Demonstrating “respect for persons” in clinical research: Findings from qualitative interviews with diverse genomics research participants

Abstract

The ethical principle of “respect for persons” in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, albeit less well understood, ethical obligations to regard individuals’ rights, needs, interests, and feelings.. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English (n=30) or Spanish (n=10) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female (93%), identified as Hispanic/Latino(a) (43%) or non-Hispanic white (38%), reported annual household income under $60,000 (70%), and did not have a Bachelor’s degree (65%); 30% had limited health literacy. We identified four key domains for demonstrating respect: (1) personal study team interactions, with an emphasis on empathy, appreciation, and non-judgment; (2) study communication processes, including following up and sharing results with participants; (3) inclusion, particularly ensuring materials are understandable and procedures are accessible; and (4) consent and authorization, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research.

Introduction

Demonstrating respect for potential and current research participants is an ethical requirement for clinical researchers conducting human subjects research.[1–2] Respect is generally understood to require recognizing persons as autonomous agents, capable of self-determination to make voluntary decisions about research participation. To show a lack of respect is to refuse an individual’s decision, deny their ability to act on their decision, or withhold information necessary to make an informed decision.[1] Yet respect for persons has broader—but less well understood—implications than protecting autonomy; it refers generally to regarding another person’s rights, needs, interests, and feelings,[3] and effectively demonstrating respect may help build trust between researchers and participants.[4–5] To the extent that mistrust is a barrier to diverse research participation that contributes to inequities in the implementation of research findings,[6–7] better understanding respect and trust may be especially important for how researchers engage with individuals from groups traditionally underrepresented in research.[8–10]

Whether somebody feels respected is inherently subjective and likely to vary across individuals, communities, and cultures.[11] It is therefore necessary to understand what behaviors demonstrate respect from the perspective of a wide range of potential participants. Some empirical work has been done to assess patients’ perspectives on respect in the critical care setting[12–13] and community-based clinics.[14] In the research setting, it has been suggested that respect encompasses post-enrollment supports throughout a study, such as maintaining privacy and emphasizing the right to withdraw.[15] However, prior empirical studies have not specifically asked what participants view as respectful behaviors in research.

To address this gap, we interviewed a diverse group of participants about what actions they perceived as conveying respect, or a lack thereof, in research. Our goal was to generate empirical evidence about research participants’ views on how clinical researchers can meaningfully demonstrate respect to potential and current participants.

Methods

We conducted semi-structured, qualitative interviews with participants in the clinical genomics implementation study Cancer Health Assessments Reaching Many (CHARM). We chose a descriptive, exploratory methodology to capture participants’ experiences, thoughts, and emotions in their own words; this approach allowed us to draw on participants’ insights to develop a pragmatic yet meaningful understanding of the empirically understudied phenomenon of respect in research without needing to rely on pre-existing frameworks or theories.[16–18]

Setting

CHARM was part of the Clinical Sequencing Evidence-Generating Research (CSER) consortium, funded by the National Human Genome Research Institute (NHGRI) with co-funding from the National Institute on Minority Health and Health Disparities (NIMHD) and the National Cancer Institute (NCI).[19] In CHARM, English- and Spanish-speaking patients age 18–49 years at Kaiser Permanente Northwest (KPNW), an integrated healthcare delivery system in the Portland, Oregon metropolitan area, and Denver Health (DH), an integrated safety-net health system in Denver County, Colorado, were invited by email, text, postcard, phone call, in-person recruitment, or provider referral to complete a patient-facing, web-based family history risk assessment. Individuals identified as at risk for Lynch syndrome or hereditary breast and ovarian cancer syndrome[20–21] were eligible to enroll in CHARM through a consent process on the same web application.[22] Potential participants could complete the risk assessment and consent entirely on their own, with phone assistance if desired, or in person with the assistance of study staff. Participants submitted a saliva sample by mail or in person for clinical exome sequencing for cancer risk.[23–24] They could also opt to receive additional findings (medically actionable secondary findings and carrier findings unrelated to hereditary cancer). During the time this interview study was conducted, all participants received results from a genetic counselor by phone. Participants were asked to complete a baseline and two follow-up surveys, the first within 1 month and the second approximately 6 months following results disclosure, and some were invited to complete one or more qualitative phone interviews. Date of birth, biological sex at birth, clinical site, and language preference were reported at the start of the family history questionnaire. The baseline survey included additional demographic questions and the BRIEF health literacy screening tool, a 4-item measure of health literacy validated against two previously validated measures.[25]

