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

BACKGROUND. The protection of confidentiality and the extent to which volun tary and meaningful informed consent can be obtained from potential partici pants are critical when recruiting patients for clinical research from canc er registries. In the current study the authors describe the influence of t wo methods of recruitment from a cancer registry (direct contact by researc h staff and contact by research staff after physicians alert potential part icipants) 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 r ecruited by way of direct contact by research staff and the remaining 65 wo men 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 b een 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 i s part of the process. It is incumbent on investigators and institutional r eview boards charged with overseeing this research that they respect confid entiality and avoid pressuring persons to participate in research. It also is critical that persons whose medical information will be entered into can cer registries be informed about this process as well as how the registry w ill be used for research. Cancer 1999;86:647-51. (C) 1999 American Cancer S ociety.