Revisiting the Distinction and the Connection Between Research and Practice.

The Belmont Report addresses the distinction between practice and research as guidance for which activities should be evaluated prospectively by a research ethics committee. This essay argues that the distinction between clinical practice and clinical research has a more fundamental significance for understanding the ethics of clinical research. After discussing the important connections between clinical research and clinical practice, the essay examines in detail ethically significant differences between these two sorts of activities. This sets the stage for a critique of clinical equipoise, widely regarded as a fundamental principle of clinical research ethics.

Belmont in Europe: A Mostly Indirect Influence.

This paper traces the reception of the Belmont Report in Europe and its influence on the development of European research ethics thinking and European research ethics systems. It is very difficult to trace a clear, linear reception history because it is difficult to disentangle the influence of the Report from the influence of concurrent developments, such as the 1975 revision of the World Medical Association Declaration of Helsinki and the requirement for research ethics review in the Vancouver Group's 1978 "Uniform Requirements for Manuscript Submission." The Report's insistence that the focus of research ethics should be the rights and interests of the individual research subject, and the use of an ethical framework and not ethical theory as the basis of analysis and justification of recommendations, were nevertheless very important for the development of research ethics. The divergence between Europe and the US in the governance of non-biomedical research can at least partly be explained by the absence of strong drivers for the introduction of research ethics committees outside of biomedicine in Europe, and by the ability of non-biomedical researchers to mobilize effectively against the introduction of such committees.

Conducting reproductive research during a new childhood cancer diagnosis: ethical considerations and impact on participants.

PURPOSE: Research among adults shows benefits and low perceived burden of engaging in behavioral research. However, questions remain regarding the ethics of conducting behavioral research in pediatric populations during sensitive situations, including during a new life-threatening diagnosis or at end-of-life. We examined reactions to participating in a behavioral reproductive research study among male adolescents newly diagnosed with cancer and their parents, as a step towards optimizing fertility preservation utilization in a population where future infertility is common. METHODS: Pediatric literature regarding the ethics of behavioral research was reviewed. In our pilot, forty-four participants (19 mothers, 11 fathers, 14 male adolescents newly diagnosed with cancer) from 20 families completed demographic questionnaires and a fertility preservation decision tool developed by the study team. Qualitative interviews exploring the impact of study participation were subsequently conducted. Verbatim transcripts were coded for thematic content using the constant comparison method. RESULTS: Literature review showed positive reactions to research participation among youth/caregivers. In our pilot study, 89% (n = 17) of mothers, 64% (n = 7) of fathers, and 71% (n = 10) of adolescents reported at least one benefit of participating. Eleven percent (n = 2) of mothers, 36% (n = 4) of fathers, and 29% (n = 4) of adolescents said they were not affected; none of the participants reported a negative effect. CONCLUSION: Consistent with prior literature, our study suggests behavioral reproductive research prior to cancer treatment can offer direct benefits to participants and society, without increasing burden. These findings will inform future interventions to improve long-term psychosocial and reproductive outcomes for youth with cancer.

Rethinking the Belmont Report?

This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it.

A right to confidentiality or a duty to disclose? Ethical guidance for conducting prevention research with children and adolescents.

Conducting prevention research with children and adolescents raises ethical challenges especially regarding confidentiality. Research with children and adolescents often applies methodologies which aims at the disclosure of sensitive information about practices that impact on adolescent mental and physical health such as sexual activity, smoking, alcohol consumption, illegal drug use, self-damaging and suicidal behaviour (ideation and attempts). The scope of the article is to review normative documents that cover topics relevant for confidentiality when conducting research with children and adolescents. A systematic literature search in MEDLINE was performed to identify relevant international and European guidelines and codes of ethics that cover health, behavioural and social science research. Additionally, the European Research Ethics website was consulted for double check. However, none of the documents aimed at biomedical, behavioural or social research offers concrete support in resolving practical research ethics problems regarding confidentiality. The codes show a lack of clarity in any circumstances in which the researcher might have an obligation to breach confidentiality by disclosing sensitive information. Only little information is given on what kind of disclosed information, if disclosed, might justify breaching confidentiality. The findings prove a need for normative documents to address the ethical questions regarding confidentiality arising in research practice explicitly and specifically. Moreover, further forms of ethical guidance should be developed to support ethical research with children and adolescents.

Little Albert's alleged neurological impairment: Watson, Rayner, and historical revision.

