Henrietta Lacks
In this episode, Devan and Tyler discuss the life and afterlife of Henrietta Lacks. Her cells were taken without her consent and used in tens of thousands of research experiments. We discuss what has and hasn’t changed in research ethics.
Transcript
0:03
Come to another episode of Bioethics for the People.I'm joined by my Co host Doctor Devin Stahl, who according to her student reviews should be cloned and teach all of the bioethics.And he's Tyler Gibb, who, according to his students, is best described as the goat of bioethics.
0:27
Good morning, Tyler.Hello Devin.So I'm up today.Yeah, I got a case.I'm excited.What case have you brought for us today?OK.Today we're going to talk about a case that I think has been pretty widely publicized and a lot of our listeners will probably have some familiarity with it.
0:45
OK, What new could I possibly say?I don't know, but I think it's still worth going through this case.Sure.All right.So the case is of a woman named Henrietta Lacks.Have you heard of her?Yes, Henrietta Lacks.I have heard of Henrietta Lacks.
1:01
OK, So what do you know about Henrietta Lacks?All right.Henrietta Lacks was a African American woman who was living or born in and around Baltimore, I think, in the 1930s.
1:16
Nineteen 40s.Ish is my memory and she unfortunately passed away due to I think an ovarian cancer, maybe cervical cancer.And there's something unique about her, her cell line, like the mutation that happened that caused the cancer that ended up killing her.
1:37
Something about it being able to be like regenerated and then doing tests on it.Something like that, using research.That's about as much as I know and Oprah cares about it.I was going to say people maybe heard about this because there was a movie about Henrietta Lex and her family that came out a few years back, and Oprah plays one of her daughters.
1:58
And so Oprah really cared.And and then this was inspired by a book by a reporter who wrote about Henrietta Lex's life and her afterlife.So it's become like a really popular story.And I think when we get into the case, you'll see why.It's become so popular and the kind of ethics issues that it raises, especially in research ethics.
2:15
OK, OK All right.Let's start at the beginning.Henrietta Lacks was born in Roanoke, VA, in 1920.We just celebrated her 100th birthday not too long ago, So there was a lot of kind of buzz around it A few years back.She was four years old when her mother died, and Henrietta's father took her and her nine siblings.
2:36
Lot of kids.Can you imagine?I don't even want to think about it.Turner, nine siblings to Clover, VA to live on their grandparents farm.So Henrietta grew up on a farm.She was described by her friends as tough but also warm and generous.And when she was 20 years old she married David Lacks and they had five children.
2:57
And after World War 2 there was kind of a boom in cities and they moved to Baltimore to find work.So in 1951, the 31 year old Henrietta.Told her husband that she was experiencing pain and she thought she had a knot in her womb.
3:15
That's how she described it, which was, you know, just causing her immense amount of pain.And she tried to tolerate this pain for a long time, but eventually it just became so overwhelming that she said I need to see a doctor, OK?How old is she at this point?She's 31, 31, OK, yeah.So she goes to see her local doctor, but her doctor runs some tests and he says I'm not really sure what this is.
3:36
I think you need to see a specialist.So her husband drives her to Johns Hopkins Hospital.Have you heard of it?Heard of it?Very famous hospital to have this not examined and this is like a 20 mile trip.So at the time this is kind of a big ordeal for them to go all the way to Johns Hopkins.
3:53
And why did they have to go to Johns Hopkins?Well, because they're black and Johns Hopkins is one of the only hospitals that has a quote UN quote colored Ward oh.OK, Yeah.So it's a public hospital and it has a separate ward for.You know, black people, which would have been common at the time and unfortunate this is where they, you know, have top notch doctors and where she can be seen as a black woman.
4:17
Great.Yeah.So, I mean it seems like a a good option.I mean, having being able to be treated at Johns Hopkins I think is pretty helpful.It's a great, great hospital world right now.Yeah.And today, it's a great hospital.
4:32
That's right.Yeah.All right.So they go and seek treatment at the famous Johns Hopkins, right?One that maybe not treatment yet, but just a diagnosis.Okay, She sees a gynecologist, Doctor Howard Jones, and he discovers a large malignant tumor on her cervix and he diagnosis her with cervical cancer.
