Interpreting Consent for Research on Archived Tissue

A researcher believes that breast cancer occurs only when a combination of inherited and acquired genetic mutations occur, and theorizes that biopsied breast tissue might be used to detect earlier pre-cancerous mutations that might help predict who is at increased risk of cancer. The scientist wants to use archived tissue samples and correlate them with later medical records indicating whether the person went on to develop breast cancer. The scientist wants to know whether certain early mutations are especially likely to predict later cancers, or alternatively whether the sheer number of mutations in key sites in the genome might be used as an index of risk.

Given the latency of breast cancer, the scientist prefers tissue at least ten to thirty years old, for which there is accurate and complete medical follow up. Unfortunately, at the time the tissues were obtained, informed consent for their use in research was either not asked at all, or was obtained through a very brief and general consent form. Neither researchers nor patients anticipated this kind of research when the tissues were gathered.

• Were the consents given then adequate to use the tissue for research today?
• What if no record of consent exists for a particular sample?
• Should the persons be tracked down and asked to consent specifically for this study?
• What are the reasons for or against this course?