Black L., Simard J., Knoppers B.M., "Genetic Testing, Physicians and the Law: Will the Tortoise Ever Catch Up with the Hare?", (2010) 16 Ann. Health L.,115
Abstract: As science progresses and new treatments for (and genetic susceptibility to) disease are discovered, questions arise as to how physicians relate this information to patients. This is especially important in the field of cancer research, where the study of genetics has changed how researchers think about causes and therapies. As genetic tests become cheaper and more widespread and as potential patients continue to hear and read sensational stories about genetic disorders and testing, the question becomes: Will physicians face new liabilities based on inaccurate or misleading results, or for disclosing (or failing to disclose) relevant results to family members of a patient.

---

Borry P., Howard H.C., Sénécal K., Avard D., "Health-related direct-to-consumer genetic testing: a review of companies' policies with regard to genetic testing in minors",

(2010) 9:1 Familial Cancer 51

Abstract: More and more companies are advertising and selling genetic tests directly to consumers. Considering the ethical, legal, and psychological concerns surrounding genetic testing in minors, a study of companies’ websites was performed in order to describe and analyze their policies with respect to this issue. Of the 29 companies analyzed, 13 did not provide any information about this matter, eight companies allowed genetic testing upon parental request, four companies stated that their website is not directed to children under 18 years, and four companies suggested that in order to be tested, applicants should have reached the age of legal majority. If private companies offer genetic tests which are also offered in a clinical setting, can they be expected to adhere to the existing clinical guidelines with regard to these tests? If so, a certain ambiguity exists. Many companies are emphasizing in their disclaimers that their services are not medical services and should not be used as a basis for making medical decisions. Nonetheless, it remains debatable whether genetic testing in minors would be appropriate in this context. In line with the Advisory Committee on Genetic Testing, the Human Genetics Commission addressed the problem of non-consensual testing and recommended not to supply genetic testing services directly to those under the age of 16 or to those not able to make a competent decision regarding testing.

---

Caulfield T., Knoppers B.M., "Consent, Privacy & Research Biobanks", (2010) 1 Genome Canada, 1, online: URL
Abstract: In March 2009, Time Magazine picked biobanking as one of the TOP 10 Ideas changing the world right now. Indeed, large biobanks, linked with health, demographic and administrative data, are proliferating in countries around the world, not least of which is Canada, Scientists are poised internationally with an unprecedented ability to tease out complex interactions between genes and environment, enhancing our understanding of health and disease and paving the way towards a future of personalized medicine and public health. Meanwhile, existing legal and policy frameworks for personal data protection are founded on the concept of informed consent, the application of which has proven to be challengingfor advancing biobank research and related scientific progress in Canada. This Policy Brief explores three possible policy options for implementing the concept of consent in the context of research biobanks: 1) specific and fully informed consent for each project; 2) broad initial consent accompanied by appropriate governance; and 3) opt-out model, The types of research biobanks being contemplated include: large populationbased biobanks, disease-specific biobanks and biobanks created from left-over archival tissue originally collected in the context of clinical care.

---

Joly Y., McClellan K.A., Knoppers B.M., "Personalized Vaccines and Public Health Genomics: Anticipating and Monitoring the ELSIs", (2010) 8 Current Pharmacogenomics and Personalized Medicine, 4
Abstract: Personalized vaccines have the potential to be one of the most promising genomics applications in public health. Personalized vaccines could improve global health by addressing some of the most threatening diseases of our time. In order to ensure that personalized vaccine research and development are not derailed by unforeseen novel ELSIs, it is important to think ahead about the potential pitfalls and socio-ethical repercussions of research in this field.

---

Knoppers B.M., Abdul-Rahman (Zawati) M.H., "Health Privacy in Genetic Research: Populations and Persons", (2009) 28:2 Politics and the Life Sciences, 99
Abstract: [None available]

---

Tassé A.M., Budin-Ljøsne I., Knoppers B.M., Harris J.R., "Retrospective access to data: The ENGAGE consent experience", (2010) 18 EJHG 741–745, online: URL
Abstract: The rapid emergence of large-scale genetic databases raises issues at the nexus of medical law and ethics, as well as the need, at both national and international levels, for an appropriate and effective framework for their governance. This is even more so for retrospective access to data for secondary uses, wherein the original consent did not foresee such use. The first part of this paper provides a brief historical overview of the ethical and legal frameworks governing consent issues in biobanking generally, before turning to the secondary use of retrospective data in epidemiological biobanks. Such use raises particularly complex issues when (1) the original consent provided is restricted; (2) the minor research subject reaches legal age; (3) the research subject dies; or (4) samples and data were obtained during medical care. Our analysis demonstrates the inconclusive, and even contradictory, nature of guidelines and confirms the current lack of compatible regulations. The second part of this paper uses the European Network for Genetic and Genomic Epidemiology (ENGAGE Consortium) as a case study to illustrate the challenges of research using previously collected data sets in Europe. Our study of 52 ENGAGE consent forms and information documents shows that a broad range of mechanisms were developed to enable secondary use of the data that are part of the ENGAGE Consortium.

---

Tazzite A., Roky R., Avard D., "Les implications éthiques de la conservation des échantillons biologiques", (2009) 2:3 Journal international de bioéthique, 87
Abstract: [Available only in French]

---