Background: Participation in clinical trials among people with disabilities, particularly developmental disabilities (DD), has been limited. Nurses, particularly those providing navigation, can play a key role in educating patients about clinical research.
Objective: To explore oncology nurses’ reports of the inclusion of individuals with DD in clinical trials.
Methods: We surveyed the oncology nurses working in a large statewide outpatient provider network that conducts clinical trials about care for their adult patients with DD. The online survey included questions about their professional background and care of patients with DD, as well as items about referral and participation of patients in clinical trials.
Results: Nurses in this sample worked as oncology nurses for 12 years on average, and 65% had provided care for between 1 and 6 patients with DD. Seven respondents had not cared for any of these patients. Among the 69 nurses who responded regarding clinical trial referrals, only 16 indicated that, to their knowledge, eligible patients with DD were referred for clinical trials; 7 were aware of patients with DD who did participate.
Conclusions: Concerns about patients’ ability to voluntarily consent to participate in research must be balanced against the ethical principle of the right of individuals with disabilities to participate fully in healthcare research. This study’s results suggest that much work remains to be done to make clinical trials accessible to cancer patients with DD. Nurses, along with other healthcare professionals, must understand how to educate, recruit, and retain patients with DD in clinical research. This includes fostering informed consent for potentially vulnerable groups and overcoming other barriers to clinical trial participation.
Adults with developmental disabilities (DD) acquire their disabling conditions before age 22, and these conditions generally last throughout each individual’s life. They include conditions such as autism, cerebral palsy, Down syndrome, and hearing and vision loss. For the 7.4 million individuals with DD in the United States, the resulting impairments, whether physical or disabilities in learning, language, or behavior, can impede day-to-day functioning.1 These conditions can make access to good quality healthcare challenging, including for those diagnosed with cancer.2-4 Indeed, historically, cancer patients with various disabilities have experienced disparities in cancer care.5-8
As reflected in the NCCN guidelines,9 one aspect of quality patient care is access to clinical trials, which should be designed to promote broad representative patient enrollment. Nevertheless, although clinical trials are essential for evaluating new treatments to improve patients’ care, participation in clinical trials remains relatively low. In addition, disparities in clinical trial participation can result in unequitable translation of research findings to practice, and targeted strategies are needed to reach diverse patient populations. The National Cancer Institute10 has reported that 70% of people look to their healthcare providers for information about clinical trials, but providers may be reluctant to include adult patients with disabilities in clinical trials because of concerns about their ability to provide informed consent or their ability to engage in studies’ procedures.11 In a review of clinical trials funded by the National Institutes of Health (NIH) from 2018 to 2021, researchers found that the eligibility criteria in 75% of the identified studies directly or indirectly excluded adults with intellectual disabilities.12 Indirect exclusion—perceived as opposed to objectively assessed inability to participate—was found in nearly 65% of the studies. For example, the common requirement that study participants must be able to read and write English may exclude not only those whose first language is not English, but also those with some intellectual disabilities. The review’s authors concluded that excluding individuals presumed to lack the capacity to provide consent is rarely scientifically justified. In a review of 2374 clinical trials registered from 2010 to 2020, Camanni et al13 found that those with emotional and behavioral disabilities followed by those with intellectual disabilities were most likely to be excluded. More recently, Agaronnik et al14 reported that among clinical trials listed on ClinicalTrials.gov between 2019 and 2023, researchers often excluded cancer patients with more restrictive functional status than the draft Food and Drug Administration guidelines. None of the studies they reviewed listed accommodations they had made so that people with disabilities could participate.
In its guidance for investigators and institutional review boards, the NIH has recommended that categorical exclusion of certain populations from clinical trials should be avoided.
