Integration of ethical considerations into HTA reports: an analysis of integration levels using a systematic review.

OBJECTIVE: To describe the type and level of ethical integration in published health technology assessment (HTA) reports and systematically identify the ethical approaches utilized. METHODS: A literature search was conducted with the Google™ search engine using the keyword "ethic" between 1 January 2015 and 20 August 2019. Only HTA assessment reports with a section on ethics were retained and classified according to their level of ethical integration: no ethical analysis, ethical issues highlighted, assessments according to legal or social norms, and assessments from a moral or axiological perspective-using a qualitative methodology to distinguish such integration. RESULTS: This review yielded 188 reports with a section identified as being on ethics, produced by seventeen HTA agencies in eleven countries. One hundred and thirty-six reports did not develop an ethical analysis, thirty-one highlighted ethical issues, seventeen conducted a norm-based ethical assessment using a descriptive approach grounded in social norms, and four developed an assessment grounded in a moral or axiological perspective. The bioethical "four-principles" framework was used, but mainly for presenting ethical issues and not as a moral framework. CONCLUSIONS: The majority of reports featuring a section on ethics mention ethical considerations without ethical analysis. Ethical issues are grouped with legal, social, and organizational issues and treated as contextual considerations that decision makers should be aware of. When reports present systematic norm-based ethical assessments from a descriptive perspective or ethical assessment based on a moral or axiological perspective, there is a tendency to ground these analyses in frameworks created for the purpose and reliant on a concept of ethics supporting them.

How does HTA addresses current social expectations? An international survey.

OBJECTIVES: Integration of ethics into technology assessment in healthcare (HTA) reports is directly linked to the need of decision makers to provide rational grounds justifying their social choices. In a decision-making paradigm, facts and values are intertwined and the social role of HTA reports is to provide relevant information to decision makers. Since 2003, numerous surveys and discussions have addressed different aspects of the integration of ethics into HTA. This study aims to clarify how HTA professionals consider the integration of ethics into HTA, so an international survey was conducted in 2018 and the results are reported here. METHODS: A survey comprising twenty-two questions was designed and carried out from April 2018 to July 2018. Three hundred and twenty-eight HTA agencies from seventy-five countries were invited to participate in this survey. RESULTS: Eighty-nine participants completed the survey, representing a participation rate of twenty-seven percent. As to how HTA reports should fulfill their social role, over 84 percent of respondents agreed upon the necessity to address this role for decision makers, patients, and citizens. At a lower level, the same was found regarding the necessity to make value-judgments explicit in different report sections, including ethical analysis. This contrasts with the response-variability obtained on the status of ethical analysis with the exception of the expertise required. Variability in stakeholder-participation usefulness was also observed. CONCLUSIONS: This study reveals the importance of a three-phase approach, including assessment, contextual data, and recommendations, and highlights the necessity to make explicit value-judgments and have a systematic ethical analysis in order to fulfill HTA's social role in guiding decision makers.

ETHICS IN HEALTH TECHNOLOGY ASSESSMENT: A SYSTEMATIC REVIEW.

OBJECTIVES: Integration of ethics into health technology assessment (HTA) remains challenging for HTA practitioners. We conducted a systematic review on social and methodological issues related to ethical analysis in HTA. We examined: (1) reasons for integrating ethics (social needs); (2) obstacles to ethical integration; (3) concepts and processes deployed in ethical evaluation (more specifically value judgments) and critical analyses of formal experimentations of ethical evaluation in HTA. METHODS: Search criteria included "ethic," "technology assessment," and "HTA". The literature search was done in Medline/Ovid, SCOPUS, CINAHL, PsycINFO, and the international HTA Database. Screening of citations, full-text screening, and data extraction were performed by two subgroups of two independent reviewers. Data extracted from articles were grouped into categories using a general inductive method. RESULTS: A list of 1,646 citations remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. The social need most often reported was to inform policy decision making. The absence of shared standard models for ethical analysis was the obstacle to integration most often mentioned. Fairness and Equity and values embedded in Principlism were the values most often mentioned in relation to ethical evaluation. CONCLUSIONS: Compared with the scientific experimental paradigm, there are no settled proceedings for ethics in HTA nor consensus on the role of ethical theory and ethical expertise hindering its integration. Our findings enable us to hypothesize that there exists interdependence between the three issues studied in this work and that value judgments could be their linking concept.

