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. Author manuscript; available in PMC: 2025 Sep 23.
Published in final edited form as: J Empir Res Hum Res Ethics. 2025 May 20;20(3):87–96. doi: 10.1177/15562646251341655

Recruitment Techniques Used for Clinical Trials and the Potential Impact of Nudges: Qualitative Interview Study with Recruiters

Molly Volkmar 1, Jewels Watts 2, Lauren Kaiser-Jackson 1, Ben Schwan 2,6, Cathy Wolfsfeld 1, Eric Kodish 2,4,5, Aaron J Goldenberg 2, Jessica Berg 3, Erin Rothwell 1, Maxwell Mehlman 7, Kimberly Kaphingst 1
PMCID: PMC12453566  NIHMSID: NIHMS2106520  PMID: 40390625

Abstract

While clinical trials are essential to improving public health, little research has examined the range of recruitment techniques used or whether they involve behavioral nudges. Behavioral nudges have been defined as “any aspect of the choice architecture [the manner in which options are presented] that alters people’s behavior in a predictable way without forbidding any options or significantly changing their economic incentives” (Thaler & Sunstein, 2008, p. 6); these may influence individuals’ autonomy in deciding to participate. To investigate, the study team conducted 39 semi-structured interviews with clinical trial recruiters at two academic medical centers, asking about their recruitment techniques and any perceived ethical concerns. Through inductive qualitative analysis, five main themes emerged: impact of relationships (among recruiters, healthcare teams, and participants), financial compensation, community benefit, study risks and benefits, and personalized study information. The study then assessed whether these techniques were seen as nudges and explored their ethical implications for informed decision-making.

Keywords: Recruitment techniques, informed consent, nudges, clinical trial recruitment, qualitative research

Introduction

Clinical trials are key to improving individual and public health. These trials ensure that new procedures and medications are safe and effective and promote our understanding of possible side effects. GlobalData’s Pharmaceutical Intelligence Centre notes that 22,338 clinical trials were initiated in 2023 (Beaney, 2023). While clinical trials are a necessary part of getting new treatments to the market, recruitment can be challenging (Chaudhari et al., 2020). Recruiting became even more difficult following the COVID-19 pandemic as many studies rapidly moved to online platforms (Strujo, 2020).

Innovative approaches to recruitment are often used to improve accrual in clinical trials. Recruiters can develop specific techniques that they believe increase recruitment rates, although research characterizing the use of different techniques is limited. In addition, it is important to understand how these techniques might affect a potential participant’s autonomy. According to the Belmont Report (1979), respect for autonomy requires obtaining informed consent, a part of which includes providing “sufficient information to a potential participant, in a language which is easily understood by [them], so that [they] can make the voluntary decision regarding ‘to’ or ‘not to’ participate in a research study” (Nijhawan, 2013, p.134). Because respecting the autonomy of potential participants is so important, recruiters have a responsibility to avoid any threats to the informed consent process in recruitment.

One potential type of technique that may affect individuals’ autonomy regarding participation in clinical trials are behavioral nudges. A nudge has been defined as “any aspect of the choice architecture [the manner in which options are presented] that alters people’s behavior in a predictable way without forbidding any options or significantly changing their economic incentives,” (Thaler, R. H., & Sunstein, C. R., 2008, p.6)1. Nudging can be found in various aspects of day to day life. For example, one study showed that simply placing a message in a shopping cart that claimed the majority of shoppers purchased fruits and vegetables was an effective nudge in getting more shoppers to buy fruits and vegetables (McGrath, G.M., 2023).

However, while behavioral nudges have been examined in health promotion contexts such as smoking cessation (Blaga, 2020), limited prior research has examined their potential use in the context of recruitment into clinical trials. The ethical implications of nudging in health promotion may be potentially different from nudging in clinical trial recruitment since clinical trials can involve various risks and benefits that people need to fully consider and understand before agreeing to participate. It is therefore important to investigate whether and how behavioral nudges are being used in recruitment into clinical trials.

