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The Ethics of Research with Human Subjects pp 113–147Cite as

Informed Consent

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Part of the book series: International Library of Ethics, Law, and the New Medicine ((LIME,volume 74))

Abstract

In the first four chapters of this book, I examined the historical and philosophical foundations of the ethics of research with human subjects and developed a theoretical framework for decision-making. The key insight of this framework is that promoting trust is an important principle for making ethical decisions concerning research with human subjects. In the book’s remaining eight chapters I will apply my framework to various topics in human research ethics and discuss its implications for practice and policy. The first topic I will address is informed consent, since trust and consent are closely connected.

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Notes

  1. 1.

    Chapter 11 will disclose additional disclosure requirements in the revision to the Common Rule.

  2. 2.

    The shared decision-making approach to medical choices can viewed using a subjective standard for information disclosure because a shared decision is one in which the physician and patient both work together to share information relevant to the decision. This approach is subjective because what is relevant to the decision is determined, in part, by the patient’s preferences and values. See Charles et al. (1997), Whitney et al. (2004).

  3. 3.

    Consent can reduce or prevent liability for negligence, battery, fraud, conversion, and other torts. For example, battery is commonly defined as unconsented or unwanted touching that causes harm. If someone consents to being touched, they cannot sue for battery. Assumption of risk is a legal defense to a negligence lawsuit . If you inform someone about a risk and they agree to participate in the activity, they have assumed the risk. See Berg et al. (2001).

  4. 4.

    The privacy rule of the Health Insurance Portability and Privacy Act (HIPAA) allows an IRB or privacy board to approve research involving review of medical records (National Institutes of Health 2004).

  5. 5.

    The proposed revisions to the Common Rule exclude internal quality improvement and quality assurance projects from being classified at research (Department of Homeland Security et al. 2015).

  6. 6.

    Chapter 11 will discuss how the revised Common Rule deals with research involving de-identified biological samples and data.

  7. 7.

    The Common Rule does not include any provisions for emergency medical research.

  8. 8.

    The revisions to the Common Rule include a simplified consent procedure for research involving biological samples or data, which will be discussed in Chap. 11.

  9. 9.

    See Juengst (1998a, b) for a discussion of conceptual and practical problems with community consent.

  10. 10.

    An exception to this rule would be emergency medical research. I argued above that individuals should be able to opt-out of research. However, emergency medical research is a bit different than the examples we have been discussing, since in emergency medical research opting-out the choice is between opt-consent and no consent. One could argue that opt-out consent is more respectful of autonomy than no consent.

  11. 11.

    It is worth noting that investigators recently conducted a modified version of the Milgram experiment in which subjects could give each other mild electric shocks or a financial penalty. The subjects took turns being the punisher and the victim. The shocks and financial penalties were real and there was no deception. The subjects and experimenters were all female to control for gender effects. The investigators evaluated the subjects’ willingness to obey authority by varying the conditions of the experiment. In one variation, the experimenter did not instruct the punisher to administer a punishment: the punisher was free to choose whether to punish. In another variation, the experimenters instructed the punishers to administer a punishment: the punisher was coerced. The punishers were more willing to administer a punishment when they were instructed to do so and they felt less moral responsibility for their actions. None of the subjects withdrew from the experiment or reported distress (Caspar et al. 2016).

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  1. National Institutes of Health, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA

    David B. Resnik

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Resnik, D.B. (2018). Informed Consent. In: The Ethics of Research with Human Subjects. International Library of Ethics, Law, and the New Medicine, vol 74. Springer, Cham. https://doi.org/10.1007/978-3-319-68756-8_5

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