4:48
Over the next eight months, LAX receives radium treatment.Which was, I know, I see your face.Radium was the premier treatment at the time.So this wasn't like, oh, we're going to give poor black people radium treatment.This was really what everybody would have gotten at the time.
5:05
Standard of care, standard of care at the time.Turns out radium is not great for your body.Yeah.Isn't that what Marie Curie taught us about?All right, so the treatment of the of the day, the treatment du jour is radium.
5:22
And how is it administered?Is it like injected or something?I don't even know what.Yeah, I actually don't really know either.Interesting.Anyway, OK, so bad.Cervical cancer, Standard of care.Is radium if it's kind of, well, you know, not that.
5:38
Like the stuff we give for cancer today is not toxic, right?So maybe better than radium, but still not great.Like still rough.She's receiving treatment at the time a surgeon, Lawrence Wharton Junior, takes 2 dime sized pieces of tissue from her cervix while she's under anesthesia as they're getting samples.
6:00
This was also common.The samples are collected from her without her knowledge or consent, but this would have been standard procedure at the time.You know, you collect samples and you give them to researchers working at Johns Hopkins.Because there is.A group of researchers who are looking at cell lines at the time.
6:18
And so you wouldn't have gotten consent for this then.I think I want to talk in a second about whether you'd get consent for it now.But these retrievals were standard.They happened to every patient, not just black patients in the colored ward.All patients.So.
6:33
So he gets these samples.The samples are processed by a woman in the lab named married Cuba.Check.She labels the tubes.Heela.HeLa for Henrietta Lacks the so the 1st 2 letters of her first and last name, which again standard naming procedure at the time.
6:51
We would not do this today.Don't label samples with somebody's name, patient names with patient names, but I I think that the HE, LA cells are really well known, right?I mean, people have heard of those, they're really common.And is it true that we didn't know that Heila stood for Henrietta Lacks for like a long time, right?
7:10
That's right.Because at some point, when, like, it became obvious that you needed to anonymize these samples, they started using a different name for her.They sort of gave her pseudonyms.So we didn't know her name for a while because they started calling the donor something else, not Henrietta Lacks, so something else that fit with HeLa.
7:31
They get these cells and it's like pretty obvious pretty quickly that they're remarkable.Unlike any human cell anyone had ever studied before, her cells didn't die quickly in the laboratory.They thrived and multiplied.So there had been some other animals where they We saw this happening, but it had not happened in human cells before.
7:52
Her cells were just multiplying gangbusters.That was the scientific term at the time.Just kidding.Gangbusters.But they just kept multiple.They were doubling every 20 to 24 hours, and they just weren't dying.And that.They just hadn't.They hadn't seen that before.
8:08
The researchers in this lab, Mary and Doctor Guy, had been researching this for decades, trying to find cell lines that would grow outside of the body.And they really couldn't do it for any more than like maybe one trial on the cells.So her cells are just ground breaking.
8:23
They and they see this almost right away.Mary runs to Doctor Guy.She says.We found what we've been looking for, an immortal cell line.They they they think that they could probably keep cultivating this cell line for eternity the way that they're multiplying, which is amazing.
8:40
Yeah.So it's so amazing and that it comes from a woman's cancer that, I mean, tragically she ends up dying from it.But it's amazing that that type of the mutation that in the cell line that she in the cells that she had creating the cell line.
8:57
I think, I mean, that's like a miracle of modern science, right?Absolutely.I'm not a biologist, so our listeners can correct me if any of this is wrong.But here's what I understand about cell lines.Biologists use cell cultures to grow cells in laboratories to do all sorts of basic science and clinical science to help us understand cellular mechanisms.
9:18
And also clinical applied research.So we test new drugs on cell lines to see if those drugs are toxic.So before we start doing things in even animals, we'll we'll test drugs on cell lines just to see what it does to the cells, because if it kills all the cells, probably not worth pursuing before Henrietta Lacks scientists are trying to grow cells in labs from human tissue.
9:38
But the problem is that these cells just tend to die pretty quickly and you can only run maybe one experiment on them before you have to start over on a new cell line.But Henrietta lack cells don't die.They just keep growing and replicating, and they're still doing that decades later.So we still have this same line.
