Ethical decision-making in research: identifying all competing interests. Commentary on "Six Domains of Research Ethics"

Ethical dilemmas are the result of conflicts between potential benefits or harms for two or more competing interests. Therefore, ethical decision-making implies a responsibility to identify those interests, harms, and benefits. For this purpose, researchers have responsibilities to the research, the subjects of research, other researchers, the institution, society, the environment, and self.     

Group risks, risks to groups, and group engagement in genetics research

This essay distinguishes between two kinds of group harms: harms to individuals in virtue of their membership in groups and harms to "structured" groups that have a continuing existence, an organization, and interests of their own. Genetic research creates risks of causing both kinds of group harms, and engagement with the groups at risk can help to mitigate those harms. The two kinds of group harms call for different kinds of group engagement.     

User involvement in research: power and compromise

The extent to which collaborative research can redress power imbalances is debated with reference to some of the relevant literature. Different ways in which research can be collaborative and power shared between researchers and participants are discussed. The benefits and challenges specific to collaboration in the area of mental health research are considered, illustrated with examples from research we conducted into the experience of taking antipsychotic medication. Copyright © 2001 John Wiley & Sons, Ltd.     

The resident researcher: An alternative career model centered on community

Considers the potential benefits and costs of an alternative career model for community researchers, one in which professionals specialize in the community where they live. By virtue of their local familiarity, resident researchers can make more informed judgments about research problems and methods. They can employ longitudinal designs to assess change and be available to assist in interpretation and implementation of research. Potential costs include the possibility of provincialism, unintended researcher effects, ethical dilemmas, the need to cultivate community relations, and role conflicts. Interdisciplinary training programs and research field stations can contribute to the development of the resident researcher role. Researchers in the community can help generate grass roots support for social science research. We acknowledge Louise Shedd Barker's helpful comments and suggestions on an earlier version of this article.     

Psychoanalysis and the United States research university: current trends

In this essay the author describes the status of the humanities within United States research universities, and notes that there is a place in the research university for clinical analysts with non-quantitative research interests, who are seen as humanities scholars by other humanities specialists. He discusses the current trend in psychoanalytic research in the United States, which perpetuates an historically well-known divide between quantitative and non-quantitative investigators, and causes non-quantitative clinician-researcher analysts to seek a workplace outside organized analysis, as it exists within the American Psychoanalytic Association. He goes on to describe the way a clinical analyst with a strong non-quantitative research commitment has found a supportive home for his investigations in a humanities institute in a research university. That analyst has been welcomed as a colleague by university-based humanities scholars, and has found that those collegial relationships offer creative freedom and interdisciplinary stimulation. The author notes that a cadre of analysts, enriched by such experiences, will be better equipped to bridge the divide which exists between non-quantitative and quantitative analytic researchers, for the benefit of psychoanalytic research in the future. The author also illustrates the benefits experienced by university-based humanities scholars when they collaborate with clinical analysts, and suggests this makes stronger ties between psychoanalysis and research universities more likely in the future.     

For the Good of the Group? Balancing Individual and Collective Risks and Benefits in Community Psychology Research

Balancing risks and benefits is a necessary ethical task for social science researchers. Community psychologists must often consider risks and benefits not just for individual participants, but also for the group, system, or society that those individuals inhabit. Little ethical guidance currently exists for how to navigate this ethical challenge across these multiple levels. In this article, we use a case example of social network research incorporating multiple levels of analysis to identify common risks and benefits and understand their relationship to each other. We conclude by discussing distinctive ethical considerations revealed by this case example.     

Perinatal substance abuse and human subjects research: are privacy protections adequate?

