Volume 20, Issue 6, June 2020, Page 25-27.

Biobanks for long-term research pose challenges to the legal and ethical validity of consent to participate. Different models of consent have been proposed to answer some of these challenges. This paper contributes to this discussion by considering the meaning and value of consent to participants in biobanks. Empirical data from a qualitative study is used to provide a participant view of the consent process and to demonstrate that, despite limited understanding of the research, consent provides (...) the research participants with some level of control and a form of self determination that they value. Participation is framed as a moral act of a responsible citizen providing reinforcement of self identity. Consent symbolizes the trust invested in researchers and research institutions to use the biobank for the public good. The paper argues that consent continues to play an important role in biobank participation and that a participant view should inform proposals to modify consent processes. (shrink)

Against a background of increasing regulation regarding access to medical information and the presentation of patients' confidentiality, the case of genetic information raises interesting questions about whether the application of general rules is appropriate in all situations. Whilst all genetic information is not equally sensitive, some of it is highly predictive. It also allows deductions to be made about other family members. It may not be regarded as particularly sensitive when compared to other types of medical information and those to (...) whom it applies may not be as anxious about preserving their confidentiality as compared with—for example, the prospect of seeing research into cause and cures for rare diseases put in hand. These distinctions also find resonance with the general public. Resolving conflicting tensions will require subtlety, not a blunt “one size fits all” model. (shrink)

The results of the first randomized controlled trial of a medical treatment were reported in 1947. The antibiotic streptomycin was demonstrated to be dramatically superior to bed rest alone in treating tuberculosis. Looking back on this trial in 1990, A. B. Hill, the distinguished medical statistician who played a prominent role in the use of randomization in this study, made a telling statement about the moral climate of clinical research at the time: "Of course, there were no ethical problems in (...) those days: we did not ask the patient’s permission or anybody’s permission. We did not tell them they were in a trial—we just did it" (1990, 78). From our perspective today it is obvious that it is not true that there .. (shrink)

Given the increasing need for solid organ and tissue transplants and the decreasing supply of suitable allographic organs and tissue to meet this need, it is understandable that the hope for successful xenotransplantation has resurfaced in recent years. The biomedical obstacles to xenotransplantation encountered in previous attempts could be mitigated or overcome by developments in immunosuppression and especially by genetic manipulation of organ source animals. In this essay we consider the history of xenotransplantation, discuss the biomedical obstacles to success, explore (...) recent developments in transgenic sourcing of organs and tissues, and analyze the problem of infectious disease resulting from xenotransplantation (xenosis). We then apply a model of risk analysis to these risks. The conclusions of this risk analysis are used in an ethical evaluation of informed consent in xenotransplantation, with an ethical foundation in Kantian autonomy and Levinasian heteronomic alterity. Our conclusion is that individual and collective informed consent to the infectious disease risks of xenotransplantation requires an open, participatory and dialogical public policy process not yet seen in the United States and Europe. Until that process is created, we propose caution in xenotransplantation in general and a postponement of solid organ xenotransplants in particular. (shrink)

Respect for patients’ autonomy has taken a central place in the practice of medicine. Received wisdom holds that respect for autonomy allows overriding a patient’s treatment preferences only if the patient has been found to lack capacity. This understanding of respect for autonomy requires a dichotomous approach to assessing capacity, whereby a patient must be found either to have full capacity to make some particular treatment decision or must be found to lack capacity to make that decision. However, clinical reality (...) is more complicated, and, in borderline cases, different physicians may arrive at disparate judgments of capacity. In such cases, when capacity-determination protocols fail to achieve consensus, physicians would benefit from guidance regarding the clinical decision-making process necessary to elucidate the most ethically sound course of action. This article considers one such case and argues that, in a limited number of cases, respect for autonomy may require overriding a patient’s stated treatment preference when a capacity determination is equivocal, even though the patient has not clearly demonstrated a lack of capacity. (shrink)

Volume 25, Issue 3, March 2025, Page 158-160.