Sample

Two non-overlapping cohorts of CHARM participants were eligible for our interviews: those who had (1) submitted a saliva sample but not yet received results, and (2) received negative results and completed the first follow-up survey. We limited the second cohort to those receiving negative results (i.e., no primary or additional findings) to avoid requesting additional study activities when they might be invited to do other study interviews related to positive findings. To ensure we could reach thematic saturation on issues raised by participants who were members of groups traditionally underrepresented in research, we further limited interview recruitment to CHARM participants whose study records indicated they were members of a racial/ethnic minority group and/or residents in a geographic area with limited socioeconomic status, and we used purposive sampling to conduct 25% of our interviews with participants whose preferred language was Spanish. We invited CHARM participants by email, or mail if they did not have an email address, with up to three follow-up phone calls. Interviews took place within approximately one month of the date the participant became eligible.

Interviews

We developed a semi-structured interview guide based on our study questions and review of the relevant literature related to evaluating respect and trust in research and healthcare. Key questions related to the concept of respect in research are shown in Table 1. We pilot tested the interview guide for length and clarity with two CHARM study patient advisors. The final interview guide and protocol were approved by the KPNW IRB, with IRBs at all other sites involved in this interview study agreeing to rely on that determination.

Table 1.

Interview questions about respect in research

Topic	Question
Respect and lack of respect in CHARM	For these next few questions, I’ll ask you to think back to when you were invited to join the CHARM research study. Do you remember deciding whether you wanted to join the CHARM research study? [clarify if needed] Could you tell me about anything that made you feel respected when you were making that decision? Could you tell me about anything that made you feel a lack of respect when you were making that decision? Suggested probes [following each question]: [lack of respect only, if they can’t think of anything] Could you imagine anything that might make you feel a lack of respect? What about your friends or family? What about the individual research staff? What, if anything, did they do that made you feel [a lack of] respect[ed]? What about the way the research study was set up? Were there any parts of the research study that made you feel [a lack of] respect[ed]?
Respect and lack of respect in hypothetical observational study	Now I’d like to imagine a different type of research study. In this research study, imagine that the researchers aren’t asking people to do anything extra, but they want to collect information from people’s medical records to compare how different medications affect people’s health. Does that example make sense? [clarify if needed]In this example, what sorts of things could the research team do in this research study to show respect? In this example, what sorts of things could the research team do in this research study to show a lack of respect? Suggested probes [following each question]: How could they set up the research study in a way that shows [a lack of] respect? How could they create research study materials in a way that shows [a lack of] respect? How could research staff who are talking with patients show [a lack of] respect?

All interviewers (three English speakers and one native Spanish speaker) were trained on the interview guide. All interviews were conducted one-on-one by phone and audio recorded with permission of the interviewee. Interviews lasted 20–60 minutes each, with most about 30–45 minutes. English recordings were professionally transcribed, and Spanish recordings were professionally transcribed in Spanish then translated to English by certified translators. Recordings and translations were stored on a secure, internal file server. Interviewers reviewed each transcript for accuracy and removed potentially identifying information. Cleaned transcripts were uploaded to the cloud-based qualitative analysis platform Dedoose (dedoose.com) for coding and analysis.

Analysis

We used a qualitative descriptive approach to analyze the data to identify researcher-specific behaviors that interviewees perceived as conveying respect.[26] A distinguishing feature of this approach is that it allows the data to guide coding and uses the participants’ own words when possible to describe the phenomenon.[18] We developed a qualitative coding framework using deductive and iterative inductive techniques.[17] Our coding framework incorporated domains from the interview guide and in vivo codes from open coding of four transcripts. After the framework was created, it was tested on another two transcripts and additional revisions were made. The final framework included 15 sub-codes that captured activities that interviewees identified as conveying respect in the research setting. Then two coders were trained on and systematically applied the framework to all transcripts, meeting periodically with a third study team member to review codes, resolve discrepancies, and identify potential changes to the framework. Transcripts were coded independently in batches and 25% of all transcripts were coded and reviewed by both coders to ensure consistency. We summarized excerpts that were coded under each sub-code, which we then iteratively reviewed to identify where content overlapped or shared similarities such that it could be grouped together into broader categories, until we reached consensus on a set of key categories. The categories reflected activities and behaviors occurring at different stages of a research study through which our interviewees perceived respect.[27]