9:55
Scientists already knew that cancer cells tend to grow more rapidly and stay alive longer than other cells, but they don't grow indefinitely.Eventually the telomeres kind of shorten and the cells die.And that's why we die.Apparently this is like all the kind of research into anti aging stuff is all on these, like telomeres in cells.
10:13
OK, Henry Lacks's cancer cells have some sort of mutation where they're just immortal.They just will not sort of.The telomeres are shortening, they're not dying.They keep going anyway.That's all I know about that.Don't ask me anymore about telomeres, but but that seems really useful from a scientific perspective because if you can use the same material to do multiple tests on right, so it takes out one of those variables.
10:36
So.Right.And so Doctor Guy is saying he's, like, holding press conferences.He says we found it, this amazing discovery of an immortal human cell line.And soon he starts getting phone calls from all of his, you know, buddies who are like, give us some of these cells, like, you know, just cut a few off and send them to us.
10:51
And he's like, yeah, OK, just just pay me for the cost of shipping them to you.So he's like, not really even making money off this.This is just so ground breaking.That he starts shipping these cells all over the world.So it doesn't take long before multiple labs have these cells going back to LAX, as you said, in spite of her treatment, she, her cancer really rapidly metastasizes throughout her body and she later that year at the age of 31 dies.
11:18
She's buried at in an unmarked grave, leaving behind her grief stricken husband and her five children.It's just tragic, right?So when she dies.George Guy asks her husband David for permission to perform an autopsy so he can collect more samples from Henrietta, but he doesn't exactly tell David why.
11:43
Anyway, so that there's like a watch the movie, It's really interesting.But their interaction is, you know, he kind of says I we need to know more about her cancer.Would you allow us to take some samples?He initially says no, but after some pestering, he agrees.To let them take more samples or to do the autopsy, A partial autopsy on her.
12:01
So this doctor at this point recognizes the value, scientific value, if not financial value of this cell line and wants more right.So the is the autopsy purely a pretext?Well, so they need to do the autopsy in order to get the more samples from her, right?
12:18
But yeah, but they don't need to do the autopsy.No, no, they don't need to do an autopsy.They they know why she died, right?Which is typically why you would do an autopsy.Yeah.Yeah.OK.So a little sketchy.They did get permission, but like, was it really informed consent?Doesn't seem like it, according to her family.Back to sort of like what is discovered about these cells doesn't take long for them to have a real medical impact.
12:39
So in 1952, her cells are used to develop the polio vaccine.And I don't know if you've heard of polio.Real big deal.Yeah.So long time avid listener of the podcast Grandma Nancy in Idaho Falls, ID, Survivor of polio.
12:56
Oh wow, yeah.Shout out Grandma Nancy.So she probably recognizes the value of polio vaccines, Yes.Yeah.So they set up a whole lab at Tuskegee University to use her cells.So they're so, like, amazing and so fast growing.
13:11
They have to, like, create whole laboratories just to keep her cells.Wait, Tuskegee in Alabama?Yeah, The Tuskegee.Yeah.Oh, interesting.OK, heard of Tuskegee as well.Yeah, yeah, we at some point we should talk about Tuskegee too, because other things happen there.They have a whole laboratory there dedicated to her cells and her cell line.
13:29
And not long after, there are other companies that start to help just sort of ship out these cell lines to researchers for a fee.There are folks making money off of her cells, mostly to get them to other researchers to be able to use.So since then he LA cells have been used in like countless studies.It's like impossible to over sell what her cells have been used for.
13:49
There is like almost no research that has used cell lines that haven't used her cell lines.They've been used to understand the effects of radiation, steroids, cancer, bacteria.They've been used and in 2001 they said they had been used in over 75,000 studies, 75, 1000 studies.
14:08
Yeah, and they're they were used to develop vaccines not only for polio, but HPV, COVID-19 cancer viruses to study the human genome, the effects of radiation and poisons, to improve cloning and in vitro fertilization and medications for HIV, Parkinson's, leukemia, the flu.
14:25
I mean just everything.Everything you can imagine.Did I read someplace that NASA used some of her cell lines and like, maybe there's cells in space or there were cells in space?Yep.Wow.So she's been in space.So the World Health Organization estimated that if you weighed all the cells that have ever grown from her cell line, they would be like 50 million metric tons of cells.
