Research is only valuable if all parties have a thorough understanding of what the study entails, even in blind or double blind studies. The participants cannot provide valid responses if they are not aware of what is happening to the in the study. Whether a medical, psychological, social, or other form of study, having information about the purpose, intent, and tools used with the participant the subjects need details to provide accurate feedback (Callahan & Hobbs, 2010). Unfortunately, it is not a matter of standard practice to provide the subjects all of the information necessary to willingly give consent to participate in the study. Researchers have not always provided accurate information to the participants to the detriment of their health. Policies are necessary to demand a guarantee of minimum level of information shared with the participants. However, that does not provide enough of a guarantee that the paperwork given to the subject accurate and fully explained to the participant. For the purpose of this discussion, one must accept the likelihood of researchers to copy the information in the articles in the same style of wording as found in the requirements. While researchers understand the language of the consents, individuals who may not have as much education or experience with the concept of research consents, often fail to understand what they consent to exactly.
The discussion about consents and the ethical considerations begins with
Article 3.1 (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 (b) Consent can be withdrawn at any time.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 [sic] data or human biological materials (Canadian Institutes of Health Research, 2010, p. 27).
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The article writes the three points beginning the discussion about consents in a straightforward manner. The consent to participate is voluntary. A participant should not feel forced into the study, meaning it was their choice to participate, undergo the treatment, or placed in the control group. While this article does not clarify this point, and it should, the consent is voluntary only when the participant receives all information. This is a sticky point as the participant will not know if the researchers shared all the information necessary. The belief of voluntary finds basis on the belief the researchers shared all the necessary information, but often that is not the case. Circumstances exist where the researchers deliberately fail to disclose all information. Other situations occur when the researchers unintentionally left out information. Still other examples exist of the researchers running into new information or complications unforeseen. In a number of studies, the original researchers farmed off the research to other hospitals, clinics, or medical professionals with instructions as complete as possible but the sub-contractors for the lack of a better word, failed to provide the full description of information. Additionally, the problem could stem from the incorrect interpretation of the information from the researchers to the sub-contractor to the participant.
Obviously, it is nearly impossible to have a perfectly run study with all information given in the proper manner to all participants to provide an informed consent that remains voluntary. Often the focus is on the voluntary portion of the consent and not the problems with the accuracy of the voluntary based on receiving all information, positive and negative. There are ways to address this issue; however, it relies on the integrity and ethical considerations of the individual researcher (McMillian, n.d., p. 2).
Kant’s theory on ethical considerations aptly applies in this case. The rightness for the reason determines if the actions are ethical. Researchers with the intent to share all information to the participant but an error occurred and corrects the problem demonstrates more ethical behavior than one who withholds information purposely (McMillian, n.d., p. 2). The other two considerations listed above demonstrate the extent of the ethical considerations of the voluntariness of the consent.
Article 3.2, 3.3, 3.4, and 3.5 further discusses the manner in which the researchers develop the consents. While the information appears to cover all the necessary areas, one has to wonder if the consents given in written form receive thorough reading with understanding by the participants. Consider article 2.3 “Researchers shall provide to prospective participants, or authorized third parties, full disclosure of all information necessary for making an informed decision to participate in a research project” (Canadian Institutes of Health Research, 2010, p. 27). The question to ask is if an average participant understands what the above statement means. When developing consent forms, simple is better when using language to explain what the researchers intend, provide, need, risks, and benefits (Shapiro, 2001, p. 3).
Article 3.3 does a good job covering the ethical issues of information changing during the study and the researcher’s responsibility to continue to update the participants. However, the only problem is again the language used. In article 3.4, many participants may not understand ‘material incidental findings discovered’ (Canadian Institutes of Health Research, 2010, p. 27). Kant’s theory certainly applies here; the researchers may have included the required elements of consent, but did they do it in the right manner, no. The article failed to speak in a plain manner because of its intended audience of researchers and to address the need to write according to the intended population. Additionally, ‘authorized third parties’ used in 3.2 and 3.5, fails to explain the definition of authorized third parties.
- Callahan, T. C., & Hobbs, R. (2010). Ethics in Medicine. University of Washington, School of Medicine. Retrieved 13 April 2013 from: http://depts.washington.edu/bioethx/topics/resrch.html#ques1.
- Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. (2010). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Retrieved 13 April 2013 from: www.pre.ethics.gc.ca.
- McMillian, J. (n.d.). Moral Theory.
- Shapiro, H. T. (2001). Ethical considerations in research on the human subject, a time for change….again. The 6th Annual Raymond Waggoner Lecture, University of Michigan.
