This article outlines procedures for the feedback of individual research data to participants. This feedback framework was developed in the context of a personalized medicine research project in Canada. Researchers in this domain have an ethical obligation to return individual research results and/or material incidental findings that are clinically significant, valid and actionable to participants. Communication of individual research data must proceed in an ethical and efficient manner. Feedback involves three procedural steps: assessing the health relevance of a finding, re-identifying (...) the affected participant, and communicating the finding. Re-identification requires researchers to break the code in place to protect participant identities. Coding systems replace personal identifiers with a numerical code. Double coding systems provide added privacy protection by separating research data from personal identifying data with a third "linkage" database. A trusted and independent intermediary, the "keyholder", controls access to this linkage database. (shrink)

The article “Ethical Responsibilities for Companies that Process Personal Data” (McCoy et al. 2023) provides a principled and pragmatic ethical framework for companies collecting, sharing, and usin...

Anti-selection occurs when information asymmetry exists between insurers and applicants. When an applicant knows they are at high risk of loss, but the insurer does not, the applicant may try to use this knowledge differential to secure insurance at a lower premium that does not match risk.

Mitochondrial replacement therapy (MRT), also called nuclear genome transfer and mitochondrial donation, is a new technique that can be used to prevent the transmission of mitochondrial DNA diseases. Apart from the United Kingdom, the first country to approve MRT in 2015, Australia became the second country with a clear regulatory path for the clinical applications of this technique in 2021. The rapidly evolving clinical landscape of MRT makes the elaboration and evaluation of the responsible use of this technology a pressing (...) matter. As jurisdictions with less strict or non-existent reproductive laws are continuing to use MRT in the clinical context, the need to address the underlying ethical issues surrounding MRT’s clinical translation is fundamental. (shrink)

Five years ago, an article co-written by two of us (Joly and Simard) presented an emerging trend to disclose certain individual genetic results to research participants. Since then, both technologies and research practices have evolved significantly. Given this rapid evolution, our goal is to provide updated and thorough guidance on this issue. Our paper begins by identifying the ethical principles that support the return of results: justice, beneficence, and respect for persons. Then, it presents the results of an analysis of (...) international norms on the return of results, covering both general and individual research results. It reveals existing divergence and consensus on these topics within the international community. With the goal of promoting greater harmonization, we conclude by proposing a flexible framework for the return of individual research results. (shrink)

Five years ago, an article co-written by some of us presented an emerging trend to disclose some individual genetic results to research participants within the international research community. At the time, ethical norms and scholarly publications on the return of results often did not distinguish between the return of research results in general and the return of unexpected results. Both technologies and research practices have evolved significantly. Today whole genome and exome sequencing are increasingly affordable and frequently used in genetic (...) research. Because these techniques produce a vast amount of interpretable and non-interpretable data about an individual, the issue of how to manage information generated by such technologies needs to be considered. However, the development of international ethical guidelines has not kept up with the rapid pace of technological progress. Indeed developments in genomic biobanking also challenge the duty to disclose research results. (shrink)

The European Union approach to data protection consists of assessing the adequacy of the data protection offered by the laws of a particular jurisdiction against a set of principles that includes purpose limitation, transparency, quality, proportionality, security, access, and rectification. The EU's Data Protection Directive sets conditions on the transfer of data to third countries by prohibiting Member States from transferring to such countries as have been deemed inadequate in terms of the data protection regimes. In theory, each jurisdiction is (...) evaluated similarly and must be found fully compliant with the EU's data protection principles to be considered adequate. In practice, the inconsistency with which these evaluations are made presents a hurdle to international data-sharing and makes difficult the integration of different data-sharing approaches; in the 20 years since the Directive was first adopted, the laws of only five countries from outside of the EU, Economic Area, or the European Free Trade Agreement have been deemed adequate to engage in data transfers without the need for further administrative safeguards. (shrink)