Therefore, to add to the limited prior research on this important topic, this study sought to understand more about what recruitment techniques are being used, and recruiters’ perspectives on those techniques, by interviewing recruiters directly.

Methods

Participants

We interviewed staff members who recruit for clinical trials (“recruiters”) at two U.S. academic medical centers. Recruiters had to be 18 years of age or older, English-speaking, and to have recruited for at least one active clinical trial in the past year, ensuring the data collected was reflective of current practices. Participation was not limited by sex, race, or ethnicity.

Outreach to recruiters varied based on consultation with the Clinical and Translational Science Award (CTSA) hubs at the study sites. At the University of Utah, one of the Principal Investigators (PIs) of the interview study or a study coordinator gave a brief presentation at four research staff meetings and distributed information through the research staff listservs, and 22 recruiters were interviewed. At Case Western Reserve University, 17 PIs of clinical trials were contacted and 11 gave permission to contact their recruiters. From there, 18 recruiters were contacted, 15 of whom participated in the study. One recruiter referred two others. At both sites, after the initial outreach, recruiters emailed the study coordinator to schedule a time to complete the informed consent process for an interview.

Interview Procedures

An interviewer from each site was trained by a study team member experienced in qualitative interviewing methods. Interviewer training involved three sessions, which included didactic presentations, review of the semi-structured interview protocol, and practice with interviewing skills.

The interviewers used a semi-structured interview guide that focused on different areas of the recruitment process. Every interview began with open-ended questions about the recruiter’s experience recruiting for clinical trials and general recruitment approaches they use across trials. The interviewer then asked more specific questions about how the recruiter approached recruiting for different types of studies (eg. minimal risk vs. more than minimal risk) and questions about the study the recruiter was currently working on. The final section of the interview guide asked the recruiter to think of any techniques that could be considered a “nudge” and their thoughts on the use of those techniques. The interview guide is provided in Appendix A.

The semi-structured interviews were conducted and recorded via Zoom. In total, 39 recruiters were interviewed, 22 at the University of Utah and 17 at Case Western Reserve University, at which point saturation of themes was determined to have occurred. The interviews averaged around 36 minutes and participants were sent a $50 Amazon gift card after completing the interview. All study procedures were approved through a single IRB protocol with the University of Utah serving as the IRB of record.

Analysis

Interviews were transcribed verbatim by a professional transcription company and then de-identified. The transcripts were about 14.5 pages long on average.

Three coders conducted a qualitative content analysis of the interview transcripts using Dedoose software. In this inductive process, the coding team created a draft codebook based on the interview guide and then refined the initial codebook through a consensus process. The three coders then independently coded a set of five transcripts and updated the codebook. After the codebook was finalized, each coder was designated the primary coder for a group of transcripts. Each transcript was then independently coded by a different secondary coder. All discrepancies were discussed by the coding team and the analysis was based on consensus codes.

Once all the coding was finalized, themes were developed to describe the recruitment techniques and potential recruitment nudges. In this process, each member of the coding team reviewed all quotes for each individual code and co-occurrence of codes and drafted emerging themes from the data. The coding team discussed emerging themes in an iterative process including the larger research team until the thematic structure was finalized.

Results

The recruiters were asked to complete a demographic survey before being interviewed. Of the 39 recruiters the average age was 35. 80% of recruiters interviewed were female, 15% were male, and 5% were non-binary. 12% listed their ethnicity as Hispanic or Latino, 85% identified as non-Hispanic or Latino, and 3% preferred not to answer. 87% identified their race as White, 8% identified as Asian, 3% answered Black or African American, and 2% preferred to self-identify. Among the 39 recruiters that were interviewed, 108 active clinical trials were discussed in the interviews: 21 trials were minimal risk with potential for direct benefit, 41 trials were minimal risk with no direct benefit, 33 trials were more than minimal risk with potential for direct benefit, and 13 trials were more than minimal risk with no direct benefit.

The major themes that describe the recruitment techniques and potential recruitment nudges included: the impact of relationships (recruiter-healthcare team relationship, recruiter-participant relationship, and health care provider-participant relationship), financial compensation, benefit to community, study risks and benefits, and personalized study information. Each theme is described in more detail below with exemplar quotes. Additional exemplar quotes are shown in Table 1.

