Policy Statement Analysis the Tri-Council

Policy Statement Analysis

The 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) the 2008 version specifies an ongoing responsibility with respect to informing subjects of every element necessary for valid consent; (4) the 2008 version adds a section pertaining to incidental findings that is absent from the 2003 draft; and (5) the 2008 version also adds a specific burden of establishing a justification and specific need for any departure from the general consent requirement in conjunction with procedures established for the approval of such departures by the research ethics board (ERB).

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 a specific obligation to issue statements assuring participants of the absence of any obligation to participate or to continue participating in the study; (4) disclose possible commercial use of the study; (5) detail the method of disseminating information related to the study; (6) disclosure of whether or not participants will be identified; (7) identify appropriate qualified individuals designated to explain scientific or scholarly aspects of the study; (8) identify additional appropriate resources for information; (9) identify those who are expected to have access to the information, the manner in which confidentiality will be protected, and the way study results may be used; (10) disclosure of the specific circumstances under which researchers could decide to terminate the participation of the subject in the study; (11) provide information of any costs, payments, expense reimbursement, and injury compensation; and (12) the explicit disclosure that providing consent for participation does not also constitute the waiver or relinquishment of any legal rights.

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