(1) My most recent experience with "problematic" IRB reviews was watching a student spend six MONTHS to get approval to administer a self-efficacy questionnaire to Introductory Psychology students. An instrument that has been used in dozens of cultures, with zero injuries, much less fatalities. This would have taken longer, had not extraordinary measures been taken just before the end of the academic year.
There is NO reason the review process should take longer than the research will take!
There is NO reason it should take longer to complete the forms for the review than the research will take!
Quaint ideas? Perhaps so, like thinking an ordinary citizen ought to be able to complete a tax return without "professional" help I suppose.
(2) While this was going on, I listened in a meeting to someone opine that meta-analyses were unethical, because the original subjects did not know their data were to be reused and had not given their permission for reuse. Whew! But it would not surprise me to see this argument materialize as policy.
These are just the most recent problems I have personally encountered, but they are consistent with complaints I have heard from various people in assorted places, especially in recent years. I am left with a critical question: Do we really need to waste trees this way?
Obviously my answer is "no." I recently attended a public festival (Stampede) where I was approached twice to be surveyed about different topics, and I also observed two other people approached for yet another topic. In no case was an informed consent form used, yet no fatalities were observed. And, I confess, I did not have IRB approval to eavesdrop and observe these activities ... please, promise you won't tell!
And, any number of on-line surveys by private enterprises get right to the point, and assume that if you aren't interested they don't have to give you permission to go elsewhere! How nice it is, to be TREATED like a grown-up.
Then there are the tele-marketers, who never have a consent form. But you can just hang-up the phone, politely or otherwise. How nice it is, to be able to BEHAVE like a grown-up.
Then I ask myself: why it is that some lines of inquiry are more straight-forward. Consider the discrepancy noted at the end of the Lingua Franca article, whereby journalists collect data from people without IRB clearance. Just think, you could hardly expect "Deep Throat" to sign a consent form, eh? Is this waiver because journalists are more ethical than psychologists?
Isolated as we are, we sometimes discount our local experiences as not being representative of IRBs everywhere -- surely insanity is a local phenomenon. But here are a couple of experiences recounted by colleagues elsewhere:
Think about that: if your child came home to interview you for an essay and presented a consent form ...
After reading this one, I am reminded of Ebbinghaus, who did his memory research on himself as the only subject (as did Dr. Jekyll). I wonder, do REBs and IRBs think we have to apply to them to do research on ourself? Would you bet they don't think they have the authority?
Just remember that next time you are walking down the street and a stranger approaches: gender, eye colour, hair colour, those sorts of things are confidential and you have no right to know them. Nor, I suppose, should one make inferences about the IQ of the IRB reviewer?
Another colleague at a large southwestern institution relays a story of a proposal that received IRB approval with a plan to use 200 subjects. When 300 subjects unexpectedly became available, the IRB claimed the need to review the proposal again! Why would what is ethical with 200 participants become questionable with 300?
Some incidents are not just bureaucratic over-reach, but tragic examples of abuse.
The first is the way an IRB was used as a club to harass Justine Sergent, a bright young neuropsychologist, into suicide. (Some news clippings on this sorry affair are here.) Of course the federal ethics agencies didn't do it personally nor directly, but the thought that the feds can just wash their hands and walk away angers me greatly.
The second is the case of Nancy Oliveri, who did what everyone in the real world considers to be the ethical thing, and then became the target herself. She went public with the harmful effects of a drug after her supervisors did nothing. Kill the messenger! IRBs couldn't stop her supervisors a priori, and they don't seem to feel up to disciplining them after the fact, nor will they do anything to stop the harassment of her. So I have to ask then, just what do we need them for?
The third is the case of Lou Pagliaro in Edmonton. He had the audacity to go public with what he saw as the presence of drugs in places the schools and police didn't want to acknowledge, and so the university was induced to try to shut him up by claiming he hadn't obtained ethics approval. Cleared by an independent investigator, cleared by the Psych department, but the harassment goes on. Are the feds going to punish the university for misusing the elephant gun? Yeah, sure.
I am aware of another instance in the Cal State system, where a colleague was at his father's death bed in the hospital. He was called back to campus by the IRB officer to sign again 13 copies, this time in blue ink, original signatures being required on all copies. By the time he got back to the hospital, his father had died. Do we need to put up with this nonsense? The feds may not be pulling the trigger, but the elephant gun is hard at work.
I suspect these are only the tip of the iceberg, with others getting only local attention, if any, because as Pagliaro says young academics can't go public. Instead of mastering their discipline, they have to learn to please the local zealots.
Abuses such as above will not be corrected by local education (indoctrination?) in research ethics. We are NOT all equal opportunity offenders! REBs can't stop human failures (like leaving that file cabinet unattended briefly), and they can't stop acts of malfeasance. And the local abuse is ultimately the responsibility of the federal regulation promoters.
No, your experiences are not isolated distortions, unfortunately, and I would be glad to list here any such cases you may care to share. Do not assume things are more rational elsewhere, it's not just a local effect. Zealots are increasingly apparent.