No this isn’t about how Bruce Wayne as a young boy witnessed the murder of his parents. Nor is it about Clark Kent having to be jettisoned off of his planet. These origin stories are pretty grim. So it is with informed consent. This is how informed consent became a doctrine governing behaviors of physicians in their interactions with patients. Clinical practice finds its origins in two court cases. The first is back in 1767 in England. It is the case of Slater v Baker and Stapleton. In the US we have the Schloendorff v Society of NY Hospitals around 1912. The name alone is worthy of mention. Both of these court cases established that patient consent is a legal requirement. You need permission to intervene. There is no one document or set of guidelines about how to do this in clinical practice.
The origin story for clinical research resides in the experience of World War II. The World Medical Association in a response to the atrocities committed by medical staff in World War II published the Declaration of Helsinki. Let’s focus on the research portion of the story.
The Declaration was first published in 1964. It has been amended nine times since. My experience is that organizations typically claim that their informed consent forms are compliant with the Declaration of Helsinki. Its development was a response to the lack of obtaining consents in research. We have to remember these are documents, so they aren’t actual practice. The real question is if the physician follows the documents guidelines would patient rights be respected.
The document is interesting as it attempts to regulate physician behavior across multiple goals. The consent of the patient/subject is merely one among many. Under its General Principles #4 it maintains that the physician had multiple duties. Physicians have to safeguard the health of the patient. The patient's well-being should also be observed. Although one might think these two are identical, they don't have to be treated that way. If health is only physical health then one can be both healthy but their well-being may suffer. The broader the concept of health you have the more it overlaps with well-being. There are places where they do not mean the same thing. Financial well-being is not the same as health though it certainly has a role in promoting health. I have witnessed a number of situations over the years of people making decisions based on preserving wealth for their children in lieu of health. The last item in this paragraph is to observe the rights of the patient at all times. Hmmm....This may be a problem since observing the rights to make decisions may lead to bad health. The fact that this possibility forms a large part of the bioethics literature and legal cases indicates it needs to be addressed. At this point in the document, it does not refer to competing duties and how they are to be resolved. Maybe later?
Indeed, the document confirms that the goal of medical research is not the health of the subjects undergoing research. They are not there to be treated clinically. At least that is not the primary purpose (Think Phase 1 Study). This doesn't preclude that they are being treated clinically as well. But that would not be the primary purpose of the interaction.
We have a tension here. In the clinical setting patients come in to resolve or prevent symptoms. The physician is there to promote the same ends. The purpose of the research is to gain new information or as the document states “knowledge”. Still there are multiple obligations placed on the physician investigator. They are “to protect the life, health, dignity, right to self-determination, privacy and confidentiality of personal information of research subjects.”
It is not always possible to fulfill all of these obligations. Sometimes patients will make a choice that does not protect their life or health. The recent pandemic illustrated this in spades. It isn’t new. Much of literature deals with this priority fight between duty to provide the best health care interventions against the right to self-determination. Patients choose courses of action (or inaction) that do anything but promote their best health. Sometimes it is because there other values that the patient holds more dearly and they can’t have both.
The Declaration offers that the ethical duty to respect self-determination takes precedent. In this way it is similar to clinical practice. The respect for the patient’s decision remains paramount.
This in of itself doesn’t explore the differences between the research and clinical contexts. The clinical situation has overlap in terms of improving health. The goal for the investigator in research and is to gain knowledge. I realize individuals have other motivations as well. Personal growth, financial reward, recognition by peers are some possibilities.
On the patient side their goal may be seeking novel treatment because nothing else works. They may be interested in furthering knowledge for others. It can be both. Under certain circumstances it is money for their time.
My experience in looking at over 1000 informed consents for research over the years (I got tired of counting), is that they have a heavy focus on tamping down the therapeutic possibilities of participation. After all you don’t want to entice someone into participating by leading them on about something that has not been proven effective.
So how well has this informed consent requirement worked in clinical research? The implementation has been quite different. There is the involvement of Institutional Review Boards. They review consent forms prior to passing them on to patients. They review protocols so that filter out studies that have too much risk compared to the potential benefit. It is a set of checks and balances not seen or at least not regulated on the clinical side.
Has it been successful where the practice setting has not? How much do these differences impact the practice of informed consent in the research setting? Finally, should we engage in to a shift towards shared decision-making as a result?
Next post we will look at the data out there about informed consent in clinical research.
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