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

Lacks, the grandson who you saw in the picture with Francis; Veronica Spencer, who was a

great-granddaughter from another son of Henrietta's; and Clyde Yancy, who is a member of our advisory

council. I will just skip that, we got lots of press.

So where are we now? We have, since August 19th, received -- actually, that says four.

We now have, over the weekend, a new one, we have five requests for access to HeLa data.

So working group is meeting for its inaugural meeting on September 12th, this week. They

will be reviewing those five data access requests, and we are optimistic that they will be operating

by consensus so that they can, as a group, send forward consensus recommendations to

provide -- to recommend to the Advisory Committee to the Director that access be granted or

not, or they can also request that there be more information solicited from the investigator.

There are a couple -- so one thing has been really important, particularly to Francis,

but I think it's been important to all of us, that this controlled access work effectively

and efficiently. So we want to be able to not have this stand in the way of research

moving forward. And, of course, you know, as researchers, would not like to have anything

slow us down by more than about three nanoseconds, so we are trying to have this process move

as quickly as possible. It is a new process, so this first round through, you know, we

were sort of getting our sea legs underneath us, but we -- if all works according to plan,