The Tri-Council Policy Statement 2 (TCPS 2) is a set of ethical guidelines for research involving humans in Canada. It is intended to protect the rights and welfare of research participants and to ensure that research is conducted in a responsible and ethical manner. All researchers who conduct research involving humans in Canada must follow the TCPS 2.
The TCPS 2 applies to all research involving humans, regardless of the funding source or the institution where the research is conducted. It also applies to research conducted by students, regardless of their level of education. Researchers who are not sure whether their research falls under the TCPS 2 should consult with their institution’s research ethics board.
The TCPS 2 is a living document that is updated regularly to reflect changes in the research landscape. The most recent version of the TCPS 2 was released in 2018. Researchers should be familiar with the latest version of the TCPS 2 and ensure that their research is compliant with the guidelines.
When Does TCPS 2 Apply?
The TCPS 2 applies to all research involving humans in Canada, regardless of the funding source or the institution where the research is conducted. This includes research conducted by students, regardless of their level of education.
Research Involving Humans
The TCPS 2 defines research involving humans as any research that involves the collection, use, or disclosure of personal information about individuals. This includes research that involves:
- Surveys or questionnaires
- Interviews
- Focus groups
- Observational studies
- Clinical trials
- Genetic studies
Excluded Research
The TCPS 2 does not apply to research that does not involve humans. This includes research that involves:
- Animals
- Plants
- Inanimate objects
- Data that has been anonymized or de-identified
Who Must Follow TCPS 2?
All researchers who conduct research involving humans in Canada must follow the TCPS 2. This includes researchers who are:
- Faculty members
- Staff members
- Postdoctoral fellows
- Graduate students
- Undergraduate students
- Research assistants
- Respect for persons
- Concern for welfare
- Justice
- Obtaining informed consent from participants
- Protecting the privacy and confidentiality of participants
- Minimizing the risks of harm to participants
- Providing participants with support if they experience any adverse effects from the research
- Ensuring that the benefits and burdens of research are fairly distributed
- Reviewing and approving research proposals
- Monitoring ongoing research
- Providing advice to researchers on ethical issues
- Investigating complaints about research misconduct
Researchers who are not sure whether their research falls under the TCPS 2 should consult with their institution’s research ethics board.
Institutional Responsibility
Institutions that conduct research involving humans are responsible for ensuring that their researchers comply with the TCPS 2. This includes providing researchers with training on the TCPS 2 and establishing procedures for reviewing and approving research involving humans.
TCPS 2 Core Principles
The TCPS 2 is based on three core principles:
Respect for Persons
Respect for persons means that researchers must treat research participants with dignity and autonomy. This includes obtaining informed consent from participants before conducting research and respecting their right to withdraw from the research at any time.
Concern for Welfare
Concern for welfare means that researchers must take steps to protect the safety and well-being of research participants. This includes minimizing the risks of harm to participants and providing them with support if they experience any adverse effects from the research.
Justice
Justice means that the benefits and burdens of research should be fairly distributed. This includes ensuring that research participants are not exploited and that the results of research are shared equitably.
TCPS 2 Ethical Obligations
The TCPS 2 outlines a number of ethical obligations that researchers must follow when conducting research involving humans. These obligations include:
Researchers who fail to comply with these ethical obligations may be subject to disciplinary action from their institution or from the Tri-Council agencies.
TCPS 2 Review Process
All research involving humans in Canada must be reviewed and approved by a research ethics board (REB) before it can begin. REBs are independent committees that are responsible for ensuring that research is conducted in a responsible and ethical manner.
REB Responsibilities
REBs have a number of responsibilities, including:
REB Membership
REBs are typically composed of a mix of researchers, ethicists, and members of the public. This ensures that REBs have a broad range of perspectives on ethical issues.
FAQ
What is the TCPS 2?
The TCPS 2 is a set of ethical guidelines for research involving humans in Canada. It is intended to protect the rights and welfare of research participants and to ensure that research is conducted in a responsible and ethical manner.
Who must follow the TCPS 2?
All researchers who conduct research involving humans in Canada must follow the TCPS 2. This includes researchers who are faculty members, staff members, postdoctoral fellows, graduate students, undergraduate students, and research assistants.
What are the core principles of the TCPS 2?
The TCPS 2 is based on three core principles: respect for persons, concern for welfare, and justice.
What are some of the ethical obligations that researchers must follow when conducting research involving humans?
Researchers must obtain informed consent from participants, protect the privacy and confidentiality of participants, minimize the risks of harm to participants, and provide participants with support if they experience any adverse effects from the research.
What is the role of research ethics boards (REBs) in the TCPS 2 review process?
REBs are independent committees that review and approve research proposals to ensure that research is conducted in a responsible and ethical manner.
Conclusion
The TCPS 2 is an important set of ethical guidelines that all researchers who conduct research involving humans in Canada must follow. The TCPS 2 is based on the core principles of respect for persons, concern for welfare, and justice. It outlines a number of ethical obligations that researchers must follow, including obtaining informed consent from participants, protecting the privacy and confidentiality of participants, minimizing the risks of harm to participants, and providing participants with support if they experience any adverse effects from the research.