14:48
It's like, unfathomable to me, right?And just so we're clear, all of these cells contain her DNA, right?So you know if if anything is a genet is like an identifier of who you are as an individual, like your DNA code.
15:05
Is that right?Yes, Yeah, keep that in the back of your head because like, this will come up in a second.OK, So even though her cells are like making global headlines like everyone has heard of of he LA cells, at this point her family doesn't know anything about her connection to these cells.
15:20
Like until about 20 years after her death.And this is in part because they want to keep her identity confidential.And so like I said, they were using other kind of names to describe this woman, so her family didn't recognize kind of that.The other thing to know is that in 1966, scientists discovered that many of the cell lines they were working with, they didn't realize were contaminated by he LA cells.
15:45
Have you heard of this?Yes, I I yeah, a colleague of mine.I don't know if he's still at this is institution had like a 20 year research lab and everything and graduate students and then found out that whatever cells he was working on were contaminated and then it like blew up his whole research project.
16:04
Right.So this happened to a lot of researchers that they, it was, they sort of dubbed us the Heela bomb, that if your cell lines were contaminated with heela cells, you weren't actually researching the thing you thought you were researching, right?Because they were.You were researching her again.All over again.
16:20
So if you thought you were researching some other kinds of cells and they were actually contaminated with her cells, you can't be confident that the thing, the findings that you had were real findings, right?Like like ruined a bunch of research because people had just not been.I guess they were allowing these cell lines to be contaminated, so they weren't doing their diligence of whatever it takes.
16:40
Don't ask me what that means, Devin.Please tell us more about laboratory technique.I do.I do not know at one point.They say like the only way to remedy this.If we need to know if our cell lines are contaminated, we need to know like more about her DNA and but we know she has living children.
16:58
If we can get them to give us some of their DNA, we can test it against our cell lines to see if if they have been contaminated as well.It's like, so using the children is like a cross check, like a double check, cross check, yeah.Yes, the family was told so and but people knew They still remember Henrietta Lacks and they knew her family still went to Johns Hopkins to get medical care.
17:20
So somebody said just call him up and ask him to give us samples.And so they Hopkins, somebody at Hopkins calls family members, They say we want to test family members for the same cancer that Henrietta had.Would you come in and give us a blood sample?So they kind of lie to them that kind of like that was a lie.
17:36
That's not what they were testing.They weren't testing for cancer.They just needed their DNA to test against other cell lines.Wow.And what year is this?Ish.This is in the 60s, OK, 1960s.Yeah, Even though Hopkins tries to keep Henrietta's name anonymous in the 1970s, her name is sort of widely known by journalists and scientists.
17:53
In 1973, Babette Lacks, who is Henrietta's daughter-in-law, met a man at NIH at a cocktail party.They're talking, he says.I work with this cell line from a woman whose name was Henrietta Lacks, and Babette goes what My mother in But you know, she she died a long time ago.
18:14
And he says, yeah, yeah, this woman died a long time ago.Her name is Henrietta Laxon.She died of circle cancer.And Babette is like, Oh my gosh, yeah, I think that's my mother-in-law.And so this friend brings her a medical textbook to sort of show her who this woman was.
18:30
And all that these cell lines had accomplished.And in that medical genetics textbook, they open it up and there's a picture of Henrietta Lacks.Oh my gosh.Yeah, of her mother-in-law in the textbook.Of her mother-in-law.Yeah.And the family had, like, never known this and never gave permission for that picture to be used in this textbook.
18:47
Their minds are, like, blown at this point.And they're like, kind of rightly pissed.Yeah, absolutely.Can you imagine opening up a pic a medical textbook that I assume you know The chances of them randomly stumbling across the a medical textbook and finding this picture on their own is like 0 right?
19:07
I work in bioethics and I don't open up a lot of, like, random medical genetics.Yes.Never.Yeah, I don't have one, even on my shelf.I'm looking around.I don't think I have.I'm not stumbling across medical textbooks.Right.Like, why would you?Nobody would ever open a medical textbook unless they, like, needed it for a Med school class.
19:26
But yeah, opening up and seeing a family member.A deceased family member.Yeah, wow.Yes.So I think that there's a lot to criticize here about how Johns Hopkins went about this.First of all, Doctor Guy says that he didn't make any money off of these cells.
