Medical testing without consent
February 4, 2010 10:01 AM   Subscribe

Isn't consent required for medical testing? I'm having a hard time seeing how this can be legal. Obviously, they can't ask the baby for consent, but surely the parents should be asked?

From the article: "Newborn babies in the United States are routinely screened for a panel of genetic diseases. Since the testing is mandated by the government, it's often done without the parents' consent, according to Brad Therrell, director of the National Newborn Screening & Genetics Resource Center. In many states, such as Florida, where Isabel was born, babies' DNA is stored indefinitely, according to the resource center."

In the future, if these babies are discriminated against for false positives (as in this article), what sort of legal recourse would they have?
posted by to Health & Fitness (22 answers total) 3 users marked this as a favorite
Probably none. When you go in for medical treatment, you don't need to consent to each and every step of every procedure or test that's done. That would be unreasonable. So, when a mother goes in for routine pre-natal care, the physicians do what they always do, and if that includes government-mandated tests, that includes government-mandated tests.

The storage and discrimination issue is tricker, because there really isn't much in the way of good law there. I'm not aware that people have any kind of privacy interest in their genome--particularly if knowledge about it is gained in the course of medical testing--and the law on discrimination on the basis of genetic markers is still largely prototypical and far from uncomplicated.

On one hand, you've got pretty rigorous anti-discrimination doctrines embedded in our constitutional jurisprudence. On the other hand, you've got a culture and a legal system which pays an incredible amount of deference to "science," however constructed, and thus has a very difficult time saying that scientifically verified and justifiable knowledge cannot be the basis for decisions, even unpleasant ones. Anti-discrimination laws tend to focus on unjustified discrimination, i.e. there's no good reason for discriminating on the basis of race or religion, but tend to make room for justified discrimination, i.e. the ADA not withstanding, you can refuse to hire someone in a wheelchair to wait tables because they're essentially incapable of doing the job.

So with the issue of genetic discrimination, all of the nasty discrimination issues, some including race, come back to the fore. Previous arguments against discrimination, i.e. that it was irrational and unjustified, don't really work against genetic discrimination, which is rational and justified. What now?

The answer is that no one really knows. I seem to remember a few states experimenting with some laws about prohibiting genetic testing as a basis for rating health insurance premiums, but that's about as far as anyone's gotten with it. It's all too new, and law develops slowly. Much ink will be spilled about this before we have any good answers here.
posted by valkyryn at 10:13 AM on February 4, 2010 [1 favorite]

Response by poster: Thanks, valkyryn, that definitely helps me figure out what the issues are here...suspected we might be on a legal frontier but didn't know for sure.
posted by at 10:16 AM on February 4, 2010

Best answer: We definitely are. From a different-but-related perspective, part of the research work I do involves genetic testing. Our test results do not go into anyone's medical records, but there's always the risk of confidentiality breach although it's never happened. Until recently, it's been required by our review board that our informed consent process and forms need to include discussion about the fact that should there somehow be a confidentiality breach, in the future someone could be discriminated against in employment, insurance, etc. due to information from this genetic testing.

Mot all that long ago, we were informed that due to the Genetic Information Non-Discrimination Act, it will soon be illegal to discriminate in at least some areas based on results of genetic testing. The review board was still reviewing this new law, figuring out the ramifications, and figuring out what changes they're going to require us to make in our consent forms and consent discussions. But they said there definitely will be changes, and important ones, and soon. I can't imagine that newborn genetic testing wouldn't also be subject to this same law.
posted by Stacey at 10:27 AM on February 4, 2010

Best answer: 45 CFR 46 is the federal code governing research on human subjects which is either conducted by or funded by the federal government. In particular, Sect. 116 spells out requirements for informed consent, and even more particularly, subsections (c) and (d) provide for exceptions to the general informed consent requirements:
(c) An IRB [Institutional Review Board] may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
(1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and

(2) The research could not practicably be carried out without the waiver or alteration.
(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
(1) The research involves no more than minimal risk to the subjects;

