Titel Deelnemers "Korte inhoud" "Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso" "L. Paré Toe, Raffaella Ravinetto, Sabine Dierickx, Charlotte Gryseels, Halidou Tinto, N. Rouamba, I. Diallo, Y. Cissao, K. Bayala, S. Hausmann, Joan Muela Ribera, D'Alessandro, Koen Peeters" "BACKGROUND: Over the last years, the number of clinical trials carried out in low-income countries with poor medical infrastructure and limited access to health care has increased. In these settings, the decision of participating in a clinical study may be influenced by factors related to participants' vulnerability that limit the efficacy of the informed consent. METHODS: A mixed methods social science study, based on the triangulation of qualitative and quantitative data, was carried out in a socio-economically disadvantaged and semi-urban area of Bobo Dioulasso, Burkina Faso. The study aimed at assessing the relevance of the informed consent procedure on the decision-making process of the parents and/or guardians of potential participants in a pediatric malaria trial. RESULTS: For most parents (70.4%), the decision of participating had already been taken before undergoing the informed consent process and was based on the information conveyed through the community. Access to free and good quality health care often inspired this decision. In addition, the parents' willingness to have their child included in the trial made them develop active strategies to achieve this purpose. DISCUSSION: In a context of socio-economic vulnerability and poor access to free health care, the process of informed consent does not always accomplish its goal of informing people and enabling them to make a free and informed decision. This information role is somehow anticipated by the community and trial participation becomes a strategic action to secure otherwise unavailable health resources leading community members to decide on participation even prior to the informed consent process." "Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso" "Lea Paré Toe, Raffaella M. Ravinetto, Charlotte Gryseels, Halidou Tinto, Noèl Rouamba, Ibrahim Diallo, Yacouba Cissao, Korotimi Bayala, Susanna Hausmann-Muela, Joan Muela Ribera, Umberto d'Alessandro, Koen Peeters Grietens" "Background:Over the last years, the number of clinical trials carried out in low-income countries with poor medical infrastructure and limited access to health care has increased. In these settings, the decision of participating in a clinical study may be influenced by factors related to participants’ vulnerability that limit the efficacy of the informed consent. Methods:A mixed methods social science study, based on the triangulation of qualitative and quantitative data, was carried out in a socio-economically disadvantaged and semi-urban area of Bobo Dioulasso, Burkina Faso. The study aimed at assessing the relevance of the informed consent procedure on the decision-making process of the parents and/or guardians of potential participants in a pediatric malaria trial. Results:For most parents (70.4%), the decision of participating had already been taken before undergoing the informed consent process and was based on the information conveyed through the community. Access to free and good quality health care often inspired this decision. In addition, the parents’ willingness to have their child included in the trial made them develop active strategies to achieve this purpose. Discussion:In a context of socio-economic vulnerability and poor access to free health care, the process of informed consent does not always accomplish its goal of informing people and enabling them to make a free and informed decision. This information role is somehow anticipated by the community and trial participation becomes a strategic action to secure otherwise unavailable health resources leading community members to decide on participation even prior to the informed consent process. [ABSTRACT FROM AUTHOR]" "The attitude of Flemish paediatricians regarding informed consent of adolescents" "Michel Deneyer, Jacques Otten, Johan Urbain M Marchand, Ronald Buyl, C. Clybouw, Yvan Vandenplas" "BACKGROUND: Since 2002 the Belgian law requires an informed consent of the patient before each medical intervention. This provision applies also for adolescent patients on condition that the physician considers the young patient as competent to autonomously participate in the decision making process. AIM: The purpose of this study is to evaluate to what extent Belgian paediatricians from the Flemish part of the country have implemented the legal requirements for informed consent of adolescent patients, in particular when they consult alone. METHODS: In the frame of a larger study regarding the relation between paediatricians and their patients, a questionnaire was sent via regular mail to 570 Flemish paediatricians, evaluating how and how often they obtain an informed consent of the adolescent when consulting a physician unaccompanied. RESULTS: In only 1% of all consultations an adolescent consulted the physician alone and agreed to a medical intervention on his/her own. The information given by the paediatrician did not differ if the adolescent consulted alone or was accompanied by (one of) his/her parents for the following items: purpose and type of treatment (100% vs 100%), duration of treatment (92% vs 94%) and aftercare (89% vs 93%). However, the information differed with regard to alternatives to the treatment (65% vs 76%), degree of urgency (89% vs 95% ), treatment related risks (82% vs 90%) and cost (21% vs 45%). 