Determining Ethical Incentives in Biomedical HIV Research: Insights from Researchers,Regulators,and People Living with HIV

Abstract

Incentives are crucial for recruiting and retaining participants in research studies, yet researchers and regulators often struggle to determine appropriate incentives due to ethical concerns and a lack of clear guidelines. We conducted interviews and focus groups with three stakeholder groups—biomedical HIV researchers (n = 12), institutional review board (IRB) members (n = 12), and people living with HIV (PLWH) (n = 69)—to explore their perspectives on incentives and ethical decision-making in biomedical HIV research. Our findings revealed disparities in perspectives; researchers and IRB members were most concerned about offering high incentives, while PLWH were most concerned about incentives being too low. Consensus highlighted the need for diverse incentive options, transparency, standardized guidelines, and community engagement to address both ethical and practical challenges.

Keywords

HIV people living with HIV incentives ethical payments compensation reimbursement research participation

Introduction

Incentives are payments or benefits (e.g., cash, gift cards, services) offered to research participants to encourage participation and improve recruitment and retention, beyond reimbursement for expenses or compensation for time and inconvenience (Gelinas et al., 2018). Within broader research participant payment frameworks, scholars distinguish several models: reimbursement for direct expenses (e.g., transportation, meals, lodging), compensation for time and inconvenience, appreciation payments as tokens of gratitude, and incentive payments designed to encourage enrollment by exceeding actual costs or compensation for burden (Grady, 2005; Wendler et al., 2002). While the International Ethical Guidelines for Health-related Research Involving Humans (Council for International Organizations of Medical Sciences [CIOMS], 2016) address reimbursement and compensation—recommending that participants be reimbursed for expenses and compensated for time and inconvenience without creating undue inducement—they do not define incentives or provide guidance on their use beyond noting that they can be studied as interventions.

Empirical evidence indicates that views on incentives vary across stakeholders. A survey of U.S. Institutional Review Board (IRB) members and professionals involved in research oversight identified widespread concern that higher incentives could increasingly influence research participation decisions, with many endorsing expansive definitions of coercion and undue influence that may unnecessarily restrict payments (Largent et al., 2012). In contrast, research participants, including economically marginalized individuals, have reported that monetary incentives are important motivators for enrollment and view them as legitimate economic benefits rather than undue, unjust, or coercive influences (Largent et al., 2022; Slomka et al., 2007). Investigators and IRB chairpersons also differ: a U.S. survey revealed investigators consider incentivization important for encouraging study participation, while IRB chairs do not prioritize this factor when setting payments (Ripley et al., 2010). Research in Kenya shows that participants consider both financial and non-financial benefits (e.g., free clinical assessments, learning opportunities) as incentives, indicating that assessments of undue inducement should account for more than just monetary payments (Chi et al., 2022).

While altruism motivates some research participation (Dubé et al., 2020; Prakash et al., 2018), it is often insufficient for studies that involve specific demographics, higher risks, or limited direct benefits (Ripley et al., 2010; Yancey et al., 2006). In these contexts, incentives become essential for recruitment and retention (Parkinson et al., 2019), and are sometimes viewed as a reciprocal exchange for study data (Abadie et al., 2019). This is especially true in biomedical HIV treatment and cure-related research, where participants often face multiple social vulnerabilities (e.g., living with HIV, sexual minority, racial/ethnic minority, lower socioeconomic status) and clinical risks (e.g., invasive procedures, comorbidities) while having minimal prospects for direct personal benefit (Collins et al., 2017; Resnik, 2015).

Despite widespread use of incentives, standardized guidance for determining appropriate types or amounts is lacking (Brown et al., 2016). Incentive data are rarely reported systematically (Anderson & Brown, 2021); a systematic review found 95% of randomized controlled trials in top medical journals did not report them (Trung et al., 2017). Consequently, incentive decisions often rely on subjective assessments of risks, burdens, and benefits (Gelinas et al., 2018), influenced by institutional norms, precedent, regulations, and advice from other investigators (Brown et al., 2018), and practical factors like study procedures, time commitment, population, and budget (Grady, 2005; Largent & Fernandez Lynch, 2017). This results in substantial variability in incentive practices, even within the same institutions (Brown et al., 2019; Brown et al., 2021).

