Thursday, December 27, 2012

Is Ethics Review Like a Building Permit?

In the course of his response to Dyck and Allen, David Hunter also challenges claims by Whitney and Schneider that ethics review costs lives by delaying research for months or years. I am unpersuaded by Hunter's claims.

Hunter writes,

People often complain about the need for council approval for building projects because these approvals delay projects from being completed. Does this mean that council approval makes builders significantly less efficient? Well, unless they actually down tools until they have approval, no it does not; instead, what happens is that they work on another project until approval comes through. Hence it would be wrong to say that the need for council approval makes builders less efficient even if it does slow down specific building projects. It is likewise mistaken to think that regulation of this kind will mean less houses will be built in a specific time period; while specific houses may be delayed, overall the same amount of building work will go on.

The same holds true for researchers: while they wait for research ethics approval they are not simply sitting around doing nothing having downed test tubes; instead, they will be working on other things including other research projects and new proposals. Hence while research ethics regulation might delay specific projects it does not dramatically decrease the amount of work that the researchers involved are doing. Insofar as their work is saving lives they will still be doing that regardless of the length of time the approval process takes. In other words, roughly the same quantity of research is being carried out even if specific research projects are delayed. Some researcher time will be taken up by filling in ethics forms, attending meetings and so on. However, much of this time will either be valuable work (by encouraging the researchers to think through the ethics of their project) or parasitic on existing work such as writing up a research protocol. While there is no doubt some delay here it is on a relatively small scale compared with the claims of Whitney and Schneider.

The second part of this argument--that filling out forms imposes delay "on a relatively small scale"--does not address accounts that ethics approval alone can consume hundreds or thousands of person-hours and consumer up to half the funds of a research project. Nor does it address the claims by Roberts et al. that "consent rituals" can delay urgent treatment, obscuring its effect.

More intriguing, though, is Hunter's comparison of scientific research to building construction. If you are waiting for a permit on one project, he asserts, you can work on another.

I have doubts about this analogy, which Hunter offers strictly as an armchair exercise, with no references to studies of the building industry. First of all, for large projects, increased regulation has indeed slowed down the overall pace of building. In writing my first book, I interviewed engineers who told me that their work had become vastly more complex after the passage of the National Environment Policy Act, which required environmental impact statements for federally funded projects. These statements had ripple effects in time and money, since the transit authority or other organization could not simply go into suspended animation while awaiting approval. While I tend to think that environmental laws do necessary work balancing the costs and benefits of major projects, it's pretty clear that they make infrastructure harder to build.

Perhaps Hunter was thinking of smaller projects (he mentions houses) that face less regulation. If so, I find this version of the analogy doubtful. While cutting-edge architects may respond to one another's projects, for the most part, one house can proceed without reference to another. Hunter seems to imagine that scientific research teams can also run multiple, simultaneous projects on wholly independent schedules, so that delay in one will not hamper the others.

But I thought that scientific research is supposed to build on previous projects. Thus, creating knowledge is less like erecting buildings and more like breeding animals. The longer each generation takes to mature, the longer until the breeder achieves the desired results. Three simulataneous research projects each taking three years will be less valuable than three projects that each takes one year, with each new project building on its predecessor.


BPiper said...

Hunter also ignores the problems encountered by graduate students who must obtain IRB approval before starting their masters or doctoral research. Those students don’t have other research that they can work on while waiting, and this can make a difference in their lives. In our experience, for example, a distressing number of M.A. students in anthropology who would like to finish their degree in 2 or 3 semesters end up spending another semester because of IRB delays. At a private university that does not offer tuition support to masters level graduate students, this delay can be extremely expensive. Our doctoral students have it a little better, since their proposals are typically submitted for IRB approval at the same time that those proposals are submitted for external funding, and the IRB approval normally gets sorted out earlier, but we do have the occasional student who gets set back one or two semesters because of some red flag in their proposal – red flags that invariably (in my 30+ years of experience) turn out to be chimeras.

Zachary M. Schrag said...

Thanks for this comment. You are quite right that the IRB hammer falls hardest on graduate students.

Hunter may have been thinking specifically about the life-saving medical research discussed by Schneider and Whitney, not the social sciences. But even here, delaying graduate education in the way you describe may cost lives. As the President’s Council of Advisors on Science and Technology recently noted, "Overly long times to degree are costly, waste precious graduate education resources, and serve as a disincentive for attracting bright minds to STEM fields." Excessive IRB delays thus threaten the scientific enterprise at the graduate student level.