Results

Interviewee characteristics

We interviewed 40 CHARM participants out of 71 invited (56% completion rate), including 30 in English and 10 in Spanish. Interviewees were primarily female (93%). Most identified as Hispanic/Latino(a) (43%) or non-Hispanic white (38%); reported annual household income under $60,000 (70%), including 48% under $40,000; and did not have a Bachelor’s degree (65%), including 18% without a high school diploma or equivalent. Thirty percent had limited health literacy. Complete interviewee characteristics are shown in Table 2.

Table 2.

Interviewee characteristics (N=40)

	n	(%)
Recruitment site
KPNW	20	(50)
DH	20	(50)
Preferred language
English	30	(75)
Spanish	10	(25)
Mean age (range)	36	(23–49)
Sex
Female	37	(92.5)
Male	3	(7.5)
Race/ethnicity
Asian	4	(10)
Hispanic/Latino(a)	17	(42.5)
Middle Eastern or North African/Mediterranean	1	(2.5)
Native Hawaiian/Pacific Islander	1	(2.5)
White or European American	15	(37.5)
Multiple responses	1	(2.5)
Prefer not to answer	1	(2.5)
Highest level of education
Less than high school	5	(12.5)
Some high school, no diploma	2	(5)
High school diploma, GED, or equivalent	6	(15)
Some post-high school training, no degree or certificate	8	(20)
Associate college degree, or completed post-high school training with degree or certificate	5	(12.5)
Bachelor’s degree	8	(20)
Graduate or professional degree	4	(10)
No response	2	(5)
Annual household income
Less than $20,000	8	(20)
$20,000 to $39,999	11	(27.5)
$40,000 to $59,999	9	(22.5)
$60,000 to $79,999	4	(10)
$80,000 to $99,999	1	(2.5)
$100,000 to $139,999	3	(7.5)
$140,000 or more	2	(5)
No response	2	(5)
Limited health literacy*	12	(30)

^*Based on responses to the BRIEF health literacy screening tool[25]

Based on our interviews, we identified four key categories of activities through which a research team can demonstrate respect to participants: personal study team interactions, study communication processes, inclusion, and consent and authorization. Exemplar quotes and examples of how to convey respect are shown in Table 3. We did not identify differences between interviewees based on cohort, clinical site, or language preference, so our results are presented collectively.

Table 3.

