Facilitators,barriers,and recommendations related to the informed consent of Marshallese in a randomized control trial

Abstract

Background

The Pacific Islander population is the second fasting growing population in the United States and Arkansas is home to the largest Marshallese population in the continental US. The Marshallese community have significant health disparities with high prevalence of diabetes, heart disease, and obesity compared to the general US population. Using a community-based participatory research approach, researchers and Marshallese community stakeholders identified diabetes as the top health issue for research.

Methods

From 2014 to 2018, a randomized control trial was conducted comparing standard diabetes management education with a culturally adapted family model of standard diabetes management education delivered in participants’ homes by Marshallese community health workers and certified diabetes educators. Interviews were held with Marshallese participants to document their experiences with and perceptions of the informed consent process for this randomized control trial.

Results

Participants provided feedback on the process of enrolling in the study, describing barriers and facilitators to giving informed consent from their perspective, and offering recommendations for improving the informed consent process.

Conclusion

Findings suggest that informed consent with underserved communities, including immigrant and migrant populations who do not speak English or have limited English proficiency, is possible, and that using a community-based participatory research approach can help facilitate the informed consent process.

Keywords

Pacific Islanders Marshallese health disparities diabetes informed consent randomized control trial community-based participatory research

Introduction

The Pacific Islander population is the second fastest growing population in the United States (US) and has increased 40% from 2000 to 2010.^1,2 Arkansas is home to the largest Marshallese population in the continental US, which grew by 197% from 2000 to 2016.^3,4 In 1986, the Republic of the Marshall Islands (RMI) joined a Compact of Free Association with the US that allows Marshallese migrants to freely enter, live, work, and study in the US without a visa in exchange for US military control over a strategic base of operations in the Pacific.⁵ The Marshallese community have significant health disparities with a high prevalence of diabetes, heart disease, and obesity compared to the general US population.^6–13 In addition, many Marshallese are uninsured or underinsured^8,14,15 and encounter multiple barriers when accessing health care.^16–21 Addressing Marshallese health disparities is constrained by a complex history that includes the US military’s nuclear weapons testing program conducted in the Marshall Islands from 1946 to 1957.²² Sixty-seven nuclear devices equivalent to 7200 Hiroshima-sized bombs were detonated in the RMI.²² The nuclear tests contributed to the community’s health disparities because it contaminated local food sources and exposed many Marshallese to high levels of radiation.^22–24 US scientists conducted the Project 4.1 study to research the health effects of Marshallese exposed to nuclear radiation; however, the study was conducted without the informed consent of Marshallese participants and translation of study documents into Marshallese.^22,25–27 The historical trauma of Project 4.1 has caused many Marshallese to distrust researchers and be reluctant to participate in research.^28,29

Beginning in 2012, researchers with the University of Arkansas for Medical Sciences (UAMS) engaged the Marshallese community in a research partnership built on the principles of community-based participatory research (CBPR) of including community members in all aspects of research.^30–32 CBPR is a research paradigm that engages community stakeholders by sharing power and responsibility with the principal investigator over the research process.^32–34 CBPR has been demonstrated as an effective approach for research with populations facing barriers perpetuated by historical trauma.^35–39 UAMS researchers utilized a CBPR approach to engage Marshallese community stakeholders throughout the research process, from defining the research question, designing the intervention, to making decisions about budgets and staffing, and facilitating the dissemination of study findings to participants and the broader Marshallese community. A description of UAMS researchers’ engagement with the Marshallese community is described elsewhere.^30,31 Marshallese community stakeholders identified diabetes as the top health issue for research.³² From 2014 to 2018, UAMS conducted a randomized control trial (RCT) comparing standard diabetes management education (DSME) with a culturally adapted Family-Model DSME delivered in participant homes by Marshallese community health workers and certified diabetes educators. The protocol and results of the study are published in Contemporary Clinical Trials Communications and Diabetes Care, respectively.^40,41 The intervention and data collection were conducted in the participants’ language of choice (Marshallese or English) because most Marshallese either do not speak English or have limited English proficiency. During the study, interviews were held with participants to document their experiences with and perceptions of the informed consent process. Analysis of this interview data led to a number of insights about how consent practices, consent forms, and consent regulations effect research with the Marshallese community.