Table 1.

Additional Exemplar Quotes Illustrating the Major Themes

Major Theme Categories Extra Exemplar Quotes
Impact of Relationship
Recruiter-participant Relationship “I will always ask if they have any questions, and I will always take the time that it needs to listen to whatever they want to talk about. Literally there has been conversations that are quite lengthy, but I think that as we all know that the patient is always first, that sometimes people need a listening ear as to what’s going on in their life. If that is something that I am being able to provide as a representative of the institution, then give them the time. I think that we don’t ever know what a person’s circumstance is ever just looking at a chart as far as extra things that they might wanna be talking about or sharing about their family history with their cancer history.” – University of Utah Participant 18
Participant-Physician/PI Relationship “My thinking behind that is everyone kind of trusts their doctor. You know that this person went to school for so many years, and then they also did a residency. If they’re in a specialty, then they did a fellowship. You’re aware that they’re an expert in their field. You know, they come in with the white coat, and it’s synonymous with a doctor, and people trust. Whereas if just a coordinator comes in, they may not have that sense of trust and being comfortable, just because they don’t really have that immediate recognition of ‘this person knows what they’re talking about.” – Case Western Reserve University Participant 04
Recruiter-Healthcare Team Relationship “I think the other way that I was able to get referrals for this, is by interacting with the care team that takes care of patients with substance abuse. I would reach out to those physicians. Go in person and introduce myself. Show them the project that we were working on. Talk to them about my philosophy on how I treat patients. What I would be willing to do to help with keeping them connected into the care team? Hopefully, help with their ability to stay on Suboxone and stop use. At first, they don’t know me. Once they got an idea of who I am as a person and what I was willing to do for the patients, I had one physician that I would actually go to the center where he sees patients, and he would see the patient. Then he would walk them down the hall and personally introduce them to me.” - Case Western Reserve University Participant 02
Financial Compensation “Well, I think it just—optically, I feel like it looks better for organizations to do that because you don’t want—I don’t want people to think that I just want them in a study because I want them to get money. You know what I mean? I feel like you’ve got to do your due diligence and explain the risk first, and then go into the benefits later kind of a thing.” – Case Western Reserve University Participant 06
Benefits to Community “Yeah. We don’t have direct benefits with being minimal risk and stuff, but I do try to like I said before just say how cool it is, and how it’s fun to participate in research. I’ve found with [doctor’s name] studies they’re not really hard sells because people like to give back and this is an easy way to give back, specifically caregivers, so we do express that benefit, “Some people like to do this type of research because it makes them feel like they’re contributing back, and we’d be really grateful for anything that you’re able to contribute.” Our benefits are smaller than other studies, but I do press a little bit on how cool it is and how impactful it will be for them to participate.” – University of Utah Participant 16
Study Risks and Benefits “I think I kind of go back and forth between the two, but I probably do the benefits first. Yeah, I definitely do the benefits first and then go into the risks. I think giving them the benefits first puts a more positive outlook on what they’re going to be experiencing. I think that if you go straightaway into—like for the [trial], if I was to say, “Hey, we wanna get—we want you to have a [procedure]. Here’s all the risks, and this is why it’s beneficial,” I think that it might scare off patients a little bit, versus hearing how awesome this research is and what we’re gonna gain from it and then saying, “This is what could possibly happen.’” – University of Utah Participant 07
Personalized Study Information “… depending on people’s knowledge base, if someone has never heard of [study name] … we definitely go into more information, more background versus someone, if we know that someone is a genetic counselor for example.” – University of Utah Participant 11
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Impact of Relationships

Most recruiters mentioned some form of relationship that they believed helped them to successfully recruit participants into clinical trials. Many recruiters mentioned that cultivating a relationship with the healthcare team was helpful in screening and identifying potential participants who would be eligible for and enthusiastic about participating in research.

