Abstract
Altruism is a well-established reason underlying research participation. Less is known about altruism in adolescent-parent decision-making about clinical trials enrolling healthy adolescents. This qualitative investigation focused on identifying spontaneous statements of altruism within adolescent-parent (dyadic) discussions of participation in a hypothetical phase I clinical trial related to adolescent sexual health. Content analysis revealed several response patterns to each other’s altruistic reasoning. Across 70 adolescent-parent dyads in which adolescents were 14 to 17 years of age and 91% of their parents were mothers, a majority (61%) of dyadic discussions included a statement reflecting altruism. Parents responded to adolescents’ statements of altruism more frequently than adolescents responded to parents’ statements. Responses included: expresses concern, reiterates altruistic reasoning, agrees with altruistic reasoning, and adds to/expands altruistic reasoning. Since an altruistic perspective was often balanced with concerns about risk or study procedures, researchers cannot assume that altruism will directly lead to study participation. Optimizing the informed consent process for early phase clinical trials involving healthy adolescents may include supporting parents to have conversations with their adolescents which will enhance their capacity to consider all aspects of trial participation.
Altruism is considered an important and common reason given for participating in clinical research and can be defined as selfless motivation or behavior directed toward benefiting others, or arising out of concern for others (Jansen, 2009). Although it is well-established that altruism influences the decision-making of adults to participate in clinical research (Agarwal et al., 2007; Balfour et al., 2010; Jenkins et al., 2013; McCann et al., 2010), there is limited information about how adolescents consider altruism in their decision-making (Stanford et al., 2003; Wendler et al., 2012) or how adolescents and parents might consider altruism in a joint decision-making process regarding research participation by the adolescent.
The consideration of adolescents’ and parents’ altruistic perspective may be particularly pertinent for early phase trials of healthy volunteers, since parents will very likely be part of the consent process and the studies do not provide direct benefit to the individual participant. Of particular interest are studies of reproductive health, since adolescents should be included under the ethical principles of beneficence and justice, and yet there is often reluctance to include them due to concerns about the sensitive nature of the content and the potential complexities surrounding parental permission and adolescent consent (Nelson et al., 2010).
From the pre-school years, children engage in pro-social (or altruistic) reasoning; however, cognitive capacity changes qualitatively from early childhood through young adulthood. Thus, it is likely that adolescents will view altruism in the context of clinical trials differently than their parents based on experience and maturation. For instance, parents may be more likely to consider multiple factors and appreciate the role of research in improving the well-being of future generations (Freund and Blanchard-Fields, 2013) while early adolescents may be idealistic or egocentric (Eisenberg et al., 2005; Rich and Ginsburg, 1999). It is possible that parents may view these discussions as an opportunity to enhance their adolescents’ capacity to weigh multiple factors and/or enhance their perspective-taking (Mays et al., 2004).
This investigation focused on adolescent-parent conversations regarding participation in an early phase sexual health clinical trial by qualitatively examining spontaneous altruistic statements; examining adolescents’ and parents’ responses to each other’s altruistic reasoning; and describing how altruism was discussed in the context of other decision factors.
Methods
Setting and participants
Participants were recruited from the adolescent primary care clinics of two large medical centers in New York City. The study clinics serve a predominantly low-income and ethnic/racial minority adolescent population. Adolescents 14 to 17 years of age and one of their parents or legal guardians were eligible to participate if they spoke English or Spanish. The study was approved by the Institutional Review Boards of Columbia University Medical Center and Weill Cornell Medical College. All participants provided written informed consent/assent to enroll in a longitudinal study addressing willingness to participate in a clinical trial examining the safety of a topical microbicide for sexually transmitted infections/human immunodeficiency virus (STI/HIV) prevention in adolescents. This investigation reports on interview data collected at baseline.
Procedures
Simultaneous individual (adolescent and parent separately) and subsequent dyadic (adolescent and parent together) interviews were conducted face-to-face by trained interviewers. Individual interviews included a description of a hypothetical phase I randomized clinical trial designed to test whether an experimental gel/topical microbicide (inserted into the vagina for females and applied onto the penis for males) for STI/HIV prevention was safe for use in adolescents 14 to 17 years of age. Participants were given a verbal description (with a copy to follow along) of the hypothetical study; this description contained all of the basic elements of informed consent (study description available from the authors). The information was presented by the interviewer in a manner analogous to an informed consent process. Adolescents and parents were subsequently asked to describe the trial as if they were describing it to a friend (adolescent) or to another parent (parent) and indicate whether they would assent to participate (adolescent) or provide permission to participate (parent) if the trial was currently open to enrollment. The key elements of the hypothetical trial were as follows:
The experimental gel was found to be safe in adult women and associated with minor side effects (e.g., vaginal irritation, itching, burning). The gel has not yet been tested in men. The clinical trial would consist of three study visits within a 30-day period. At each study visit, adolescents would have their blood drawn and a physician would perform a genital exam. Adolescents would be randomly assigned to experimental or placebo gel to use for seven days (during which they would have to remain abstinent). Adolescents would be compensated US$100 in cash and a US$5 metro card after the end of each visit.