Because disparities in clinical trial enrollment can hinder the equitable and effective translation of research into practice, it is critical to implement targeted strategies to increase recruitment and participation rates across diverse patient populations. In its guidance for investigators and institutional review boards, the NIH14 has recommended that categorical exclusion of certain populations from clinical trials should be avoided: “Impaired decision-making capacity need not prevent participation in research, but additional scrutiny and safeguards are warranted for research involving individuals with such impairments.” In addition, barriers to participation, such as lack of transportation, concerns about costs, or lack of accessible patient information about clinical trials, should also be addressed.
Nurses play a key role in patient education, so they can be instrumental in educating adult cancer patients about clinical research. Therefore, in this study we explored oncology nurses’ perceptions of the inclusion of individuals with DD in clinical trials.
Data were collected via an online survey. Following an exempt determination from the author’s institutional review board (Study 00004179), we recruited nurse participants from a statewide network of outpatient oncology providers in Texas. As of 2022, the network included 282 clinics and cared for 497,664 patients; 53 locations offered clinical trials. More than 2200 patients in the network have been enrolled annually in clinical research. The network’s director of nursing sent network oncology nurses, including licensed vocational nurses, registered nurses, and advanced practice registered nurses, an email invitation to complete an anonymous Qualtrics survey concerning care for patients with DD. The invitation described the study’s purpose and stressed that the nurses’ participation was voluntary. One month later, a reminder notice was sent to encourage nurses to return the survey.
Survey participants consented online to participate in the survey. In addition to completing questions about their professional background, role in their clinics, and care of patients with DD, the nurses were asked a series of close-ended questions about referral of patients for clinical trials, and whether patients with DD participated in clinical trials.
One hundred twenty-two usable surveys were completed, with 72 respondents answering the questions about referral of patients for clinical trials. The sample consisted of nurses who had worked in oncology for 12 years on average; 59% were oncology-certified nurses. One-fourth of the nurses were primarily chemo/infusion nurses; 19% were primarily managers/administrators; 13% were primarily medical oncology nurses; 8% were primarily desk nurses; 11% identified as research nurses; and another 11% were nurse practitioners/clinical nurse specialists. Patient navigation support is integrated into the role of many nurses in the network. Sixty-five percent of the nurses had cared for 1 to 6 patients with DD; 7 had not cared for any patients with these disabilities. Although half of the respondents had a friend or family member with DD, 54% reported no previous training to work with patients with DD.
Only 16 nurses indicated that to their knowledge, eligible patients with DD were referred for clinical trials (Table 1). Among the nurses who answered the question about those who were referred, 7 were aware of patients with DD who participated, and 1 reported that patients with DD were not interested in participating in clinical trials. The remainder responded that they did not know whether any of their patients with DD participated in clinical trials. One nurse added the following: “I had a cognitively delayed patient who qualified for a research trial; however, research team dismissed this patient as a candidate because ‘they wouldn’t be able to understand or consent.’”
To our knowledge, this is the first study to explore outpatient oncology nurses’ understanding of clinical trial participation among cancer patients with DD. Because patient education is a key component of the oncology nurse’s role, it is important that oncology nurses, particularly nurses who provide patient navigation support, understand how to educate patients with DD about clinical trials. This includes providing accessible educational materials for patients and involving individuals whom these patients trust in order to obtain voluntary informed consent. At the same time, nurses should be aware that because people with DD have historically experienced mistreatment in research, they may encounter individuals who are wary about engaging in medical research.16 As Paabo and West17 have pointed out, nurses who help their patients navigate either the clinical process or participation in clinical trials can provide important information and address misperceptions by building trust and rapport with their patients.
