by Thaddeus Mason Post, JD, PhD

In a few days, the Journal of Clinical Ethics will publish my seventeenth “Legal Briefing” column. Each column reviews recent legal developments involving a particular issue in clinical bioethics. I have covered topics from organ donation and medical futility, to home birth and conscience clauses. This one, in 25(2):152-174, is titled “Informed Consent in the Clinical Context.”

I covered this topic in two previous “Legal Briefings”: an overview in 2010 and another in 2013 that was focused on shared decision making and patient decision aids. But an updated discussion is now warranted. First, informed consent remains a central and critically important issue in clinical ethics. Second, there have been numerous significant legal changes over the past year. My coauthor and I categorize recent legal developments into the following thirteen categories:

1. Medical Malpractice Liability
2. Medical Malpractice Liability in Wisconsin
3. Medical Malpractice Liability in Novel Situations
4. Enforcement by Criminal Prosecutors
5. Enforcement by State Medical Boards
6. Enforcement through Anti-Discrimination Laws
7. Statutorily Mandated Disclosures Related to End-of-Life Counseling
8. Statutorily Mandated Disclosures Related to Aid in Dying
9. Statutorily Mandated Disclosures Related to Abortion
10. Statutorily Mandated Disclosures Related to Telemedicine
11. Statutorily Mandated Disclosures Related to Other Interventions
12. Statutorily Mandated Gag and Censorship Laws
13. Informed Consent in the Research Context

I am particularly excited about this article, because it provides an excellent foundation for my presentation, later this month, at Dartmouth’s Summer Institute for Informed Patient Choice (SIIPC14): “Revitalizing Informed Consent Law.” The title was assigned to me. But I have been pleased (indeed, delighted) to discover that I now have the evidence and arguments to make a cogent case that informed consent law really is undergoing (or about to undergo) a revolution or renaissance for the better.

Here are a few excerpts. From the introduction: “Virtually all clinicians aspire to excellence in diagnosing disease. But far fewer, unfortunately, aspire to the same standards of excellence in diagnosing what patients want. A powerful recent report shows that ‘preference misdiagnosis,’ a failure to adequately determine and consider patient desires and values, is commonplace. Moreover, clinicians are rarely even aware that they have made a preference misdiagnosis. It is the ‘silent misdiagnosis.’”

From the conclusion: “Medical associations and policymakers are focused on identifying commonly performed tests and procedures that offer little or no clinical benefit. This is a great start on reducing overuse and improving healthcare quality. But it is not enough. Benefit is a function not only of medical science but also of patient preferences. Current trends suggest that over the next few years, policymakers will further clarify that treatment inconsistent with patient preferences is treatment without benefit. As that proposition becomes more widely accepted, healthcare providers will find it more difficult (if not impossible) to obtain public or private reimbursement for tests and procedures administered without adequate informed consent.”