In 2012, Fridlund, Beck, Goldie, and Irons (2012) announced that "Little Albert"-the infant that Watson and Rayner used in their 1920 study of conditioned fear (Watson & Rayner, 1920)-was not the healthy child the researchers described him to be, but was neurologically impaired almost from birth. Fridlund et al. also alleged that Watson had committed serious ethical breaches in regard to this research. Our article reexamines the evidentiary bases for these claims and arrives at an alternative interpretation of Albert as a normal infant. In order to set the stage for our interpretation, we first briefly describe the historical context for the Albert study, as well as how the study has been construed and revised since 1920. We then discuss the evidentiary issues in some detail, focusing on Fridlund et al.'s analysis of the film footage of Albert, and on the context within which Watson and Rayner conducted their study. In closing, we return to historical matters to speculate about why historiographical disputes matter and what the story of neurologically impaired Albert might be telling us about the discipline of psychology today.

The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.

On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (a) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (b) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (c) appropriate guidelines for the selection of human subjects for participation in such research and (d) the nature and definition of informed consent in various research settings. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public comment on this recommendation.

Bioethical dimensions of cultural psychosomatics: the need for an ethical research approach.

Contemporary psychosomatics is a research-based technical discipline and its social power depends on how scientific knowledge is obtained and applied in practice, considering cultural contexts. This article presents the view that the dialogical principles on which bioethical discourse is based are more inclusive than professional ethics and philosophical reflection. The distinction is advanced between rule-guided behavior and norm-justifiable acts (substantiation and justification). The practical implications of good practices in the generation of valid, reliable, generalizable and applicable knowledge are emphasized. For practitioners and researchers, the need to reflect on the distinction between patient and research participant can avoid the therapeutic misunderstanding, a form of abuse of the doctor-patient relationship. In addition, in resource-poor settings, the dilemma presented by the know-do gap (inapplicability of research results due to financial or social constraints) is part of the ethics' realm of the profession. Future prospects include a wider use of research results in practice, but avoidance of the know-do gap (the disparity between what is known and what can be done, particularly in settings with limited resources) requires a synthetic and holistic approach to medical ethics, combining moral reflection, theoretical analysis and empirical data.

Where are we in the justification of research involving chimpanzees?

On December 15, 2011, the Institute of Medicine (IOM) Committee on the Use of Chimpanzees in Biomedical and Behavioral Research issued a final report commissioned by the National Institutes of Health (NIH). It changed the landscape of discussion about the necessity of using chimpanzees in research. The Committee advanced three principles of scientifically warranted research on chimpanzees, but NIH's statement of task provided inadequate opportunity for the Committee to investigate moral problems and their implications for public policy. The IOM Committee's report is a landmark document, but it has weaknesses in its justificatory framework, largely resulting from the Committee's narrow remit from NIH and IOM. We analyze cases mentioned in the report and argue that numerous central ethical issues are neglected, especially ones of justification. Additionally, we consider whether the principles offered by the Committee could be used as criteria governing the use of other animals in biomedical and behavioral research.

Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

OBJECTIVE: To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. METHOD: Selective qualitative review. RESULTS: Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. CONCLUSIONS: This review highlights the need for a scientific consensus statement on control groups in behavioral trials.

Contemporary discursive psychology: issues, prospects, and Corcoran's awkward ontology.

This paper is both an overview of the status of contemporary discursive psychology and a response to Corcoran's critical article. The first part of the paper reports on the main traditions that make up contemporary discursive psychology and how they relate to one another. Then it responds to Corcoran's claims that much of contemporary discursive psychology: (a) is over concerned with epistemic issues at the expense of ontological issues; (b) is too concerned with data purity while failing reflexively to address its own practices; (c) fails to address ethical, applied, and political issues in the way that a reformed 'ontological' discursive psychology would be able to; (d) fails to provide an adequate and rich account of relationality (of the kind offered by thinkers such as Bakhtin, Shotter, and Chouliaraki). The limitations of each point are addressed in turn, highlighting errors and confusions. The broadly epistemic focus is appropriate for the subject matter of discursive psychology; discursive psychology is less concerned with data purity than with pursuing the radical and empirically progressive possibilities in studying records of people living their lives in everyday and institutional settings (a surprising oversight in a discipline focused on the actions of human beings) and it has a reflexive tradition going back two decades; it has a strong and distinctive focus on ethical, applied, and political issues; it has an account of relationality that is grounded in conversational materials. A single example from interaction on a child protection helpline is analysed to illustrate the way relationality, knowledge, and intersubjectivity have been made analytically tractable in contemporary discursive research.