Domains of respect in research

Domain	Exemplar quote(s)	Examples of how to convey respect
Personal study team interactions	“The last woman that I spoke to … was just super awesome, and she answered all my questions and gave me the time. … You guys seem very informative, patient, and then really wanting to hear feedback and share anything that you guys can help out with. So I think that’s all really respectful.” (145) “Since they would be asking about the patient’s medical history, being judgmental maybe about their lifestyle, or their weight, or their medical conditions. That would be very disrespectful if they comment on it. Or if they try to maybe give unsolicited advice, that would be a big one.” (136)	Demonstrate kindness, patience, non-judgment, and interest in the participant as a person Check in with the participant to make sure they understand Show appreciation for the participant’s contributions Emphasize the benefits of the study for the individual and for society
Communication processes	“After participating, it would be nice to kind of like have the statistical information, what the study is. … And just kind of feel like, “Oh, I participated and this is the result of the study.” (129) “You guys had cool ways of communicating. I sometimes was not available by phone. So making the appointments by email to get the results, to talk to a genetic counsellor, that was really nice. And getting that scheduled appointment and not doing the phone tag, ‘If I get you, I get you,’ type of a thing. That was really helpful.” (133)	Offer multiple ways of getting in touch with the study team (phone, email, etc.) Have a specific point of contact whom participants can contact with questions Provide prompt reminders and follow-ups to participants throughout the study Share individual results and overall study findings with participants Share any relevant information with participant’s healthcare provider
Inclusion	“I mean, basically, simple questions, simple, basic questions, something anybody of any education can understand. You start putting big words in there, there’s people that can’t grasp certain things that they’re not going to understand what that means.” (146) “The researchers were able to meet with me at the closest location and was being really respectful and nice. And just willing to work with me as far as where we had to meet up at and do the study. And she was concerned about if I had enough time to go through all the questions and everything. And she made sure that I was comfortable, if I wanted to do it on a small computer or on a big screen.” (105)	Have study staff or interpreters who speak the participant’s language Write all study materials using clear and simple language Allow participants to complete the study from home or at a location that is convenient for them Offer support and accommodations for people of all abilities
Consent and authorization	“When you have enough information on what you’re providing and what you’re getting into, especially as a participant when you’re participating for a research study. When you have the information, and you know what you’re getting into, that really helps.” (161) “They sent me an email saying, ‘If you would like to participate, we’re going to give you a call.’ So they gave me a chance to think about it. … And I knew that my time-- if I didn’t want to participate in this interview, for example, I could have said no. And they would have been okay with that. And that, for me, makes me want to participate. Because it’s very clear that there is no expectation one way or the other. And I like that I have the choice.” (132)	Thoroughly and neutrally describe the study so people can decide whether to join Allow plenty of time to make a decision Give choices about levels of participation Enforce all privacy protections over participant information

Personal study team interactions

All 40 interviewees said they perceived respect through their personal interactions with members of the research team. Interviewees consistently noted that team members’ kindness, patience, and interest in their perspectives, often conveyed through taking time with them, indicated respect. Most also felt respected when the recruitment staff explained the study thoroughly, checked for comprehension, and were available to answer questions. These perspectives are provided below.

“For me, it comes down to how they treat me. They don’t treat me like a patient. They don’t treat me like a number. They treat me like a person.” (146)

“I’ve felt that they take their time with people, at least in my case; that they’ve always treated me well.” (153)

“Having the research staff person check in and really make sure that I was understanding everything … just having that awareness of nonverbal cues that might indicate that I’m not sure about things or don’t really want to participate.” (126)

Some interviewees commented on the importance of feeling appreciated for their contributions and having the research team highlight their role in achieving the study’s goals and potential societal benefits. Additionally, some said they would have felt disrespected if they felt like the research staff were judging them based on their personal characteristics or for their degree of understanding of the study, particularly during the recruitment process. Others highlighted the importance of the research staff treating each person as an individual. Representative quotes are listed below.

“I guess that’s the main thing is just showing appreciation and thanking somebody like, ‘This is really important for our research and we really appreciate your participation.’” (122)

“I wasn’t made to feel stupid if I didn’t know something. If I didn’t understand something, I could have it explained clearly and concisely.” (114)

“Respect the process of each person, because we are all quite different and we don’t all take things the same way.” (153)

Communication processes

Beyond individual interactions, about half of interviewees discussed the processes of communication that the project had in place. Many discussed the importance of getting prompt responses and reminders about study activities and next steps, including appropriate follow-up. About half of interviewees discussed receiving or having access to information, including their personal test results, health-related data, and overall study outcomes, as part of being respected. Representative quotes are shown below.

“Not having the information, kind of being left in the dark, so that would be very disrespecting. …. So I think just making sure that they follow up, that they stay on the ball, and do their best not to let things fall through the cracks. …. Our time is valuable. And somebody not taking what we’re putting into it seriously is like saying that our time doesn’t matter.” (132)

“I totally like the fact that that information was shared with my PCP. That’s really awesome because that does help out in your care. So that was really good.” (161)

Interviewees said they appreciated having a specific point of contact, but also multiple means of communicating with the study (e.g., phone, email, in person). Additionally, they noted that communication should be done using appropriate language; if the information was too specific, overly complex, or unavailable in the relevant languages, that would show a lack of respect. One person added that simple questions on eligibility screening tools or study surveys conveyed respect by minimizing the time burden on participants. Another explained:

“When the little kit arrived to send back the sample, the instructions were written really well, and not confusing, and not too long .… I think it’s respectful to make instructions very clear.” (131)