19:46
That they were never.And Johns Hopkins maintains that they were never sold or profited from, they were really used for, like, discovery and distribution and that they don't own the rights to the cell line.So that, you know, they don't have some sort of proprietary ownership of them but really gave them away.So HeLa cells are freely and widely used for scientific research.
20:05
So that's what they maintained.But here's what they say.Or here's what Johns Hopkins has said since the sort of book came out about this and people were like, what the heck, right?You know, her family never knew she.They never got informed consent from Henrietta.What's going on?Johns Hopkins sort of statement about this was, quote.Having reviewed our interactions with Henrietta Lacks and the Lacks family over more than 50 years, we found that Johns Hopkins could have and should have done more to inform and work with members of Henrietta Lacks's family out of respect for them, their privacy, and their personal interests.
20:37
Though the collection and use of Henrietta Lacks's cells and research was an acceptable and legal practice in the 1950s, such a practice would not happen today without the patient's consent.OK, Tyler, what do you know about whether or not we would do something like this today?
20:55
Is this sort of like just a hangover from the past?Today we would definitely get your consent to take samples from your body and use them in research.Is that true?I don't think that's true, Devin.It's not true, Tyler.I mean I we, I think we all pretend it's true and we wish that it's true maybe.
21:12
But this is the struggle that I have with this case and I think that what what we're going to talk about for the next, you know, rest of this episode is that there there's a couple of the kind of big cases that come out that have bioethics kind of written all over them that.
21:29
Get a lot of attention and and people start talking about and obviously this is one of them and often it's the case like Tuskegee for example where like the the unethical behavior was so obvious even obvious at the time probably.And we can say things like, you know, that would never happen today, but I don't think that Henrietta Lacks is that way, right.
21:51
I think it's more complicated.I mean, for sure they asking the family to come in and give blood samples under the guise that, you know, they were testing them to make sure they didn't have cancer was a like, blatant lie.And they knew that that was illegal at the time.
22:06
That was like not good ethics at the time.It's not good ethics today.Like you you you shouldn't that that's just kind of inconceivably wrong.But other parts of this really haven't changed all that much.So what do you know about the the common rule?The common rule it sounds, Is it just common sense?
22:25
Is it like the golden the golden common sense rule?No.You know the common rule in research ethics, right?Yep.So don't ask me to explain it right now.I mean it's it's the the the federal rules basically on how research that involves human subjects at any level has to happen, right.
22:47
So This is why institutional review boards or IR BS have have come into existence and and it's kind of their operating procedures at a federal level of how.To protect people from being exploited during research, right.Clinical research, right.
23:03
Yeah.So it's just our federal guidelines about how to make sure that human subjects research is sort of conducted ethically.And have you ever been on an IRB?Yeah, I have.I've been on a couple of IR BS it.It's super interesting.I find it super painful as well.
23:20
Yeah, yeah, you know, And we of course like, do ethics and know like what makes for ethical human subjects research.And even still, it is like pouring through protocols is a lot of work.I find it the same.I know people who love it, so good for them.Please be on an IRB if you love it, because most of us don't.
23:39
Absolutely.But it's important.So the common rule comes into effect after this guy Henry Beecher is combing through NH studies.So studies funded by the federal government on human subjects research.And he's like, holy moly, There are a lot of unethical research experiments happening, research trials happening right now.
23:57
And they're well known.The NIH is funding them.They the NIH like sort of reports on them.They're not secret.And so he was able to pull together a bunch of them.He in in the 60s, he releases this paper in the New England Journal of Medicine that's like, look at what we're doing.
24:13
And people are like, Oh my gosh, we need more regulation.So we had had research rules, ways to conduct research ethically since the Nuremberg trials after World War 2, because the Nazis did some very bad things.Yeah, we talked about that, that in other episodes, how if you get compared to Nazis, you're doing something wrong.
24:33
You're doing something wrong, yeah?And so, So Beecher was like in the 1960s, right?Mid 60s is when that paper came out, I think 66.Yeah, Did you know side note that that first he gave a presentation at a small conference?And that presentation turned into this paper, and that was actually given just outside of Kalamazoo, MI.
