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March-April 2010

Dear readers,

We are pleased to inform you that our centre, at McGill University, has launched its new website (www.genomicsandpolicy.org) to keep you up to date with our team’s activities, publications and research projects. You will also be able to access our HumGen database through this new site.

Moreover, we are delighted to announce the publication of two recent GenEdits. The first Editorial provides an overview of situations that could become exceptions to the principle of informed consent in research. The second Editorial outlines the legal issues pertaining to the secondary use of medical data and biological samples of deceased persons. At the moment, the full version of this second Editorial is only available in French but please come back soon for the English translation.

We would also like to draw your attention to a document entitled “Best Practices for Research involving Children and Adolescents” developed by the National Council on Ethics in Human Research (NCEHR), in collaboration with the Canadian Institutes of Health Research (CIHR), Health Canada and the Centre of Genomics and Policy. Although pediatric research is essential in understanding the many factors affecting the health and development of children, there is unfortunately, a lack of specific ethical guidelines for research involving children. In this context, these Best Practices outline the international and Canadian ethical norms and provide guidance relating to areas of genetic, pharmaceutical, longitudinal and palliative care research. A copy of these Best Practices is available in our featured PediaGen module (www.pediagen.org) for comments.

For our Spanish readers:

Con el fin de hacer nuestro boletín informativo GenInfo más accesible para la audiencia Hispano-parlante, desde ahora incluiremos fuentes en idioma Español en la sección de “Leyes y Políticas” (Laws and Policies). Haremos lo posible para mantener esta sección actualizada, pero si Ud. observa que hemos omitido una política o documento importante relacionado con la investigación en genética humana, por favor siéntase en la libertad de comunicárnoslo (email).”

Happy reading!

Thu Minh Nguyen and Ma'n H. Abdul-Rahman (Co-Editors-in-Chief)


Research and Deceased Persons : The Secondary Use of Medical Data and Biological Materials
Tassé A. M., Letendre M, Knoppers BM

Abstract: The proliferation of data and the banking of biological materials collected during medical care leaves the impression that an impressive amount of resources are available for research. Moreover, the longevity of these resources often exceeds the lifetime of the persons involved. In this context, the secondary use of data and biological materials from deceased individuals raises important legal and ethical questions.

(2010) 8:1 GenEdit 1-9



INTERNATIONAL / REGIONAL

Center for Society and Genomics: Always expect the unexpected: Legal and social aspects of reporting biobank research results to individual research participants
Nijmegen - November 1, 2009
Link: URL
Key Words: Autonomy - Biobank - Communication of Results - Data - Databases - DNA - Duty to recontact - Duty to Warn - Ethical Review - Follow-up - Liability - Research
European Human Embryonic Stem Cell Registry: Code of Practice for the Operation of the European Human Embryonic Stem Cell Registry
Berlin - December 1, 2009
Link: URL
Key Words: Biobank - Confidentiality - Consent - Consultation/Collaboration - Data - Databases - DNA - Embryo - Ethical Review - Ethics Review Board - Governance - Stem Cell - Storage - Tissue
International Stem Cell Forum (ISCF): Consensus Guidance for Banking and Supply of Human Embryonic Stem Cell Lines for Research Purposes
London - December 17, 2009
Link: URL
Key Words: Access Info/Material - Biobank - Confidentiality - Consent - Databases - DNA - Donor - Embryo - Embryos (created for research) - Ethical Review - Gamete - Governance - Privacy - Professional - Research - Researcher - Stem Cell - Storage - Surplus Embryos

European Group on Ethics in Science and New Technologies (European Commission) (EGE): Opinion no. 25 - Ethics of Synthetic Biology
Brussels - November 17, 2009
Link: URL
Key Words: Commercialization - Community/Population - Consultation/Collaboration - Consumer - Developing Country - Genetic Engineering - Governance - Intellectual Property - Justice - Nanotechnology - Patents
NATIONAL

