The ARCTIC Project: GE3LS

Initiatives Underway: GE3LS Portion Of The Arctic Project

The project titles listed below are currently being undertaken by the primary GE3LS researchers and are in the process of being researched, drafted and written with a view to considering the issues generally as they relate to human genetic research, privacy, and biobanks and as they specifically relate to, or touch upon, issues associated with the ARCTIC Project.

Once projects are completed and reviewed, they will be made available under Working Papers below.

Once published, papers will be removed from Working Papers and placed under Publications below. The complete paper, in adobe acrobat, along with the citation will be provided.

Personal Information, Informed Consent, Collection, Storage and Internal/International Transfer in Long-Term Genetic Databanks

Primary Researchers:

• Tom Archibald and Trudo Lemmens: Privacy of Personal Information and Long Term Genetic Databanks: Comparative Analysis of Canadian Law with respect to Issues of Incompetency.
• Lori Luther: Informed Consent, transfer of data in long term genetic databanks.

Ethical/Legal Duty to Warn and the Privilege to Disclose

Primary Researchers:

• Lorian Hardcastle: Legal analysis on the duty/privilege to warn 'serious avertable harm' information to probands and their at-risk relatives, a shorter article focused on distinctions, if any, between the research and medical community in terms of such duties/privileges, and a short guidance document for ARCTIC researchers.

Genetic Research, Privacy & Property in an International Context

Primary Researchers:

• Lori Luther and Trudo Lemmens: The ARCTIC project will be used as a model to consider the changing legal status of DNA samples over the course of a genetic research project from being part of a research subject's body, to collection of the sample through informed consent, to storage and use.

DNA Databanks and Vulnerable Populations

Primary Researchers:

• Margaret Ng Thow Hing: Analysis of the protection of research subjects in the specific context of databanking in Mauritius, based on first hand research. Consideration also of how, and to what extent, findings are relevant to research involving vulnerable people in other countries, including Canada.
• Trudo Lemmens and Lori Luther: Possible further investigation of relevant issues at a later date.

Benefit Sharing and the Commercialization of Genetic Testing

Primary Researchers:

• Ron Bouchard, Trudo Lemmens: Analysis of the ethical, legal and regulatory issues raised by the commercialization of federally funded research.
• Trudo Lemmens, Ron Bouchard and Lori Luther: Analysis and consideration of general issues related to benefit sharing and commercialization.

Access to and Disclosure of Data by/to Research Subjects/Patients

Primary Researchers:

• Trudo Lemmens and Arkadi Bouchelev: Analysis of whether the law related to access to, and disclosure of, health care information can apply to research information and physical samples as well as the possible legal difference between access to clinical files and research records containing personal information. Access by third parties to research data will also be explored as well concerns and potential harms of access to premature research data.

Genetics and Privacy (website)

Primary Researchers:

• Lori Luther, Elizabeth Cuellar Barrosa and Daniel Brinza: Collaboration on this website of Genetic Information Privacy and Biobanking at the Faculty of Law, University of Toronto.

The Development of a Colon Cancer Screening Test: Ethical and Legal Issues

A series of discussions and papers will explore ethical and legal issues related to the development of a colon cancer screening test. This sub-project will take place towards the end of the project, when more information is available on the expected sensitivity and specificity of a colon cancer screening test. Questions include: when is it appropriate to start sharing results of genetic research with research subjects and their families? When is it appropriate to introduce a genetic screening test for colon cancer on the market? What are the mechanisms to determine whether such a screening test will be beneficial? What supports should go with it, such as genetic counselling services to promote understanding of false positives and false negatives? How do we deal with uncertainty associated with such screening test? Under what conditions is it ethical to market a genetic test in light of the nature of predictive risk information? The issue of marketing is likely to become more important in the context of the development of private healthcare markets that may result from the recent Chaoulli decision.

Researchers' Access to Publicly and Privately Funded Databases

Genetic databases are a crucial resource for genetic research. Like any other finite source of research, access to databanks is controlled in various ways. Research ethics boards review protocols to determine whether the rights (including privacy rights) and well-being of research subjects are respected. Databanks also have policies to determine who obtains access and for what purposes. The commercial interests associated with access to data also raises interesting questions related to who obtains priority access to samples. The legal and ethical implications of access policies will be analyzed and discussed in a policy oriented paper.

Archibald, T., & T. Lemmens, "Loss of Capacity by Research Subjects: An Ethical and Legal Overview." Final Report prepared for The Canadian Institutes of Health Research, The Canadian Lifelong Health Initiative, Ethical-Legal-Social Issues Advisory Committee, October 27, 2006.

Archibald, T., & T. Lemmens, "Privacy of Personal Information and Long Term Genetic Databanks: Comparative Analysis of Canadian Law with respect to Issues of Incompetency," August 2005.

Bouchard, R. A., "Balancing Public and Private Interests in the Commercialization of Publicly Funded Biomedical Technologies: Is there a Role for Compulsory Government Royalty Fees?" [Submitted for Publication]

Bouchard, R. A., & T. Lemmens, "Background Document on Clinical Trials Registration and its Impact on Patents and Data Exclusivity." [Submitted for publication to the World Health Organization, March 2006].

In Press

Lemmens, T., "Conflict of Interest in Medical Research; Historical Developments,"in Ezekiel E. Emanuel et al. (eds.), The Oxford Textbook of Clinical Research, (forthcoming, 2007) Chapter 69.

Lemmens, T., & R.A. Bouchard, "Regulation of Pharmaceuticals in Canada," in J. Downie, T. Caulfield & C. Flood (eds.), Canadian Health Law and Policy,
3rd ed. (Toronto: Butterworths, 2006) 60 pp. [Submitted October 2006 for publication in 2007].

Lemmens, T., & L. Luther, "Conflicts of Interest of Clinician-Researchers" in Peter S. Singer & Adrian Viens (eds.), Cambridge Textbook of Bioethics (Cambridge: Cambridge University Press, forthcoming 2007).

Luther, L., & T. Lemmens, "Human Genetic Data Banks: From Consent to Commercialization - An Overview of Current Concerns and Conundrums." (EOLSS Contribution, UNESCO, Online). March 2007.

Lemmens, T., & R. A. Bouchard, "Comments on the Legal, Regulatory and Ethical Aspects of the WHO Clinical Trial Registry Platform," Official Submission, WHO Clinical Trials Registration Platform (April 5, 2006) Online at:
http://www.who.int/ictrp/011_Lemmens_Bouchard_5April06.pdf

Lemmens, T., M. Lacroix, & R. Mykitiuk (eds.), Reading the future?: Legal and Ethical Challenges of Predictive Genetic Testing. (Cowansville: Les Éditions Thémis, 2007). 308 pp.

Lemmens, T., & Y. Thiery, "Insurance and Human Rights: What Can Europe Learn From Canadian Anti-discrimination Law?" in H. Cousy & C. Van Schoubroeck (eds.), Discrimination in Insurance (Antwerpen: Maklu/Academia-Bruylant, 2007).

Lemmens, T. & T, Archibald, "The CMA's Chaoulli Motion and the Myth of Promoting Fair Access to Health Care," in C. Flood, K. Roach & L. Sossin (eds.), Access to Care, Access to Justice (Toronto: University of Toronto Press, 2005) 323.