Background
Clinical research staff, including research coordinators, clinical research assistants, and research nurses, are key actors in the recruitment process for pediatric clinical research. Staff have a range of participant-facing responsibilities, including recruitment, consent, scheduling, and data collection [Reference Baer, Zon, Devine and Lyss1]. Research staff frequently serve as the first introduction to clinical research for patients and their families and sometimes the family’s primary point of contact throughout the study.
Interactions between research staff and prospective participants and their families can affect the success of pediatric research. A recent survey found that parents who enrolled in a neonatal clinical trial were more likely than non-enrollees to report a positive initial impression of the research staff [Reference Weiss, Guttmann and Olszewski2]. Positive staff-family relationships are supported by approaches such as respectful communication, attention to patient and family needs, and candor about the realities of study participation,[Reference Morgan, Occa, Potter, Mouton and Peter3] as well as awareness of potential challenges such as language barriers or misgivings about research [Reference Occa, Morgan and Potter4]. Barriers to enrollment may arise if the approach is poorly timed [Reference Greenberg, Gamel and Bloom5], the family perceives a lack of empathy from the recruiter [Reference Greenberg, Gamel and Bloom5], the study and its potential benefits are not described clearly and concisely [Reference Miller, Comstock, Pierpoint, Leonard, Bajaj and Mistry6], or recruiters have biases that lead them to view underrepresented participants as non-ideal candidates for participation [Reference Niranjan, Martin and Fouad7]. Additionally, structural barriers often shape these personal interactions, for example gaps in interpretation and language translation services [Reference Newington and Metcalfe8].
While research staff play a critical role in building research relationships, their views on the relationship-building process are sparsely described, particularly in the pediatric context. This study describes the perspectives of pediatric research staff about how they engage with patients and families, including barriers and facilitators, and offers a framework for understanding the process of relationship building throughout research recruitment.
Methods
Overview
We conducted one-on-one interviews with pediatric research staff involved with study recruitment to allow for nuanced exploration of experiences and perspectives [Reference Charmaz9]. This study was approved by the Seattle Children’s Institutional Review Board.
Recruitment
Eligible participants were research staff at a single pediatric research institution and its affiliated academic medical center who were involved with participant recruitment, consent, and/or enrollment. We emailed invitations to (a) members of a clinical research coordinator core service, (b) subscribers to an internal professional development listserv, and (c) individuals we knew to be working in research recruitment in clinical settings. Participants received a $25 incentive for their time.
Interviews
We developed a semi-structured interview guide (Supplementary Appendix) based on a framework for researcher-community partnerships that addressed effective communication, respectful relationships, committed partnerships, methods to resolve problems, and sustainability [Reference Dave, Frerichs and Jones10]. We conducted two pilot interviews and revised the guide for clarity and length.
One member of our team (KMP) conducted all interviews via Microsoft Teams between November 2020 and February 2021. Interviews lasted approximately 60 minutes. We evaluated for theoretical saturation throughout the interview process, including assessing for distinctions across clinical settings, and ended recruitment when additional interviews no longer produced new themes. Audio recordings of interviews were professionally transcribed, de-identified, and verified for accuracy. Transcripts were uploaded to Dedoose [11] for data management and analysis.
Analysis
We developed a codebook using inductive and deductive techniques [Reference Dey12,Reference Hsieh and Shannon13] focused on the five domains in the interview guide, followed by an iterative process of open coding and codebook revision whereby three members of our team (SAK, KMP, EMW) independently coded transcripts then met to reach consensus. After repeating this process and reviewing with the full study team, we revised our codebook to reflect three levels of relationship-building factors, with sub-codes describing specific factors within each level (Supplementary Material). Two trained coders (KMP and TRS) then coded remaining transcripts, first together until they were consistently in agreement on 80% or more of code applications, then independently with periodic dual coding to maintain consistency. With coding completed, interview excerpts were grouped by code and each summarized. We reviewed these summaries through iterative team discussions to identify and refine preliminary themes.
We shared our preliminary themes with a subset of interviewees for verification through the process of member checking, an approach used to ensure the research team’s interpretation of the data aligns with research participants’ experiences [Reference Raskind, Shelton, Comeau, Cooper, Griffith and Kegler14]. Interviewees were offered an additional $50 to join a 60-minute webinar that included presentation of our preliminary results followed by discussion and feedback. Eleven interviewees joined one of three discussions held between August and September 2021.
Results
Interviewee Characteristics and Overview
We completed 28 interviews, representing 72% of the 39 individuals who either responded to our general outreach (n = 21) or whom we contacted directly (n = 18). Of these 39, 5 did not respond, 4 did not meet inclusion criteria, and 2 declined. Table 1 shows self-reported interviewee demographics.