Académie nationale de médecine - France: Les cellules souches du cordon et du placenta: de la recherche aux applications thérapeutiques
Paris - January 26, 2010
Link: URL
Key Words: Consent - Education - Man/Paternity - Research - Stem Cell - Storage - Umbilical Cord Blood - Woman/Maternity
Académie nationale de médecine - France: Diffusion et validation des tests génétiques en France
Paris - December 8, 2009
Link: URL
Key Words: Biobank - Genetic Testing - Insurer/Insurance
American Academy of Pediatrics (AAP): Policy Statement - Children as Hematopoietic Stem Cell Donors
Elk Grove Village - January 25, 2010
(2010) 125:2 Pediatrics, 391
Link: URL
Key Words: Assent/Dissent - Conflict of Interest - Consent - Donor - Embryo - Ethical Review - Ethics Review Board - Man/Paternity - Minor/Child - Newborn - Patient/Participant/Individual - Pre-implantation - Prenatal - Professional - Psychosocial Aspects - Somatic Therapy - Stem Cell - Umbilical Cord Blood - Woman/Maternity
American Society of Clinical Oncology (ASCO): American Society of Clinical Oncology Policy Statement Update: Genetic and Genomic Testing for Cancer Susceptibility
Alexandria - January 11, 2010
(2010) 28:5 Journal of Clinical Oncology, 893
Link: URL
Key Words: Access Info/Material - Cancer - Consent - Consumer - Counseling (Post-test) - Counseling (Pre-test) - DNA - Education - Follow-up - Genetic Testing - Patient/Participant/Individual - Privacy - Psychosocial Aspects - Public Health - Third Party
Australia/Government - National Health and Medical Research Council (NHMRC): The use and disclosure of genetic information to a patient’s genetic relative under Section 95AA of the Privacy Act 1988 (Cth) – Guidelines for health practitioners in the private sector
Canberra - October 27, 2009
Link: URL
Key Words: Autonomy - Cancer - Carrier Status - Confidentiality - Consent - Counseling (general) - Duty to Warn - Family - Genetic Screening - Genetic Testing - Patient/Participant/Individual - Professional - Right not to Know
Biotechnology Industry Organization (BIO): Comments on draft report of Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) - Public Consultation Draft Report on Gene Patents and Licensing Pratices and Their Impact on Patient Access to Genetics Tests
Washington - May 15, 2009
Link: URL
Key Words: DNA - Genetic Testing - Intellectual Property - Patents
France/Government: Proposition de loi relative au prélèvement et à la conservation des cellules souches issues du sang de cordon ombilical
Paris - September 29, 2009
Link: URL
Key Words: Biobank - Consent - Donor - Minor/Child - Professional - Stem Cell - Storage - Umbilical Cord Blood - Woman/Maternity
Human Fertilisation and Embryology Authority (HFEA): HFEA Code of Practice (8th edition)
London - October 1, 2009
Link: URL
Key Words: Access Info/Material - Adult - Biobank - Carrier Status - Compensation for Participation - Confidentiality - Consent - Counseling (general) - Counseling (Pre-test) - Deceased - Dignity - Disability - Discrimination - Donor - Education - Embryo - Embryos (created for research) - Equity - Gamete - Genetic Information - Genetic Screening - Genetic Services - Genetic Testing - Governance - Incompetent Adult - Man/Paternity - Minor/Child - Patient/Participant/Individual - Pre-implantation - Preconception - Prenatal - Privacy - Professional - Research - Researcher - Respect for Human Life - Right of Withdrawal - Stem Cell - Storage - Surplus Embryos - Third Party - Tissue - Umbilical Cord Blood - Woman/Maternity
Human Tissue Authority: Code of practice 1 - Consent
London - September 1, 2009
Link: URL
Key Words: Adult - Biobank - Communication of Results - Consent - Data - Deceased - DNA - Donor - Ethical Review - Ethics Review Board - Family - Foetus - Incompetent Adult - Minor/Child - Patient/Participant/Individual - Professional - Public Health - Research - Researcher - Right not to Know - Right of Withdrawal - Storage - Tissue - Umbilical Cord Blood - Woman/Maternity
Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS): Revised Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests
Bethesda - February 5, 2010
Link: URL
Key Words: Commercialization - DNA - Genetic Testing - Intellectual Property - Patents
The Danish Council of Ethics (Det Etiske Râd): The Future of Prenatal Diagnosis (Report Summary)
Copenhagen - November 1, 2009
Link: URL
Key Words: Access Info/Material - Autonomy - Disability - Eugenics - Foetus - Genetic Testing - Governance - Man/Paternity - Prenatal - Professional - Woman/Maternity
United Kingdom / Government: Government response to the House of Lords Science and Technology Committee Inquiry into Genomic Medicine
London - December 14, 2009
Link: URL
Key Words: Benefit Sharing - Consultation/Collaboration - Consumer - Counseling (general) - Counseling (Post-test) - Counseling (Pre-test) - Data - Genetic Testing - Insurer/Insurance - Patient/Participant/Individual - Pharmacogenomics - Privacy - Socio-Economic Aspects
SPANISH PORTAL

