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  • Eric Green: Okay, well, it's a pleasure to have Kathy

  • Hudson here. I introduced the topic briefly with a slide in my director's report, but

  • we specifically wanted to have Kathy come and talk to council. I know council would

  • be interested in this topic, but also, it really is an interesting chapter. I didn't

  • even know what the title of her talk was going to be, but it really is an interesting story

  • to be told, how this played out. I will tell you, Kathy put in countless hours, if not

  • days and days, of effort navigating a very complicated circumstance. I, and several of

  • us from NHGRI, in particular Laura Rodriguez and Mark Guyer, and a couple others, were

  • quite involved on a regular basis on phone calls with Kathy as she sort of used us as

  • partners, and -- but as advisors, and helped to sort of navigate what was a much more complicated

  • quest for her than it was for us. But I saw enough of the front line of the story to just

  • see how challenging it was, and Kathy was just masterful at it in many ways. I also

  • think that the perspective that she co-authored with Francis, although I'm sure she did most

  • of the writing, was fantastic in the end, and if you haven't read that, you really should.

  • But I am going to let her just tell this story, but I really thought it would be special.

  • The timing couldn't be any better for a council presentation directly from Kathy on this interesting

  • story, so, Kathy.

  • Kathy Hudson: Thanks, Eric, for the invitation, and it's

  • nice to be here with you all, with some friendly, familiar faces around this table and in the

  • back of the room. Thanks very much.

  • So this is -- has been an interesting story to be a part of over the last several months.

  • I'll start with -- uh-oh. So I will start with a little bit of background, which I'm

  • sure you're all very familiar with, about Henrietta Lacks. She was born in 1920. At

  • the young age of 31 she was being treated at Hopkins for an aggressive form of cervical

  • cancer. Researchers took cells from her, and ended up being able to successfully start

  • a cell line, the first human cell line, as it turns out. The family, of course, has been

  • dealing with this situation ever since they learned that their mother's cells had been

  • used in this way. So how her identity became known, and how the family's identity became

  • known, I think, is relevant here.

  • So, in 1951, George Gey at Hopkins was able to get the HeLa cell line to grow in culture.

  • In 1971, there was a commentary, actually an obituary, published in "Obstetrics and

  • Gynecology," that identified Henrietta Lacks and included a photograph of her. The obituary

  • was of George Gey, and it was written by Howard Jones, who was otherwise known to many of

  • you as the father of IBF. In 1976 Victor McKusick, the father of human medical genetics, published

  • a paper describing the Lacks' pedigree, and specifically, was looking at HLA typing because,

  • at the time, it had become well-known that many later derived cell lines were contaminated

  • with HeLa, and so if you get any cell line near HeLa, HeLa takes over. And so Victor

  • McKusick and his team contacted family members and had them come back to Johns Hopkins to

  • provide blood samples. If you've read the book, "The Immortal Life of Henrietta Lacks,"

  • you get a perspective of how there was a lack of clarity on the family's -- from the family's

  • perspective in terms of what exactly they were being asked to provide and why. So there

  • was a perception that they were being tested to find out whether or not they might have

  • the same disease that their mother died of.

  • In 1997 there was a documentary, and then probably most importantly for the general

  • public's understanding of this situation and identification of who the family is, and who

  • Henrietta Lacks was, was the publication in 2010 of "The Immortal Life of Henrietta Lacks."

  • So how many people in the room have read "The Immortal Life of Henrietta Lacks"? It seems

  • like you can't even get on an airplane nowadays without seeing somebody reading the "The Immortal

  • Life of Henrietta Lacks." So it is very, very, very widely known.

  • So if you do a Google search today for HeLa, you'll generate 2.5 million results. There

  • have been 74,000 scientific publications using HeLa cells and mentioning that. In the last

  • 10 years, most of the Nobel prizes have used HeLa cells as a part of their work, and even

  • our youngest scientists, of course, are using HeLa cells; and here are two examples from

  • the Intel Science Search and from the Siemens Competition.

  • So I don't think that many of us -- you know, all of us read the book, but I don't think

  • many of us gave much thought to what we were doing in our laboratories and the connection

  • to the family until March of this year when researchers in Germany posted the first whole

  • genome HeLa sequence in EBI, and, of course, it was mirrored in NCBI. Fairly quickly the

  • Twitter world lit up. Rebecca was aware that the sequence had been published. Rebecca Skloot,

  • the author of the book, was aware that the sequence was posted. She contacted the family,

  • and the family requested that the sequence be taken down. And, in fact, the authors agreed

  • to have the sequence taken down, and it was taken down quite rapidly, both from EBI and

  • NCBI.

  • As we started to look into the situation, we learned that there was another publication

  • pending with Nature that was funded by NHGRI. Of course, the German publication was not

  • supported by NIH. So there was an editorial that was published in the New York Times by

  • Rebecca Skloot, and in the process of generating that op ed, Rebecca reached out to her. And

  • I knew her from my days at Johns Hopkins at the Genetics and Public Policy Center because

  • she was a stringer for the Washington Post, and she wrote a very flattering article about

  • the Genetics and Public Policy Center soon after we launched, and we had remained in

  • contact ever since. So she talked to Francis Collins and myself, and ended up including

  • a quote from Francis in her editorial, and during our conversations, we asked if she

  • would connect us with the family. And she said she would think about that and talk to

  • the family about it. And that was very important for what's the rest of this story.

