We never agreed to any of this!
That was my first thought when I read the news a son of the late Henrietta Lacks, the source of the HeLa cell line, was seeking compensation for the unauthorized use of her cells (1). HeLa cells have been instrumental in advancing scientific research and medicine. A few years ago, objections to the publication of the genomic DNA sequence of HeLa led to an effort by the U.S. National Institutes of Health to recognize the importance of Mrs. Lacks’s contribution and address the concerns of her family over privacy matters (2). I can’t help think part of the reason these wounds just won’t heal must involve feelings no one in the family ever consented to anything regarding the use and disposition of the cells taken from Henrietta Lacks .
Biomedical investigators have implemented and continuously improved informed consent procedures over time. Unfortunately, we have seen some ugly battles along the way. The late John Moore, a cancer patient, sought legal redress after discovering cells taken from him had turned out to be valuable (3). Ultimately, the judges decided patients had no rights over tissues removed from them, although Mr. Moore did receive compensation due to the failure of the authorities to undertake adequate informed consent procedures in his case. The rise of powerful new DNA-based technologies has complicated an already contentious debate about consent. Is it permissible to collect samples from subjects who have agreed to their use for a specific purpose and then use left-over materials in unrelated future research projects? Objections raised by the Havasupai Indian tribe about research undertaken without explicit permission resulted in a sizable settlement (4).
The renewed battle over HeLa cells follows recent controversy over proposals to change U.S. regulations for human subject research to require consent to use stored samples for future investigations (5). These plans provoked strong objections from scientists feeling their implementation would impose administrative burdens that would not benefit patients and could actually subject them to an increased risk of being identified. The final plan takes steps to decrease demands on researchers and eliminated requirements to obtain informed consent from donors before de-identified samples are used in new studies (6).
The new regulations require investigators to advise patients if genomic DNA sequencing will be performed on samples, which increases the risks they could be personally identified. However, some larger issues of informed consent and the disposition of patient samples seem to have eluded scientists and regulators. Privacy concerns are only part of the problem. Prospective volunteers are provided information about the study at hand and they enroll or decline to participate based on that specific information. Clearly, there is no way to divine every opportunity for productive work with remnant materials that will emerge in the future. However, assuming no one will have concerns about participation is not supported by prior experience. Locking volunteers in to every project that comes along in the future is both risky and incompatible with the basic principles of respect for subject autonomy enshrined in the Common Rule. The new regulations intended to promote research by decreasing administrative burdens could backfire if situations develop where people feel the system has taken advantage of their goodwill and good deeds.
As Winston Churchill expressed it, adopting a humanistic approach is essential to ensure that ‘science is the servant and not the master of man’ (7). Creating an environment which fosters exploration will clearly benefit society. However, if the new rules leave too many people complaining they ‘never signed up for this’ we may discover we have incited disaster.
(1) A. K. McDaniels. 2017. Henrietta Lacks’ Family Wants Compensation for Her Cells. The Baltimore Sun, 15 February 2017. http://www.baltimoresun.com/health/bs-hs-henrietta-lacks-johns-hopkins-20170213-story.html
(2) E. Callaway. 2013. Deal Done Over HeLa Cell Line. Nature, 7 August 2013. http://www.nature.com/news/deal-done-over-hela-cell-line-1.13511
(3) D. McLellan. 2001. John Moore, 56; Sued to Share Profits From His Cells. The Los Angeles Times, 13 October 2001. http://articles.latimes.com/2001/oct/13/local/me-56770
(4) A. Harmon. 2010. Indian Tribe Wins Fight to Limit Research of its DNA. The New York Times, 21 April 2010. http://www.nytimes.com/2010/04/22/us/22dna.html?pagewanted=all&_r=0
(5) S. Reardon. 2016. Science Academies Blast US Government’s Planned Research-Ethics Reforms. Nature, 29 June 2016. http://www.nature.com/news/science-academies-blast-us-government-s-planned-research-ethics-reforms-1.20191
(6) S. Reardon. 2017. Controversial Patient-Consent Proposal Left Out of Research-Ethics Reforms. Nature, 18 January 2017. http://www.nature.com/news/controversial-patient-consent-proposal-left-out-of-research-ethics-reforms-1.21330
(7). M. Livio. 2017. Winston Churchill’s Essay on Alien Life Found. Nature, 15 February 2017. http://www.nature.com/news/winston-churchill-s-essay-on-alien-life-found-1.21467