Everyone who works with animals is supposed to regularly fill out and update Animal Care and Use Protocol forms that detail precisely what is happening to experimental organisms in the lab.
These protocol forms require description of the experiment, a thorough explanation of how the animal will be treated or sacrificed, any analgesic/anesthetic usage, and an estimate of how many animals per year will be treated in this fashion. There is also a section asking you why you can't do your experiments in "lower" animals or with computer modeling.
Filling out these protocols can be a bit tedious, but the second step, in which the animal committee asks you to clarify or fix what you wrote the first time, often takes even longer. Missing dosages, inappropriate anesthesia, etc are the frequent points of concern.
Now, I'm about as animal-rightsy as anyone working on rodents can be. I take seriously even psychological stress to these critters. So I'm happy that the animal committees demand thorough accounting from investigators.
In theory, these protocols must be filed and accepted before any experiments start. However, because PIs have many uses for their time, and because no one is monitoring the lab on a daily basis, and because researchers often want to start different lines of experiments without waiting for approval, in reality every PI I know fills out an animal protocol form only after the technique has already been in use for some time in the lab.
I would go so far as to say that I have never known a PI to fill out an animal protocol form ahead of experiments, except if the animal department requires the protocol before allowing researchers access to a certain room. Or perhaps when a researcher arrives at a new location and simply doesn't have animals to work with until the protocols are approved (though even then I have seen people sneak around this by getting animals from other labs).
Is there a better way for this to work? Pragmatically speaking, I just don't see any way that full protocol approval prior to experimental modifications is feasible. Labs just won't operate on administrative timescales. What if there were a way to file a sort of Notice of Intent, the way that eateries have to post their applications for liquor licenses before they're actually approved? The Notice of Intent form could be quite short--brief methods description with a comment like "We're piloting this method to see if it will be useful."
The animal committee could take the Notice as an invitation to visit the lab and make sure the investigators knew what the hell they were doing. Then there would be a time window--say two weeks--from the Notice after which investigators were required to file a real protocol amendment or to cease these experiments.
Advantages:
1) Less unregulated work. We all know it happens; we like to imagine that people are respectful of animals even in absence of real protocols; but it's never a safe assumption.
2) Not filing a Notice of Intent could become a serious offense, whereas I've never heard of anyone getting busted for starting their experiments without a protocol in place--because inspections are so rare. But since there would be no excuse for not doing it (ie no time delay between filing and starting experiments), it would be hard to defend if you were caught working without one.
3) Prompt visits from vets/other relevant people following a Notice of Intent filing could help investigators refine their protocols from the beginning, rather than following a back-and-forth with the IACUC several months after the lab has already decided how to do its experiments.
I don't think it could ever happen. It's convenient for everyone to live under the fiction that experimenters only function with approved protocols--neither the PI nor the animal committee need rush to get protocols in place, and meanwhile science goes on its merry way.
But it's sort of sad to me that everyone does operate under this fiction, because I think it engenders routine disrespect for the "meddling busybodies" over at animal care who make you change around your protocol to meet the established standards. Because of this disrespect, some trainees learn implicitly that their goal is to shield the lab from careful scrutiny, and to evade the animal care folks when they visit.
I can't think of any better solutions though.
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Headed on a week's vacation to home town and environs--happy Presidents' Day to you all.
15 years ago
43 comments:
in reality every PI I know fills out an animal protocol form only after the technique has already been in use for some time in the lab.
Wrong, wrong, wrongity wrong in oh-so-many ways.
I have known some PIs to take this approach on occasion but it is not the default by anyone I know, occurs rarely for those who do it and the vast majority of PIs would never do any such thing.
If this is really the way things go at your Institution, there are HUGE problems with oversight and the IACUC and even more importantly with faculty that think this is an acceptable way to operate.
Wow, this post has really surprised me. I have worked extensively with animals both at my grad institution as well as my current university. In neither case was it even possible to get experiments started without an approved animal protocol.
For one, no one I know ever does animal experiments in their labs. Both universities have had dedicated animal facilities which house and care for the animals and also provide space for surgeries, anesthetic equipment, and various other treatment procedures.