18.6% of the paediatricians consider age as the single criterion to evaluate the competence of the adolescent to provide an informed consent; other criteria that are considered: experience (92%), insight into and factual understanding of the clinical picture (84%). To fulfil the tasks of providing information and asking for consent, paediatricians rarely had recourse to prior established protocols (14%), they preferred to rely on proper experience and expertise (81%). Fifty percent appealed to the opinion of other health care providers. CONCLUSIONS: Although the Belgian law stipulates regulations that should be complied with by the physician during the decision making process about any medical intervention on adolescents, this legislation has rarely been put into practice, as the adolescents used their right to autonomously consent in barely 1% of all paediatric consultations. For the majority of the respondents other criteria than age were taken into account to consider an adolescent as able to provide informed consent." "Informed consent for endoscopic procedures: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement" "Raf Bisschops, Philip Roelandt" "All endoscopic procedures are invasive and carry risk. Accordingly, all endoscopists should involve the patient in the decision-making process about the most appropriate endoscopic procedure for that individual, in keeping with a patient's right to self-determination and autonomy. Recognition of this has led to detailed guidelines on informed consent for endoscopy in some countries, but in many no such guidance exists; this may lead to variations in care and exposure to risk of litigation. In this document, the European Society of Gastrointestinal Endoscopy (ESGE) sets out a series of statements that cover best practice in informed consent for endoscopy. These statements should be seen as a minimum standard of practice, but practitioners must be aware of and adhere to the law in their own country. 1:  Patients should give informed consent for all gastrointestinal endoscopic procedures for which they have capacity to do so. 2:  The healthcare professional seeking consent for an endoscopic procedure should ensure that the patient has the capacity to consent to that procedure. 3:  For patients who lack capacity, healthcare personnel should at all times try to engage with people close to the patient, such as family, friends, or caregivers, to achieve consensus on the appropriateness of performing the procedure. 4:  Where a patient lacks capacity to provide informed consent, the best interest decision should be clearly documented in the medical record. This should include information about the capacity assessment, reason(s) that the decision cannot be delayed for capacity recovery (or if recovery is not expected), who has been consulted, and where relevant the form of authority for the decision. 5:  There should be a systematic and transparent disclosure of the expected benefits and harms that may reasonably affect patient choice on whether or not to undergo any diagnostic or interventional endoscopic procedure. Information about possible alternatives, as well as the consequences of doing nothing, should also be provided when relevant. 6:  The information provided on the benefit and harms of an endoscopic procedure should be adapted to the procedure and patient-specific risk factors, and the preferences of the patient should be central to the consent process. 7:  The consent discussion should be undertaken by an individual who is familiar with the procedure and its risks, and is able to discuss these in the context of the individual patient. 8:  Patients should confirm consent to an endoscopic procedure in a private, unrushed, and non-coercive environment. 9:  If a patient requests that an endoscopic procedure be discontinued, the procedure should be paused and the patient's capacity for decision making assessed. If a competent patient continues to object to the procedure, or if a conclusive determination of capacity is not feasible, the examination should be terminated as soon as it is safe to do so. 10: Informed consent should be sufficiently detailed to cover all findings that can be reasonably anticipated during an endoscopic examination. The scope of this consent should not be expanded, nor a patient's implicit consent for additional interventions assumed, unless failure to proceed with such interventions would result in immediate and predictable harm to the patient." "From informed consent to adherence: factors influencing involvement in mass drug administration with ivermectin for malaria elimination in The Gambia" "Alexandra Elizabeth Thompson Fehr, Claudia Nieto Sanchez, Joan Muela Ribera, Fatou Jaiteh, Omar Ceesay, Ebrima Maneh, Dullo Baldeh, Jane Achan, Edgard D. Dabira, Bakary Conteh, Joske Bunders-Aelen, Henk Broekhuizen, D'Alessandro, Koen Peeters" "BACKGROUND: The World Health Organization (WHO) recommends consideration of mass drug administration (MDA) for malaria control in low-endemic settings approaching elimination. However, MDA remains a controversial strategy, as multiple individual, social, and operational factors have shown to affect its acceptability at local levels. This is further complicated by inconsistent definitions of key indicators derived from individual and community involvement-coverage, adherence, and compliance-that cast doubts about the actual and potential epidemiological impact of MDA on disease control and elimination. This study aimed to identify limitations