Do we need IRBs for IRBs? And should they be for-profit?

“These are black boxes,” said Dr. Steven Joffe, a pediatric oncologist and bioethicist of the University of Pennsylvania, who serves on the FDA’s Pediatric Ethics Committee. “IRBs as a rule are incredibly difficult to study. Their processes are opaque, they don’t publicize what they do. There is no public record of their decision or deliberations, they don’t, as a rule, invite scrutiny or allow themselves to be observed. They ought to be accountable for the work they do.”

That is part of a longer and very interesting article on whether IRBs should be for-profit, or if we even at this point have a choice:

“This shift to commercial IRBs is, in effect, over,” said Caplan, who heads the division of bioethics at New York University Langone Medical Center. “It’s automatic and it’s not going back.”

Institutional review boards — which review all research that involves human participants — have undergone a quiet revolution in recent years, with many drug companies strongly encouraging researchers to use commercial boards, considered by many more efficient than their nonprofit counterparts.

Commercial IRBs now oversee an estimated 70 percent of US clinical trials for drugs and medical devices. The industry has also consolidated, with larger IRBs buying smaller ones, and even private equity firms coming along and buying the companies. Arsenal Capital Partners, for example, now owns WIRB-Copernicus Group.

But even if the tide has already turned, the debate over commercial review boards — and whether they can serve as human subject safety nets, responsible for protecting the hundreds of thousands of people who enroll in clinical trials each year — continues to swirl.

I am not well-informed in this area, but if you refer back to the first paragraph, perhaps nobody is.  That’s worrying.

For the pointer I thank Michelle Dawson.

Comments

This is an incredibly serious problem in research today, tomorrow, and for a long time to come.
IRBs were never meant to be professionalized, but a professional class of IRB staffer has arisen.
IRBs are fundamentally a cost center to the host institution, and so even the internal ones often
have their budgets set by workload.

This would be sensible except that the IRB also makes the determination of whether research requires
IRB action, and the level of scrutiny. At a larger level, the professional IRB community determines how
entire fields fall under the review of that professional class.

This has led to all kinds of obscene outcomes with regard to human subjects protection. Historians are a
great example of a field being swept up by professionals looking to extend their own authority.

There must be separation of powers; at several scales, from the local institution to the international level.

Re: " I am not well-informed in this area, but if you refer back to the first paragraph, perhaps nobody is. That’s worrying."

The FDA regulates IRBs: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm

That's not encouraging.

8, I know, we shouldn't be regulating at all, in your view, but I was responding to Tyler's request for regulation with his phrase, regarding regulation, "perhaps nobody is."

In a perfect world, were we all angels, there would be no need for regulation. In your own mind, are you living with angels or mortals.

I am not an angel and neither are you.

I used to be an angel, but then I was cast out and fell likenlightning from heaven. True story. I should regulate everyone else.

Rest assured, you will not be put in charge if more than one person is responsible for making you the regulator unless you are very good at appearing in Congress.

Lucifer...is that you?

So we need a regulation to regulate the results of a previous regulation.

Because we are not angels.

Brilliant analysis Bill. Utterly stupendous in its depth and wisdom.

Derek, I am reminded by your statement of the physicist who claimed he discovered a solution that dissolved all materials with which it came in contact and had no place to store it. If you posit that posit that all humans are flawed, and that all regulation must thereby be flawed, you are holding a glass flask which will soon melt and drop on your foot, thereby dissolving it.

I am an angel! So get off my back you are going to crush my halo.

I am on my university's IRB, and in my opinion, way, way too many research projects are subject to IRB review. For example, if one wanted to do a survey on if someone liked Pepsi better than Coke, it would have to go through IRB. 90% of the proposals we look at are simple surveys.

How often do you review proposals that involve deceiving huge numbers of people without their knowledge? For example, if economists want to send fake resumes to thousands of job listings, does that require IRB approval? Do you think your IRB can really balance the disaggregated interests of thousands of bots, HR staffers, and managers at hundreds of different firms with the desire of your own institution's economists to do their study?

I agree with you, Curt, reluctantly, because there are ethical issues one does not even think about until you have to present a proposal to someone else to review. Self-governance in the context of self interest is not a good mix, no matter how good you think you are or how good you think your project is designed.

The other ways to study the ways in which we are underutilizing the abilities of minorities are probably more costly to society and the economy than the fake resume study design.

I believe this type of research is exempt from IRB review and the typical process, "just to be safe," is that the PI submits a summary of the proposed study and the IRB staff simply issue a quick determination that it is exempt.

In my opinion, IRBs should spend much more fine than they seem to actively monitoring studies they have already approved. In my limited experience that is when things can get more complicated.

Based on the standards of informed consent as I understand them under IRB's rules, that type of research should not be allowed because the HR types who are being studied do not/can not give consent.

Informed consent laws apply to medicine/health, not social sciences surveys, etc. Anyways, what's the prospective risk or damage to the HR person in the study design?

I've worked with both academic IRB's and professional IRB's and the differences are indescribable. With an academic IRB you are lucky to get a 1 month response to a submitted document. The IRB board will nitpick with you on the smallest choices of language in the document (hey, that's what they're paid to do, right?) forcing you to resubmit the entire document for review over minor changes. I remember one project where we first engaged the university IRB in November and were finally approved in April. This was for a study that had no possibility of any lasting effects on the participants and was exposing them to no danger. And colleagues at other institutions told me our IRB was moving quickly! One important thing to note: virtually everything about the study is required to have been completed before engaging the IRB. The IRB document is expected to contain everything related to the study even down to the exact wording of the text you use on flyers to recruit participants.