In the US, the Common Rule sets regulatory requirements for consent forms.⁴² The goal of the Common Rule is to give potential research participants detailed information on the study to ensure they understand all aspects of study participation and are able to make an informed and autonomous decision.^42,43 Informed consent documents used in health research studies have become more difficult to understand due to the increased disclosure requirements that often result in too much information for the average participant to process at once.⁴⁴ As a result, it is very common for research participants to have difficulty understanding the written information contained in consent forms.⁴⁵ While the Common Rule requires that informed consent forms present study information in concise, understandable language, challenges persist for vulnerable populations. This requires that researchers have informed consent conversations with participants while reviewing consent document to ensure informed consent from participants.^46,47

The challenges of understanding the consent process are most acute for those who do not speak English or have limited English proficiency, which includes recent immigrants, migrants, and refugees.⁴⁸ Consequently, Institutional Review Boards (IRBs) caution investigators to consider “the ethical/legal implications of subjects who do not understand English.”⁴⁹ Although such participants may give their consent, it is often not informed. A participant must fully understand the risks, benefits, purpose, and alternatives to participation before they can truly give informed consent. However, some IRBs do not allow a participant’s ability to read or speak English to be a basis for exclusion from the study.⁴⁹ The way investigators provide and convey the information necessary to obtain informed consent from participants who either do not speak English or have limited English proficiency is critical to promoting diverse, ethical human subjects research. IRB policies related to the consent of participants with limited English proficiency often include: having multiple consent options available, translating consent documents into the participants’ native languages, and having defined and specific roles and qualifications for research staff who facilitate the consent process.⁴⁹

This article presents qualitative findings related to Marshallese participants’ feedback on the informed consent process after enrolling in a RCT of a culturally adapted Family-Model DSME. In the RCT, informed consent documents were translated into the Marshallese language and were available in either Marshallese or English. The informed consent documents were developed with input from the UAMS Center for Health Literacy and used a plain language template that has been validated as improving overall readability of consent forms and has been specifically tested with people who struggle to understand health information.⁵⁰ Additionally, bilingual study staff were available during the informed consent process to review the consent document with participants and answer participants’ questions. The study staff obtaining participant consent explained the informed consent document and outlined the risks and benefits, alternative treatment arms, and requirements of the study. The consent process was conducted in a private setting and participants took as much time as needed to deliberate and decide about joining the study. Participants and the study staff obtaining the consent each signed the consent document, and participants were provided with a copy of the consent document. This article’s aim is to understand the facilitators and barriers of consenting from the participants’ perspective and to gain their recommendations on how to improve the informed consent process.

Method

Qualitative data were collected through interviews with 114 participants from 36 families. Families that chose to participate in the focus group interviews were assigned a household identification number. Thirty-six interviews were conducted with at least one primary participant and one or more family members. The 114 participants were drawn from the 432 participants who participated in the RCT of the Family-Model DSME. The study’s primary participants were 221 Marshallese adults aged 18 or older who had a type 2 diabetes diagnosis. Primary participants invited one or more adult (aged 18 years or older) family members to join the study; in this way, 211 family members were enrolled in the study, for a total of 432 participants. A full description of the study design is available.⁴⁰ All study procedures were reviewed and approved by the University of Arkansas for Medical Sciences Institutional Review Board (#203482) and are registered in clinicaltrials.gov (#NCT02407132).

All interviews were conducted in Marshallese by a bilingual study staff in the participant families’ homes or a private location selected by participants. A semi-structured interview guide was used to allow participants to share in-depth responses related to their experiences and perceptions. The interview guide ensured consistency across interviews. Each interview included at least one primary participant and one or more of his/her family members who were also enrolled in the study. Family members were included because as study participants it was important to capture their experiences in addition to primary participants. The interviews lasted approximately 30–60 min. Interviews were audio recorded and transcribed verbatim. Transcripts were translated from Marshallese into English and verified by a bilingual study staff member to ensure accuracy. Participants were provided with $20 gift cards as compensation for their time participating in the interview.

A qualitative descriptive design was used to explore participants’ experiences and perceptions related to their participation in the Family-Model DSME study.^51–53 Qualitative descriptive design does not focus on theory development but rather focuses on summarizing the experiences of participants and the meanings they ascribe to those experiences.^51–53 The study design allowed the researchers to document the facilitators and barriers to consent from the participant perspective. It also allowed the researchers to document participants’ recommendations for how the consent process could be improved. In particular, participants were asked about the process of consenting to participate in the RCT, with a goal of understanding the facilitators of and barriers to the consent process. Example interview questions included: (1) what aspects about the consent document were confusing to you?, and (2) is there another way that would make consenting to the study easier to understand or better for you?

