Consistent with previous work involving an internet survey,8
we found that many participants want to know about financial interests in research, whether or not they report that such knowledge would affect their decision to participate. However, we documented great variability in participants' desire and aptitude to understand the nature and implications of financial interests in clinical research. Many participants had difficulty understanding why financial interests might be troubling in clinical research. For example, contrary to most commentators on conflict of interest, some participants felt that financial interests would help investigators conduct ethical research. Furthermore, many participants had difficulty appreciating how financial interests might actually affect research participants or the quality of the science. This suggests that some people may not have the baseline understanding necessary to judge the risks posed by financial interests, calling into question whether simple disclosure to prospective research participants is an effective strategy, standing alone, for managing conflicts of interest in research.
One frequently discussed approach to disclosure is to describe a core of basic information and give the potential research participant an opportunity to ask questions.7,13
Presumably, this approach would satisfy differing needs for information without appreciably lengthening the consent process and document. This approach assumes that people know whether they should be concerned about financial interests at the time of consent and that they will know what questions to ask to learn more about the details and implications of such financial interests. However, we found that many participants' thoughts regarding conflicts of interest and their disclosure evolved over the course of the focus groups. It was clear that if some of these people had engaged in a consent process without the experience of the focus groups, they would not have viewed a core disclosure of financial interest as important enough to ask more questions and would not have known what questions to ask. This presents a challenge for developing strategies to manage financial conflicts of interests in clinical research. Furthermore, the observation that people's thoughts regarding financial interests evolved as a result of discussion and education raises an interesting question: What is the responsibility of the research community to educate those being recruited for clinical research and the general public about the conduct and funding of clinical research?
Our findings also shed light on the complex and variable role of risk in potential research participants' perceptions of financial interests. Many participants felt that disclosure of financial interests was more important for riskier or more invasive studies than for less risky ones. At the same time, several participants expressed that if they were very ill, financial interests would not play a role in their decision as compared with information about possible medical benefits. Complicating matters further, when participants' health was at stake, they suggested that they might not be in a good position to evaluate risks that might arise as a result of a financial interest. An important insight from these findings is that when risks are high and/or the clinical situation is dire, a person might be less able to evaluate the risks posed by a financial disclosure, even though they generally believe that such risks are important to consider.
We also found interesting and paradoxical findings regarding the role of potential research participants' trust in researchers and clinicians. Some participants expressed the view that disclosure of financial interests was important in preserving trust in doctors or researchers. For these participants, it would violate their trust to learn about a financial interest that had not been disclosed. On the other hand, a minority of participants appeared motivated to preserve the image of the trusted clinician or researcher. They indicated that they would be upset by information about financial interests, and so would rather not be told about them. This finding suggests that some participants would choose to deny or selectively not attend to disclosed financial interests. Still others wanted to know this information because they considered it relevant to deciding whether to participate, presumably because it might affect their trust. Additional work is clearly needed to better understand the role of trust in decision making about participation in clinical research.
Despite these important insights, our findings should be interpreted with several limitations in mind. First, although the use of a single moderator promoted consistency in how the sessions were conducted, it is possible that different data might have emerged with another moderator. Second, there are methodological complexities in asking about people's preferences for information and how they would use that information to make a decision. The focus on this single factor in a complex calculus, and the implicit assumption that rational decision making is expected, may have led some participants to overstate how much information they would want about financial interests. Also, people may make decisions differently from how they report that they will make them. Third, our sample in aggregate was more educated than the U.S. population average. Fourth, our study did not allow a comparison of the views of those with and without previous clinical trial experience.
In conclusion, if the goal of disclosing financial interests is to allow the research subject to assess the risk of harm, either to self or to science, our data present several cautions. Consistent with research about informed consent and consumer disclosure practices in other medical and nonmedical arenas,13,14
there are high barriers to achieving the goals of rational decision-making models. For example, to formulate properly their thoughts about financial interests in clinical research, some people will need considerable time, reflection, and assistance during the informed consent process. Nevertheless, even after such assistance, some will not understand the potential implications of financial interests and might even see them as mitigating the risks associated with participating in clinical research. Furthermore, some people will not be in a position to ask questions about financial interests even if given the chance. Finally, some people might avoid or deny information about their doctor or the clinical investigator that compromises the image of the trustworthy physician.
This does not necessarily mean, however, that disclosures should not be made. Many focus group participants thought this information was important to know, even though they could not articulate or understand very well what difference it might make. In at least 1 model of informed consent,15
information can be “material” information even though it does not affect a person's decision. Also supporting disclosure is the suggestion from our data that disclosures would increase some people's trust in clinicians, investigators, and research institutions.
On balance, those charged with protecting research participants should consider what might be a realistic goal of disclosing to potential research participants. Our data suggest that allowing potential research participants to weigh the risks of financial interests might not be as realistic a goal as the more general goal of honoring patients' right to know and avoiding harms to trust if they learn of undisclosed incentives at a later time.16