Ethically, incentives must balance avoiding coercion (payments that are too high) (Emanuel et al., 2005) with exploitation (payments that are too low) (Blumenthal-Barby & Ubel, 2021). U.S. federal regulations (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979; U.S. Food and Drug Administration [FDA], 2018) and international guidelines (CIOMS, 2016) stipulate that payments (a term encompassing incentives as well as compensation and reimbursement) should not compensate for study risks. Nonetheless, researchers, IRB members, and participants may perceive payments as offsetting risks to make research participation more acceptable (Largent, 2017). Empirical evidence suggests that research participants typically evaluate study benefits against risks, invasiveness, time commitments, and other factors, underscoring the complex interplay between incentives and overall study appeal (Devlin et al., 2022).

To inform evidence-based guidance, we conducted qualitative interviews and focus groups with people living with HIV (PLWH), HIV researchers, and IRB members/bioethicists to (1) compare their views on incentives and (2) explore ethical considerations that shape incentive decisions in biomedical HIV research.

Methods

Study Setting and Participants

We collected data as part of a larger mixed-methods, community-engaged study addressing the impact of incentives on clinical trial participation (Galea et al., 2021). The study was approved by the Socio-Behavioral Institutional Review Board at the University of California, Riverside (IRB #HS20-248) and conducted in partnership with the HIV + Aging Research Project–Palm Springs. The multidisciplinary research team included academic and community collaborators with advanced degrees and expertise in HIV prevention, public health, social work, sociology, and qualitative methods.

Following best practices for community-centered HIV research (Weinstein et al., 2023), a 12-member community advisory board (CAB), comprising PLWH, IRB members, and HIV researchers from across the U.S. guided the study. The CAB reviewed and refined recruitment materials, consent forms, and interview guides prior to IRB approval.

From November 2021 to May 2022, we recruited a purposive sample of U.S.-based stakeholders with experience in biomedical HIV research. Eligible participants were ≥18 years old, spoke English, had a phone or Internet access, and belonged to one of three groups: PLWH, IRB members/bioethicists, or HIV researchers. We initially contacted 68 individuals known to the CAB and research team, including doctors, researchers, and community activists. The study coordinator sent invitation emails (including study details and the interview guide) and recruitment flyers, with a follow-up after two weeks. An additional 54 individuals self-initiated contact with the study coordinator after learning about the study via flyers or word-of-mouth.

PLWH chose either a one-on-one interview to explore individual views or a focus group to facilitate broader discussion and idea sharing. Other stakeholders participated only in one-on-one interviews due to scheduling constraints. Of the 122 individuals contacted or self-referred, 93 participated (76.2%). Non-participation was due to scheduling conflicts or no response.

Data Collection

Interested participants received a Qualtrics^XM survey link via email, beginning with a consent form; consent was indicated by radio button. The survey collected demographics (measures were obtained from the PhenX Toolkit database; www.phenxtoolkit.org) and initial perceptions of research incentives offered to encourage participation in research studies.

Interviews and focus groups were conducted via Health Insurance Portability and Accountability Act (HIPAA)-compliant Zoom teleconference. Participants were assigned unique identification numbers to maintain confidentiality, verbally reaffirmed consent, and participated in either a one-on-one interview (n = 38) or focus group (n = 55 participants across 12 groups, with 3–6 participants per group). Interviews lasted 15–60 min and were conducted by KYG; focus groups lasted ∼90 min and were facilitated by the eight authors working in dyads. Only the participants and researchers were present during sessions. Sample sizes exceeded recommended thresholds for thematic saturation (Guest et al., 2017; Hennink et al., 2017).

Interview and focus group guides (Table 1) explored perceptions of incentives and criteria for ethical evaluation. To ensure a shared understanding, facilitators provided standardized definitions. Incentives were defined as “something received specifically to increase the chance of participation in a research project. Incentives are usually given in the form of cash, checks, gift cards, or gifts with some cash value. Receiving free health care in exchange for study participation is also an example of an incentive.” Reimbursement was defined as “payment received to cover costs like parking, childcare, lost wages, or other expenses that you might have to pay out of pocket to be able to participate in a research project.” Participants were instructed to only discuss incentives.