“… actually working with physicians or providers- like nurse practitioners or physician’s assistants- … is very helpful.” (Case Western Reserve University, Participant 14)

Many recruiters also mentioned that cultivating a relationship with the potential participants themselves was helpful in understanding the person’s motivations while also getting to know more about the participant. It also allowed them to build rapport, deepening the trust between themselves and potential participants.

“…I just love taking care of people. I’ve built this personable and professional relationship with my patients. I guess it’s just a little touch of personable with my patient, and like “you can trust me” type thing.” (Case Western Reserve University, Participant 7)

The relationship that was most often discussed and that recruiters stated was the most effective in recruitment was the relationship between the physician and/or PI and the potential participant. Recruiters discussed how a higher level of involvement from the physician/PI typically corresponded with an easier recruitment process. Recruiters perceived having the potential participant’s physician involved in the recruitment process as an effective technique. Some recruiters mentioned how that may be due in part to the medical authority physicians carry, describing how participants trust and respect their physician and are more likely to participate if a physician thinks that it is a good idea.

“I think that physician involvement is definitely a big determining factor in getting a patient to participate.” (University of Utah, Participant 7)

Financial Compensation

In many interviews, recruiters discussed how intensely and how often to discuss financial compensation in a study. Some recruiters directly related it to risk and benefit, describing that more emphasis on financial incentives is needed to enhance the appeal of a minimal risk study with no direct benefits to participants compared to other types of trials.

“…Convincing of the minimal risk ones, more of the benefit. I was talking to them more of the benefits or having to emphasize the benefits or the compensation for those trials, how much we would be paying them for their time and effort… it’s like how do we convince patients that they- or people to go on a study or trial.” (University of Utah, Participant 22)

“I think the biggest motivator is money for our population. There’s not really a lot of philosophical talk about research itself. That’s why if I find it—I have to really find it okay, the project, to sell it well. If I ask you to do all that, and I offer you $20, I wouldn’t feel good about it. I can’t sell that to you. That’s too much work for $20. For $75, I can sell it to you because I know I can do it quickly, and it will be—it’s fine.” (Case Western Reserve University, Participant 9)

A few recruiters mentioned that they were concerned about discussing financial compensation, and possibly unduly influencing a potential participant’s decision to participate.

Benefits to Community

Frequently, when there were no direct benefits to the participant, recruiters would emphasize the benefits that their participation could have on people with the same diagnosis in the future through better treatments and experiences. Recruiters felt that this encouraged individuals to participate because it highlighted benefits to their community and potential participants wanted to be helpful.

“… a lot of ours are minimal risk, there’s no direct benefit to the patient, but we do emphasize how this could change medicine going in the future and how that could affect people in the future.” (University of Utah, Participant 11)

“The biggest thing for patients is hearing, oh, some—this’ll be easier for someone else if we get what we need from this study.” (University of Utah, Participant 7)

“…I do feel like just kinda letting them know that the whole purpose of this is to benefit research and all these other people in this population.” (Case Western Reserve University, Participant 5)

Study Risks and Benefits

Recruiters had various approaches to how they discussed benefits or risks with potential participants. Many recruiters said that they preferred to keep things more positive by starting with the benefits or “sandwiching” a risk between two benefits to keep things optimistic. Other recruiters emphasized that they simply discuss risks and benefits in the order in which they are listed in the consent document. Whether recruiters started with risks or benefits first, the majority mentioned how they emphasize the benefits heavily to encourage participation.

“… It’s best to lead with what’s good about the study just while you’re gaining their interest… otherwise if I just started by explaining the risks of the study … I would lose their attention pretty fast.” (University of Utah, Participant 15)

“It’s the order from the consent form. As I’m reading through it, and I’m showing the consent form to them, I read through the risks, because they’re listed. Then I go on to benefits.” (Case Western Reserve University, Participant 13)

“I try to emphasize the benefits as much as possible, just because they wanna feel like they’re doing something good or they’re getting something out of it.” (Case Western Reserve University, Participant 4)

“I definitely like sandwich it, a positive sandwich where it’s benefit, risk, benefit. Then I’ll just like go through the list that way.” (University of Utah, Participant 17)

Personalized Study Information

Recruiters reported that they personalize the amount of information they give to potential participants based on their demeanor, health, prior knowledge, and comfort level. Recruiters noted the importance of their awareness of each potential participants’ level of medical knowledge, allowing them to tailor the amount of information necessary to make potential participants feel informed and comfortable. They stated that people are much more willing to participate when information is provided in a less formal way and adjusted based on needs and questions, as opposed to sounding like part of a standard script.

