BackgroundInformed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study (...) information and interactions with the research team.MethodsBetween January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.ResultsVolunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.ConclusionVolunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event. (shrink)

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for (...) the individual research participant. Furthermore, current proposals do not address the worry that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorization. In this paper, we show how the standard view of informed consent – consent as autonomous authorization – can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. (shrink)

In medical practice, the doctrine of informed consent is generally understood to have priority over the medical practitioner’s duty of care to her patient. A common consequentialist argument for the prioritisation of informed consent above the duty of care involves the claim that respect for a patient’s free choice is the best way of protecting that patient’s best interests; since the patient has a special expertise over her values and preferences regarding non-medical goods she is ideally placed to make a (...) decision that will protect her interests. In this paper I argue against two consequentialist justifications for a blanket prioritisation of informed consent over the duty of care by considering cases in which patients have imperfect access to their overall best interests. Furthermore, I argue that there are cases where the mere presentation of choice under the doctrine of informed consent is detrimental to patient best interests. I end the paper by considering more nuanced approaches to resolving the conflict between informed consent and the duty of care and consider the option of permitting patients to waive informed consent. (shrink)

It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant9s consent to research (...) participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan9s argument fails. The set of clinical trials that is supposed to be ethical in the face of this kind of ignorance is empty. However, I argue that his argument is nonetheless instructive in allowing us to identify three important but neglected areas for future conceptual research on informed consent. I close by arguing that research on these identified questions promises to yield a defensible view of consent, lessen the burden of ambiguity on researchers attempting to obtain consent to research participation, and facilitate socially valuable research. (shrink)

Libertarian paternalism's notion of “nudging” refers to steering individual decision making so as to make choosers better off without breaching their free choice. If successful, this may offer an ideal synthesis between the duty to respect patient autonomy and that of beneficence, which at times favors paternalistic influence. A growing body of literature attempts to assess the merits of nudging in health care. However, this literature deals almost exclusively with health policy, while the question of the potential benefit of nudging (...) for the practice of informed consent has escaped systematic analysis. This article focuses on this question. While it concedes that nudging could amount to improper exploitation of cognitive weaknesses, it defends the practice of nudging in a wide range of other conditions. The conclusion is that, when ethically legitimate, nudging offers an important new paradigm for informed consent, with a special potential to overcome the classical dilemma between paternalistic beneficence and respect for autonomy. (shrink)

The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...) children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research. (shrink)

Standard views on surrogate decision making present alternative ideal models of what ideal surrogates should consider in rendering a decision. They do not, however, explain the physician''s responsibility to a patient who lacks decisional capacity or how a physician should regard surrogates and surrogate decisions. The authors argue that it is critical to recognize the moral difference between a patient''s decisions and a surrogate''s and the professional responsibilities implied by that distinction. In every case involving a patient who lacks decisional (...) capacity, physicians and the treatment team have to make judgments about the appropriateness of both the surrogate and the surrogate''s decision. They have to assess the surrogate''s decisional capacity and attitude toward the patient as well as the reasons that support the surrogate''s decision. This paper provides a model for acceptable surrogate decisions and a standard for blocking inappropriate surrogates. Only decisions based on widely shared reasons are allowable for surrogate refusal of highly beneficial treatment. (shrink)

Psychologists are ethically obligated to obtain informed consent to psychotherapy "as early as is feasible" (American Psychological Association, 2002, p. 1072). However, the range of topics to be addressed includes both information that may be immediately and uniformly applicable to most clients via policy or rule, as well as information that is not immediately presentable because it varies widely across clients or emerges over time. In this study, licensed psychologists were surveyed regarding the earliest feasible point at which they could (...) provide information regarding specific aspects of psychotherapy. Results indicate that, although psychologists believe that they are capable of presenting some information, such as payment and confidentiality policies, at the outset, they believe that a discussion of more substantive issues, such as psychotherapy duration, goals, orientation, and activities, can take place only after some therapy has transpired. Implications are discussed regarding the process and event models of informed consent. (shrink)

We analyzed a sample of 356 forms containing information that Colorado law legally requires both licensed and unlicensed therapists to disclose to clients. The majority of forms contained the legally mandated information; fewer forms contained ethically desirable information. The average readability grade level was 15.74, corresponding to upper-level college, and 63.9% of the forms reached the highest (most difficult) readability grade of 17 +. Therapists are obeying the law, but do not appear to be taking advantage of the opportunity to (...) provide their clients useful information in an accessible way. (shrink)

The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent (...) autonomy-undermining ignorance. The problem with the standard account, we argue, is that it fails to distinguish between different forms of ignorance–in particular, error and suspending ignorance–that have very different effects on individuals’ ability to provide valid consent. While error often undermines our ability to provide valid consent, suspending ignorance, we argue, does not. Once the moral weight of this distinction is appreciated, it becomes apparent that valid informed consent requires far less knowledge than suggested by the standard account. (shrink)

The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures.

