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Absent a clear and enforceable national policy on cancer genetic testing and genetic research, the responsibility may currently be on institutional review boards to regulate those activities at their institutions through protocol approval or disapproval. The survey reported here was carried out to gain information on National Cancer Institute-designated cancer center policies governing institutional review board review of genetic protocols and the preparedness of institutional review boards to review genetic protocols. Thirty-five responses (63% response rate) were received, of which 30 were evaluable. Twenty-four responders reported that they believed that there is a need for research that may lead to improved review of genetic research and genetic testing protocols. Only 14 responders felt adequately informed of current and developing issues and legislation relative to genetic testing and research. Seven responders reported that their cancer centers require an institutional review board-approved protocol for genetic testing activities. Five responders reported that their cancer centers have a formal written policy that guides institutional review board review of genetic testing protocols. About half of the responders reported that their cancer centers have no formal written policy that guides institutional review board review of genetic research protocols. Only three responders reported that institutional review board members receive formal training to prepare them to evaluate all of the issues associated with genetic protocols. We conclude that greater effort needs to be made to establish uniform policy governing cancer genetic testing and genetic research and greater effort should be made to prepare institutional review boards formally for the review of genetic-related protocols.
Absent a clear and enforceable national policy on cancer genetic testing and genetic research, the responsibility may currently be on institutional review boards to regulate those activities at their institutions through protocol approval or disapproval. The survey reported here was carried out to gain information on National Cancer Institute-designated cancer center policies governing institutional review board review of genetic protocols and the preparedness of institutional review boards to review genetic protocols. Thirty-five responses (63% response rate) were received, of which 30 were evaluable. Twenty-four responders reported that they believed that there is a need for research that may lead to improved review of genetic research and genetic testing protocols. Only 14 responders felt adequately informed of current and developing issues and legislation relative to genetic testing and research. Seven responders reported that their cancer centers require an institutional review board-approved protocol for genetic testing activities. Five responders reported that their cancer centers have a formal written policy that guides institutional review board review of genetic testing protocols. About half of the responders reported that their cancer centers have no formal written policy that guides institutional review board review of genetic research protocols. Only three responders reported that institutional review board members receive formal training to prepare them to evaluate all of the issues associated with genetic protocols. We conclude that greater effort needs to be made to establish uniform policy governing cancer genetic testing and genetic research and greater effort should be made to prepare institutional review boards formally for the review of genetic-related protocols.
Objectives: This study was conducted to determine whether patients and accompanying persons visiting the Gynecologic Oncology Clinic were aware if a family cancer history was recorded and utilized in their medical care; whether they were aware of the importance of a family cancer history, and whether they would like to learn more about familial cancer. Methods: Sixteen- and 17-item self-report questionnaires were administered to patients and their accompanying persons, respectively, who were visiting the Gynecologic Oncology Clinic. All responses were anonymous. Results: Two hundred forty-four patient questionnaires and 114 accompanying person questionnaires were completed. Seventy-eight percent of the patients and 70% of the accompanying persons replied that a physician had inquired about their family history of cancer. Only 40% of those patients and 70% of those accompanying persons (31 and 49% of total patients and accompanying persons, respectively) replied that the inquiry was by their family physician. Sixty-seven percent of these patients and 63% of these accompanying persons reported that a written record was made of the family history. Thirty-one percent of the patients and 28% of accompanying persons knew that their family cancer history information had been used to aid in their medical care. Eighty-eight percent of the patients and 83% of the accompanying persons reported the occurrence of at least one relative with cancer; however, only 44% of the patients and 35% of the accompanying persons replied that a health care provider had ever provided teaching about the importance of a family cancer history. Seventy-five percent of the patients and 73% of the accompanying persons indicated that they would like to learn more about hereditary cancer and cancer genetics. Conclusions: This study demonstrates that patients desire information about cancer genetics and hereditary cancer. Therefore, health care providers should provide better education and information to their patients as well as improve their family history-taking skills.
Clues to genetic disorders are often first discovered during routine healthcare visits. This can create a dilemma for both the physician and the patient about what to do next. Because human genetics is a rapidly advancing field, many physicians are wondering which elements of a patient's medical history warrant a visit to the genetics clinic and which should be simply watched. In this article, Ms Facher and Dr Robin answer specific questions that the primary care physician is likely to have or to be asked about the evolving science of genetic testing.
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