Table 1. Interviewee demographics (n = 28)
Interviewees described factors that influence how they form research relationships with patients and their families at the level of the individual staff member, relational interactions with families, and institutional or other structural backdrops. We did not identify major differences across clinical settings but note any minor distinctions below.
Individual Staff Member
Individual factors affecting relationship building included how interviewees developed recruitment skills, their perceived roles, and personal motivations for their work. Table 2 shows exemplar quotes.
Table 2. Individual factors affecting relationship building: codes and exemplar quotes
* Interview code numbers omitted for interviewee privacy.
Most interviewees reported having developed recruitment skills by observing other recruiters, following standard operating procedures, or drawing on communication skills from prior jobs. Few reported receiving formal training. Interviewees perceived their roles as supporting participants by maintaining connection and continuity, providing transparent information, being a comforting and friendly presence, and being sensitive to families’ timing and circumstances. Some also discussed their role as advancing research, promoting diversity, and collaborating with other coordinators to advance their collective learning. Several interviewees discussed personal motivations for their work, including advancing equity in research, interacting with children and families, and training other coordinators to pay forward the support they received.
Relational Interactions
Relational factors spanned four stages of recruitment: before the approach, meeting a family and forming an initial connection, building a connection and discussing the study, and following up. Table 3 shows exemplar quotes.
Table 3. Relational factors affecting relationship building: codes and exemplar quotes
* Interview code numbers omitted for interviewee privacy.
Pre-approach
Some interviewees working in clinical settings spoke about the importance of checking with the primary clinical team before approaching a family to gauge their capacity for research. Reasons for not approaching a family included not meeting inclusion criteria, indications in the medical record of a complex clinical situation, which could indicate a stressful time for the family, or a lack of study materials in the family’s preferred language.
Initial Connection
Interviewees described several approaches to connecting with families upon meeting. Most discussed their style or persona; about half of these said they were careful to meet families warmly, calmly, and smiling to convey friendliness, though one noted the importance of matching the family’s energy in light of the clinical context. Several discussed their efforts to find common ground with a family, such as by asking questions to find shared interests. About a third of interviewees described clarifying their role when first approaching a family, for example by explaining the distinction between the research and clinical teams, or sharing information about their department or principal investigator. Several interviewees also spoke about the importance of confirming correct names, pronouns, and pronunciations at this stage. About a third discussed awareness of families’ perception of them based on factors like their attire or age. Several also discussed awareness of how personal biases could affect recruitment interactions and a desire to learn how to better manage these biases; additionally, a few who identified as white noted how the history of white researchers exploiting marginalized groups could influence families having reservations about talking to them. Finally, half of interviewees discussed meeting with families who use languages other than English and highlighted challenges such as additional time needed for recruitment and variable access to translated materials and/or interpreters.
Building Connection
These interviews included rich discussions of building relationships. Factors within the relationship-building process included the following: responding to the needs of the family and pediatric patient, considerations to support voluntary decision-making, and communication about study specifics.
All interviewees identified recognizing and accommodating the needs of participants and families as important and necessary for building relationships, reducing barriers, promoting equity, and honoring a family’s autonomy and humanity. Examples included flexibility in study visit scheduling, extra accommodations (e.g., providing refreshments for inpatient families, traveling to collect questionnaires, or finding childcare options), and particular awareness of timing in emergent or intensive care settings, which can be stressful and traumatic. About a third of interviewees discussed the importance of warmly engaging and interacting directly with the pediatric patient. Friendly and direct interactions with the patient, adjusted according to their developmental and cognitive needs, were strategies to empower pediatric patients and recognize their developing autonomy.
All interviewees stressed the importance of explaining the voluntary nature of research to ensure families understand their rights and make an informed decision. About a third discussed voluntariness as a key facilitator in establishing trust by reducing pressure on families and helping address the power dynamic between researchers and families. Interviewees highlighted the importance of recognizing hesitation to participate through non-verbal cues or implicit dissents (e.g., declining participation by continually asking recruiters to return later). When discussing the role of researcher-family power dynamics in relationship building, several emphasized how these dynamics are often compounded for families from marginalized backgrounds. They discussed various ways of addressing power dynamics, including giving families sufficient time to decide, clarifying the distinction between research and clinical care, and emphasizing families’ roles as the experts in their experiences.
Most highlighted the importance of using clear language during the informed consent process for building trust and helping families feel comfortable asking questions and discussing concerns. However, several noted that study materials often include complex medical jargon and vague framings that can alienate families. About half discussed providing as much detail and transparency as possible when describing the study, both to allow families to make informed decisions and to build trust. Several discussed spending extra time with families who were hesitant about participating, sometimes connecting families with investigators or clinicians to learn more. Most interviewees also highlighted the significance of questions throughout the consent process; several noted that being asked clarifying questions indicated a level of trust and that the family was thinking critically about their involvement, while a lack of questions could indicate disinterest or, conversely, familiarity with and general trust in research. Regarding families’ motivations and concerns, several interviewees described forthrightness about expected benefits and potential risks as important for building a trusting relationship. Most also discussed participant burdens and barriers, including transportation, inadequate compensation compared to lost wages, lack of support for childcare, and the disproportionate impact of these barriers on some families.
