Institutional Review Blog

Thanks for this comment. If competence is the norm...

2012-02-10T14:28:38.312-05:00

Thanks for this comment. If competence is the norm and nightmares the exception, an appeals process (as envisioned by the ANPRM) might provide an effective remedy.

The VA has lots of IRBs. Our organization had a pr...

2012-02-10T10:23:39.622-05:00

The VA has lots of IRBs. Our organization had a project involving the VA a few years ago and I don't remember anyone going through the sort of agony described here. The whole process was unremarkable.

As someone who has done multi-site research, I would agree that the process of obtaining approval from lots of sites is onerous (and necessarily so). But in my experience there's a lot of variation between sites. Some IRBs are well run and easy to work with; others are a nightmare.

Thanks for this comment. I share some of Mr. Davi...

2012-02-03T15:20:52.344-05:00

Thanks for this comment.

I share some of Mr. Davis's fears that open access could wreck valuable editorial systems. But I also share your puzzlement at his failure to mention the AAA's principled commitment to the dissemination of knowledge or that commitment's manifestation: the AnthroSource Philanthropic Initiative.

Daniel Lende points out that the AAA is being less...

2012-02-01T11:20:59.801-05:00

Daniel Lende points out that the AAA is being less than consistent in executing the principle of making results accessible with their recent stand on public access to scholarly work.

http://blogs.plos.org/neuroanthropology/2012/01/31/american-anthropological-association-takes-public-stand-against-open-access/

So, is your application pending?

2012-01-31T08:32:43.214-05:00

So, is your application pending?

Update here.

Jin Li's chief complaint was that the Brown IR...

2012-01-23T21:15:49.337-05:00

Jin Li's chief complaint was that the Brown IRB would not let her use her research data.

IRBs do not have the authority to prevent the use of research data.

Brown did not comment on this in their answer to her complaint. Brown did admit that the IRB prevented Jin Li from using her research data.

Where can I find the court's decision on this ...

2012-01-21T14:07:26.637-05:00

Where can I find the court's decision on this issue? OR whether it was settle out of court.

I agree that your findings are very useful, and I ...

2012-01-18T16:07:36.298-05:00

I agree that your findings are very useful, and I hope that linguists will use them to show that IRBs are out of step. Our disagreement is whether a system that fails 28% of the time is "working."

Your summary of my article is quite misleading. Th...

2012-01-18T16:03:21.532-05:00

Your summary of my article is quite misleading. The point is that the vast majority of the problems were clearly concentrated in two or three quite specific areas: 1) mandated data destruction; 2) inappropriately legalistic consent forms; and 3) written consent forms for working with participants who do not read and write. Part of the purpose of the article was to give linguists (particularly fieldworkers) resources to quote when preparing IRB applications so that it's clear that (1) is a totally inappropriate way to treat linguistic data; and that (2) and (3) are harmful to research participants.

The number of people who curtailed or abandoned projects because of IRB review was 3/94 - and two of those were curtailed because they assumed that it would be too much trouble to fill out the paperwork for working with children. But given that their protocols were already classed as non-exempt, there's no indication that this assumption was correct.

Many of the revisions were protocol clarification questions. A number of researchers also reported that their IRB did not require further modification to protocols once procedures had been clarified (I cannot recall how many mentioned this but I can check the original responses if you really want to know).

If I was tolerant of a system that intimidates participants and diminishes knowledge, I wouldn't be taking time out of my other research activities to help linguists deal with their IRBs. Showing that the clear majority of linguists following standard protocols for linguistic field research get their protocols approved is very useful: it provides linguists working with IRBs who don't do that with a way to show who's out of step, along with information about why field linguists work the way they do and how it protects research participants.

Good question. I think the answer is that CUNY doe...

2012-01-11T12:28:12.828-05:00

Good question. I think the answer is that CUNY doesn't believe that exempt means exempt.

CUNY policy dictates that only IRB chairs or members can determine a project to be exempt, and that "The individual making the determination of exemption has the authority to require additional protections for subjects in keeping with the guidelines of the Belmont Report, even though the research falls within an exempt category."

In other words, the IRB will do whatever it pleases.

What are the details of this research that disqual...

2012-01-11T12:18:00.650-05:00

What are the details of this research that disqualify it from a §46.101(2)(b)(2) exemption?

Thanks for this comment. As Boston College prepare...

2011-12-29T17:05:04.051-05:00

Thanks for this comment. As Boston College prepares to supply prosecutors with interview materials for which the narrators were promised confidentiality, I think all researchers must ask themselves if their "personal word" includes a promise to go to jail before complying with a subpoena.

My 'absolutely ironclad guarantee' represe...

