In the past decade, there have been a number of high-profile legal cases that have involved the removal of human blood samples from the hands of researchers.7 In one case, more than 5 × 106 dried blood spots from infants were destroyed after a suit was filed that challenged the state of Texas' right to store infant blood spots for use in future research. In all these cases, there was argument over whether the participants in these research studies had been properly informed about how their samples were going to be used. With the recent publication of The Immortal Life of Henrietta Lacks by Rebecca Skloot, about a women who unknowingly provided the first immortal human cells grown in culture (HeLa cells), the topic of informed consent is now being discussed by book clubs in living rooms and coffee shops across the country.
These cases have raised important questions about the timing and type of consent needed to obtain, store, and use samples for research purposes. To address these questions, we asked the opinions of 4 experts who represent different views on the subject of informed patient consent. David S. Wendler is an advocate for the rights of individuals who contribute to research, Arthur L. Caplan is a bioethicist, Michael Christman is the president and CEO of an independent not-for-profit basic biomedical research institution that maintains a large biorepository, and Jack Moye, Jr., is a researcher involved with the NIH's National Children's Study.
Should researchers be required to get consent for biological specimens, or are you in favor of a presumed consent with an opt-out option, with the idea that the human tissue is a common heritage of humanity, to be used for the collective good?
Jack Moye, Jr. (researcher): The concept that human tissue is a shared …