Table 1.

IRB-Approved Interview and Focus Group Questions.

Question	Researchers & IRB Members	Persons Living with HIV
Perceptions of incentives
Have you ever been involved^a in a research project with an incentive? Probes: What do you recall about the incentive provided? What was it?	X	X
How do you feel about research incentives? Probes: Are they good, are they bad, why?	X	X
What are your thoughts about the amount of financial incentives offered to participate in research? Probes: When would an incentive be “too high/too much” or “too low/too little”? What impact do you see for incentives that are “too high/too much” or “too low/too little”?	X	X
Are you more concerned about incentive payments that are too high or too low? Why?	X
How does the offer of an incentive affect your decision to participate in research?		X
If a research study offers you an incentive to take part, how would that affect your willingness to be a study participant? Probes: What is too much? What is too little?		X
Ethical decision-making regarding incentivizing research participants
How should decision makers decide on what incentive amounts are appropriate? Probes: Personal knowledge, history, database, possible study related harm	X	X
What factors do you think people (researchers, ethics boards) should consider when making decisions about the type and amount of incentives to offer a study participant? Probes: Location, population, risks, budget, advice	X	X
Which form of incentive do you feel most confident providing to study participants? Probes: Cash, gift card, gift, other; why?	X
Which form of incentive would you be most interested in receiving to participate in a research study? Probes: Cash, gift card, gift, other; why?		X

Note: ^a”Involved” was replaced with “participated” when interviewing people living with HIV.

No validated qualitative measures for HIV biomedical research incentives existed; therefore, the guides were developed by the study authors following a literature review (see Galea et al., 2021) and refined with CAB feedback. Topics included types and amounts of incentives, acceptable versus inappropriate incentive amounts, influence of incentives on participation in biomedical research, and the ethical implications of varying incentive amounts. Sessions were audio- and video-recorded, transcribed using Otter.ai, de-identified, linked to demographic survey data via participant identification numbers, and reviewed for accuracy before analysis.

Participants received a US $25 electronic gift card, consistent with local norms for participant remuneration at the PI's institution and deemed unlikely to constitute undue inducement by the IRB for this low-risk, minimal time-commitment study.

Data Analysis

The analysis aimed to identify factors each stakeholder group considered important when evaluating ethical incentives for HIV biomedical research. Using a framework analysis approach (Ritchie & Lewis, 2003), all authors reviewed de-identified transcripts to propose preliminary codes. KYG and JLL then compiled de-identified responses into a master Microsoft Excel spreadsheet and systematically coded text segments by question block. Through iterative meetings, they aligned code definitions, resolved discrepancies, and organized codes into higher-order categories and themes, resulting in an inductive codebook and hierarchical coding structure. KYG and JLL then synthesized the coded data into narrative summaries. ANP independently reviewed the final codes, categories, themes, and summaries to ensure analytic coherence and developed an illustrative coding tree, available in the Supplemental Digital Content. All authors reviewed the final narrative summaries and contributed to the development of ethical considerations, which were presented to the CAB for feedback. Methodological rigor was supported by completion of the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist.

Results

Table 2 summarizes the demographics of the 93 participants: 69 PLWH (14 interviews; 55 focus group participants), 12 researchers, and 12 IRB members (including 5 bioethicists). PLWH were aged 23–71 years (mean=56.1, SD = 10.1); 66.7% (n = 46) were assigned male at birth, 52.2% (n = 36) had completed a college degree, 26.1% (n = 18) identified as Hispanic/Latinx, and 56.5% (n = 39) identified with one or more non-White racial groups. Researchers and IRB members were aged 24–85 years (mean=52.0; SD = 17.0); 50.0% (n = 12) were assigned male at birth, 87.5% (n = 21) held graduate degrees, 4.2% (n = 1) identified as Hispanic/Latinx, and 25.0% (n = 6) identified with one or more non-White racial groups. Incentive payments were considered a benefit of research participation by 94.2% of PLWH (n = 65), 66.7% of researchers (n = 8), and 58.3% of IRB members (n = 7).