Privacy incursions in the clinical care of substance abusing pregnant women have gained lay and professional attention recently as the result of a high-profile Supreme Court finding in Ferguson vs City of Charleston et al. In March, 2001 the Supreme Court determined that nonconsensual drug screening of pregnant women by clinicians in a public hospital violated the women's Fourth Amendment rights to be secure against unreasonable search and seizure. Coercive or punitive policy approaches to perinatal substance abuse are often based on mistaken assumptions about the nature of addiction and the outcomes of punitive interventions. Much attention has been given to efforts to criminalize pregnancy for drug using women, and civil laws are also coming under increasing scrutiny. Although no state has passed a law criminalizing pregnancy and drug use, an estimated 250 women in more than 30 states have been prosecuted around the country on theories of "fetal abuse." A growing number of states (eighteen to date) have amended their civil child welfare laws to address specifically the subject of a woman's drug use during pregnancy. No one has examined how these laws and social policies could affect research that includes pregnant and parenting women; women (and their families) who stand to lose a great deal should their drug use be brought to the attention of child welfare or criminal justice authorities. We examine the adequacy of current protective mechanisms, such as federal certificates of confidentiality, in protecting research subjects (and investigators) who may be subject to punitive civil or criminal sanctions. We determine that current protective mechanisms may be insufficient to protect research subjects and that investigators and IRB members are often ignorant of the risks imposed by punitive policy approaches to perinatal substance abuse or fall prey to the same mistaken assumptions that inform punitive policies. We conclude that investigators and IRB members have a moral responsibility to understand local, state and national policies and laws governing perinatal substance abuse. Investigators and IRB members should balance the harms of punitive interventions against the protections that may, or may not be afforded to prospective research subjects as well as the prospective benefits, individual and social, of the research. In situations where criminal or punitive policies are in effect, investigators and IRB members should consider whether adequate protections can be achieved. In the context of inadequate protections, potential risks to prospective research subjects and their families may outweigh the individual or social benefits that accrue from the research. Clinical researchers are professionally obligated to work toward amending laws and policies that are not in the best interests of prospective research subjects.     

Social and Behavioral Researchers' Experiences With Their IRBs

This article examines the responsibilities of researchers who conduct exploratory research to provide a service to vulnerable respondents. The term “service” is used to denote the provision of a tangible benefit in relation to the research question that is apart from the altruistic research benefits. This article explores what this “service” could look like, who might be responsible for providing it, and the challenges associated with such a service. The article argues that not providing a tangible benefit to vulnerable research participants is inconsistent with the principle of social justice that undergirds much of the rationale for conducting health disparities research.     

Should I test more babies? Solutions for transparent data peeking

Research with infants is often slow and time-consuming, so infant researchers face great pressure to use the available participants in an efficient way. One strategy that researchers sometimes use to optimize efficiency is data peeking (or “optional stopping”), that is, doing a preliminary analysis (whether a formal significance test or informal eyeballing) of collected data. Data peeking helps researchers decide whether to abandon or tweak a study, decide that a sample is complete, or decide to continue adding data points. Unfortunately, data peeking can have negative consequences such as increased rates of false positives (wrongly concluding that an effect is present when it is not). We argue that, with simple corrections, the benefits of data peeking can be harnessed to use participants more efficiently. We review two corrections that can be transparently reported: one can be applied at the beginning of a study to lay out a plan for data peeking, and a second can be applied after data collection has already started. These corrections are easy to implement in the current framework of infancy research. The use of these corrections, together with transparent reporting, can increase the replicability of infant research.     

The harm-benefit tradeoff in "bad deal" trials

This paper examines the nature of the harm-benefit tradeoff in early clinical research for interventions that involve remote possibility of direct benefit and likelihood of direct harms to research participants with fatal prognoses, by drawing on the example of gene transfer trials for glioblastoma multiforme. We argue that the appeal made by the component approach to clinical equipoise fails to account fully for the nature of the harm-benefit tradeoff-individual harm for social benefit-that would be required to justify such research. An analysis of what we label "collateral affective benefits," such as the experience of hope or exercise of altruism, shows that the existence of these motivations reinforces rather than mitigates the necessity of justification by reference to social benefit. Evaluations of social benefit must be taken seriously in the research ethics review process to avoid the exploitation of research participants' motivations of hope or altruism and to avoid the possibility of inadvertent exploitation of high-risk research participants and the harms that would associate with such exploitation.     