Support for the Development of Technological Innovations: Promoting Responsible Social Uses.

How can technological development, economic development, and the claims from society be reconciled? How should responsible innovation be promoted? The "responsible social uses" approach proposed here was devised with these considerations in view. In this article, a support procedure for promoting responsible social uses (RSU) is set out and presented. First, the context in which this procedure emerged, which incorporates features of both the user-experience approach and that of ethical acceptability in technological development, is specified. Next, the characteristic features of the procedure are presented, that is, its purpose, fundamental orientation, and component parts as experimented by partners. Third, the RSU approach is compared with other support approaches and considered in term of how each approach assumes responsible innovation. Briefly, the RSU procedure is a way of addressing the issue of responsible innovation through an effective integration of social concerns.

Twelve tips to avoid ethical pitfalls when recruiting students as subjects in medical education research.

Medical education research has unique characteristics that raise their own set of ethical issues, which differ significantly from those commonly found in clinical research. In contexts where researchers have a dual role as teachers, free consent to participate in research may be undermined and students' data must be kept confidential from faculty who play any role in their academic or professional path. Faculty members who recruit students as research subjects within their institution for education research should pay particular attention to ensure students' consent to participate is indeed free and continuous and that their privacy is adequately protected. A good understanding of ethical standards and of the appropriate strategies to fulfill them is essential to conduct ethical medical education research and to ensure ethics approval is obtained. These twelve tips draw from the Declaration of Helsinki, from the ICMJE recommendations and from the example of their application to medical education research in a Canadian and North American context. They aim to act as a reminder and as a guide to address the main ethical issues which should be given proper consideration when designing a study involving students as subjects for medical education research.

Complementary and alternative medicine: Do physicians believe they can meet the requirements of the Collège des médecins du Québec?

OBJECTIVE: To determine whether medical training prepares FPs to meet the requirements of the Collège des médecins du Québec for their role in advising patients on the use of complementary and alternative medicine (CAM). DESIGN: Secondary analysis of survey results. SETTING: Quebec. PARTICIPANTS: Family physicians and GPs in active practice. MAIN OUTCOME MEASURES: Perceptions of the role of the physician as an advisor on CAM; level of comfort responding to questions and advising patients on CAM; frequency with which patients ask their physicians about CAM; personal position on CAM; and desire for training on CAM. RESULTS: The response rate was 19.5% (195 respondents of 1000) and the sample appears to be representative of the target population. Most respondents (85.8%) reported being asked about CAM several times a month. A similar proportion (86.7%) believed it was their role to advise patients on CAM. However, of this group, only 33.1% reported being able to do so. There is an association between an urban practice and knowledge of the advisory role of physicians. More than three-quarters of respondents expressed interest in receiving additional training on CAM. CONCLUSION: There is a gap between the training that Quebec physicians receive on CAM and their need to meet legal and ethical obligations designed to protect the public where CAM products and therapies are concerned. One solution might be more thorough training on CAM to help physicians meet the Collège des médecins du Québec requirements.

Analyses of Acceptability Judgments Made Toward the Use of Nanocarrier-Based Targeted Drug Delivery: Interviews with Researchers and Research Trainees in the Field of New Technologies.

