Policy Statement Analysis the Tri-Council Research Proposal

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Ongoing Duty to Inform

The 2008 draft version of Chapter 3: Free and Informed Consent, Article 3.3 under Section A. General Principles adds a comprehensive explanation of the specific duty of researchers to continue the information disclosure element of the duty to inform throughout the participation in the research project. In that regard, the 2008 draft version details the obligation of researchers to bring to participants' attention any information that comes to light subsequent to the initial informed consent acquisition process. That provision further details the obligation to continue providing relevant information even beyond the conclusion of the research study where appropriate or necessary.

Incidental Findings

The 2008 draft version of Chapter 3: Free and Informed Consent, Article 3.4 under Section A. General Principles adds an Incidental Findings section that is absent from the 2003 draft version. In principle, this provision defines incidental findings as findings that could have potentially significant social, psychological, health-related, or other relevant consequences to the participant.

Specifically, according to Article 3.4, researchers have an obligation to develop a plan for handling any incidental findings, to submit them to the research ethical board, and to advise potential study participants in conjunction with the informed consent acquisition process. Furthermore, Article 3.4 also sets forth that obligation within the earlier-described obligation to of continuing ongoing disclosure of any information relevant to study participants.

The Burden of Responsibility to Justify the Need for Protocol Departure

In the 2003 draft version, Section A. General Principles Article 2.1 subsection c does establish the requirement for research ethics board approval of consent procedures that alter any aspect of the general informed consent process.

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However, in the 2008 draft version, Section B. Departures from General Principles of Consent Article 3.8 imposes a new obligation on researchers to justify the need for any such departures objectively.

Implications

In general, Chapter 3: Free and Informed Consent of the 2008 draft version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans evidences substantially greater respect for the spirit of the ethical responsibilities incumbent upon researchers to ensure the breadth and quality of informed consent. This reflects an ethical concern expressed throughout contemporary ethical approaches to consent in connection with medicine and human research (Levine, 2008; Tong, 2007).

The 2003 draft version addressed some of the most important concepts and definitions, but in a manner that could be considered cursory or merely designed for quick compliance and the mitigation of potential legal risks and liabilities on the part of the researchers and the institutions conducting research (Halbert & Ingulli, 2007; Tong. 2007).

The 2008 draft version greatly enhances the protective functions of the provisions that are in common between the respective draft versions. More importantly, the 2008 draft version amends the 2003 version with provisions that establish additional obligations that were entirely ignored by the 2003 version. Undoubtedly, the 2008 draft version provides far more comprehensive and meaningful protections for the interests of research subjects......

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