Dyadic interviews were conducted immediately upon completion of the individual interviews in order to minimize the potential for contamination from extraneous discussion; these interviews were videotaped. Adolescents and parents were invited to discuss with each other their respective (individual) decisions regarding participation (adolescent) or providing permission to participate (parent) in the hypothetical clinical trial and the reasons underlying their decision. The interviewer’s role was to facilitate discussion using a semi-structured interview guide and direct the parent and adolescent to talk to one other (as opposed to the interviewer) about participation in the hypothetical trial. Upon completion of the interviews, each participant was given US$50 in cash and a US$5 metro card as compensation.
Analysis and coding
A total of 70 video-recorded dyadic interviews were available for qualitative analysis. Analyses began with initial review of each video to ascertain presence or absence of any statement related to altruism. Interview segments containing one or more statements potentially reflecting altruism were transcribed verbatim, including relevant discussion preceding or following the potential altruism statements. Interview segments in Spanish were translated by a native Spanish speaker and transcribed in English. Videos judged to not contain altruism were viewed independently by three additional members of the research team to confirm that altruism was not present. Disagreements were resolved through discussion until consensus was reached.
For coding purposes, altruism was operationally defined as a statement (phrase or sentence) that reflected reasoning to participate in the hypothetical clinical trial or research in general in order to help others, benefit society, contribute to health research or prevention, and/or contribute to science. Statements by adolescents or parents that met this definition were coded as altruistic, irrespective of their willingness to participate in the trial if it were offered. Two of the authors (NRC, CYW) independently performed initial coding of the transcripts for each video containing altruism. The initial coding was verified by two additional authors (CRB, LSI), with disagreement being resolved through discussion and refinement of the definition of altruism. Further refinement of the definition of altruism led inductively to a coding strategy that captured the following: a) the “source” of the altruism; i.e., who in the dyad initiated or introduced altruism into the conversation (adolescent or parent); b) the “target” or focus of the altruism (e.g., other adolescents, science); and c) the “outcome,” or response to the altruism by the non-initiating member of the dyad including how altruism was discussed in the context of other decision factors, such as the potential risks of the trial. This coding was performed using conventional content analysis (Hsieh and Shannon, 2005).
Results
Participants
Among the 70 dyads, 29% (n=20) were sons with parents while 71% (n=50) were daughters with parents; 91% of parents were mothers. The mean age of the adolescents was 16 years (SD=1.0; range 14–17); the mean age of the parents was 46 years (SD=9.9; range 33–67). Most parents (81%, n=57) and adolescents (83%, n=58) identified as Hispanic/Latino, primarily of Dominican descent. Non-Hispanic dyads were predominantly African American (n=10). Thirteen adolescents (19%) reported having penile-vaginal intercourse. There were 31 dyadic interviews conducted in English, 16 conducted in Spanish, and 23 in which the adolescent spoke primarily in English and the parent spoke primarily in Spanish.
General analyses
Forty-three of the 70 dyadic interviews (61%) contained at least one statement that reflected altruism. There were four parents who participated in the dyadic interviews twice, each with a different adolescent. Thus, there were four pairs of dyads consisting of sibling pairs. The dyads consisting of sibling pairs did not appear to differ from the broader group of dyads with respect to the source, target, or response to altruism; therefore, these sibling pairs were included in the overall analysis.
With regard to the “source” of the altruism, 10/43 dyadic interviews contained altruism statements made only by the adolescent, 16/43 contained altruism statements made only by the parent, and 17/43 contained altruism statements by both the adolescent and the parent (nine adolescent-initiated and eight parent-initiated).
Various “targets” of altruism were identified. For example, adolescents and parents indicated that they would want to help youth, aid future generations, prevent STI/HIV infections, as well as contribute to science (Table 1).
Targets of altruism by parent and adolescent.
HIV/AIDS: human immunodeficiency virus/acquired immunodeficiency syndrome; STI: sexually transmitted infections.
Altruism targets are not mutually exclusive.
Altruism was discussed in the context of other trial-related factors, such as study risks (e.g., side effects of the gel), the potential for discomfort or embarrassment (e.g., genital exam), and study requirements (e.g., multiple visits, abstinence). These other factors were raised along with altruism, particularly in the context of responding to the other individual’s reference to altruism. Specifically, of the 33 parents who made an altruism statement, 28 (85%) did so in the context of mentioning other trial-related factors; in comparison, 15 of 27 adolescents (55%) appeared to consider altruism as well as other factors.
