Tri-Council Policy Statement 22010

Ethical Conduct for Research Involving Humans

The TCPS 2

• First version of TCPS released in 1998• Updates in 2000, 2002, 2005 and now

replaced by TCPS 2 (2010)• Changing ethical and social context• Three councils:

– CIHR Canadian Institutes of Health Research– NSERC Natural Sciences and Engineering

Research Council of Canada– SSHRC Social Sciences and Humanities

Research Council of Canada

Core Principles (Ch. 1)

• “Respect for human dignity requires that research involving humans be conducted in a manner that is sensitive to the inherent worth of all human beings and the respect and consideration that they are due.” (Ch. 1)

• Involves:– • Respect for Persons– • Concern for Welfare– • Justice

Scope of the Policy

• The policy applies to all…– “(a) research involving living human

participants;

– (b) research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.” (Article 2.1)

Exemptions

• “Research that relies exclusively on publicly available information does not require REB review when:– (a) the information is legally accessible to

the public and appropriately protected by law; or

– (b) the information is publicly accessible and there is no reasonable expectation of privacy.” (Article 2.2)

Observation in Public Places

• REB review not required when– (a) it does not involve any intervention

staged by the researcher, or direct interaction with the individuals or groups;

– (b) individuals or groups targeted for observation have no reasonable expectation of privacy; and

– (c) any dissemination of research results does not allow identification of specific individuals. (Article 2.3)

Secondary Analysis

• “REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information.” (Article 2.4)

Balancing Potential Benefits and Risks of Harm

• Researchers must seek a balance between the benefits…– “that positively affect the welfare of society as

a whole through the advancement of knowledge for future generations, for participants themselves or for other individuals”

• And the risk of harm…– “anything that has a negative effect on the

welfare of participants, and the nature of the harm may be social, behavioural, psychological, physical or economic.”

(Ch. 2 B)

Consent (Ch. 3)

• Related to “Respect for persons”• Documentation required• Consent = “free, informed and ongoing

consent”– “(a) Consent shall be given voluntarily.– (b) Consent can be withdrawn at any time.– (c) If a participant withdraws consent, the

participant can also request the withdrawal of their data or human biological materials.” (Article 3.1)

Issues related to Consent• Must be voluntary and informed

(disclosure of potential risks and benefits)

• No undue influence or coercion

• If incentives are used should not be overly large

• The burden is on the researcher to ensure that participants understand fully

• Incidental findings must be disclosed

• Debriefing may be needed

• Medical emergencies

Justice (Ch. 4)

• Justice = “Fairness and equity in research participation” (Ch. 4)

• Exclusion by gender, age, ethnicity, language, disability, sexual orientation etc. may compromise equity

Privacy and Confidentiality (Ch. 5)• “Privacy refers to an individual’s right to be

free from intrusion or interference by others. It is a fundamental right in a free and democratic society.”

• “confidentiality refers to the obligation of an individual or organization to safeguard entrusted information.”

• Related issues: security = “measures used to protect information” and identifiability of individuals (Ch. 5 A)

Research Ethics Boards (REBs)

• Every institution responsible for setting up an independent REB appropriate to the range of research done at that institution

• At least 5 members– Both male and female– 2 with expertise in area– 1 ethics expert– 1 law expert– 1 unaffiliated community member

Conflict of Interest (Ch. 7)

• Conflict of interest may involve

• The institution

• REB members

• The researcher (i.e. dual role, interpersonal, financial or other affiliations)

First Nations, Inuit, and Metis Peoples (Ch. 9)

• Much research in this area has been carried out by non-aboriginals

• Must respect history, culture and tradition• Safeguard against imbalance of power• May require different interpretation of

ethical principles• Read this chapter carefully if doing

research in this area!

Qualitative Research (Ch. 10)

• READ CHAPTER 10 THOROUGHLY BEFORE STARTING YOUR PROJECT!!