After data collection, the research team began initial coding by naming each data segment with short summations to organize the data for more focused codes. The research team coded transcripts for both a priori and emergent themes and collaboratively discussed themes to ensure scientific rigor and intercoder agreement. Two researchers experienced in qualitative methods coded the data independently and an additional confirmation coder reviewed and approved the coded data. Codes were finalized and organized in a codebook. Marshallese staff provided feedback on qualitative coding throughout the process to ensure that nuanced meanings of participants’ responses and feedback were accurately captured.

Results

A total of 114 participants representing 36 participant families participated in an interview. The mean age of participants was 42.9 years old (SD = 14.7). Half were female. Table 1 presents participants’ characteristics.

Table 1.

Biometric and demographic characteristics at study baseline for focus group participants (n =114).

	Mean (SD) or %
Age	42.9 (14.7)
HbA_1c	8.0 (3.1)
BMI	30.9 (6.5)
Male	50
Married	55
Education
Less than HS	63
HS/GED	25
Higher than HS	12
Employed	43
Currently taking any diabetes medication	20

BMI: body mass index; GED: general education diploma; HbA_1c: hemoglobin A_1c; HS: high school.

Qualitative data are organized under the a priori themes: (1) understanding of consent, (2) facilitators of consent process, (3) barriers to consent, and (4) consent recommendations. Sub-themes that emerged under each a prior theme are also presented.

Understanding of consent

Participants reported that they fully understood the purpose of the consent process, stating “it was very clear for us and we understood everything” (Household [HH] 68). Participants also reported a lack of concerns related to the consent process because they “really understood it when you explained it” (HH 58). Participants also stated that they appreciated the need to understand the study before they signed the consent. “We also know that whatever we need to sign [to consent] we must understand before we sign” (HH 23). Many of the participants reported that they understood that signing the consent document indicated that they were agreeing to join the study and allow data collectors to obtain biometrics, such as height, weight, lipids panel, and blood pressure. For example, one participant explained that the consent form granted “permission for [data collectors] to come into our home and draw blood, to check our blood pressure” (HH 15). Another stated, “As for my understanding, the document that I signed was a permission to draw blood from me among other things regarding health-related matters and other information” (HH 87).

Facilitators of consent process

Two sub-themes emerged from participants’ discussions of the facilitators of the consent process: (1) use of verbal and written Marshallese native language in the consent process and all consent materials and (2) study staff effort and time to ensure understanding. Every participant reported that conducting the consent process in their native language was crucial to participant understanding. As one participant explained “we understand [the consent form] for it’s in Marshallese … we know what they [study staff] are saying” (HH 26). Other participants echoed the importance of in language consent to their understanding, reporting “we read the Marshallese copy” (HH 58) and “we really understood what [the consent form] is about and as we also get the Marshallese copy and read it” (HH 96). In addition, many of the participants stated that study staff used multiple methods and took the time necessary to fully explain the consent and ensure participants understood what they were consenting to. Participants stated “the person who read [the consent form] and explained the consent knew very well about the document and helped me understand it” (HH 78). Several participants reported they understood the consent process because study staff “explained it really well” (HH 81) and “we really understood the way it was explained to us and as they gave us the Marshallese copy we also read” (HH 102).

Barriers to consent

Participants reported barriers to the consent process that included: (1) poor health leading to participant errors and frustration with the process of re-consenting or correcting the consent, and (2) not remembering the purpose of consent as the study progressed. Several participants explained how their health status was a barrier to the consent process because poor eyesight, limited mobility, and pain often resulted in errors on consent documents that had to be corrected. Health problems “lead to mistakes happening when filling out documents and signing the consent” (HH 91). One participant explained that because of diabetes their “vision is not perfect” (HH 15) making the process of completing the consent document challenging. Similarly, another participant stated their “blurry vision is why some of the information provided were [written on] the wrong lines” of the consent documents and having to get up to retrieve their glasses to redo the paperwork “is painful especially to those that are hurting” (HH 91). Participants also reported distress with correcting consent documents. A participant explained that “having to sign the same consent repeatedly can be irritating and stressful” (HH 19). Another participant from the same household stated having to repeatedly correct consent forms “can be very stressful to do” even though it must “be done in order for the UAMS employee to submit clean, accurate documents” (HH 19).