The assessment of nanotechnology applications such as nanocarrier-based targeted drug delivery (TDD) has historically been based mostly on toxicological and safety aspects. The use of nanocarriers for TDD, a leading-edge nanomedical application, has received little study from the angle of experts' perceptions and acceptability, which may be reflected in how TDD applications are developed. In recent years, numerous authors have maintained that TDD assessment should also take into account impacts on ethical, environmental, economic, legal, and social (E3LS) issues in order to lead to socially responsible innovation. Semi-structured interviews (n = 22) were conducted with French and Canadian researchers and research trainees with diverse disciplinary backgrounds and involved in research related to emerging technologies. The interviews focussed on scenarios presenting two types of TDD nanocarriers (carbon, synthetic DNA) in two contexts of use (lung cancer, seasonal flu). Content and inductive analyses of interviews showed how facets of perceived impacts such as health, environment, social cohabitation, economy, life and death, representations of the human being and nature, and technoscience were weighed in acceptability judgments. The analyses also revealed that contextual factors related to device (nature of the treatment), to use (gravity of the disease), and to user (culture) influenced the weighting assigned to perceived impacts and thus contributed to variability in interviewees' judgments of acceptability. Giving consideration to researchers' perspective could accompany first steps of implementation and development of nanomedicine by producing a first, but wide, picture of the acceptability of nanocarrier-based TDD.

Effects of disciplinary cultures of researchers and research trainees on the acceptability of nanocarriers for drug delivery in different contexts of use: a mixed-methods study.

The acceptability of nanomedical applications, which have the potential to generate ethical and societal impacts, is a significant factor in the deployment of nanomedicine. A lack of fit between nanomedical applications and society's values may result from a partial consideration of such impacts. New approaches for technological evaluation focused on impact perception, acceptance, and acceptability are needed to go beyond traditional technology assessment approaches used with nanotechnology, which focus mainly on toxicological and safety criteria. Using a new evaluative approach based on perceived impacts of nanotechnology, the objective of this study was to assess perceptions among researchers and research trainees familiar with emergent technologies and from different disciplinary background the scope of acceptability judgments made towards the use of nanocarriers. This mixed-methods study was based on scenarios presenting two types of drug-delivery nanocarriers (carbon, synthetic DNA) in two contexts of use (lung cancer treatment, seasonal flu treatment). Researchers and research trainees in the natural sciences and engineering, and the social sciences and the humanities were invited by email to take part in this project. An online questionnaire followed by semi-directed interviews allowed characterization of disciplinary divergences regarding to impact perception, acceptance, and acceptability of the scenarios. The results suggest that impact perception is influenced by disciplinary culture. Also, trends can be seen between respondents' profiles and variables of acceptance and acceptability, and certain components of the acceptability judgement are specific to each disciplinary culture. The acknowledgment and consideration of these disciplinary divergences could allow, among others, for opening up interdisciplinary dialogue on matters related to the acceptability of nanomedical applications and their developments.

The acceptability of nanocarriers for drug delivery in different contexts of use: perceptions of researchers and research trainees in the field of new technologies.

BACKGROUND: Despite marked optimism in the field of nanomedicine about the use of drug-delivery nanocarriers, uncertainties exist concerning nanocarriers' possible unintended impacts and effects. These uncertainties could affect user acceptance and acceptability. "Acceptance" refers to the intention to put a technology or a device to a specified use. "Acceptability" refers to a value judgment that accounts for acceptance. The objectives of this study were to characterize impact perception, acceptance, and acceptability in relation to drug-delivery nanocarriers in different contexts of use, and to explore relationships among these concepts. METHODS: A sample of European and Canadian researchers and graduate research trainees active in the field of new technologies was recruited by targeted email invitation for participation in a web-based questionnaire study. The questionnaire presented scenarios for two contexts of use (lung cancer, seasonal flu) of drug-delivery nanocarriers with two compositions (carbon, synthetic DNA). Respondents' impact perception, acceptance, and acceptability judgment in relation to each kind of nanocarrier in each context of use were measured with Likert scale questions and scored using categorical values. RESULTS: Two hundred and fourteen researchers and graduate research trainees completed the questionnaire. The results showed that nanocarrier composition influenced impact perception: as compared with the carbon nanocarrier impact perception, the positive impacts of the synthetic DNA nanocarrier were perceived as more significant and more likely to occur than its negative impacts. Composition did not influence acceptance or acceptability. Context of use significantly influenced acceptance and acceptability of both kinds of nanocarriers: researchers were more likely to accept the use of nanocarriers to treat lung cancer than the seasonal flu. The results also showed a significant relationship between acceptance and the perceived usefulness of the treatments. CONCLUSION: Nanocarrier composition does not appear to influence acceptance or acceptability. On the other hand, the nanocarriers' perceived usefulness and context of use are both major factors in accounting for acceptance and acceptability.

