TCPS 2 (2014) Updates to guidance re: Privacy, Secondary Use of Data/Biological Materials and Alterations to Consent Requirements Laura-Lee Balkwill, Policy Analyst Wendy Burgess, Policy Analyst Susan Zimmerman, Executive Director CAREB - Vancouver April 2015

Agenda Evolution of TCPS 2 Consultation overview Updates to guidance Privacy Secondary use of data/biological materials Alterations to consent requirements Questions

Evolution of TCPS 2 Updates: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans created in 1998 by: Canadian Institutes of Health Research Natural Sciences and Engineering Research Council Social Sciences and Humanities Research Council Updates: December 2010: 2nd edition released December 2014: TCPS 2 (2014) released

Recent changes to TCPS 2 PRE is committed to ongoing Policy evolution Your interpretation requests and SRCR/PRE policy analysis led to revisions that: filled policy gaps clarified guidance and/or definitions addressed emerging issues Public consultation - Fall, 2013 to January, 2014 Comments reviewed, revisions drafted, vetted TCPS 2 (2014) released December 2014 http://pre.ethics.gc.ca/eng/resources-ressources/news-nouvelles/nr-cp/2014-12-18/

Privacy * Definitions are the same for human biological materials Identifiable information* Information is identifiable if it may reasonably be expected to identify an individual, when used alone or combined with other available information. Information is non-identifiable if it does not identify an individual, for all practical purposes, when used alone or combined with other available information. * Definitions are the same for human biological materials

Privacy Identifiability is an assessment that is made in the context of a specific research project. Example: a research project that relies solely on the secondary use of coded information: If the researcher has access to the code, the information is identifiable If the researcher does not have access to the code, the information is non-identifiable Consider aspects of the research that may make the information identifiable E.g., size of population, unique characteristics

Privacy * Definition is the same for human biological materials Anonymous information is information that has never had identifiers associated with it* For the purposes of TCPS 2, ‘non-identifiable’ is not the same as ‘anonymous’ Identifiability is an assessment made in the context of the research project Anonymous information is anonymous irrespective of the research project * Definition is the same for human biological materials

Why do we care? There is an exemption from REB review for the secondary use of anonymous information/human biological materials (Article 2.4). There is an exception to the general requirement to seek consent for the secondary use of non-identifiable information/human biological materials (Articles 5.5B, 12.3B).

research involves secondary use of information REB review not required REB review required Consent not required Consent may not be required if REB approves Consent required Information anonymous? non-identifiable? Research meet conditions of Art. 5.5A? Y N

Alterations to consent requirements Article 3.7 (2010) Criteria for REB approval: no more than minimal risk; unlikely to adversely affect welfare; it is impossible or impracticable to do the research with prior consent; participants will be debriefed if possible and appropriate; and the research does not involve a therapeutic intervention, or other clinical or diagnostic interventions Article 3.7A (2014): Criteria for REB approval: no more than minimal risk; unlikely to adversely affect welfare; it is impossible or impracticable to do the research with prior consent; the precise nature and extent of any proposed alteration is defined; and any debriefing plan shall be in accordance with Article 3.7B and may allow withdrawal of data and/or human biological materials

Alterations to consent requirements Rationale for removal of 3.7(e) Posed an unnecessary barrier to research based on methodology rather than on ethical issues The other criteria – including no more than minimal risk and unlikely to affect welfare – are sufficient to prevent the use of deception and/or lack of consent in higher risk research Consistent with other international guidance such as: The U.S. Common Rule Australian National Statement on Ethical Conduct in Human Research Council for International Organizations of Medical Sciences: International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS)

Alterations to consent requirements Article 3.7B (New): Criteria for REB approval: Debriefing must be part of all research involving an alteration to consent requirements (see Article 3.7A) whenever it is possible, practicable and appropriate; Participants in such research must have the opportunity to refuse consent and request the withdrawal of their data and/or human biological materials whenever possible, practicable and appropriate Debriefing is the default requirement

Alterations to consent requirements New glossary entries for: Possible/impossible: If an action can be done, regardless of the level of difficulty required to do it, it is possible. If an action cannot be done under any circumstances, it is impossible. Practicable/impracticable: If an action is possible and it is reasonable to expect it to be done, it is practicable. An action is possible but not practicable when it is unreasonably difficult to do, or, the action will jeopardize the ability of the researcher to address the research question.

Research Ethics Education Resources TCPS 2: Course on Research Ethics (CORE) Interpretation service Posted interpretations Webinars www.pre.ethics.gc.ca

Questions?

PANEL ON RESEARCH ETHICS Please get in touch PANEL ON RESEARCH ETHICS 350 Albert Street, Ottawa, ON K1A 1H5 613-996-0072 www.pre.ethics.gc.ca secretariat@rcr.ethics.gc.ca 16