Chapitre 3. On some issues of ensuring the rights of minor patients in Russian medical law: ethical and legal aspects of autonomy.

Patient autonomy as a fundamental principle of modern bioethics is considered in the context of the legal status of a minor in medical law. The authors discuss the specifics of the autonomy of a minor patient, which is determined by the age factor. The following international legal standards defining the bioethical foundations of the legal status of a minor in the medical field are considered: the right to informed voluntary consent, the right to information and confidentiality. The content of the legal concept of “autonomy of a minor patient” is revealed. The autonomy of a minor patient is considered by the authors as the ability to act and make health-related decision independently, and is presented in several aspects: first, the ability to seek medical help; second, the right to provide information in an accessible form; third, the right to decide on consent or refusal of medical intervention; fourth, the right to confidentiality. Foreign experience is provided and features of fixing the principle of autonomy of a minor in Russian legislation in the field of health care are analyzed. Main problems of implementing of the principle of patient autonomy and directions for further research in this area are outlined.

Chapitre 4. Autonomy of minors questioned: Russian case with the loss of medical secrecy.

What is the value of confidentiality? Russian society faced this issue in 2020, when minors aged 15 to 18 lost their privacy. The amendment to the Federal Law, caused the situation, was received ambiguously, but quickly ceased to be the subject of public discussion. In my article, I study this event in a bioethical context, considering the topics of privacy, autonomy and relativity. Social discussion was not productive, since the arguments of both sides contained a double-edged argument: depending on existing relations in a family, the amendment will have a positive or negative meaning. By pointing out all the weaknesses of this shift in emphasis to relationships (that also implies the uselessness of the concept of relational autonomy here), I designate a real problem. A conflict situation has evolved both within bioethical principles and within the single principle – respect for autonomy. Due to the lack of confidentiality, the opportunity to act according to one’s own personal plan, presupposed by informed consent, is devalued. Autonomy turns out to be incomplete, twofold: it exists only for onetime decisions, and it is not in the long-term perspective because of a possibility of interference by others (parents, guardians) in this decision-making process. Since such criteria of autonomous action as intentionality and noncontrol may be violated, the autonomy of minors becomes contradictory. To avoid this, the autonomy should be either established as partial, or, by insisting on the return of confidentiality back to minors of the specified age, restored as full. Partial autonomy is a paradox, and a teenager should be endowed with what I call, considering the age criteria, the “presumption of autonomy”. If we do not give up autonomy completely, then we must restore its context consistently and non-contradictory: the ability of minors of this age category to make medically significant decisions requires the restoration of confidentiality and vice versa. Additionally, I investigate privacy’s impact on confidentiality: in Russian bioethics and medical practice, privacy is not considered as a source of other rights, the initial principle organizing the discourse.

Research recruitment and consent methods in a pandemic: a qualitative study of COVID-19 patients' perspectives.

BACKGROUND: Virtual data collection methods and consent procedures adopted in response to the COVID-19 pandemic enabled continued research activities, but also introduced concerns about equity, inclusivity, representation, and privacy. Recent studies have explored these issues from institutional and researcher perspectives, but there is a need to explore patient perspectives and preferences. This study aims to explore COVID-19 patients' perspectives about research recruitment and consent for research studies about COVID-19. METHODS: We conducted an exploratory qualitative focus group and interview study among British Columbian adults who self-identified as having had COVID-19. We recruited participants through personal contacts, social media, and REACH BC, an online platform that connects researchers and patients in British Columbia. We analyzed transcripts inductively and developed thematic summaries of each coding element. RESULTS: Of the 22 individuals recruited, 16 attended a focus group or interview. We found that autonomy and the feasibility of participation, attitudes toward research about COVID-19, and privacy concerns are key factors that influence participants' willingness to participate in research. We also found that participants preferred remote and virtual approaches for contact, consent, and delivery of research on COVID-19. CONCLUSIONS: Individuals who had COVID-19 are motivated to participate in research studies and value autonomy in their decision to participate, but researchers must be sensitive and considerate toward patient preferences and concerns, particularly as researchers adopt virtual recruitment and data collection methods. Such awareness may increase research participation and engagement.