Table 2.

Demographic Characteristics of Participants by Stakeholder Group (N = 93).

Variable	Persons Living with HIV (n = 69)	Researchers & IRB Members (n = 24)
Age, mean; SD (range)	56.1; 10.10 (23–71)	52.0; 17.02 (24–85)
Sex at Birth, n (%)
Female	23 (33.3)	12 (50.0)
Male	46 (66.7)	12 (50.0)
Gender, n (%)
Woman	22 (31.9)	10 (41.7)
Man	44 (63.8)	13 (54.1)
Other	3 (4.3)	1 (4.2)
Ethnicity, n (%)
Hispanic/Latinx	14 (20.3)	1 (4.2)
Not Hispanic/Latinx, or unknown	55 (79.7)	23 (95.8)
Race, n (%)
Black/African American	28 (40.6)	1 (4.2)
White	30 (43.5)	18 (75.0)
Other/multiple races-ethnicities	11 (15.9)	5 (20. 8)
Educational Attainment, n (%)
High school	6 (8.7)	0 (0)
Some college	27 (39.1)	0 (0)
Undergraduate degree or equivalent	13 (18.8)	3 (12.5)
Master's degree or equivalent	9 (13.0)	2 (8.3)
Doctoral degree or equivalent	14 (20.3)	19 (79.2)

Key qualitative themes are summarized below, with supporting data in the Supplemental Digital Content.

Diverse Incentives Reported, Cash Incentives and Choice Preferred

Participants reported wide variation in both incentive amounts and types offered and received, which they attributed to differences in study burden, procedures, and risk. PLWH most often described receiving incentive amounts ranging from US $25–$1,500, with higher amounts for more invasive study procedures (e.g., lumbar puncture or biopsy) and a reported maximum of $6,000. Researchers and IRB members reported higher overall average incentives, up to $15,000 for participants who completed an entire study. PLWH also reported receiving non-monetary incentives, including healthcare and access to post-study interventions. For example, one PLWH described enrolling in an unpaid clinical trial because “I was getting better medical care in the research study than I was getting in my primary care” (PLWH, non-Hispanic Black woman).

Preferences for incentive type varied across groups. PLWH generally favored cash due to its flexibility and broad usability, whereas researchers and IRB members often relied on gift or prepaid debit cards due to institutional policies and administrative constraints. One researcher shared:

Our patients prefer cash…[but] there are times when cash is either a risk or not possible… some major universities have rules about if your research has a registered funding stream through a grant … you have to use these stupid reloadable debit card things. (Researcher, non-Hispanic White woman)

Despite this discrepancy, participants across all stakeholder groups reported a desire to offer participants a choice among incentive options, to accommodate diverse needs, particularly given documentation and tax-reporting barriers may limit cash incentives for certain populations.

Incentives as Recruitment Tools and Expressions of Appreciation

Across stakeholder groups, participants described incentives as both practical tools for recruitment and symbolic expressions of appreciation. PLWH emphasized that incentives facilitate participation amid financial hardship and can “bring more people to the table…some of them might really need that gift card” (PLWH, non-Hispanic White woman), even among those motivated by altruism. Researchers and IRB members similarly viewed incentives as critical for study completion, with one IRB member noting that clinical trials often “start rolling, and then just don’t finish,” and that incentives help “increase recruitment rates… so that you can actually complete the research… and deliver the social benefits that are supposed to justify the risks to participants” (IRB member, non-Hispanic White man). Participants across all stakeholder groups also framed incentives as affirming individuals’ time, effort, and essential contributions to research.

Ethical Concerns About High Incentives

Researchers and IRB members commonly expressed concern that excessively high incentives could constitute undue inducement, compromise risk and burden assessment, or threaten data integrity. One IRB member cautioned, “I think history has shown us that if incentives are unreasonably high, people may not consider fully the complexity of those research projects and what they're being expected to do” (IRB member, non-Hispanic White man). Some PLWH resisted this characterization, emphasizing their agency and attentiveness during informed consent.

