The Ethics of Informed Consent
Balancing personal autonomy with scientific progress with noted bioethicist and oncologist Dr. Ezekiel J. Emanuel
Deborah Zoe Laufer’s play Informed Consent takes its name from the procedures in place to protect human subjects of scientific studies from being harmed by that research. It was introduced after World War II in the wake of forced experimentation on prisoners of concentration camps. The resulting Nuremberg trials produced a list of ten guiding principles aimed at protecting human research subjects. The first entry on that list is the requirement of “voluntary, well-informed, understanding consent of the human subject in a full legal capacity.”
Today, informed consent is a basic ethical obligation of researchers, meant to ensure that participants know precisely what will be asked of them and exactly what will happen with any information or material they provide. Researchers work with their review boards to ensure that the consent language accurately reflects the procedures and anticipated outcomes of the study, or at least that it accounts for any conceivable outcomes.
Informed consent also protects the researcher, who generally wants the ability to follow where the experiment leads without being bound to stop because they lack consent from the subjects. Crafting consent language that accounts for future, unforeseen use of samples and data allows scientists to continue studying. To that end, participants are often asked for both written and verbal consent, detailing the research being done and what the gathered information may be used for in the future. There are tiers of consent that range from very specific to very broad; the more specific the consent, the better for subjects, as they have the most control over their samples. But broader consent is better for researchers, as it gives them more freedom, both in the short term and in the unforeseeable future:
SPECIFIC CONSENT is extremely narrow. Researchers must recontact participants for renewed consent each time a new use for their specimen or information arises.
TIERED CONSENT presents subjects with an array of consent options, ranging from very narrow to very broad. See the table below for an example of tiered consent language.
GENERAL CONSENT allows the participant to grant future use of the specimen or information in as yet unknown ways.
PRESUMED CONSENT informs the subject that their specimen or information will be used in the future unless the participant expressly forbids it.
Broader consent also leads to more valuable data; the more widely a specimen or data can be used, the more scientists can benefit from it. Specific consent, while giving the subject the most autonomy and control, severely limits the work that can be done on their specimen, making that information less useful in the longterm. But specimens that can be shared, stored, and studied without restraint allows for more discovery — and often more funding and notoriety for the scientist who puts the data to best use. At the center of this is the question of ownership: do you own your blood once it leaves your body, or did you give up that ownership when you gave away your blood?
These aren’t questions that are easily answered. Sometimes, though, progress outweighs consideration of the person or culture, as is the case with the tribe in Informed Consent and in the true story upon which the play is based. While physical harm is currently taken into consideration and avoided, other kinds of harm — emotional, psychological, cultural — may not be considered. If a minority population is uncomfortable with broad consent, they may be left out of a study altogether. Considering how to properly address the needs of these vulnerable populations can be a struggle for a field constantly striving for progress and discovery.
According to noted bioethicist and oncologist Dr. Ezekiel J. Emanuel, one of the leading thinkers on medicine and society of our time, questions often come down to a conflict of values. In this video, he asks questions that sit at the heart of the play:
“So it’s really thinking about the values that underlie decisions; how you weigh competing values. How do you justify them? That is, how do you give people reasons so that they ought to agree?”
On Tuesday, January 24, Dr. Emanuel will join us at the Lantern for a fascinating discussion on the nature of scientific progress, particularly in medicine where the engagement of human subjects is both necessary and ethically challenging. Additional panelists include bioethicist and pediatric oncologist Dr. Steven Joffe and playwright Deborah Zoe Laufer. In Conversation: Bioethics, Theater, and Identity immediately follows the 6:30PM performance of Informed Consent and is free with ticket purchase.
As a procedure, informed consent asks that both the researcher and the researched come to a place of mutual understanding, respecting the boundaries of the subject while furthering the cause of the scientist. As a play, Informed Consent asks us to examine our willingness and ability to look beyond ourselves, and to honor the values of our fellows as much as our own.
Please join us for Informed Consent at Lantern Theater Company. The show runs from January 12 — February 12, with a special IN CONVERSATION event with Dr. Ezekiel J. Emanuel and other special guests on January 24. Visit our website for tickets and information.