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This paper proposes a set of recommendations for the return of research results and incidental findings in paediatrics. The Network of Applied Genetic Medicine of Quebec spearheaded the initiative to develop the Statement of Principles on the Return of Research Results and Incidental Findings, which was the result of a consultation process with clinical and research experts in the field. To formulate the Statement of Principles, the authors (i) reviewed empirical and grey literature on the return of research results and incidental findings in Europe and Canada, (ii) conducted a qualitative study of stakeholder groups, (iii) developed, and (iv) validated the recommendations through consultations with the stakeholder groups. The Statement of Principles provides a useful disclosure tool for deciding when, and under what circumstances to return research results and incidental findings. It addresses the issue of return of results in genetic research generally, and has also specific principles for various research contexts, including paediatric research. It delineates ethical issues unique to paediatric research, and provides a framework to guide research ethics committees as well as the research community in addressing these issues. Key words: genetic/genomic research, paediatrics, return of results, incidental findings, ethics. Cet article propose une serie de recommandations au sujet de la communication des resultats de recherche et des decouvertes fortuites en pediatrie. Le Reseau de Medecine Genetique Appliquee (RMGA) du Quebec a supervise et endosse l'Enonce de principes sur la communication des resultats de recherche et des decouvertes fortuites, lequel est le fruit d'un processus de consultation mene aupres d'experts cliniques et en recherche dans ce domaine. Pour formuler cet Enonce de principes, les auteurs ont (i) passe en revue la litterature empirique et grise sur le sujet de la communication des resultats de recherche et des decouvertes fortuites en Europe et au Canada, (ii) realise une etude qualitative aupres de parties prenantes, (iii) developpe et (iv) valide les recommandations via des consultations impliquant des parties prenantes. L'Enonce de principes apporte un outil de divulgation utile pour decider quand et dans quelles circonstances il convient de communiquer les resultats d'aide a la decision de recherche et les decouvertes fortuites. Il aborde la question de la communication des resultats de la recherche genetique de maniere generale et apporte egalement des principes specifiques pour differents contextes de recherche, dont la recherche en pediatrie. Il cerne les enjeux ethiques qui sont uniques a la recherche pediatrique et fournit un cadre pour guider les comites d'ethique en recherche ainsi que la communaute scientifique en ce qui a trait a ces enjeux. [Traduit par la Redaction] Mots-cles: recherche genetique/genomique, pediatrie, communication des resultats, decouvertes fortuites, ethique., Introduction Rapid advances in research and clinical sequencing underscores the immediacy of national and international consensus regarding the return of research results and incidental findings. Although a number of professional [...]

Introduction The consumer role in health research is becoming increasingly prominent in many countries. Australia has a Medical Services Advisory Committee (MSAC) largely comprising physicians and health economists, but also [...]

Genesis In the beginning, there was the Nuremberg Code. But in 1964, the recently established World Medical Association saw that Code, that it was not good. So World Medical Association [...]

Background Governments increasingly emphasize the importance of public input in processes related to policy and decision making. (1) Over the last decades, public input has become standard practice in, for [...]

Abstract Background Obtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Methods Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. Results The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. Conclusions The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics.

Abstract Background Non-therapeutic trials in which terminally ill cancer patients are asked to undergo procedures such as biopsies or venipunctures for research purposes, have become increasingly important to learn more about how cancer cells work and to realize the full potential of clinical research. Considering that implementing non-therapeutic studies is not likely to result in direct benefits for the patient, some authors are concerned that involving patients in such research may be exploitive of vulnerable patients and should not occur at all, or should be greatly restricted, while some proponents doubt whether such restrictions are appropriate. Our objective was to explore clinician-researcher attitudes and concerns when recruiting patients who are in advanced stages of cancer into non-therapeutic research. Methods We conducted a qualitative exploratory study by carrying out open-ended interviews with health professionals, including physicians, research nurses, and study coordinators. Interviews were audio-recorded and transcribed. Analysis was carried out using grounded theory. Results The analysis of the interviews unveiled three prominent themes: 1) ethical considerations; 2) patient-centered issues; 3) health professional issues. Respondents identified ethical issues surrounding autonomy, respect for persons, beneficence, non-maleficence, discrimination, and confidentiality; bringing to light that patients contribute to science because of a sense of altruism and that they want reassurance before consenting. Several patient-centered and health professional issues are having an impact on the recruitment of patients for non-therapeutic research. Facilitators were most commonly associated with patient-centered issues enhancing communication, whereas barriers in non-therapeutic research were most often professionally based, including the doctor-patient relationship, time constraints, and a lack of education and training in research. Conclusions This paper aims to contribute to debates on the overall challenges of recruiting patients to non-therapeutic research. This exploratory study identified general awareness of key ethical issues, as well as key facilitators and barriers to the recruitment of patients to non-therapeutic studies. Due to the important role played by clinicians and clinician-researchers in the recruitment of patients, it is essential to facilitate a greater understanding of the challenges faced; to promote effective communication; and to encourage educational research training programs.