Participants across stakeholder groups also raised concerns that large incentives might prompt misreporting or expectancy effects, with participants providing false information to obtain payment. A researcher explained:

If you offer somebody a real large incentive, and the reason for them to be in that study is just the incentive… there is a natural tendency in human beings to give you what you want to hear… to continue participating in the study. (Researcher, non-Hispanic White man)

Researchers and IRB members also raised concerns that high incentives may encourage fraudulent participation through misrepresentation of eligibility.

Low Incentives Deter Participation and Undermine Trust

Participants across stakeholder groups agreed that incentives perceived as “too low” can deter research participation. PLWH emphasized that inadequate incentives signal disrespect for participants’ time and effort and undermine trust in the research process. One PLWH explained:

You have to demonstrate trustworthiness every day … that means compensating people fairly and equitably. [If] the incentive is seen as low, why should that community trust you? You're coming in, and you're telling them, ‘we want you to do all this stuff, and we're gonna throw you a few handfuls of birdseed, and you should be happy for that.’ That isn't how you build trust. (PLWH, non-Hispanic White man)

To address concerns about insufficient incentives, participants across stakeholder groups suggested establishing minimum thresholds for incentives tied to study burden, including time commitment, procedural invasiveness, and required follow-up, with some PLWH identifying absolute floors below which participation would feel exploitative. One PLWH explained:

I tend to agree that there's a minimum threshold… reflective of how much you expect us to go through. [If there are] repetitive appearances or extra work … then I would expect it [the incentive] to be a little bit higher. (PLWH, non-Hispanic Black woman)

Population-Specific Factors Should Guide Ethical Incentive Design

Participants from all stakeholder groups agreed that ethical incentivization should account for population-specific factors that shape the burdens of research participation. Socioeconomic status was often cited as affecting both appropriate incentive amounts and who participates, which can influence study generalizability. As one PLWH explained:

Someone who has a stable income is financially secure, they may not be motivated to enter into a study that only has a $25 gift card … So then in your data, you're getting information that's really skewed towards potentially a lower socioeconomic status. (PLWH, Hispanic multiracial man)

Participants across stakeholder groups further endorsed adjusting incentives to promote the inclusion of women and historically underserved racial and ethnic groups. They also emphasized the need to tailor incentive types and amounts to participants’ geographic location and to account for disease-specific risks, such as overall health status and stage of disease progression. Some PLWH also highlighted structural and economic vulnerability as a broader context shaping how incentives are perceived and used, noting that research participation can be a means of meeting basic needs:

It's really a social justice issue that some people feel they have to rely on studies to be able to eat… What's the role of an incentive when someone is dependent upon research study after research study, the incentive of their studies to be able to eat or survive or take care of basic needs? (PLWH, Hispanic multiracial man)

Collaborate with Community Members to Guide Ethical Incentivization

Participants across stakeholder groups emphasized the importance of involving community members in determining incentive types and amounts. Engagement through CABs, employment on research teams, or other collaborative mechanisms was described as essential for ensuring that incentives are appropriate. Researchers and IRB members further emphasized that meaningful community collaboration can provide evidence to justify incentive amounts, supports trust-building, and improves recruitment. One researcher explained:

There's a whole big, beautiful, diverse world out there of people who want to share their bodies, their time, and their experiences…[to] build that trust, and actually get good data, you need to hear these people… what they feel their time, their bodies are worth…” (Researcher, non-Hispanic White nonbinary person)

Enhance Transparency and Standardization in Incentive Decisions

Researchers and IRB members reported that inconsistent institutional policies, especially in multi-site studies, make it difficult to apply incentives consistently. They noted that determinations of ethical incentives often relied on informal benchmarking and individual IRB members’ judgements, rather than standardized guidance. Across stakeholder groups, participants emphasized the need for transparency in incentive determination, including accounting for geographic differences in what is considered appropriate or coercive, and supported developing data repositories that link study characteristics (e.g., invasiveness, analytical treatment interruptions) to the types and amounts of incentives offered. One researcher remarked:

A database or a repository where there's information about what types of activities studies have required, and what participants have been compensated… that can help researchers land on an incentive amount. (Researcher, non-Hispanic White man)

Finally, some participants also noted that clear reporting by sponsors about study practices and incentives could strengthen trust and accountability in research.