Argentina/Gobierno: Recomendaciones de la Comisión Asesora en Terapias Celulares y Medicina Regenerativa
Buenos Aires - Marzo 1, 2009
Link: URL
Key Words: Células Madre (Troncales) - Comercialización - Compensación por Participación - Cordón Umbilical - Estándar de Cuidado - Gobernabilidad - Investigación - Investigador - Paciente/Participante/Individuo - Profesional
Ministerio de Ciencia, Tecnología e Innovación Productiva, Presidencia de la Nación: Clave para el Debate sobre Células Madre
Buenos Aires - Septiembre 15, 2009
Link: URL
Key Words: Células Madre (Troncales) - Comercialización - Compensación por Participación - Consentimiento - Cordón Umbilical - Dignidad - Donador - Embriones - Embriones supernumerarios - Estándar de Cuidado - Gobernabilidad - Investigación - Investigador - Paciente/Participante/Individuo - Revisión Ética - Tejido


International Conference on the theme: "Between Wisdom and Ignorance - The Impact of the New Technologies on our Understanding of What it is to be Human"
Organized by: Chaire La philosophie dans le monde actuel - Laval University
Date: April 9-10, 2010
Location: Quebec, (Quebec), Canada
Information: http://www.nouvelles-technologies-2010.ulaval.ca/en/index.html

Canadian Human Genetics Conference
Organized by: Canadian Institute of Health Research (CIHR), Canadian Gene Cure Foundation
Date: April 18-21, 2010
Location: Saint-Sauveur, (Quebec), Canada
Information: http://www.genecure.ca/en/programs/canadian-human-genetics-conference/about-the-event/

P3G Annual Meeting
Organized by: Public Population Project in Genomics
Date: April 26-27, 2010
Location: Montreal, Quebec, Canada
Information: http://www.p3g.org/secretariat/ueventsMontreal10.shtml/

Implementation and Integration
Organized by: The Human Variome Project
Date: May 10-14, 2010
Location: Paris, France
Information: http://www.humanvariomeproject.org/meetings/paris/

Biobanques et consentement: les enjeux légaux et éthiques à considérer selon les spécificités des participants
Organized by: CGP
Date: May 10, 2010
Location: Montreal, Quebec, Canada
Information: http://www.acfas.net/programme/c_78_17.html

The Biology of Genomes
Organized by: Cold Spring Harbor Laboratory
Date: May 11-15, 2010
Location: Cold Spring Harbor (NY), United States
Information: http://meetings.cshl.edu/meetings/genome10.shtml

Consortium Meeting
Organized by: ENGAGE
Date: May 31-June 1, 2010
Location: Helsinki, Finland
Information: http://www.euengage.org/events.html

European Human Genetics Conference 2010
Organized by: European Society of Human Genetics
Date: June 12-15, 2010
Location: Gothenburg, Sweden
Information: https://www.eshg.org/eshg2010.0.html

Summer Institute - Genetics, Ethics and Clinical Translation
Organized by: ENGAGE and P3G
Date: June 22-25, 2010
Location: Egmond aan Zee, Netherland
Information: http://www.euengage.org/Summer_Institute_2010.html


Avard D., Harmsen E., "Informed Consent and Multiplex Genetic Screening", Encyclopedia of Life Sciences (Chichester: John Wiley & Sons, Ltd., 2010)
Abstract: Recent advances in genome-wide genotyping together with new technologies provide unprecedented opportunities for multiplex screening. These advances provide insight into diseases, hold promises to improve clinical practices to address lifestyle changes, inform reproductive decisions, identify newborns at risk as well as possibly move genetic screening out of the realm of the clinics into direct-to-consumer market forces. Advances in multiplex genetic screening raise ethical issues with regard to consent. Some of the concerns that may arise include how to: manage the incidental and excess information; integrate information about susceptibility testing into the clinic, given the complexity of the information; address the psychosocial impact and educate health professionals about the meaning of the results. If multiplex screening is used in genomic research and made available in the clinic, each ethical issue deserves consideration in the consent process and should be discussed.

