On the plane ride back from Italy I started reading The Immortal Life of Henrietta Lacks. Since I've been back, I've progressed all of 5 pages further, not because I don't like the book, but because there's too much freaking stuff to do! Anyway, I would recommend it. It reads like fiction, AND you might actually learn something.
Win, win!
One of the things that struck me was how the author talks about her consent procedure, and how awful it was. Now, a lot of other scientists at the time really were horribly unethical. However, from what people say, the real problem with Ms. Lacks's consent procedure was that it was poorly documented. She was asked/told about donating her cells, and she agreed, according to them. What seems to be the problem is that nobody else in her family really understood what was going on. Which is a real problem. I just don't know that all the consent procedures we have in place now actually prevent that from happening today. We're just better at covering our asses as researchers.
I bring this up because of the following:
In my labor and delivery consent form, all it talks about the entire form (all 11 pages of it -- I'm serious) are the complications that can happen during labor. And then, right before you sign your life away there is the following 3 line statement:
I understand that during this procedure, certain of my tissue(s), bodily substances and/or fluids may be removed and used, disposed of, or transferred by the University of X Health System for educational and research purposes not specifically related to my treatment.
Nowhere else in the document is research mentioned.
And you know? I found that to be pretty unethical. I DO research, for Christ's sake, and I'm all for expediting the process, but I can tell you for a fact that the IRB would want consent from my research subjects to use their body parts for any study, and that the specific studies they could be used for would have to be specified.
I also found it unethical that this was mentioned only at the end of an 11 page consent form which most people probably do not read, and many people probably do not have the literacy to make it through. Nobody went over the consent process with me verbally, nobody was available to answer any questions I might have, and nobody ever verbally mentioned research to me.
It's a giant fail as far as I'm concerned, and borderline coercive. If I don't sign away this right, are they going to refuse to provide me care? There's no place for me to even initial that I agree or disagree with this particular clause. It's not that I would definitely say no to the use of my tissues for research, it's that I want to know what they will be used for. They are my body parts, and I SHOULD know that.
Anyway, does anyone have any thoughts about this?
30 Pearls of Wisdom:
I agree and find that part of the consent unethical and CREEPY. I think the part about the research needs a whole consent form of it's own so you know what the University is/isn't allowed to do and how your tissue will be handled.
I have never thought about it (and I'm sure I've signed forms just like yours), but now that I do I feel you have and excellent point. It just seems wrong.
I need to think about this some more. Thanks for bringing it up.
-Having done studies that relied on exactly this clause, the rational is as follows: as long as the samples are deidentified (meaning that no one could ever link the subject to the sample, no code sheets are retained, etc), there is no "risk" to the subject from further research. Since there is no risk, no further consent is needed.
-As you know, consent forms cannot be altered by subjects because they are IRB approved. This means that subjects either consent to the entire form, as written, or they don't. If an investigator wants to write a new form then they can, but usually the language you describe is "standard" and present in all operative/procedural consent forms.
With those two things said, I agree with your discomfort. As the HeLa and other stories show, this is highly prone to abuse by avaricious research departments/institutions. But what can we do? The courts have spoken ...
If you haven't read Rebecca Skloot's article "Taking the Least of You" (I dont know if its in the book or not) ... then I linked it here for ya
Best,
TS
Hon, You are aware I do clinical research for a living, right?
This is NOT an IRB consent form. This is a consent for a surgical procedure. There is no study number associated with it, and no way for me to contact the IRB if I have questions. There is no descriptions of the possible risks or benefits of "participating," and even if these ARE minimal, they are required to be present on ANY research consent form.
If they want me to "donate my tissues to science" then I'd better be able to see what that actually means. Otherwise, I will be transferring my care to a non-teaching hospital. I don't give a fuck what the courts think.
Your logic would mean that I cannot opt out of having a medical student deliver my baby, that I cannot opt out of research, and that I cannot opt out of any procedure listed on that form, since that is also all part of the boilerplate language. Isn't that kinda the opposite of what you said in your last comment?
You also should be careful when you throw around phrases like "no risk." The risk of confidentiality loss is considered a real risk and is taken incredibly seriously by every IRB that I have ever worked with.