  • So in thinking about how to address the problem of what to do with the sequence that had been

  • taken down, and what to do with the sequence that was pending at Nature, we gave a lot

  • of serious consideration to how to make sure that we generated a solution that was the

  • right size for the problem; so not to create a solution that was ginormous and sort of

  • super-sized, but not also to create a solution that was too modest for the importance of

  • the situation. So in generating the solution to this problem, there were a lot of people

  • who played really, really important roles, notably Eric, Mark Guyer, Brad, Laura, and

  • Larry Thompson from the Genome Institute, as well as a slew of people from NCBI who

  • were instrumental in working with us, and folks in the Office of the Director. And this

  • was also a topic of conversation among the NIH leadership on a number of occasions with

  • the Institute directors from across the NIH.

  • So we had an opportunity, with the help from folks at Johns Hopkins, to meet with the family

  • over a series of months, and that was a fascinating experience. This is Francis taking a selfie

  • -- I'd never heard of a selfie; that's how under a rock I live -- on the day that we

  • announced our agreement with the Lacks family at Johns Hopkins, and standing directly next

  • to Francis is Jeri Lacks, her brother David Lacks, and their mother, standing there together.

  • There were many other members of the Lacks family who were present when we announced

  • our agreement.

  • So, on -- I can't remember the date, and I don't have my glasses, so I can't say it.

  • So we managed to reach an agreement, which I will talk to you a little bit about, and

  • also talk to you about how I think that this agreement is something that is going to be

  • evolving, and your input and thoughts would be really welcome. We did manage to reach

  • an agreement, and Jay Shendure's paper was published with the second full human genome

  • sequence, a commentary by Francis and I, and, at the same time, the German sequence was

  • reposted, but this time in dbGaP, so both Shendure sequence and the German sequence

  • were made available at the time of this publication.

  • So over the course of our time with the Lacks family -- and let me just say a couple of

  • words about the Lacks family. So the Lacks family is multi-generational, and it was multi-generations

  • that were participating in these discussions. They attended these meetings with me, and

  • Francis, and a couple of folks from Hopkins over a period of months. Where we began with

  • trying to just understand what the circumstance was, and then, over time, working towards

  • what would be the options for how we move forward, and then what were the respective

  • pros and cons, good, bad, and ugly, of each of those options. There were anywhere between

  • nine and 12 family members at any given meeting, and during the intervening times between our

  • meetings, they had discussions with their broader family, and at the end of the day,

  • they had a consensus position, which I think is a remarkable thing. I can't reach a consensus

  • agreement with my nuclear family about where to go to dinner.

  • [laughter]

  • So they really, you know, they are a remarkable, remarkable family.

  • So, elements of the agreement. So we opted to put the two whole assembled genomes into

  • controlled access in dbGaP, and require that researchers apply for access in order to get

  • to that. And the terms for access that a researcher must agree to in order to get access is that

  • they will use the sequence for biomedical research only; that they won't attempt to

  • contact the family; that they disclose whether they have plans for intellectual property,

  • or to develop a commercial product or service; and that they include a commitment to include

  • an acknowledgement in publications and presentations. And, in fact, I should note that Jay Shendure's

  • paper includes such an acknowledgement, and it's sort of the model of the first application

  • of that -- of that policy. So the policy also requires that future whole-genome data be

  • deposited into dbGaP, and we already have another submission that is in process, so

  • that would be the third HeLa sequence that will be in dbGaP.

  • In order -- so the way that dbGaP works for GWAS data, and this was a real learning experience

  • for me, and hat tip to Laura Rodriguez for walking me very slowly through this because

  • it was new; dbGaP sort of emerged after I left NIH the last time. So, ordinarily, there's

  • a Data Access Committee that looks over requests for access to data sets and determines whether

  • or not the researcher's proposal meets those criteria that were laid out in the original

  • consent. In this case, there is no consent. So what we are relying on are these conditions

  • that were set forth by the family, and it's important that this is a very unique circumstance,

  • and a point that we've tried to make over and over again about how this is not a precedent

  • for anything. This is an agreement that we've reached with the family to address a particular,

  • unique circumstance in science and ethics.

  • So our working group is going to operate much like a data access committee, but current

  • NIH data access committees are made up of NIH employees. It became apparent to us that

  • it would be advantageous to include members from the family in the review process, and

  • so that meant it couldn't be a DAC in the old-fashioned ways, and there are legal issues

  • in mixing feds and non-feds, so we ended up creating a working group of the Advisory Committee

  • to the Director, which is the highest advisory group to Francis, and we have had advisory

  • groups on a slew of important issues over the years. We currently have a working group

  • to the NIH director working on developing the scientific plan for the BRAIN initiative.

  • We have now the HeLa Data Access Working Group, and they will review each of these requests

  • as they come in.

  • The requests are submitted through a dbGaP study page; so there is a parent page about

  • HeLa, and then there are two, soon to be three, sub-pages. And on this page are special instructions

  • for researchers that really lay out the requirements that we want them to address in their data

  • access requests, and then also information about the data access working group, and also

  • the mechanism of how to submit another HeLa genome, if you have one.

  • So the HeLa Data Access Working Group was put together on the day that we announced

  • all these things that we announced. It is chaired by Renee Jenkins, who is an adolescent

  • medicine doc at Howard University. Also included are folks who you certainly know: Russ Altman;

  • Ruth Faden from Johns Hopkins, who was involved in discussions with the family, and so she

  • has a pre-existing relationship with the family that I think will be really helpful; David