by Erica Heath, 2009 Advancing Ethical Research Conference Faculty Member
Late—very late—one recent night I finished Rebecca Skloot’s fascinating new book, The Immortal Life of Henrietta Lacks (hereinafter “TILoHL”). Before sharing my thoughts, though, I’d first like to tell you how the book came to my attention.
I was driving home from work one day listening to Terri Gross interview Ms. Skloot on NPR’s Fresh Air. Her account of the arduous process of getting permission from the Lacks family to write the book was compelling, and I drove straight to the local bookseller, but they were already sold out. I placed an order and left feeling disappointed.
Thereafter, it seemed impossible to escape the book’s presence: At my next IRB meeting, three members talked about the Fresh Air interview, and our chair was reading the book. A few days later, she loaned me her copy, and asked that I pass it on when I finished. The chair’s copy of the book is now being read by a friend’s daughter who is working with HeLa (short for “Henrietta Lacks”) cells in one of her college classes.
When I was about halfway through TILoHL, The bookstore called to tell me that my own copy had arrived. I picked it up, and it is now making its way through our office where I’m hoping my colleagues will get the same kick I did out of recognizing people and places from the annals of IRB history.
The book weaves the story of the Lacks family with that of the development, distribution, and use of the HeLa cell line. Among the themes that are relevant to IRBs are those of informed consent, the commercialization of tissue (or other biologics), the treatment of donors, and resultant suspicion of biomedical research.
Jay Katz’s seminal book, Experimentation with Human Subjects, which Skloot cites, has been an occasional noon-time read of mine. The first part of his book contains original documents Dr. Katz collected from the Jewish Chronic Disease Hospital episode, in which an investigator injected live cancer cells into patients without consent. The Jewish Chronic Disease Hospital case was one of several revelations that spurred Congress to create the IRB system.
Whenever I read this section of the Katz book, I felt as though there was something missing in the Jewish Chronic Disease Hospital saga. When I read the account of that research in Ms. Skloot’s book, I experienced an “ah-ha” moment when I realized that the live cancer cells came from the HeLa cell line. I at last felt as though I had the rest of the story, and finally understood the investigator’s flawed rationale for his ethically objectionable study.
In the IRB world, we have ongoing arguments about when or whether researchers have any duty to determine if original consent was gained for secondary or tertiary use of tissue in research. Ethics and reality/practicality often conflict; some studies say donors desire an opportunity to give consent, while others don’t see the point of obtaining consent so long as the samples are anonymous.
What roles do IRBs play? It is easy and probably appropriate to determine if the de-identified specimens are not human research subjects and leave it there. IRBs could ask the end-user researchers if consent was given, but they often cannot know, don’t need to have IRB approval, and should not, therefore, be asked to bear the burden of consent. We can require repositories obtaining residual samples from clinical tests to assure consent was given, but outside of medical centers there may be no opportunity to do so. Or, we can require anyone transferring specimens to assure that consent was given, but few places have mechanisms to track it. Unless everyone involved in harvesting those specimens for research agrees that consent is a desirable norm, documenting consent will be elusive. The tragedy of the Lacks family’s experiences will endure until there is a clear and ethical policy.
The public is becoming increasingly informed about biomedical ethics and more and more people have heard of IRBs. I no longer automatically sigh when I am asked what I do; Skloot’s book is a bestseller. Michael Crichton’s book Next (certainly not his best, as it’s quite contrived, and as the science is questionable) was built around many of the same issues; it remains in many airport book stores. Both books have a must-read Afterwards by the authors.
Will we ever see a movement toward requiring initial consent for research use of tissue? It’s my opinion that, sooner or later, we will. What do you think?
In any case, I highly recommend both Skloots’ and Crichton’s books for all those interested in these issues. And, if you run across an old copy of Dr. Katz’s book, grab it for your IRB library!