Informed consent for molecular-based diagnostic and prognostic studies in the cancer patient.

The consent of the subject who is donating cells, tissues, organs or body fluid for research purposes is a precondition for biomedical research on human samples. Before such consent can be obtained, comprehensive information should be provided to the subject by the investigators. This information includes the scope of research, the intended use of subject's body parts and associated data, the risks and benefits associated with the research project, and the right to withdraw their consent at any time without prejudice. Consent is free and must not be obtained under any kind of pressure. The traditional practice of obtaining consent for unspecified future use of biological samples and data generated from clinical trials is no longer adequate for genetic research. However, the investigator has still interest to keep the definition of the field of research as broad as possible. Privacy is an issue of importance for the patient, who is the primary supplier of human samples, and for his relatives. Benefit sharing is another field of contradictory discussion. Normal volunteers are a special case among gene expression studies. An example of informed consent form is provided. Copyright 2003 S. Karger AG, Basel