“… I think it’s important to try to match the level of your participants. You can’t talk scientific and hoighty toighty. They don’t understand it. If you can lower yourself to make it—and not even lower in a negative way, but just make it understandable and be very clear in your expectations.” (Case Western Reserve University, Participant 9)

“…We try to tailor it to the participant. Everybody knows what a library is. We are really trying to create a library. We try to stick to the specifics, but in a more common kind of language, so not biorepository that half of them won’t know what that means. If you say, ‘We’re collecting samples so that other researchers can then request samples,’ then it’s easier for them to understand.” (Case Western Reserve University, Participant 9)

Discussion

Informed consent is a critical part of clinical trial recruitment that is based on ethical principles including respect for the participant’s autonomy. It is a recruiter’s responsibility to ensure that a participant’s autonomy is respected. Part of respecting the potential participant’s autonomy is ensuring that prospective participants are given all the information necessary to make a voluntary and informed choice prior to making a decision, and that the information provided is complete, relevant, and easy to understand (Sacristan, 2016). In the interviews conducted as a part of this study, recruiters identified a number of different types of techniques that they utilized in recruitment and consent process including: drawing on the relationships between the participant and the recruiter, physician, and/or PI, discussion of financial compensation, discussion of benefit to community, format of presentation of study risks and benefits, and personalizing study information. Recruiters also reflected on whether different recruitment techniques could serve as behavioral nudges, influencing participants’ ability to make informed decisions. The recruitment techniques that recruiters mentioned most often as extremely effective and as potential behavioral nudges included involving the participant’s physician in the recruitment process as a trusted source, describing the benefits of the study to the participant first and in more detail than the risks, and emphasizing the financial incentives of the study during the recruitment process.

A key technique described consistently by recruiters was the involvement of the participant’s physician in the recruitment process, which was often seen as a natural or necessary part of the process. This technique was seen as highly effective in recruitment, with the impact increasing as the level of the physician’s activity increased. While empirical studies examining the impact of a physician-participant relationship on recruitment are limited, prior literature has described participant’s preference for their physicians over recruiters during the consent process (Wright et al., 2002; Fletcher et al., 2012). This is often due to a higher level of trust, rapport, physician knowledge and participant confidence in physician expertise, and the feeling that the physician is protecting the person’s best interest due to their role as their physician and because there is an established relationship (Bosisio et al., 2021; Resnick et al., 2003). Concerns have been raised that, especially when there is a pre-existing participant-physician relationship, the conflict of the physicians’ role as both clinician and investigator may lead to inappropriate limitations on who is asked to participate and the perception of the clinician as being paternalistic (Newington & Metcalfe, 2014). Further ethical concerns about involving the potential participant’s physician in clinical trial recruiting has been one reason that some institutional review boards have required separate study recruiters in some clinical trials. Empirical and normative analysis is needed to evaluate what actions a physician can and ought to take when encouraging their patient’s decision making, what runs the risk of being a nudge and in what contexts (i.e. minimal vs more than minimal risk) that might be problematic, and what might undermine the consent process (Black et al., 2013; Taylor et al., 1987).

