Highlights of Minutes - March 11, 2010
Advisory Committee on Ethical, Legal and Social Issues (ELSI) for the Canadian Longitudinal Study on Aging (CLSA)
Fifth Meeting
CIHR Boardroom, 9th Floor, 160 Elgin Street, Ottawa ON
9:30 a.m. – 4:00 p.m. EST, Thursday March 11, 2010
Highlights Of Minutes
NOTE: Committee members participate in their personal capacity and work collectively to achieve committee goals rather than act as representatives of any group or interest.
Members:
Patricia Kosseim, Genome Canada (Co-Chair)
Daryl Pullman, Memorial University of Newfoundland (Co-Chair)
Mylène Deschênes, Public Population Project in Genomics Canada
Khaled El Emam, CHEO Research Institute
Debra Grant, Information and Privacy Commissioner of Ontario
Kieran O'Doherty, University of British Columbia
Norman O'Donnell, Community Member
Nola Ries, University of Alberta (Teleconference, p.m. only)
Jill Scott, LLB, LLM, Barrister & Solicitor (Teleconference)
Don Willison, Ontario Agency of Health Protection and Promotion
Ex officio members:
Kristiann Allen, CIHR Ethics Office
Linda Mealing, CIHR, CLSA
Christina Wolfson, CLSA Co-Principal Investigator, McGill University
Regrets:
Carman Baggaley, Office of the Privacy Commissioner of Canada
Trudo Lemmens, University of Toronto
Guests:
Paddi O'Hara, O'Hara Consulting, CIHR
Jennifer Uniat, Senior Research Associate, CLSA
SUMMARY: The primary purpose of this meeting was to provide advice regarding the Draft Privacy Policy. It was also an opportunity to obtain clarification from the CLSA on issues that would inform the work of this Committee.
Community member
1. The Committee welcomed Norman O'Donnell as a community member and thanked him for his willingness to participate.
Update on Participation in NCEHR Conference
2. CLSA Clarification on Key Questions2. On February 19, 2010 the CLSA and the Canadian Partnership for Tomorrow Project (CPTP) participated in a joint ethics panel at the National Council on Ethics in Human Research (NCEHR) annual conference. Topics of discussion included: 1) ELSI structure and governance in the context of each study; 2) Processes for communicating with research ethics boards (REBs) and coordinating REB review; 3) Reporting back of results and involvement of physicians, if any; 4) Plans for disseminating the work of the ELSI Committees (including publications) for the benefit of the broader research community; and, 5) Governance of research platforms as distinguished from specific research studies. The session was well received by the audience and there are plans to hold a second joint session at the CAREB annual conference in April 2010 where the focus will be on specific ELS issues such as consent, incapacity and incidental findings.
Conflict of interest disclosure
3. There were no conflicts reported.
Publications disclosure
4. There are plans to collaborate on a paper for the Journal of Academic Ethics based on the joint panel at the NCEHR 2010 conference. In addition, the ELSI committee will consider submission of a paper on some aspect of aging to the Canadian Journal on Aging Suggestions for topics were discussed, including the governance structure of the study.
CLSA Clarification on Key Questions
Clarification on Key Questions5. At the last meeting (February 19, 2010), the Committee identified several ELSI questions to pose to CLSA Principal Investigators that would inform their work and service on the Committee. These questions were fully discussed as follows:
i. What is the process of de-identification and managing access to de-identified data and re-identification codes? The Committee was informed that the guardian of any directly identifying information is the National Coordinating Centre (NCC) at McMaster University in Hamilton. The NCC will be responsible for removing names and contact information. The plan is to make information available to those researchers given approval by the Data Access Committee (DAC) in keeping with the terms of the consent given. The DAC will ensure that there is REB approval for each protocol and conduct a scientific review if one has not been conducted. The Committee suggested that it might be beneficial to require security audits from researchers who want access to the data.
ii. Can the governance structure vis-à-vis the CLSA Data Access Committee and other bodies attached to the study be clarified? The Committee discussed the need for clarification on who handles complaints and who has ultimate responsibility for the CLSA. Also, the committee identified a need to clarify the ways in which the project is both a platform and a study, since these could each have different authority structures. The Committee suggested that dedicated CLSA personnel be made responsible for checking that the data sets requested by researchers include only the minimal amount of potentially identifying information before it is released to researchers in accordance with an appropriate access request process.
iii. What happens to the data of participants who lose capacity or die during the course of the study? The Committee was informed that participants are asked for "contacts" (e.g., in the event that participants move, the contact may be able to connect them with the CLSA again).The Committee suggested that participants be asked, up front, for a potential proxy should they lose the capacity to provide ongoing consent. In most provinces there is legislation to describe the "Substitute Decision Maker" hierarchy but specific documentation is needed for the CLSA.
iv. What are the plans for ongoing involvement in governance structure of research participants in the study? The Committee was informed that the CLSA has discussed the possibility of a Community Liaison committee.
Draft privacy policy
6. The Committee had a detailed discussion on each of the principles and specific sections of the Privacy Policy. Consensus was reached on essential points and they will be transformed into formal written advice. Committee recommendations included that:
i .A Chief Privacy Officer be hired to support the personal information management practices of the CLSA and to address any compliance issues that may arise in the course of the study;
ii. A Privacy Impact Assessment be conducted on the overall structure of the CLSA and that it be periodically updated in accordance with evolving standards and practices;
iii. The nature of the CLSA as both a research platform and specific research studies on healthy aging be clarified and that the Privacy Policy be generally adapted to reflect both these aspects of the CLSA;
iv. The terms and conditions of access to CLSA, including a description of eligible user groups, be clarified as these will significantly affect various key principles in this Privacy Policy;
v. The definitions section be reviewed in tandem with all revisions of the Privacy Policy to consistency and avoid overlap; and,
vi. More specific standard operating procedures and best practices on various key aspects of the Privacy Policy be detailed in separate documents and integrated by reference.