Candidate evaluation for breast implantation presents a more important obstacle to the fulfillment of the normative requirements of informed consent than do the social roles of women or cultural norms governing female beauty. I argue that women's decisions to receive breast implants may indeed be informed, competently made, and substantially voluntary, but that the cultural construction of beauty may undermine women's autonomy by influencing the evaluation of surgical candidates and risk disclosure during informed consent.

Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confusing double standard has been established. 'Daily consent' is reviewed, if at all, only in retrospect. Doctors are merely exhorted (...) to obtain informed consent; they often minimise uncertainties about 'best' treatment and they feel duty-bound to provide patients with an unequivocal recommendation for action. 'Study consent' in a clinical trial is reviewed prospectively, and doctors are compelled by regulation to point out that there is insufficient evidence to make a rational choice between two compared treatments. It has been impossible to devise informed consent practices that satisfy, in full, the competing moral imperatives of respect for autonomy, concern for beneficence with emphasis on the value of health, and a vigil for justice. A way must be found to experiment with various discretionary approaches that would strike a realistic balance among competing interests. (shrink)

Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing children who are capable (...) to make their own decisions. This suggests children are capable of assent when they become able to understand the research in question. While development varies across individual children, existing data suggest most children develop this ability by approximately age 14. Until instruments are developed to assess the assent capacity of individual children, this age should be used as the threshold for assent. In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected. While the assent requirement may be waived when research participation offers the potential for important medical benefit that is unavailable outside the research context, analysis suggests that children’s sustained dissent should be respected in all cases. (shrink)

It is possible to retrieve viable sperm from a dying man or from a recently dead body. This sperm can be frozen for later use by his wife or partner to produce his genetic offspring. But the technical feasibility alone does not morally justify such an endeavour. Posthumous semen retrieval raises questions about consent, the respectful treatment of the dead body, and the welfare of the child to be.We present two cases, discuss these three issues, and conclude that such requests (...) should generally not be honoured unless there is convincing evidence that the dead man would want his widow to carry and bear his child. Even with consent, the welfare of the potential child must be considered. (shrink)

This essay lays the groundwork for a novel conception of autonomy that may be called “effective autonomy”—a conception designed to be genuinely action guiding in bioethics. As empirical psychology research on the heuristics and biases approach shows, decision making commonly fails to correspond to people’s desires because of the biases arising from bounded cognition. People who are classified as autonomous on contemporary philosophical accounts may fail to be effectively autonomous because their decisions are uncoupled from their autonomous desires. Accordingly, continuing (...) attempts to value patient autonomy must go beyond existing philosophical conceptions of autonomy to consider the background conditions of human decision making. (shrink)

BackgroundThis case report discusses an ethical communication dilemma in prehospital patient interaction, involving a patient who was about to board a plane at a busy airport. The article argues that the situation raised dilemmas about communication, patient autonomy and paternalism. Paramedics should be able to find good solutions to these dilemmas, but they have not received much attention in the literature on prehospital ambulance work.Case presentationThe patient had chest pains that were consistent with serious heart disease, but she wanted to (...) catch her plane and was unwilling to let paramedics assess her heart activity by means of an electrocardiogram (ECG). The paramedics had to decide, there and then, whether the patient’s refusal to submit to an ECG should be respected, or whether they should set the patient’s expressed wishes aside by exercising verbal power and persuasive communication techniques. The paramedics chose to do the latter. It later turned out that the patient was grateful that the paramedics had been very direct, almost brutal, in their communication. When the patient regained her autonomy, she saw clearly that taking time to obtain and monitor an ECG was the best option for her.ConclusionLooking forward in time might be a good professional strategy for deciding whether ethical paternalism in communication is justified. If there is good reason to believe that patients who later regain their autonomy will agree that paternalistic verbal actions were in their best interests, and if acting in accordance with patients’ preferences can have severe negative health consequences for them, then paramedics have good reason to believe that ethical paternalism is justified. (shrink)

