Well a few simple questions about deep seated emotional trauma (e.g. molestation), or embarrassing or taboo subjects can present risks to patients. So like you say. Sometimes.
The question is who decides and how they make the decision? Surely it should involve someone other than the investigator, and have clearly defined rules so people know what to expect. Hence the IRB.
The point reiterated several times is that they were already asking the patients all of those questions as part of their normal procedure, without any of the alleged protections provided by the IRB. Once they wanted to use the data that they were already collecting anyway it suddenly became a huge risk that required all of this bureaucracy to mitigate.
Yes, but there is a key distinction between the practice of medicine and clinical experimentation. The first is (in theory) is done for the benefit of the patient receiving treatment. The second is done to test a hypothesis.
Putting a patient at risk to treat them (e.g. chemotherapy) is very different than putting them at risk to get data for a publication or NDA. There's no reason what's tolerable in one context should be in the other.
The thing is, in this case, there was no one in the 2nd category who wasn't also in the 1st category. The question is already being asked to treat them. The risk is already being taken. Using the data from that action for research doesn't expose them to any additional risk.
Ultimately, the issue is this: it costs less overall for the author to just comply with the standard way studies are done, than for the committee to carve out and justify exceptions just for his study.
The author complains of the IRB not doing Methods 101. Perhaps the author should have done Methods 201, then he would understand the concerns (which many human experimenters in this thread have elaborated on). As stated elsewhere, so many of the author's wounds are self-inflicted.
The author's point is not that his time was wasted. It's that the system is broken.
Sure, he could have spent a lot of time and effort to learn and adapt to the broken system, and his study would have been done, and fewer people would perhaps be misdiagnosed.
But the point is that it shouldn't be this hard to make the world a better place.
The IRB is there to protect innocent subjects from malicious studies. It's not that the system is 'broken', it's just 'not perfect'.
It's actually been pretty disturbing to read this whole thread. So many HNers who complain endlessly about the relatively trivial metadata that corporations collect on us and sell, they would quite happily get rid of this committee that ensures any studies done on them meet minimum ethical requirements and ensure that subjects know that they're being tested on.
Read the responses in this thread from other people who have done studies on humans that requires passing through one of these committees. Actual people who know what they're for rather than armchair critics. All of them present the same opinion: IRB's are annoying and sometimes a little frustrating, but thank god they're there, because they protect the public. Every researcher is going to claim that their study will cure cancer, but not every researcher is being truthful (because they're humans, after all), and plenty of researchers don't care if they hurt their subjects in order to add a feather to their caps.
The nature of scientific research ensures that there can be no "standard way studies are done". When you are trying to discover entirely new things, you will undoubtedly come into new situations that were not accounted for when the standardization is created.
It may be inconvenient, but advancing human knowledge does require that humans use their capacity to reason and examine circumstances on an individual basis rather than mindlessly checking boxes on some one-size-fits-all form.
The incentive for the IRB is to be as thorough and put up as many obstacles as possible. Both from a blame deflection standpoint and a bureaucratic empire building standpoint.
I'm not aware of any force pushing in the other direction to make the scrutiny proportional to the risk.
If this is true - and I'm just some programmer reading stuff on the web who knows little of real life IRBs - the end result is a system that overproduces IRB red tape and underproduces science.
Of course, complaining about a system is easy. Figuring out a better system is not.
> I'm not aware of any force pushing in the other direction to make the scrutiny proportional to the risk.
Each research institution has its own IRB, which I expect is composed by faculty/researchers. The have an incentive not to block their own institution from producing any research output whatsoever.
The question is who decides and how they make the decision? Surely it should involve someone other than the investigator, and have clearly defined rules so people know what to expect. Hence the IRB.