Another technique that emerged as important in the interviews was financial compensation. In literature, this has been shown to be a very effective recruitment method; one meta-analysis of nine studies asking for responses to electronic health surveys found that when a study used financial compensation, participants were more than twice as likely to respond (David, 2014). Many of the recruiters in our study discussed how they emphasize monetary incentives or find them helpful in “selling” the study. Some acknowledged the ethical issues that come up with putting an emphasis on payment as a benefit of participation. A few recruiters worried about unduly influencing potential participants depending on how and how often payment was mentioned. While current guidance exists on how to avoid unduly influencing participants with financial benefits, namely that IRBs can “restrict levels of financial or nonfinancial incentives for participation,” and that they “should carefully review the information to be disclosed to potential subjects to ensure that the incentives and how they will be provided are clearly described” (Office for Human Research Protections, 2019), similar guidance does not exist for behavioral nudges. Financial compensation in research has been a concern in literature for many institutional review board and ethics professionals. Interestingly, some recruiters felt that participants were not offered enough compensation for their time and risk, a view that has been echoed in literature (Largent & Lynch, 2017). More research should be conducted to better understand how high financial compensation can be before it constitutes undue influence. However, merely utilizing and emphasizing financial compensation may work as a potential nudge (Strang et al., 2016). Dunn and Gordon (2005) have identified a number of economic and market forces at work in research and influencing participation, with financial compensation being just one benefit among many that a potential participant must weigh. Recruiters should be aware of the choice architecture surrounding financial compensation, and may consider whether to increase or decrease the emphasis on monetary incentives depending on other factors such as the risk of the study or other benefits the study might offer (Dunn & Gordon, 2005).

Discussing the benefit that one’s participation could have for others with similar conditions in the future was also mentioned as a very effective way to encourage participation when there were no direct benefits to the participant. Many studies, particularly in cancer research, have examined what motivates potential participants to participate in clinical research, finding self-interest and altruism to be primary motivators (Sawyer, 2017; Godskesen et al., 2014; Truong et al., 2011; McCann et al., 2013). Because potential participants should be aware that the ultimate goal of research is to benefit the community, promoting this understanding is thought to be not only ethically permissible but required to avoid the therapeutic misconception (Olsen et al., 2020). Recruitment techniques that focus on altruism may create an easier decision-making process for participants whose primary motivation is altruism (Raskoff, 2022). However, this raises normative questions about how much and in what form it is ethically permissible for this technique to be applied. Further, there is also the concern that an emphasis on altruism could lead potential participants to underestimate study risks (Olsen et al., 2020).

In addition, we found that the sequence in which study risks and benefits are described varied greatly among recruiters. Those who described risks first talked about wanting to be honest and transparent with potential participants, while those who described benefits first or “sandwiched” a risk between two benefits mentioned wanting to increase interest and keep things on a positive note. This brings up the possibility of effects from the order in which items are presented (Shteingart et al., 2013). For example, with benefits presented both at the beginning and end of a conversation, a potential participant might remember these better due to primacy and recency effects, raising the concern that risks might not be remembered (Bansback et al., 2014). A prior qualitative study found that one of the main driving factors in decision-making related to participation in a cancer clinical trial was whether the primary focus was on treatment benefits or on adverse effects (Madsen, 2007). This brings up an important point about presentation of information techniques as all approaches involve some choice architecture. Since risks and benefits must be discussed, more research is needed to determine how best to present information to enhanced informed choice.

Lastly, recruiters discussed how they tailor the information they give to a potential participant during recruitment based on the person’s prior knowledge, condition, demeanor, and possible anxiety. A study done by Bansback and colleagues (2014) described using personalized order effects to better promote participant’s decision making by tailoring the information first presented to the possible participant based on what was most important to them (Bansback et al., 2014). Prior literature has described recruiters’ techniques to build their own relationships with potential participants, often with a hand-off from the person’s clinician, to better understand the participant (Wright et al., 2002; Kraft et al., 2022; Morgan et al., 2017). There is the concern though that in creating these deeper relationships with potential participants, recruiters may introduce confusion about their role in the person’s care. A review that investigated factors that impact recruitment found that some participants preferred and felt more reassured by face-to-face recruitment versus a letter or information sheet and that “they highly valued the personal information and discussion of the trial which made them feel safe” (Houghton et al., 2020, p. 10). Other research has shown that nonverbal communication and other communication techniques centered around relationship building can improve rates of recruitment (Morgan et al., 2017; Morgan et al., 2016). The effect is dependent on the participant’s situation, with some people preferring more flexibility and less face-to-face interaction or pressures to give a response (Houghton et al., 2020). This suggests that recruiters should carefully evaluate the choice architecture used during the informed consent process and consider its impact on autonomy.