Objectives: To study the consent process experienced by participants who are enrolled in a molecular genetic research study that aims to find new genetic mutations responsible for an apparently inherited disorder.Design: Semi-structured interviews and analysis/description of main themes.Participants: 78 members of 52 families who had been recruited to a molecular genetic study.Results: People were well informed about the goals, risks and benefits of the genetic research study but could not remember the consent process. They had mostly been recruited to take (...) part by trusted clinicians or their relatives but had little memory of, or concern about signing consent forms. Families appeared to regard the research as a continuation of their, or their relatives’, clinical care.Conclusions: Ethical review should be more flexible in its attitude to consent forms and written information sheets for some sorts of research. For rare genetic disease studies where research has been discussed fully within the clinical setting then the consent obtained at that time could suffice rather than needing extra consent at a later stage. However, clinician-researchers will need to ensure that their duty of care extends for the duration of the research and beyond. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Rights, autonomy, privacy, and confidentialityare concepts commonly used in discussionsconcerning genetic information. When theseconcepts are thought of as denoting absolutenorms and values which cannot be overriden byother considerations, conflicts among themnaturally occur.In this paper, these and related notions areexamined in terms of the duties and obligationsmedical professionals and their clients canhave regarding genetic knowledge. It issuggested that while the prevailing idea ofautonomy is unhelpful in the analysis of theseduties, and the ensuing rights, an alternativereading of personal self-determination canprovide a firmer (...) basis for ethical guidelinesand policies in this field. (shrink)

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The (...) continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page 17-18, August 2011.

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

In June 1992, a national mail survey was directed to 204 state inpatient psychiatric institutions. This study was implemented following the 1992 Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requirement that hospitals put in place some means with which to address ethical issues. The goals of the study were: 1. to examine state mental hospital characteristics and their response to the JCAHO requirements; 2. to describe healthcare ethics committee (HEC) composition, function, and role; 3. to study patient and family (...) access to a HEC; and 4. to discover ethical issues most frequently addressed. The survey response rate was 71%. Of the 145 responders, 62 had HECs in place, and 53 were in the process of implementing HECs. There were no differences between JCAHO accredited institutions and non-accredited facilities with regard to having HECs. Physicians accounted for 22% of HEC membership, followed by nurses (15%), and administrators (12%). Twenty-six percent of facilities systematically notified patients about existence of the HEC; 71% of facilities had no patient request for HEC services in the last year. A patient's danger to others, and resuscitation policy were issues most frequently (23%) heard by HECs. (shrink)

Treatment informed consent aims to preserve the autonomy of patients in the clinician – patient relationship so as to ensure valid consent. An acceptable method of evaluating understanding of consent information is by assessing the extent of recall by patients of the pieces information believed to have been passed across. When concerns are not satisfactorily addressed from the patients’ perspective, recall of consent information may be low. This study is a questionnaire – based cross – sectional interview of consecutive adult (...) surgical patients who could give their respective medical histories and who were booked for elective major surgical procedures over a period of 7 months in a tertiary health institution in southeastern Nigeria. Four to five days after a formal consent session, during ward admission, extent of recall of information on the nature of the disease condition or diagnosis, the nature of the planned procedure and the risks involved in the planned procedure were assessed and analyzed on the background of how satisfying the consent sessions were from individual patient’s perspective. Generally, the recall of nature of disease condition and nature of planned procedure is better than recall of risks involved in the planned procedure. More specifically however, recall in these 3 domains is significantly better among the patients that affirmed that their concerns were satisfactorily addressed. The findings from this study support that no effort should be spared in ensuring that the consent information are satisfying to the patients from the patients’ viewpoint. (shrink)

What is informed consent in medicine? For more than a generation, this deceptively simple question has vexed the law, discomfited medicine, and generated much inspired, provocative, and even contentious commentary.The question has also spawned several lawsuits. On one side stand patients who claim that, at the time of consent, they were ignorant of a particular risk; who state that, with more or different information, they would have chosen a different treatment; and who argue that, because of an adverse outcome, they (...) now deserve remuneration. On the other side, doctors uneasily watch the lengthening list of suits. Some, troubled by the law's expectations, have reacted by variously describing informed consent as a myth, a fiction, an unattainable goal, or a snare to entrap physicians. They point to the legal commentary condemning informed consent law as ill-defined, diffuse, and fraught with inconsistency, hazy at its best and virtually indecipherable to physicians at its worst: and lacking a fair standard to determine when a patient has sufficient knowledge to give effective consent. (shrink)