Discussion

Researchers and IRBs face challenges in establishing appropriate incentives due to ethical concerns and a lack of clear guidelines. By comparing the perspectives of three key stakeholder groups in biomedical HIV research, we highlight four important findings.

First, all groups recognized incentives as crucial for recruitment and retention, and a means of valuing participant contributions (Resnik, 2015). Although U.S. research regulations prohibit presenting incentives as benefits of study participation—reflecting a protective logic that prevents payment from offsetting or justifying exposure to research risk (U.S. Food and Drug Administration (FDA), 2018)—94% of PLWH in our study nevertheless viewed incentives as a benefit, revealing a disconnect between formal ethics frameworks and participants’ lived perceptions of research participation (Wertheimer, 2013). Some PLWH also identified access to comprehensive healthcare and post-study interventions as important incentives, indicating that benefits of participation extend beyond financial compensation and may help bridge gaps in HIV care (Barnabas & Celum, 2017). While PLWH preferred cash incentives, all groups indicated a desire for flexibility in incentive types to accommodate diverse participant preferences. This aligns with a 2021 U.S. survey that found PLWH's incentive preferences vary by age, gender, race, ethnicity, and location, indicating a one-size-fits-all approach may limit participant diversity (Polonijo et al., 2022).

Second, perceptions of ethical incentivization amounts differed by stakeholder group. IRB members and researchers were primarily concerned that high incentives could lead participants to overlook study risks or compromise data integrity, whereas PLWH emphasized that low incentives signal disrespect, are perceived as inadequate recognition of participants time and efforts’, and may undermine trust and respect, deterring participation. These findings highlight the importance of including participant perspectives in ongoing debates about incentivization, which often lack empirical input from the research participants who are most affected by these issues (Halpern, 2011; Devlin et al., 2022). Educating participants about study procedures and risks, as previously recommended for minoritized populations (Devlin et al., 2022), may help mitigate researchers’ and IRB members’ concerns about high incentives by minimizing the potential for undue inducement.

Third, stakeholders agreed that factors such as disease stage, socioeconomic status, geographic location, race, ethnicity, and gender should guide incentive decisions. They also called for greater transparency and standardization in how incentives are determined. Current decision-making concerning participant payment often relies on free market principles, nominal gestures of gratitude, reimbursement for expenses, or standard hourly wages (Resnik, 2015). Our findings support the notion that incentive types and amounts should be tailored to the needs of the participants being recruited (Campbell et al., 2023). Documenting incentive amounts and rationales, including demographic considerations, in institutional or national databases could promote fairness, transparency, and standardization (Brown et al., 2018).

Fourth, all stakeholder groups emphasized the importance of community involvement in determining incentive types and amounts. Community expertise should be centered in ethical discussions in biomedical HIV research and is vital for understanding motivations for research participation (Dubé et al., 2021). Community engagement through CABs or other collaborative methods are demonstrated to enhance recruitment, build trust, and foster health equity (Weinstein et al., 2023). Our study suggests that such involvement may also ensure that incentives are appropriate and effective.

Strengths and Limitations

While this qualitative study drew on diverse perspectives from three key stakeholder groups in biomedical HIV research, findings should be interpreted in relation to the study context and sampling strategy. We used purposive sampling to capture a range of experiences with research incentives across PLWH, HIV researchers, and IRB members/bioethicists from various U.S. geographic and professional contexts. Sample sizes exceeded typical thresholds for thematic saturation (Guest et al., 2017; Hennick et al., 2017), supporting analytic adequacy. Nevertheless, transferability may be limited by contextual factors. Recruitment through the social networks of the CAB and study investigators may have shaped the range of perspectives included, and HIV-related stigma may have deterred participation by some eligible individuals, potentially underrepresenting certain viewpoints.