Responses to initial altruism statement
In many instances (n=27) adolescents and parents responded directly to one another’s altruism statements. It should be noted, however, that in dyads where there was no response (n=16), there were more instances in which adolescents did not respond to their parents’ altruism statement (n=13/16) as compared to parents not responding to their adolescents’ altruism statement (n=3/16). Four response patterns were identified that characterized the way that members of the adolescent-parent dyads responded to the other member’s initial altruism statement. These included: 1) expresses concerns, 2) reiterates altruistic reasoning, 3) agrees with altruistic reasoning, and 4) adds to altruistic reasoning. These were not mutually exclusive. For example, participants sometimes responded to the other participant’s altruistic comment by raising concerns (e.g., risks, side effects, physical discomfort) while also reiterating the altruistic statement. Participants often reiterated the altruistic statement and also expressed agreement with the statement. However, reiterating an altruistic statement did not necessarily mean that they agreed with the statement. Also, participants sometimes added to the altruistic statement but also expressed concerns.
The following is an example of an adolescent expressing altruism (toward her community) and the mother responding by expressing her concern about risks:
… But then again if we don’t take risks or we don’t, like, help our community then we won’t know what, like, pros can happen. Get it?
I’ll have other people take the risk but not you.
In the following dyad, the daughter expresses a desire to help other youth, while her mother reiterates and agrees with her rationale but also expresses concern:
I would participate because it would help others see if it was safe or not, I mean, whether if it was the placebo or experimental gel. To see if it was just safe. I don’t think it would be a big problem … I mean, ‘cause then, if it was safe, you know, others of my age or younger would be able to use it, so yeah.
And what do you think about her reasons for participating?
Her reasons are very nice, the reasons that she just mentioned. For the cause of helping others. These points are good, but in reality, underneath, I understand that this study, really how it’s based, how is she going to help others if she is not sexually active?
In the following example, the mother expands on the daughter’s desire to help and then expresses concern:
Um, I said yes, kind of, because I don’t know, the side effects made me like, but then I don’t know, because I would like to help so, yea, I said yes.
I had a similar feeling about it … Um, I like the idea of participating in something that might help everyone down the road, even help me in the future if I had that problem. But my main concern was side effects. And my main reason for saying that I had to discuss it with you first is because of my concern about side effects.
While in most cases it was the parent who expressed a concern in response to their adolescent’s altruistic reasoning, in some cases it was the adolescent who expressed the concern. Adolescents expressed concerns that generally focused on physical discomfort associated with the study procedures. For example, in the following dyad, the father shares his altruistic reasoning which prompts his daughter to add to his reasoning as well as express her own concerns:
… But that you had the right to want to participate and that the general outcome of something like that, of a girl or a woman having power to protect themselves from sexually transmitted diseases I thought was a good benefit. You know, that it would be, it would be good to, to …
Have a product like that on the market?
On the market, if it was safe. Yes. Ok, so that’s how I basically felt about it.
That’s what I said. Um, I mean the last part I said, that, like, it would be good to have a product like that on the market. That um, I said I would probably participate in the study. I might be a little uncomfortable with the exams though.
In the next dyad, the mother appears to try to leverage altruistic reasoning. The daughter identifies with the idea of helping but is still not interested in participating:
… Because by taking part in it, you’re helping out other teenagers, remember that too. You’re helping out other teenagers that, you know, are going to be sexually active and need a gel to use. So basically you’re helping others.
I don’t think I’d do it.
How does hearing what your mom just said make you feel about the study?
I like helping people, making them happy. But this is just one of those things that just, it’s just more harder. Like, yeah, I don’t think I would like to do it, so yeah. Not really.
In the following dyad, the mother discusses the need for people to participate in studies for the greater good, but her daughter is concerned about side effects:
It’s your decision. Because the study would be done to you, not to me, so. Like I told him [Interviewer], someone had to do the test for Gardasil before it came out in hospitals. Probably this study can help other women who have diseases acquired sexually. But this isn’t for me, this is for you, so.
It said in the paper that women had like, things down there, with the gel. So yeah. Like irritations, and I don’t want that.