Of course, the results presented here must be interpreted in light of potential selection bias resulting from a convenience sample recruited from an outpatient clinic network in a single large state. In addition, self-reported data may be subject to recall bias or possible lack of clarity in survey questions. Moreover, nurses not directly involved in the clinical research process may not be aware of all the clinical trial participants with DD in their network. Nevertheless, the fact that only 16 of 72 nurses reported that eligible patients with DD were referred for clinical trials and only 7 patients participated suggests that much work remains to be done for clinical trials to be accessible to cancer patients with DD. As one respondent’s comment suggested, concern about the ability of these patients to give informed consent for research participation can be a major factor in clinical research decisions about not referring them for clinical trials. Because physicians are often the lead investigators on clinical trial studies or the ones who first inform patients about studies in which they might consider participating, they are often in a position to exclude people with DD from clinical trials if they decide patients might lack the ability to participate. Therefore, additional training is needed for physicians, nurses, and other members of research teams about inclusion of people with DD. The training could address accommodations to recruitment procedures, simplification of informed consent documents, and appropriate modifications in research protocols (making materials available in alternative communication formats, for example) to involve adults with DD as appropriate. Other barriers to participation also remain to be addressed. These include unreliable transportation and lack of compensation for expenses such as taking off time from work, as well as potential concerns of patients, their families, and caregivers about participation in clinical trials.
Concern about the ability of these patients to give informed consent for research participation can be a major factor in clinical research decisions about not referring them for clinical trials.
Voluntary informed consent is vital to protecting the rights and well-being of research participants. There is a growing literature about how to enhance informed consent and overcome other barriers that may limit participation of those with DD.12,13,18 As shown in Table 2, strategies include using a design that incorporate alternative communication modalities, with plain language to make consent materials more understandable (this may benefit other groups as well). Other researchers have emphasized building a trusting relationship with potential participants, taking time to explain the study, using interactive questioning to assess understanding, and allowing time for people with DD to process the provided information and ask questions.12 This is especially important for individuals who might be vulnerable to coercion or undue influence in deciding about research participation. While we recognize the challenges of establishing informed consent with individuals with intellectual disabilities, the importance of promoting the right to be included in clinical research and make decisions about research participation is vital. Categorical assumptions about limited abilities of people with disabilities to consent to participate in research should be avoided.
Supported decision-making involves an individual who is trusted by the person with DD and who can help interpret the meaning of clinical trials information so that the adult with DD can make an informed decision about participating in research. Some individuals with DD have legally appointed guardians who must be informed about the individual’s research participation. In these situations, guardians must give consent, and the adult with DD must be allowed to assent to participate. These guardians, who are often family members, may have particular concerns about safety and undue burden on the patient, so that researchers seeking their consent must be prepared to thoroughly explain the clinical trial’s process and the procedures that are in place to protect the patient and minimize the burden of participation.
The ability to give voluntary informed consent will vary, depending on factors such as study design, risks associated with the research, safeguards used to minimize risks, and anticipated benefits of the research. Patients’ education about their participation should reflect these factors, and the NIH15 provides detailed guidance about how to convey study information to promote voluntary informed consent. Further guidance is available from projects such as Project CONNECT, funded by the Patient-Centered Outcomes Research Institute,19 about how to empower individuals with disabilities to participate in research. Researchers and those who assist them with recruitment need training to effectively implement these strategies. This training should address implicit bias about the capabilities of people with DD, which may be at the root of the restrictive indirect inclusion criteria found in previous research. In addition, staff should determine whether other barriers to participation in clinical trials exist in their facilities, such as inaccessible research spaces, or recruitment materials that should be revamped with universal design in mind.
In conclusion, concerns about patients’ ability to voluntarily consent to research participation must be balanced against the ethical principle of the rights of individuals with disabilities to participate fully in clinical research. Supporting them to participate in clinical trials not only demonstrates respect for them but also enables nurses and other healthcare providers to be fully informed about the effects of various treatments on people with DD. To promote equitable inclusion of people with disabilities in research, nurses and others involved in research should develop clearly documented scientific and ethical justifications for their studies’ eligibility criteria and avoid broad nonspecific language that can lead to the exclusion of categories of individuals. In addition, accommodations to facilitate informed consent and research participation as needed should be provided. As people with disabilities often remind us, “nothing about us without us.”
The authors have no conflicts of interest to disclose.
Partial funding was provided by The Shivers Cancer Foundation. The authors thank John Bellquist, PhD, for his assistance in editing this manuscript.
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