Biology/Medical Question: Harvesting from humans--legal?

soapdish

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So what kinds of body fluids, tissue, misc. substances are you *not* legally allowed to harvest from humans? Or is it a case of--with permission from the person, scientists can take anything they want?

It seems like just when I think “ok, scientists can’t possibly obtain that legally” I find some information online that says “oh yes they can”.

Acquisition of everything from cadaver tissue, organs, semen, breastmilk, stem cells, bone marrow, blood, plasma, even pituitary gland extract (though I don’t think this is allowed anymore--I can’t be sure) is gathered from humans for one purpose or another. I am sure I am leaving out some here too--any additions to this list? I am open to exploring them all.:)

I understand that even with the legally obtained things, there is often a question of ethics/religion etc.

And I think that even though obtaining things with permission may be legal, how the substances are used can be illegal. For example scientists can run tests and experiments and even give the substances to rats legally, yet it would be illegal to perform the same tests or give the substances to humans until approved by the food and drug admin. Is that right?

I am also pretty sure that even if legally obtained/harvested, the reselling of body fluids/substances for recreational purposes would be illegal, correct? That seems like a no-brainer to me.

Cheesy Example: Doctors can obtain human blood for a blood bank, but can’t turn around and sell it to the public as a beverage for example. (Or at least I am pretty sure you can’t do that--though it never ceases to amaze me what we are and aren’t allowed to do legally :Shrug:).
 
My problem is that, in my current WIP, I am working with a company that is harvesting a substance from humans and selling it on the black market (I know the reselling part is illegal). I just can’t figure out if how they are getting it is illegal, or just unethical and taboo.

They are obtaining it with permission from live people. No one dies in the process of donating and in fact people are lining up to volunteer because the process of harvesting is pleasurable.

I just can’t determine whether this can be done on the surface with the world knowledgeable about it (under the guise that the substance is being used for research in treating diseases). Or if it is a case where all happenings need to be done underground and hidden from the public.

Hope that makes sense? If you need me to clarify anything please let me know. Any help or direction would be greatly appreciated!!!:)
 

dolores haze

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They are obtaining it with permission from live people. No one dies in the process of donating and in fact people are lining up to volunteer because the process of harvesting is pleasurable.

I doubt it's pleasurable, but donating human eggs can be quite lucrative.
 

Kitty Pryde

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I wonder what human substance is pleasurable to harvest... ;)

Seriously, though, while it's illegal to pay for organs, some fluids can be paid for. Sperm donors and plasma donors receive money in the US. And egg donors too. Surrogate mother get paid to carry a child in their womb, but it works out so the child isn't "sold" to the birth mom.

FDA monitors blood and tissue stuff, and there are regulations for all of it. Some are approved and others are not--if unapproved, you can't put them into a person. FAQs:http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/QuestionsaboutTissues/ucm101559.htm
 

veinglory

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A person and their family can donate any part of the body they wish. However collection could be illegal if done against the wishes of either, or from a person whose tissues would be an unacceptable risk to anyone receiving them (for example due to communicable disease). It is also illegal in most cases to pay an amount above "cost".
 

2Wheels

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I think you can certainly set it up under the guise of legitimate research. The perps could be a pharmaceutical/biotech firm who are going to fund a university researcher. The whole research protocol is drawn up, sent for ethics board review etc. The pharma bunch get to use university medical personnel to "collect", and can give a portion of the donation to the researcher for their seemingly ethical study, whilst retaining a portion "for future related research/study". It's the retained portion that could be filtered off, depending on the volume required.

It does kind of depend on WHAT it is that's being donated, who's collecting it, and who's responsible for processing/storing it etc.
 

semilargeintestine

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I wonder what human substance is pleasurable to harvest... ;)

Seriously, though, while it's illegal to pay for organs, some fluids can be paid for. Sperm donors and plasma donors receive money in the US. And egg donors too. Surrogate mother get paid to carry a child in their womb, but it works out so the child isn't "sold" to the birth mom.