It has simply never been possible to waltz into such a place without a protocol. You need to order animals through the animal people (which you can't do without a protocol), you need to reserve equipment and experimental space (which you can't do without a protocol), you often need help from the vet (yep, protocol), then you have to dispose of animals, etc, etc. All of these things have involved massive administrative oversight at both of the institutions where I have worked.
This is a pain in the ass, but it really is necessary. I can't believe that no one follows these procedures at your university. I feel bad for the animals. What do you guys do, do all of your animal work in the lab, all of your own ordering, feeding, cage-cleaning, etc?
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I think what Jekyll is suggesting is not so much beginning to work with mice in a lab for the first time - which does require a massive administrative investment - but beginning a new series of experiments with the mice you already have. Like Jekyll, I've known plenty of people who will start a new line of experimentation before filing the protocol revision forms for formal approval. Where I worked before, and here at MassivePharma, I know it's rather common.
The justification that comes up most frequently is that doing new experiments on an existing protocol is such a little change that it isn't worth filing all the paperwork to run a pilot experiment. Your existing protocol covers animal handling, health management, anesthesia, humane sacrificing, etc, so why bother with a ton of forms if you're just going to harvest a different tissue in a necropsy for new experiments?
I'm not sure there's a way to address the problem, though. It's not so much the onerousness of the task as simply doing the task itself. Making the Notice of Intent a one-page document that takes ten seconds to complete will be almost as high of a barrier as filling out a full protocol revision. A lot of scientists see these things as hoops to jump, rather than important & necessary management, and if they can get around the hoop instead of jumping through it, they will always choose Option B.
It's important to recognize that it's not your local IACUC that makes all these rules. They're just charged with enforcing them. If things really are being done the way you describe at your institution the PI's are courting a whole world of hurt. Bad, bad, bad hurt. From the Feds. Hurt that will extend to even the most compliant labs.
I have a colleague who chairs our IACUC. He's lost half his hair since starting that job and the other half is decidedly grayer. It's the potential for behavior such as you describe that has done that.
This is a great post. I actually work in a lab that operates much like the situation DJMH describes. We've has a well established rodent colony for decades, and dozens of animal protocols detailing myriad procedures that have been on the books since time immemorial. We also can and do perform procedures in our laboratory space if and when we are set up better to do it there than in the special procedures in the colony.
I agree whole-heartedly that IACUC oversight is important to ensuring the welfare of the animals used in research, but like DJMH, at our institution it takes 1-2 months for a new protocol submission to even be reviewed by the IACUC, and then another 1-2 months (bc they only meet once/month) to get it approved...assuming that there don't ask for major rewrites.
So, best case scenario, you can't start performing your new procedure for two months after submitting...and it rarely follows the best case scenario timeline.
Furthermore, one post-doc recently undertook a new procedure that was quite complicated and that was adapted from another system. She had to test several parameters (which had to be specifically written into the IACUC protocol) in order to optimize the procedure. If she had first written a protocol detailing everything she had to optimize, waited for approval to do it, then optimized, resubmitted the protocol for the experimental procedure in its optimized state, waited for approval and then, only then, began her experiments she estimates it would have taken a year (and she would have been scooped). So she optimized first, then submitted, and continued to do her experiments in the months between submission and approval - her protocol did get approved so it's not as if she was doing things that weren't going to be allowed in the long run.
I think that IACUC oversight is a good thing, but considering the pace at which scientific research his conducted these days it's ridiculous and counter-productive to have to wait that long. It would be a lot better for everyone involved if the process were streamlined in the way DJMH suggests.
CEiA - I think the setup varies between labs and institutions. I know some labs at ours who sort of keep a few critters on hand for occasional experiments while it is not the main focus of the lab, these are run very differently from a "mouse lab".
VetMed still is responsible for the day-to-day care of the animals...but since there are so many protocols with so many procedures that we use aaaaallllll the time, and everyone is on the protocol and trained to do the procedures, the lab members are integral in the daily operations of the mouse colony, and the care of the mice that they use. It is rare to need extra special permission to use this that or the other thing once you've been trained, added to the protocol, and given keycard access to the facility.
1) if you are adding to an existing protocol, in theory it is mich easier than making a new one. In theory.