Furthermore, participants in almost all interviewed households stated that they believed they understood the consent process as the time of consent but some participants were unable to fully recall the complete contents of the consent form at the end of the study. A participant recalled, “I understood at the moment because I signed [the consent form] but now I forgot most of it” (HH 81). Another participant stated “it has been months since” consent was completed and they “have forgotten most of it” (HH 91). One participant said, “I can’t remember because there were so many things” on the consent form (HH 26), while another explained they remembered signing “the document, but not everything from it” (HH 36).

Consent recommendations

Participants also provided their recommendations for ways to improve the consent process. These included: (1) consent refresher, (2) allowing study staff to correct errors, and (3) simplifying consent documents. Some participants suggested offering a consent refresher during intervention visits saying “so we can remember” (HH 15). Another participant stated “the consent should be repeated [and] explained half way through study” (HH 91) so its purpose is fully understood and not forgotten study by participants. Participants also offered recommendations related to ensuring consent forms were properly completed. Several participants suggested the study staff should be granted permission to correct participant errors on consent documents. For example, participants stated study staff “who are in charge of a study [could] sign on behalf of the participant in order for documents or consents to be accurate” or “just have the person obtaining consent make changes or corrections” (HH 19). Another participant said:

Instead of the UAMS employee having to bring back a new document for the participant to fill out and sign again, just have someone who works for UAMS to make the changes. We trust that the corrections made are honestly made. When UAMS have to bring back documents to be redone, it takes up everyone’s time. (HH 91)

Participants also expressed that simplifying the consent document language and content could improve the consent process. One participant suggested “maybe change the wordings and eliminate sentences or contexts that are not necessary” (HH 19) to ensure the consent form is in plain language and understandable. Another participant explained that “the area where information of the participant should be filled out and signed” (HH 91) should be made as simple as possible so it is clear where and how the form should be completed and signed.

Discussion

The majority of participants reported that the informed consent process was effective and understandable. Participants reported the positive experience with the consent process was predicated on bilingual study staff verbally reviewing the informed consent form and providing them with a written copy in their native Marshallese language. This finding is consistent with studies that have shown patients who have lived in a country for years and speak its language report that a translator aids their understanding.⁵⁴ It is important to note, though, that not everyone who speaks a language is a translator, and that not all translators are the same. This study utilized bilingual study staff, who have special knowledge of both health care and study participation. It is vital from an ethical perspective to utilize a professional translator rather than a patient’s friend or family member in order to avert potential purposeful interference with information as well as to avoid accidental errors resulting from the challenge of translating complex clinical information.⁵⁵

Participants also cited a deep trust in the study staff and noted their appreciation that the study staff took as much time as needed to ensure participant understanding. This finding is consistent with other studies that found person-to-person extended discussions were effective in improving participant understanding of informed consent.^44,56,57 Furthermore, the use of simple, plain language in the consent form may have helped ensured that participants understood the study’s purpose, requirements, and risks and benefits before they agreed to participate.⁵⁰

While participants stated they understood the purpose of consent and reported an overall positive experience, they also reported encountering barriers during the consent process. In particular, participants stated that poor health due to complications from diabetes caused them to make mistakes on their consent forms that had to be corrected. Researchers should consider ways to mitigate such issues in future studies through use of assistive devices like magnifiers and ergonomic pens. Many participants expressed frustration that they had to re-consent and suggested having study staff complete their consent forms so there would not be any mistakes or need to re-consent participants. Participants explained they trusted study staff to complete consent forms for them and correct their mistakes. However, participants did not seem to understand that it is not an acceptable or ethical research practice to allow study staff to complete or correct consent documents. Researchers may consider engaging a Community Advisory Board to provide insights on how to address this issue with research participants. Community Advisory Boards have shown to be effective in facilitating research by offering advice to researchers about informed consent and the design and implementation of study protocols.⁵⁸ This study suggests that some rules such as only having the participant correct dates and spelling on the documents may not be appreciated by participants who may see their intention to consent as more important than their written documentation of consent.