Limitations

The results from this study are based upon recruiters’ perspectives and their experience recruiting, and we were not able to investigate whether the described recruitment techniques affected potential participants’ ability to make informed choices. Whether or not the nudges described here impact enrollment rates requires additional research, and whether that impact raises ethical issues is yet another area for exploration. In addition, the recruiters who were interviewed were from two U.S. institutions and it is possible that use of different recruitment techniques varies across other institutions and countries. We were not able to examine the effects of specific recruiter sociodemographic characteristics or institution in order to protect the confidentiality of the recruiter participants, and this is an important area for future research. While this study focused on recruiters’ perceptions, it is also important to investigate how IRB or institutional policies might be barriers or facilitators to recruiting diverse and inclusive study populations. Finally, all interviews were conducted in English, potentially limiting insights from recruiters who conduct recruitment activities in other languages.

Conclusion

Individuals who recruit participants for clinical trials play a critical role in the research enterprise, but there has been little research focused on recruitment techniques despite the fact that choices made in how information is presented during the informed consent process may have significant ethical implications. This qualitative study identified a number of techniques used by recruiters, and their views on potential ethical issues. The effects of these recruitment techniques on the consent process and the ethical implications of their use should be further investigated. We believe that it is imperative to understand the relationship between recruitment techniques and nudging both to better protect the informed decision making of potential participants and to help later development of a taxonomy of nudges for wider use in normative analysis.

Educational Implications

The recruitment techniques identified by clinical trial recruiters in this study raise potential ethical questions in regard to the informed consent process. By identifying the recruitment techniques that recruiters use frequently and personally identify as effective in recruiting participants, we can examine their use in more detail and work to understand the ethical implications of how these techniques are being used. These findings show the importance of education about informed consent in human subjects trainings for clinical trial recruiters so that widely used techniques are utilized in ways that support informed decision making regarding participation among potential trial participants.

Best Practices

The qualitative interviews identified a number of recruitment techniques that recruiters reported using because they personally find them to be effective, including physician involvement in the recruitment process, highlighting the benefit that participation in the research study could have on other people with the same medical condition, and highlighting monetary incentive. Even though the techniques may be used widely, they could potentially be used differently by each individual recruiter. We recommend developing standard approaches and training modules for utilizing these techniques in ways that support both informed consent and effective recruitment into clinical trials.

Research Agenda

This article focuses on the recruitment techniques identified by clinical trial recruiters as techniques that they use and identify as effective. However, additional research is needed to examine the use of these recruitment techniques in other settings and contexts, as well as whether these techniques could be considered nudges and the resulting impact on the informed consent process. To uphold informed consent and a participant’s right to choose regarding participation in clinical trials, more research into the ethical implications of these recruitment techniques is crucial.

Supplementary Material

Supplementary file

Acknowledgments Section

We thank the participants for sharing their perspectives in the interviews.

Funding Statement

Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health, USA under award number R01TR004245.

Footnotes

Declaration of conflicting interest

Dr. Kodish serves as a consultant and external member of the Data Sharing Committee for Incyte.

Ethical approval and informed consent statements

The study is approved as a single IRB protocol by the University of Utah Institutional Review Board. All participants provided informed consent with a waiver of documentation of consent prior to the interview.

1

There are a variety of other definitions of nudges (Hansen, 2016; Sunstein, 2018; Mongin & Cozic, 2018, Saghai, 2013) that have refined and built upon the original definition to offer a narrower or broader view of what a nudge entails. Due to the lack of normative research on a nudge in clinical research, the original, broad, definition of a nudge was intentionally chosen here.

Data Availability Statement

The data supporting the findings of this study can be obtained by making a request to the corresponding author, subject to institutional data transfer agreements as needed.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplementary file
NIHMS2106520-supplement-Supplementary_file.docx (68.6KB, docx)

Data Availability Statement

The data supporting the findings of this study can be obtained by making a request to the corresponding author, subject to institutional data transfer agreements as needed.

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