Participants represented a national sample of research stakeholders, all of whom received the same incentive (US $25 gift card) for the same level of participation, which exceeded the federal minimum wage for approximately two hours of participation (demographic survey plus interview or focus group). This incentive may have preferentially attracted participants motivated by payment, potentially influencing engagement or emphasis in responses. Though interview questions were developed with input from the CAB to ensure relevance and appropriateness for the study population, some questions used evaluative framing (e.g., referencing incentives as “too high” or “too low”), which may have shaped how participants conceptualized and discussed incentives and constrained the range of perspectives expressed. We sought to reduce this potential bias by initially asking broader, more neutral questions (e.g., “How do you feel about research incentives?”) before introducing more evaluative prompts.

Conducting interviews and focus groups in English via teleconference excluded non-English speakers and those without reliable phone or internet access. Although focus groups can foster dynamic conversation, they may also encourage groupthink; therefore, facilitators were trained in best practices (adapted from Pollard et al., 2015), including strategies to manage dominant speakers and encourage diverse viewpoints. Facilitators represented diverse professional and demographic backgrounds and rotated across sessions, though matching facilitator and participant characteristics was not feasible and may have influenced participant disclosure.

Formal member checking was not conducted due to feasibility constraints and concerns about participant burden. To enhance rigor and trustworthiness, we employed multiple strategies, including triangulation across coders, peer debriefing during codebook development, maintenance of an audit trail, reflexive team discussions about positionality and potential bias, and CAB feedback on preliminary themes.

Conclusion

This study highlights the critical role of incentives in recruiting and retaining participants in biomedical HIV research, and some of the challenges faced by researchers and IRBs in determining appropriate incentivization. Disparities emerged, with researchers and IRB members concerned about high incentives, while PLWH worried that low incentives could undermine their value and trust in the research process. Consensus among stakeholders emphasized the need for transparency, standardization, a diverse range of incentive options, and the engagement of community members in discussions about incentives.

Best Practices

Including the participant community in discussions about incentivization is essential, as each stakeholder in the research process brings unique biases shaped by their professional backgrounds and lived experiences. When determining appropriate incentive amounts, it is important to consider the specific needs and preferences of the participant group, as well as broader factors such as rising costs of living, tax reporting requirements that impact how much income individuals can earn without jeopardizing social service benefits, and documentation requirements that may exclude undocumented individuals from participation. Collecting both qualitative and quantitative national data from various stakeholder groups would provide broader context to inform more equitable and effective incentivization strategies.

Research Agenda

Future research should prioritize the inclusion of the research participant community in discussions about incentives. While this study utilized separate focus groups for each stakeholder group, exploring the dynamics of collaboration among these groups may yield richer insights. Involving other relevant stakeholders in the research process, such as funding agencies, grant writers, and budget officers, could provide valuable perspectives. Future research should also explore intangible motivations for research participation, such as altruism, to better understand the full range of factors influencing decisions to participate.

Educational Implications

Given that IRB members and researchers tended to express concerns about offering excessively high incentives, while potential research participants voiced worries about incentives being too low, open communication between these stakeholders is essential. Facilitating discussions that incorporate the perspectives of the participant community can provide valuable insights to IRB members and researchers into what participants consider to be fair and motivating, without being coercive. Ethics-focused conference panels should also consider including this topic to foster greater understanding and collaboration across stakeholders. Additionally, our findings emphasize the need for refined CIOMS (2016) guidance, including explicit guidance on incentives intended to encourage study recruitment and retention, which are conceptually distinct from reimbursement or compensation and outlined in both U.S. Food and Drug Administration (FDA) (2018) guidance and a recent framework for ethical payment to research participants created by a vast collaborative working group of leaders in the bioethics field from academia, the federal government, industry, and IRBs (Gelinas et al., 2018).

