Attitudes toward Potential Participant Registries

Abstract

Difficult participant recruitment is a consistent barrier to successful medical research. Potential participant registries represent an increasingly common intervention to overcome this barrier. A variety of models for registries exist, but few data are available to instruct their design and implementation. To provide such data, we surveyed 110 cognitively normal research participants enrolled in a longitudinal study of aging and dementia. Seventy-four (67%) individuals participated in the study. Most (78%, CI: 0.67, 0.87) participants were likely to enroll in a registry. Willingness to participate was reduced for registries that required enrollment through the Internet using a password (26%, CI: 0.16, 0.36) or through email (38%, CI: 0.27, 0.49). Respondents acknowledged their expectations that researchers share information about their health and risk for disease and their concerns that their data could be shared with for-profit companies. We found no difference in respondent preferences for registries that shared contact information with researchers, compared to honest broker models that take extra precautions to protect registrant confidentiality (28% versus 30%; p = 0.46). Compared to those preferring a shared information model, respondents who preferred the honest broker model or who lacked model preference voiced increased concerns about sharing registrant data, especially with for-profit organizations. These results suggest that the design of potential participant registries may impact the population enrolled, and hence the population that will eventually be enrolled in clinical studies. Investigators operating registries may need to offer particular assurances about data security to maximize registry enrollment but also must carefully manage participant expectations.

Keywords: Clinical trial; recruitment; registries.

Fig. 1

Respondent willingness to enroll in registry modalities. The frequency of participant responses related to the willingness to enroll for each of five potential participant registry operation modalities is displayed. Modalities include mail, telephone (phone), Internet without password requirement (Internet/no pass), Internet with a password requirement (Internet/pass), and email.

Fig. 2

Respondent levels of concern. The proportion of respondents who indicated each level of concern is illustrated for each of seven areas related to registry operations: sharing registrant information with pharmaceutical companies (“Sharing with pharma”), sharing registrant information with insurance companies (“Sharing with insurance”), unwanted phone calls (“Unwanted phone calls”), unwanted email (“Unwanted email”), sharing registrant information with healthcare professionals outside of the healthcare system (“Sharing with outside doctors”), unwanted mail communication (“Unwanted mail”), and sharing registrant information with health-care professionals within the healthcare system (“Sharing within healthcare”).