What happens to a blood sample, or tissue from a biopsy, once the procedure is done and a nurse walks away with it? Most patients simply assume that it is used for whatever medical test their doctor ordered, but they do not consider what happens afterwards. Contrary to what most assume, tissue and other bodily matters that are the “leftovers” of a medical procedure can be used for research purposes. In fact, under the old Common Law Rule, researchers do not need to notify or obtain permission from patients before using such leftovers. The only limitation is that the bio-specimen must be non-identifiable. However, in recent years, scientists have discovered a way to re-identify anonymous samples by relying on DNA testing and publicly available information. Ethical concerns about re-identifying bio-specimens are reminiscent of concerns that surround the famous case of Henrietta Lacks, who died in 1951; yet, her so-called “immortal cells” are still used in laboratories to this day.
In order to address these concerns, the Department of Health and Human Services (“HSS”) has recently proposed a rule that would change the consent requirements. In particular, the rule would require researchers to obtain very broad consent for use of all bio-specimens, even those that are anonymous. In short, patients would be consenting to the use of their tissue and other bodily matters in all potential and unknown future research. The consent would also include permission for the researchers to access the patient’s identifying information. HHS has not yet released a template for the consent form. And while this rule would be a step forward in mitigating ethical concerns, critics say that even stricter requirements must be in place to ensure truly “informed” consent.