(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

(3) The research could not practicably be carried out without the waiver or alteration; and

(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
I'm not clear whether this particular research falls under any of these exceptions, but it at least demonstrates that there are exceptions to the general informed consent requirements. The HHS FAQ on informed consent may also be of interest, and mentions some other exceptions as well.
posted by DevilsAdvocate at 10:29 AM on February 4, 2010

These programs are administered at the state level, so there are 50 sets of rules. For instance, the mandatory law in NY says hospitals have to test "every such infant or child in its care" and only has an exception for religious objections:
The provisions of this section shall not apply in the case of any infant or child whose parent or guardian is a member of a recognized religious organization whose teachings and tenets are contrary to the testing herein required and who notifies the person charged with having such test administered of his objection thereto.
Given that, there is no reason they shouldn't notify parents of the testing.
posted by smackfu at 10:34 AM on February 4, 2010

Also, you might find this article interesting. It's from 2004 and essentially arguing the other side , that not enough testing was done. "Gracie Clay’s mother says her child could still be alive had she been born in, say, Mississippi instead of Georgia."
posted by smackfu at 10:38 AM on February 4, 2010

See, DevilsAdvocate's post is why it's generally a bad idea to quote specific statutes, regulations, or cases on the Green: there's no indication that that regulation has anything whatsoever to do with the issue raised by the OP.

What's being done is not research, and is probably not federally funded. It's diagnostic.

None of us have enough facts to know what laws apply to these facts, and even if we did, it would be inappropriate to try to make such an application in this space.
posted by valkyryn at 10:49 AM on February 4, 2010

Best answer: valkyryn, from the article linked in the OP: "According to the state of Minnesota's Web site, samples are kept so that tests can be repeated, if necessary, and in case the DNA is ever need to help parents identify a missing or deceased child. The samples are also used for medical research." [emph. mine] Also, "According to a study done by the state of Minnesota, more than 20 scientific papers have been published in the United States since 2000 using newborn blood samples."

If Minnesota were using the samples only for genetic testing, you would be right that 45 CFR 46 would not be applicable, but the article makes clear that that is not the case.
posted by DevilsAdvocate at 10:58 AM on February 4, 2010

valkyryn, I think that given that OP seems to have asked for general information on a hypothetical claim a family might have in future and not with reference to any particular present situation, I think this is a question where it is appropriate to take a broader view and give the OP lots of on-topic information. Given that this isn't a case where, it seems to me, the admonishment "Go see a lawyer" is appropriate - because the OP doesn't wish to take legal action or resolve a particular problem - and that you are making just as unfounded conclusions (i.e. that there is no research) as those you criticize, the general "Here are some legislative and news items pertaining to this approach" is probably helpful to OP. Of course, OP, feel free to correct me if I am wrong.
posted by bunnycup at 11:05 AM on February 4, 2010

Best answer: 45 CFR 46 totally exempts from IRB review "Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects." These studies could be covered under that.

But the right to informed consent also exists in the common law, so that's not the end of the story.
posted by yarly at 11:12 AM on February 4, 2010

these issues get discussed in a recent fresh air - 'Henrietta Lacks': A Donor's Immortal Legacy
posted by nadawi at 11:16 AM on February 4, 2010

Response by poster: To clarify: I'm curious about all the ramifications, not just present day, or on a specific case (i.e. I don't have kids, so they wouldn't be subject to my current state law or any other), starting from what I understood to be the case, legally (you have to get consent unless there's some reason not to, such as you've just come in to the ER and you're out cold and they have to treat you but they can't exactly ask first).

I'm also curious because even though I think having a wider pool of samples to draw from is good from a scientific basis, there's some real fear about how our information could potentially be used in a discriminatory way (I didn't know about GINA until this thread!).