Inclusion

More than half of interviewees identified inclusion as an element of respectful research. This meant ensuring the information provided was comprehensible to all potential participants and that people of all races and ethnicities, education levels, abilities, languages, and cultures could participate. Many of these interviewees said that clear and simple study materials, to ensure anyone would be able to answer the questions, were inherent to a respectful study:

“Giving as much possible information about what the study is while keeping it relatively simple for people to read, I think, would be really great. Because then everybody would be included that even if their reading level isn’t particularly high or whatever the case may be.” (114)

Interviewees also noted the importance of study staff offering support and accommodations to improve accessibility, such as by helping to understand the materials or access the information on a computer:

“A person from the clinic asked me if I had any issues with using the computer, I told them that I did, and so someone came over … and took down my questionnaire.” (153)

Others, about half of all interviewees, identified aspects of the study design that improved accessibility, including not having to pay anything to participate and being able to enroll and complete all study activities from home—including web-based enrollment, providing a saliva sample by mail, completing surveys online and interviews by phone, and getting study results by phone or letter instead of needing to come in for an appointment. One person appreciated being able to participate remotely due to their social anxiety; for others it was more accommodating of their work or childcare schedules:

“With me working nights and so many hours, if I had to go to the hospital during the day and fill out the forms and stuff, I probably wouldn’t have gotten it done.” (101)

Consent and authorization

About a quarter of interviewees explicitly discussed the importance of the informed consent process for showing respect. Even if they did not specifically mention informed consent, most interviewees discussed transparency about key consent elements as part of respect, desiring a clear and thorough explanation of the study’s objective(s), design, procedures, value, risks and benefits, data collection practices, and privacy protections. They wished to have this information available to them in a consistent and convenient manner and said that research being conducted without their knowledge or without a clear explanation of the purpose would show a lack of respect:

“Oh, I liked that there was a lot of consent. I mean, it’s reams and reams of information, but at the same time, it’s good to know the consents and that kind of stuff. I know that the medical community doesn’t always have it as straight as that.” (154)

“We don’t even know if we can help or participate in studies if they just take our information and don’t even ask for authorization. … I want to know that if you all are counting my participation, that I am the one authorizing it and not that you all are making decisions for me.” (128)

Close to half of interviewees also said it was important to present study information neutrally. They appreciated that participation was described as not mandatory, there was no pressure, and they had adequate time to reach their decision. Some added that having opt-in or -out options felt particularly respectful, appreciating that they could choose which results they wanted to receive and even change their mind later:

“It was very clear why people say no, why people say yes. I felt like it was very neutral and it wasn’t trying to push you in one direction or the other. … I feel like that’s respectful when people don’t try and push their own agenda.” (106)

“After I [joined the study], I was like, I’m not sure I actually want to know and so I’m pretty sure I still have the option of like not getting that information even though I participated and that was missed. So like I want to be a part of research and I think it is super important but just knowing that I have the option of whether or not what I want to do with that information afterward.” (108)

Many interviewees specifically discussed the importance of ensuring privacy, anonymity, and/or confidentiality, including having institutional policies to protect confidentiality. Many discussed the importance of following through on promises related to privacy, including only using participants’ data as authorized:

“I would want a very clear statement … that that information would be kept private …. I would want to know for myself that that information would not affect my ability to live a happy, functioning life in society…. So having a very clear and non-negotiable kind of a statement stating that my information will never be used like that would be important to me.” (132)

“[What would show a lack of respect?] Collecting information that was not originally okayed, just carelessness in some way letting people to have access that was not— people who weren’t supposed to or something like that.” (108)

Discussion

In interviews with research participants from diverse racial/ethnic, socioeconomic, and language backgrounds, we identified personal study team interactions, study communication processes, inclusion, and consent and authorization as domains researchers should pay attention to when making efforts to demonstrate respect. Here, we suggest how research teams might implement each of these findings.

