Alejandro Gonzalez
9/5/23
IDMD 101: Medical Foundations I
Presentation Assignment
This week’s topic is about consent, and for today’s readings specifically about informed
consent and autonomy.
The first article from Faden and Beauchamp discusses what is informed consent and
breaks it up into two different “senses”. Sense1 is about informed consent being an autonomous
decision where the patient’s role in making decisions about their healthcare is emphasized and
they actively authorize a proposal or medical procedure. Sense2 is more of an institutionally or
legally effective route of authorization. The focus here is on rules and requirements needing to be
met that were set up by institutions. So, it’s not just an autonomous decision but also a need for
compliance with established procedures. It then goes on to discuss the challenges of balancing
the ethical principles of patient autonomy with established rules. In the end, I believe that Faden
and Beauchamp have more of a favor to sense1, stating that it is the true meaning of informed
consent and that the shared decision-making, which involves a legal definition that aligns more
with sense2, is confusing and rather ineffective.
The second article from Millum and Bromwich also talks about the ethical considerations that
need to be made about informed consent, but this is more focused on the topic of medical
research. For them, it breaks down into two different requirements. One is a disclosure
requirement, where the researcher must disclose all information that is relevant to the participant
and what the participant would reasonably be expected to be told. The second is an
understanding requirement which is that the participant should know that they are being asked
for consent, how to exercise their right to give or refuse consent, and what they are giving
permission for. What the authors emphasize though is that the main function of informed consent
is to make sure the consent is valid and there is a promotion of good communication and
decision making. There were cases presented where patients really didn’t know the full extent of
the research, but that consent was still valid if patients understood the key elements. This then
leads to the importance of effective communication which the article mentions current practices
involving obtaining consent, such as lengthy and complex forms, does not promote that. Rather
agree with and welcome some recent changes in regulations that utilize concise presentations
that give the key information to patients.
So, we can see how both articles discuss the concept and ethics behind informed consent,
though the first article focuses more on medical procedures while the second article is about
medical research.
Discussion questions:
1. How do you define “informed consent”?
2. What is the balance between patient and rules? Whose rights should take precedence?
3. How much should a patient know/ be aware of before consenting?
4. What improvements/changes would you propose to enhance the ethical conduct of
research?
Notes:
• Noah takes an eliminative focus on informed consent, wants each consent form to be
unique to the study and the population group, so you can’t really define informed consent
in one concrete way.
• Some argue for a legal definition of informed consent to protect doctors.
• Without a definition, it leads to inconsistencies and grey areas.
• Consent is needed so doctors don’t take advantage of patients.
• Should have a legal decision, but room for adaptability.
• Adults can consent to whatever they please, but for a minor its different and the doctor
should take control.
• Parents would know best for their children.
• Cannot force anyone to do anything.
• Where should we draw the age of consent in a medical sense?
• What about children in an abusive relation with their parents
• Physicians should report to authorities but should sustain the patient.
• Should be a check list of things being ticked off such as risks/procedures act.
• And allows for patients to ask to follow up questions.
• If the side effects are headaches its less sever then a side effect of kidney failure
• Should make consent forms easier to understand and shorter.
• No pregnant woman wants to enter research trial.
• Consent is more of a humanities problem than a legal one.
Summary of the discussion:
There were a lot of tangents to the main conversation of informed consent, but the summary of
how the discussion ended is as follows. Firstly, that we should have a legal definition for consent
to protect doctors (and hospitals). But the challenge is that we wanted there to be some fluidity
so we can adapt it to different situations. When it came to whose rights should trump all is that
the patient ultimately had free will and autonomy, but it then got complicated when it came to
minors and where we draw the line of the age of consent. Finally, kind of combining the last two
questions, patients should ideally know and understand all essential elements of a research
experiment before consenting, and we can do better by presenting information in an effective and
concise way, and if the participant has any questions or concerns, they should be an environment
where they are able to facilitate this.
Response:
Overall, I was happy with the discussion we had, though a little hectic at sometimes. As always
there are points and flaws to both sides, but I took away that in the end we came to an eventual
agreement on most things. What really came to a point for some people was patient autonomy
and how much emphasis we put onto it. Some believed that the doctor should do what they think
is in the patient’s best interest, even if the patient doesn’t necessarily agree with the procedure,
while others believed we should respect people’s decisions. I didn’t expect for some people to
believe that there was no need for us to define consent or the fact that we should just experiment
wildly on animals, and the conversation also took a turn to vaccines which I want entirely
expecting either. Finally, the crux problem of informed consent is how much should the patient
understand and how much should the researcher disclose. The one point that really clicked with
me was the line “could impair kidney function”, and the fact that people might not even know
how their kidneys function. So, the problem is that even if we disclose information, how specific
should we get, which could lead to making forms longer and more complex. I believe a solution
is to create a safe and trusting environment so that when a participant receives a form, that is
concise and shorter, they can freely ask questions so that they can fully understand the aspects of
the research.