Ethical research involves a careful assessment of the risks and benefits to participants. The potential positive and negative consequences of participating in research must be well understood by investigators, research staff, review boards, research participants, and others involved in the research enterprise. Participation benefits may be tangible outcomes of the research. For example, patients may be motivated to enroll in a clinical trial if they perceive that their health may improve through participation, and positive health outcomes are assessed as a part of the study protocols. Participants are also informed about the potential negative health outcomes or side effects which may result from the experimental treatment. But in non-treatment focused research, health or other personal benefits to participants are less commonly measured, and the benefits of participating may be more difficult to quantify. The same is true for risks of participation. In observational research, potential risks may not be as easily anticipated.

Understanding the range of potential benefits and risks from study participation may help inform investigators about participant motivation to join the research, including when direct personal benefits are not expected. Motivation to participate in research is understudied, especially for research beyond randomized controlled trials.¹ Though the decision to participate is complex, varies based on the type of research, and differs with the intensity or invasiveness of procedures, altruism, financial compensation, and personal medical benefit likely play a role.² Perceived benefits, as well as participants’ views of their membership in and loyalty to a longitudinal research study, are also likely to be important motivators for continued participation.³ Understanding people’s motivations for research participation and their perceived personal gains from participation may inform study recruitment and retention.

Researchers’ understanding of participants’ motivation to participate is limited by a lack of understanding of participants’ positive experiences. Unlike the emphasis placed on the collection of adverse event data in clinical research, participants are rarely asked about benefits experienced over the course of their participation. Outside of clinical trials, risks resulting from research participation are also rarely collected. Implementing surveys that collect information about perceived risks and benefits may improve the quality of risk-benefit analysis for future research and uncover unexpected direct or indirect benefits.

Social consequences, outcomes that affect how a person experiences society or their relationship with others, are one component of risk-benefit evaluation that may have implications for research participation. Potential social consequences are ideated by research staff prior to study initiation to be listed on the consent form, but they are not typically collected from research subjects themselves during the time they are participating. In the limited research discussing these consequences, they may also be referred to as positive social impacts (PSIs), beneficial social impacts (BSIs), or negative social impacts (NSIs).⁴ The potential societal impacts of research on a broad scale may be well described in the consent form and other study documents, but the personal social consequences resulting from research participation is poorly understood.⁵ Social consequences, both positive and negative, may be intrinsically linked to perceived risks and benefits from a participant perspective. But identifying these potential outcomes in the early stages of study development can be difficult, as they may be abstract. Collecting data on perceived social outcomes as part of research participation may inform a more nuanced view of risk-benefit assessments.

The objective of the current analysis was to examine social consequences – positive and negative – reported by participants in a two-year, longitudinal sexual network study. We implemented a brief survey at each quarterly follow-up visit that captured the positive and negative consequences that participants experienced due to their involvement in the research. We also assessed whether reporting positive consequences at first follow-up was associated with improved retention in the study.

Among this community-based sample of MSM, reporting positive consequences due to study participation was common. More than three-fourths of the sample reported experiencing benefits at one or more points throughout the study. Negative consequences were reported rarely; the most common were related to negative reactions after someone in the participant’s life learned about the study. Generally, these events were linked to stigma surrounding sex or sexuality. Contrary to what we had hypothesized, we found no link between reporting benefits and study retention.

Evaluating risks and benefits of research is imperative to the protection of human subjects. Though monitoring risk via reporting of adverse events is standard practice in clinical research, benefits assessments of participation are not common. Having a comprehensive understanding of both direct and indirect risks and benefits resulting from participation may aid the conduct of research at all stages of the research process. Additionally, this understanding can inform investigators about potential motivations to participate in research, especially in cases where benefits are not explicitly built into the study design. The gap in assessing indirect benefits of participation in observational and other non-treatment focused research has been minimally explored.¹⁰ This gap extends to indirect risks and unanticipated negative outcomes. Most research exploring risks and benefits is concentrated among clinical trials that have expected positive health outcomes.¹¹ In non-treatment studies, altruism has been reported inconsistently as a motivator to participate.¹² The high frequency of reported benefits in this study is consistent with the few instances of related research in the literature.¹³ In an analysis of indirect benefits in a small HIV clinical study, psychological benefits, HIV knowledge, more intimate relationships, and positive behaviors were all expressed as benefits resulting from participation. ¹⁴ These secondary benefits may play a role in encouraging continued active participation in research.