24:54
Oh really?Yeah, at A at a retreat.I can't remember the name of the treat, but it was owned by.It's owned by Michigan State now, but it was owned originally by the Upjohn Chemical Corporation.Oh, interesting.So.Yeah, it was like this like executive retreat and he went there and gave this paper kind of like a.
25:10
And if you look at the footnotes of this paper, it says like thanks for the feedback from my colleagues at this blah blah blah and mentions where he.First, gave this paper so Kalamazoo, MI, Michigan Shadow.No, I did not know that.That's a really fun fact.Go Kalamazoo.Side note, yes, good side note, OK.
25:29
The common rule kind of comes out of that like bombshell paper that Beecher produces.And we say, gosh, you know, we thought we were just these like great, we had these great ethical scientists.It turns out they were doing some stuff that's not so ethical, especially around informed consent.That's one of the big pushes like you have to people have to know that they're going into research if they're going to be human subjects.
25:49
But samples, biosamples, biospecimens are kind of different in that it's not clear to me or apparently the common role that they're they are people.Do biospecimens count as human subjects?
26:07
Right.They fall underneath that umbrella of protection.Or not?Or are they something different?Are they something else?Do you need consent to research on them?Are they somehow just so different?Like, clearly they come from humans, but that doesn't mean they are themselves human.
26:23
Yeah, I've heard.I've heard somebody describe this as like, like comparing it to fingernails.Like, obviously if you clip your fingernails and throw them away, you don't think of that as like a valuable part of your body, but it still came from your body, right?But how much?Genetic material or whatever.
26:39
How many fingernail clippings actually create enough of a person, a critical mass of a person, to get the same rights or protections, right?Yeah, well, and like if you found out that someone was collecting your cut fingernails and keeping them in a little plastic baggy, would that feel like a violation?
26:59
How did you know that has happened to me?No.Yes, that feels weird, right?Yeah, it feels really weird.Right.And we, we come across this sometimes when we're talking about people in regards to organ donation after death, right.
27:16
Some, a lot of people would be like, oh, I don't care what happens in my body, blah, blah, blah.But we do care what happens to our body.And we like, you know, if someone's collecting fingernail clippings or hair from your brush or even like your trash, right?Like there's something that feels like violating about that and.
27:34
If they're collecting my fingernail clippings and selling them on the Internet and making tons of money and winning Nobel prizes, I don't think I'd have feelings about that.I would definitely have feelings about that in 2017.So not that long ago, the common rule was updated and in part there was this really big push to start treating biosessiments differently.
27:54
So up until that point, anytime you go to the hospital and you have a procedure or you give blood, have you ever like had blood taken?Yeah.You know what?I, I, I my wife used to work at a blood collection center, so I'm well versed in the donation of blood.
28:12
And have you ever had a medical procedure where, like, some part of your body was taken out of you?I had my tonsils taken out.Does that count?That counts, yes.Tonsils are a part of your body, and now they're not.If that's ever happened to you, somebody could.A researcher could ask for some of those samples, just like they did with Henrietta Lacks, and start studying them for research purposes without your knowledge or consent.
28:38
Is it part of the consent that I signed, like as part of the procedure?Like, is it like part of the package of consents that I give before the surgery?Yeah.So often it is part of some sort of like, yeah, broader consent that, you know, you're consenting to it and then some languages slipped in there.
28:55
But I will say like you may not remember this because it maybe it was too long ago, but when you had your tonsils taken out, do you remember the nurse when she was going through the consent form spelling that out?Also we could use your tonsils in research.No, no, they would never say that so.I I got my tonsils taken out after law school while I was doing my PhD.
29:13
Oh, OK.So you, like you were probably wise enough to have noted that.But I didn't object to it.Yeah.So when we talk about consent for medical procedures, it's not like we just hand.We shouldn't anyway, just hand over a form and it's like of complicated legalese and go sign here like it's your Apple contract, which I don't think anyone in the history of the world has actually ever read, or at least no one I've ever met.
29:36
You know, you just sign it away.But really, with medical consent, you're supposed to make sure that the person understands what they're consenting to.And so even if the language about research has slipped into that, it's not actually gone through as part of the medical consent to the procedure.They're really concerned about you understanding kind of like the risks of the procedure.
