Palmer Montalbano recommends using public policy that reinforces altruism as a solution to the problem that truly informing patients about the risks of participation in cancer research trials would hinder recruitment.

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According to recent data from the US, approximately 6% of the thousands of eligible cancer patients sign up for medical research trials. Many of these patients, who have exhausted all other treatment methods, sign up for Phase I cancer studies. However, most patients fail to understand that Phase I trials are not designed to benefit them, but are instead meant to test toxicity levels of new drugs. The misalignment between research intent and participant understanding, called “therapeutic misconception”, poses a threat to informed consent. If someone does not understand the purpose of a study, can they really agree to participate?

One major reason why therapeutic misconception exists is because of the incentive systems inherent to research – participants need to be recruited for studies, and recruitment can be difficult. To stress the risks taken by subjects disincentivizes participation, which hinders a researcher’s work. Whether consciously aware of this bias or subconsciously influenced by the system of rewards, researchers are in the difficult position of needing to recruit participants and ensuring they give proper consent.

Photo Credit: Alex Green/Pexels. Image Description: An interviewer writing in notepad and talking to a research participant.

Another reason therapeutic misconception persists is humans hold on to beliefs despite information to the contrary. People will maintain an opinion even after presented information that contradicts their beliefs. If a patient believes a study will have therapeutic benefits, it is difficult to sway that view. This type of motivated reasoning also impacts decision-making because patients cling to hope for cures. A patient may generate a feeling of hope within milliseconds of hearing about a research trial, which influences the reasoning that follows. Patients likely interpret information in a way that aligns with their preconceived emotions.

Many believe that cancer trials would fail to recruit enough participants if subjects correctly analyzed the risks and rewards of participating in Phase I trials. Few, they say, are altruistic enough to undergo more pain at the end of their life without hope for some personal benefit. However, I think this attitude is a mistake.

Some argue it is acceptable to exchange hope to understand dosage safety. Others want doctors, who have their patient’s best interests in mind, to help inform patients of the risks and benefits of trials. However, little effort is made to change the values of patients, and society, in favour of altruism – an approach that should be explored.

By stating that nobody is altruistic enough to truly participate in research trials, we reinforce self-oriented hope as the appropriate response to cancer research. Instead, we can promote the virtue of altruism to change the behaviour of both researcher and patient to obtain true informed consent. One option is to highlight the importance of the sacrifices subjects have made to the proliferation of medical advances. We praise and distinguish first-responders for saving lives during times of crisis, military service members for defending our nation, and political activists for promoting human rights and peace. We could apply this praise as well to those who participate as subjects in biomedical research, administering rewards such as national medals, publication of names in reports, and declaring a national holiday for individuals who sacrifice for the advancement of science. By presenting human subjects as heroes putting themselves at risk for the benefit of others, individuals may be more willing to acknowledge the risk they are taking and still agree to participate based on a desire to be heroic rather than for personal benefit. Researchers would then feel less pressure to misrepresent information if they can achieve the necessary number of participants. Perhaps this approach would spill over into other areas of society and encourage more altruistic, communal behavior.

An objection to this recommendation is that promoting altruism creates an opportunity for research organizations to reduce compensation for research participation, since subjects might participate without compensation. However, there is no level of compensation that can appropriately address the end of human life. Instead of trying to balance dollars against immeasurable value, we should focus on respecting persons while they live, which includes obtaining truly informed consent.

Others would say this approach to therapeutic misconception would be either ineffective or coercive. I acknowledge this approach may fail to encourage enough altruism to change patient intent and behavior, yet it would still be a valiant attempt at increasing informed consent and could benefit society in other ways by encouraging thinking of others rather than ourselves. Current practices are more coercive than encouraging good behaviour. In the case of praising altruism, there is no harm to non-participants, and the benefits are not so large that they obscure the decision. A public medal or an inscription on a statue is a small benefit for risking one’s health. But a feeling of pride for having contributed to new drugs that saves lives? That is a reward worth pursuing, even at the end of life.

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Palmer Montalbano is a Master of Science student in Bioethics at Harvard Medical School.