Now I work with a commercial IRB and we get 24 hour turn arounds on documents. If we want to change the wording on a flyer? "That'll be $250 and 24 hours please."

And since I am sure you're a good researcher, there are few substantive issues for the commercial IRB to call out in your studies. But do you have complete confidence that commercial IRBs do just as good a job as academic ones? Perhaps due to misaligned incentives, or just a lack of rigor in their lightening fasts reviews, might they expose patients to harm that an academic board would have prevented?

And I am referring to researchers here who might have, almost certainly unintentinally, designed a study that has some inappropriate risks.

I have no pretensions about the quality of these review agencies. I know that the IRB agency is reading the documents because they occasionally suggest edits, but I find it hard to believe that they're able to thoroughly review these documents in 24 hours. I also would find it hard to believe that they have the necessary expertise staff to properly review the proposals submitted to them. Nevertheless, the same is true for academic IRB's (one of the reasons the IRB I mentioned in my first post took so long to go through the process was because the review board lacked members with familiarity of the research area to properly review the safety consequences of certain elements of the study design).

I find it hard to defend the Academic IRB system though. The combination of the number of studies subject to review, the detail required in the process, the boards' tendency to meddle, and the lack of specialized knowledge taking part in the review process means that the academic IRB system feels broken.

I am with Unhappy: very same experiences with university and private IRB's.

I can also approve your research for $250 in 24 hours.

Yo dawg I heard you like accountability.

So we got you a review board for your review board so you can check for abuse of power while you check for abuse of power. /too obvious?

I agree with Dave Smith and Unhappy Researcher that the academic IRBs are really bad news. I have been encountering these in many ways without becoming boring, but indeed they are slow and arbirtrary. It is also my observation that the ones at lower ranked universities are more likely to engage in just completely ridiculous and damaging behavior because they are less knowledgeable and dealing with fewer projects. So they try to prove the meaning of their existence by becoming especially petty and miniscule in their complaints with no idea of the waste involved in what they are doing or other larger issues of human experimental research.

It's interesting that IRB's as discussed here are limited to those studies which involve human subjects. Was it just last week where a post-doc had designed a custom gas valve and lost her arm in a subsequent static discharge? If I pump a couple of tons of dissolved dye into a frakking well, that doesn't involve human subjects, either. Admittedly, other government agencies, other than FDA, do have oversight. How about using rat muscles to power a synthetic sting-ray (in the news now, btw). What is the scope of ethics and morals (not to mention law and regulation)? Should some 20-something PhD be expected to know that OSHA has a toilet stall wall height standard? (it has a minimum distance between bottom of the wall and the floor.) While is is clear we need IRB for human subject research - both biomedical AND psychological/sociological, its also clear to me that organizations should have some oversight responsibility concerning animal treatment, environmental effects, and personnel safety (both physical and mental). I think having a preliminary checklist which is available to public inquiry (immediately upon submission) which asks questions about what, how, who, and where ought to be the first step in any serious formal review process. Certainly some of the process which is now essentially black box, could and should be transparent. One of the comments here asserted that the research s/he wanted to undertake was certain to have no "lasting effects" on the study subjects. Since this would only be possible if their short-term memories were incapacitated, and since any known process of doing that involves significant risks, no matter how fervent s/he believes the assertion it is probably false. If I'm in Chicago on Friday at 3p.m. I can't also be in Manhattan at that time. Everything we experience has a lasting effect, obviously. Opportunity costs. A 3rd party is clearly necessary for a reasonable level of objectivity in determining what the costs and risks are and whether they are acceptable. But just because it's true, doesn't mean the process must require months of deliberation amongst large numbers of responsible persons. The complexity of the IRB should reflect the complexity of the research. This is especially true now in a world where trigger words (or images) and 'uncomfortable' situations or language can be used to justify federal investigations and sanctions.

In my neck of the woods THIS is an IRB: http://cache2.asset-cache.net/gc/78341437-andrew-hoggett-and-mark-travers-patrol-the-gettyimages.jpg?v=1&c=IWSAsset&k=2&d=CSIMBv%2FaraCCLNLdbJQvXniXx4KO4FDND15SYKxJ6omZ9lQaY1mMebEbqDOUsvTX

A little off-topic, but a few weeks ago Tyler mentioned giving a talk about RCTs (random controlled trials, I assumed) and public choice issues. These seem like quite unrelated topics, Google is no help to me, and so I'm curious about how Tyler sees them intersecting.

Reference website and it's worse than you think.
It's where profits over people reside.
http://hcrenewal.blogspot.ca/2016/07/bad-apple-or-bad-orchard-narrative-of.html

No better example of research fraud/duplicity than the documentation of participation of the highest levels u.s. Gov't counsel in the Gallo, NIH, HIV/HTLV-III affair.
What enlightened human ascribes legitimacy to the question of whether anyone should trust the decisions of private corporation IRBs nominally supervised by politically appointed lackeys from the FDA or any other Govt organizations?

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