29:56
They people wouldn't discuss with you, kind of like what might happen to your biospecimens afterwards.So if it's part of a consent, it's not part of that process, it's probably maybe it might be in like a form that you sign when you're signing like the 18 forms, right when you first get in there.Yeah, yeah.
30:12
And and I think if someone were to object, and I mean if it feels like you're on a train track, right.And.Going through the procedure like the pre op stuff and signing all the paperwork and then they do the procedure and then stuff gets sent to pathology and whatever.It's all part of this kind of train going down the track and if you were to object to that or I don't know if you wanted if I wanted to keep my tonsils or something.
30:37
Even just asking that question just kind of like throws everything off like people are like don't know how to.Handle that, because that's not the way things are done.Yeah.And and it actually is probably like pretty unlikely that we would let you keep your tonsils.Yeah, they said.No?I asked.That's gross.
30:53
Why would you?What were you going to do with your tonsils?I'm.Just going to put them in a jar on my my shelf.Oh, that's something my sister would do.That's gross.That's why Darien's the best.That's why she's the best.SO in 2017, there is this question.Should we be maybe getting better consent for biospecimens?
31:12
So I'm going to send you this table right before the changes.These were the options on the board.Will you kind of spell them out for our listeners?Yeah, OK, so on the left side of this table you sent me, it says models, so different types of consent and on the writers description, so starting at the top.
31:35
No consent.Individuals are not approached for permission for research use of biospecimens.So that was the case with Henrietta Lacks, right?You don't need consent.OK, no consent.General notification, which is defined as individuals are actively or passively alerted to the research use of biospecimens and offered an opportunity to opt out or opt in.
32:00
All right.And then blanket consent is?Individuals are asked to consent to all future research with no limitations or conditions.The next is broad consent.
32:16
Individuals are asked to consent to the collection and storage of biospecimens for future unspecified research, which will occur under conditions defined at the time of consent.All right, I think that one the best so far.Are we are we going to rate these?OK.
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The next is categorical consent.Individuals are asked to consent to the collection storage of biospecimens for future research use, and are offered a checklist of options to stipulate by whom and what ways they can be used.
32:48
All right seems pretty good, too.Dynamic Consent individuals are provided with an interactive digital system that allows them to tailor, modify, and update consent choices as their circumstances change.And in response to specific studies, Wow, that gives a lot of power to the the donor there.
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OK.And then finally study specific consent.Individuals are contacted and asked for consent for each research use.All right, so if you were in charge of writing the common rule, knowing what you know about biospecimens, which of these do you like best?
33:29
What's hard about this is that you're trying to balance like logistics and practicality, right?Obviously the most patient friendly form would be the study specific consent, where you are always being asked to use before any use.But also, that seems so burdensome.
33:45
Like, unworkably burdensome, right?Because we don't know, right?Imagine if they had to.You couldn't have imagined what he LA cells would be used for at the time that they were collected.You know, we wouldn't have all those things today if we had only sort of specified 1 research study they could be a part of, right?
34:02
And then, you know, maintaining even just like contact information with somebody for every single time use.Goodness, I actually kind of like broad consent.So broad consent, again, it's individuals are asked to consent to collection and storage for future unspecified research, which will occur under certain conditions defined at the time of consent, I think.
34:24
That feels like a good middle ground.Yeah.Yeah.And a lot of people advocated for that.I will say our friend Tom Tomlinson did some studies where he brought people together.And if you, it turns out, if you just ask people kind of categorically, hey, do you, would you mind if you know if a researcher used your biospecimen to do research?
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And people will generally say, like, pretty overwhelmingly, yeah, that I think that's OK Like I'm not using that thing.I I like to be asked.But you go ahead.However, when you just give them an example of like 10 things that their biospecimen might be used for, like like 10 studies, people get a lot more nervous.
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If you say, for example, Oh yeah, your specimen might be used in research that helps us do in vitro fertilization better in the future or helps us to perform safe abortions in the future.You know, if you're a person who doesn't agree with those things, you might say, Oh no, I would hate for my body to be used to advance that kind of science.