And finally, I have a friend who ended up having both children at home after one of their friends were tested for something else without their consent in the hospital -- they didn't want to have their children tested for anything without specifically consenting, which is what this news story reminded me of!
posted by at 11:54 AM on February 4, 2010

I'm wondering if she consented without realizing it ... in the approximately 30 pages of paperwork I signed, initialed, circled, marked, read, and so forth during my preregistration for my son's birth, and then upon arrival for the delivery, I consented to the (state-mandated) heel stick for him that tests for common genetic problems/metabolic diseases.

(I believe in my state you can opt out of at least some of it.)

I've had friends who gave birth at the same hospital indignantly tell me, "I never consented to a heel stick!" And I'm like, "uh, yeah you did, you just got bored of reading the paperwork." Ditto the eyedrops and the vitamin K shot. Not that there aren't places out there that aren't respecting informed consent. But a lot of people simply don't bother to read the paperwork and then are mad about it alter. And at my hospital they literally stood at my shoulder and TOLD me what each page was ... "This is to authorize emergency anesthesia in case we have to do an emergency C-section .... this is to authorize immediate post-natal treatment for your child, including X, Y, and Z ...." And some of my friends STILL didn't recall consenting to any of it.
posted by Eyebrows McGee at 12:19 PM on February 4, 2010

relevant excerpt from the fresh air interview i posted -

GROSS: This might seem a little arcane to people, you know, whether this woman's cells should have been paid for, what kind of acknowledgment she should get. But you point out in your book, we all have cells that are stored someplace. I never really thought of it that way, but is that true, we all have cells that are stored someplace?

Ms. SKLOOT: Pretty much. It's hard to say everybody does. But yeah, the majority of Americans at this point certainly have, very likely have their tissues on file somewhere.

GROSS: How, like why?

Ms. SKLOOT: Well, so there are a lot of different ways that this happens, and one of them is through, you know, you go to the doctor, and you get a biopsy. In a lot of cases, you know, you sign a consent form that says the doctor can dispose of this however, you know, he or she sees fit. Some cases it says you can use this for educational research or research purposes. And that basically means they can take them, store them and do whatever they want with them.

And in a lot of cases, so any child born in the U.S. after since the 1960s, it's a law that you have to all newborns have to be tested for genetic diseases. So everybody gets a little, you know, blood prick, and they test you for diseases, which is great. We need that. It's saved a lot of lives. But then a lot of those samples are often saved. So pretty much any child born since the '60s has gotten has their stuff on file somewhere. Circumcision samples are often saved, you know...

GROSS: Where is all this stored?

Ms. SKLOOT: Oh, there are banks and banks and banks, and there are so many difference places. Some of them are for-profit, some of them are non-profit. Some of them are in hospital basements. The range is really huge. Some of them are just these enormous factories, and the others is, like, some guy's basement, you know, with a bunch of vials in them.

GROSS: And are most of these cells just kind of sitting there, as opposed to being used for research?

Ms. SKLOOT: We don't really know. A lot of them are being used in research. Some of them probably aren't. This is the thing. It's just this is something that's been sort of building for a long time, and it's only recently scientists are starting to sort of say wow, you know, these fetal blood samples are this incredibly valuable resource. We should create these banks and sort of start maybe being a little more organized about it.

It's interesting, there's actually over Christmas, a lawsuit - there's a lawsuit, actually two of them, one in Texas and one in Minnesota, where some families found out that their children's fetal blood samples had been stored and were being used in research, and they sued the states.

So over Christmas, a court actually ruled in favor of these families in the state of Texas, and the state of Texas had to destroy over 5.3 million samples taken from kids, you know, and stored for research without their knowledge or their parents knowledge.

And that is huge. That's never happened before. No court has ruled in favor of the tissue, you know, quote-unquote, donors in any case like this, and having the result be we're going to destroy all this stuff very sort of quietly.

I mean, literally, I don't very few people even seem to notice that this happened is a bit disturbing, I think, on the larger scale for scientists, right. So one of the big fears and one of the reasons this whole issue of how should we deal with consent and property rights and those things with cells, one of the reasons it hasn't been dealt with for so long is because it's so complicated.