Second, let me offer an apology for not having a handout for this talk. I do have a website that contains most of my talks and published papers, as well as various other ravings collected over thirty-plus years of ruminating, and you are each welcome to visit it and acquire for your own reading pleasure or other legitimate purposes (such as composing refutations of my foolish views) such copies as you may require. Just don’t steal my ideas and misrepresent them (...) as your own! The address is http://www.richard-t-hull.com. This paper should be posted there within the month. (shrink)

New applications in medicine, science and technology are changing our lives. The delicate border between clinical trials and conventional diagnostic / treatment methods is becoming more evident. At this border new questions arise that need both rational and humanistic answers and that affect humankind‘s understanding of self: What are our responsibilities towards human subjects in clinical trials? What are our responsibilities towards patients and decisionally impaired psychiatry patients? What are rules about the routine techniques on decisionally incompetent psychiatry patients? What (...) are the economic parameters‘ affecting decisions?Many current research projects are concerned with the ethical problems of clinical trials of newly used medication, clinical trials of newly used measurement techniques, clinical trials proposed as conventional treatment methods, new measuring methods or conventional measuring methods on irrelevant patient groups; all being concerned with clinical trials of EEG and neuroscience. In 2009, the Ministry of Health of Turkey implemented new legislation on ―clinical trials and newly established independent ethics committees ‖. These independent and multidisiplinary IRBs analyze research projects and make recommendations about them. What should be the rationale about psychiatric patients in Turkey in a global setting? (shrink)

Volume 19, Issue 5, May 2019, Page 43-45.

Adding to the literature on the feasibility of deliberative democracy, this article catalogs the practices, institutions, and psychological proclivities that have been cited as obstacles to the realization of a deliberative democratic politics. It then makes the case that one of the irremediable obstacles, ideology, is also the the necessary starting point for actual deliberation.

Patient consent has been formulated in terms of radical individualism rather than shared benefits. Medical education relies on the provision of patient consent to provide medical students with the training and experience to become competent doctors. Pelvic examination represents an extreme case in which patients may legitimately seek to avoid contact with inexperienced medical students particularly where these are male. However, using this extreme case, this paper will examine practices of framing and obtaining consent as perceived by (...) medical students. This paper reports findings of an exploratory qualitative study of medical students and junior doctors. Participants described a number of barriers to obtaining informed consent. These related to misunderstandings concerning student roles and experiences and insufficient information on the nature of the examination. Participants reported perceptions of the negative framing of decisions on consent by nursing staff where the student was male. Potentially coercive practices of framing of the decision by senior doctors were also reported. Participants outlined strategies they adopted to circumvent patients’ reasons for refusal. Practices of framing the information used by students, nurses and senior doctors to enable patients to decide about consent are discussed in the context of good ethical practice. In the absence of a clear ethical model, coercion appears likely. We argue for an expanded model of autonomy in which the potential tension between respecting patients’ autonomy and ensuring the societal benefit of well-trained doctors is recognised. Practical recommendations are made concerning information provision and clear delineations of student and patient roles and expectations. (shrink)

Cardiopulmonary resuscitation is frequently performed on patients who, in retrospect, had a very low chance of survival. This is because all patients are ‘For cardiopulmonary resuscitation’ on admission to hospital by default, and delays occur before cardiopulmonary resuscitation can be ‘de-prescribed’. This article reviews the nature of potential harms caused by futile cardiopulmonary resuscitation, the reasons why de-prescription may be delayed, recent legal judgements relevant to timely do not attempt cardiopulmonary resuscitation decision making, and the possible detrimental effects of do (...) not attempt cardiopulmonary resuscitation discussions on end of life care. The moral and operational feasibility of a model in which informed consent must be obtained before cardiopulmonary resuscitation is attempted in some patient groups is then explored. (shrink)

Personal data use is increasingly permeating our everyday life. Informed consent for personal data use is a central instrument for ensuring the protection of personal data. However, current informed consent practices often fail to actually inform data subjects about the use of personal data. This article presents the results of a requirements analysis for informed consent from both a legal and usability perspective, considering the application context of educational assessment. The requirements analysis is based on European Union (...) law and a review of current practices. As the main outcome, the article presents a blueprint which will be the basis for the development of an informed consent template that supports data controllers in establishing an effective and efficient informed consent form. Because the blueprint, and subsequently, the template, distinguishes between legal and usability requirements, it also provides the basis for the mapping of legal requirements in other contexts. (shrink)

One way in which liberal theories have argued for the legitimacy of the state is by means of a principle of implicit consent. Since Hume, critics have argued that the price of dissent would be too high for such a strategy to be successful. Some theorists have replied that the high price involved in not agreeing to do something does not need to be a defeating condition of consenting. Other theorists have proposed institutional reforms which will diminish the costs (...) of dissenting. In this paper, it is argued that the failure of an implicit consent approach is more fundamental than what this debate seems to suggest. (shrink)

Alzheimer's disease and other forms of dementia are among the fastest growing health problems in America. Dementia incidence tends to increase with age, and the elderly are the fastest growing segment of the population. Medical and social sciences research on dementia involving demented patients is both ongoing and necessary. However, as noted in a report of the Office for Human Subjects Research, “while research with intellectually impaired people generates valuable … data, it also provides significant ethical challenges.