2) I think we have to aknowledge an additional purpose of IACUC: to cover the university's collective asses. This insane amount of red tape is not just in place to protect animals. It's to prevent lawsuits.
I'm glad you wrote this post. I've seen this behavior, or at least, I've seen the least-offensive end of this behavior, e.g. harvesting an additional tissue after sacrificing an animal, a lot of times. There it doesn't bother me, except I'm not sure the PI ever gets around to updating the paperwork for some of the minor stuff. And frankly, someone on the IACUC committee might well know a good scientific reason why that tissue might not be in tippy-top shape with a given protocol- so it seems to me to be counterproductive to not submit the paperwork eventually (even though paperwork is always a pain).
But other variations in protocols- getting CO2 from dry ice vs. pressurized... have always made me a bit nervous. Still trying to figure out how to bring that up.
No, no, no - this is not standard, and I hope reader do not come way thinking it is. I think, Dr J is oversimplifying. You absolutely cannot do animal work without a protocol in place - and you risk your funding and everyone else's if you do. Big no-no.
What you might be referring to is the potential for doing experiments that are not exactly those detailed in the protocol, but substantially similar (harvesting tissue to run a blot for protein A vs harvesting tissue to do in situ for gene B). The difference in the details of the science are not really discernible to IACUC members (as long as it's not duplicative or trivial), and not cause for concern if the animal handling & numbers are unchanged. The protocol should be updated if there are substantial changes (you can make amendments to existing protocols with justification); and protocols have to be updated every 2-3 years anyway, but you do this while the old one is still in place.
If your IACUC takes more than a month to review your application (not including requests for more info/changes, but that still should take < a few weeks), that needs to be improved.
2) I think we have to aknowledge an additional purpose of IACUC: to cover the university's collective asses. This insane amount of red tape is not just in place to protect animals. It's to prevent lawsuits.
WRONG!!!! These committees (and IBC) that are mandated by an arm of the Federal government. They are obliged to adhere to the guidelines provided by the Federal government.
Neurowoman is absolutely correct in that this kind of behavior risks everyone's Federal funding at your institution. Dealing with IACUC might be a royal pain in the ass, but it's a hell of a lot better than the potential alternative.
OH MY GOSH. We NEVER do experiments on animals without an approved protocol. Period. NEVER. We can't even order animals without an approved protocol.
If we are going to modify the procedure, we write an amendment. Period. Sometimes I have to bug people to get an amendment (to a previously approved protocol) approved quickly.... and I'm willing to do that. I also never, never let students who are not on my protocol work on live animals. Sometimes this means I have to plan ahead- when I know someone's joining, or working temporarily in the lab.
And Becca- harvesting an additional tissue after the animal is dead is not a violation of any protocol- to my knowledge- as long as the animal is DEAD when the tissue is taken.
Wow, I stirred the pot with this one. Ambivalent Acad and I seem to be talking about the same phenomenon. You have a lab set up and running smoothly with various established and accepted protocols. Someone wants to do something different--not just harvesting some extra tissue after the animal is dead, but say injecting a drug into an animal that is under anesthesia. The anesthesia is approved protocol, the drug is not. (To clarify, this is an imaginary situation. Everything I'm doing really is on the protocol correctly, and I know because I helped my advisor file the amendment.)
You know the drug isn't harmful or noxious--it's supposed to improve liver enzyme function or some such. But you are absolutely supposed to amend the protocol before you do it. Do you really wait the two months? In a rodent lab? Most people try it first and file second.
I agree that things are, and should be, different in labs working with primates or cats or dogs or whatever. And the whole point of my post was that I think things OUGHT to operate better in rodent labs. But in practice, the delay introduced by the animal committees is too long, as DGT and AA say. DrdrA, I've never known these committees to be rushed--like AA, ours meets at predefined times.
Becca--I agree that when people start futzing with approved anesthesia parameters, as you describe, it makes me nervous too. Part of why I wrote this post was because (as is clear from the responses) people don't acknowledge or aren't aware that it happens on a regular basis. I think we should have a more honest conversation about what's really going on in the lab.
