earlier versions of this bill, passed twice by the Congress but vetoed by President Bush each time (House of Representatives, 110th Congress 2008).1 Depending on how one reads the 2008 version of the act, it could also apply in certain respects to hESC research that is not federally funded. We proceed on the assumption that the act applies at least to federally funded stem cell research. Therefore, it appears that the president or the Congress, or both, will approve of an expanded policy of federal funding of hESC research, as well as other forms of human pluripotent stem cell research. [End Page 79]This policy would make the guidelines developed by a committee appointed by NAS, a prestigious private body of American scientists and related experts, the primary basis for the development of new federal guidelines for oversight of hESC research in the United States. This would have certain advantages in that those familiar with the relevant scientific issues are likely to address them accurately and stem cell investigators are apt to accept restrictions on their research written by fellow scientists and ethics and policy experts whom they perceive as strong supporters of stem cell research. However, it also would have certain disadvantages. Chief among these is that the NAS committee appointed to write guidelines for this research, in its concern to see stem cell science move forward after a period in which many scientists and others maintained that it had been unduly restricted, might have overlooked or deferred consideration of some pressing ethical and policy issues. We maintain that this is the case—although we also maintain that the NAS guidelines provide a responsible foundation for developing NIH guidelines for stem cell research. Consequently, we propose that an NIH task force charged by the director of NIH with writing new guidelines for hESC and other stem cell research should revise and expand the NAS guidelines in ways that we propose below, as well as others that it considers necessary, and make it obligatory for those seeking federal funding of such research to follow these new guidelines.We highlight certain areas in which an ethical case can be made for strengthening the existing NAS guidelines and certain areas in which more fundamental ethical reflection—and building on that, additional guideline/policy development—seems warranted. Among the sections of the NAS guidelines that need clarification and reworking, we include those regarding consent to embryo donation, which provide one of their central focuses, and the development of human-nonhuman chimeras, which they address relatively briefly. In addition, we maintain that new guidelines need to be written to address the nascent ethical and policy issues raised by the possibility that human gametes will be induced from pluripotent stem cells in the next few years and that... (shrink)

Cloning Trevor, a story about therapeutic cloning research, appeared in the June issue of The Atlantic Monthly. The story gives a human face to the people whom therapeutic cloning could benefit. It presents an argument for government funding and it puts the usual calls for a moratorium on embryonic stem cell research to allow for more debate, in a less favourable light. The story also highlights some problems with ethical oversight.