This study investigated Belgian and Dutch parental opinions on confidentiality and consent regarding medical decisions about adolescents. Through an online survey, we presented six cases (three on confidentiality, and three on consent) to 1,382 Belgian and Dutch parents. We studied patterns in parental confidentiality and consent preferences across and between cases through binomial logistic regressions and latent class analysis. Participants often grant the right to consent for a treatment to the adolescent, but the majority diverges from (...) the adolescent’s preferences regarding confidentiality. More educated participants would rather not be informed about cases regarding a sexually transmitted disease or depression than lower educated participants. Further analysis shows that participants’ preferences correspond to authoritative (47%), permissive (30%) and authoritarian (17%) parenting styles. Belgian and Dutch parents are willing to grant some degree of autonomy, but they want to be informed about specific health issues. Parental views on confidentiality and granting consent appear to mirror existing parenting styles. (shrink)

BackgroundGenealogical research and ancestry testing are popular recreational activities but little is known about the impact of the use of these services on clients’ biological and social families. Ancestry databases are being enriched with self-reported data and data from deoxyribonucleic acid analyses, but also are being linked to other direct-to-consumer genetic testing and research databases. As both family history data and DNA can provide information on more than just the individual, we asked whether companies, as a part of the (...) class='Hi'>consent process, were informing clients, and through them clients’ relatives, of the potential implications of the use and linkage of their personal data.MethodsWe used content analysis to analyse publically-available consent and informational materials provided to potential clients of ancestry and direct-to-consumer genetic testing companies to determine what consent is required, what risks associated with participation were highlighted, and whether the consent or notification of third parties was suggested or required.ResultsWe identified four categories of companies providing: 1) services based only on self-reported data, such as personal or family history; 2) services based only on DNA provided by the client; 3) services using both; and 4) services using both that also have a research component. The amount of information provided on the potential issues varied significantly across the categories of companies. ‘Traditional’ ancestry companies showed the greatest awareness of the implications for family members, while companies only asking for DNA focused solely on the client. While in some cases companies included text recommending clients inform their relatives, showing they recognised the issues, often it was located within lengthy terms and conditions or privacy statements that may not be read by potential clients.ConclusionsWe recommend that companies should make it clearer that clients should inform third parties about their plans to participate, that third parties’ data will be provided to companies, and that that data will be linked to other databases, thus raising privacy and issues on use of data. We also suggest investigating whether a ‘generational consent’ should be created that would include more than just the individual in decisions about participating in genetic investigations. (shrink)

The participation of adolescents in genetic research engenders unusual problems concerning the nature of their informed consent. In this study we analyze 70 consent documents collected from genetics investigators in the United States who conduct research with children and adolescents. We find that many consent documents do not reflect either the current or the developing ethical and legal standards for research with adolescents and that in many cases the documents are simply confusing or unclear. We make recommendations (...) for change to reflect more adequately the changing perspective concerning the autonomous decision-making capacity of adolescents. (shrink)

IntroductionIn the context of giving risk information for obtaining informed consent, it is not easy to comply with the ethical principle of “primum nihil nocere.” Carelessness, ignorance of nocebo effects and a misunderstood striving for legal certainty can lead doctors to comprehensive and brutal risk information. It is known that talking about risks and side effects can even trigger those and result in distress and nonadherence to medication or therapy.MethodsRecently, we have reported on significant clinically relevant effects of verbal (...) and non-verbal suggestions on maximal muscular arm strength in healthy volunteers and in patients at two time points before surgery. Maximal strength during arm abduction was measured by dynamometry of the deltoid muscle group. Suggestions from clinical everyday life were formulated as presumed negative and neutral versions.ResultsHere, we report on the effects of two versions of risk information in 45 patients. After sole mentioning risks of a puncture for the placement of a pain catheter, the maximal arm muscle strength was significantly reduced to 83% of baseline several days, and to 84% the evening before surgery. Strength was not significantly decreased and close to baseline at T1 and T2 when risks and benefits of a pain catheter were combined in one sentence. The difference between both versions was significant. With persistent normal distribution of values, the effect was due to uniform reactions of many patients, not to strong reactions of a few. High suggestibility and increase of anxiety with approaching surgery were identified as influencing factors for the neutralizing effect of modified wording.ConclusionWe not only suggest an alternative formulation for risk information to avoid nocebo effects but present an objective method to quantify and compare effects of different wordings. Thereby, we provide evidence that concurrently given positive aspects can neutralize negative effects during medical interview. (shrink)