Follow-up
About half of interviewees spoke about following through with participants, for example addressing previously expressed concerns, providing reminders, checking in on clinical needs, and making themselves available for questions. Additionally, just over half discussed the value of building relationships longitudinally, with several noting that studies with only one point of contact can be difficult for building relationships.
Structural Backdrops
Interviewees identified structural factors that influenced building relationships with families, including factors related to access and diversity, clinical relationships, and the COVID-19 pandemic. Table 4 shows exemplar quotes.
Table 4. Structural factors affecting relationship building: codes and exemplar quotes
* Interview code numbers omitted for interviewee privacy.
Many interviewees discussed factors affecting access to research, including translation into languages other than English and Spanish, inadequate incentives or reimbursements, childcare needs, transportation needs, and ability to obtain referrals to research through specialized care. About half noted a distinct lack of diversity among participants, particularly across dimensions of race, ethnicity, and language, and several discussed the need to diversify research teams to better reflect the patient population. Some interviewees spoke about community stakeholders being involved in study design or providing feedback on their participation, and one noted that a lack of community involvement made them feel the study’s goals were disconnected from the community it aimed to serve. About half discussed research oversight, sometimes as creating challenges (e.g., for translating consent materials or providing incentives), but also as assuring families that studies were appropriately monitored.
More than half of interviewees discussed how a family’s prior clinical relationships or past experiences with the institution, including its reputation, could facilitate research relationship building and sometimes motivate – or discourage – participation. Most also discussed the role of clinicians and/or medical chart access to support recruitment, although some recalled being asked not to approach a family for medical or social reasons even if the patient was otherwise eligible. Half of interviewees described additional challenges with the integration of research and clinical care, describing a lack of scheduled research visits in some clinical settings and a need to defer to clinical activities. One noted the importance of increasing research presence and strengthening research-clinical ties in satellite clinics. Several interviewees commented that families sometimes felt stressed by multiple requests for different research studies.
Finally, more than half of interviewees identified new challenges during the COVID-19 pandemic. These included difficulty seeing non-verbal cues while recruiting remotely or while donning personal protective equipment (PPE), disruptions to families’ experiences due to limitations on clinical visitors, increased difficulty accessing interpreters, need for greater scheduling flexibility to accommodate families’ increased logistical barriers, adjusting to and standardizing virtual consent processes, and increased hesitancy about participation due to families’ concerns about in-person visits, for example for children unable to wear a mask for the duration of a study visit. Approaches to relationship building during the pandemic included increasing consistency with email communications, gauging interest by speaking with healthcare providers, using video conferencing to allow for unmasked face-to-face interactions, printing a photo of oneself to share when wearing PPE, and giving families space to discuss their challenges.
Discussion
Interviews with research staff revealed that factors at the individual, relational, and structural levels influence relationship building with potential participants and their families. Across these levels, four overarching themes became apparent: (1) staff experience tensions as well as supportive relationships with various actors, which influence their ability to perform tasks and address challenges; (2) integration with clinical teams can facilitate relationship building, but it is also important to clearly distinguish research from clinical activities; (3) voluntariness is seen as foundational to obtaining valid consent as well as building trusting relationships; and (4) contributors to inequities and access barriers are prevalent at multiple stages of research.
First, staff saw themselves as variably supported by or in tension with other individuals and groups, including other coordinators, investigators, and institutional priorities and processes. Prior work has shown that research staff see themselves as advocates for multiple perspectives – clinical patients, research participants, and the research study – simultaneously [Reference Davis, Hull, Grady, Wilfond and Henderson15]. Consequently, staff sometimes must navigate conflict between patient care and study requirements [Reference Fisher and Kalbaugh16]. Our interviews support these findings and illustrate numerous actors and dynamics that facilitate or impede their advocacy roles. For example, staff noted that they sometimes had different priorities from their principal investigators or had to navigate complex institutional processes. As staff are well positioned to observe the impact of such priorities and processes on potential participants and their families, it is important that they be empowered to describe barriers that families experience to their teams and have a voice in institutional policy development.
