Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

On the traditional view, moral distress arises only in cases where an individual believes she knows the morally right thing to do but fails to perform that action due to various constraints. We seek to motivate a broader understanding of moral distress. We begin by presenting six types of distress that fall outside the bounds of the traditional definition and explaining why they should be recognized as forms of moral distress. We then propose and defend a new and more expansive (...) definition of moral distress and examine how it can enable the development of a taxonomy of moral distress. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

The Covid‐19 pandemic has highlighted many of the difficult ethical issues that health care professionals confront in caring for patients and families. The decisions such workers face on the front lines are fraught with uncertainty for all stakeholders. Our focus is on the implications for nurses, who are the largest global health care workforce but whose perspectives are not always fully considered. This essay discusses three overarching ethical issues that create a myriad of concerns and will likely affect nurses globally (...) in unique ways: the safety of nurses, patients, colleagues, and families; the allocation of scarce resources; and the changing nature of nurses’ relationships with patients and families. We urge policy‐makers to ensure that nurses’ voices and perspectives are integrated into both local and global decision‐making so as to minimize the structural injustices many nurses have faced to date. Finally, we urge nurses to seek sources of support throughout this pandemic. (shrink)

New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk–benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. (...) Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research. Instead, we propose that the individual risks for the pregnant woman and the fetus should be justified by the benefits for them and the study’s social value. Studies that meet this overall proportionality criterion but have mildly unfavorable risk–benefit ratios for pregnant women and/or fetuses may be acceptable. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

Ethically challenging situations routinely arise in the course of illness and healthcare. However, very few studies have surveyed patients and family members about their experiences with ethically challenging situations. To address this gap in the literature, we surveyed patients and family members at three hospitals. We conducted a content analysis of their responses to open-ended questions about their most memorable experience with an ethical concern for them or their family member. Participants described 219 unique ethical experiences that spanned many of (...) the prevailing themes of bioethics, including the patient-physician relationship, end-of-life care, decision-making capacity, healthcare costs, and genetic testing. Participants focused on relational issues in the course of experiencing illness and receiving medical care and concerns regarding the patient-physician encounters. Many concerns arose outside of a healthcare setting. These data indicate areas for improvement for healthcare providers but some concerns may be better addressed outside of the traditional healthcare setting. (shrink)

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by (...) a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas. (shrink)

Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting about money as opposed to (...) a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make. (shrink)

Purpose/methods: This study investigated the relationship between ethics education and training, and the use and usefulness of ethics resources, confidence in moral decisions, and moral action/activism through a survey of practicing nurses and social workers from four United States (US) census regions. Findings: The sample (n = 1215) was primarily Caucasian (83%), female (85%), well educated (57% with a master's degree). no ethics education at all was reported by 14% of study participants (8% of social workers had no ethics education, (...) versus 23% of nurses), and only 57% of participants had ethics education in their professional educational program. Those with both professional ethics education and in-service or continuing education were more confident in their moral judgments and more likely to use ethics resources and to take moral action. Social workers had more overall education, more ethics education, and higher confidence and moral action scores, and were more likely to use ethics resources than nurses. Conclusion: Ethics education has a significant positive influence on moral confidence, moral action, and use of ethics resources by nurses and social workers. (shrink)

Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants (...) in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. Results and Discussion This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal. (shrink)

Using payment to recruit research subjects is a common practice, but it raises ethical concerns that coercion or undue inducement could potentially compromise participants’ informed consent. This is the first national study to explore the attitudes of IRB members and other human subjects protection professionals concerning whether payment of research participants constitutes coercion or undue influence, and if so, why. The majority of respondents expressed concern that payment of any amount might influence a participant’s decisions or behaviors regarding research participation. (...) Respondents expressed greater acceptance of payment as reimbursement or compensation than as an incentive to participate in research, and most agreed that subjects are coerced if the offer of payment makes them participate when they otherwise would not or when the offer of payment causes them to feel that they have no reasonable alternative but to participate . Views about undue influence were similar. We conclude that human subjects protection professionals hold expansive and inconsistent views about coercion and undue influence that may interfere with the recruitment of research participants and impede valuable research. (shrink)

Payment to recruit research subjects is a common practice but raises ethical concerns relating to the potential for coercion or undue influence. We conducted the first national study of IRB members and human subjects protection professionals to explore attitudes as to whether and why payment of research participants constitutes coercion or undue influence. Upon critical evaluation of the cogency of ethical concerns regarding payment, as reflected in our survey results, we found expansive or inconsistent views about coercion and undue influence (...) that may interfere with valuable research. In particular, respondents appear to believe that coercion and undue influence lie on a continuum; by contrast, we argue that they are wholly distinct: whereas undue influence is a cognitive distortion relating to assessment of risks and benefits, coercion is a threat of harm. Because payment is an offer, rather than a threat, payment is never coercive. (shrink)

