The Basis of Ethical Human Research

Informed Consent 1

Informed Consent:

The Basis of Ethical Human Research

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Informed consent is without question the basis and touchstone of ethical human research. However, it is fraught with challenges, both in theory and in practice. These challenges include researchers’ inability to accurately, effectively, and complete express essential information; difficulties in patient comprehension, and prevailing uncertainties as to the true extent of patients’ understanding of what they are consenting (or not consenting) to. The concept of informed consent is predicated upon the notion of a mutually trusting, beneficial, and forthright relationship between patient and researcher; it is also based upon the assumption of researchers’ ability to communicate and patients’ ability to understand, both with complete accuracy, relevant—and vital—information. When a patient’s health, safety, and privacy are at stake, nothing less than complete and un-coerced consent will suffice. However, studies have shown what experience bears out: that this is far more easily said than done.

The concept of informed consent hinges upon the premise of choice, the patient or participant’s ability to freely choose the course of action that best aligns with his/her own values, goals, beliefs, and interests, particularly in regard to the dispensation of his/her own body and information and materials related to it. In a literature review of consent protocols practiced at biobank research facilities, D’Abramo, Schildmann, and Vollmann (2015) found that many such facilities practice a form of “limited consent”, in which participants seek to direct and circumscribe the way in which their personal data are used and to what extent. However, the researchers note that participants seem frequently to misunderstand the consent process and, frequently, to overestimate the powers of the restrictions they seek to set in place (p. 68). The result is often a use of participants’information that the patients did not intend but for which they have provided legal consent. This gap between participants’ values and intended choices, the legal mechanisms of consent, and the overall intentions and scope of medical research is one that must be bridged in patients are truly to be self-determining over their own bodies and information and if human medical research is truly to be conducted in a way that honors patient autonomy and sovereignty.

In a pilot study to investigate strategies to improve informed consent practices, Kass, Taylor, Ali, Hallez, and Chaisson (2015) found statistically significant improvements when two methods of informing participants were used in conjunction: the FAQ, followed by a question and answer session (p. 61). Significantly, written information was absorbed most effectively when it was presented in this FAQ form, using short, bulleted lists. It appears that participants are better able to internalize and recall these short, clear chunks of information, as opposed to the traditionally voluminous and discursively dense consent forms of the past. The follow-up question and answer period, likewise, is essential in enabling participants to test and affirm their own understanding, which is the basis of true informed consent. This follow up also facilitates the retention of vital information, as key details presented in the FAQ are both reiterated and clarified through discussion.

Our bodies are the first and last possession we will ever own. It is the only thing that we carry with us from cradle to grave, from first breath to last. For medical researchers, the sanctity of the patient’s body must be paramount. The progression of medical science, however, requires that sometimes we sacrifice a bit of that autonomy, that privacy, for the greater good of the human family. This should only be done, however, through a free, uncoerced, and fully-informed choice. It is incumbent upon researchers not to allow their own hopes, intentions, or values, particularly relating to a study they inevitably hold dear, to inflect their research practices. It is all too easy in the research process for researchers to impose their will, subtly, perhaps, and often even subconsciously, either by assuming the patient understands more than s/he truly does or by presenting vital information in such a way as to preclude patient understanding and discourage him/her from seeking out clarification. Comprehensive measures that combine palatable written information with rigorous discussion, such as those studied by Kass et al (2015), can help to ensure that free and informed consent is truly exactly that.

References

D’Abramo, F., Schildmann, J., & Vollmann, J. (2015). Research participants’ perceptions and views on consent for biobank research: A review of empirical data and ethical analysis. BMC Medical Ethics, 16, 60-71.

Kass, N.E., Taylor, H.A., Ali, J., Hallez, K., & Chaisson, L. (2015). A pilot study of simple interventions to improve informed consent in clinical research: Feasibility, approach, and results. Clinical Trials,12(1), 54-66.