Due to the COVID-19 pandemic, many research groups started conducting research activities virtually. In this study, we invited individuals who had COVID-19 to share their views about how researchers recruit patients and get their consent to participate in studies about COVID-19. Through interviews and focus groups, we found that British Columbians who had COVID-19 are motivated to participate in COVID-related studies, as long as researchers maintain usual precautions around data privacy and accommodate preferences for participation. Future studies may use these patient perspectives to make informed decisions that will increase and support patient recruitment, consent and retention in research studies.

Patient choice: the shape of consent post-Montgomery.

The law relating to consent and the process dentists need to go through to gain valid and informed consent to treat patients changed significantly following the landmark ruling of Montgomery v Lanarkshire Health Board. In this paper, we revisit the history of patient consent, give an update on the current legal situation in the UK, and produce a unique 'consent workflow' to aid in the process of gaining valid and informed consent to treat. The aim is to clarify the legal standing and provide a framework that dentists and other healthcare professionals can adapt to their current clinical practice while increasing the confidence of those involved in the consent process; both professionals and patients.

A study protocol for comparing the treatment of varicose tributaries either concomitantly with or separately from endovenous laser ablation of the incompetent saphenous trunk (the FinnTrunk Study). A multicenter parallel-group randomized controlled study.

BACKGROUND: Opinions on the treatment of varicose tributaries in relation to saphenous ablation in varicose disease vary. Moreover, the possible role of the tributaries regarding the recurrence of varicose disease remains unclear. The aim of the FinnTrunk study is to compare two different treatment strategies for varicose disease in a randomized setting. In group one, the initial treatment will entail endovenous laser ablation (EVLA) of the incompetent saphenous trunk without tributary treatment. In group two, the varicose tributaries will be treated with ultrasound-guided foam sclerotherapy (UGFS) concomitantly with truncal ablation. The primary outcome measure is the need for additional procedures during the follow-up. The secondary outcome measures are the cost of treatment and recurrence of varicose disease. METHODS: Consecutive patients with symptomatic varicose disease (CEAP clinical class C2-C3) will be screened for the study. Patients who fulfil the study criteria and give their informed consent will be scheduled for the procedure and randomized to either study group. Patients will be followed-up at 3 months, 1 year, 3 years, and 5 years. The post-procedure pain score based on a numeric rating scale (NRS) and also the use of analgesics, as well as possible procedure-related complications will be recorded at 3 months. Patient-reported outcome measures (PROMs) will be recorded at 1 year. Data pertaining to the additional treatment of varicose tributaries, the Aberdeen Varicose Vein Questionnaire (AVVQ), the Venous Clinical Severity Score (VCSS), and the health-related quality of life (EQ-5D-5L) will be collected at each follow-up visit. A duplex ultrasound (DUS) examination will be performed at each visit, and data on varicose tributaries and the need for additional treatment will be recorded. TRIAL REGISTRATION: Registered on ClinicalTrials.gov, ID NCT04774939.

Consent for determination of death by neurologic criteria in Canada: an analysis of legal and ethical authorities, and consensus-based working group recommendations.

This article addresses the following question: should physicians obtain consent from the patient (through an advance directive) or their surrogate decision-maker to perform the assessments, evaluations, or tests necessary to determine whether death has occurred according to neurologic criteria? While legal bodies have not yet provided a definitive answer, significant legal and ethical authority holds that clinicians are not required to obtain family consent before making a death determination by neurologic criteria. There is a near consensus among available professional guidelines, statutes, and court decisions. Moreover, prevailing practice does not require consent to test for brain death. While arguments for requiring consent have some validity, proponents cannot surmount weightier considerations against imposing a consent requirement. Nevertheless, even though clinicians and hospitals may not be legally required to obtain consent, they should still notify families about their intent to determine death by neurologic criteria and offer temporary reasonable accommodations when feasible. This article was developed with the legal/ethics working group of the project, A Brain-Based Definition of Death and Criteria for its Determination After Arrest of Circulation or Neurologic Function in Canada developed in collaboration with the Canadian Critical Care Society, Canadian Blood Services, and the Canadian Medical Association. The article is meant to provide support and context for this project and is not intended to specifically advise physicians on legal risk, which in any event is likely jurisdiction dependent because of provincial or territorial variation in the laws. The article first reviews and analyzes ethical and legal authorities. It then offers consensus-based recommendations regarding consent for determination of death by neurologic criteria in Canada.

