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

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.