Research Proposal on "Policy Statement Analysis the Tri-Council"
Research Proposal 5 pages (1336 words) Sources: 4 Style: APA
[EXCERPT] . . . .
Policy Statement AnalysisThe Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2008 draft version is substantially different from its 2003 first draft predecessor. In particular, the chapter dedicated to "Free and Informed Consent" is much more extensive in the 2008 draft. In addition to the expansion of existing sections, the 2008 draft also amends the prior version with the addition of new principles and concepts that were entirely missing from the 2003 draft version.
Moreover, whereas both the 2003 and 2008 draft versions address the conceptual difference between merely signing consent forms and establishing that such signatures genuinely represent valid consent based on meaningful comprehension, the 2008 draft version seems to incorporate that fundamental principle throughout the chapter. By comparison, the corresponding concept is just a nominal reference in the 2003 draft version. Generally, Chapter 3 of the 2008 draft version marks a clear evolution of the extent to which many traditional aspects of ethical concepts must be applied to research in the intervening five years between their respective authorship.
Without exception, the new changes are beneficial to potential research subjects and reflect a much greater awareness and concern for the possible detrimental effects of research on subjects. Some of the most important changes manifested in the new version are that: (1) it explicitly details the informed consent withdrawal rights of subjects; (2) it expands the criteria for voluntariness of consent from one very small paragraph in the 2003 version to 3 full pages in the 2008 version, comprising 10 subsections; (3)
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Informed Consent Withdrawal Rights
In the 2008 draft version of Chapter 3: Free and Informed Consent, Article 3.1 under Section A. General Principles
adds the explicit statement describing the rights of study participants (in sum and substance) to change their minds, for any reason, or for no reason, and to withdraw from the study after it has begun. The 2008 draft version incorporates this provision within the duties of the researchers to include that right of participants within their obligation to inform them fully in conjunction with securing informed consent. By contrast, the 2003 draft version does refer to the withdrawal rights of study participants but does not otherwise address this obligation in connection with the specific information required to be included in the process of informing participants during the consent acquisition process.
Voluntariness of Informed Consent
The 2003 draft version of Chapter 3: Free and Informed Consent, Article 2.2 under Section B. Voluntariness provides, in its entirety, (in sum and substance) that free and informed consent be freely given, without manipulation, undue influence, coercion, and that such undue influence consists of inducement, deprivation, the exercise of control or authority over study participants. Otherwise, that is the extent of the definition and requirements provided in the 2003 draft version.
In comparison, the concept of voluntariness is elevated to the first section of Section A. General Principles and Article 3.2 substantially expands the definition of concepts and criteria outlining the voluntary consent obligation. In that regard, the 2008 draft version adds a provision in Article 3.2 detailing the obligation of researchers to provide prospective participants with the opportunity to pose questions for the purposes of deciding whether or not to participate. That section further details this concept in 12 individual subsections (a through i).
In sum and substance, those subsections establish the requirement to: (1) fully inform prospective participants of the purpose of and methods used during the study; (2) provide an understandable description of foreseeable potential harms and possible consequences associated with them; (3) satisfy… READ MORE
Quoted Instructions for "Policy Statement Analysis the Tri-Council" Assignment:
Please write on the chapter about free and informed consent.
Instructions for the term paper:
Take one chapter from the Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans and compare it to the related chapter from the draft second
edition of the same document. Explain how the new chapter amends the ethical standards
that are in the original document. Indicate to what extent you agree with those changes.
Support your position with reasons. You can find both documents at
http://pre.ethics.gc.ca/eng/policy-politique/tcps-eptc/readtcps-lireeptc/.
How to Reference "Policy Statement Analysis the Tri-Council" Research Proposal in a Bibliography
“Policy Statement Analysis the Tri-Council.” A1-TermPaper.com, 2009, https://www.a1-termpaper.com/topics/essay/policy-statement-analysis-tri-council/7253. Accessed 3 Jul 2024.
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