Background Little is known about communication between patients, families, and healthcare providers regarding ethical concerns that patients and families experience in the course of illness and medical care. To address this gap in the literature, we surveyed patients and family members to learn about their ethical concerns and the extent to which they discussed them with their healthcare providers. Methods We surveyed adult, English-speaking patients and family members receiving inpatient care in five hospitals in the Washington DC-Baltimore metropolitan area from (...) July 2017 to March 2020. Descriptive statistics were used to determine the frequency, comfortableness, and helpfulness of discussions regarding ethical concerns experienced when sick or receiving medical care. Univariable and multivariable stepwise logistic regression models were used to identify associations between healthcare provider and respondent characteristics and attitudes and (1) the likelihood of speaking to a healthcare provider about their ethical concern and (2) their level of comfort during these discussions. Results Of 468 respondents who experienced ethical issues, 299 (64%) reported discussing the situation with a member of their healthcare team; 74% (197/265) of respondents who had such a discussion found the discussion comfortable, and 77% (176/230) of respondents found the discussion helpful. To make discussions more comfortable and helpful, respondents proposed suggestions in open-ended responses involving (1) content and quality of communication; (2) positive healthcare provider qualities such as empathy, open-mindedness, knowledge, honesty, and trustworthiness; and (3) other contextual factors including having adequate time and available resources. Conclusions Patients and families often have ethical concerns that they discuss with clinicians, and they want clinicians to be routinely receptive and attentive to such discussions. (shrink)

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...) considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency. (shrink)

Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as “venerable” to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or logically untenable, while others (...) can be better resolved by improved study designs than by blanket exclusion of poorer individuals from research participation. The scientific objective to generate generalisable results and the ethical objective to fairly distribute both the risks and benefits of research oblige researchers not to unnecessarily bar economically disadvantaged subjects from clinical research participation. (shrink)

Well before patient-centered or patient-controlled research became trendy, and earlier than calls to preferentially refer to research subjects as participants, Bob Veatch wrote “The Patient as Partner” Veatch presciently argued that research patients should not be thought of as passive subjects nor material from which to obtain data, but rather as partners in discovery. In this manuscript, I will explore Veatch’s conception of patient as partner in research and how that idea has evolved and been implemented over time and consider (...) some of the remaining challenges. Complexities of patient partnership include: clarifying the types of research in which patient partnership is most appropriate, recognizing the various possible levels of patient engagement in each case, avoiding tokenism and striving for respectful partnership, and keeping in mind the appropriate implementation of protections and safeguards. Bob Veatch would be pleased with the progress that has been made in creating research partnerships with patients, while also undoubtedly pushing us to continue to do better. (shrink)

Background: In 2014, companies began covering the costs of egg freezing for their employees. The adoption of this benefit was highly contentious. Some argued that it offered women more reproductive...

IRBs often face dueling values in research: their historically grounded mission to protect research participants from harm conflicts with more recent attention to the importance of including underr...

Background Respect for autonomy is a key principle in bioethics. However, respecting autonomy in practice is complex because most people define themselves and make decisions influenced by a complex network of social relationships. The extent to which individual autonomy operates for each partner within the context of decision-making within marital or similar relationships is largely unexplored. This paper explores issues related to decision-making by couples for health care and the circumstances under which such a practice should be respected as compatible (...) with autonomous decision-making. Discussion We discuss the concept of autonomy as it applies to persons and to actions, human interdependency and gender roles in decision-making, the dynamics and outcomes of couples’ joint decision-making, and the ethics of couples’ joint decision-making. We believe that the extent to which couples’ joint decision-making might be deemed ethically acceptable will vary depending on the context. Given that in many traditional marriages the woman is the less dominant partner, we consider a spectrum of scenarios of couples’ joint decision-making about a woman’s own health care that move from those that are acceptably autonomous to those that are not consistent with respecting the woman’s autonomous decision-making. To the extent that there is evidence that both members of a couple understand a decision, intend it, and that neither completely controls the other, couples’ joint decision-making should be viewed as consistent with the principle of respect for the woman’s autonomy. At the other end of the spectrum are decisions made by the man without the woman’s input, representing domination of one partner by the other. Conclusions We recommend viewing the dynamics of couples’ joint decision-making as existing on a continuum of degrees of autonomy. This continuum-based perspective implies that couples’ joint decision-making should not be taken at face value but should be assessed against the specific cultural, ethnic, and religious backgrounds and personal circumstances of the individuals in question. (shrink)

In their target article, Morain and colleagues (2019) tackle the long-standing and thorny issue of whether and when it might be ethical for a physician-investigator to obtain research consent from...

