According to the stated ethical principles associated with the fields of biological and medical research, people can participate in the study only after providing their consent. Moreover, the consent should be informed. Thus, informed consent from participants in the ethical requirement for conducting the necessary research (Basic ethical principles, 2012). The critical principles connected with the concept of consent are provided in The Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. The main idea of the articles in which the issue of consent is discussed is to state the importance of the person’s autonomy and free will while deciding to participate or not in research. The participant’s consent is obligatory for starting the study and developing the project. Thus, the ethical principles provided in the definite articles of The Canadian Tri-Council Policy Statement concerning the issue of the participants’ consent can be discussed as the moral protection for persons against the inappropriate usage of the personal data of any kind during the research.
The necessity to state the ethical principles on the participants’ consent is based on a lot of examples of manipulating the personal data or involving persons in the research without their will. From a philosophical perspective, any person has the right to decide about his or her actions. Moreover, this decision should not be imposed or affected by the other persons. Thus, respect for the person and human dignities are the central ethical and philosophical notions with references to which the question of the consent can be discussed (Brownell & Brownell, 2002). However, focusing on the issue from the historical perspective, it is possible to state that these ethical principles are often violated. It is essential to refer to the example of the Tuskegee experiment conducted in the USA and to many publications in the US academic journals related to 1952-1965 which presented the results of the studies the participants of which did not know about their participation and the life-threatening harm of the experiments (Research ethics boards, 2004). As a result, Canada presented the first strategies and approached to control the research ethics in 1978 as a reaction to the problematic situation regarding the medical ethics over the world (Research ethics boards, 2004). The next attempts to contribute to the current regulations developed and improved the ethical principles adopted in Canada, and the main focus was made on the question of consent because of the necessity to protect the participant (CMA: Code of Ethics, 1996). That is why the development of strict and precise ethical principles regarding the participants’ consent can be discussed as an effective measure to overcome further ethical issues.
The articles on the consent process presented in The Canadian Tri-Council Policy Statement can be discussed as ethical because they depend on fundamental human rights and moral norms. Article 3.1 states the free will and autonomy of the person in the process of providing consent. Thus, “consent shall be given voluntarily” and “consent can be withdrawn at any time” (The Canadian Tri-Council Policy Statement, 2010, p. 28). Human dignity and respect for the person are met concerning the provided formulations. The concentration on the voluntary nature of the decision helps prevent the cases when people are influenced by the researchers or other persons to participate in the research (CIHR best practices, 2005). Thus, the undue manipulation and possible coercion can be avoided with references to Article 3.1 of the Statement. This idea is also correlated with the principles of starting the project reflected in Article 3.5.
The decision of the person should be based on the analysis of all the risks and threats. That is why the complete information on the aspects of the research should be provided for the participant, as it is stated in Article 3.2. However, this article refers to the controversial issue of authorized third parties. The problem is in the fact the authority of third parties is still one of the most discussed ethical questions concerning the medical research (Beauchamp, 2001; Fisher, 2009; Truscott & Crook, 2004). The principle of informed consent is closely associated with the idea of the informed decision. It is stated in Article 3.3 that “researchers have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research” (The Canadian Tri-Council Policy Statement, 2010, p. 33). Thus, the research is the ongoing process, and the participant has the right to know the aspects of the study and findings without references to the research stage. These principles help participants stop their participation in the research if they feel any risks and consider the process as harmful for them (Baylis, 2011). Article 3.3 and Article 3.4 add to the participants’ right to be aware of the research process and its details, which are significant for them.
Although there are controversies in the discussion of the role of the authorized third parties in the process, the articles can be discussed as ethical because they respond to the main ethical principles adopted in the medical research practice. Humans’ rights, values, and wishes are reflected in the formulations of the articles from The Canadian Tri-Council Policy Statement on the aspects of the consent process.
References
Basic ethical principles. (2012). Web.
Baylis, F. (2011). Health care ethics in Canada. Canada: Cengage Learning.
Beauchamp, T. (2001). Principles of biomedical ethics. Canada: Oxford University Press.
Brownell, A., & Brownell, E. (2002). The Canadian Medical Association Code of Ethics 1868 to 1996: A primer for medical educators. Annals, 35(4), 240-243.
CIHR best practices for protecting privacy in health research. (2005). Web.
CMA: Code of Ethics. (1996). Web.
Fisher, J. (2009). Biomedical ethics: A Canadian focus. Canada: Oxford University Press.
Research ethics boards: A historical background. (2004). Web.
The Canadian Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (TCPS). (2010). Web.
Truscott, D., & Crook, K. (2004). Ethics for the practice of psychology in Canada. Canada: University of Alberta.