Framework for the analysis of nanotechnologies' impacts and ethical acceptability: basis of an interdisciplinary approach to assessing novel technologies.

The genetically manipulated organism (GMO) crisis demonstrated that technological development based solely on the law of the marketplace and State protection against serious risks to health and safety is no longer a warrant of ethical acceptability. In the first part of our paper, we critique the implicitly individualist social-acceptance model for State regulation of technology and recommend an interdisciplinary approach for comprehensive analysis of the impacts and ethical acceptability of technologies. In the second part, we present a framework for the analysis of impacts and acceptability, devised-with the goal of supporting the development of specific nanotechnological applications-by a team of researchers from various disciplines. At the conceptual level, this analytic framework is intended to make explicit those various operations required in preparing a judgement about the acceptability of technologies that have been implicit in the classical analysis of toxicological risk. On a practical level, we present a reflective tool that makes it possible to take into account all the dimensions involved and understand the reasons invoked in determining impacts, assessing them, and arriving at a judgement about acceptability.

Moral Arguments in the Debate over Nanotechnologies: Are We Talking Past Each Other?

How are we to understand the fact that the philosophical debate over nanotechnologies has been reduced to a clash of seemingly preprogrammed arguments and counterarguments that paralyzes all rational discussion of the ultimate ethical question of social acceptability in matters of nanotechnological development? With this issue as its starting point, the study reported on here, intended to further comprehension of the issues rather than provide a cause-and-effect explanation, seeks to achieve a rational grasp of what is being said through the appeals made to this or that principle in the range of arguments put forward in publications on the subject. We present the results of the study's analyses in two parts. In the first, we lay out the seven categories of argument that emerged from an analysis of the literature: the arguments based on nature, dignity, the good life, utility, equity, autonomy, and rights. In the second part, we present the background moral stances that support each category of argument. Identifying the different categories of argument and the moral stance that underlies each category will enable a better grasp of the reasons for the multiplicity of the arguments that figure in discussions of the acceptability of nanotechnologies and will ultimately contribute to overcoming the tendency towards talking past each other that all too often disfigures the exchange. Clarifying the implications of the moral arguments deployed in the debate over nanotechnologies may make it possible to reduce the confusion observable in these exchanges and contribute to a better grasp of the reasons for their current unproductiveness.

The Social and Ethical Acceptability of NBICs for Purposes of Human Enhancement: Why Does the Debate Remain Mired in Impasse?

The emergence and development of convergent technologies for the purpose of improving human performance, including nanotechnology, biotechnology, information sciences, and cognitive science (NBICs), open up new horizons in the debates and moral arguments that must be engaged by philosophers who hope to take seriously the question of the ethical and social acceptability of these technologies. This article advances an analysis of the factors that contribute to confusion and discord on the topic, in order to help in understanding why arguments that form a part of the debate between transhumanism and humanism result in a philosophical and ethical impasse: 1. The lack of clarity that emerges from the fact that any given argument deployed (arguments based on nature and human nature, dignity, the good life) can serve as the basis for both the positive and the negative evaluation of NBICs. 2. The impossibility of providing these arguments with foundations that will enable others to deem them acceptable. 3. The difficulty of applying these same arguments to a specific situation. 4. The ineffectiveness of moral argument in a democratic society. The present effort at communication about the difficulties of the argumentation process is intended as a necessary first step towards developing an interdisciplinary response to those difficulties.

