Anyone who has surgery, a biopsy, or even blood drawn probably doesn’t think much about what happens to their tissue or blood after it has been removed. Some of these samples are discarded, but many are stored in freezers and used later for various kinds of medical research. Sometimes we give consent for our tissue to be used in research, but other times it is stored without our knowledge or consent. The recently revealed story of Henrietta Lacks provides an excellent case in point.
What sorts of ethical questions are raised when leftover tissue samples are used in medical research? This project seeks to examine some of these questions and offer suggestions regarding how hospitals and researchers should use leftover tissue samples to conduct important medical research. Questions include: when (if ever) does research on leftover tissue samples present so little risk to donors that consent becomes unnecessary? How explicit and specific should hospitals and researchers be in informing patients that their tissue may be stored and used for research? Some tissue samples have been stored for decades, and the donor is either unknown or has died—can these samples be used without consent? How can researchers anticipate risks not only to individuals, but also to families and even ethnic groups? What are the ethical implications when scientists or corporations profit from the use of such tissue?
Our group includes trained scientists, administrators of IRB programs, philosophers, theologians, political scientists and editors. Our diversity of expertise enriches our discussions and, we hope, will result in a publication that is useful for scientists, physicians, ethicists, and others interested in research on “leftover” clinical tissue samples.
This project is generously supported by the Patrick and Catherine Weldon Donaghue Medical Research Foundation.