Research ethics are principles that guide the research process. These principles are means of making sure that vulnerable persons acquire protection from exploitation and other types of harm. In Canada, research ethics are contained in Articles 3.1 – 3.5 of Tri-Council Policy Statement (TCPS).
Historical and philosophical concept behind Articles 3.1 – 3.5 of TCPS
The history of informed consent goes back to the 1930’s when American courts upheld the significance of knowledgeable assent in research. This was a result of the outrage at the brutality of Nazi experiments with human beings (Schuklenk, 2005). Later, in 1966, Henry Beecher a chief philosopher in the area of research ethics published an article in which he quoted 22 incidences of unethical actions in research. Among the incidences was a study whereby a doctor in Brooklyn inserted live cancer cells into dementia patients devoid of their consent. Beecher, through his work, tried to show that conducting research without participants consent is abusive. Nevertheless, abuse continued and 6 years later, the Tuskegee syphilis experiment came into exposure (Schuklenk, 2005). This experiment used human beings suffering from syphilis in a study, whereby the patients remained under observation rather than being treated. Eventually, many of them died and others transmitted the disease to their families. This led to creation of research ethics that would enhance respect for human beings and justice.
Article 3.1
This article guarantees consideration of willingness to take part in a research before recruitment. Article 3.1 is ethical because it recognizes a person’s right to make choices depending on personal beliefs and values. As such, the article protects the rights of a person to take part in a research process willingly and prevents a person from taking part in a research unwillingly. Thus, this article instills authority to research participants through allowing them to accept or decline an offer to participate in research. Therefore, Article 3.1 conforms to the principle of autonomy.
Article 3.2
This article requires researchers to give potential respondents research information as specified by Research Board of Ethics (RBE). The information given should guide the potential participant in deciding whether to consent, or decline to participate. Article 3.2 is ethical because it recognizes a person’s right to take actions depending on personal beliefs and values. As such, this article gives participants power to make autonomous decisions upon getting substantial understanding of the research activities. The article also prevents research respondents from participating in actions that do not correspond to their values and beliefs. However, the autonomy of the respondent may lack consideration in some situations. For instance, in the health-care setting, a nurse can progress without consent if there is enough evidence to show that disclosure will make a patient incompetent to reject, or consent to treatment. Such an action corresponds to the principle beneficence, as the nurse will progress for the benefit of the patient. Therefore, Article 3.2 conforms to both the principle of autonomy and beneficence.
Article 3.3
This article upholds that research is a continuous process that is prone to change, and in the same way, consent should be continuous. Thus, the article calls for the researcher to notify participants of any evolving roles and confirm from them whether they still consent. Article 3.3 is ethical because it acknowledges a person’s right to make choices depending on his or her values. In the course of research, roles of participants may change depending on research objectives. For instance, in a study aimed at evaluating illnesses associated with HIVAIDs, a need to analyze the contents in their sputum may arise. Upon this realization, researchers should notify participants that they would have to produce sputum for assessment. If there is a participant who feels that this contradicts to her societal norms, or personal beliefs, then he or she may choose not to participate in this area. Thus, Article 3.3 protects participants against participation when new rules do not conform to their values and beliefs. Therefore, Article 3.3 conforms to the principle of autonomy.
Article 3.4
This article calls for researchers to inform participants of any incidental findings. The article also provides clear rules to follow when there are incidental findings. Failure to inform participants of any incidental findings would deny participants their rights to full disclosure. However, such disclosure should not cause harm to participants. Thus, this article is ethical because it supports full disclosure, which recognizes a person’s right to take actions depending on personal beliefs and values. On the other hand, this article is unethical because it does not provide for incidental findings that may cause harm to participants. According to the principle of nonmaleficence, a researcher should not inflict harm intentionally. Therefore, Article 3.4 conforms to the principle of autonomy but defies the principle of nonmaleficence.
Article 3.5
This article stipulates that research shall begin only after the participants, or their authorized third parties, have provided their consent. The article recognizes that some people cannot make competent decisions and thus, need third parties. Therefore, this article is ethical because it treats all persons equitably. As such, the article ensures acquisition of informed consent for person who cannot make sound through authorized third parties. This prevents incapacitated people from taking part in a research unwillingly. Therefore, Article 3.5 conforms to the principle of justice.
Reference
Schuklenk, U. (2005). Module one: Introduction to research ethics. Developing World Bioethics, 5(1), 1471-8731.