Tri-Council Policy Statement 2010 Ethical Conduct for Research Involving Humans

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans The Research Ethics Framework: “Norms for the ethics of research involving human subjects are developed and refined within an ever-evolving societal context, elements of which include the need for research and the research community, moral imperatives and ethical principles, and the law.” From

The Guidelines Include Sections On: The Need for Research Overall Moral Imperative: Respect for Human Dignity Guiding Ethical Principles Using A Subject-Centred Perspective Academic Freedoms and Responsibilities Ethics and Law Putting Principles into Practice

Guiding Ethical Principles Respect for Human Dignity Respect for Free and Informed Consent Respect for Vulnerable Persons Respect for Privacy and Confidentiality Respect for Justice and Inclusiveness Balancing Harms and Benefits Minimizing Harm Maximizing Benefit

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)

The Guidelines Apply: Whether the research is funded or not; Whether the funding is internal or external; Whether the subjects are from inside or outside the institution; Whether the subjects are paid or unpaid; Whether the research is conducted inside or outside Canada; Whether the research is conducted inside or outside the institution; Whether the research is conducted by staff or by students; Whether the research is conducted in person or remotely (e.g., by mail, electronic mail, fax or telephone); Whether the information is collected directly from subjects or from existing records not in the public domain; Whether the research is to be published or not; Whether the focus of the research is the subject; Whether the research is observational, experimental, correlational or descriptive; Whether a similar project has been approved elsewhere or not; Whether the research is a pilot study or a fully developed project; Whether the research is to acquire basic or applied knowledge; Whether the research is primarily for teaching or training purposes or whether the primary purpose is the acquisition of knowledge.

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)

Ethics Framework and Core Principles “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

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

Fairness, Equity and Justice 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 “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 is 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

Ch. 7 Conflict of Interest 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 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 See Ch. 9 of policy for elaboration

Qualitative Research Qualitative research differs in its approach Involves inductive understanding, diversity of approaches, ongoing reflexivity, takes place in multiple, evolving contexts, involves partnerships with research participants Is a special case See Ch. 10 of policy for more detail