First, our interviews suggest that personal interactions with research staff—particularly those working at the front lines of recruitment—are a common way for potential and current participants to perceive respect. This finding illustrates the importance of building a culture of respect among all members of a research team and ensuring team members can effectively carry out their critical role in conveying that culture to participants. One way for research teams to empower their staff to interact with participants as respectfully as possible might be to provide formal training in skills like empathy and professionalism. While many individuals have experience or innate abilities in these areas, training can provide tools to strengthen these skills among all team members and keep them front of mind during interactions with participants. However, training opportunities for staff are limited outside of basic required modules in good clinical practice and human subjects research, especially for training that focuses on demonstrating respect and building trust.[28–30] To best develop these trainings, empirical work is needed to further clarify what participants need from these interactions—for example, seeking consensus among individuals from diverse backgrounds and cultures on what their top priorities are in these interactions and which of these priorities must be achieved through staff interactions versus other means, while also understanding how individual needs and preferences may differ. Empirical work should identify barriers that research staff face in meeting those needs, including how best to build a culture of respect within the research teams and institutions where they work.[31–32] In addition to training, the value that participants place on feeling appreciated for their contributions suggests that research teams may want to explore the possibility of emphasizing the study’s likely societal benefits during recruitment and consent. While this approach may run counter to usual IRB guidance for how to engage with potential participants,[33] openly acknowledging the ways that participants are contributing to scientific advancement may be an important starting point in developing a trusting relationship.[34]

Second, a research team’s overall approach to communication with participants may play an important role in demonstrating respect. Processes and modes of communication, while seemingly logistical in nature, are highly visible to participants and can demonstrate that the study team is taking their contributions seriously and making an effort to meet them where they are. To this end, research teams could consider developing concrete plans for how to communicate, perhaps through a newsletter or website, about things like individual results, study findings, or changes to risks or benefits,[15] or even the possibility of study termination,[35] to ensure these communications are timely and complete.

Third, interviewees emphasized how a study’s efforts to include participants from diverse backgrounds—such as drafting materials in accessible language, providing high-quality translations and bilingual study staff, and offering remote access to study participation for those unable to attend in person—could demonstrate respect. The lack of diversity in clinical trials is widely recognized as problematic, and many barriers to access remain.[7] Efforts to minimize these barriers not only work to include individuals who might otherwise have been excluded, but may also signal to the broader community of participants and potential participants that the study is genuinely invested in equity and inclusion. One way to minimize barriers is for researchers to explore non-traditional approaches like web-based enrollment, which are increasingly shown to be effective and ethically sound,[22,36–37] and proactively consider how to incorporate these approaches into their studies.

Fourth, interviewees said being respectful meant being as transparent as possible and providing people with meaningful choices about whether and how to participate whenever reasonable. Informed consent, which incorporates values such as transparency and individual control,[38] is well recognized as part of conveying respect in research.[39] Our findings suggest that participants may desire transparency and choices that go beyond what is offered by a typical informed consent process. Applying these findings across different research settings, this might mean considering offering options about which categories of genomic sequencing results to receive[40] or using a dynamic consent process to allow biobank participants to make ongoing choices.[41–42] While these processes may add some degree of burden—for example, in the biobank context, challenging whether seeking broad consent for future research uses is sufficient in all cases—research teams should be thoughtful about what choices they are or are not offering to participants and be aware of how this may affect participants’ perceptions of respect. At the same time, our findings illustrate the importance of managing and executing privacy and data sharing promises made during the consent process.

Limitations

Although our sample size was robust and our interviewees represented several different dimensions of diversity, this qualitative study was limited to English- and Spanish-speaking participants in one study at two clinical sites. In particular, men and people who identified as racial/ethnic minorities other than Hispanic/Latino(a) were underrepresented. Individuals with other backgrounds and languages, with different or no research experience, and/or at different clinical locations may think about respect differently. While we did not identify differences between groups of interviewees, this study was not designed to compare groups so there may be differences that we were unable to detect in our interviews.

Conclusion

The experience of respect, or a lack thereof, is inherently subjective, and our interview findings highlight four key domains that diverse participants identified for researchers to attend to as they seek to meaningfully demonstrate respect for persons in the practice of clinical research. While some of the approaches identified here may be simple changes for research teams to make, others will require additional evidence or a shift in normative thinking to incorporate them into research. Further empirical and normative work should explore these potential approaches and evaluate their impact on perceived respect, trust, and recruitment and retention.