Focus Group Discussants
One hundred individuals participated in 10 focus groups. Discussants were mostly female (73%) and African-American (76%), between the ages of 40–49 years (36%; see table ). By chance, 2 of the focus groups were comprised only of individuals who identified themselves as African-American and 1 group only of individuals who identified themselves as White.
Demographic characteristics of focus group participants (n = 100)
Responses to Research Study Vignettes
To illustrate some of the different options for returning research results to the focus group discussants and to serve as the basis for discussion, 3 hypothetical vignettes were read. Following each vignette, discussants were asked to consider the scenario, whether it seemed like a fair study with respect to the issue of returning results and whether they would participate in a similar type of study if approached. In general, both positive and negative issues were raised about each vignette when discussing ‘fairness’ and ‘potential participation’ (table ). When considering whether they would choose to participate in a similar study, reported factors fell across 3 general categories: motivations (e.g. personal benefit and altruism), balance of burden/harm with compensation (compensation being material or informational) and trustworthiness of the research study and the researchers.
Concerns raised by discussants about each vignette regarding fairness and issue of returning research results
In response to Vignette 1, discussants identified the following positive attributes: being able to help medical research and other affected individuals (altruism) (mentioned by 8 groups), the potential personal or family benefit (6 groups), the low potential for harm due to already being affected (4 groups), and that the subject was fully informed about the study and what he would/would not receive with respect to individual or summary research results (2 groups). The biggest drawback of the study appeared to be the lack of availability of an individual research result (5 groups) and general concerns about privacy and confidentiality (4 groups). In most groups, the majority of discussants reported they would likely participate in this type of study. The fact that the prospective research participant already had the disease was a significant factor both with respect to whether the focus group discussants would participate and whether they would wish to learn of their individual research results.
‘… If I enter a study personally, I mean, I know people that have different opinions, but I would want to know the results personally. I mean that would be one of the motivations besides contributing to the study.’ (FG 4, male)
‘[I would want to know] … because it would be beneficial to me and also to my children.’ (FG 4, female)
‘Well, I think, as a participant, very little is asked of him. So, I mean, if it's a cost factor, I would be okay not getting results.’ (FG 2, female)
‘… It will be okay. You told me straight up … I wouldn't expect [a personal result].’ (FG 10, female)
‘I'd like options … of how the results are going to be, you know. What is the final conclusion? I want to know what I am a part of.’ (FG 3, female)
‘I don't think I would participate because I wouldn't get anything back … I would have too many unanswered questions.’ (FG 5, female)
More than twice as many issues were raised in response to Vignette 2 as compared to the other vignettes. Positive features of the study included the low burden to participate (5 groups) and the potential to contribute to research that could benefit one's population group (5 groups). As with the first vignette, the most frequently raised problem with the study was the lack of availability of individual research results (6 groups). Other negative issues included mistrust of the study design due to lack of contact with researchers (5 groups) and discomfort with the focus on African-Americans (4 groups). In addition, some discussants were uncomfortable that data would be stored in a database maintained by the government, in reference to databases operated by the National Institutes of Health or other federal agencies. Notwithstanding the concerns, the majority of discussants again reported they would likely participate in this type of study.
‘It's just something about that word, “government”, because there were other studies in the past on the African-American population. And I probably would not [participate].’ (FG 2, female)
‘… It's just too impersonal because you have got to send all this in. It can be lost.’ (FG 6, female)
‘I like the fact that it's completely anonymous, and there's no way to link [the sample] back to the person.’ (FG 10, female)
‘I would [participate], I mean, if I had an interest in just helping mankind … it's like donating blood. I go to donate blood – I'm not personally wanting to know where it's going. I just know that it's going to help somebody.’ (FG 3, female)
‘I would participate in it because it would be for the African-American people.’ (FG 5, female)
For Vignette 3, although the return of individual research results was considered a significantly positive aspect (5 groups), it was the availability of options for individual or summary results that was raised most frequently as an attractive feature of the study (7 groups). In addition, given the at-risk status of the prospective research subject, the potential personal and/or familial benefit was also repeatedly mentioned as an advantage to the participant (7 groups). Discussants also, however, expressed concern about the uncertainty of the research findings (5 groups), potential worry related to learning personal results (3 groups) and concerns about privacy and confidentiality (3 groups).