Evaluation of clinical innovation: a gray zone in the ethics of modern clinical practice?

BACKGROUND: Various stakeholders can have differing opinions regarding ethical review when introducing new procedures with patients. OBJECTIVE: This pilot study examines the way in which Research Ethics Boards (REBs; Institutional Review Boards) and clinical biochemists (CBs; laboratory medicine specialists) differ in their interpretation of what is research and what should be considered common practice versus innovation versus experimentation when introducing new procedures with patients. It also explores whether these groups agree on who is responsible for the ethical review of new procedures. METHODS: A validated case scenario for the introduction of a new diagnostic test into clinical practice was sent to CBs and REBs across Canada. Participants were asked to determine whether the scenario constituted research; whether the test procedure should be considered as experimental, innovative, or commonly accepted care; and whether the project required approval by a REB and, if not, who should be responsible for ethical review. RESULTS: Results showed 81% of 37 CBs and 52% of 27 REBs identified the scenario as research. Responsibility for ethical review was assigned to REBs by 44% of REBs and 54% of CBs. Of all participants, 53% classified the test procedure as 'innovative', 8% as 'experimental', whereas 17% classified it as 'commonly accepted'. CONCLUSIONS: This pilot study indicates a substantial variation in the ethical assessment of innovation in clinical care. This suggests the need to further elaborate on the types of innovation in health care and categorize the nature of the risks associated with each.

[Beyond the criticism addressed to research ethics committees: a choice of governance]. / Au-delà des critiques adressées aux comités d'éthique de la recherche: un choix de gouvernance.

In 1998 in Canada and Quebec, two policies regarding research ethics transformed the evaluation approach of clinical research following the Code of Nuremberg and subsequent Declarations of the World Medical Association. Even after almost ten years of implementation, these policies still arouse debate in the research milieu. If for many, these debates essentially reflect the inherent difficulties in any implementation process, in which resistance to change and the modification of policies and action plans, we believe that there is a more fundamental stake, rarely mentioned or debated, that of the choice of governance. In this article we start by proposing a classification of the different modes of governance: professional deontology, and ethical and administrative rights. Secondly, we show how the debates and criticisms addressed to the Research Ethics Committee of Quebec and Canada attains their full meaning in light of this basic stake: the divergence of the mode of governance to favour ethics in research.

A biobank management model applicable to biomedical research.

BACKGROUND: The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information. METHODS: We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants. RESULTS: The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking. CONCLUSION: Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment.

Changes in students' moral development during medical school: a cohort study.

INTRODUCTION: The requirements of professionalism and the expected qualities of medical staff, including high moral character, motivate institutions to care about the ethical development of students during their medical education. We assessed progress in moral reasoning in a cohort of medical students over the first 3 years of their education. METHODS: We invited all 92 medical students enrolled at the University of Sherbrooke, Que., to complete a questionnaire on moral reasoning at the start of their first year of medical school and at the end of their third year. We used the French version of Kohlberg's Moral Judgment Interview. Responses to the questionnaire were coded by stage of moral development, and weighted average scores were assigned according to frequency of use of each stage. RESULTS: Of the 92 medical students, 54 completed the questionnaire in the fall of the first year and again at the end of their third year. The average age of the students at the end of the third year was 21 years, and 79% of the students included in the study were women. Over the 3-year period, the stage of moral development did not change substantially (i.e., by more than half a stage) for 39 (72%) of the students, shifted to a lower stage for 7 (13%) and shifted to a higher stage for 8 (15%). The overall mean change in stage was not significant (from mean 3.46 in year 1 to 3.48 in year 3, p = 0.86); however, the overall mean change in weighted average scores showed a significant decline in moral development (p = 0.028). INTERPRETATION: Temporal variations in students' scores show a levelling process of their moral reasoning. This finding prompts us to ask whether a hidden curriculum exists in the structure of medical education that inhibits rather than facilitates the development of moral reasoning.