Season 4, Episode 5: Suspicious Minds
This episode and the previous one featured very ill patients - Wes with his resistant HCV and a woman in Lincoln, Nebraska, who is infected with vaccinia virus - each of whom were faced with a choice of whether or not to undergo experimental treatments. On the one hand, each of them would likely die without treatment, but on the other hand, the treatments might not help them at all and might actually speed up their deaths! It's not an easy choice for them to make - but it is their choice.
What is autonomy?
Autonomy means, literally, to self-rule or self govern. A political term, originally cited in ancient Greece, it referred to independent cities or states that were able to make their own laws.
In the modern context of health care, it is used to refer to the ability of persons or patients to make decisions about themselves. Respect for the autonomy of others is one of the most important guiding principles in health care and health care research, as mentioned in a previous installment of ReGenesis: Science & Society.
Many believe that respect for the autonomy of persons should override any other ethical considerations, such as whether a treatment is thought to be in a person's best interests. Although this is the subject of ongoing debate, it remains that respect for autonomy forms an important part of the foundation of Western societies - not just in health care, but also in all aspects of life and lifestyle choices.
In Canada, our ability to freely choose how we live, raise our children or express ourselves is protected under the Charter of Rights and Freedoms. In the United States, liberty and the rights of the autonomous individual are embedded in the US Constitution.
Why so much talk about autonomy in health care?
In the past, most health care professionals - e.g., nurses and physicians - were entrusted to make decisions on behalf of their patients. Patients accepted that their health care providers had unique and special knowledge that enabled them to make decisions in the best interests of others, and so they often deferred important and highly personal decisions to their health care providers.
This approach, sometimes referred to as "paternalistic", has for the most part been replaced over the past couple of decades with an approach that acknowledges that persons and patients should have the right to make informed decisions about their own health. In other words, people should have the right to "self rule".
Underlying this newer approach is an understanding that while health care professionals may well have special knowledge, ideas about what is in one's best interests are highly subjective and variable among diverse persons, as are individual values and beliefs.
What about respect for autonomy in health care research? Is it different?
In the context of health care research, autonomy underlies the concept of informed consent. This is the right of research participants to be informed about the research in which they are thinking about participating. Informed consent involves two aspects: cognitive (capability) and volitional (voluntariness).
The cognitive requirement of autonomy states that participants must have the ability, or capacity, to understand all aspects of the research. This means that they must be able to understand and give due consideration to what the research goals are, what their participation would involve, the risks and potential benefits of the research, and how the researchers would protect their privacy and keep information about them confidential. Researchers must ensure that this information is communicated to potential participants at a level which they can understand and provide the opportunity for those individuals to ask questions.
The volitional condition of autonomy refers to the ability of the person to freely volunteer to take part in research, without feeling forced or subjected to undue influence or coercion.
Sounds good, right? Well, when we think about whether patients actually do understand all aspects of research and whether or not they are truly able to freely volunteer in health care research - and in particular, high-risk research like we saw in these episodes of ReGenesis - a few red flags are raised. Why?
Risks and harms
When we are talking about risk in research, we are talking about risk of harm, but not just potential physical harm. It can also refer to: psychological harm, such as being unduly distressed or upset; social harm, such as being embarrassed or exposed in front of people; or financial harm, through loss of income or missed time from employment. It's also important to note that harm is a subjective notion; that is, it is different for each one of us and so any risk of harm must be assessed by each and every participant before they make a decision to participate.
The degree of risk may also differ from person to person, depending on state of their physical and emotional well-being. For a healthy person, having blood tests as part of a research project involves little risk, most of which is related to bruising and minor discomfort. However, to a person who is desperately ill or has a profound fear of needles, having a blood test might involve a higher risk. Researchers have an ethical obligation to consider the potential risks to which individual participants in their research may be exposed.
When we consider very low risk health research, or research that is very unlikely to cause any harm to participants, while it is still important that participants are fully informed and volunteer freely to participate, the stakes are simply not as high. However, with high risk health research, the stakes are much higher as the chances that participants might be harmed if they take part in the research are much greater. This makes it all the more important that people thinking about participating in research understand what participation entails, what the potential benefits might be, and what risks they might face.
Research involving very high risk is usually only allowed in situations in which the potential benefits are also very high - like the possibility that an experimental treatment might save a person's life when all other treatments have failed. Like Wes, many potential participants in high-risk research are in critical health situations in which the research intervention represents a "last chance" at a cure or amelioration. In these kinds of situations, however, a concern arises because participants may be highly vulnerable, emotionally upset, distressed or willing to expose themselves to significantly high risks even when the possibility of getting individual benefits is very remote. Additionally, their decision-making capacity may be affected by their illness.
These are important ethical considerations for researchers to think about when they are explaining the risks and potential benefits of high-risk research to patients during the informed consent process. This is not to say that those in critical health situations are unable to make autonomous decisions. Not at all. Simply put, the stakes and the risks are much higher; therefore researchers have to be that much more careful and rigorous during the informed consent process. In Wes' case, Rachel was very clear with him that the experimental treatment might kill him - which it almost did! - and yet, he weighed his options and decided to proceed anyway.
So?...
It turns out, unfortunately, that the experimental treatments didn't help the woman in Lincoln and did not cure Wes. In the real world, this would not come as a big surprise. Health care research rarely offers direct benefits to individual participants. Research is far more likely to benefit future generations of patients. Indeed, for many participants, the drive to participate in health care research is highly altruistic rather than born of concern for one's self. Thankfully, there are many people willing to take part in research; without them, we could not hope to develop new, more effective, and safer treatments for all that ails us.
-- Nancy Walton, PhD
About the Author
Dr. Nancy Walton is Associate Professor and Associate Director of the School of Nursing, Faculty of Community Services, at Ryerson University in Toronto. She is also the Chair of Ryerson's Research Ethics Board. She has a PhD from the Collaborative Program in Bioethics at the University of Toronto and is currently a member of the National Council on Ethics in Human Research.
Want to read and learn more?
For more on research ethics in Canada, visit these sites:
http://www.ncehr-cnerh.org/english/home.php
http://pre.ethics.gc.ca/english/policystatement/policystatement.cfm
For more on global research ethics and policy, visit these sites:
http://www.wma.net/e/policy/b3.htm
http://www.who.int/ethics/research/en/
To read more about autonomy, try clicking here:
http://plato.stanford.edu/entries/personal-autonomy/
http://plato.stanford.edu/entries/autonomy-moral/