I imagine it would be extremely awkward for you to say to your PI, "Hey, this isn't on the protocol, shouldn't we file an amendment?" And indeed, I would be nervous about saying something like that myself. That's why I was thinking a lower bar to jump over might be more acceptable to people, although I take DGT's point that it's still a bar and therefore inertia will win.
Dr.J&Mrs.H.-
At my institution, amendments do not necessarily need to be reviewed by the full committee. In fact- AUPs themselves are not necessarily reviewed in a meeting where all the committee members sit down together- unless there are a particular defined set of circumstances in the AUP that necessitates this, or unless one of the IACUC members has a question/ problem.
Becca, what drdrA said. Once an animal is euthanized for an approved reason, the need for iacuc coverage expires.
And the whole point of my post was that I think things OUGHT to operate better in rodent labs. But in practice, the delay introduced by the animal committees is too long, as DGT and AA say. DrdrA, I've never known these committees to be rushed--like AA, ours meets at predefined times.
In some places (like the institutions where I have worked), things DO operate better, even in rodent labs. The delay introduced by the committee is something that needs to be planned for in advance. Also, as DrdrA mentions, I have always been able to file an expedited addendum when absolutely need be. Addendums don't always have to go through the full committee.
But you still do file an addendum before trying the experiment? Again--I just don't think that's true everywhere.
AA wrote:
Furthermore, one post-doc recently undertook a new procedure that was quite complicated and that was adapted from another system. She had to test several parameters (which had to be specifically written into the IACUC protocol) in order to optimize the procedure. If she had first written a protocol detailing everything she had to optimize, waited for approval to do it, then optimized, resubmitted the protocol for the experimental procedure in its optimized state, waited for approval and then, only then, began her experiments she estimates it would have taken a year (and she would have been scooped). So she optimized first, then submitted, and continued to do her experiments in the months between submission and approval - her protocol did get approved so it's not as if she was doing things that weren't going to be allowed in the long run.
You don't see the reasons why this was so very wrong? First the postdoc did not know that the protocol as she performed it would be approved. Second, look at it from the point of view of the group that got scooped. Let's assume they did everything by the book and got their protocol approved by IACUC before doing the experiment. Is it right that the postdoc in your lab won that race by breaking the rules? I'm not naive enough to believe people don't cut corners in order to avoid being scooped, but the means certainly do not justify the end in this case.
Dr. J & Mrs. H wrote:
Someone wants to do something different--not just harvesting some extra tissue after the animal is dead, but say injecting a drug into an animal that is under anesthesia. The anesthesia is approved protocol, the drug is not. (To clarify, this is an imaginary situation. Everything I'm doing really is on the protocol correctly, and I know because I helped my advisor file the amendment.) You know the drug isn't harmful or noxious--it's supposed to improve liver enzyme function or some such. But you are absolutely supposed to amend the protocol before you do it. Do you really wait the two months? In a rodent lab? Most people try it first and file second.
If you absolutely know that the drug is harmless, that also means you know what the end result is, so why are you doing the experiment?* You do new experiments because you don't know the end result. So you don't know that the drug is harmless. That is why you must submit an amendment first.
*Yes, I know this was a hypothetical example.
Obviously in my example, the idea was that the experimenter was looking at some effect not visible--eg does the level of protein X change, or whatever. Even when you know something is not noxious, it can cause changes that you would like to measure.
Often you know quite well whether the IACUC will accept your new protocol or not, at least in some format. E.g., you did similar protocols in your last lab no problem. But the delay over such things like precisely the dose of X or Y...this is why AA's pal got the job done by circumventing the rules.
Odyssey - I'm not saying that I'm comfortable with how it went down. I'm very not. Having it approved after the fact does not make circumventing the rules OK. Means do not justify ends.
However, to echo DJMH, there was very little doubt that this protocol would be approved...whenever the IACUC eventually got around to it. All but some technical details of the procedure are approved on several of the myriad protocols that our lab holds. Other labs hold approved protocols for this procedure, and this post-doc only wanted to tweak it a bit to fit her system better. Actually, post-doc was a little uncomfortable about not having the approval in-hand, but nonetheless, this is how it went down.
As for "winning the race" with other group - I think it's also an unfair disadvantage if one group has to wait months for an approved protocol if others can push through an addendum in a matter of weeks, as other people are describing here.