In April 1999, Dr. Curt Freed of the University of Colorado in Denver and Dr. Stanley Fahn of Columbia Presbyterian Center in New York presented the results of a four-year, $5.7 million government-financed study using tissue from aborted fetuses to treat Parkinson’s disease at a conference of the American Academy of Neurology. The results of the first government-financed, placebo-controlled clinical study using fetal tissue showed that the symptoms of some Parkinson’s patients had been relieved. This research study involved forty subjects, (...) nineteen women and twenty-one men; all suffered from Parkinson’s disease for an average of 13.5 years. In the study, each subject underwent neurosurgery: “four tiny burr holes, drilled through the wrinkle lines above the eyebrows into the skull, to clear a pathway to the brain. But only half received injections of fetal cells into the putamen, the region of the brain that controls movement; the other half received nothing. One year later, three members of the placebo group said their symptoms had improved.” In two-thirds of the transplant recipients, the fetal tissue took hold and seemed to establish a new network to produce the missing neurochemical dopamine. (shrink)

BackgroundThe legal and ethical guidelines of psychological professional associations stipulate that informed consent by patients is an essential prerequisite for psychotherapy. Despite this awareness of the importance of informed consent, there is little empirical evidence on what psychotherapists’ attitudes towards informed consent are and how informed consent is implemented in psychotherapeutic practice.Methods155 psychotherapists in Switzerland completed an online survey assessing their attitudes regarding informed consent. ResultsAmong the surveyed psychotherapists, there was a high consensus on important information that should be communicated (...) to patients in the context of informed consent. Almost all psychotherapists rated confidentiality and its exemptions (95%) and self-determined decision-making (97%) as important. The importance to disclose information regarding fees and the empirical effectiveness of the provided treatment, were both seen as important by more than 80% of participants. The disclosure of personal information about the therapist was rated as important by 60%. Other aspects, which are not direct components of informed consent but rather overarching goals, were also evaluated rather homogeneously: self-determined decision making of the patient was rated as important by almost all of the surveyed psychotherapists (97%). The following components were also judged as important by a majority of the participants: promotion of hope (80%) and discussion of treatment goals (93%). Most psychotherapists described the implementation of informed consent as an ongoing process, rather than a one-time event during the first session of therapy. Therapists’ age, postgraduate training, treated patient group, and setting influenced attitudes towards informed consent.ConclusionsThe present study shows that informed consent is perceived by psychotherapists as both a challenge and a resource. The implementation of informed consent in psychotherapy requires further research from a clinical and ethical perspective. (shrink)

Ethical research with children requires a special concern for their well-being as individuals. Researchers are therefore expected to report problems children experience and to refer children for assistance. This article addresses difficulties that can arise as researchers attempt to meet this obligation in research with low-income ethnic minority children. Potential difficulties include both failure to report and overreporting suspected problems. The role of institutional review boards in researchers' reporting and referring behavior is also discussed.

Traditionally, there have been few legal actions brought against psychotherapists that allege negligent psychotherapy and negligent treatment of psychiatric disorders. However, in the case of Osheroff v. Chestnut Lodge, a patient-physician (Dr. OsheroE) sued Chestnut Lodge, a private psychiatric facility, for negligence based on the staff's decision to apply a psychodynamic model of treatment (through psychotherapy) and not a biological model. The case sparked a heated debate between adherents of the psychodynamic model and those of the biological model. This article (...) explores the implications of the Osheroff litigation for mental health professionals. It is proposed that an interactive informed consent process be used to protect psychotherapists against Osheroff-type litigation. (shrink)

Patients belonging to ethnic, racial, and religious minorities have been all but excluded from the legal academy’s ongoing conversation about informed consent. Perhaps this is just as well, since the conversation appears to have concluded that the doctrine has failed to serve as a meaningful regulation of clinical relationships. Informed consent does not operate in practice the way it was intended in theory. More than a decade ago, Peter Schuck noted the “informed consent gap” that distinguishes the “proper” law of (...) informed consent “on the books” from the actual consent law in action, and called for a more contextualized approach to informed consent. Susan Wolf later called for a systemic approach to informed consent in order to accommodate multiple decision points in the managed care setting. Some reformers have sought enhancements to expand the doctrine. (shrink)