You are not powerless here, even though the way the form has been presented to you makes it seem as though you are, because you've still got some time before your delivery.
You have two possible lines of action. One is just to strike through the paragraph you don't like, put your initials in the margin, sigm and date the form and send it back. Even if the hospital notices the change, it may not be a problem for them. And if it is, their choice at that stage is to say "if we don't get your cells we won't treat you", which is going to look pretty bad for them.
Alternatively, discuss the form and the consent requirement with the person who sent it to you. If that person doesn't have the power to agree your required changes to it, get them to find the person who does have that power.
Good luck.
I'm really thrown by that clause. And disturbed. My son was in a teaching hospital, and we were presented with any number of studies and procedures, all of which had consent forms. Those for the studies were explained in detail.. what the risks/benefits were, exactly what research would be done with the samples or information, and questions were addressed.
As for procedures.. after an incident with a resident that we did not care for, we were asked if we wanted to disallow students in partaking in Hunter's care. We were offered the OPTION of participating in studies, but were also told that participation (or lack thereof) would not affect the standard of care, or level of attention he would receive.
If I'd seen a clause about tissue being taken for research.. not told what type of research (not that I would refused based on its usage, but because I really care what's being done with my or my child's body parts).. or not been given the option to refuse.. I'd be taking my ass (or my son) to a different medical establishment. The end.
Hunter's Mom -- Exactly! I am completely ok with participating in research, I just want to know what it is, have the risks and benefits spelled out for me, and know what steps the research team is taking to mitigate these risks. If they want to keep my tissues for a tissue bank or disease registry, then I'd better be signing a consent form that says that, not a consent form that says they can do whatever they want to my tissues.
The medical establishment has a long way to go in improving trust with its patients, and this clause does NOT help their cause.
Yeesh! I clearly struck a nerve here. Since it wasn't entirely clear, I'll clarify now: I was explaining, but NOT defending, the rationale for using that language in your form.
I did mis-state the term for this type of study. It is "minimal risk", not "no risk".
You may transfer your care to a non-teaching hospital, but that wouldn't change your control over "your" tissues/samples (even non-teaching hospitals can still have research studies ... and even medical students ... I've seen/experienced both). I agree with your concern over the tissue-donation language, which is why I linked that article since it explains the back and forth better than I can. It will make you angrier than you already are.
Also, I think you misunderstood my point about consent forms, whether IRB approved or not. You absolutely have the right to express any preferences about your care and may place any restrictions on your care. That includes barring students from your room, refusing blood products, refusing anesthesia, refusing an episiotomy, refusing laceration repair, or anything else you would like to refuse.
HOWEVER, my understanding about consent forms is that a patient cannot "opt out" of consent forms by crossing out lines that they don't like.
If you wish to "opt out" (meaning to express restrictions on your care), we were taught to tell our patients to verbally instruct your health-care providers to document restrictions in the chart note and/or provide them with a legal document that expresses any wishes/restrictions. That is what I would recommend that you do, instead of crossing out parts of a form.
If you have complicated restrictions on your care, then bring a legal document with you to each physician's office visit / to the hospital when you deliver that clearly states your restrictions.
I did a really basic IRB form (for a questionnaire with no identification of respondents, no names on the questionnaire) and had to give each a copy of a letter explaining the study, and making it clear they didn't have to participate and that choosing not to participate wouldn't be a problem in any way.
This isn't an IRB thing, this is a sloppy "maybe I want to do something later" thing.
I hope you can change the terms to suit your needs better.
This is old (BMJ, 2000) but, to quote the authors, "Many believe that the transplant and donor pool would shrink if the commercial potential were realised by the public."
http://www.bmj.com/content/321/7262/658.6.full
In the case of Henrietta Lacks, most of the researchers and clinicians involved with her case seemed to have the best of intentions (really!). No one could have foreseen HeLa cells would be so useful, and profitable. It also wasn't, and still isn't, possible to predict every potential use for a patient's tissues; for example, no one in the 1950s was thinking about studying AIDS. That's one reason you may receive little or no information re: potential uses for your tissues.
It's a special irony that many of Henrietta Lacks' surviving relatives are uninsured and unable to afford health care. I don't blame them at all for feeling abused.