But you still do file an addendum before trying the experiment? Again--I just don't think that's true everywhere.
YES, I file and have the addendum approved before the experiment, and most everyone else I know does too. Maybe it's not true everywhere, but it's true here. We also aren't in a huge frickin rush, the stuff we do is unlikely to be scooped, but I think that potential justifation is bullocks anyway.
As for "winning the race" with other group - I think it's also an unfair disadvantage if one group has to wait months for an approved protocol if others can push through an addendum in a matter of weeks, as other people are describing here.
There are many possible disadvantages depending on where and who your are. Academic science is not a fair system. If your local IACUC seems unreasonably slow, then that's a matter to take up with your administration. It is not a valid justification for performing unapproved procedures on lab animals.
And if the said protocol were a matter of cobbling together pieces of existing protocols, then you're talking about a simple amendment. If it needed to be a new protocol, then sorry, you cannot guarantee in advance that it will be approved.
I don't work with animals. But MY funding is put at risk whenever some ass-clown at my institution pulls this kind of crap. Perhaps someone here could explain why some postdoc's need to avoid being scooped is more important than my lab personnels' need to have jobs? Remember, these are Federal regulations, not just some red tape someone at your institution dreamed up when they had nothing better to do.
Odyssey - I get your point, and I agree.
Being but a lowly grad student, I don't know for sure the inner workings of the IACUC or the why the IACUC only meets as often (or not, rather) as it does. My impression (though I obviously have not had first-hand experience with this) from all the griping around here, from every PI that has to file animal use protocols is that they have tried to apply some pressure to the IACUC admin to get them to meet more often and/or streamline the system so that these kinds of unnecessary delays do not occur. My impression is that their concerns are being blown off. It is also possible that I have misunderstood the situation I described as I was not directly involved. It's possible that post-doc and PI were, in the end, able to file an addendum and that I never heard about the resolution of it, just the frustration surrounding the initial problem. Again, I am only getting this info third or fourth hand...but this suggests to me that the researchers are trying to work within the system, but the committee is either not understanding that their schedule means scientists have to wait up to a year to do their experiments, or they just don't care. Either way, it's not good. For anybody. I'm not defending it or pointing out blame...I'm just saying that it's not working as it should from either end. I don't know how to fix it, nor do I think that I've got the power to do so in my current position.
Here's another tricky one - supposedly you have to list every line of transgenic mouse you will use for a given animal protocol. In a mouse genetics lab, which carries upwards of a hundred strains of mice and constantly receives new strains for new work or for collaborations...is it really worth it write a new protocol for every critter that comes in?
This makes sense if your animals have fundamentally different properties that might affect everything else in the colony, or requires special handling. Immuno-compromised animals seem like reasonable candidates for their own protocol. However, what if you've already got a gazillion different lines that express something innocuous (say, GFP in various different organs) and then you want to import a mouse that expresses GFP in the liver? This mouse is in all other respects the same as a bazillion other mice in your colony, except that it expresses GFP driven by a different promoter. You're going to do the same things with it as you already do with all your GFP mice, so should you really have to go through protracted months of waiting for your protocol to finally see the IACUC committee before you're allowed to import it? Maybe this is a case for addenda - I don't know, but it seems like a crap-load of hassle for no good reason to me.
Which brings us back to DJMH's point - it would be better if we could get protocol approvals to approach some kind of efficiency and it would be better if there was not variation on the efficiency from one institution to the next. It's not really OK to circumvent the system for all the reasons that Odyssey points out...but the system needs to change.
Or how about this one - your lab has an approved protocol to do procedure A. Another lab has an approved protocol for procedure B, but not procedure A. They would like to try procedure A to see if it works in their system, but no one in their lab has done (nor is trained and approved obviously to do) procedure A. So they come to your lab to learn how to do procedure A and to see if it works to answer the question they're after.
I see this happen a lot too...is this non-compliance? If so, who is being non-compliant? If not, how do you handle this situation so that it is compliant?
Here's another tricky one - supposedly you have to list every line of transgenic mouse you will use for a given animal protocol. In a mouse genetics lab, which carries upwards of a hundred strains of mice and constantly receives new strains for new work or for collaborations...is it really worth it write a new protocol for every critter that comes in?