A literature search was conducted on studies of new drugs used with patients with schizophrenia reported by U.S. and non-U.S. researchers from 1966–1993, yielding 41 U.S., and a total of 24 other non-U.S. studies, among them 11 British studies. Results of the U.S. and non-U.S. studies were pooled separately and compared. Among several comparable conditions discussed, the lack of any data on suicides in the U.S. studies was observed. For a second statistical analysis of suicide rates ‘person-years’ were calculated to (...) adjust for differing washout durations. The results obtained include findings that the percentage of patients relapsing in U.S. studies was slightly lower than in non-U.S. studies ; the percentage of patients dropping out in U.S. studies was higher than in non-U.S. studies ; known location of dropout patients in U.S. studies was 1.7%, compared to 2.6% in non-U.S. studies. The most interesting finding was that no suicides were reported in U.S. studies, compared to 0.6% of patients reported in British studies. Some U.S. studies used ‘challenge doses’, such as amphetamines or L-dopa; no non-U.S. studies reported their use. Compared to U.S. studies, those by non-U.S., and particularly British, researchers appeared to report adverse events in their studies. ‘Challenge’ drugs were not used; suicides were reported. It is estimated that the probability that no patients suicided who participated in the U.S. is small—one in 500. (shrink)

Background There is little dispute that the ideal moral standard for surgical informed consent calls for surgeons to carry out a disclosure dialogue with patients before they sign the informed consent form. This narrative study is the first to link patient experiences regarding the disclosure dialogue with patient-surgeon trust, central to effective recuperation and higher adherence. Methods Informants were 12 Israelis, aged 29–81, who underwent life-saving surgeries. A snowball sampling was used to locate participants in their initial recovery process upon (...) discharge. Results Our empirical evidence indicates an infringement of patients’ right to receive an adequate disclosure dialogue that respects their autonomy. More than half of the participants signed the informed consent form with no disclosure dialogue, and thus felt anxious, deceived and lost their trust in surgeons. Surgeons nullified the meaning of informed consent rather than promoted participants’ moral agency and dignity. Discussion Similarity among jarring experiences of participants led us to contend that the conduct of nullifying surgical informed consent does not stem solely from constraints of time and resources, but may reflect an underlying paradox preserving this conduct and leading to objectification of patients and persisting in paternalism. We propose a multi-phase data-driven model for informed consent that attends to patients needs and facilitates patient trust in surgeons. Conclusions Patient experiences attest to the infringement of a patient’s right to respect for autonomy. In order to meet the prima facie right of respect for autonomy, moral agency and dignity, physicians ought to respect patient’s needs. It is now time to renew efforts to avoid negligent disclosure and implement a patient-centered model of informed consent. (shrink)

Volume 19, Issue 5, May 2019, Page 22-24.

Background Despite recent developments aimed at creating international guidelines for ethical global health research, critical disconnections remain between how global health research is conducted in the field and the institutional ethics frameworks intended to guide research practice. Discussion In this paper we attempt to map out the ethical tensions likely to arise in global health fieldwork as researchers negotiate the challenges of balancing ethics committees’ rules and bureaucracies with actual fieldwork processes in local contexts. Drawing from our research experiences with (...) an implementation and evaluation project in Jamaica, we argue that ethical research is produced through negotiated spaces and reflexivity practices that are centred on relationships between researchers and study participants and which critically examine issues of positionality and power that emerge at multiple levels. In doing so, we position ethical research practice in global health as a dialectical movement between the spoken and unspoken, or, more generally, between operationalized rules and the embodied relational understanding of persons. Summary Global health research ethics should be premised not upon passive accordance with existing guidelines on ethical conduct, but on tactile modes of knowing that rely upon being engaged with, and responsive to, research participants. Rather than focusing on the operationalization of ethical practice through forms and procedures, it is crucial that researchers recognize that each ethical dilemma encountered during fieldwork is unique and rooted in social contexts, interpersonal relationships, and personal narratives. (shrink)

When science takes man as its subject, tensions arise between two values basic to Western society: freedom of scientific inquiry and protection of individual inviolability.... At the heart of this conflict lies an age-old question: When may a society, actively or by acquiescence, expose some of its members to harm in order to seek benefits for them, for others, or for society as a whole?

