Once upon a time some researchers gave people diseases and prevented their treatment without those folks’ consent or knowledge. Other researchers let volunteers think that they were torturing folks. This so horrified many that they created a system of regulation where any academic “experiments” must have prior approval by an Institutional Review Board (IRB). And that system has expanded to the point of requiring prior approval for
IRB's are not about human protection anymore- they have gone way overboard- and make it hard to even use already existing data in analysis that can save lives. The VA Medical Center system is especially choked up with institutional paranoia such that much good work is not done and resources are wasted,
A commentator on my blog has just pointed me to your post.As a researcher, I've been very exercised on this issue.Oh, and increasingly you *can't* publish your results without ethics approval - journals want confirmation it was obtained.In my post I suggest a mechanism, based on evolution, as to why we have got to this sorry state of affairs,http://deevybee.blogspot.com/In the UK, the Academy of Medical Sciences has done a great report which attacks overregulation (see my blog for details) - government at last seems to be listening.
Seems to me that since so much university research is sponsored by the Federal Government anyway, the sponsors already constitute a semi-IRB. And frankly, given that our Federal Government is already broke, I personally would prefer that we not add any more bureaucracy to it.
IRBs are made of professors policing other professors at the same school. It seems like they should have strong incentives to be lax, to allow their colleagues to increase their reputation, and thus the reputation of the school. It would be another matter if there were a single national IRB policing more distant strangers.
- researchers are required to treat mice *much* more kindly than ranchers are required to treat cows
- in some research, informed consent statements have been ruled invalid, IIRC under the assumption that the average person is not smart enough to give informed consent, so not only do you need to get consent, you need to provide proof that the subjects understood what they were consenting to
Edward Jenner, developing smallpox vaccine, 1796. But - it was a good thing for him to do so! Even though he had a very high chance of killing his first subject. He saved many, many lives by doing so.
You leave out all the reporting requirements after approval takes. I am familiar with IRB in Biotech research and in this field reports have to be sent to the FDA and the IRB and both followed up. I don't know about social science, but the reporting in Biotech is as bad as the approval. Both require huge data dumps, interviews, etc.
What about the ethical responsibility of a doctor to tell a patient they have a disease if they know it to be true? I do not think telling the patients they have "bad blood" was sufficient.
Tyrrell, I can also see IRBs as trying to bring low the scientists who see themselves too far above us.
Yes, but it's not just that non-scientists resenting scientists' status. That wouldn't explain the lack of restrictions on publications that you point out. IRBs don't exist primarily to counteract the scientist's dominant position in the scientist/non-scientist relationship. That dominance might be resented, but it appears minor and innocuous compared to the scientist's dominant position in the scientist/subject relationship. It is our fear of being placed under the latter kind of dominance that motivates public support for IRBs. That, at any rate, is how it seems to me.
I think the main problem with IRBs is that they have gone from 'Protect Research Subjects' to 'Prevent the Institution from Ever Getting Sued'. Thus we get the ridiculous over-focus on minutia and consent forms that read like legal documents.
I fully concur that IRBs are out of hand in social sciences and in computer science. People stand up for them in principle, but in practice they're really stifling university research.
IRB's are not about human protection anymore- they have gone way overboard- and make it hard to even use already existing data in analysis that can save lives. The VA Medical Center system is especially choked up with institutional paranoia such that much good work is not done and resources are wasted,
A commentator on my blog has just pointed me to your post.As a researcher, I've been very exercised on this issue.Oh, and increasingly you *can't* publish your results without ethics approval - journals want confirmation it was obtained.In my post I suggest a mechanism, based on evolution, as to why we have got to this sorry state of affairs,http://deevybee.blogspot.com/In the UK, the Academy of Medical Sciences has done a great report which attacks overregulation (see my blog for details) - government at last seems to be listening.
Think more the Stanford prison experiment.
Seems to me that since so much university research is sponsored by the Federal Government anyway, the sponsors already constitute a semi-IRB. And frankly, given that our Federal Government is already broke, I personally would prefer that we not add any more bureaucracy to it.
IRBs are made of professors policing other professors at the same school. It seems like they should have strong incentives to be lax, to allow their colleagues to increase their reputation, and thus the reputation of the school. It would be another matter if there were a single national IRB policing more distant strangers.
This is also a good place to mention
- researchers are required to treat mice *much* more kindly than ranchers are required to treat cows
- in some research, informed consent statements have been ruled invalid, IIRC under the assumption that the average person is not smart enough to give informed consent, so not only do you need to get consent, you need to provide proof that the subjects understood what they were consenting to
Edward Jenner, developing smallpox vaccine, 1796. But - it was a good thing for him to do so! Even though he had a very high chance of killing his first subject. He saved many, many lives by doing so.
You leave out all the reporting requirements after approval takes. I am familiar with IRB in Biotech research and in this field reports have to be sent to the FDA and the IRB and both followed up. I don't know about social science, but the reporting in Biotech is as bad as the approval. Both require huge data dumps, interviews, etc.
What about the ethical responsibility of a doctor to tell a patient they have a disease if they know it to be true? I do not think telling the patients they have "bad blood" was sufficient.
http://en.wikipedia.org/wik...
Am I the only one who finds it amusing that "gras" is French for "fat"?
Tyrrell, I can also see IRBs as trying to bring low the scientists who see themselves too far above us.
Yes, but it's not just that non-scientists resenting scientists' status. That wouldn't explain the lack of restrictions on publications that you point out. IRBs don't exist primarily to counteract the scientist's dominant position in the scientist/non-scientist relationship. That dominance might be resented, but it appears minor and innocuous compared to the scientist's dominant position in the scientist/subject relationship. It is our fear of being placed under the latter kind of dominance that motivates public support for IRBs. That, at any rate, is how it seems to me.
I think the main problem with IRBs is that they have gone from 'Protect Research Subjects' to 'Prevent the Institution from Ever Getting Sued'. Thus we get the ridiculous over-focus on minutia and consent forms that read like legal documents.
I remember that IRB oversight really stepped up at my school when this happened at Columbia.
The Institutional Review Blog is a good read for people interested in this topic.
http://www.institutionalrev...
I fully concur that IRBs are out of hand in social sciences and in computer science. People stand up for them in principle, but in practice they're really stifling university research.
Right, IRBs are for universities, and they are an additional requirement on top of other regulatory review.