Personal Choice in Research: Respecting Reasons for Participation and Nonparticipation

As researchers, we rely on the willingness of people to participate in our studies, and participant recruitment and retention continue to be one of the biggest challenges. There are numerous reasons for this, some that we can address and others that we might just have to accept.

An FHI Clinical team member recently described her experience with the unwillingness of her mother, who has mild dementia and for whom she’s a caregiver, to participate in a clinical trial. Yet, when presented with the opportunity by her neurologist, her mother opted out — she didn’t like the idea of being reminded of her dementia and her “deteriorating” state. This reaction by her mother emphasized to her that clinical research might not appeal to everyone or tell the person’s whole story.

Hearing her story also prompted our team to consider a component of research that can be overlooked as we move through our day-to-day activities of planning and conducting trials — the personal reasons for choosing whether to participate in research. 

Check out this article to read more about how Joy Toro, Senior Clinical Strategy Director, balances her experience as a caregiver for her mother, healthcare accessibility and representation in clinical trials.

If we take a moment and consider the trends of participation, we might recognize three groups of potential participants those who:

  1. Always show a willingness to participate
  2. Have some barriers to participation
  3. Are just not going to participate
Acknowledging where we can or should intervene, while respecting people’s wishes, can be an important component of successful recruitment and retention.
Sign me up!

The enthusiasm of some people to step up and say yes to research can be refreshing, especially in a trial for which recruitment has been particularly challenging. This willingness can stem from:

However, only tapping into this ever-willing population comes with some drawbacks, including potential disparities in clinical trial enrollment that could have important downstream effects. If the trial sample has an over-representation of people who are more likely to have the means (higher socioeconomic status), time (older, retired, unemployed) or access (close proximity to research centers), the generalizability of the findings to patients seen in real-world practice could be compromised.
I might need some convincing...
This potential lack  of inclusivity and representativeness in trials is one reason why so much attention has been paid to how to encourage more hesitant people to participate in research. Important barriers include:
Similarly, solutions to these barriers have received focus from the research community — what can we design into the trial to make it easier or less inconvenient for people to participate? Practical considerations such as financial assistance for trial-related out-of-pocket expenses, remote visits, providing transportation and offering child care on site can make it easier and less costly.6 Emotional reservations and lack of awareness could be overcome by educating physicians and other healthcare providers about research opportunities, building relationships with the patient or person before asking them to participate, involving community leaders in recruitment and providing culturally sensitive and relevant trial materials. The trial itself can be re-evaluated to determine if all secondary endpoints are necessary or could be collected in smaller sample subsets, whether the frequency of data collection could be reduced or if some endpoints could be collected remotely.
I'm just not interested.
Yet, despite all of our best efforts, there will inevitably be people who are just not interested in participating, and, admittedly, it is unreasonable to expect everyone to participate in all research. For example, a recent survey found that 90% of adults in the United States agreed that clinical trials are important to advancing science, yet a large proportion (45%) also stated that it is not important for everyone who is eligible to take part in a clinical trial.10
For some conditions, fatigue and being “too sick” can be major obstacles, where even agreeing to participate can be viewed as a significant obligation in the face of difficulties with performing relatively normal daily tasks.6 Others can feel overwhelmed by their health issues,9 and the perceived burden of participation can outweigh the potential benefits.7 This extends to caregivers, for whom the act of providing care for a loved one can be time-consuming and emotionally draining, let alone adding the responsibilities of research. The burden of participating in these cases can impact the psychological well-being of the participant and caregiver(s) as well as the ability to cope with a diagnosis and the resulting decrease in health.
And it's okay.

So, at the end of the day, we can and should address potential barriers to participation. To ensure our efficacy and safety findings can be applied to the people affected — whether by a disease or the outcomes of a vaccine or preventative treatment — we need to perform our due diligence to include a sample of people in our research that is representative of that larger population. At the same time, take a moment and remember that we are asking a favor of complex human beings who might be going through one of the toughest parts of their lives. And it’s okay for them to say no.

References
  1. Godskesen T, Hansson M, Nygren P, et al. Main motives behind participation in clinical cancer trials. Eur J Cancer Care 2015;24:133-141. https://doi.org/10.1111/ecc.12184
  2. Moorcraft SY, Marriott C, Peckitt C, et al. Patients’ willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials 2016;17:17. https://doi.org/10.1186/s13063-015-1105-3
  3. Browne JL, Rees CO, van Delden JJM, et al. The willingness to participate in biomedical research involving human beings in low- and middle-income countries: a systematic review. Trop Med Int Healt. 2019;24(3):264-279. doi:10.1111/tmi.13195 
  4. Townsend A, Cox SM. Accessing health services through the back door: a qualitative interview study investigating reasons why people participate in health research in Canada. BMC Med Ethics 2013;14:40
  5. Madsen SM, Holm S, Davidsen B, et al. Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials. J Intern Med 2000;248(6):463-474. doi: 10.1046/j.1365-2796.2000.00755.x.
  6. Bixo, L, Cunningham, JL, Ekselius, L, Öster, C, Ramklint, M. ‘Sick and tired’: Patients reported reasons for not participating in clinical psychiatric research. Health Expect 2021; 24(Suppl. 1): 20– 29. https://doi.org/10.1111/hex.12977
  7. Barnes M, Wiles N, Morrison J, et al. Exploring patients’ reasons for declining contact in a cognitive behavioural therapy randomised controlled trial in primary care. Br J Gen Pract 2012;62(598):e371-e377. doi:10.3399/bjgp12X641492
  8. Nipp RD, Hong K, Paskett ED. Overcoming barriers to clinical trial enrollment. American Society of Clinical Oncology Educational Book 2019;39:105-114. doi: 10.1200/EDBK_243729
  9. Wanger T, Foster NR, Nguyen PL, Jatoi A. Patients’ rationale for declining participation in a cancer-associated weight loss study. J Cachexia Sarcopenia Muscle 2014;5(2):121-125. doi:10.1007/s13539-014-0128-z
  10. Public Perception of Clinical Trials. Research America 2017 Available at: https://www.researchamerica.org/sites/default/files/July2017ClinicalResearchSurveyPressReleaseDeck_0.pdf. Accessed on March 2, 2022.
  11. Nipp RD, Lee H, Powell E, et al. Financial burden of cancer clinical trial participation and the impact of a cancer care equity program. Oncologist 2016;21:467-474.

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