Several benefits in the present analysis, such as “gained knowledge,” “awareness about sexual behavior, sexual health risk, and/or STI testing frequency,” “improved mental health,” and “improved relationships,” echo the psychological and behavioral benefits observed in other sexual health and HIV research.¹⁵ These benefits may be more present for sexual and gender minorities, as this population is disproportionately affected by HIV/STIs and stigma, which may result in mental health burden.¹⁶ The present study is unusual in longitudinally tracking reported consequences.⁹ The proportion of participants reporting positive consequences trended downward over time, with an uptick at the final visit. This pattern suggests that participants may experience study-related benefits more in the first several months of participation or that they only felt the need to report that benefit at the study’s start, even if the benefit continued. The increase in positive consequences at the final follow-up visit may be explained by acquiescence bias, with participants wanting to end participation in a positive or agreeable way. The increase may also capture a broader positive experience of their total time in the study.

The unlisted positive consequences reported by participants provide some key insights, especially related to sexual health promotion. Participants highly valued receipt of free HIV and STI testing and treatment, indicating that this testing may have been a strong motivation for continued study participation. The prioritization of clinical-related outcomes as benefits aligns with other research looking at participant-reported consequences of participation.¹⁷ Additionally, participants highlighted the impact that study participation had on taking more responsibility for their sexual behavior and on prompting conversations with others about sexual health. Several participants also emphasized the “extra financial help” which the study was able to provide, as also displayed by “financial improvement” being among the top listed positive consequences selected by participants. This may indicate that financial compensation is a primary motivator for attending follow up.

Negative consequences were rarely reported by participants in this project. In two prior studies, both focused on HIV vaccine efficacy trials, negative social outcomes of participation were reported at 8% and 18%, with negative reactions from friends, family, and partners making up the vast majority, which is markedly higher than the 3% in the present study.¹⁸ This difference may be explained by study design or by environmental, social, and temporal differences between studies. These studies illustrate the need for continued sensitivity in research enrolling people from stigmatized populations. Participation in sexual health research can lead to reduced self-stigma, allowing sexual and gender minority individuals to feel more confident sharing their experiences with others. However, it’s important to be mindful of the potential for negative reactions and advise participants to be cautious when sharing study information. Stigma affects people at multiple levels – the personal experience of those facing stigma, those who perpetuate it, and institutions that play a role in creating an inclusive or exclusive culture.¹⁹ We captured the personal experiences of a small subset of participants who faced stigma, but these experiences may have limited generalizability to other research involving stigmatized populations.¹⁸

All negative consequences were reported at either the first or second follow-up visits. Participants may have been more at risk of social harms in the early stages of participation when they were more likely to share study information (intentionally, if they were recruiting contacts through RDS, or unintentionally) with others. At the same time, “reduced stigma” was a positive consequence reported by more than half of study participants. Considered together, participants may have opened themselves up to potential stigma at the study’s start when first speaking about their study experiences. These conversations may have led to creating a less stigmatized personal environment, which may be driving the lack of social harms reported during the latter half of the study.

This analysis highlights the importance of understanding both the perceived harms and benefits of participating in sexual health research. In this study, because the reporting of positive consequences was so common and negative consequences so rare, analyzing associations between consequence reporting and outcomes such as retention was challenging and imprecise. This could be, in part, due to the fact that the question about positive consequences was worded more expansively on the survey than the question about negative consequences. Future research can expand upon potential indirect negative consequences outside of those resulting from negative social interaction. Because consequence reporting did not occur until the first follow-up visit, participants who did not come back after enrollment were unable to contribute, which may have resulted in an underrepresentation of negative consequences experienced by participants who chose not to return. As has been pointed out in similar research looking at self-reported benefits of participation, participants may be more likely to report benefits when being interviewed by staff, as opposed to answering survey questions alone, because of social desirability bias.¹⁷

Our analysis uncovered several themes which are important considerations for bridging the gap between researchers and participants. Understanding what incentivizes and demotivates participants from being actively engaged with the research might lead to improved retention and more valuable findings. In this study, participants highly valued gaining knowledge, heightened awareness of risk behavior, and free medical care. Additionally, many emphasized compensation for their time as a primary benefit. Others appreciated how participation improved their communication and relationships with people in their life. Gaining a better understanding of unexpected indirect benefits provides a participant-centered perspective and allows for more informed decision making. These positive themes should be taken into account during informed consent and regulatory processes to fully educate participants and others involved in the research enterprise of what benefits may indirectly result from participation. More importantly, tracking these benefits across research disciplines may help reveal a fuller picture of the participant experience. The same is true for negative outcomes. This study highlights the ongoing impact of stigma on sexual minorities and the importance of considering this in research, but more exploration of indirect risks of participation is needed. By examining both positive and negative consequences, we can gain a deeper understanding of the real-life impact of research and align researchers' expectations with participants' experiences.