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Law, Medicine & Ethics The Journal of Law, Medicine & Ethics (JLME): Material published in The Journal of Law, Medicine & Ethics (JLME) contributes to the educational mission of the American Soci- ety of Law, Medicine & Ethics, covering public health, health T HE J OURNAL OF disparities, patient safety and quality of care, and biomedical science and research, and more. Editorial Office law, medicine & ethics Journal of Law, Medicine & Ethics, 765 Commonwealth VOLUME 44:1 • SPRING 2016 Avenue, Suite 1704, Boston, MA 02215 USA Phone: 617-262-4990; Fax: 617-437-7596 E-mail: [email protected] Board of Editors Letters to the Editors: Comments on articles in the Journal should be addressed to the Editor at the editorial office or emailed to [email protected]. Anita Allen-Castellitto, J.D., Ph.D. Zita Lazzarini, J.D., M.P.H. University of Connecticut Health Center Submission Guidelines: For submission guidelines, University of Pennsylvania Law School please contact the editorial office at thutchinson@aslme. • • org. Submission guidelines are also available online at Troyen A. Brennan, M.D., J.D., M.P.H. Theodore R. LeBlang, J.D. http://jlme.sagepub.com. CVS Caremark Southern Illinois University School of Medicine The Journal of Law, Medicine & Ethics (ISSN 1073-1105) Harvard School of Public Health (J812) is published quarterly—in March, June, September • • and December—by SAGE Publications, 2455 Teller Baruch A. Brody, Ph.D. Robert J. Levine, M.D. Road, Thousand Oaks, CA 91320 in association with the Baylor College of Medicine Yale University American Society of Law, Medicine & Ethics. Send address • changes to the Journal of Law, Medicine & Ethics, c/o SAGE • Publications, 2455 Teller Road, Thousand Oaks, CA 91320. Arthur L. Caplan, Ph.D. Wendy K. Mariner, J.D., LL.M., M.P.H. University of Pennsylvania Medical Center Boston University School of Public Health Copyright © 2016, the American Society of Law, Medicine & • Ethics. All rights reserved. No portion of the contents may be • reproduced in any form without written permission from the R. Alta Charo, J.D. Maxwell J. Mehlman, J.D. publisher. University of Wisconsin Law School Case Western Reserve University • • Subscription Information: All subscription inqui- ries, orders, back issues, claims, and renewals should James F. Childress, M.A., Ph.D. Alan Meisel, J.D. be addressed to SAGE Publications, 2455 Teller Road, University of Virginia University of Pittsburgh School of Law Thousand Oaks, CA 91320; telephone: (800) 818-SAGE • • (7243) and (805) 499-0721; fax: (805) 375-1700; e-mail: Christine I. Mitchell, R.N., M.S., [email protected]; http://www.sagepublications.com. Ellen Wright Clayton, M.D., J.D. Subscription Price: Institutions: $864 . 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Advertising and Reprints: Current advertising rates and Karen H. Rothenberg, J.D., M.P.A. specifications may be obtained by contacting the adver- Saint Louis University School of Law University of Maryland School of Law tising coordinator in the Thousand Oaks office at (805) • 410-7772 or by sending an e-mail to advertising@sagepub. • com. To order reprints, please e-mail [email protected]. Jeffrey P. Kahn, Ph.D., M.P.H. Johns Hopkins University Margaret A. Somerville, A.M., FRSC Acceptance of advertising in this journal in no way implies McGill University endorsement of the advertised product or service by SAGE, • the journal’s affiliated society(ies), or the journal editor(s). • No endorsement is intended or implied. SAGE reserves the Marshall B. Kapp, J.D., M.P.H. Florida State Colleges of Medicine and Law Daniel P. Sulmasy, O.F.M., right to reject any advertising it deems as inappropriate for M.D., Ph.D. • this journal. University of Chicago Nancy M. P. King, J.D. • Supplements: Address all correspondence to Barbara University of North Carolina Eisenberg, SAGE Publications, Thousand Oaks, California School of Medicine Susan M. Wolf, J.D. 91320, (805) 410-7763 (phone), [email protected] University of Minnesota Law School (e-mail). • • John D. Lantos, M.D. Change of Address for Non-Members: Six weeks’ advance Center for Practical Bioethics Stuart J. Youngner, M.D. notice must be given when notifying of change of address. Case Western Reserve University Please send the old address label along with the new address to the SAGE office address above to ensure proper identifica- tion. Please specify the name of the journal. 2 journal of law, medicine & ethics T HE J OURNAL OF LAW, MEDICINE & ETHICS contents VOLUME 44:1 • SPRING 2016 SYMPOSIUM This introduces part two of JLME’s first ever two-part symposium. The first half of this symposium appeared in our Winter 2015 issue. Part II: Harmonizing Symposium Articles 24 Privacy Laws Biobanks as a Central Part of the to Enable 7 Finnish Growth and Genomic Locating Biobanks in the Canadian Strategies: How to Balance Privacy in International Privacy Maze an Innovation Ecosystem? Biobank Katie M. Saulnier and Yann Joly Sirpa Soini Although Canada has not yet enacted any biobanking- Finland has aimed to make itself an international leader Research specific privacy law, guidance and oversight are provided in genomic research and related business and, in working via various federal and provincial health and privacy- towards that goal, has enacted biobank legislation. The related laws as well as via ethics and policy documents. Biobank Act requires biobanks to gain approval, be super- Guest Edited by The primary policy document governing health research, vised, and register at the national level. Numerous other the Tri-Council Policy Statement: Ethical Conduct for laws may also apply in any given research setting, such Mark A. Rothstein Research Involving Humans, provides the framework as the Personal Data Act, the Medical Research Act, and for the strong role of Research Ethics Boards in Canada, the Act on Medical Use of Human Organs and Tissues. and Bartha Maria and limits research funding from Canada’s three main In terms of privacy protection, anonymization is gener- federal funding agencies to those who agree to adhere to ally not permitted under Finnish law and therefore most Knoppers its policies. The broad consent model is gaining traction biobanks pseudonomize data and samples. However, in Canada, although lack of legal and constitutional prece- the broad understanding of what is identifiable data in dence for the broad consent or opt-out options makes this Finland has created difficulties in sharing with non-EU an evolving issue. In general, data is required to be coded; countries. Furthermore, consent to biobank research is 1 more specific security measures are outlined in guidelines only applicable to the sample and related data, not to data Letter from that may be implemented by local policy. International stored in other health-related registries, and consent is sharing is allowed, and Canada meets the European only to the field of research for that particular biobank. Union’s standards for receipt of data and samples. These restrictions impede the sharing of samples and data the Editor for research. 20 Cover image ©Corbis 35 Biobanking in Estonia Privacy Laws and Biobanking Aime Keis in Germany Estonia is a democratic, parliamentary republic with a health care system that is built on the principle of com- Nils Hoppe pulsory, solidarity-based insurance and the all-round While the possibility of enacting a sui generis Biobank availability of services of private service providers.
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