RéSUMé: Cet article répond à la question suivante : les médecins doivent-ils obtenir le consentement du patient (au moyen d'une directive médicale anticipée) ou de son mandataire spécial pour réaliser les examens, évaluations ou tests nécessaires pour déterminer si le décès est survenu selon des critères neurologiques? Bien que les organes juridiques n'aient pas encore fourni de réponse définitive, selon la jurisprudence et l'éthique, les cliniciens ne sont pas tenus d'obtenir le consentement de la famille avant de procéder à une détermination de décès selon des critères neurologiques. Il y a un quasi-consensus dans les lignes directrices professionnelles, les lois et les décisions judiciaires disponibles. De plus, la pratique courante n'exige pas le consentement pour procéder aux examens permettant de déterminer une mort cérébrale. Bien que les arguments en faveur de l'exigence d'un consentement aient une certaine validité, leurs défenseurs ne peuvent pas surmonter des considérations plus importantes contre l'imposition d'une exigence de consentement. Néanmoins, même si les cliniciens et les hôpitaux ne sont peut-être pas légalement tenus d'obtenir le consentement, ils devraient tout de même aviser les familles de leur intention de déterminer le décès selon des critères neurologiques et offrir des aménagements raisonnables temporaires lorsque cela est possible. Cet article a été mis au point en collaboration avec le groupe de travail sur les questions légales et éthiques du projet de Définition uniformisée de la mort cérébrale et de critères fondés sur des données probantes pour sa détermination au Canada et développé avec la Société canadienne de soins intensifs, la Société canadienne du sang et l'Association médicale canadienne. Cet article vise à étayer et fournir un contexte au projet et ne vise pas à conseiller spécifiquement les médecins sur le risque juridique qui, de toute façon, varie probablement en raison des différences légales provinciales et territoriales. L'article commence par passer en revue et analyser la jurisprudence et les considérations éthiques. Il propose ensuite des recommandations consensuelles concernant le consentement pour la détermination du décès selon des critères neurologiques au Canada.

Offering Lottery Entry as an Incentive for Research Participation Compromises Informed Consent.

This paper argues that offering entry into a lottery as an incentive to those who participate in research studies represents a challenge to the principle of informed, coercion-free consent that is considered an essential ingredient of permissible recruitment to studies. This is, first, because information about the chances of winning in this context is normally unavailable to potential participants and, without this, they cannot accurately weigh up the risks and potential benefits of participation. Second, even when this information is available, such an incentive capitalizes, I contend, on the difficulty of weighing up small probabilities, exploiting the fact that people tend to be beset by cognitive biases that make it challenging to make decisions rationally. The resulting conclusion is that we should not view lotteries as more ethical than simply paying participants, when the latter is feasible.

Survey of Informed Consent Procedures in Urology: Disclosing Resident Participation to Patients.