And what my reaction to that Texas thing was, I saw that and thought uh oh, if we start having state-by-state rulings like this, where one state destroys 5.3 million in one part of a state, you know, and state by state we start having these things happen, it's sort of preempting this larger discussion of what to do with the samples and how to do this in a way that isn't going to hurt science but will also protect the people.
posted by nadawi at 12:23 PM on February 4, 2010

Best answer: DevilsAdvocate, you aren't reading the regulation properly. You cited subsection 46.110, which has to do with "Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research." This isn't actually relevant to the OP's question at all, as far as I can tell.

But more to the point, the relevant part of this regulation isn't subsection 46.110, but 46.101, which you didn't cite, and which defines the scope of the section. Specifically, 45 CFR 46 is strictly limited to research on human subjects. Which is not what's being done here. As such, the regulation you cited is completely inapplicable, regardless of the purposes to which these samples are being put.

As such, your answer--and all discussions of it--are misleading. That they have been marked as "Best Answers" is precisely why this approach is a bad idea and why most lawyers on the site tend not to do this.

bunnycup, you're right, this isn't really a "Go get a lawyer" question, and I'm completely on board with links to relevant news articles and relevant discussion. The mention of the existence of the Genetic Information Nondiscrimination Act is a good addition to the discussion, as it indicates that Congress has in fact considered this issue.
posted by valkyryn at 12:38 PM on February 4, 2010

When we took a labor & delivery class in the fall before our baby was born, we were told that they do three standard things right when a baby is born (Sibley hospital in DC):

1. They apply antibiotic eyedrops,
2. The give a shot of vitamin K,
3. They take blood for those genetic tests.

The doctor who taught the class told us we were free to refuse any of them. My impression was that we would have had to fill out paperwork to refuse the tests and treatment.
posted by davextreme at 12:45 PM on February 4, 2010

I gave birth in a Massachusetts hospital last spring, and we were given a whole pamphlet of information about what kind of tests are done, how the blood is drawn, etc. We had to sign a slip giving permission, and we also agreed to let the state test for some extra genetic conditions that weren't on the regular state panel. I can't remember if declining was an option, but I think it probably was.
posted by sutel at 1:00 PM on February 4, 2010

Just to clarify, (at least here in Washington state), they are not sequencing genomes here, they are running specific tests and then storing the leftover sample, so it's a bit inflammatory for CNN, though technically accurate I guess, to talk about government banking of your baby's DNA. They're blood samples.
posted by Slarty Bartfast at 1:08 PM on February 4, 2010

DevilsAdvocate, you aren't reading the regulation properly.

valkyryn, you aren't reading my answer properly. You appear to have missed the part at the end where I said, "I'm not clear whether this particular research falls under any of these exceptions, but it at least demonstrates that there are exceptions to the general informed consent requirements."

Specifically, 45 CFR 46 is strictly limited to research on human subjects. Which is not what's being done here.

I assume you're drawing the distinction between research on human subjects and research on biological materials taken from human subjects? If that's the case, you're right, I had overlooked that distinction.

That they have been marked as "Best Answers" is precisely why this approach is a bad idea

By "this approach," you mean citing specific regulations, the same way you cited 45 CFR 46.101?
posted by DevilsAdvocate at 1:11 PM on February 4, 2010

Specifically, 45 CFR 46 is strictly limited to research on human subjects. Which is not what's being done here

If the DNA sample is being collected for the purpose of research, then the collection would definitely be covered by 45 CFR 46. Here's some guidance from HHS's Office of Human Research Protection, which enforces 45 CFR 46.
posted by yarly at 1:47 PM on February 4, 2010

Yes, but there is implied consent in some cases and verbal consent in others. In certain circumstances written consent must be obtained. (IANAL.)

Don't know anything about the holding onto of the genetic information, but these are diseases you would definitely want your child tested for. Example: phenylketonuria (if not put on the special diet, your child can have profound mental retardation) and congenital hypothryoidism (if left untreated causes cretinism).
posted by gramcracker at 3:05 PM on February 4, 2010 [1 favorite]

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