Compliance City Blues: Dealing with the IACUC or IRB or OSHA

Aug 07 2017 Published by under Uncategorized

When I was a wee thing, compliance issues consisted of not blowing up the lab (too often). Or not using extension cords as clotheslines for hanging up wet X-rays to dry ("really, Dr. Theron, it wasn't like it was plugged in or anything"). I can't speak to what IRB's were like, as I wasn't doing any human research in those distant days. But we all have heard of the horrible excesses and unethical goings on of the times. If you haven't read Rebecca Skloot's excellent book The Immortal Life of Henrietta Lacks  you should.

For those of us that work with animals, we all know and love and work with, the Institutional Animal Care and Use Committees that govern our research lives. I lived through the no IACUC through ineffective IACUC through the regulated situation in which we do our work today. I have sat on my University's IACUC in the past, and been the stats person for the IACUC. It was in no sense fun. Even free lunch did not help.

My rule: do not offend the IACUC. Follow the rules. yes they will seem arbitrary. Yes you will be irritated and forced to compromise things that, in your perception, are Best for The Science.

I know plenty of people who bend the rules. But one of the things that I have learned is that by and large IACUC rules are not good ones to be bent.  I know people who live by "tis better to ask for forgiveness than permission". IME, this seldom works with IACUC's and their escalating scales of penalties.  Some Big Dogs I know are beyond rules. The worst, when caught, blame people under them, oblivious to the culture they have created. Some PI's are quite compulsive and follow everything. I had a colleague whose benchtop had outlines in masking tape, with a number, of where every piece of equipment needed to be, and a cross-indexed master list of places and equipment. In the days before personal computers, this was a hand-typed list.

In my lab, IACUC, IRB and compliance are unbendable, rules which cannot be bent. I've got two lines of justification for this: ethical and practical. Practical involves the level of problems that occur when one is caught breaking rules. These problems can grow into a moratorium on doing research with animals, a situation which can be devastating to all of the people in the lab. The decisions on which rules to bend are essentially ethical ones. None of us would do something that we perceived as "hurting the animals". And even if this instance of breaking the rules wouldn't hurt the animal, another instance might. The trouble with rules is that you can't plan for every instance.

I have found that the temptations to bend the rules usually stem from poor planning. Something MUST be done, or the experiments will fail, and the means to do so are not within the protocol (people, drugs, etc). The other category of bending comes from laziness or obliviousness, though it is seldom seen that way: I just don't want to get out of bed to go check on the animals. Or I am doing something else and plain forgot. These situations can be addressed with more planning, and taking working with animals more seriously.

Working with non-rodents, large animals, expensive animals tends to encourage the planning necessary to avoid these problems. It's harder to persuade people, trainees, collaborators, that mice deserve the same respect as dogs. This is part of the PI's job. The time a PI invests in laying down the no-nonsense, we are serious about protocol compliance, and I expect it from everyone, is well worth it.

The IACUC and animal facility at my new place is wonderful. They are reasonable about violations (yes, my lab had one, yes we, me and the trainee, learned from the experience). But I've been places where it's not quite that way. I assure you, finding out that your IACUC has a sadistic streak is not anything anyone wants to do.

 

 

 

 

 

 

 

5 responses so far

  • qaz says:

    I have found IACUC can be your friend if you work with them to write a general protocol. At my university, they will work with you to help you write a protocol with ranges that can provide flexibility while still maintaining legality.

    Also, at my university, we have procedures for emergencies, which mostly entails getting written (emailed) permission from the vets.

    But I agree with you completely. Permission not forgiveness. Establish a lab culture of care and safety early and thoroughly. I tell them the UCLA story and that I don't want to go to jail for their death from carelessness.

    • potnia theron says:

      Just like everyone else you meet (not actually, but its not a bad rule of thumb): make the IACUC your ally. Most IACUCs/vet staff will help. Most IACUCs and vet staffs (staves?) are interested in promoting research. But I've seen other models.

      Your point about emergencies is well taken. All universities MUST have a vet on call. Good ones will have a vet that will work with you to solve the problem. It's our role to make sure that our peeps know this.

  • chall says:

    If anything from my experience count it's that :""tis better to ask for forgiveness than permission" is the WORST way to deal with IRB, IACUC or other ethical boards. I'm acting as the compliance person in my lab/program and from what I say it's best to have a dialogue with the people since they are often interested in making it the easiest and best way and not have extra work so if you present them with "I'd like to do this, what's the proper and best way to go about it" they usually work with us. That also means that when (if) you find yourself having a unintentional violation it's more obvious that it was based on a mistake/bad process rather than intentionally skirting the guidelines and regulations.

    Of course, I have had to repeat this quite a few times to my colleagues "they are not our enemy but rather our friends to keep us to do good science"....

  • Microscientist says:

    The key to this is to have people working at IACUC, Env. Safety etc., who see their job as helping you to do science safely.
    Unfortunately, at my Uni we currently have a head of Env. Safety who wants to play cop. He really enjoys "gotcha" moments when he can point out things you have done wrong. It makes for a horrible relationship where no one approaches his office for help with anything. It also makes us less safe.

    • potnia theron says:

      It's the "gotcha" administrators that I cannot stand. I've dealt with them. They are insecure people who wear their badge of pride & honor. I recall (but cannot put my hands on) a study about people with authority vs. status, or something similar. Authority without the status prompts people to act like jerks, was the conclusion.

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