Based on extensive questionnaire data, this paper focuses on parents’ views about children’s right to decide about participation in research. The data originates from 4000 families participating in a longitudinal prospective screening as 1997. Although current regulations and recommendations underline that children should have influence over their participation, many parents in this study disagree. Most (66%) were positive providing information to the child about relevant aspects of the study. However, responding parents were split about whether or not children should at (...) some point be allowed decisional authority when participating in research: 41.6% of the parents reported being against or unsure. Those who responded positively believed that children should be allowed to decide about blood-sampling procedures (70%), but to a less extent about participation (48.5%), analyses of samples (19.7%) and biological bank storage (15.4%). That as many as possible should remain in the study, and that children do not have the competence to understand the consequences for research was strongly stressed by respondents who do not think children should have a right to decide. When asked what interests they consider most important in paediatric research, child autonomy and decision-making was ranked lowest. We discuss the implications of these findings. (shrink)

The past 15 years have witnessed a call for allopathic medicine to incorporate psychosocial perspectives into education and clinical practice. While a biopsychosocial perspective has influenced academic medicine in areas such as primary care and psychiatry, its direct impact on clinical medicine has been questionable. One barrier to the incorporation of psychosocial information into medicine which has only recently received attention has been different cultural assumptions which govern medicine versus the social-behavioral sciences. These assumptions are examined in the context of (...) four issues: knowledge paradigms, models of education, acculturation of psychosocial knowledge into medicine, and patient autonomy. This cultural analysis provides a vantage point for understanding similarities as well as points of divergence between psychosocial and biomedical knowledge and practice. (shrink)

Transcranial direct current stimulation is a safe and efficient intervention for treating major depressive disorder. However, research has suggested heterogeneity of response between patients. The emerging field of precision psychiatry aims to use statistical modeling of multi-modal data to tailor treatment to the single patient. To this end, more in-depth analysis of randomized controlled trials will be relevant due to limited availability of other large datasets with high phenotypic detail and to develop tools for personalization within counterfactually controlled environments to (...) distinguish specific vs. non-specific patterns in treatment data. Previous research has aimed at identifying patient-related factors associated with better response. However, most analyses have operated on the group-level, ignoring natural clusters within the patients' constituting factors, their individual trajectories of symptom improvement, and their presented symptoms. Furthermore, group-based modeling strategies were limited to explanatory approaches using in-sample hypothesis-testing, that are ill-suited to prognosticate outcomes of single patients. This dissertation provides a methodological framework for reevaluation of existing clinical trial data to provide future investigations with more differentiated units of analysis and to complement explanatory approaches with predictive modeling strategies enabling prediction of single-patient outcomes. Using data from a landmark 3-arm clinical trial paradigmatic for a rigorously controlled experimental design the dissertation provides three blueprint studies for modeling heterogeneity of tDCS response: Study 1 characterized response to tDCS by considering patient-individual dynamics of symptom change over the course of treatment. Distinct trajectories of tDCS response could be identified, representing patient subgroups with varying strength and speed of improvement. These results suggest development of individualized treatment protocols and exploration of prolonged treatment courses. Study 2 reevaluated the efficacy of tDCS, in distinct, naturally occurring clusters of depressive symptoms. Using unsupervised machine learning, a global depression measure was parsed into 4 distinct symptom clusters. Analysis of cluster-scores showed superiority of tDCS and escitalopram over placebo in core depressive symptoms, but only tDCS was superior in improving sleep and only escitalopram was superior in improving guilt/anxiety symptoms, suggesting treatment selection based on patients' symptom profiles. In Study 3 supervised ML algorithms were employed to predict response to tDCS. In this proof-of-concept approach, response could be predicted above chance on the single-patient level, but overall accuracy was modest. Features employed for model training were explored using interpretable ML methods. Trained algorithms were provided to the field for expansion as well as tests of generalizability and incremental utility. The presented studies illustrate how in-depth secondary analyses of clinical trial data can aid personalization of treatment. The provided methodological framework can be expanded and generalized to other contexts and interventions that show heterogeneity of treatment effects. Yet, the empirical studies also epitomize challenges precision psychiatry is faced with, including low data availability, low outcome granularity, and limited external validation opportunities. The dissertation concludes with a discussion of challenges and future directions resulting from infrastructural demands in data acquisition, data management, data sharing, and interdisciplinary collaboration. (shrink)