Discussion
The findings of the current study add to the literature on the role of altruistic reasoning in research participation for parents and adolescents. Our study extends the finding that adolescents and adults consider altruism in their decision-making (Agarwal et al., 2007; Balfour et al., 2010; Jenkins et al., 2013; Stanford et al., 2003; Wendler et al., 2012) by examining the conversations between parents and healthy adolescents (mostly of Latino descent) as they discuss an early phase clinical trial for sexual health. Both adolescents and their parents spontaneously mentioned altruistic reasoning, although the adolescents were less likely than their parents to spontaneously mention both altruism and concerns about the risks associated with study participation. When they did mention concerns, it more frequently focused on aspects of the procedures. The lower frequency of adolescents (relative to parents) addressing both altruism and other factors may reflect a greater difficulty among adolescents to consider multiple perspectives on an issue; alternatively, it is possible that they simply were less likely to verbalize all of their thinking. However, these findings are consistent with other published studies (e.g., Brody et al., 2005, 2009) in which adolescents (relative to parents) demonstrate greater willingness to enroll in more than minimal risk studies. This may be because adolescents and parents have different roles (for oneself or one’s adolescent) or because adolescents have more difficulty considering the risks associated with participation and are less focused on considering multiple perspectives when making decisions than their parents.
Consistent with published literature on the limits of altruism (Hunter et al., 2012; McCann et al., 2010), discussions surrounding participation in a clinical trial in this qualitative study appeared to involve multiple factors, of which altruism was just one. Some researchers have called for the promotion of altruistic values in order to increase participation rates in clinical research (Ocampo-Martinez, 2005; Williams et al., 2008). Our findings suggest that appealing to altruism may resonate with many prospective participants, but may not result in an increase in trial participation due to a confluence of factors that enter into decision-making. For instance, adolescents and parents in the current study were clearly aware of the scientific, health, and societal importance of participating in clinical trials but, for many, other factors clearly entered into their consideration of the trial. For adolescents, these factors included the physical discomfort they might experience when actually undergoing study procedures, whereas for parents, these factors included the perceived long and short term risks. Importantly, however, even in the context of expressing concerns, parents often reiterated, agreed with, or sometimes expanded upon the altruistic reasoning of their adolescent. These observations are a novel addition to the literature and may reflect an apprenticeship model around research participation decision-making in which parents guide their adolescent’s decision-making to be increasingly independent by elaborating on and further developing their adolescent’s altruistic reasoning (Mays et al., 2004).
This study is not without limitations. First, the clinical trial was presented as a hypothetical trial that was not actually being offered to participants. It is possible that adolescents and parents would have discussed altruism less, or engaged in a different conversation if the trial were actually being offered. Nevertheless, the hypothetical context enabled us to study how parents and adolescents consider early phase clinical trials among those who would or would not enroll in the trial. Furthermore, the trial description closely aligned with actual microbicide trial protocols; this provides confidence that the factors adolescents and parents considered (along with altruism) are valid and relevant. A second limitation is that most dyads were composed of mothers and daughters; very few fathers participated. Thus, while our data may not fully capture the views of fathers, our data likely reflect the scenario in which clinical trials seeking to enroll adolescents would actually occur – in the clinic setting where mothers are more likely to be present with their daughters or sons. Thirdly, as the sample size was small and slightly skewed toward older adolescents within the 14 to 17 year age range, it was not possible to examine the data by age; this limitation obscured our ability to reveal potential developmental differences in altruistic reasoning across adolescence. Finally, altruism was not specifically queried or included as a prompt in the interview guide, and the interviewer had latitude in facilitating the conversation between adolescent and parent. Thus, it is likely that more dyads would endorse altruism if specifically asked, and parents and adolescents may have expanded on each other’s thoughts in a different manner than they would have in a natural setting.
Future research should examine the role of altruism in the context of decision-making surrounding clinical trials for health issues relevant to adolescents that do not intersect with sexual behavior. Furthermore, in light of evidence that the cognitive capacities for altruistic reasoning differ between early adolescents, older adolescents, and young adults (Eisenberg et al., 2005), larger studies should explore the developmental differences with regard to the expression of altruism and other motivating and inhibiting factors related to clinical trial participation.
The findings of the current study can be used to inform the recruitment and assenting/consenting process in clinical research. For instance, when prompted to do so as part of this investigation, adolescents and parents engaged in a conversation about clinical trial participation that included altruism and other key factors. It seems reasonable to conclude that, as part of the informed consent process for an actual trial, adolescents and parents would benefit from having conversations similar to those that occurred in the context of this study. In this way, the informed consent process can be conceptualized as an opportunity for parents to raise multiple viewpoints and possibilities with their adolescents from their unique position as parents. Researchers should consider how best to involve or support parents’ efforts to help their adolescent carefully consider altruism alongside of other factors as part of the informed consent process and facilitate a nuanced discussion of research participation that results in decisions that are mutually satisfying and acceptable.
Footnotes
Declaration of Conflicting Interests
The authors declare that there is no conflict of interest.
Funding
This work was supported by grants 5R01 HD067287, UL1 TR000040, and UL1 TR000457 from the National Institutes of Health.