Is it worth it? I don't know. It's irrelevant anyway. You are required to either submit a new protocol or amend an existing one. Where I am, the animal facilities will not accept a new transgenic mouse line without prior IACUC approval. I know this because a) some of my colleagues tend to be quite vocal about this, and b) the chair of our IACUC (the one losing his hair) is a friend of mine. I would imagine that in many cases this is dealt with as an amendment.
I don't know why your IACUC does not meet more regularly. The membership should be made up largely of PI's who work with animals, so they really should understand the need to deal with protocols in as efficient a manner as possible.
Or how about this one - your lab has an approved protocol to do procedure A. Another lab has an approved protocol for procedure B, but not procedure A. They would like to try procedure A to see if it works in their system, but no one in their lab has done (nor is trained and approved obviously to do) procedure A. So they come to your lab to learn how to do procedure A and to see if it works to answer the question they're after.
If they apply procedure A to an unapproved system, then I would imagine that's non-compliant. If personnel from lab A demonstrate procedure A on system A to personnel from lab B, then no problem.
Obviously there are many shades of gray here and a veteran member of an IACUC would be better able to answer these things.
Odyssey - Thanks for your thoughts. This discussion has been rather enlightening. Some of these situations are quite confusing, and since graduate students and post-docs aren't writing the policies (and depending on the labs, they may not be involved in writing the protocols) it's hard to know the ins and outs.
As far as whether writing another protocol for another mouse strain is "worth it"...I wasn't asking from the point of view of the investigator, but from the point of view of whomever sets the policies on these things. My question was really is it worth it for federal regulators to require that specific kind of regulation? It seems overly bureaucratic to me when it would be better to invest more time (especially if it is so limited that they can only meet once a month), energy and regulation on what is actually being done to the animals.
DJMH- It may be true that not everyone files their amendments when they should. But I can tell you that I myself do not, and do not allow my personnel to, do procedures on rodents (or any other experimental animal) that I do not have approval for. Period.
I also teach the ethical use of animals in research to various categories of students, where I strongly make the point that prior IACUC approval is absolutely required for experimentation on live animals- even, if the experiment is a modification of an existing protocol.
As far as whether writing another protocol for another mouse strain is "worth it"...I wasn't asking from the point of view of the investigator, but from the point of view of whomever sets the policies on these things. My question was really is it worth it for federal regulators to require that specific kind of regulation? It seems overly bureaucratic to me when it would be better to invest more time... on what is actually being done to the animals.
Well, just as an example, imagine that you are doing experiment X on totally healthy Mouse Strain A (say Balb c) and then you decide you want to use a nude (i.e. immunodeficient) mouse model instead. The ramifications of doing experiment X on these two strains of mice might be very different, and the mice may require different care, monitoring, analgesics in accordance. IACUC should have oversight in these matters... it is not simply bureaucratic... because proper treatment of the animals is at stake.
CEiA - Actually the example you give is the same one that I use as what strikes me as a totally reasonable need for different protocol for each mouse strain.
What seems overly bureaucratic to me is when you have 30 different lines of tg mice, all on say a B6 background, which express GFP in 30 different tissues bc of the slight changes (tissue specific promoters, for instance) to the transgene that they carry. Then you want to get another tg mouse on a B6 background that expresses GFP in the liver (otherwise identical to all the other critters in your colony) and you need a new protocol to import it. This kind of subtle difference in mouse strains seems like it shouldn't need a new protocol to me - but I certainly don't make the policy.
This is a purely hypothetical example, and I'm not even sure that you do need a new protocol in this case. But for all the belly-aching that goes on around here under such circumstances, I am left with the impression that this is what the IACUC requires, and that they also don't want to meet in a timely manner to make it happen.
I don't have any first-hand insight on this - but seems that either our institution's IACUC is sort of dysfunctional, or the PIs are being whiny, or both.
Again, I am not at all refuting the necessity of having oversight or the responsibility of PIs to comply. I'm merely suggesting, like DJMH, that the system should be improved.