Competing interests: The need to control conflict of interests in biomedical research

Individual and institutional conflict of interests in biomedical research have becomes matters of increasing concern in recent years. In the United States, the growth in relationships — sponsored research agreements, consultancies, memberships on boards, licensing agreements, and equity ownership — between for-profit corporations and research universities and their scientists has made the problem of conflicts, particularly financial conflicts, more acute. Conflicts can interfere with or compromise important principles and obligations of researchers and their institutions, e.g., adherence to accepted research norms, duty of care to patients, and open exchange of information. Disclosure is a key component of a successful conflict policy. Commitments which conflict with a faculty member's primary obligations to teaching, research, administrative responsibilities, or patient care also need attention. Institutional conflict of interests present different problems, some of which are discussed in an analysis of an actual problem posed by two proposed clinical trials. This paper is adapted from a lecture presented to a Symposium on Scientific Integrity, Warsaw, Poland, 23 November 1995. Daniel Steiner was Vice-President and General Counsel of Harvard University (1972–92) and in that capacity became familiar with conflict of interest issues. He is currently Counsel to the Boston law firm. Ropes and Gray, and is Adjunct Lecturer in Public Policy at the John F. Kennedy School of Government. Harvard University.     

临床试验中的利益冲突：伦理和政策问题

人们对于研究人员、赞助商和研究机构三者之间的经济利益关系给予越来越多的关注,人体试验研究中的经济利益与其他利益有所不同,这种经济利益会导致偏见或诱导不正当的行为,尤其是当有从研究中获益的机会存在时,将会影响到研究人员关于应该选择哪个受试者,应该提供给受试者什么样的医疗服务,甚至应该如何正确使用受试者保密的健康信息方面的判断,由经济利益引起的明显的风险同样也会威胁公众的学术机构研究使命的支持,从处理临床试验中利益冲突的准则,什么样的经济利益是研究中的重大经济利益。准则的实施等方面进行了详尽的叙述,最后指出没有潜在受试者和公众的信任,我们就不能有效地开展研究。     

Feminist Resources for Biomedical Research: Lessons from the HPV Vaccines

Several feminist philosophers of science have argued that social and political values are compatible with, and may even enhance, scientific objectivity. A variety of normative recommendations have emerged regarding how to identify, manage, and critically evaluate social values in science. In particular, several feminist theorists have argued that scientific communities ought to: 1) include researchers with diverse experiences, interests, and values, with equal opportunity and authority to scrutinize research; 2) investigate or “study up” scientific phenomena from the perspectives, interests, and conditions of marginalized stakeholders potentially affected by the research; and 3) make gender, ethnicity, class, and geographical location “visible,” or use them as categories of analysis when appropriate. Yet, more work is needed to determine what exactly these recommendations would require, and the benefits they would yield, in specific research contexts. Using the recent development of the human papillomavirus (HPV) vaccines, we examine how these three feminist recommendations would have applied. We argue that these principles would have yielded several epistemic and social benefits in the HPV case, as well as in biomedical research more generally. That is, biomedical research guided by these principles would not only be epistemically superior, but also more socially responsible.     

Harms and deprivation of benefits for nonhuman primates in research

The risks of harm to nonhuman primates, and the absence of benefits for them, are critically important to decisions about nonhuman primate research. Current guidelines for review and practice tend to be permissive for nonhuman primate research as long as minimal welfare requirements are fulfilled and human medical advances are anticipated. This situation is substantially different from human research, in which risks of harms to the individual subject are typically reduced to the extent feasible. A risk threshold is needed for the justification of research on nonhuman primates, comparable to the way risk thresholds are set for vulnerable human subjects who cannot provide informed consent. Much of the laboratory research conducted today has inadequate standards, leading to common physical, psychological, and social harms.     

American Indian Researcher Perspectives on Qualitative Inquiry About and Within American Indian Communities

It is presumed that Indigenous researchers are optimally positioned to conduct research about or within their own or other Indigenous communities. However, these researchers may still experience challenges, barriers, and distressing events that are important to identify. Qualitative inquiry may be a particularly vulnerable context for Indigenous researchers given the nature of data collection methods and an emphasis on researcher–participant relationships. This paper details the personal reflections of two American Indian (AI) researchers who carried out qualitative research focused on AI issues and/or communities. The first project examined undergraduate students’ opinions of the use of AI imagery in the form of a race‐based university mascot. The second was a study of the mental health needs of AI youth and families in an urban community. Several themes characterized both of their experiences and might be generalizable to others working in these contexts: (a) coping with racism and microaggressions; (b) the role and impact of identity politics; (c) community insider/outsider tension; and (d) managing personal distress associated with the research topics and process. These themes are discussed to illuminate ways that Indigenous researchers, engaged in research on Indigenous topics and/or with Indigenous communities, are challenged and affected by their work.     