Second, staff described the importance of being connected to clinical teams while also distinguishing research from clinical care. Staff highlighted the value of a “warm handoff” (i.e., a known clinician introducing a family to the research team) for forming an initial connection, as well as how positive prior relationships with the clinical team and/or institution can facilitate research – and, conversely, how a limited relationship, lack of clinical integration, or negative past experiences can limit or encumber research engagement. These findings build on prior work showing that many parents prefer to learn about research from their clinical care team [Reference Weiss, Guttmann and Olszewski2] and that clinical experiences can influence patients’ views about research participation in an integrated setting [Reference Kraft, Cho and Gillespie17]. While discussing the importance of, and the need to streamline, clinical research integration, our interviewees were also careful to clarify the distinction between the two, illustrating the key role of research staff in maintaining ethical boundaries between research and clinical care [Reference Largent, Joffe and Miller18]. Embracing this role could present opportunities for staff to identify and address other ethical concerns at the clinical research boundary, such as the therapeutic misconception (i.e., not understanding that the goal of research is to produce generalizable knowledge rather than to benefit research participants) [Reference Henderson, Churchill and Davis19]. This topic was not explored in these interviews but could be a focus of future work.
Third, staff strongly emphasized the importance of voluntariness and the multiple measures they took to ensure voluntary choices. Voluntariness was described as key to trust building. By alleviating pressure for families, staff gave families space both to make a decision that was right for them and to feel that they could trust the research team. As several of our interviewees noted, and has been discussed in the setting of the neonatal intensive care unit [Reference DeMauro, Cairnie, D’Ilario, Kirpalani and Schmidt20], this may be particularly important in stressful clinical contexts.
Fourth, our interviewees discussed multiple examples of inequities and access barriers that introduce potential for disparities in research. For example, many staff noted challenges related to translating research materials into other languages. Research staff are uniquely situated to observe a wide range of barriers that may be revealed during the relationship-building process. While their perspectives alone cannot offer a complete picture, they represent an invaluable bridge between the experiences of participants and the research institution, and a deeper understanding of their observations is warranted.
Limitations
This study described perspectives of staff working in one pediatric research institution and its affiliated academic medical center; staff working in other institutions may identify additional considerations and priorities. While we spoke with staff working across a range of pediatric clinical research settings, there may be additional viewpoints not represented in our sample, for example, from those working with adolescent patients in different clinical contexts, especially when the patient and their family may have different perspectives about participating. Furthermore, the staff we interviewed were primarily female, non-Hispanic white, and highly educated, and thus reflect limited perspectives on recruitment. Nevertheless, the depth of reflection and engagement by these interviewees provides a robust description of their perspectives. Future work should build on our findings and evaluate needs for research staff across a broader representation of the profession. This study was limited to research staff because of the absence of their voice in the extant literature; other stakeholders may, and likely do, have different perspectives and priorities. Future work must assess how these themes correlate with views of other stakeholders, most importantly parents or legally authorized representatives tasked with making the enrollment decision and pediatric patients themselves. This study should also be contextualized by its timing during the COVID-19 pandemic. While we were able to conduct robust remote interviews using videoconferencing tools that were familiar and easily accessible to our study population, we acknowledge the potential impact of the broader context on our recruitment, data collection, and interpretation. Finally, the authors acknowledge that our role as researchers, some working in the same institution as the staff who were interviewed, informs our interpretation of the data. To ensure the trustworthiness of our analyses, we incorporated the member checking process to validate our preliminary findings, and we involved authors from a variety of institutions and types of roles throughout study development, data collection, and interpretation.
Conclusion
Pediatric research staff play a critical role in supporting families of potential participants and recognizing ethically important issues during recruitment such as access barriers, threats to autonomy, and other needs of patients and their families. Efforts to improve research recruitment can build on the framework of staff perspectives on research relationship building presented here, and future work should aim to empower staff to fulfill their role as advocates for prospective participants and their families.
Supplementary material
To view supplementary material for this article, please visit https://doi.org/10.1017/cts.2022.469
Acknowledgments
The authors sincerely thank all those who contributed their time and thoughts to participate in these interviews. Thank you to our clinical collaborators for supporting recruitment, to staff at the Treuman Katz Center for Pediatric Bioethics for assistance with piloting the interview guide, and to attendees of the Treuman Katz Center Research Seminar for intellectual feedback on drafts of this work. This study was supported by a Pediatric Pilot Funds Award (Kraft/Weiss) from the Seattle Children’s Center for Clinical and Translational Research. Additional support was provided by the National Institutes of Health through the National Human Genome Research Institute (K01HG010361, supporting Stephanie Kraft), the National Center for Advancing Translational Sciences (UL1TR002003, supporting Emily Anderson, and UL1TR002319, supporting Laura Baker and Jodi Smith), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (K23HD103872, supporting Elliott Weiss), and the Seattle Children’s Research Institute Summer Scholars Program (supporting Tara Sullivan).
Disclosures
The authors have no conflicts of interest relevant to this article to disclose.
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