Uninformed Consent?

After having the privilege of hearing about the process of human scientific studies and the nuances of informed consent with Dr. Ben Chapman of North Carolina State, I was left with a troubling thought about what it means to be informed.  Chapman, in his podcast Food Safety Talk Podcast Episode 163: “Grown on Chia Pets”, discussed a particular participant that challenged the consent process of one of his studies.  The chief complaint of the participant was that he felt betrayed that he was not properly informed before taking part in the study. To avoid biased results, researchers often use deception studies. Deception studies, by nature, cannot fully inform participants on the true aim of the study. The question I was left with was: Should we allow deception studies to continue being used?

In Percival Everett’s Zulus, Alice is offered safety by being smuggled out of the city to a rebel camp by Theodore Theodore.  Alice consents. However, her consent is meaningless. When she consents the only information she was given is that Theodore Theodore says “I will do everything I can to help you”.  Later, Alice finds out that she will be subjected to imprisonment and a violating verification of her pregnancy. Although Alice provided consent by asking for help, she in no way consented to the horrible acts she would have to endure.  Alice was extremely uninformed and forced to suffer because of the deceit of the rebels. To properly consent, Alice needed far more information than what she was provided.  Alice was not informed of everything that she would later encounter and therefore is a violation of informed consent.

Harriet A. Washington describes another situation of uninformed consent in her book Medical Apartheid.  She recounts a story from Jesse Williams about participating in a footwear experiment that was really an attempt to induce a foot fungus that was extremely difficult to treat. “Investigators went to remarkable lengths to deceive inmates about the harms inherent in the tests”. This is clearly a violation of attaining properly informed consent. While Williams was prison he was never given a consent form. Even if he had the ability to consent to a study of this nature, he was grossly under-informed about the true nature of the study.  Williams experienced a lack of informed consent because he has deliberately misinformed about the aims of the study. He was also not aware of the risks that accompanied the true nature of the experiment. Williams’s lack of knowledge of risks and the true goal of the experiment would have prevented his ability to provide informed consent if he was given the opportunity.

Alice and Williams’s situations demonstrate a clearly unacceptable lack of information. However, deception studies also withhold information from participants. Deception studies are considered necessary and ethical in today’s human research environment.  According to the University of Wisconsin’s Health Sciences Institutional Review Board, deception studies are necessary in order to  “obtain unbiased data with respect to the subjects’ attitudes and behavior when complete or truthful disclosure is expected to produce biased results”. Human beings often aim to please, so if they know the aim of the study they tend to alter their behavior. The IRB of the University of Wisconsin indicates that researchers are allowed to active deceive and passively deceive research participants. Active deception involves providing inaccurate information to participants. Passive deception is intentionally withholding information that is vital to the study. Alice experienced passive deception because she did not fully understand what would actually occur at the rebel camp. Williams experienced active deception because the information provided was inaccurate to the actual details of the study. Alice and Williams both experienced deception in ways that current researchers utilize.

If the deception that was described in Medical Apartheid and Zulus was considered unjust, should researchers today be allowed to use the same methods? Yes, because there are oversight organizations that prevent deliberately detrimental practices. Chapman deliberately deceived his study’s participants by not disclosing that they would come into contact with non-pathogenic E.coli bacteria. I believe that Chapman was just in doing so because the Institutional Review Board protects participants. The IRB ensures that studies can only involve minimal risks to participants and risks described to the participants cannot inaccurately represent actual risks. In William’s case, the risks were not described accurately and thus an oversight board would have prohibited this study.  Institutional review boards also have provisions that force researchers to reveal the actual details of the study to participants and allow them to withdraw from the study and completely eliminate any data acquired. These provisions protect subjects from initially consenting and then not being able to revoke their consent. Subjects may not be fully informed at the beginning of the experiment but are completely informed before their information is used.

In an ideal world, deception studies would not be necessary. True informed consent is currently not a reality in human studies. Deception is required in order to gain accurate knowledge to provide a benefit to the population as a whole. As long as research participants are not being taken advantage of and only experience minimal risk, deception studies should be allowed to continue. In the case of Chapman, deceiving his participant was a source of great regret and felt that he personally had a responsibility to revise his study to avoid problems in the future even though his study held up to IRB guidelines. Researchers, like Chapman, act in good faith and are subject to many rules that ensure the full protection of participants. While willingly deceiving research subjects may seem in bad taste, it remains a necessity.

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