‘For some people [learning individual results] could be a very positive thing. For others it could be a very negative thing … I think it would be good for individuals to have the option of saying, yes, I want to know or no, I don't want to know.’ (FG 4, female)
‘In my case, if the researcher says that they have no idea, and they're looking for something, I don't want to know because if they don't know how to fix it, what – just the burden is on me to suffer and with no help from them.’ (FG 4, female)
‘It would be good to know if you have those things, but I don't think I would want my name in that information – connected – to be out.’ (FG 4, female)
‘I think I would want to know because whatever they gained, whatever they learned, you could always take it to your primary physician and if they – they would be able to explain things more … his primary physician should be able to take it from there.’ (FG 5, female)
In addition to the issues highlighted above, the apparent lack of compensation (e.g. food and money) was mentioned by 4 different groups in response to 1 or more vignettes. Although this was not specifically described in any vignettes, its absence was noted and described as an important factor to at least some of our discussants.
Perspectives on Learning Research Results
Building upon the vignette discussion, we sought to understand what factors would influence discussants’ interest in learning of their individual research results, whether they believed they were entitled to their individual results, and the perceived obligation of researchers to make individual research results available. Many discussants stated they would be interested in learning of their individual research result, regardless of the certainty of the results, type or severity of disease and availability of treatment. Some discussants noted that whether or not the research participant was affected with the disease being studied would influence the perceived value of learning of their research results. In addition, given the nature of genetic information, several discussants recognized that the research result may become significant in the future as more research is done.
‘That's your ending point, but that could be someone else's [starting point] – when something closes, another something else opens.’ (FG 3, female)
‘… I mean, there's not a cure now. Next week, there might be one.’ (FG 3, female)
‘… even if there's no treatment or cure, you can at least prepare … make sure that [your family] is set before your disease starts to really affect you, I guess. So yeah, I'd want to know.’ (FG 10, female)
When asked to consider if there were any circumstances in which they may not want to receive an individual result, several responded they would always want to receive them. Some discussants, however, indicated that they would be less interested in learning of their results if it would cause worry or be too traumatic to know (echoing earlier comments), while others indicated they would only want to learn their results if a treatment or intervention were available. A few also commented that they may not be able to understand the results.
‘Yeah, what's your DNA really gonna tell you? Somebody else with some of your traits, the T and A's might be – you know, what are they gonna tell you?’
‘They could tell you about potential predictions.’
‘But which would cause the stress level to increase. Why would you want to know about it?’ (conversation between 2 female discussants) (FG 7)
‘… sometimes getting information back from research that hasn't proven yet, can really set off a chain reaction in a person that could make things worse for them.’ (FG 10, female)
The balance of burden and benefits was repeatedly considered in both quantitative (e.g. time and discomfort vs. monetary compensation) and qualitative terms (e.g. risks of misuse of genetic information vs. personal relevance of results information). As highlighted below, loss of confidentiality and discrimination were also raised as a potential concern.
‘The only thing is would it prevent you from getting insurance or employment, or something like that?’ (female)
‘Or getting into a college, even?’ (male) (FG 4, conversation)
If it was raised spontaneously, we informed discussants of state and newly enacted federal protections to prevent health insurance and employment discrimination based on genetic information. Regardless, the moderator often mentioned these protections at the end of discussion. We did not probe whether existence of legal protections diminished fears about discrimination.
Discussants were divided as to whether they believed they were entitled to their results and no consensus emerged, as exemplified by the comments below. Some discussants thought that they should get something back since they were personally involved (e.g. providing a DNA sample) or because results may be personally relevant or useful (for themselves or family members). Others stated that if it was clearly disclosed in the informed consent, a person should not expect results. Several discussants qualified their opinions by saying they should have ‘the option’ to receive results.