Bédard K., Wallace S., Lazor S., Knoppers B.M., "Potential Conflicts in Governance Mechanisms used in Population Biobanks", in Kaye J. & Stranger M. (eds.) Principles and Practice in Biobank Governance (United Kingdom: Ashgate, 2009)
Abstract: [None Available]

Bombard Y., Miller F.A., Hayeems R.Z., Avard D., Knoppers B.M., "Reconsidering reproductive benefit through newborn screening: a systematic review of guidelines on preconception, prenatal and newborn screening", (2010) 18:7 European Journal of Human Genetics, 751
Abstract: The expansion of newborn screening (NBS) has been accompanied by debate about what benefits should be achieved and the role of parental discretion in their pursuit. The opportunity to inform parents of reproductive risks is among the most valued additional benefits gained through NBS, and assumes prominence where the primary goal of identifying a treatable condition is not assured. We reviewed 53 unique guidelines addressing prenatal, preconception and newborn screening to examine: (1) how generating reproductive risk information is construed as a benefit of screening; and (2) what conditions support the realization of this benefit. Most preconception and prenatal guidelines – where generating reproductive risk information is described as a primary benefit – required that individuals be given a ‘cascade of choices’, ensuring that each step in the decision-making process was well informed, from deciding to pursue information about reproductive risks to deciding how to manage them. With the exception of three guidelines, NBS policy infrequently attended to the potential for reproductive benefits; further, most guidelines that acknowledged such benefits construed voluntarism narrowly, without attention to the choices attendant on receiving reproductive risk information. This review suggests that prenatal and preconception guidance identifies a coherent framework to support the pursuit of reproductive benefits through population screening programmes. Interestingly, attention to reproductive benefits is increasing among NBS guidance, yet reflection on how such benefits ought to be pursued remains limited. Traditional norms for NBS may require reconsideration where the remit of screening exceeds the primary goal of clinical benefits for infants.

Bordet S., Bennett J., Knoppers B.M., McNagny K.M., "The changing landscape of human-animal chimera research: A Canadian regulatory perspective", (2010) 4 Stem Cell Research, 10, online: URL
Abstract: [None Available]

Isasi R.M., Knoppers B.M., "Towards Commonality? Policy Approaches to Human Embryonic Stem Cell Research in Europe", in Plomer A. & Torremans P. (eds.) Embryonic Stem Cell Patents: European Law and Ethics (London: Oxford University Press, 2009)
Abstract: [None Available]

Kirby E., Lévesque E., Avard D., "MIREC’s Biobank - Ethical Considerations", (2009) 5 MIREC Newsletter, 10
Abstract: [None available]

Knoppers B.M., "Genetics: From Fate to Fortune-Telling", (Fall 2009) WOA Alumni Magazine, 15, online: URL
Abstract: The word 'genetics' conjures up Mendel's peas, the film Jurassic Park or Gattaca, and today, a mail-order Internet "know your genes" service. Whether it is the importance placed on one's biological origins and family tree, or DNA tests that free wrongly convicted persons, genetics is slowly integrating into our lives, not only our imaginations.


• PHG Foundation – Monthly News : http://www.phgfoundation.org/pages/update.htm
• CDC Office of Public Health Genomics - Genomics & Health Weekly Update:
    http://www.cdc.gov/genomics/update/current.htm


Editor-in-chief: Thu Minh Nguyen  |  Associate editor: Ma'n H. Zawati |  Contributing editors: HumGen Team   | Webmaster: Dan-Thanh Truong  | Director: Bartha Maria Knoppers  |  Research Director: Denise Avard


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