13 Advances in Informed Consent Research

Abstract

Almost since the origins of the informed consent doctrine, physicians and researchers have been frustrated by the difficulty of attaining meaningful consents—consents that truly fulfilled the high ideals of the doctrine. This difficulty quickly led to a series of empirical studies showing that patients did not understand informed consent disclosures. Almost as quickly, critics pointed to methodological flaws in those studies. Recent years have seen empirical ethicists explore new directions in informed consent, both in the methods used to study consent and in innovative approaches for improving the consent process. This chapter begins with an overview of the expanding research methodologies and considers some recent research findings. It then explores some of the theoretical innovations that have resulted, describing certain problems that remain in consent, and considering the efforts being made to overcome them.

The trade-off between impartiality and freedom in the 21st Century Cures Act

“…It is worth recalling here the so-called therapeutic misconception: against the intuitions of many trial participants, RCTs are not primarily carried out for their benefit, but rather to generate evidence that will protect future patients from unwanted harms. Misunderstanding this point leads patients to overestimate the benefits of trial participation and downplay its risks (Candilis and Lidz 2010). At the same time, we may have reached a point in pharmaceutical history where patients can easily rebel against trial protocols, making medical experimentation unfeasible unless patients' preferences are somehow accommodated.…”

Objectually Understanding Informed Consent

“…Bioethicists have frequently said that what is required is that patients understand a possible intervention. For example, Beauchamp and Childress (2013) make the point (with respect to autonomy) that what is required is “self‐rule that is free from both controlling interference by others and limitations that prevent meaningful choice, such as inadequate understanding .” (101, emphasis mine) Some philosophers (e.g., Faden and Beauchamp 1986; Candilis and Lidz 2010) maintain that understanding is required for informed consent, and even those who do not go that far would be likely to acknowledge that some kind understanding or other is a good‐making feature of informed consent.…”

Bioelectronic Medicine—Ethical Concerns

“…Informed consent requires considerable time and communication skills and should not just be viewed as a process whereby a form is signed. There is still a need for more research to improve the understanding of and processes for informed consent (Candilis and Lidz 2010).…”