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Responding to requests from adult patients for neuroenhancements: guidance of the Ethics, Law and Humanities Committee.

ABSTRACT: In the last decade, persons who have no diagnosed medical or mental health condition are increasingly seeking and utilizing, for the ostensible purpose of enhancing their memory or cognitive skills, prescription drugs that were originally developed to improve executive function or memory in persons diagnosed with disorders such as attention deficit hyperactivity disorder or Alzheimer disease. Evidence suggests that this practice, now known as neuroenhancement, is gathering momentum. As a result, neurologists may be encountering patients without a diagnosed illness asking for medications with the goal of improving their memory, cognitive focus, or attention span. Strong arguments have been made for and against this practice, often reflecting strongly held convictions concerning the appropriate practice of medicine. The purpose of this report is to provide neurologists with an overview of the ethical, legal, and social issues surrounding the use of pharmaceuticals prescribed to enhance or augment normal cognitive or affective functioning, as well as practical guidance for responding to an adult patient's request for neuroenhancement.

SUBMITTER: Larriviere D

PROVIDER: S-EPMC2769556 | biostudies-literature | 2009 Oct

REPOSITORIES: biostudies-literature

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Responding to requests from adult patients for neuroenhancements: guidance of the Ethics, Law and Humanities Committee.

Larriviere Dan D Williams Michael A MA Rizzo Matt M Bonnie Richard J RJ

Neurology 20090923 17

In the last decade, persons who have no diagnosed medical or mental health condition are increasingly seeking and utilizing, for the ostensible purpose of enhancing their memory or cognitive skills, prescription drugs that were originally developed to improve executive function or memory in persons diagnosed with disorders such as attention deficit hyperactivity disorder or Alzheimer disease. Evidence suggests that this practice, now known as neuroenhancement, is gathering momentum. As a result, ...[more]

PMID: 19776378

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Project description:OBJECTIVE:The general purpose for ethics consultations is to deliberate on issues on medical and scientific research and act towards the safeguard of the patient's rights and dignity. With the implementation of European Union (EU) Regulation 536/2014 on clinical trials and cost and time-optimization, the nature of consultations and the bodies they are carried out might be to some extent affected. Accordingly, we sought to gain an updated perspective on the current role and current practices of ethics consultations nationwide in both clinical and research settings. METHODS:The study was carried forth by a three-step mixed-method approach: i) review of policies/regulations for ethics committee (EC) nationwide; ii) a structured survey on ethics consultation activity completed by each EC during 2016; iii) incorporated into the third part, a qualitative assessment with a selected sample of 8 key-informants for a semi-structured interview, discussing EC history, the ethics consultation function, and the professional experience of consultants. RESULTS:Review of the policies/regulations promoted by ECs showed that 72,6% (n = 69) of all the ECs (N = 95) being actually capable of providing ethics consultation service by policy. 71 ECs (74.7%) responded to the survey on ethics consultation requests; among them, 48 (67.6%) provided ethics consultations of which 23 (23/48) actually received requests for this service in the year 2016. Many ECs did not have a structured database in place to provide precise figures of requests received in the last year nor of their contents. CONCLUSION:To date, ethics consultation in clinical and research practice is largely underappreciated and not well understood by users. The consultants themselves lack a comprehensive vision of work carried out in their field, and bioethics training programs to keep them updated. Despite clinical ethics consultation services should not necessarily be mandatory, following the recent EU Regulation on clinical trials, institutional ethics consultation bodies should be re-evaluated.

Project description:BackgroundApproval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.MethodsWe obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.ResultsTwenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.ConclusionThe number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.

Project description:BackgroundThere is a strong and growing interest in biomedical ethics and medical humanities (BEMH) within medical education for facilitating key components of medical professionalism and ethics, clinical communication and observational skills, and self-care and reflective practices. Consequently, United States (US) medical institutions have begun to incorporate BEMH through formal Scholarly Concentrations (SCs). This is the first study to examine the impact of a US BEMH SC, from student experience in medical school to post-graduate development, as perceived by graduate physicians.MethodsGraduated students who participated in the BEMH SC or did extensive BEMH research prior to the BEMH SC's establishment (n = 57) were sampled for maximum variation across graduating years. In telephone surveys and interviews, participants discussed the perceived impact of the BEMH SC on (a.) student experience during medical school and (b.) post-graduate development. Interviews were audiotaped, transcribed, and de-identified. The authors iteratively generated a codebook; two raters coded independently, adjudicated codes, and completed inter-rater reliability (IRR) tests. The authors subsequently conducted a team-based thematic analysis, identifying emergent themes.ResultsNineteen BEMH graduates were interviewed. Results were analyzed according to (a.) student experience and (b.) post-graduate development. Overall, respondents perceived impacts in reinforcing knowledge and skills in clinical ethics; solidifying self-care and reflective practices; refining a sense of professional identity and integrity for ethically challenging situations; and promoting student skills, productivity, and later careers involving BEMH.ConclusionA comprehensive US BEMH SC achieved the purported aims of BEMH in medical education, with graduate physicians perceiving persisting effects into clinical practice. Furthermore, the structure and format of a SC may offer additional advantages in promoting student scholarly skill and productivity, career development, and professional identity formation-core competencies identified across clinical training and ethics programs. Our findings indicate that a BEMH SC is effective in achieving a range of desired immediate and post-graduate effects and represent a particularly promising venue for BEMH in medical education. We believe these findings to be of critical significance to medical educators and administrators when considering how best to incorporate BEMH into SCs and medical curricula.

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Responding to requests from adult patients for neuroenhancements: guidance of the Ethics, Law and Humanities Committee.

Publications

Responding to requests from adult patients for neuroenhancements: guidance of the Ethics, Law and Humanities Committee.

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