2011-12-29T11:31:28.232-05:00

My 'absolutely ironclad guarantee' represented my personal word, as a cop-to other cops-while I was a serving police officer. This section of the article referred to a grad school project that never was published- for that and other reasons (I promised the participants that I wouldn't ever publish what they gave me for one). Lessons learned! But in regarding the IRB, their demands were impossible to satisfy; there are many, many similar cases cited in this extensive literature.

Clearly you can't retire yet. I bought and s...

2011-12-17T08:17:06.602-05:00

Clearly you can't retire yet.

I bought and starting reading your book last night. Very good stuff.

I can only encourage every other social science researcher to buy and read this (unfortunately) essential book.

Thanks for this comment, and welcome to the blog. ...

2011-12-15T12:54:22.130-05:00

Thanks for this comment, and welcome to the blog. I hope that it will give a different perspective from what you might get from, say, PRIM&R.

As you will read, I am skeptical of the "flexibility" argument, since it is the vagueness of the current regulations that encourages much IRB abuse. See Less Flexibility, More Freedom from 2009.

I just discovered this blog the other day, and hav...

2011-12-15T12:44:53.971-05:00

I just discovered this blog the other day, and have been fascinated by several postings already. I am a staff member in a University IRB support office and a Certified IRB Professional (CIP). Because we are a primarily social/behavioral research institution, we tend to be more a more generous IRB than many of those described in this blog. Nevertheless, problems (such as delays) remain.

I've often heard historians argue that IRBs and IRB offices often do not understand the nature of historical research. While I believe this is true, I also believe that many of these same IRBs do not understand the flexibility that is built into the Regulations to accommodate this kind of research. In fact, it may be more accurate to say that there is a failure of nerve on the part of IRBs to exercise this flexibility even when they do understand it.

I often fear that any change in the Regulations will result in less flexibility.

Anyway, those are just some quick thoughts for you... I'm enjoying this blog :)

Thanks for these thoughtful comments. I should hav...

2011-11-23T14:45:38.809-05:00

Thanks for these thoughtful comments. I should have mentioned that the authors do not merely "generalize from their own personal experience and anecdote"; they also cite a number of other publications noting similar problems with IRBs.

I agree that these two researchers could have used some guidance on the limits of confidentiality. Unfortunately, their IRBs seem to have lacked the expertise necessary to provide such guidance, and instead made matters worse. Nor is this surprising. As Joan Sieber noted back in 2001, "There is now a literature of virtually hundreds of approaches to protecting privacy or assuring confidentiality. This literature is rarely sought out by IRBs, researchers, or teachers of research methods. Most are not even aware that it exists. . . ."

The coercive power of IRBs relieves them of the need to achieve and demonstrate true expertise while discrediting the idea of any kind of ethics review. Deregulating social science research might encourage individual researchers and departments to seek out true expertise. See "Michael Rowe on Situational Ethics."

Interesting. I do not see any evidence that the di...

2011-11-23T10:58:12.308-05:00

Interesting. I do not see any evidence that the disconnect is "typical". You'd think researchers would know better than to generalize from their own personal experience and anecdote.

The requirements in the Librett case are clearly ridiculous and contrary to the requirement to minimize risk. The IRB seems to be more concerned about institutional risk.

However, Librett is wrong if he thought he could offer "an absolutely ironclad guarantee that any revelations would never be traceable to an identifiable person." Researchers should never make promises that might not hold up. You'd think a detective, whose job is to identify people who beleive they won't be identified, would no better. Better to describe for the subject the steps taken to greatly reduce the risk. Telling subjects that there is "no risk" is unethical.

In the Perrone case there should be no requirement for signed informed consent because this is covered, as noted, by 117(c)(1). I agree that requiring documentation be made available as an option is stupid but following the minimizing risk requirement elsewhere in the regs an IRB is more than justified in ignoring it. If there are conflicting requirements I think it is fair game for the reviewers have to make a sensible choice.

They allowed her to keep audio recordings and keep keys to the participants identities despite the legal risk? If they were doing their job they'd want to severely limit the collection of identifiable data and the time it could exist in an identifiable state. And if you collect this identifiable data that makes you ineligible for 117(c)(1). It states "the only record" linking is the consent form. If you want that documentation exemption you can't record other identifying data. That doesn't make any sense. I wonder if they required her to get a certificate of confidentiality? I'm skeptical about how effectiveness of CoCs but at least it's something.

Perrone seems to be almost as clueless as she makes her IRB out to be. The part about the option of lying to the court shows really bad judgement.

If a breach of confidentiality creates significant risk, you want to severely limit any data that could be identifying including documented consent. You don't want audio recordings or keys files or anything like that. You want to create de-identified data that can't be re-linked without great difficulty or where there is significant doubt about the validity of the recreated links. If the only links are in the researcher's memory, then there is plenty of room for "I'm not sure who said what". Do enough interviews, and believe me, that's true.