Contemporary Psychotherapy: Gold Mines and Land Mines

Psychotherapy has a rich past and great potential. However, psychotherapists should be aware of several areas of strength as well as some problem areas. Strengths include the benefits of a strong therapeutic alliance, a diverse range of theories, and quality research that documents the effectiveness of psychotherapy. Weaknesses include conflicting theories, financial matters, and misunderstandings between clinicians and researchers. Hopefully, mental health professionals can focus on mining the gold from the gold mines while also working to understand and disarm the land mines.     

The beginning of the end for chimpanzee experiments?

The advanced sensory, psychological and social abilities of chimpanzees confer upon them a profound ability to suffer when born into unnatural captive environments, or captured from the wild – as many older research chimpanzees once were – and when subsequently subjected to confinement, social disruption, and involuntary participation in potentially harmful biomedical research. Justifications for such research depend primarily on the important contributions advocates claim it has made toward medical advancements. However, a recent large-scale systematic review indicates that invasive chimpanzee experiments rarely provide benefits in excess of their profound animal welfare, bioethical and financial costs. The approval of large numbers of these experiments – particularly within the US – therefore indicates a failure of the ethics committee system. By 2008, legislative or policy bans or restrictions on invasive great ape experimentation existed in seven European countries, Japan, Australia and New Zealand. In continuing to conduct such experiments on chimpanzees and other great apes, the US was almost completely isolated internationally. In 2007, however, the US National Institutes of Health National Center for Research Resources implemented a permanent funding moratorium on chimpanzee breeding, which is expected to result in a major decline in laboratory chimpanzee numbers over the next 30 years, as most are retired or die. Additionally, in 2008, The Great Ape Protection Act was introduced to Congress. The bill proposed to end invasive research and testing on an estimated 1,200 chimpanzees confined within US laboratories, and, for approximately 600 federally-owned, to ensure their permanent retirement to sanctuaries. These events have created an unprecedented opportunity for US legislators, researchers, and others, to consider a global ban on invasive chimpanzee research. Such a ban would not only uphold the best interests of chimpanzees, and other research fields presently deprived of funding, but would also increase the compliance of US animal researchers with internationally-accepted animal welfare and bioethical standards. It could even result in the first global moratorium on invasive research, for any non-human species, unless conducted in the best interests of the individual or species.     

How Payment for Research Participation Can Be Coercive

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent-undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment.     

Observations on the Responsible Development and Use of Computational Models and Simulations

Most previous works on responsible conduct of research have focused on good practices in laboratory experiments. Because computation now rivals experimentation as a mode of scientific research, we sought to identify the responsibilities of researchers who develop or use computational modeling and simulation. We interviewed nineteen experts to collect examples of ethical issues from their experiences in conducting research with computational models. We gathered their recommendations for guidelines for computational research. Informed by these interviews, we describe the respective professional responsibilities of developers and users of computational models in research. In particular, we examine whether developers should disclose the full computational codes, and we explain how developers and users should minimize harms from improper uses of models.     

Perceived Risks and Benefits in a Text Message Study of Substance Abuse and Sexual Behavior

To inform ethical procedures for human subjects research using mobile health (mHealth), we examined perceived risks and benefits of study participation among emerging adults (N = 54) with drug use who completed text message assessments of substance use and sexual behaviors. Most participants reported comfort with participation and some reported perceived benefits, such as improved relationships. Perceived risks were infrequently reported, including negative emotions and legal or financial concerns. In conclusion, participants from a vulnerable population reported few perceived harms of participation in longitudinal mHealth assessments of sensitive behaviors. Researchers should continue characterizing participants’ perspectives on ethical aspects of mHealth research.