AbstractThe American Urological Association (AUA) and American College of Surgeons (ACS) codes of professionalism require surgeons to disclose the specific roles and responsibilities of trainees to patients during the informed consent process. The objective of this study is to analyze how these requirements are met by urology training programs. An anonymous electronic survey was distributed to the program directors (PDs) of the 143 Accreditation Council for Graduate Medical Education urology residency programs in the United States in 2021. Information was collected regarding program demographics, aspects of the program's consent process, and the disclosure to patients of the role and participation of residents in their surgery. There were 49 responses to the survey (34.3% response rate). Nearly 70 percent of PDs reported that attending physicians lead the consent process. The topics covered during consent discussion include possible complications (25%), expected recovery time (23%), length of the surgery (22%), the people involved (18%), and their specific roles (7%). Many PDs do not explicitly discuss trainee involvement (48.8%) or when a resident is to perform the majority of the case (87.8%). The majority of PDs (78.8%) communicate medical student involvement, but 73.2 percent reported having a patient decline participation of a trainee after describing their role. Despite the AUA and ACS codes of professionalism, many urologists do not disclose resident involvement in surgery to patients. Further discussions are needed to explore how to better balance resident education and patient autonomy.

The Role of Decision-Making Capacity in Gathering Collateral Information.

AbstractPsychiatric disorders usually do not have characteristic physical exam findings, imaging, or lab values. Psychiatrists therefore diagnose and treat patients largely based on reported or observed behavior, which makes collateral information from a patient's close contacts especially pertinent to an accurate diagnosis. The American Psychiatric Association considers communication with patients' supports a best practice when the patient provides informed consent or does not object to the communication. However, situations arise in which a patient's objection to such communication is the product of impaired decision-making and the benefits of obtaining collateral information represent best practice. In this article a framework for addressing these situations is proposed using a full decisional capacity evaluation, followed by an alternate decision-making process by concurrence from a second physician. It is recommended that a patient's refusal to allow the gathering of collateral information should be addressed exactly like refusals for other diagnostic or treatment interventions.

Get this thing out of my body! Factors determining consent for translational oncology research: a qualitative research.

BACKGROUND: Depending on the needs of scientific research at a given time, biobanks make biological samples and data available to researchers. In this article, we aim to describe the reasons and underlying logic that determine the decision to grant or deny consent to the conservation of tumour samples in a biological resource platform for research purposes. We make use of the CARPEM biological resource platform model, where broad consent is required. METHODS: The results are based on semi-structured interviews, conducted between 2019 and 2021, with 25 individuals having various profiles. RESULTS: All the people interviewed readily accepted the principle of conserving a tumour sample for research purposes. They explained their decision by citing the desire to participate in research dedicated to improving therapeutic medicine. Their trust in research institutions or in doctors was an important factor in their consent. The tumorous nature of the samples also played an important role, as did the absence of constraints. Finally, the high level of consent was also based on the difficulty they had in conceiving what the future risks might be once the sample had been taken, whereas the fact that they did not know the nature or purpose of the research to be carried out when they signed the consent form posed some problems. These results stem from a lack of a culture of ethics among the people interviewed. CONCLUSION: The information provided in the context of consent at the CARPEM tumour bank seems inadequate for consent to be considered 'informed', given the low level of knowledge that people have of the risks and issues. Information is missing even though we feel it would not change consent or only marginally. This raises questions, since part of the act of granting consent is based on the implicit trust French people have in the hospital that collects the data and in research practices in general. In the minds of those who participate, transparency is the ground on which trust rests. Lack of transparency could be deleterious for future research practices. However, it is not by striving to improve information leaflets that the consent-related information will improve but, rather, by more effectively helping future patients to assimilate that information.

A one-size-fits-all approach to data-sharing will not suffice in lifecourse research: a grounded theory study of data-sharing from the perspective of participants in a 50-year-old lifecourse study about health and development.