BTW, I think you should transfer care. You seem to have many objections to the compromises one is asked to accept at a teaching hospital.
Outrider -- Re: Henrietta Lacks, perhaps you should re-read the second paragraph of my post, because we appear to be in agreement.
The issue is not with research per se (how many times do I have to say this), but with the language that is used in this form. If they want to be able to use my tissues (or medical record for that matter) because I go to their hospital that is completely fine with me, HOWEVER they need to state in an up front manner what they intend to do with my information, what the risks and benefits are, and at least some of the possible uses (I am aware that not everything is forseeable -- no shit). What they did is shove a 3 line clause in at the end of a procedural consent form that did not cover 1/10th of what they're supposed to for a research study. It comes across as sketchy. Plus, one of the benefits of participating in research is that you know that you're doing it. In this case, I would never know, so there really are no benefits, only risks.
Don't make me roll my eyes at you. Normally your comments are more productive than this.
This is a really interesting post and resulting discussion. In my previous life, I worked in a research lab that used placentas/umbilical cords for research, and this was an issue that we had to grapple with. I don't remember all of the specifics of the situation, but ultimately it was decided by the ethics board that the usual consent procedures (i.e. patients signing consent to participate in a specific study) were not required because 1) the placentas/umbilical cords were considered "medical waste" (unless requested by patients for their personal use); 2) there was no way of connecting the placentas/umbilical cords to the individuals involved; and 3) the research being done fell within what would be considered "ethically acceptable" by the majority of the population. As a result, women delivering at the hospital signed very similar consent forms to the one that you're being asked to sign. They did have the option of not allowing their placenta/umbilical cord to be used, and there were a few women who chose that option.
It is a worthy ideal to want people to be able to review and approve any studies in which their tissue may potentially be used; however, if this is the standard to which we want researchers held, we need to recognize that this will create limitations for medical research. At the time that specimens are collected, it is often difficult or impossible to anticipate all of the studies that may be conducted on those specimens. A good example of this is tumour banks - at the time that tumour samples are being collected, we can't possibly know all of the different DNA sequences/proteins/etc. that researchers may in the future want to investigate in those samples. If we demand that researchers get approval for all studies on human tissue samples, then we limit the ability of researchers to go back to resources such as tumour banks and investigate molecules that are discovered after the tissues are collected.
It's my belief that it's in the best interest of society for researchers to be able to use anonymous tissue samples, even without consent from patients for a specific research project, as long as the research is approved by an ethics committee and considered to be ethically acceptable by the majority of society. (For example, testing for the presence of a molecule in breast cancer specimens would be ethically acceptable by the majority of society; cloning cells from someone's breast cancer specimen to use for breast augmentation procedures would not.) That being said, I recognize that not everyone in society shares this view; however, I think it's important for people who feel differently to remember that there is a cost in terms of knowledge and research to limiting access to tissues.
SD -- The thing is, I am ok with my tissues being used for research, and potentially also to be kept in a tumor bank for research to be done in the future. You are completely correct that it is impossible to anticipate all future studies, and in fact the NIH is interested in funding research on what is the most ethical way to consent subjects to these sorts of things.
However, it is clear to me that having a 3 liner at the end of a procedural consent form does not come across as transparent (my husband was equally taken aback by its language -- I didn't even mention it to him before he read it), there should be an opt out (there is not on this form), and really? How hard would it be to have a consent form for participation in a tissue registry with transparent language stating that your tissues could be used in future studies, and that the hospital would not have to inform you of those studies, and that you would not benefit in any way? If your logic is correct, that most people would not object, I don't particularly see the problem with having a form like that. If your logic is NOT correct -- and many people really would refuse to participate -- then that makes me think that we really do need to have a form like that.
I agree totally with your point about the language on the form. If I remember correctly (and I'm going back years and years in my memory, so I may not have the details perfect), at my institution we had a two-part system for dealing with consent to the use of tissues. The first was a one-paragraph statement about tissues potentially being used for research and about patients having the option of not contributing their tissues. The second was a longer document that actually outlined the research that was currently being conducted using the tissues, along with a statement that other research projects not included in the document may also use the tissues currently or in the future. I think such an approach is a good way of informing patients of the research that is being conducted and the reason for needing tissues without creating too many barriers to research. A nice compromise, if you will.