So, where does this leave us? Sure there are IRBs who do a bad job, but there are researchers who need adult supervision.

The time is now to press for a proposed rule that ...

2011-11-05T18:28:06.357-04:00

The time is now to press for a proposed rule that eliminates totally and completely regulation of the social sciences and humanities. The Obama Administration is trying to show its bona fides in deregulation. Eliminating current censorship and torture by IRBs could save tens of millions of hours and billions of dollars a year in wasted "paperwork" and "information collection" costs that are currently illegally imposed in violation of the Paperwork Reduction Act and the First Amendment. The man in charge is Cass Sunstein, head of the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget, and a former University of Chicago professor. It is time for him to earn his pay. The woman in charge is Kathleen Sibelius, Secretary of HHS. We do NOT want to wait until next spring for a conference on the ANPRM, we want a proposed rule (NPRM) this winter, aimed at eliminating IRB review of riskless social and humanities research and at preventing IRBs from even reviewing whether such research is exempt or "excluded." Send Sunstein and Sibelius a message, and enlist thinktank and other external support. Remember that the current rule actually says that 99 percent of all social science is excluded, and doesn't even bother to discuss history and the humanities, which were not ever regarded as human experimentation that even needed to be excluded. The current rule does not give IRBs any authority to review exempt research, let alone to decide whether or not it is exempt. This is a problem that can easily be solved, if only the Administration will face it frontally. The time for academic discussion is over. The time for action is now.

Thanks for this comment. I should have said earli...

2011-11-02T10:55:41.914-04:00

Thanks for this comment.

I should have said earlier that I agreed with you about the "massive flaw in the Common Rule itself," and only disagreed about your reading of the Belmont Report. Both documents cause headaches, and those headaches are aggravated the National Commission's failure to reconcile the Belmont Report with its IRB recommendations, which formed the basis of the Common Rule.

The ANPRM represents an overdue acknowledgment of many of the flaws in the Common Rule, but it fails to ask about the Belmont Report. In my personal comments on the ANPRM, I suggested that "the Belmont Report should be retired and replaced with a statement on research ethics that can be updated to reflect current thinking and experience."

I won't disagree with you on the Belmont Repor...

2011-11-02T10:34:39.199-04:00

I won't disagree with you on the Belmont Report, though the document itself does not acknowledge the limitations you point out. The essential point I was trying to make is that the Common Rule is unambiguous that informed consent is required if there is more than minimal risk to the subjects. Hence, any research on employees that could lead to their firing is presumptively illegal under the rule. Given the almost unbounded scope of activities that count as "research" under the Common Rule, OHRP was essentially fulfilling its bureaucratic mission. The problems (plural) lie with the Rule, not with with some major misinterpretation by bureaucrats. One could certainly argue that in this case the employees weren't really the "subjects" of the research, or that it wasn't really "research" and I don't disagree with those arguments. But if the employees were research subjects, then voluntary informed consent was required. That is a crazy result, and one created by the text of the Rule.

Also, please see Tom Beauchamp's comments on t...

2011-10-27T11:35:51.085-04:00

Also, please see Tom Beauchamp's comments on this matter:

Because the definition is so nonspecific, regulatory requirements that use the definition may judge that some activities that are questionably research involving human subjects nonetheless must be treated as such. Government requirements are today commonly applied even if 'human subjects' may not need to be protected by the rules of human-subjects research. A sweeping – that is, all-inclusive conception – of 'human-subjects research' can have immediate and unjustifiable practical impact on attempts to upgrade medical care . . ."

Beauchamp Derides Federal Definition of Research

Thanks for this comment. I cannot agree that the ...

2011-10-27T11:13:01.153-04:00

Thanks for this comment.

I cannot agree that the Belmont Report is "very clear" on this issue, particularly since it does not conform to the sentiments the commissioners expressed in their deliberation. And rather than specifying "a very narrow range of circumstances" in which consent is not needed, the Belmont Report confesses ignorance about a vast and undefined realm called "social experimentation."

I disagree with your conclusion. Both the Belmont ...

2011-10-27T11:07:56.579-04:00

I disagree with your conclusion. Both the Belmont Report and the Common Rule are very clear that subjects of research must give informed consent in all but a very narrow range of circumstances. Being an employee is not an exception. OHRP is simply following the legal standard set out in the Common Rule. The problem is not its interpretation, but a massive flaw in the Common Rule itself. There are many kinds of research where informed consent should not be required, and it should not be mandated or even presumptively preferred in those cases. This is one of the obvious categories where the rule is wrong and needs to be changed.