Replicating Milgram: Would people still obey today?

The author conducted a partial replication of Stanley Milgram's (1963, 1965, 1974) obedience studies that allowed for useful comparisons with the original investigations while protecting the well-being of participants. Seventy adults participated in a replication of Milgram's Experiment 5 up to the point at which they first heard the learner's verbal protest (150 volts). Because 79% of Milgram's participants who went past this point continued to the end of the shock generator's range, reasonable estimates could be made about what the present participants would have done if allowed to continue. Obedience rates in the 2006 replication were only slightly lower than those Milgram found 45 years earlier. Contrary to expectation, participants who saw a confederate refuse the experimenter's instructions obeyed as often as those who saw no model. Men and women did not differ in their rates of obedience, but there was some evidence that individual differences in empathic concern and desire for control affected participants' responses.

The power of the situation: The impact of Milgram's obedience studies on personality and social psychology.

Few psychological studies, if any, can claim a legacy as imposing as the obedience studies of Stanley Milgram. Their impact was of notable consequence in the separate spheres of research ethics, research design, and theory in psychology, and they changed the ways that psychologists conceptualize and conduct their research. The authors discuss the legacy of these studies, especially as they effected dramatic changes in the fields of personality and social psychology. The article concludes with a discussion of what psychological science has lost in the aftermath of Milgram--high impact studies--and the salience that such research has in illuminating the most significant problems of our society, studies that could produce great human benefits.

Reflections on "Replicating Milgram" (Burger, 2009).

In "Replicating Milgram: Would People Still Obey Today?" Jerry M. Burger reported a high base rate of obedience, comparable to that observed by Stanley Milgram (1974). Another condition, involving a defiant confederate, failed to significantly reduce obedience. This commentary discusses the primary contributions of Burger's study in terms of (a) its novel methodological variation on Milgram's original paradigm (the "150-volt solution") and (b) its attention to ethical concerns so as to minimize participant discomfort and ensure institutional review board approval. Burger's technique could unlock research on behavioral aspects of obedience, which has been essentially muted for several decades. However, Burger's intensive efforts to improve the ethics of the study may be exaggerated, are uncertain in their effectiveness, and pose impractical demands. Different procedures used by Milgram and Burger in the modeled refusal condition preclude a clear explanation for the results and challenge Burger's emphasis on the comparability of his and Milgram's experiments. This study documents the complexities of extending research on destructive obedience in the context of contemporary ethical guidelines.

Obedience lite.

Jerry M. Burger's partial replication of Stanley Milgram's (1963, 1965, 1974) classic experiments on obedience to authority is considered from the viewpoint of a contributor and witness to the original obedience experiments. Although Burger's replication succeeded in terms of gaining the approval of his local institutional review board, it did so by removing a large portion of the stressful circumstances that made Milgram's findings so psychologically interesting and so broadly applicable to instances of real-world destructive obedience. However, Burger has provided an initial demonstration that his "obedience lite" procedures can be used to extend the study of certain situational and personality variables beyond those examined by Milgram.

From New Haven to Santa Clara: A historical perspective on the Milgram obedience experiments.

This article traces the history of obedience experiments that have used the Milgram paradigm. It begins with Stanley Milgram's graduate education, showing how some aspects of that experience laid the groundwork for the obedience experiments. It then identifies three factors that led Milgram to study obedience. The underlying principles or messages that Milgram thought could be extracted from his experiments are then presented, and the evidence in support of them is assessed. Jerry M. Burger'srecent replication of Milgram's work--its place in the history of obedience research and its contribution to furthering the understanding of destructive obedience--is then examined.

Developing distress protocols for research on sensitive topics.

Two protocols that were developed to address risks related to emotional distress in an ongoing, qualitative, community-based study of adolescent dating violence are presented. The first protocol is for use in telephone screening to identify individuals at high risk of adverse emotional reactions. The second protocol guides interviewer's responses to emotional distress expressed by participants during in-depth research interviews. The study is briefly described, and the process used to develop the protocols is discussed. The process of developing the protocols caused the authors to reconsider some previously held assumptions about human subject protections in research on sensitive topics.