Participants also reported that while they felt like they understood the consent at the time it was signed, they did not fully remember the purpose of consent as the study progressed. This finding is consistent with findings in previous studies that have demonstrated that participants often forget key information regarding the consent as a study progresses,^59,60 and multiple studies have shown that patients have trouble relaying the aims and risks of studies for which they have consented.⁶¹ Participants suggested it may be helpful to them if there were consent refreshers where study staff briefly review the major elements of the consent form at each data collection event during a study. Furthermore, while participants stated that they understood the plain language consent and appreciated the time that study staff took to explain the consent documents, participants recommended reducing the length and wording of consent forms so they contained only the most relevant or necessary information. This finding is consistent with recommendations that researchers provide concise consent forms that focus on the key study information in order to assist prospective participants or their legally authorized representative with understanding the purpose of the study and the associated risks of participation.⁴³

These findings show the importance of the changes made in the Revised Common Rule, which emphasize participant understanding. Over the past four decades informed consent documents have become more difficult to understand due to increased disclosure requirements, which often results in too much information for the average reader to process.⁴⁴ Research-related consent forms typically contain complex information regarding study procedures, use unfamiliar medical and research terms, and may include difficult to understand legal terminology.^44,59 As a result, it is very common for research participants to have difficulty understanding the information in the consent form.⁴⁵ To remedy this, the newly enacted Final Rule for the Protection of Human Subjects (the Revised Common Rule) implemented in 2019 requires that consent be “in language understandable to the subject” and mandates that the “beginning portion of the informed consent must be organized and presented in such a way that facilitates comprehension.”⁶² Additionally, consent forms under the revised Common Rule must now begin with “a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.”⁴² These regulatory changes give researchers and IRBs the “opportunity to fundamentally change and improve the consent process and the consent form in human subjects research.”⁶³

Limitations

This qualitative evaluation of the consent process for a RCT of a culturally adapted Family-Model DSME study is not without limitations. First, there was no objective measure testing participant’s knowledge of the content of the consent document. Second, only Marshallese living in Arkansas were included in the study and findings may not be generalizable to other immigrant or migrant groups. Finally, only 114 participants in 36 households were interviewed. While this is a relatively large sample that allowed us to reach saturation, it may not reflect all experiences of the Family-Model DSME participants. The western worldview of the researchers could have influenced the analysis of participant responses; to reduce this bias, Marshallese stakeholders reviewed codes and coded data to ensure participants’ experiences and perceptions were accurately reported.

Policy and practice recommendations

Translating scientific knowledge into action is an important part of the CBPR partnership between the Marshallese community and UAMS researchers. Insights from this study are important to informing research policy and practice. When working with participants whose first language is not English, it is important to provide consent information both verbally and written in participants’ native language. Using study staff who understand the cultural nuances of the population may also be important to building trust with participants and may improve participants’ willingness to ask questions and therefore aid understanding. As recommended by the revised Common Rule, the beginning part of consent documents should be concise and organized in a way that presents key information first.⁴² Researchers should work to ensure their consent documents use plain language and may also want to explore using alternative consent formats that may prove difficult to complete for those with vision or mobility issues. Alternative consent formats (such as video, comic book, pictorial) may help overcome language barriers and concisely communicate information in an easy to understand format. Finally, it is recommended that continuous consent refreshers and/or alternative consent formats such as video consent information be available to participants so that they can return to the consent information as needed throughout the study.

Conclusion

The present study suggests that informed consent with underserved communities, including immigrant and migrant populations who do not speak English or have limited English proficiency, is possible, and that using a CBPR approach can help facilitate that process. Furthermore the study, which was conducted prior to the revised Common Rule, suggests that the new mandates that now require that consent be “in language understandable to the subject” and “a concise and focused presentation of the key information” are appropriate and should aid in the informed consent.⁴² However, the study findings suggest that some rules, such as only having the participant correct dates and spelling on the documents, may not be understood or appreciated by participants who may see their intention to consent as more important than their written documentation of consent. Overall, the article adds to the limited literature on facilitators, barriers, and recommendations for conducting informed consent with immigrant and migrant populations who do not speak English or have limited English proficiency.

Footnotes

Declaration of conflicting interests

The author declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Financial support for the study was provided by a grant from the Patient-Centered Outcomes Research Institute (#AD-1310-07159). Initial funding for a pilot project of the study was provided by a University of Arkansas for Medical Sciences College of Medicine Intramural Sturgis Grant for Diabetes Research from the Sturgis Foundation. Additional support for the community-based participatory research team was provided by a Translational Research Institute grant (#1U54TR001629-01A1) from the National Center for Advancing Translational Sciences of the National Institutes of Health. The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the funders.

ORCID iD

Pearl A McElfish

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