Results from our study suggest that in deciding whether to participate in genetic research, patients often engage in benefit-to-risk assessments that include not only direct individual benefits and harms but broader benefits and harms to the social groups with which they identify. When asked about factors that influence their decision to donate samples for genetic research, a majority of patients considered how that research might benefit their families, members of their racial or ethnic communities and the general public. Similarly, our results suggest that in deciding to participate in genetic research, most patients consider how that research could potentially harm the larger social groups with which patients identify. The majority of the patients we surveyed reported that they took concerns about potential discrimination based on findings from genetic research seriously and that their willingness to donate biological samples for future genetic research would be decreased as a result of these concerns. Together, these findings suggest that potential group benefits and harms are important to patients who are considering participation in genetic research.
This broader approach to weighing the potential benefits and risks of research participation is out of step with regulatory guidelines in the U.S. Current guidelines for the protection of research subjects focus narrowly on the risks of the research process itself and its potential impact on individual participants rather than the potential impact of research on socially identifiable groups such as racial or ethnic communities [8
]. Current research regulations and policies encourage investigators, IRB members and others to exclude assessments of potential benefits and risks to others, particularly to the extent that such a broader focus may detract investigators and IRB members from serving as responsible advocates for individual research volunteers [11
]. Similarly, in examining the informational needs of patient-subjects, ethicists and commentators on clinical research have tended to emphasize the disclosure of potential benefits and risks of research to individual subjects during the informed-consent process rather than on broader disclosures of the potential implications of a study for identifiable social groups and the communities in which a study takes place [30
Our findings that patients often assign a great deal of importance to group-level considerations – and make decisions about their personal participation in a research study based in part on an assessment of the risk-to-benefit ratio of that study for the racial or ethnic groups with which they identify – has important implications for how investigators frame their studies when recruiting subjects. Our data suggest that researchers should be prepared to discuss potential group-level harms and benefits with research subjects. It also may be helpful to incorporate a discussion of the impact of genetic research on identifiable social groups into informed-consent documents and other informational materials used to enroll subjects.
The potential implications of our data for IRBs are less clear. IRBs may not be well positioned to assess the long-term impact of genetic research on heterogeneous social groups. There may be circumstances in which IRBs can anticipate potential group harms and suggest ways of addressing those risks, for example where a local community is both clearly defined and directly affected by a research study, but routine evaluation of group-level considerations in all research studies would place a substantial burden on IRBs. Concerns also might be raised about the extent to which IRBs possess the appropriate expertise to engage in these group-level assessments of benefits and risks of research. IRBs should be sensitive to these matters but candid in acknowledging their limitations.
Our data have more significant implications for the design and governance of biobanks. The salience of group-level concerns for many patients suggests that biobank policies should address the potential impact of studies using stored biological materials on participant groups. Even though the potential impact on larger social groups may be unknown or difficult to assess for unspecified future research, the salience of these issues for some patients supports discussion of group-level considerations with potential donors. Given that many biological samples are collected and stored in biobanks for very long periods of time, many researchers using these samples will never have direct contact with the original sample donors. Nonetheless, investigators using these materials can have direct interactions with other individuals who share many of the same cultural and social values as the original donors. These discussions are not only an important step in building trust between participants and researchers but may have the potential to mitigate the negative effects of biobanking research on specific populations by increasing awareness among community members and enhancing public dialogue about the use of stored biological materials.
The development of ‘group focused’ informational materials will require researchers and biobanks to recognize that some populations are more concerned about group-level considerations than others. While our study found that a majority of patients consider the impact of genetic research on individuals and social groups outside of the immediate researcher-subject dyad, we observed differences between black and white participants with respect to beliefs about group harms and benefits. While considerations of potential benefits to their families and to the public in general were taken into account equally by black and white patients in deciding whether to donate a sample for genetic research, potential benefits to one's own racial or ethic group appeared to be a stronger factor in the decision-making of black patients. While these data show that both black and white patients were concerned about potential group discrimination based on genetic research results, the impact of these concerns on willingness to participate in research was greater among black patients. Sixty-four percent of black patients said that concerns about potential discrimination would be a significant factor in their willingness to donate a sample, compared to only 36% of white patients. There may be multiple explanations for these differences, but it is not surprising that members of historically disadvantaged racial or ethnic groups conceptualize the benefits and harms of research in broader terms and thus take concerns about the potential impact of genetic research on their communities more seriously in deciding whether to participate in research. Additionally, it is important to note that while these data concerning the effects of potential group discrimination are significant, they reflect only the concerns of patients who would agree to donate biological materials for research in at least some circumstances. These data do not capture the concerns of African American patients who indicated that they would never provide biological materials for genetic research. Future studies might explore why some populations have higher levels of group centered concerns about research and seek to clarify the nature of these concerns in greater detail. Given the difficulty of assessing group-level concerns about research, these data will help researchers better prepare to engage communities in discussions about the broader social impact of their work.
This study has several limitations. First, because participants were asked to comment on their general attitudes about the hypothetical donation of a biological sample for research, these data do not assess actual willingness to enroll in particular genetic research studies. Our sample is not representative of the U.S. population, nor even all patients seeking health care at academic medical centers. Nevertheless, these data can shed light on the types of patient perspectives found at academic medical institutions engaged in genetic research or DNA biobanking. Secondly, because patients who would not allow a sample to be used in future genetic research under any circumstances were not included in this sample, our analysis may not reflect the attitudes and opinions of those patients who are most concerned about the impact of genetic studies on groups. Consequently, our data may underestimate the prevalence these group-level concerns among patients. Additionally, this study only assessed concerns about discrimination in relation to patients’ self-reported racial or ethnic group and did not collect data on other kinds of social groups with which our respondents may have identified. Lastly, these data were collected before the passage of the Genetic Information Nondiscrimination Act (GINA) in the U.S. Patient attitudes regarding the donation of clinical samples for genetic research, and concerns about potential discrimination based on genetic research results, may be affected the passage of this legislation. However, the effectiveness of the protections established through GINA, and its overall impact on patient attitudes, is not yet known [32