'Community' Input into the Consent Process

The current definitions of informed consent fail to make us consider one very important aspect that defines our lives; that is, the sense of community.

Erica Heath

One of the best summaries of informed consent is the succinct language in the first Nuremberg principle. After the assertion "The informed consent of the subject is absolutely essential," it goes on to define it. Consent should be backed with information and the ability to comprehend it, be given by a person who can exercise the power of choice and who is legally capable of giving it, and it should be voluntary. This excellent definition was enough for me to use as a baseline and touchpoint for a long, long time.

The Belmont Report principle of "Respect for Persons" takes the definition further. An autonomous individual is "an individual capable of deliberation about personal goals and of acting under the direction of such deliberation." It stresses that "to respect autonomy is to give weight to autonomous persons' considered opinions and choices." While we are admonished to protect those with diminished autonomy, there is no admonition to encourage the autonomy of the normal prospective subject.

Does it take a village?

One way to encourage the exercise of autonomy is to acknowledge that most study subjects are not only individuals, but are also members of multiple personal communities. Autonomous people have spouses and partners, parents and children, friends, book clubs and prayer groups, therapists, spiritual leaders, and the Internet. We often try out ideas and share troubles and woes with these personal communities.

Although we may agree that it takes a village to raise a child, we on IRBs are very uncomfortable with "community consent" such as in the context of a village in which a woman, for instance, defers to a husband or chief, or where a communal decision is made. This is antithetical to our concepts of autonomy.

Sign on the dotted line

We tend to support the other end—the individual end—of the spectrum. The consent document itself reinforces this. It is signed by one person. We suggest asking lots of questions and give the contact for the investigator and the IRB, but do not suggest that they could ask another patient or subject, a spouse or friend, or check the Internet for advice. We may say "take your time," but we end the form with, "You will receive a signed copy of this form to keep," with the implication that until it is signed, it will not be offered

Certainly there are logistical reasons to gain consent and start a study at the same appointment. Why ask a person to make two trips when one will do? And time is money for everyone, including subjects.

Decision-making styles

Most of us are not fully autonomous in isolation. We can be frightened, intimidated, and overwhelmed. Some of us have trouble thinking quickly. A chapter I fondly remember from the classic baby boomer book,

What Color is Your Parachute,

was about decision-making style. Are you a strong and immediate decision maker, a ponderer, a percolator, a collector of opinions, or a put-it-off-at-all-costs decision-maker? All were fine styles, but you had to know about yourself. The traditional, "ideal" consent situation favors the immediate decision maker.

I have often envisioned a consent process in which the consentee was able to take a consent document home, get comfy with a glass of wine (or cup of tea), sit by the fire (or at the kitchen table) to review the form with a spouse, partner, or pastor. This person would return with an annotated consent form ready for discussion.

Were I in charge of the world, I would add to the Nuremberg definition, "with time to consider the decision." I would reinforce the Belmont Report's concept of Respect to add three words. "The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge and to encourage autonomy and...."