The 3,4,5’s of Informed Consent

In the midst of the demands and responsibilities of a new school year, education researchers are immersed in logistical considerations for projects starting (or continuing) in 2012-2013.  An important consideration for every research project is the issue of consent which, in education, is most often discussed in terms of active or passive consent.  Consent demands even more time for consideration in the health sector where it is not only a component of research activities but is also critical to the patient-physician relationship.  In Hall, Prochazka and Fink’s (2012*) article “Informed consent for clinical treatment”, they provide an excellent overview of the components and purpose of informed consent.  Although written from the health care perspective, their reflections and recommendations lead to interesting conversations when you consider them from an education research perspective.

Hall et. al. offer these reminders and warnings with respect to consent:

“The consent form should not be confused with the consent process; the form merely documents that the process has occurred.”

“Unfortunately, pressures for efficient workflow may shift the focus of the informed consent process from robust conversation to the mere requirement of getting a signature.”

“The standardized form best suited for documenting administrative compliance may not be ideally suited for documenting the goals of care or the type of discussion that builds trust.”

The 3 purposes of informed consent

Informed consent serves ethical, legal and administrative purposes:

  • Ethical: support for autonomous decision-making
  • Legal: protection of rights
  • Administrative: documentation of who is involved and that ethical and legal requirements were observed (which serves as a safeguard)

The 4 elements of informed consent

For consent to be truly considered to be “informed”:

  • The decision-maker should have the capacity to make decisions.
  • The decision-maker should be provided with sufficient details necessary for making a choice
  • The decision-maker should show his or her understanding of the disclosed information
  • The decision-maker should freely authorize the plan.

The 5 components to include in a discussion seeking to obtain informed consent

A conversation that results in obtaining informed consent includes a review of:

  • Why action is needed (diagnosis)
  • What action is recommended (treatment)
  • What risks and benefits associated with the action
  • What alternative actions are available (and risks and benefits of those alternatives)
  • What the consequences might be of not acting

Although this article is not available online for free, you can read the discussion that ensued here.   For those without access to the article, the American Cancer Society compares the difference (in health care) between consent for standard treatment vs. consent for participation in a clinical trial in their article “How is informed consent for a clinical trial or research study different from consent for standard treatment?”.

*Hall, D., Prochazka, A., & Fink, A. (2012). Informed consent for clinical treatment. Canadian Medical Association Journal, 20(184), 533–40.

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