FDA monitors blood and tissue stuff, and there are regulations for all of it. Some are approved and others are not--if unapproved, you can't put them into a person. FAQs:http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/QuestionsaboutTissues/ucm101559.htm

It's not entirely true that it's illegal to pay for organs. It's illegal to sell your organs to someone, but it's not illegal to be compensated by an organisation to cover the costs of the surgery and recovery.
 

soapdish

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Thanks guy!
Helpful info so far.

Dolores-eggs--yes that's one I missed, thank you! I am pretty sure it's not pleasant to donate many of the things on my list--but that one does make my ovaries hurt a little. LOL

KittyPryde
I wonder what human substance is pleasurable to harvest...;)
Not that substance, :tongue but yes, the act to obtain it is the same (at least one of the acts, there are a couple of other less dirty ways too). But you are on the right track.
Thank you for the link too--that is tremendously helpful.
Sperm donors and plasma donors receive money in the US. And egg donors too. Surrogate mother get paid to carry a child in their womb, but it works out so the child isn't "sold" to the birth mom.
Yeah, but I am not concerned about whether the donors are paid--that's the best part about what I am trying to set up, they don't have to be paid, they are lining up to do it for free. In fact, the goal is for them to turn around and buy the refined product back from the company they are donating it to.

The best example I can think of (though not illegal) is one that I used to encounter in landscaping. We'd clear out a bunch of yard debris from a client's property, haul it to a topsoil place where they'd refine it and turn it into soil/mulch etc. We'd pay them to "dispose" of our debris and then, in the very same trip, we'd buy a truck load of mulch for another project on our way out. We didn’t buy the exact same debris back from them, but pretty darn close (I bet we bought bits of the debris we sold to them the week before).

This has always fascinated me and I am trying to illustrate the same thing, but with the human body.

However collection could be illegal if done against the wishes of either, or from a person whose tissues would be an unacceptable risk to anyone receiving them (for example due to communicable disease).
You raise an interesting point here, veinglory. I have considered this, though I think in my case the substance wouldn't actually carry that risk. However, what could be along the same lines is that by giving it to humans it could cause other bad things to happen (like insanity, depression and numerous other things). That alone would probably be enough to make what they are doing illegal. Especially if they don’t stop once they discover the side effects.
 

veinglory

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There is also the case that, at least in New Zealand, you may not own a body, you may only use a body for ethically valid reasons under government permit, and you may not use a body for profit. Thus a purely commercial application would not be legal. I suspect the same is true in the US.
 

Kitty Pryde

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KittyPryde Not that substance, :tongue but yes, the act to obtain it is the same (at least one of the acts, there are a couple of other less dirty ways too). But you are on the right track.
Thank you for the link too--that is tremendously helpful.
Yeah, but I am not concerned about whether the donors are paid--that's the best part about what I am trying to set up, they don't have to be paid, they are lining up to do it for free. In fact, the goal is for them to turn around and buy the refined product back from the company they are donating it to.

The best example I can think of (though not illegal) is one that I used to encounter in landscaping. We'd clear out a bunch of yard debris from a client's property, haul it to a topsoil place where they'd refine it and turn it into soil/mulch etc. We'd pay them to "dispose" of our debris and then, in the very same trip, we'd buy a truck load of mulch for another project on our way out. We didn’t buy the exact same debris back from them, but pretty darn close (I bet we bought bits of the debris we sold to them the week before).

This has always fascinated me and I am trying to illustrate the same thing, but with the human body.

I am simultaneously intrigued and revolted, so kudos :D

But yeah, if you are selling this mysterious human substance to people (bleargh), the FDA would oversee it. (OTOH, I work in an industry that's overseen by the FDA, and they are ridiculously understaffed and they can only regulate the most serious infractions. It's kinda plausible that if the whole business was sort of on the downlow, the FDA might not crack down on it.)
 