Epigenetic research has brought several important technological achievements, including identifying epigenetic clocks and signatures, and developing epigenetic editing. The potential military applications of such technologies we discuss are stratifying soldiers’ health, exposure to trauma using epigenetic testing, information about biological clocks, confirming child soldiers’ minor status using epigenetic clocks, and inducing epigenetic modifications in soldiers. These uses could become a reality. This article presents a comprehensive literature review, and analysis by interdisciplinary experts of the scientific, legal, ethical, and societal issues (...) surrounding epigenetics and the military. Notwithstanding the potential benefit from these applications, our findings indicate that the current lack of scientific validation for epigenetic technologies suggests a careful scientific review and the establishment of a robust governance framework before consideration for use in the military. In this article, we highlight general concerns about the application of epigenetic technologies in the military context, especially discrimination and data privacy issues if soldiers are used as research subjects. We also highlight the potential of epigenetic clocks to support child soldiers’ rights and ethical questions about using epigenetic engineering for soldiers’ enhancement and conclude with considerations for an ethical framework for epigenetic applications in the military, defense, and security contexts. (shrink)

The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors’ clinical information for research and regulatory purposes, and existing practices that limit research participants’ ability to control what (...) is done with their genetic data, amplify the privacy concerns. (shrink)

Empirical research regarding genetic discrimination in the province of Quebec is largely limited. As such, this study aims, through a qualitative methodology, to explore and collect the opinions, experiences and knowledge of Quebecers regarding GD. In accordance with the exploratory objectives of this study, we chose the online forum approach as a means to extract qualitative data that would most accurately represent the perspectives of the Quebec public on various themes relating to GD. Participants’ comments on the forum indicate that (...) there are tangible fears concerning DG in Quebec as well as a need for social debate on this important issue, as an integral part of the genetic revolution and personalized healthcare. (shrink)

Although Canada has not yet enacted any biobanking-specific privacy law, guidance and oversight are provided via various federal and provincial health and privacy-related laws as well as via ethics and policy documents. The primary policy document governing health research, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, provides the framework for the strong role of Research Ethics Boards in Canada, and limits research funding from Canada's three main federal funding agencies to those who agree to adhere to its (...) policies. The broad consent model is gaining traction in Canada, although lack of legal and constitutional precedence for the broad consent or opt-out options makes this an evolving issue. In general, data is required to be coded; more specific security measures are outlined in guidelines that may be implemented by local policy. International sharing is allowed, and Canada meets the European Union's standards for receipt of data and samples. (shrink)

With a population of over 1.3 billion, China is the most populous country in the world. It is facing an acute aging population problem, with a projected 440 million residents over age 60 and 101 million over age 80 by 2050. Furthermore, rapid industrialization and urbanization in China have resulted in serious air pollution and associated public health problems, including an increase in respiratory diseases and cancers. These and other demographic trends have generated concerns about the cost of health care (...) and its impact on population health. In recent years, the Chinese government has invested heavily in the fields of translational research and biobanking with the hope that research in both fields can yield effective solutions to improve the public’s health and quality of life. The establishment of national biobanks was identified as a major initiative needed for the biomedical industry in the 12th Five-Year National Development Plan of Strategic Emerging Industries promulgated by the State Council in 2012. (shrink)

With a population of over 1.3 billion, China is the most populous country in the world. It is facing an acute aging population problem, with a projected 440 million residents over age 60 and 101 million over age 80 by 2050. Furthermore, rapid industrialization and urbanization in China have resulted in serious air pollution and associated public health problems, including an increase in respiratory diseases and cancers. These and other demographic trends have generated concerns about the cost of health care (...) and its impact on population health. In recent years, the Chinese government has invested heavily in the fields of translational research and biobanking with the hope that research in both fields can yield effective solutions to improve the public’s health and quality of life. The establishment of national biobanks was identified as a major initiative needed for the biomedical industry in the 12th Five-Year National Development Plan of Strategic Emerging Industries promulgated by the State Council in 2012. (shrink)