• Qualitative research is a special case– Involves inductive understanding, diversity of

approaches, ongoing reflexivity, takes place in multiple, evolving contexts, involves partnerships with research participants

• Qualitative approaches are “inherently dynamic” and “grounded in different assumptions” than quantitative research

Aspects Of Qualitative Research(from Introduction to Ch. 10)

• Inductive understanding• Diversity of approaches• Dynamic and continuous process• Multiple and evolving contexts• Limited sample sizes• Diversity of research aims/goals• Negotiated and ongoing consent• Collaborative process• Limited generalizability of results

Research Ethics Board Review• Overall, qualitative subject to same general

guidelines as quantitative (above)– i.e. consent, confidentiality, privacy

• No REB required for exploratory phase (unless pilot study undertaken – Article 6.11)

• But also special ethical issues involved– Related to gaining access, building rapport etc.– May not be able to identify during design phase– Preliminary and exploratory activities like note-taking,

passive observation or diary writing common and do not require REB consent

– Review and consent becomes necessary later when relationships are established or need for privacy/confidentiality is identified (Article 10.1)

Consent in Qualitative Research (Article 10.2)

• Same general guidelines for consent as in Ch. 3• But in qualitative, signed written consent not

always feasible• Attempts to obtain consent, whether written or

oral should be documented via field notes, etc. or completed questionnaires

• Participants in positions of power or who regularly interact with the public can be assumed to have signified consent by virtue of having agreed to speak to researcher– Should also be documented

Observational Studies (10.2)• Non-participant (naturalistic) studies

– Need to be careful– If observation in public space where participants

have expectation of privacy, then REB review and consent may become necessary

• Participant (ethnographic) studies– Covert may not require consent

• Natural or virtual environments vary in expectations of privacy

• Observational studies in public places where no expectation of privacy are exempt

Privacy (Article 10.3)• Breach of privacy may arise from identification of

individuals, groups or communities when research is published or disseminated

• But if no identification of individuals made, then is regarded as minimal risk

• If consent is not sought, researcher must demonstrate to REB that precautions to protect privacy and confidentiality taken

• You may not violate the privacy of individuals who had a reasonable expectation of privacy or confidentiality when acting or interacting

• Consent not needed when personal or identifying information is not collected

Other Issues

• Dissemination of results (Article 10.4)– Need permission to identify participant– Need to respect participant’s contribution i.e.

oral histories

• Waiver of anonymity must not compromise other individuals involved in the research

• Emergent research designs (Article 10.5)– Provide all possible info to REB and consult

regularly as design evolves

Ch. 11 – 13 of TCPS2

• These chapters relevant for research in health, medical and biological sciences

• Cover:– Clinical trials– Human biological materials– Human genetic research

TCPS 2: CORE — Tutorial

• The TCPS 2: CORE (Course on Research Ethics) is an online tutorial with an overview and introduction to the TCPS 2.

• Has 8 modules with quizzes, progress reports and a certificate of completion at the end.

• Please click this link to register and access the CORE tutorial

• Please review also: – Brescia University Policy– Queen’s University Digital Data Policy

Queen’s Digital Data Policy, 2012

• One relevant criterion that determines whether naturalistic observation research needs ethics review is whether or not the people being observed are seeking to be observed. Similarly, when a user posts material on a site widely known to be viewable by the general public this may be taken as evidence that this user expects their material to have public visibility. In contrast, when a user posts material in a members-only chat room or discussion venue, or to a forum that is focused on a small sub-set of the population, this is to be taken as evidence that users do not anticipate that their material will be viewed by people outside this “community”.

Eight Criteria for Exemption(source: Queen’s Digital Data Policy)

• Criterion #1. The researcher can freely see the information online without having to register as a member of the discussion venue (e.g. chat room, discussion forum, listserv, etc.)

• Criterion #2. The discussion venue has no policy prohibiting research, or the reproduction, redistribution, and/or reprinting of its content.

Criteria (cont.)• Criterion #3. The owner/moderator of the

discussion venue does not indicate in any way that messages posted on the site are private, confidential, or meant to be viewed only by people matching the characteristics of a particular interest group.

Criteria (cont.)

• Criterion #4. The researcher will not be engaging in any deception of the users, such as ‘posing’ as a member of a group or suddenly becoming a regular contributor to the discussion venue. Similarly, the researcher, or anyone working on behalf of the researcher, was not already a member of the discussion venue for their own interest and is now making use of their membership for research purposes.

Criteria (cont.)• Criterion #5. The researcher will not

directly contact any human sources of digital content.

• Criterion #6. Websites that are frequented by minors (persons under the age of 18) must not be part of the research project. Similarly, digital communication in any form that can be identified as being from a minor must not be included in the data collection.

Criteria (cont.)

• Criterion #7. The research plan must indicate that the identities of users (including nicknames and pseudonyms) will be disguised in any presentations or publications of the research works.

• Criterion #8. The research plan must indicate that verbatim quotes will not be used in any presentations or publications. Paraphrasing and coded categorization of content are acceptable.