BACKGROUND: Data-sharing is increasingly encouraged or required by funders and journals. Data-sharing is more complicated for lifecourse studies that rely upon ongoing participation, but little is known about perspectives on data-sharing among participants of such studies. The aim of this qualitative study was to explore perspectives on data-sharing of participants in a birth cohort study. METHODS: Semi-structured interviews were conducted with 25 members of the Dunedin Multidisciplinary Health and Development Study when aged between 45 and 48 years. Interviews were led by the Director of the Dunedin Study and involved questions about different scenarios for data-sharing. The sample consisted of nine Dunedin Study members who are Maori (the Indigenous peoples of Aotearoa/New Zealand) and 16 who are non-Maori. RESULTS: Principles of grounded theory were applied to develop a model of participant perspectives on data-sharing. The model consists of three factors that inform a core premise that a one-size-fits-all approach to data-sharing will not suffice in lifecourse research. Participants suggested that data-sharing decisions should depend on the cohort and might need to be declined if any one Dunedin Study member was opposed (factor 1). Participants also expressed a proven sense of trust in the researchers and raised concerns about loss of control once data have been shared (factor 2). Participants described a sense of balancing opportunities for public good against inappropriate uses of data, highlighting variability in perceived sensitivity of data, and thus a need to take this into account if sharing data (factor 3). CONCLUSIONS: Communal considerations within cohorts, loss of control over shared data, and concerns about inappropriate uses of shared data need to be addressed through detailed informed consent before data-sharing occurs for lifecourse studies, particularly where this has not been established from the start of the study. Data-sharing may have implications for the retention of participants in these studies and thus may impact on the value of long-term sources of knowledge about health and development. Researchers, ethics committees, journal editors, research funders, and government policymakers need to consider participants' views when balancing the proposed benefits of data-sharing against the potential risks and concerns of participants in lifecourse research.

Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure.

BACKGROUND: Informed consent is an accepted ethical and legal prerequisite for trial participation, yet there is no standardised method of assessing patient understanding for informed consent. The participatory and informed consent (PIC) measure was developed for application to recruitment discussions to evaluate recruiter information provision and evidence of patient understanding. Preliminary evaluation of the PIC indicated the need to improve inter-rater and intra-rater reliability ratings and conduct further psychometric evaluation. This paper describes the assessment, revision and evaluation of the PIC within the context of OPTiMISE, a pragmatic primary care-based trial. METHODS: This study used multiple methods across two phases. In phase one, one researcher applied the existing PIC measure to 18 audio-recorded recruitment discussions from the OPTiMISE study and made detailed observational notes about any uncertainties in application. Appointments were sampled to be maximally diverse for patient gender, study centre, recruiter and before and after an intervention to optimise information provision. Application uncertainties were reviewed by the study team, revisions made and a coding manual developed and agreed. In phase two, the coding manual was used to develop tailored guidelines for applying the PIC to appointments within the OPTiMISE trial. Two researchers then assessed 27 further appointments, purposively sampled as above, to evaluate inter-rater and intra-rater reliability, content validity and feasibility. RESULTS: Application of the PIC to 18 audio-recorded OPTiMISE recruitment discussions resulted in harmonisation of the scales rating recruiter information provision and evidence of patient understanding, minor amendments to clarify wording and the development of detailed generic coding guidelines for applying the measure within any trial. Application of the revised measure using these guidelines to 27 further recruitment discussions showed good feasibility (time to complete), content validity (completion rate) and reliability (inter- and intra-rater) of the measure. CONCLUSION: The PIC provides a means to evaluate the content of information provided by recruiters, patient participation in recruitment discussions and, to some extent, evidence of patient understanding. Future work will use the measure to evaluate recruiter information provision and evidence of patient understanding both across and within trials.

Medical staff's sense of awareness of informed consent for adolescent cancer patients and the need for decision-making support practiced from the perspective of trauma-informed approach.

It has not been established how to assess children's and adolescents' decision-making capacity (DMC) and there has been little discussion on the way their decision-making (DM). The purpose of this study was to examine actual situation and factors related to difficulties in explaining their disease to adolescent cancer patients or obtaining informed consent (IC). The cross-sectional questionnaire survey was conducted. Physicians who have been treating adolescent cancer patients for at least five years answered a self-administered questionnaire uniquely developed about clinical difficulties in explaining, IC and factors related patient's refusal of medical treatment (RMT). Descriptive statistics for each item and a polychoric correlation analysis of the problems and factors related to the explanation were conducted. As a result, fifty-six physicians were participated (rate of return: 39%). Explaining the disease and treatment to patients (83.9%), IC to patients (80.4%), and explaining the disease and treatment to parents (78.6%) was particularly problematic. Difficulties to provide support related with patient's refusal of medical treatment and to explain disease and treatment for patient and parents were related to difficulties obtaining IC for the patient. Conclusion: There are clinically difficult to explain for the patient or parents and to obtain IC for the patient. It is necessary to establish a disease acceptance assessment tool for the adolescence generation so that it can be applied in the field.