‘If they tell you at the onset, you are not going to get the results back, then it's up to you to make that decision. You don't participate if you are expecting to get some results back because they done told you, you not.’ (FG 6, female)
‘If it's not for [commercial] profit and just for the good of the people, then I don't feel any entitlement.’ (FG 9, female)
‘Well, as long as it's not mandatory that a person receives back their individual results, I think, like I personally would have no problem being in a study.’ (FG 9, female)
In response to a question about whether researchers are ever justified in not returning individual results, some discussants agreed that researchers may be justified if they believed it may cause harm to the participants or were inconclusive. They also understood that the additional costs and effort required to recontact participants may affect the study design (e.g. smaller sample size).
‘[Justified] in not sharing what the information would mean, no, I don't think [so].’ (FG 5, female)
‘… if it could harm the person in some way, to make them do something different that may or may not help them.’ (FG 2, female)
‘If for some reason they find the study is flawed.’ (FG 4, male)
‘I think “too expensive” and “time consuming” would be 2 good factors. To be honest, whether I get the results back or not would fall low in the scale of me deciding whether to do a study or not.’ (FG 2, female)
Others felt that the lack of clinical relevance, clinical utility or even the potential for harm were not justifiable reasons for researchers not to return individual results. In addition, apart from the perceived value or harm of returning results, some simply felt that researchers should not decide on behalf of their participants regarding the clinical relevance or utility of results. Since the information may be important for their personal health and well-being, some believed that researchers did not have the authority or the medical expertise to make those types of decisions.
‘It's not their place because that “MD” would be behind their name if [it] was. That's not their call to make.’ (FG 3, female)
‘I think the person who's doing – that's participating – should have that option, and I don't think it should be the researcher.’ (FG 8, female)
‘I don't think that the researchers should make that decision, selection of choice for the participant. That is something that the participant should have say-so in.’ (FG 5, female)
In the survey, we asked discussants to consider the importance of 4 factors that may influence their interest to learn their individual research result. Three of the factors (accuracy of results, personal relevance and clinical utility) were equally important considerations (78–80% indicated them as very important), while potential harms for discrimination was a significantly less important factor (65% indicated it as very important; p < 0.001; data not shown).
Communication of Research Results
If individual research results were to be returned, the majority of groups preferred to receive their results in-person along with a written record. Some discussants indicated they might be willing to pay a small fee in order to receive their individual research result though most were not. Similar to the focus group dialogue, the survey results showed that most discussants preferred to receive their individual research results in-person, choosing to learn them from their physician (42%), followed in preference by a post letter from the researcher (32%) and a call from the researcher (16%).
Potential Impact on Participation in Research
Discussants were divided about whether they would participate in a genetics/genomics study that would provide a summary report only or no information at all. Some readily indicated that they would participate in such studies, while others stated that their decision to participate in a study that did not return individual results would depend on the disease and/or how detailed the summary report would be.
Discussants acknowledged that their personal reasons for participating in a particular study would likely affect their desire and/or expectation to receive individual research results (e.g. altruism vs. vested interest (affected participant or family member)). It was repeatedly commented that they may be willing to receive little or no benefit with respect to availability of individual research results if very little effort or time was required, it involved minimal discomfiture and if the results were not considered highly important (e.g. genetics of baldness). Lastly, the provision of research results, whether individual or summary results, was perceived as providing a layer of ‘transparency’ between the participant and the research as well as the researchers. This was especially important in Vignette 2 in which there was minimal contact with the research team.
‘Yeah, I'd feel like they're creating relative transparency. They're trying to share all this information. If I was really curious, which I assume I would be, then I could go and get as much information as they could give me … I'd want as much as I could have.’ (FG 9, female)
‘I think the attitude is “are you doing this for the good of your fellow man,” and that is your payback, or “do you need a personal payback?”’ (FG 8, male)
‘If I give a sample – [the] researcher, that's the person that I'm in contact with … I'm just not going to give you blood and you go [away] with it, and I don't know nothing.’ (FG 6, male)
The survey data showed that although the majority of discussants indicated they would be very or somewhat likely to participate in a genetics research study regardless of whether results were returned, significant differences were noted based on whether individual or summary results were to be returned. Significantly more discussants (94%) indicated they would be very/somewhat likely to participate in a study that returned individual research results compared to one that offered to return a summary report (74%; p < 0.00001) versus one that did not return any results (66%; p < 0.00001) (fig. ).
Likelihood of participating in a genetics research study given 3 hypothetical policies on returning results.