While much attention has gone towards ethical, legal, and social implications of direct-to-consumer genetic testing over the past decades, the rise of new forms of consumer omics has largely escaped scrutiny. In this paper, we analyze the product descriptions, promotional messages, terms of service, and privacy policies of five epigenetic and seven microbiomic testing companies. The advent of such tests online represents a significant shift in consumer omics, from a focus on inherited molecules with genetic tests, to broader interest for (...) information about the lives of individuals, such as chronological and biological age, exposures, and lifestyle. Building on previous literature about direct-to-consumer genetic testing, and taking this shift into account, we identify limitations, gaps and inconsistencies in current practices and policies of the new companies. Best practice standards and regulations applicable across different omic sample and data types is a necessary first step in the promotion of responsible consumer omics. (shrink)

Anticipatory policy for gene editing requires assessing public opinion about this new technology. Although previous surveys have examined respondents’ views on the moral acceptability of various hypothetical uses of CRISPR, they have not considered whether these scenarios are perceived as plausible. Research in construal level theory indicates that participants make different moral judgments about scenarios seen as likely or near and those seen as unlikely or distant. Therefore, we surveyed a representative sample of 400 Americans and Canadians about both the (...) likelihood and the permissibility of 23 commonly discussed uses of gene editing. Respondents with more knowledge of gene editing generally thought these applications would be more likely within the next 20 years. There was a strong positive relationship between the perceived likelihood and permissibility of most CRISPR applications. Our results suggest that ongoing public engagement efforts for gene editing could be improved by taking its perceived time-frames into account. (shrink)

Epigenetics – the study of mechanisms that influence and modify gene expression – is providing unique insights into how an individual’s social and physical environment impact the body at a molecular level, particularly in populations that experience stigmatization and trauma. Researchers are employing epigenetic studies to illuminate how epigenetic modifications lead to imbalances in health outcomes for vulnerable populations. However, the investigation of factors that render a population epigenetically vulnerable present particular ethical and methodological challenges. Here we are concerned with (...) demonstrating how, in targeting certain populations for epigenetic research, this research may be pathologizing socio-cultural and medical practices in those populations in a way that increases their vulnerability. Using a case study approach, this article examines three vulnerable populations currently of interest to epigenetic researchers – Indigenous, autistic, and transgender populations – in order to highlight some of the challenges of conducting non-stigmatizing research in epigenetics. (shrink)

This book explores the scope, application and role of medical law, regulatory norms and ethics, and addresses key challenges introduced by contemporary advances in biomedical research and healthcare. While mindful of national developments, the handbook supports a global perspective in its approach to medical law. Contributors include leading scholars in both medical law and ethics, who have contributed specially commissioned pieces in order to present a critical overview and analysis of the current state of medical law and ethics. Each chapter (...) offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, and offers dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: Bioethics, health and human rights Medical liability Law and emerging health technologies Public health law Personalized medicine The law and ethics of access to medicines in developing countries Medical research in the genome era Emerging legal and ethical issues in reproductive technologies This advanced level reference work will prove invaluable to legal practitioners, scholars, students and researchers in the disciplines of law, medicine, genetics, dentistry, theology, and medical ethics. (shrink)

(2011). ACCE, Pharmacogenomics, and Stopping Clinical Trials: Time to Extend the CONSORT Statement? The American Journal of Bioethics: Vol. 11, No. 3, pp. 11-13.

The American Journal of Bioethics, Volume 12, Issue 1, Page 13-15, January 2012.

ABSTRACTGenetic testing results and research findings raise concerns about access to genetic information by insurers. Recently, the Canadian Life and Health Insurance Association reaffirmed its prerogative to request, for underwriting purposes, the disclosure of clinical and research genetic test results if the participant/patient or his physician has knowledge of the results. Studies have shown that access to genetic information to determine insurability can, in limited instances, lead to actual, or fear of, genetic discrimination, result in individuals refusing to undergo testing (...) or declining participation in genomic research, and being asked to pay higher premiums or denied access to certain types of insurance. Obtaining informed consent for genetic testing and genomic research is crucial and should take into account the potential need to disclose possible insurability risks to patients and participants. Our study analyzed clinical and research consent forms, templates and guidelines from Quebec to investigate two questions: whether consent forms include clauses providing information on potential insurability risks and when such potential risks are included, what information is provided and how it is formulated. Our findings show that current information on insurability risks in Quebec’s forms/guidelines lack coherence, potentially resulting in patients/participants receiving inconsistent information. (shrink)