Supplemental Material

sj-docx-1-jre-10.1177_15562646261441345 - Supplemental material for Determining Ethical Incentives in Biomedical HIV Research: Insights from Researchers, Regulators, and People Living with HIV

Supplemental material, sj-docx-1-jre-10.1177_15562646261441345 for Determining Ethical Incentives in Biomedical HIV Research: Insights from Researchers, Regulators, and People Living with HIV by Karah Y. Greene, Brandon Brown, Jerome T. Galea, Jasmine L. Lopez, Karine Dubé, Jeff Taylor, Christopher Christensen and Andrea N. Polonijo in Journal of Empirical Research on Human Research Ethics

Supplemental Material

sj-docx-2-jre-10.1177_15562646261441345 - Supplemental material for Determining Ethical Incentives in Biomedical HIV Research: Insights from Researchers, Regulators, and People Living with HIV

Supplemental material, sj-docx-2-jre-10.1177_15562646261441345 for Determining Ethical Incentives in Biomedical HIV Research: Insights from Researchers, Regulators, and People Living with HIV by Karah Y. Greene, Brandon Brown, Jerome T. Galea, Jasmine L. Lopez, Karine Dubé, Jeff Taylor, Christopher Christensen and Andrea N. Polonijo in Journal of Empirical Research on Human Research Ethics

Footnotes

Acknowledgements

The authors thank the members of our community advisory board for helping to guide this study, including Marcia Ellis, William Freshwater, Sondra J. Fogel, Liz Anderson, Kristi Vaugn, David Palm, William B. Carter, Thomas J. Villa, Dawn Averitt, Loreen Willenberg, and Dario Kuzmanović.

ORCID iDs

Karah Y. Greene

Brandon Brown

Jerome T. Galea

Karine Dubé

Christopher Christensen

Andrea N. Polonijo

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported in part by the Merck Investigator Initiated Studies Program (grant number 59270) of Merck & Co., Inc.

Declaration of Conflicting Interests

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

Supplemental Material

Supplemental material for this article is available online.

Author Biographies

Karah Y. Greene is a doctoral student at the University of South Florida School of Social Work and is interested in the role of incentives on participant recruitment and retention, especially in HIV research. She collected the data, contributed to the analysis, and prepared the initial draft of the manuscript.

Brandon Brown is professor of medicine at the University of California, Riverside. His interest in the ethics of payment in research arose from his experience conducting clinical trials. He was principal investigator of this study, participated in data collection, and supported manuscript preparation and review prior to submission.

Jerome T. Galea is an associate professor in the School of Social Work at the University of South Florida. His interest is on the impact of incentives on research participation and how investigators arrive at payment amounts. His collaboration in this project included focus group facilitation, participant recruitment, and a review of the paper for intellectual contents.

Jasmine L. Lopez completed her bachelor's degree in psychology at University of California, Riverside at the time of data collection and aided in data analysis and manuscript development, as well as a review of the paper for intellectual contents.

Karine Dubé is an associate professor in the Perelman School of Medicine at the University of Pennsylvania. She is a senior socio-behavioral scientist and experienced research program manager who integrates biomedical research, social sciences, ethics, and patient engagement around HIV-related research in the United States and Sub-Saharan Africa. She has 20 years of experience in infectious disease-related work. Karine is passionate about centering the voice of the patients in infectious disease cure research. She provided guidance on data analysis and reviewed the paper for intellectual contents.

Jeff Taylor is the executive director of the HIV + Aging Research Project–Palm Springs in California. He works closely with stakeholders in HIV care, including academic partnerships centering community voices in research studies. Taylor contributed to the project's focus group and interview question development, participant recruitment, and reviewed the paper for intellectual contents.

Christopher Christensen is the research and programs director of the HIV + Aging Research Project–Palm Springs in California. He works closely with stakeholders in HIV care, including academic partnerships centering community voices in research studies. Christensen contributed to the project's focus group and interview question development, participant recruitment, and reviewed the paper for intellectual contents.

Andrea N. Polonijo is an assistant professor of sociology at University of California, Merced. She studies how social factors such as socioeconomic status, race, and sexual orientation influence health behaviors and health outcomes. She worked closely with Brandon Brown as a postdoctoral scholar, contributed to data collection and analysis, and led the writing and editing of the final manuscript.

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