The Meaning of Informed Consent

“Something is voluntary, which is done neither through force nor through ignorance.”

Saint John of Damascene in Orthodox Faith

The Meaning of  Informed Consent

The Belmont Report (1979), echoing the Nuremberg Code (1947) and the Declaration of Helsinki (1964), underlines the need of informed consent in research involving human subjects. Federal Regulations on the Protection of Human Subjects require that an investigator obtain informed consent of any human being, or their legally authorized representative, before engaging them as subjects in research (45 CFR §46.116). Specific requirements are listed therein for a legally effective consent. These measures are taken to ensure that participation in research is voluntary.

What makes an action voluntary?

The classic definition of voluntary is given by Aristotle. In his words: 
τὸ ἑκούσιον δόξειεν ἂν εἶναι οὗ ἡ ἀρχὴ ἐν αὐτῷεἰδότι τὰ καθ᾽ ἕκαστα ἐν οἷς ἡ πρᾶξις. "A willing act would seem to be one of which the source is in oneself, when one knows the particular circumstances in which the action takes place.” (Joe Sachs translation, 2002). This is a complete definition, by genus and specific difference. Let me explain.

Voluntary activity is classified in the broader category of natural activity (this is the genus), the characteristic of which is to proceed from an internal principle. To natural activity is opposed violent activity, which proceeds from an external principle. The very tangible example that is given by medieval commentators is that of a stone which is thrown up in the air. For the stone, going up is violent motion, but coming down is its natural motion: left to itself, the stone falls.

What differentiates voluntary activity from other forms of natural activity, and sets it apart as of a specific kind, is that it is accompanied by a knowledge of the end pursued and its circumstances (this is the specific difference). Most properly, this kind of activity is that of a human being, who having the use of reason, can know goals as goals, the means to get there in the circumstances, and understand the relationship between the means and the end sought. 

Involuntary is the opposite of voluntary. We can identify three basic kinds of involuntary.

(1)   Negative involuntary. This describes activities which are of such a kind that they are incapable of being voluntary, as is the case of the motion of bodies which do not possess knowledge. An example is the movement of the stars.

(2)   Privative involuntary. This describes an activity which has the aptitude of being fully voluntary, but lacks the specific element while still having the generic element. This is the case of someone who pursues a goal but is ignorant of key circumstances. For example, a student buys a cheap car that happens to be a lemon. He freely chose to buy the car but did not know it was a lemon. He wanted a car, but not a lemon!

(3)   Contradictive involuntary. This describes an activity which lacks the generic element of the voluntary, namely, proceeding from an internal principle. Contradictive involuntary connotates the action of an external principle which acts despite a positive repugnance. An example is a kidnapping. 

This division of the involuntary indicate its various causes. Negative involuntary is of no concern to the ethicist. The causes of privative and contradictive involuntary, however, deserve all of his attention, since they can interfere in what should be a voluntary activity (for example in human subjects research). Ignorance causes privative involuntary, while coercion causes contradictive involuntary. This is the meaning of the phrase quoted at the beginning from Saint John of Damascene in Orthodox Faith, “something is voluntary, which is done neither through force nor through ignorance.”

The Belmont Report addresses both of these causes and firstly, that human participants in research should be duly informed:

“It may be that a standard of "the reasonable volunteer" should be proposed: the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation.” (Belmont Report, C. Applications, 1. Informed Consent, PP: Information)

It is also the duty of the researcher to make sure that this information is presented at an appropriate level and adequately understood by the potential subject. 

Secondly, the Report makes clear that the future participant must act free of external coercion or even undue influences:

“An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.” (Belmont Report, C. Applications, 1. Informed Consent, PP: voluntariness)

If consent were given in the presence of coercion or undue influence, we would not have a “valid” consent, one which is given freely, coming from the participant himself.