soapdish

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I think you can certainly set it up under the guise of legitimate research.
OK, good--so that’s what I have done already. In fact it was originally set out to be legitimate research, but then they discovered a few other things that looked more lucrative.
The perps could be a pharmaceutical/biotech firm
Yep, they are.
who are going to fund a university researcher.
Interesting. OK, I can work with that, definite potential there.
The whole research protocol is drawn up, sent for ethics board review etc. The pharma bunch get to use university medical personnel to "collect", and can give a portion of the donation to the researcher for their seemingly ethical study, whilst retaining a portion "for future related research/study". It's the retained portion that could be filtered off, depending on the volume required.
Ok, this sounds perfect. I have already established an ethics review committee of sorts that sits on the company’s campus, but are outside consultants. With a few tweaks I could probably weave in the university angle.
Thanks 2Wheels!
 

soapdish

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Answers sprang immediately to mind, but none suitable for an all-ages board...
Maryn, creative like that
:roll:Trust me when I say it's been very fun scary researching.

I am simultaneously intrigued and revolted, so kudos :D
Cool. Hopefully readers will be too. My favorite things to read are the things that simultaneously squick me out and draw me in for more, so that's what I am hoping to achieve. Thanks for the tip on the FDA. Could be useful.:)

It's illegal to sell your organs to someone,
So with this in mind…here is another dumb question from me: Is it illegal to sell your body fluids to someone? Not a medical firm or in the name of research, but just sell it to another person because they want it?
What about fingernails? (to pick an abstract thing) I know that sounds weird, but I am being serious. Are these things just gross or actually illegal?

Would it only be considered illegal if the recipient would be in danger of contracting a communicable disease? Would this mean that in order for it to not be illegal, all you’d have to is make sure to go through the proper channels? Like being compensated for donating blood--technically you are selling your blood to someone (because there is an end recipient) but you just have to send it through the proper channel?
 

katiemac

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I know this isn't exactly what you're talking about, but companies are patenting gene sequences. They can't patent the actual sequence, but they can replicate it and then patent the replica.
 

soapdish

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I know this isn't exactly what you're talking about, but companies are patenting gene sequences. They can't patent the actual sequence, but they can replicate it and then patent the replica.

Actually this is pretty helpful. Based on what you said, I went off in research mode again--looking into Gene Therapy and Hormone Therapy. Fascinating stuff and probably closer to what I am interested in.

So I guess, based on what I have read, scientists can harvest blood, organs, body fluid, eggs etc. and inject/transplant it all into humans legally (as long as it’s done with permission and under FDA guidance).

But what about genes and hormones? Can they inject the real-deal human hormone into another human? Or can they only replicate or make a synthetic version and give that to humans?

When you go through estrogen replacement therapy--you are getting a synthetic estrogen, right? Why can’t--or maybe I should say, can you, be given someone else’s ACTUAL estrogen? And if you can’t, why not?

I am so lost in research...at this point I think I am going to have to set my novel in the future just to have ways to explain why things can or can’t happen---or I am going to have to add a supernatural element so “magic” can solve all my scientific plot holes. LOL :D
 

katiemac

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I'm doing a bunch of genetic research myself, but haven't really delved into hormones yet. Human growth hormone is on my list to research next, though.

But what about genes and hormones? Can they inject the real-deal human hormone into another human? Or can they only replicate or make a synthetic version and give that to humans?

When you go through estrogen replacement therapy--you are getting a synthetic estrogen, right? Why can’t--or maybe I should say, can you, be given someone else’s ACTUAL estrogen? And if you can’t, why not?

There is no such thing as nonsynthetic hormone replacement, as far as I know. Whether it's physically impossible to injection someone's real hormones into another human, I don't know. (Rejection rates and whatnot.) But my guess, and this is PURELY a guess, is that an unbalanced hormone level (depending on the hormone) can seriously screw up a person, so trying to harvest hormones from a person may be dangerous to that person. I don't believe hormones replenish as naturally as, say, blood, but I may be wrong there. But it seems like if you took enough hormones from someone to be helpful, you'd have to give that person a supplement to replace them, which seems redundant. I have no idea what happens to hormone production at death.

The other reason is that since they can get most hormones from plants or synthetics, why bother with looking at humans? Obviously your novel will be different, but these are my basic thoughts.