and enabling factors impacting involvement at different stages of a large cluster-randomized trial assessing the effect of combining dihydroartemisinin-piperaquine (DP) and ivermectin (IVM) in malaria transmission in The Gambia.METHODS: This social science study used a mixed-methods approach. Qualitative data were collected in intervention and control villages through ethnographic methods, including in-depth interviews (IDIs), focus group discussions (FGDs), and participant observation conducted with trial participants and decliners, community leaders, and field staff. A cross-sectional survey was conducted in the intervention villages after the first year of MDA. Both strands of the study explored malaria knowledge and opinions, social dynamics influencing decision-making, as well as perceived risks, burdens, and benefits associated with this MDA.RESULTS: 157 IDIs and 11 FGDs were conducted, and 864 respondents were included in the survey. Barriers and enabling factors to involvement were differentially influential at the various stages of the MDA. Issues of social influence, concerns regarding secondary effects of the medication, costs associated with malaria, and acceptability of the implementing organization, among other factors, differently affected the decision-making processes throughout the trial. Rather than a linear trajectory, involvement in this MDA trial was subjected to multiple revaluations from enrolment and consent to medicine intake and adherence to treatment.CONCLUSIONS: This study went beyond the individual factors often associated with coverage and adherence, and found that nuanced social dynamics greatly influence the decision-making process at all phases of the trial. These issues need to be consider for MDA implementation strategies and inform discussions about more accurate ways of reporting on critical effectiveness indicators." "Old Challenges or New Issues? Genetic Health Professionals' Experiences Obtaining Informed Consent in Diagnostic Genomic Sequencing." "Danya Vears, Pascal Borry" "BACKGROUND: While integrating genomic sequencing into clinical care carries clear medical benefits, it also raises difficult ethical questions. Compared to traditional sequencing technologies, genomic sequencing and analysis is more likely to identify unsolicited findings (UF) and variants that cannot be classified as benign or disease-causing (variants of uncertain significance; VUS). UF and VUS pose new challenges for genetic health professionals (GHPs) who are obtaining informed consent for genomic sequencing from patients. METHODS: We conducted semi-structured interviews with 31 GHPs across Europe, Australia and Canada to identify some of these challenges. RESULTS: Our results show that GHPs find it difficult to prepare patients to receive results because a vast amount of information is required to fully inform patients about VUS and UF. GHPs also struggle to engage patients - many of whom may be focused on ending their 'diagnostic odyssey' - in the informed consent process in a meaningful way. Thus, some questioned how 'informed' patients actually are when they agree to undergo clinical genomic sequencing. CONCLUSIONS: These findings suggest a tension remains between sufficient information provision at the risk of overwhelming the patient and imparting less information at the risk of uninformed decision-making. We suggest that a shift away from 'fully informed consent' toward an approach aimed at realizing, as far as possible, the underlying goals that informed consent is meant to promote." "Using provocative design to foster electronic informed consent innovation" "Evelien De Sutter, Stef Verreydt, Koen Yskout, David Geerts, Pascal Borry, Marc Ferrante, Bart Van Der Schueren, Isabelle Huys" "BACKGROUND: The development of technological applications in clinical research, such as electronic informed consent (eIC), is on the rise. The involvement of end users throughout the design process of eIC is of utmost importance to improve the current informed consent process. METHODS: Using a provocative design, we conducted interviews with 30 clinical research participants. Provotypes were used as a starting base to discuss various aspects relevant to eIC. By providing a medium to encourage divergent thinking, participants' views and concerns were solicited. Thematic analysis was undertaken using NVivo. RESULTS: The majority of participants placed trust in the principal investigator or the hospital to perform the role of eIC hosting party. Differing opinions were reported on the amount of information required related to stakeholders' access to an eIC system, and thus, to participants' personal data, to enable trust in an eIC system. Nevertheless, this study indicates a general willingness of participants to share personal data with physicians and pharmaceutical companies on an international level, and to receive requests for new research studies via an eIC system. Participants suggested to tailor an eIC system based upon their preferences, for example, regarding whom they want to share their personal data with. Moreover, they expressed a desire to choose how they can contact the research team, and to indicate which study-related information they would like to receive electronically. In addition, positive opinions were voiced on the integration of a test to assess participants' understanding before providing their eIC. CONCLUSIONS: Following a research through design approach, insights have been generated which inform the design of eIC. Provotypes were designed