What exactly counts as "educational" and "research"? Does training a new lab tech count as "educational" and otherwise not permissible if that line isn't there?
Is this a sneaky way to jack your stuff or a you-never-know CYA?
Colin -- I think it's written to be intentionally vague so as to provide the broadest protection possible to the University. But yes, this is part of the problem I have with it. Literally ANYTHING could fall under "education" or "research."
>>one of the benefits of participating in research is that you know that you're doing it. In this case, I would never know, so there really are no benefits, only risks>>
What's the risk, if you aren't being subjected to procedures purely for the sake of research and your privacy is safeguarded? I'm quite certain HIPAA applies.
As for benefit, there's likely none, other than that warm, fuzzy feeling of contributing to the greater good.
Consent forms are written by attorneys. The purpose, as you've said, is to cover the hospital's @$$. This is also the reason they "slip in" that phrase about students being involved in patient care, and probably other disclaimers to which some (maybe even you, or I) might object. The problem is, true informed consent takes time, and time is not well-reimbursed. True informed consent may not even be possible, but that's a topic better-suited for a thick text than a comment on a blog.
You don't like it, but that's how it's done. This is what it's like to be a patient.
BTW, in veterinary medicine, it's considered malpractice to conduct a necropsy without the owner's consent, in the absence of a valid public health threat. Of course, it's legal to sell animal tissues. Hamburger, anyone?
We actually had a discussion about this book (was required reading) about the ethical nature of the book.
Everyone agreed that at the time the physicians and researchers hearts were in the right place. I do not often use ignorance as a crutch, but in some ways it is a little understandable. It was most likely left vague because they had not encountered their first lawsuit which would invariably cause them to tighten up their language.
Although I think if you mentioned that this occurred in the early 1950s, peoples comments in this post would change.
They would change even more so if they read the book.
That being said, I consider this a must-read for anyone in a health care profession. It is something that we can all learn from and it is surprisingly touching. The care and patience the author took in explaining the situation to her children is astounding... and sad at the same time.
Outrider,
Actually, that's not how informed consent for research on human subjects is done. Your comment suggests to me that you don't have a lot of experience with human subject's research.
Your post struck a chord: On going for my 8 week scan here in South Africa the 'consent form' told me that the company would automatically send all results to the medical insurance company (non-optional), though I had to specify that they be sent to my doctor.
The fear of my medical insurance company refusing to pay -- the receptionist informed me that if I refused to sign because of that clause she would then have to call the insurance for special approval -- meant I didn't stand up for my rights and just signed it. This isn't just a theoretical problem: a family friend being treated for stage IV lung cancer was just cut off by her medical insurance because the CT scans showed that after 5 months of chemo the tumours were the same size -- though no growth.
No, I don't have much experience with research involving human subjects. Perhaps this is why we're splitting hairs here, because I suspect we agree more than we disagree. I am under the impression that consent requirements and procedures would probably differ for patients participating in a specific research project (scenario A) vs. patients who sign a general consent form such as the one presented to you for your labor and delivery (scenario B). This doesn't surprise me, but then again, I don't work in human research.
For example, If Henrietta Lacks were alive and undergoing treatment today, she'd have signed a consent form similar to the one your physician presented to you (scenario B), *unless* she were formally enrolled as a subject in a research project (scenario A). One huge difference: today, her family never would have found out how her tissues had been used, because laws protecting patients' privacy are more comprehensive nowadays.
Am I correct?
This is not to say I don’t find scenario B mildly disturbing, especially since I’ve signed such a consent form myself, at a non-teaching, non-research hospital.
I think if Henrietta Lacks's situation happened today, probably her consent process would have looked a lot like the researchers say it did then. Meaning that they probably would have consented her above and beyond the generic consent that they made her sign to have the procedure. Only, she would have had to sign a bunch of papers which, as you point out, would have given her family zero legal recourse. It's possible that that just the generic consent would have been used, but I think enough people today would take issue with that (even if technically it covers what the researchers did), that they probably would take the extra step to consent her fully.
There is actually quite a bit of debate regarding how to consent patients to participate in tissue banks. I am told there are several RFAs out for research on this. Believe it or not, human subjects research protection is a HUGE field for research. My mentor did his entire dissertation on it.
