Biological Specimens, Biobanks, and Informed Consent
Research using human biological specimens is booming, yet many questions regarding such research remain unanswered. Is informed consent necessary for the use of human biological specimens in research, and if so, what counts as informed consent? Is it sufficient to give donors an opportunity to opt out, or must they be provided with information about the purposes of the research and affirmatively consent? What about property rights – does the donor “own” his or her biological specimen and have a right to control its use? And if such research leads to patents and commercialization, do the donors have a right to share in any resulting profits? Even if donors do not possess property rights, what about the potential impact of such research on the donor’s (and his or her family’s) right to privacy? And are there special concerns regarding research using vulnerable populations, such as newborn babies, indigenous tribes, and others groups?
This is a really hot topic – in the past year, several articles on this subject were published on the front page of the New York Times, and a book about a poor black woman whose cancer cells were taken without her knowledge or consent to create a profitable cell line became a bestseller! Rebecca Skloot, the author of The Immortal Life of Henrietta Lacks, captures the issue beautifully:
“How you should feel about all this isn’t obvious. Scientists aren’t stealing your arm or some vital organ. They’re just using tissue scraps you parted with voluntarily. But still, someone is taking part of you. And people often have a strong sense of ownership when it comes to their bodies. Even tiny scraps of it. Especially when they hear that someone else might be making money off those scraps. Or using them to uncover potentially damaging information about their genes and medical histories.”
Three important precedents determine the law in this area and suggest that donors possess neither property nor privacy rights over their biological samples: the cases are Moore v. Regents of the University of California, Greenberg v. Miami Children’s Hospital, and Washington University v. Catalona. Read together, these cases reveal that individuals possess no property rights in their body parts once they have been separated from their bodies because recognition of such rights would be repugnant and could restrict research; however, researchers, hospitals, and universities may possess property rights in the biological materials that are stored in biobanks, as well as the cell lines or genetic information produced from them. These cases also establish that physicians owe a fiduciary duty to their patients to disclose information regarding their own research and pecuniary interests in order to obtain informed consent for medical treatment. However, researchers owe no duty to their subjects and informed consent requires only that the donation of biological materials for research be voluntary, not coerced; it does not require the provision of information about the goals of the research or the researcher’s economic interests because imposition of such duties might impede research.
Yet two recent developments may have transformed the legal landscape with respect to research using human biological specimens. In every state, blood spots are routinely collected from newborn babies without their parents’ knowledge or consent in order to detect and treat a variety of genetic diseases. However, Texas and some other states started to stored these blood samples indefinitely and made them available to others for research use. A group of Texas parents sued the state health agency for violating their rights to privacy and liberty under the Due Process Clause of the 14th Amendment, arguing that the blood spots contain deeply private medical and genetic information that was expropriated without their knowledge or consent, and the federal district court refused to dismiss their complaint. This resulted in a new law in Texas requiring parents to be given the opportunity to opt-out of such research, as well as a settlement agreement which gave the state 70 days to destroy approximately 5 million blood samples collected from newborn babies over the past 7 years.
The Havasupai Tribe of Arizona also filed a lawsuit challenging use of blood samples which they voluntarily gave to researchers from Arizona State University to find out whether there was a genetic basis for the high rate of diabetes among Tribe members because the researchers also used the DNA samples for studies about schizophrenia, the degree of inbreeding, and the geographical origins of the Tribe in Asia that contradict the Tribe’s cultural and religious values. Havasupai Tribe members filed a lawsuit against the researchers and ASU, contending that they gave their blood only for the purpose of diabetes research so there was no consent to do other research. However, the court ruled that there was informed consent because Tribe members had signed a form granting blanket consent to donate their blood for research “to study the causes of behavioral/medical disorders.” Although the Tribe lost the legal battle, it was morally vindicated in April 2010, when ASU agreed to a settlement to “remedy the wrong that was done.” ASU agreed to pay $700,000 to 41 members of the Tribe, return the remaining blood samples, and provide other forms of assistance to the Tribe (such as scholarships and help in setting up a clinic).