Ethical ramifications of alternative means of recruiting research participants from cancer registries

Abstract

BACKGROUND The protection of confidentiality and the extent to which voluntary and meaningful informed consent can be obtained from potential participants are critical when recruiting patients for clinical research from cancer registries. In the current study the authors describe the influence of two methods of recruitment from a cancer registry (direct contact by research staff and contact by research staff after physicians alert potential participants) on these issues. METHODS Enrollment rates were tabulated using each recruitment method and complaints received from potential participants regarding recruitment were reviewed. RESULTS Of 416 women approached to participate, the first 351 women were recruited by way of direct contact by research staff and the remaining 65 women were recruited by research staff after their physician had sent them an alert letter. There was no difference in the enrollment rate using the two methods. One potential participant believed that her confidentiality had been violated and another hung up the telephone when contacted directly; two potential subjects reported feeling pressure to participate because their physician sent them a letter. CONCLUSIONS Although concerns regarding violating confidentiality clearly are justified when recruiting research participants from cancer registries, patients also may feel pressure to participate if physician notification is part of the process. It is incumbent on investigators and institutional review boards charged with overseeing this research that they respect confidentiality and avoid pressuring persons to participate in research. It also is critical that persons whose medical information will be entered into cancer registries be informed about this process as well as how the registry will be used for research. Cancer 1999;86:647–51. © 1999 American Cancer Society.

Recruitment of representative samples for low incidence cancer populations: Do registries deliver?

“…Forty-three percent of all identified AYAs could not be approached due to clinician refusal or non-response. This suggests that a large proportion of survivors are being excluded for reasons not related to study eligibility or emotional health, indicating that the balance between the ethical principles of beneficence and patient autonomy may need to be considered [12,41,42]. …”

Active recruitment increased enrollment in a hereditary cancer registry

“…Being part of a population-based registry is involuntary, and patients are often unaware that their cancer diagnoses may be available to researchers. When patients included in population-based registries are contacted by researchers and invited to take part in a study, they are sometimes surprised and may feel that their confidentiality has been violated [8]. This introduces some ethical concerns about contacting individuals who are not aware of being part of a registry, particularly for those who suffer from conditions, such as hereditary cancer, that have a component of social risk [8].…”

Developing registries of volunteers: key principles to manage issues regarding personal information protection: Figure 1

“…In the application of this principle, and considering existing registry models, we propose a three-step information flow (figure 1). 1 2 4 11–13…”

“…Little has been published about the management of confidentiality within the context of volunteer registries for research. Indeed, the existing literature mostly concerns the use of clinical registries (not volunteer registries) for research purposes 4 5. Moreover, standards for mandatory public health registries (like communicable diseases registries) are not applicable to volunteer registries.…”