Consent, Obtaining Participant

Core Principles

Despite differences among the various codes, there are core principles that can be summarized here: Potential participants must be told about the research purposes and procedures, including the nature of the involvement being requested of them. These people must also be apprised of any reasonably foreseeable ill effects of that involvement (risks or discomforts), as well as the benefits to themselves or others that will likely accrue. They may not be pressured to take part in a project or any component of it; they must be allowed, at any time and without reprisal, to withdraw themselves and/or the data they provided. Further, any limits on confidentiality must be made explicit. Finally, participants must be allowed to raise questions and concerns, and be given contact information to facilitate their doing so.

Putting principle into practice is a complicated undertaking that involves many judgment calls. Questions abound. For example, just what information should be conveyed, how much, and by what means? What is the extent of risk, and who should assess it? What constitutes pressure? Conflict-of-interest concerns suggest that matters like these cannot be left to the researcher, and they are not. Federally mandated Institutional Review Boards (IRBs) in the United States, Research Ethics Boards (REBs) in Canada, and similar committees in other jurisdictions are charged with the responsibility of overseeing the process. The ethics-review applications that researchers are obliged to submit to their review committees must cover the topic of informed consent.

In practice, the standard procedure for acquiring participant agreement makes use of the written consent form: a prepared statement that participants are given to read and sign prior to becoming involved in a project. Boards tend to favor this consent procedure. Besides the obvious advantage of standardization, the written consent form presents a specific, detailed description that committee members can scrutinize (and, if need be, return for revision). Since signatures testify concretely to knowledgeable agreement, these forms also offer the institution some protection against lawsuits, especially where (as in biomedical research) there is real potential for significant harm.

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