I am a little startled by the reactions here - in a good way. I didn't know that non-animal research funding could be affected by non-compliance of their colleagues - that's terrifying. Since I am only at the beginning of my career and have been somewhat indoctrinated into the culture of my current institution, like DJMH I assumed that people were this blase about the paperwork everywhere else too. I had no idea about the potential consequences, so I'm really glad to be learning this long before I try to start my own lab. I should say that people here are VERY conscientious about humane treatment of the animals, but it seems, not the paperwork. Hopefully this will change - pronto!
I understand that some of you feel strongly that non-compliant labs or lab members are behaving badly, but let me reiterate: AmbiAcad, DGT, becca and I all see this sort of thing happen. If you spend a lot of time being outraged at the moral compass of our labs, then you are missing the point: it's happening all the time, and the question is, what's the best solution? Do you really think that we're all going to go scold the PIs we know who are complicit in this? No fucking way. Report them to the IACUC? You're out of your mind.
These are not rogue bad actors--this is a consistent occurrence across many labs. So let me repeat: what's the best solution?
I would be curious to hear whether the IACUCs at different institutions have different policies about such things as: expedited amendments; frequency of committee meeting; scheduled or unscheduled lab visits; etc. What are the factors that support a compliant research environment rather than a non-compliant one?
Right off the bat, the speed of the committee's action is an obvious one, but I bet you-all can think of others.
This kind of subtle difference in mouse strains seems like it shouldn't need a new protocol to me
AA, just FYI, stuff like this doesn't usually require a new protocol, just an addendum. Addenda are typically short one-page affairs that request a protocol modification and then succinctly justifies the change.
Dr. J, I think the question that you are asking is very difficult to answer without knowing the specific structure of your institute. It seems (just from the varied comments here) that different places are going to require different solutions.
Honestly, the speed of committee action is of utmost importance, and if this single thing was improved, I think most everyone would be more compliant. Compliance would also be assisted by less red tape (reducing the bureaucratic burden on the researchers) and committees that are less fussy about protocol/addendum approval. One other thing I'd like to see at my institute is an IACUC committee that actually understands my science, because as it is, IACUC rules are not enforced uniformly among researchers in my lab (despite our similar science). The committee often thinks compounds are toxic when they're not, or they ask for evidence of FDA approval on a device that we are just beginning to develop in our lab (really putting the cart before the horse with that one). All of these things are annoyances that researchers would rather not have to deal with.
I came late to this story, but your description practically made my head explode. No, no, no. This is not OK.
I am late as well, and also my head is going to explode.
As Odyssey so aptly put it, all federal funding can be pulled from an institution that has one investigator acting in this manner. And in addition, all animals can be banned from an institution running animal protocols like this (USDA rules). These are all federal guidelines that must be followed.
It's a matter of respect for the other PIs in the institution.
And amendments to protocols, in my experience, do not require full committee review, usually just institution oversight. At R1 (no med school here) we have several staff members who can sign off on amendments, as they just did on mine. I did not need a full review.
DrJ&MrsH you ask a very tough question as to what to do to make things better in a slack environment. Of course the official answer is that it is the responsibility of each and every user of animals to participate in the system. From tech to grad to postdoc if you do not know that you have coverage you should not be doing the experiments. Period. And you should know...ignorance is no excuse.
but of course we live in the real world.
Perhaps you could, much as in the case of budget, take the tone of furthering your education on protocol issues and start asking mildly pointed questions about whether and why it is okay to seek forgiveness rather than permission. or to intentionally deceive the Iacuc, etc.
Say you've noticed a lot of it, colleagues elsewhere say that would be treated severely if caught. ask how different Iacuc's see things.
just play really dumb...
What DM said.
My outrage is not necessarily aimed at the people commenting here, but more at the institutions that apparently have a very blase attitude towards these things. It is, IMHO, criminal that trainees be put in a situation where it is considered okay to ignore Federal regulations. As DM noted, ignorance is no excuse. Should your IACUC or the Feds decide to audit a lab where this kind of thing occurs regularly, ALL members of the lab will be held responsible. One thing that hasn't been noted here yet is that possible penalties go further than "just" suspending funding and potentially banning future animal work. Criminal charges can also be brought against offenders. This is very serious stuff.