The objective of this study—a substudy to a phase I bioequivalence study—was to compare the effect of standard and concise consent forms on research volunteers’ comprehension of and satisfaction with consent forms, as well as to assess the effect of select volunteer characteristics, such as financial motivations to participate in research, on their comprehension. A 36-item questionnaire measured volunteers’ comprehension, satisfaction, and motivations for participation. Volunteers were randomized to the standard Pfizer consent form or a concise, easier-to-read form. We approached (...) 139 volunteers to participate, and 138 completed the questionnaire . The cohorts did not differ in sociodemographic characteristics. We found that the average comprehension scores for the standard consent form cohort and the concise consent cohort were about the same, and that satisfaction with the consent form was high in both cohorts. Surprisingly, volunteers with a financial motivation had significantly greater comprehension of the study. (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.

Background The COVID-19 pandemic continues to disrupt every society as SARs-CoV-2 variants surge among the populations. Health care providers are exhausted, becoming ill themselves, and in some instances have died. Indeed, hospitals are struggling to find staff to care for critically ill patients most in need. Previous work has reported on the unending work-related conditions that hospital staff are laboring under and their subsequent mental and physical health strains. Health care providers need support, but it is not clear where that (...) support is to come from. While much research has reported on the COVID-19-related fears of nurses and physicians, fewer studies have focused on supportive features of the hospital work environment and how it may provide relief to front-line health care providers.Purpose This purpose of this study was to explore an often-overlooked resource within hospital systems across the United States—clinical ethicists—and examine their many roles during COVID-19 and the types of ethical issues they addressed with nurses, physicians, administrators, and others.Methods This was a primary analysis of semi-structured, qualitative interviews with 23 clinical ethicists across the United States. The interviews were conducted from November 2020–April 2021 and were audiotaped, transcribed verbatim, and de-identified; both inductive and deductive analyses were used to identify qualitative themes.Results Five major themes were identified: ethical issues that were increasingly more complex, moral distress that was “endemic,” shifting ethical paradigms from the focus on the individual to the population, fostering a supportive environment, and organizational ethics: variation in the value, roles, and policy input of clinical ethicists.Conclusions Our findings report on the integral and expanded role of clinical ethicists at an unprecedented time in our nation, and how they stepped forward to support front-line clinicians in hospitals across the country. (shrink)

To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of (...) potential participants' informed consent. An analysis of individuals' interests suggests that potential participants need to understand three additional facts to understand that they are being invited to participate in research: 1) research contribution: those who enroll in the study will be contributing to a project designed to gather generalizable knowledge to benefit others in the future; 2) research relationship: the investigators will rely on participants' efforts to gather the generalizable knowledge to benefit others; and 3) research impact: the extent to which participating in the study will alter what participants do and what happens to them. (shrink)

Respect for autonomy is a key principle in bioethics. However, respecting autonomy in practice is complex because most people define themselves and make decisions influenced by a complex network of social relationships. The extent to which individual autonomy operates for each partner within the context of decision-making within marital or similar relationships is largely unexplored. This paper explores issues related to decision-making by couples for health care and the circumstances under which such a practice should be respected as compatible with (...) autonomous decision-making. We discuss the concept of autonomy as it applies to persons and to actions, human interdependency and gender roles in decision-making, the dynamics and outcomes of couples’ joint decision-making, and the ethics of couples’ joint decision-making. We believe that the extent to which couples’ joint decision-making might be deemed ethically acceptable will vary depending on the context. Given that in many traditional marriages the woman is the less dominant partner, we consider a spectrum of scenarios of couples’ joint decision-making about a woman’s own health care that move from those that are acceptably autonomous to those that are not consistent with respecting the woman’s autonomous decision-making. To the extent that there is evidence that both members of a couple understand a decision, intend it, and that neither completely controls the other, couples’ joint decision-making should be viewed as consistent with the principle of respect for the woman’s autonomy. At the other end of the spectrum are decisions made by the man without the woman’s input, representing domination of one partner by the other. We recommend viewing the dynamics of couples’ joint decision-making as existing on a continuum of degrees of autonomy. This continuum-based perspective implies that couples’ joint decision-making should not be taken at face value but should be assessed against the specific cultural, ethnic, and religious backgrounds and personal circumstances of the individuals in question. (shrink)

Lynch and colleagues describe positive and cautionary lessons learned from recent extraordinary research efforts to develop COVID-19 vaccines and therapeutics and consider whether some of th...