By disrupting normal gut microbiota, antibiotic therapies pose a major risk to the treatment of Clostridium difficile infection (CDI), a debilitating and potentially fatal intestinal infection. Consequently, there is a pressing need for the development of an effective, novel, nonantibiotic treatment. One such treatment is fecal microbiota therapy (FMT), which restores gut microbiota in CDI patients and has gained popularity in recent years due to its high efficacy rate. Health Canada has recently proposed to regulate FMT as a 'biological drug' following the U.S. Food and Drug Administration's approach. Moreover, as an interim policy, Health Canada proposed to exercise a risk-based interpretation regarding the clinical trial requirements for FMT used in treating CDI, limited to patients unresponsive to conventional therapies. This article first discusses important considerations for an alternative classification of FMT and stresses the need to develop a policy dependent upon scientific developments in the field, away from a one-size-fits-all approach. Second, it briefly explores some concerns related to the recourse to this provisional interpretation to guide the use of FMT in the treatment of patients with CDI unresponsive to conventional therapies subject to Health Canada's recent policy. [ABSTRACT FROM AUTHOR]

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Progress in understanding childhood disease using next-generation sequencing (NGS) portends vast improvements in the nature and quality of patient care. However, ethical questions surrounding the disclosure of incidental findings (IFs) persist, as NGS and other novel genomic technologies become the preferred tool for clinical genetic testing. Thus, the need for comprehensive management plans and multidisciplinary discussion on the return of IFs in pediatric research has never been more immediate. The aim of this study is to explore the views of investigators concerning the return of IFs in the pediatric oncology research context. Our findings reveal at least four contextual themes underlying the ethics of when, and how, IFs could be disclosed to participants and their families: clinical significance of the result, respect for individual, scope of professional responsibilities, and implications for the healthcare/research system. Moreover, the study proposes two action items toward anticipatory governance of IF in genetic research with children. The need to recognize the multiplicity of contextual factors in determining IF disclosure practices, particularly as NGS increasingly becomes a centerpiece in genetic research broadly, is heightened when children are involved. Sober thought should be given to the possibility of discovering IF, and to proactive discussions about disclosure considering the realities of young participants, their families, and the investigators who recruit them. [ABSTRACT FROM AUTHOR]

Advancements in genomic technology and genetic research have uncovered new and unforeseen ethical and legal issues that must now be faced by clinician–researchers. However, lack of adequate ethical training places clinician–researchers in a position where they might be unable to effectively assess and resolve the issues presented to them. The literature demonstrates that ethics education is relevant and engaging where it is targeted to the level and context of the learners, and it includes real-world based cases approached in innovative ways. In order to test the feasibility of a combined approach to ethics education, a conference was held in 2012 to raise awareness and familiarize participants with the ethical and legal issues surrounding medical technology in genetics and then to have them apply this to reality-based case studies. The conference included participants from a variety of backgrounds and was divided into three sections: (i) informative presentations by experts in the field; (ii) mock REB deliberations; and (iii) a second mock-REB, conducted by a panel of experts. Feedback from participants was positive and indicated that they felt the learning objectives had been met and that the material was presented in a clear and organized fashion. Although only an example of the combined approach in a particular setting, the success of this conference suggests that combining small group learning, practical cases, role-play and interdisciplinary learning provides a positive experience and is an effective approach to ethics education. [ABSTRACT FROM AUTHOR]

Objectives: There have been multiple calls for explicit integration of ethical, legal, and social issues (ELSI) in health technology assessment (HTA) and addressing ELSI has been highlighted as key in optimizing benefits in the Omics/Personalized Medicine field. This study examines HTAs of an early clinical example of Personalized Medicine (gene expression profile tests [GEP] for breast cancer prognosis) aiming to: (i) identify ELSI; (ii) assess whether ELSIs are implicitly or explicitly addressed; and (iii) report methodology used for ELSI integration.Methods: A systematic search for HTAs (January 2004 to September 2012), followed by descriptive and qualitative content analysis.Results: Seventeen HTAs for GEP were retrieved. Only three (18%) explicitly presented ELSI, and only one reported methodology. However, all of the HTAs included implicit ELSI. Eight themes of implicit and explicit ELSI were identified. “Classical” ELSI including privacy, informed consent, and concerns about limited patient/clinician genetic literacy were always presented explicitly. Some ELSI, including the need to understand how individual patients’ risk tolerances affect clinical decision-making after reception of GEP results, were presented both explicitly and implicitly in HTAs. Others, such as concern about evidentiary deficiencies for clinical utility of GEP tests, occurred only implicitly.Conclusions: Despite a wide variety of important ELSI raised, these were rarely explicitly addressed in HTAs. Explicit treatment would increase their accessibility to decision-makers, and may augment HTA efficiency maximizing their utility. This is particularly important where complex Personalized Medicine applications are rapidly expanding choices for patients, clinicians and healthcare systems. [ABSTRACT FROM AUTHOR]