Ping, DJMH.
What Odyssey said. Seriously, this stuff can shut down animal work at an entire department or university. It just happened somewhere, though where is escaping me at this moment. Fed grants won't pay for animals that are out of protocol -- so someone else has to ante up. If a university chooses, this could become an individual liability -- if they allege that the transgression was outside the scope of the person's duties (and, mind you, they have professional compliance officers for that very purpose, to blame you, personally).
I'm keeping my fingers crossed that some trainees are misunderstanding the protocols, and that those protocols have been written broadly enough to include some kinds of modifications (for example, it's probably possible to write a protocol to include a large category of potential drugs to be tested).
But, if the protocol says you're testing drug A and you test drug B, seriously, it could shut down an entire universities animal program.
Those working on rodents might escape more frequently, but there are lots of avenues for this kind of transgression being discovered, including Freedom of Information Act requests (in some universities, protocols have to be released when requested by the public).
So. Don't do this. Make sure you don't participate in anything remotely tainted like this. Consider finding someone to talk to about the concerns.
(My head is starting to flash red -- I'm the first anonymous poster)
Do you really think that we're all going to go scold the PIs we know who are complicit in this? No fucking way. Report them to the IACUC? You're out of your mind.
Why on earth not?
Seriously. There's no other course of action that's defensible, is there?
I know that such reports happen here, filed by undergrads, grad students, postdocs and faculty. They're taken very seriously and are a major player in enforcing compliance. I only just started the lab, but all the lab folk are in *no* doubt that if they see something that concerns them, or that they even think may not be approved, the appropriate action is to check with the IACUC folk.
And protocols? I filed a massive protocol before I arrived, detailing essentially every procedure and reagant I thought that I might want to use - and I have still had to file modifications. Has it held up work? Well, yes. But - echoing others - there's no option.
Wow. I thought that I was done with being flabbergasted after the "I am scientist but willing to believe impossible things because someone tells me that I should" discussion, a response to which I am still working on. My flabber is utterly gasted for the month..
As a grad student I refused to run experiments when our animal protocol came up for renewal and my PI was lazy about getting it submitted for renewal and it expired (they have to be re-reviewed and renewed every year at my institution). Many other labs just borrow animals (because you can't order animals) and continue running experiments, but sorry, if we don't have an animal protocol I'm not running the experiments...technically you can't publish the data from any experiments run without a protocol (hence the statement in methods sections that you ran the experiments with the local IACUC approval--to state that you did in a paper when you didn't is unethical and can result in retractions, etc. if found out). Other grad students thought that I was nuts to refuse to run experiments, but I don't have to worry about anyone ever calling my data into question and plus I think that it's important to have oversight on animal experiments (my PI respected my decision, and got the protocol submitted ASAP and every year afterward the resubmission was turned in 2 months early to allow for time for re-approval so that there was never another gap in our protocol). Yes, it would be nice if the committee met more frequently, but honestly it seems that many PIs would still put off submitting the protocols simply because they don't want to do the paperwork...
I find it unfortunate that some IACUCs behave with such animosity toward researchers and seem perfectly content to inhibit research activities rather that facilitate safe and humane experimentation.
First, what DrugMonkey said at the start, and what several others have said throughout these comments - doing unapproved work can be disastrous to your university's research program. (And no, that's not overstated!)
We never do anything without filing an addendum, but at my university we can get an addendum approved in a couple of days if we've written the protocol correctly (with wide enough ranges). Addenda do not need to go through the whole committee.
For small but really time-critical items, we can get addenda approved immediately by calling the veterinarians. This means that there's absolutely no reason not to get the permission beforehand.
At my university, we are in the process of cracking down on any sort of non-approved protocol. (And we don't have anything like what Dr.J/Mrs.H is reporting.) If it happens, you should let the lab know how dangerous it is.
For us, the biggest help has been teaching PIs how to write IACUC protocols. Remember, IACUC protocols are not grants, they are legal documents. This means that you cannot say "dosage will be X" and use Y, instead you want to say at the start "dosage will be between X and Y" (and be broad!). Don't write a new protocol for every animal strain - write a protocol that covers lots of animal strains.
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