The willingness of human research participants (people who enter studies conducted by researchers) is critical to the progress of scientific inquiry and the development and testing of new medical treatments. Yet, very few people relative to the number of patients with a condition, or healthy people in general, actually participate in research. This may be due to a number of factors, not limited to lack of awareness, lack of time, or logistical constraints, such as availability of transportation. More importantly, potential research participants may be wary of getting involved in research. Well-publicized abuses in past research studies, such as the Tuskegee Syphilis Study, do not make such wariness unfounded, and even hesitation based on a lack of familiarity with the research process or the protections afforded research participants is understandable, especially when one is faced with a life-threatening condition.
Current oversight of publicly and privately funded research is strong, and has been responsive to correcting past practices that would today be deemed unethical (such as conducting invasive testing on prisoners, who, because of their confinement and lack of options, are now considered a group that require special protections). Research conducted at medical institutions and universities must pass thorough review by an Institutional Review Board. These ensure that all research adheres to ethical guidelines, including informed consent of those agreeing to participate and procedures to reduce any harms and ensure privacy.
Nevertheless, some of the procedures commonly understood by researchers to be essential for scientific rigor may make potential participants uncomfortable. For instance, randomly assigning individuals to experimental conditions is necessary to balance groups on factors that could muddy the results of the research. This, however, may go against potential participants’ desire to have some autonomy in the process of determining their treatment, and is unfamiliar because it is unlike the way that clinicians typically devise a treatment plan, whether it be for physical or mental health, for their patients.1
In deciding whether a research study or a clinical trial is right for them, potential participants should be armed with some knowledge. First, participating in a clinical trial can give patients access to a new treatment that is unavailable elsewhere, something that patients are often quite eager for, but this treatment is also, by definition, untested, meaning that its effects are unknown. A principle known as “clinical equipoise” means that an experimental treatment can only be ethically pitted against a control or standard of care treatment in a clinical trial if it is unknown which would be the most effective treatment. A benefit for trial participants, however, is that even if assigned to a control condition, this condition may be the standard of care, delivered in a state-of the-art manner. Alternatively, participants may be offered an experimental treatment after a trial is completed as part of what is called a wait list control. Patients should be advised that they need to be clear about what treatment costs will be covered by the trial and which would be borne by themselves or their insurance carrier, as trials do not typically provide extended care or complete health care. By having one’s usual health care provider work with the research team, a patient can make sure that the study procedures will not conflict with other medications or treatments that he or she is receiving.
Recent reports suggest that as new experimental treatments for cancer are being developed there is a paucity of participants available to enter trials, especially for rare cancers.2 So, patients who do get involved in clinical trials can be assured that they are contributing in important ways to medical knowledge, and will receive good care as part of being in a trial. How can one learn about clinical trials? Sometimes health care providers, especially if they are part of large research centers, will be a point of contact for these. Clinicaltrials.gov is a database of clinical studies that can connect patients, their family members, and health care providers around the world with potential research studies on a variety of diseases and conditions. It is a government web site that does not receive funding or advertising from commercial entities or display commercial content. Available trials involve medical and psychological interventions for people with or at risk for cancer. Researchmatch.org is another more general site that helps recruit human research participants.
For those interested in learning more, the National Cancer Institute (NCI) provides information on clinical trials as well as a cancer specific database of trials sponsored by the NCI, https://www.cancer.gov/about-cancer/treatment/clinical-trials. This includes information on what clinical trials are, who pays for what, ethical oversight, how to decide to take part, as well as important questions to ask.
1. Moyer, A. (2009). Psychomethodology: The psychology of human participation in science. Journal of Psychology of Science and Technology, 2, 59-72.
2. Kolata, G. (2017, August 12). As cancer drug tests multiply, some struggle to find patients. The New York Times, p. A1.