The Tri-Council Policy Statement 2 (TCPS 2) is an ethical framework that guides research involving humans in Canada. It is a requirement for researchers who receive funding from the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC).
TCPS 2 sets out ethical principles and guidelines for research involving human participants. It addresses issues such as informed consent, privacy, confidentiality, and the protection of vulnerable populations. Researchers who follow TCPS 2 are committed to conducting ethical research that respects the rights and dignity of human participants.
TCPS 2 is not only a requirement for researchers who receive funding from the three federal granting agencies. It is also a widely accepted ethical framework for research involving humans in Canada. Many universities and research institutions have adopted TCPS 2 as their own ethical guidelines for research.
Ethics Review
All research involving human participants must be reviewed and approved by a Research Ethics Board (REB). REBs are independent committees that assess the ethical implications of research proposals and make recommendations about whether the research should be approved.
REB review is an important part of the research process. It helps to ensure that research is conducted ethically and that the rights of human participants are protected.
Who Needs REB Approval?
All researchers who plan to conduct research involving human participants must submit their proposals to an REB for review and approval. This includes researchers who are funded by the three federal granting agencies, as well as researchers who are not funded by these agencies.
REB Composition
REBs are made up of a diverse group of individuals, including researchers, ethicists, and community members. This diversity helps to ensure that REBs have the expertise and experience to make informed decisions about the ethical implications of research proposals.
Informed Consent
Informed consent is a fundamental principle of ethical research involving humans. It means that participants must be fully informed about the risks and benefits of research before they agree to participate.
Researchers must provide participants with a clear and concise explanation of the research, including the purpose, procedures, and potential risks and benefits. Participants must also be given the opportunity to ask questions and to make a voluntary decision about whether or not to participate in the research.
Exceptions to Informed Consent
There are some exceptions to the requirement for informed consent. For example, informed consent may not be required if the research poses minimal risk to participants or if it is not feasible to obtain informed consent from participants.
Privacy and Confidentiality
Privacy and confidentiality are important ethical considerations in research involving humans. Researchers must protect the privacy of participants and ensure that their personal information is kept confidential.
Researchers must take steps to minimize the risk of privacy breaches, such as using secure data storage and limiting access to personal information. They must also obtain participants’ consent before using or disclosing their personal information.
Confidentiality Breaches
Confidentiality breaches can have serious consequences for participants, including damage to their reputation, social stigma, and even physical harm. Researchers must take all reasonable steps to prevent confidentiality breaches.
Protecting Vulnerable Populations
Vulnerable populations, such as children, the elderly, and people with disabilities, are at increased risk of exploitation and harm in research. Researchers must take special precautions to protect vulnerable populations from harm.
Researchers must assess the risks and benefits of research involving vulnerable populations and take steps to minimize the risks. They must also obtain informed consent from participants or their legally authorized representatives.
Additional Protections
In addition to the ethical principles and guidelines outlined in TCPS 2, there are a number of other laws and regulations that protect vulnerable populations in research. Researchers must be aware of these laws and regulations and comply with them.
FAQs
What is the Tri-Council Policy Statement 2 (TCPS 2)?
TCPS 2 is an ethical framework that guides research involving humans in Canada. It sets out ethical principles and guidelines for research involving human participants, such as informed consent, privacy, confidentiality, and the protection of vulnerable populations.
Who must follow TCPS 2?
Researchers who receive funding from the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC) must follow TCPS 2. Many universities and research institutions have also adopted TCPS 2 as their own ethical guidelines for research involving humans.
What is Research Ethics Board (REB) review?
REB review is an independent assessment of the ethical implications of research proposals. REBs make recommendations about whether research should be approved and provide guidance to researchers on how to conduct their research ethically.
What is informed consent?
Informed consent means that participants must be fully informed about the risks and benefits of research before they agree to participate. Researchers must provide participants with a clear and concise explanation of the research, including the purpose, procedures, and potential risks and benefits.
What are vulnerable populations?
Vulnerable populations are groups of people who are at increased risk of exploitation and harm in research. These groups include children, the elderly, and people with disabilities.
Conclusion
TCPS 2 is an important ethical framework that protects the rights and dignity of human research participants in Canada. Researchers who follow TCPS 2 are committed to conducting ethical research that is respectful of the participants’ privacy, confidentiality, and autonomy.
TCPS 2 is not only a requirement for researchers who receive funding from the three federal granting agencies, but it is also a widely accepted ethical framework for research involving humans in Canada. It is important for researchers to be aware of TCPS 2 and to comply with its ethical principles and guidelines.