True Informed Consent Requires Understanding And Trust From Patients
By Kathryn Kelly, MD, founder and medical director, Kelly Collaborative Medicine
In clinical research, the need to obtain informed consent requires us to make participants fully aware of the nature of a clinical trial, including its risks and benefits. We must be able to demonstrate that participants voluntarily agreed to take part in a trial with an understanding of the research and its possible outcomes.
Certain best practices are clear: We must be honest and transparent. We must use language that is easy to understand and take time to assess the participant’s level of comprehension. The communication should take place as a discussion – an interactive process.
If the participant is not a confident English speaker, it is important to either have staff who are truly fluent in the participant’s language or hire a medical interpreter. The individual must speak to someone who understands nuances and colloquialisms in their language.
Furthermore, we must keep careful documentation of the patient’s consent. New findings or changes must be communicated to the patient during the study and, if applicable, we must obtain ongoing consent. It must be clear to the participant that they can ask questions whenever they arise, and that the individual has the appropriate contact information to do so.
These are vital elements of the formal process, but acquiring true informed consent involves much more. Obtaining true informed consent should be ongoing, a dedicated effort to build trust, respect, and understanding within the communities we serve.
Culture And Bias
For many groups, the challenges of giving consent begin long before they join a specific study. Health inequity continues to impact many patient populations, and as a result, limits their knowledge — and often trust — of clinical research. Consequently, these patients may have more difficulty understanding what a clinical trial entails, including the specifics of their medical condition and possible outcomes from the study.
Historical events may also contribute to the significant mistrust some patients feel toward clinical research. In the Black community, for example, a strong collective mistrust is fueled by events such as the Tuskegee syphilis study, the mistreatment of Henrietta Lacks, and other incidents of historic bias encountered by members of their community within the healthcare system.
We can tell prospective participants about safeguards that have been put in place, including the use of institutional review boards to ensure compliance with regulations set by the Department of Health and Human Services and the FDA, as well as state and local entities, and we may gain the trust of some. We can tell participants that the review boards include community representatives and operate independently of trial sponsors and investigators, and we may earn the trust of more.
But most importantly, we must listen to the patient. It is vital to walk into the room unbiased, ready to investigate and understand the patient’s perspective.
Some cultures have dramatically different views on medicine, illness, and the cause of disease. Some have family and social decision-making structures that may weaken the individual’s agency. Some patients may be entirely unavailable for any trial procedures on certain days or months due to religious practices. It is vital to uncover these factors, respect them, and understand them as part of the true informed consent process when we engage with trial participants.
Trust And Representation
As a physician, I know that trust is central to my practice. Trust is symbiotic. When I can earn the trust of my patients, this then allows me to provide them with the best care I can.
One advantage of embedding clinical trials at the point of care is that some study participants are already my patients, so we start from this foundation of understanding. For those who are not current patients in my clinic, it is important to prioritize connection and understanding right from the start. I want to establish trust and help them understand that I strive to always provide the best medical advice I can. Sometimes, that means encouraging them to enroll in a clinical trial. Sometimes, we may agree that research is not the optimal care option for them at that time.
Trust is also built by providing communities with greater access to the medical care they need. More experience and regular touchpoints with healthcare professionals not only bolsters the patient-physician relationship but also increases the likelihood that diseases will be diagnosed promptly. The integrated care model lets us prioritize connecting communities and care.
Representation is another means to build trust: when patients see members of their community represented among researchers, trial staff, and physicians, they are more likely to trust us when we approach them about clinical trial opportunities. For example, Black women make up only 2.8%1 of all physicians in the United States. In my experience, patients of color often have better outcomes when treated by Black physicians, and there is research to support this.2 It is clear that a patient’s relationships with their physician affect their confidence in the medical system as a whole, and thus influence how likely they are to participate in a clinical trial as well.
Education Combats Misinformation
Once a patient is diagnosed, educating and coaching them (and potential caregivers) is important to help them understand their condition and any subsequent expectations of treatment during a clinical trial. However, this does not guarantee a simple or smooth informed consent process.
There is a lot of information — and misinformation — online today, and I have seen bias and digital algorithms heavily influence what patients believe.
This was especially evident to me in connection with COVID-19 vaccines. Many patients trusted me to treat their diabetes, high blood pressure, and cholesterol, yet they doubted the value of my information about the vaccine. I believe the greater the trust going into the situation, the greater the chances that a patient will accept our care recommendations. Trust is key. Ultimately, as physicians and investigators, we are responsible for offering clear, scientifically-backed information based on the existing knowledge that we have, being transparent about its origins and limitations, to empower the patient to make an informed decision. From there, we must leave it in the hands of the patient.
Safeguarding Vulnerable Populations
The blanket term vulnerable population is used widely in clinical research; however, it is important to acknowledge that there are often severe differences among the patients within these communities. How we treat our most vulnerable patients must correlate with the reality of their situation: their ability to give informed consent will influence our decision about proposing clinical trial participation.
For example, my practice, based in Silver Spring, Maryland, and part of Privia Health, has contracted with the homeless shelters in Montgomery County for primary care. We also run the county’s homeless medical respite. I provide care for individuals experiencing homelessness, but I will not include them in clinical research. Members of this population are too vulnerable to give true informed consent.
Many struggle with mental illness, making it impossible to properly and reliably assess their competency. Those experiencing homelessness are also under extreme financial pressure. The strong need for monetary compensation can make them very vulnerable to agreement without true consideration and understanding of what they are consenting to.
There are times when it is beyond our capabilities to create true comprehension, and we must respect this. By staying alert and identifying such situations as early as possible during conversations with prospective participants, we can help protect vulnerable populations from potential harm. There are both rewards and risks involved with clinical trial participation, and a comprehensive understanding of both is an ethical requirement when obtaining true informed consent.
The Path Forward
As we work to develop new treatment options and ensure they are safe and effective across populations, it is imperative that we also prioritize community. By listening intently to patients’ needs and evaluating their situation with that same level of care, we can build mutual trust and understanding of clinical research well before a patient is approached about the opportunity to participate in a clinical trial.
References:
- Ly DP. Historical Trends in the Representativeness and Incomes of Black Physicians, 1900-2018. J Gen Intern Med. 2022;37(5):1310-1312. doi:10.1007/s11606-021-06745-1
- Alsan, Marcella, Owen Garrick, and Grant Graziani. 2019. "Does Diversity Matter for Health? Experimental Evidence from Oakland." American Economic Review, 109 (12): 4071-4111. DOI: 10.1257/aer.20181446
About The Author:
Dr. Kathryn Kelly, MD, is a board-certified internal medicine physician working in the Washington, DC, area. She is the founder and medical director of Kelly Collaborative Medicine, an affiliate of Privia Health, in Silver Spring, Maryland.