The right answer is: No. Why bring this issue up? HBO will be showing a movie based on the 2010 bestseller The Immortal Life of Henrietta Lacks tomorrow starring Oprah Winfrey. In 1951, black Baltimorean Henrietta Lacks had surgery to remove a cervical cancer tumor. Her physician took some cells from the tumor which he turned into the first immortal line human cell line. The HeLa cell line has been subsequently used in thousands of biomedical research projects. Lacks died later that year of her cancer, and her family was not told about the HeLa cell line.
One of the central themes of the book was whether or not Lacks' physician should have asked for consent and provided compensation for the use of her cells. Spurred by the controversy engendered by the book, the U.S. Department of Health and Human Services proposed revisions to the Common Rule that protects people who volunteer for federally funded research studies. The proposed revisions would have substantially increased the burden on researchers with regard to obtaining consent from patients for the subsequent use of their medical wastes, uh, biospecimens.
I am happy to report that in their op/ed, "Science Needs Your Cells," in today's New York Times two bioethicists agree with me that such requirements are largely useless and would substantially slow down medical progress. From the op/ed:
First, no one is taking biospecimens from patients' bodies without their permission. Patients have consented to the clinical procedure as important to their medical care. What harm could come from using leftover materials, which would otherwise be thrown away, for research?
Perhaps we should be concerned about risks to a patient's privacy, but that is why we remove the identifying information. Although researchers have shown that it is possible to "de-anonymize" specimens — using clues to link them back to individuals — there have been no reports of anyone doing this for nefarious reasons. And even if there were, the answer would be to sanction the culprit through fines or criminal charges, not to make it harder for researchers to get these samples in the first place.
What is left, then, is our claim to autonomy: Many of us intuitively feel we should be able to control how biospecimens derived from our bodies are used. But leftover biospecimens are just medical waste to most of us, as we lack the expertise to imbue them with scientific value. Nor have we done anything to make them valuable, other than being born with a particular genetic variant or afflicted with a particular malignancy.
This is why calls to pay patients are misplaced. In addition, unlike HeLa, in which one patient's biospecimens led to dramatic advancements, most developments come from studying materials from many patients — each biospecimen contributes only marginally to the result.
These relatively weak claims to control and compensation do not justify the demands more restrictions would place on biospecimen research. Hindering this research is worrisome because its benefits are so great. Among many examples, they include the identification of mutations in tumors (lung, skin and others) that can be targeted with drugs that markedly improve quality of life and survival.
Requiring consent might not seem like a big deal. But it is. Consent might require tracking patients down later, whenever a study is proposed, which can be difficult or impossible. Alternately, it might involve asking patients to agree generally to any future research at the time blood is drawn or a biopsy is taken. Either way, it can be a costly, bureaucratic headache. Which patients said yes, which said no, and to what, exactly?
They are correct. And the good news is that most the proposed consent revisions to the Common Rule have been dropped.
With regard to compensation, in her Times' interview about the movie Oprah Winfrey notes that some Lacks family members had sought a payment of $10 million from her and HBO.