Informed Consent Forms for Clinical Research on Genetic Testing for Breast Cancer Susceptibility

Abstract

The purpose of this study was to develop procedures to recruit participants and consent forms to enhance informed decision making for prospective participants in a research involving genetic testing for susceptibility to breast cancer. The consent process should be taken place in multi-stages. We made the consent forms for the proband and families and also the documents to inform the test results. The consent forms consist in the directions to medical professionals and information to the participants. The pretest consent form described facts about genes, genetic testing for hereditary breast cancer, and the other legal requirements to obtain informed consent. The consent for disclosure of the test results to family members at risk and the consent for the provision of blood sample for the future research have to be obtained respectively. To evaluate effectiveness of these written materials, five patients with family history of breast and/or ovarian cancer were interviewed with questionnaires before and after providing the consent forms. Patients receiving the consent forms showed increased comprehension and stated that the information were helpful. Findings suggest that the written materials are useful methods to improve participants, understanding of the genetic testing.