35:20
It gets more like, tricky if you sort of spell out the kinds of things because people just have a hard time imagining right.Your everyday person just doesn't imagine what their biospecimen could be used for.So he had, like, kind of compelling evidence to say, you know, people actually aren't as OK with this as you might think.
35:35
Yeah, interesting. 2017, that was all ignored.None of these consents were.They didn't go with any of this.They kind of went with like a general notification, unless you had a biospecimen that had a complete like DNA profile, in which case you would need consent for that.Oh, interesting.
35:52
So if you were going to collect like the whole genomic information about the that because it's so easily tied back to you, then you would need like stronger consent.But in general, we're just doing like general notification at this point.So you don't you're you're kind of consenting in the sense of like it's part of it might be part of the paperwork, but you probably never noticed it, yeah.
36:08
And is opt in, opt out options mandatory or is that kind of like as?The researcher wants or yeah, I yeah, I don't know that there's any like really specific rule I know today.Like if you get biospecimens, you don't have to go back and get consent to do research on them.
36:26
Or if like you get something that you did consent research for, you can use it later for secondary research.You don't have to go back and get more consents for it.So there's all sorts of like it just doesn't count as a human subject, right.So you get the waiver for these bio specimens, unless of course they so clearly with their whole genomic information tied back to the person.
36:44
Interesting, huh?Yeah.Wow.So I I think based upon that I don't know that Henrietta lacks, well, obviously, like the the manipulation and the deception aside, I don't know.It would be much different, Yeah.
37:00
I'm not sure it really would.I think that that could happen today or at least the collecting of her specimen to use.We wouldn't call them he LA cells because that is not like anonymizing them well enough, right.So we would assign like a number to them probably that couldn't be tied back to any living person.
37:15
So and that's the requirement is you have to de identify them.So not just anonymous, you have to actually de identify like any markers that could be tied back to the person.And if you do that, then there's not anything more you need to do, yeah.So I'm not sure what would be different today.Yeah, interesting.Interesting was, was that point made in Oprah's documentary?
37:35
It wasn't a documentary.Oh yeah, it was like a like a fictionalized.But they didn't talk about that, the common role, you know, I've actually never seen it.Is that embarrassing.I've seen like, clips of it.So our research assistant pulled clips of it for me, but I haven't, like, sat down to watch the entire thing.All right.We'll do that.
37:51
We'll do that, yeah.Sorry, Sorry Oprah, I love you but I didn't watch it.So just as a footnote to this episode, I want to say that Henrietta Alexis family has currently is in a lawsuit with one of the multi billion dollar biological companies, Thermo Fisher Scientific.
38:06
That is been what they claim, like enriched by Henrietta Alexis Cells.There has been a foundation set up for Henrietta Lacks, and her children now have had access to funds that have been raised for her family.But they're they still think that this one company has been unjustly enriched by using her cells and that they should have some say over her cells and access to that fund.
38:27
So there is a lawsuit happening right now, so we'll have to wait to see what happens.It was filed in August of this year.Oh, so just recently, yeah, yeah.I saw a traveling exhibit, I think it was a grandson or some family member was kind of touring small small town libraries and doing like like exhibitions and stuff of family mementos and things that we hosted him here.
38:53
And it was really great.It's really lovely.So such an interesting, complex story with a lot of layers that people have.I think maybe.Really strong opinions that aren't necessarily as informed as we would want those opinions.Well, I often hear this is like, oh man, remember way back when when they didn't care about informed consent and it often gets cast as like an the problem of informed consent.
39:16
The big ethics issue is informed consent.And it might be, but it hasn't changed.Yeah, interesting.Great case.Great case.Devin, thanks Tyler.OK.All right.See you.Bye, bye.Thanks for listening to this episode of Bioethics for the People.We can't do this podcast by ourselves.
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We've tried and it's not pretty.Our team includes our research interns, Michaela Kim, Madison Foley and Macy Hutto.Special thanks to Helen Webster for social media and production support.Our theme music was created and performed by the talented Chris Wright, friend to all, dad to two, and husband to one.
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Podcast Art was created by Darian Golden Stall.You can find more of her work at Darian Golden stall.com.You can find more information about this episode and all of our previous seasons at bioethicsforthepeople.com.We love to connect with our listeners.All of our episodes can be found wherever you listen to podcasts.
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