Schrag on updating the IRBs

Zachary Schrag has a PDF up on recent efforts to update IRBs. Count me in as vehemently in favor of two of the proposals that are apparently up for discussion.

First, there is the coverage of fields that simply don't have the human risks that medical research does:

Define some forms of scholarship as non-generalizable and therefore not subject to regulation. As noted above, the current regulations define research as work “designed to develop or contribute to generalizable knowledge.” Since the 1990s, some federal officials and universities have held that journalism, biography, and oral history do not meet this criterion and are therefore not subject to regulation. However, the boundaries of generalizability have proven hard to define, and historians have felt uncomfortable describing their work as something other than research.

I would add computer science to the list. A cleaner solution is as follows:

Accept that the Common Rule covers a broad range of scholarship, but carve exceptions for particular methods. Redefining “research” is not the only path to deregulation contemplated by the ANPRM, so a third possibility would be to accept Common Rule jurisdiction but limit its impact on particular methods.

Schrag's PDF gives limited attention to this option, but it seems the most straightforward to me. If a research project involves interviews, studies, or workplace observations, then it's just shouldn't need ethics review. The potential harms are so minor that it should be fine to follow up on reports rather than to require ahead-of-time review.


Schrag also takes aim at exempt determinations:

Since the mid-1990s, the federal recommendation that investigators not be permitted to make the exemption determination, combined with the threat of federal sanction for incorrect determinations, has led institutions to insist that only IRB members or staff can determine a project to be exempt. Thus, “exempt” no longer means exempt, leaving researchers unhappy and IRBs overwhelmed with work.

Yes! What kind of absurd system declares a project exempt from review but then requires a review anyway?

IRBs under review

There are several interesting blog entries up at blog.bioethics.gov concerning the ongoing presidential review of Internal Review Boards.

I liked this line:

“We pushed for an ethical reform of system, real oversight, and now we are left with this bureaucratic system, really a nitpicking monster,” Arras said, addressing Bayer. “And I am as stupefied as you are.”

I am not sure why this pattern would be stupefying. A great many things that people attempt to do don't work out as intended. IRBs are just one more for the list, albeit one that has lingered for decades.

I am not as sanguine about the reviewers about this conclusion about whether another "Guatemala" could happen:

“Of the many things that happened there, no, it could not happen again because of informed consent,” said Dafna Feinholz, chief of the Bioethics Section, Division of Ethics and Science and Technology, Sector for Social and Human Sciences, United Nations Educational, Scientific and Cultural Organization.

The idea is that since IRBs require informed consent of study participants, the Guatemala experiments could never again happen, because the study participants would know what is going on.

I hope so, but consider the following evil scenarios:

• A wealthy autodidact negotiates directly with local authorities and runs the experiment on his own dime. No university is involved, so no IRB review even happens.
  
• A university researcher learns about a disease outbreak in some part of the world. The researcher waits two years and then applies for a research grant to study the effects of the disease. Since the researcher did nothing for the first two years, there was nothing for the IRB to review.
  
• The Professor Muckety, Chair of Hubert OldnDusty at BigGiantName University, announces a grand new experiment that he expects will cure cancer. He invites all of the upcoming faculty in his area to take part in it, and there will be numerous papers and great acclaim to all the participants. The IRB at BigGiantName U.'s is stacked with faculty that are totally brainwashed into thinking the experiment is for the greater good. Will they really take a stand against the project?
  

I would not be so sure that, despite all the efforts of IRBs, an evil experiment couldn't happen again.

Whenever something goes wrong, there is a natural reaction for everyone to yell, "DO SOMETHING!" IRBs are the result of such an outcry. They are there to project human subjects, but I don't believe they are very effective at that. I believe that the MucketyMucks largely breeze through the red tape doing whatever they like, and instead we are staffing a bunch of bureaucrats to check that the smaller players filed form T19-B in triplicate, double spaced and typed with a manual type writer.

To improve on the current mess, carving out a large exempt category would be a large improvement. Surveys, observations, and other experiments with minimal opportunity for harm shouldn't need prior review.