To go into a bit more detail about the consent process for research, typically the subject is handed a 4-8 page document that describes the study, the risks and benefits (including things like loss of confidentiality and the benefit of feeling like you've potentially helped someone in the future), how any risks will be mitigated, and who you can contact if you have any questions or concerns about the study. The research coordinator goes through this painstakingly with each subject (at least they're supposed to), and if necessary reading it to the subject, answering questions along the way.
Now, I'm definitely not proposing such a process for a surgical consent form. However since that is what I am used to when I consent subjects for my studies, I was a bit taken aback by the three liner tucked at the very end of the form basically asking me to sign my rights to everything away. That's all. Like I've said, I'm happy, thrilled, etc. to participate in research, even a tissue bank where my tissues may get stored for future use. I just feel that I ought to be able to opt out and have it not affect my care, and that I should have a little more information than three lines that do little more than absolve the university of responsibility.
So, you're probably right, we do agree. No hard feelings, ok? You're one of my favorite commentors.
:-)
Also, giving it more thought, I was too hasty in my declaration that I would transfer my care. Frankly, given liability insurance in PA I don't think there's a single non-academic hospital that delivers obstetric care (perhaps I could go to NJ?), so even if I wanted to avoid it I couldn't.
I would cross out and inital the section(s) you disagree with. I doubt poeple at the hospital look at it either.
Now I need to go find my form and read it again---I remember reading through the entire thing with my last pregnancy and getting thoroughly freaked by all the possibilities despite the fact that I was intellectually well aware of them. But I do not remember anything about research. This time I just signed it and handed it back in the office. (By the way, last time, I had to sign it again at the hospital...so the whole process is really just so you have a chance to read it. The practice I go to is huge, and affiliated with a huge hospital and all outpatient stuff is on EMR(not sure if hospital is fully EMR or if a hybrid). Its not like they are going to deliver my consent form to the OB ward and hunt it down when I show up.
I did have another sketchy consent experience during this pregnancy---I went for my genetic counseling/13 week US/bloodwork appt. First I was sent to the genetic counselor, who asked me if I wanted to participate in a study that would look at certain aspects of my US & some markers in blood & correlate to delivery outcomes. She didn't go into details or give me anything to read or sign; I figured I'd be given that by the maternal-fetal medicine team that did the US. She slapped a sticker on my chart saying "study". At the US they mentioned they were taking additional pics for the study, and they drew an extra tube of blood. I realized after I left that I never signed anything or got any more information. I happened to be taking a class on research ethics taught by an administrator in the University IRB---so I talked to her about it nd she suggested I talk to my OB provider (clearly she hadn't BEEN to this practice, there are 20 providers and you may see a different one each time....my next appointment wasn't for a month, with a nurse practioner). Long and short, I never figured it out, and I honestly was too busy to make a stink about it, but I know it was done inappropriately.
As for your consent...I also learned in this class that it is standard to have some clause on all consents at our teaching hospital about your info being used for education/research---it allows your info to be used for chart reviews of de-identified data. But I agree completely that the part about using TISSUES seems way beyond that, and should at the very least, be a separate & optional signature.
I'm not sure what the proper way to deal with it is, if you do want to opt out. If you don't get anywhere with the practice, you can always contact the IRB.
Ana -- That is really sketchy, with the genetic counseling study. I also really appreciate your thoughts on this. And I agree -- medical records are entirely different from tissues!!
I think the interesting question is - if you crossed it out would it matter? Since this is a standard form, My guess is that unless you took your placenta away(really the only thing from birth that we'd be talking about), it's numbered and would still end up going to studies because 99.9% of people consent. I bet that unless you asked for it to be kept, I would go into the huge Bag-o-placenta's in research anyways.
Just me -- I think you're probably right.
I loved that book.
One of my old attendings was doing some fascinating research on placentas and how the sometimes waywardly migrating tissue was linked to vascular malformations at birth. She is no longer at our pediatric institution - having long been recruited away by the AVM greats.
I hate grossing in placentas - they are a bloody hell of a mess - would gladly donate them to research, if researchers were actually interested in them (most are not).
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