Dr. Henry Beecher, a renowned Harvard Medical School anesthesiologist, sent shock waves through the medical research community and the lay press when he described 22 examples of “unethical or questionably ethical studies” by reputable researchers at major institutions in his now well-known 1966 New England Journal of Medicine article. Beecher concluded this exposé by noting: “The ethical approach to experimentation in man has several components: two are more important than the others, the first being informed consent.... Secondly, there is the (...) more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator”. Beecher’s... (shrink)

Patients and family members (N = 671) were surveyed in five Mid-Atlantic U.S. hospitals to ascertain the number and kinds of ethical concerns they are presently experiencing or have previously experienced while being sick or receiving medical care. Seventy percent of participants had at least one (range 0–14) type of ethical concern or question. The most commonly experienced concerns pertained to being unsure how to plan ahead or complete an advance directive (29.4%), being unsure whether someone in the family was (...) able to make their own decisions (29.2%), deciding about limiting life-sustaining treatments (28.6%), wondering about disclosing personal medical information to others in the family (26.4%) and not being sure whether to undergo treatment because of cost (26.2%). Most were interested to some degree in getting help from ethics consultants in the future (76.6%). Given this prevalence, common concerns might usefully be addressed systematically, rather than exclusively on a case-by-case basis. (shrink)

Volume 19, Issue 9, September 2019, Page 5-7.

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

Over the course of human life, health care decision‐making is often interdependent. In this article, we use “interdependence” to refer to patients’ engagement of nonclinicians—for example, family members or trusted friends—to reach health care decisions. Interdependence, we suggest, is common for patients in all stages of life, from early childhood to late adulthood. This view contrasts with the common bioethical assumption that medical decisions are either wholly independent or dependent and that independence or dependence is tightly coupled with a person's (...) decision‐making capacity. In this article, we array various approaches to decision‐making along a continuum of interdependence. An appreciation of this continuum can empower patients and elucidate ethical challenges that arise when people transition between different kinds of interdependence across the life span. (shrink)

In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research (...) ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection. (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)

Ethical concerns about randomising persons to a no-treatment arm in the context of Ebola epidemic led to consideration of alternative designs. The stepped wedge design, in which participants or clusters are randomised to receive an intervention at different time points, gained popularity. Common arguments in favour of using this design are when an intervention is likely to do more good than harm, all participants should receive the experimental intervention at some time point during the study and the design might be (...) preferable for practical reasons. We examine these assumptions when considering Ebola vaccine research. First, based on the claim that a stepped wedge design is indicated when it is likely that the intervention will do more good than harm, we reviewed published and ongoing SW trials to explore previous use of this design to test experimental drugs or vaccines, and found that SW design has never been used for trials of experimental drugs or vaccines. Given that Ebola vaccines were all experimental with no prior efficacy data, the use of a stepped wedge design would have been unprecedented. Second, we show that it is rarely true that all participants receive the intervention in SW studies, but rather, depending on certain design features, all clusters receive the intervention. Third, we explore whether the SW design is appealing for feasibility reasons and point out that there is significant complexity. In the setting of the Ebola epidemic, spatiotemporal variation may have posed problematic challenges to a stepped wedge design for vaccine research. Finally, we propose a set of points to consider for scientific reviewers and ethics committees regarding proposals for SW designs. (shrink)

Research ethics consultation is increasingly recognized as a potentially valuable mechanism for addressing the depth and breadth of ethical issues that arise in research related to human health and well-being. However, fundamental questions remain, including: What is “research ethics consultation”? And what is its justification beyond the purposes already served by existing entities? We examine how a research ethics consultation service may differ from or complement the role of an institutional review board by offering a definition of research ethics consultation (...) and by exploring the potential scope of a consultation service in terms of types of clients served, questions addressed, and advice provided at various stages of the research process. We then consider the relationship between research ethics consultation services and IRBs, as well as the issues that may arise between them, including possible conflicts of interest. (shrink)

The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking and notice of proposed rulemaking. Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations where commentators think the rules unduly restrict important research. We believe that this was a missed opportunity to make desirable changes, and that given (...) the usual process the next opportunity to revisit the Common Rule is unacceptably remote. In this article, we argue that the Common Rule should be regularly reassessed, with a mechanism for making substantive changes. Drawing on lessons learned from the recent revision process, we make recommendations about ways to structure future attempts to maximize the ability to make timely and necessary changes. (shrink)