to help participants think beyond what is familiar to them. Study findings revealed that not all situations were perceived as provocative, because of participants' motivation to advance scientific research and the trust they place in the research team. Nevertheless, the use of provocative design resulted in additional insights, generated by clinical research participants, which could be considered in the further design of eIC." "End-of-life decisions and minors. Do minors have the right to refuse life preserving medical treatment? A comparative study" "Christophe Lemmens" "The principles of the right to informed consent and informed refusal are quite clear for competent adult patients. The right of a competent adult patient to give his informed consent before medical treatment can be started, is a patients' right that is recognised all over the world. The logical corollary of the right to informed consent is the right to informed refusal. A competent adult patient also has the right to refuse medical treatment by simply withholding or withdrawing his consent. A physician who starts medical treatment without the informed consent of his patient will be held liable for battery. Can these same principles be applied to minors? In other words: do minors also have the right to refuse medical treatment? Can a minor refuse even life preserving care? The interests of the involved parties (minor, parents and state) have to be weighed against each other case by case. A thorough examination of the available case law shows that the best interests of the minor are paramount. This best interests- standard guides judges in their making of a decision. However, this is certainly not always in accordance with reality. In fact, minors can be mature enough to refuse treatment at a much earlier time than the age of legal majority, whatever the consequences of that refusal may be." "Do minors have the right to refuse medical treatment? A comparative study" "Christophe Lemmens" "The principles of the right to informed consent and informed refusal are quite clear for competent adult patients. The right of a competent adult patient to give his informed consent before medical treatment can be started, is a patients' right that is recognised all over the world. The logical corollary of the right to informed consent is the right to informed refusal. A competent adult patient also has the right to refuse medical treatment by simply withholding or withdrawing his consent. A physician who starts medical treatment without the informed consent of his patient will be held liable for battery. Can these same principles be applied to minors? In other words: do minors also have the right to refuse medical treatment? Can a minor refuse even life preserving care? The interests of the involved parties (minor, parents and state) have to be weighed against each other case by case. A thorough examination of the available case law shows that the best interests of the minor are paramount. This best interests- standard guides judges in their making of a decision. However, this is certainly not always in accordance with reality. In fact, minors can be mature enough to refuse treatment at a much earlier time than the age of legal majority, whatever the consequences of that refusal may be." "Dual consent? Donors' and recipients' views about involvement in decision-making on the use of embryos created by gamete donation in research" "I Baia, C. De Freitas, C. Samorinha, Veerle Provoost, S. Silva" "Background Reasonable disagreement about the role awarded to gamete donors in decision-making on the use of embryos created by gamete donation (EGDs) for research purposes emphasises the importance of considering the implementation of participatory, adaptive, and trustworthy policies and guidelines for consent procedures. However, the perspectives of gamete donors and recipients about decision-making regarding research with EGDs are still under-researched, which precludes the development of policies and guidelines informed by evidence. This study seeks to explore the views of donors and recipients about who should take part in consent processes for the use of EGDs in research. Methods From July 2017 to June 2018, 72 gamete donors and 175 recipients completed a self-report structured questionnaire at the Portuguese Public Bank of Gametes (response rate: 76%). Agreement with dual consent was defined as the belief that the use of EGDs in research should be consented by both donors and recipients. Results The majority of participants (74.6% of donors and 65.7% of recipients) were willing to donate embryos for research. Almost half of the donors (48.6%) and half of the recipients (46.9%) considered that a dual consent procedure is desirable. This view was more frequent among employed recipients (49.7%) than among non-employed (21.4%). Donors were less likely to believe that only recipients should be involved in giving consent for the use of EGDs in research (25.0% vs. 41.7% among recipients) and were more frequently favourable to the idea of exclusive donors' consent (26.4% vs. 11.4% among recipients). Conclusions Divergent views on dual consent among donors and recipients indicate the need to develop evidence-based and ethically sustainable policies and guidelines to protect well-being, autonomy and reproductive rights of both stakeholder groups. More empirical research and further theoretical normative analyses are needed to inform people-centred policy and guidelines for shared decision-making concerning the use of EGDs for research."