Current policies and practices regarding the disclosure of financial interests in clinical research are in a state of flux and uncertainty. Our findings help to ground discussions about financial disclosures by identifying their likely effects. Several important points arise from the findings. First, contrary to concerns that potential research participants might be unable to grasp the nature and implications of financial interests in research,16
we found that respondents were sensitive to some of the financial interests disclosed. Respondents consistently viewed a researcher owning equity less favorably than a researcher receiving per capita payments. Respondents appeared to view other types of financial interest as falling somewhere between the 2 extremes. This finding suggests that some potential research participants can differentiate among types of financial interests. Also, policy makers should consider the relative sense of unease we observed about researchers owning equity as they determine what types of financial interests to permit in clinical research.
Second, disclosures of other financial interests did not substantially affect respondents’ willingness to participate in the hypothetical clinical trial. In general, respondents were very willing to participate (45% to 59%). Consistent with this finding, most respondents assigned far less importance to information regarding financial interests than to other information about the trial. The findings regarding respondents’ unease about researchers owning equity and the lack of an effect on willingness to participate corroborate data reported by Kim et al.8
and Hampson et al.9
In contrast to our findings regarding willingness to participate, trust in medical researchers and institutions was substantially affected by the type of financial interest disclosed. The disclosures made over one third of respondents less trusting of researchers and institutions, although they led to greater trust for some respondents. Greater trust might result from viewing disclosure as an indication of a researcher’s honesty.10,17
Differences in trust among the types of disclosures occurred regardless of the respondent’s level of trust before reading the information about the hypothetical clinical trial. Changes in trust appeared to be related to variations in willingness to participate and in respondents’ perceptions that financial interests lowered the scientific quality of the hypothetical trial. However, the small size of these relationships suggests that they are separate variables. The findings regarding trust are important, given how central trust can be to participation in research and to public acceptance of research findings,18
and considering the need to ensure that the clinical research enterprise merits the trust that participants confer on it.
Recent widespread attention to financial interests in clinical research may help to explain why many respondents were not surprised by such interests in the scenarios. However, some respondents were surprised, especially those who learned that the researcher held an equity interest in the research, suggesting that it would be inappropriate not to disclose such information when recruiting research participants. Surprise following enrollment could result in disappointment, anger, or noncompliance among participants. Moreover, this finding raises challenging questions about what types of disclosures are appropriate to help ensure that research participants are adequately informed before enrollment.
The main findings did not differ by disease or disease severity. We selected participants with 1 of 2 specific diseases to make the scenarios more salient and realistic, and we posed risks that were greater for those with greater disease severity to test the potential effects of disclosures in different research contexts. The consistency of the findings across the 4 disease-severity categories suggests that the findings may be generalizable to other clinical and research scenarios.
The survey has several limitations. It asked respondents about their willingness to participate in hypothetical clinical trials relevant to their conditions rather than in actual clinical trials. Further research is necessary to confirm the findings in the context of actual clinical research. In addition, the experiment was conducted using a specialized convenience sample of self-selected Internet users. One challenge in research on clinical research itself is that there is no registry of all trial participants in the United States, making it difficult to assess the generalizability of any research findings to the target population. Compared to adults who identified themselves as clinical trial participants in a large, nationally representative sample in the United States,19
our sample had a similar distribution of race/ethnicity. However, our sample had relatively fewer adults older than 60 years. In addition, although the proportion of college graduates was similar, our sample had a relatively higher proportion of participants with some college education (as opposed to a high school education). Thus, while the relative differences (or lack of differences) among the disclosure types might generalize to broader populations, it is unclear how well the absolute levels of the outcome variables can generalize. Finally, it is likely that the quantitative measures of patient reactions used in this study do not reflect the richness and subtlety of patients’ full experiences.
In conclusion, we found in this study, with the exception of researcher owning equity, disclosure of most financial interests in research, as recommended in recent policy statements,7,20
is unlikely to affect the willingness of potential research subjects to participate in research. This conclusion appears to hold for patients with both lesser and greater disease severity. Furthermore, patients viewed financial interests as less important than other information about the study. Future efforts should be directed at determining how best to disclose acceptable financial interests so as to achieve adequate understanding while not unduly burdening the research enterprise. This does not preclude efforts to identify and eliminate unacceptable financial relationships in clinical research. In addition, given that disclosures can affect participants’ trust, it will be important to monitor potential negative effects on trust over time.