Johane Patenaude

A biobank management model applicable to biomedical research

BackgroundThe 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 participants information.MethodsWe 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.ResultsThe 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 participants confidentiality and 4) adequately deals with the ethical issues at stake in biobanking.ConclusionUntil 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.

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.

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.

Framework for the Analysis of Nanotechnologies’ Impacts and Ethical Acceptability: Basis of an Interdisciplinary Approach to Assessing Novel Technologies

Abstract 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.

Evaluation of Clinical Innovation: A Gray Zone in the Ethics of Modern Clinical Practice?

BACKGROUNDVarious stakeholders can have differing opinions regarding ethical review when introducing new procedures with patients.OBJECTIVEThis 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.METHODSA 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.RESULTSResults 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’.CONCLUSIONSThis 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.

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.

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

Abstract 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.

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.

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.