The Informed Consent Process: Voluntariness

There are many ethical issues involved with prenatal testing for Down syndrome. I hope in time to address as many as possible. To start with, however, is the ethical concept that commentators have cited as making the offering of prenatal testing a moral obligation: informed consent.

Informed consent has a rich history that developed in the United States through court decisions and was codified as an international norm in The Nuremberg Code. Out of respect for an individual’s autonomy–the ability to do as one chooses–came the heightened level in the medical context of “informed” consent. Because of the complexity of medical decisions, in order for a person’s right to choose to be respected, that choice must be an informed decision.

There are several authorities on what constitutes informed consent: ACOG has an ethics committee opinion on it; the Joint Commission has a standard covering it; and, court decisions across the nation detail the requirements for informed consent. None of these authorities express the concept of informed consent exactly the same, but there are common elements:

1. Threshold elements: capacity to understand and decide; voluntariness in deciding.
2. Information elements: disclosure of material information; recommendation of a plan; understanding of disclosure and recommendation.
3. Consent elements: decision in favor of a plan; authorization of the chosen plan.

[These elements are expressed in Fletcher’s Introduction to Clinical Ethics, 3d ed., at 142].

I hope to address these elements of informed consent in the context of prenatal testing for Down syndrome over a series of weekly posts. I will begin with one of the threshold elements: voluntariness.

ACOG explains the importance of voluntariness to exercising informed consent in this way:

Free consent is an intentional and voluntary choice that authorizes someone else to act in certain ways. In the context of medicine, it is an act by which an individual freely authorizes a medical intervention in her life, whether in the form of treatment or participation in research or medical education. Consenting freely is incompatible with being coerced or unwillingly pressured by forces beyond oneself.

Voluntariness is fundamental to exercising informed consent: if consent is not voluntarily given, then how can it even be considered “consent”?

And, yet, healthcare professionals have admitted that they have either emphasized the negatives or the positives of Down syndrome in order to arrive at a desired decision, or, even, outright coerced their patients into making a decision after a prenatal diagnosis. Disability advocates have criticized the administration of prenatal testing as setting a standard of a “good birth”–by prenatal testing’s very existence, critics argue, it suggests the tested-for condition should be avoided and accepting prenatal testing is what responsible mothers should do. This criticism is corroborated in the stories of mothers being told by others when they see their child with Down syndrome, “isn’t it a shame everyone doesn’t have prenatal testing?”

So, of course, for informed consent to be truly “consent” it must be voluntary. And, certainly there are many experiences where women did exercise voluntary choice and were not coerced by their health care provider, their partner, or the stigmatizing effect of prenatal testing. But, there are also those decisions that were not voluntary, which leads to this post’s question:

ACOG is right now considering new guidelines in light of new prenatal tests based on a maternal blood sample. What should be part of those guidelines to ensure that decisions to accept or decline prenatal testing for Down syndrome are voluntarily made by expectant mothers?