Developing strategies to address disparities in retention communication during the consent discussion: development of a behavioural intervention.

BACKGROUND: Clinical trials are essential to evidence-based medicine. Their success relies on recruitment and retention of participants: problems with either can affect validity of results. Past research on improving trials has focused on recruitment, with less on retention, and even less considering retention at the point of recruitment, i.e., what retention-relevant information is shared during consent processes. The behaviour of trial staff communicating this information during consent is likely to contribute to retention. So, developing approaches to mitigate issues in retention at the point of consent is necessary. In this study, we describe the development of a behavioural intervention targeting the communication of information important to retention during the consent process. METHODS: We applied the Theoretical Domains Framework and Behaviour Change Wheel to develop an intervention aimed at changing the retention communication behaviours of trial staff. Building on findings from an interview study to understand the barriers/facilitators to retention communication during consent, we identified behaviour change techniques that could moderate them. These techniques were grouped into potential intervention categories and presented to a co-design group of trial staff and public partners to discuss how they might be packaged into an intervention. An intervention was presented to these same stakeholders and assessed for acceptability through a survey based on the Theoretical Framework of Acceptability. RESULTS: Twenty-six behaviour change techniques were identified with potential to change communication of retention-information at consent. Six trial stakeholders in the co-design group discussed means for implementing these techniques and agreed the available techniques could be most effective within a series of meetings focussed on best practices for communicating retention at consent. The proposed intervention was deemed acceptable through survey results. CONCLUSION: We have developed an intervention aimed at facilitating the communication of retention at informed consent through a behavioural approach. This intervention will be delivered to trial staff and will add to the available strategies for trials to improve retention.

Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk-based Mammascreening study.

INTRODUCTION: Understanding participants' concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk-based MAmmascreening study (PRISMA). The original PRISMA informed consent was project-specific (i.e., breast cancer research), limiting the scope of secondary research. We explored participants' needs for broadened consent to preserve informed decision-making while maximising the potential re-use of data. METHODS: Focus groups (FGs) were performed following a semistructured discussion guide. Two independent researchers analysed the data thematically using an inductive approach. FINDINGS: Twenty-three asymptomatic women and 13 women diagnosed with breast cancer were randomly divided into six FGs. Four superordinate themes were identified: (1) Normalization, (2) Attitude towards the pharmaceutical industry, (3) Privacy and (4) Knowledge. Our participants viewed data sharing as an important conduit for advancing medical science. Perceived integrity was more often attributed to noncommercial than commercial parties, with a marked mistrust towards the pharmaceutical industry. Most requested information needs related to data protection. Participants' ideal consent process would confer a range of options; for example, they would be able to choose with whom data can be shared, whether data will be de-identified or anonymous, the expiration date of their consent and how, if requested, general and personal study results would be disclosed. CONCLUSION: Our participants expressed clear information needs and a strong desire to be actively engaged in future data sharing decisions. Given that many researchers collaborate with commercial parties, building public confidence in these institutions would be beneficial. Illustrative examples addressing privacy concerns and clarifying difficult terms would aid consent decision-making. Although our participants displayed great altruism in sharing their data and accepted that broad consent would ultimately facilitate future research, broad consent did not reflect their ideal situation. Dynamic consent may be an option but warrants further feasibility research. PATIENT AND PUBLIC CONTRIBUTION: Women were recruited from the general breast cancer screening population. Their perceptions and information needs, as reported in this study, will not only inform broadened consent for PRISMA but ideally guide other consent templates and decisions regarding consent processes.