Human Subject Review as Resource (Reply to CRTNET #6414).

Submitted to CRTNET

(see also my prior post: IRBs and Revolutions)

Phil Backlund does the discussion a great service with the wonderful example of the Human Subject Review (IRB) process gone wrong. The note cited is "ludicrous", and I suspect intentionally so. It is often difficult to differentiate protest, in the form of irony and satire, from serious statements. One suspects that the note in question was written as a protest against the current IRB process. Ironic, satirical, or serious, however, the note nicely illustrates what is wrong in the current process.

IRB's are being used as an anticipatory judicial mechanism. That is exactly how the note treats its local Human Subjects Review Board in the suggestion that the research "can NOT move forward ... without first getting approval from the HSRC Office". The treatment is reinforced in the assertion that "if they gain approval and implement the survey, it should also be made very clear that the ASCWU-BOD could be legally responsible for any inappropriate use of the information or any unintended harm ... that might result from participation". It should not be. This is NOT what an IRB should be, and I do not believe that the current legislation requires it to be such.

IRB's should be a resource with limited veto power. As a resource it should have two purposes. First, in conformance with Federal requirements that Federally funded research be reviewed by an IRB, it should provide such Federal reviews as a service to the grant process. Second, regardless of funding source (and going back to the pre-legislative purpose of Human Subject Review committees, they should act as a resource in those rare cases where the researcher can reasonably project that there is a possibility of harm associated with the research. As a resource they should seek to help the researcher to minimize the prospect of harm and to set up mechanisms such that harms can be recognized and rapidly remediated if they occur. If the prospect of harm is too great and/or if it is difficult or impossible to recognize and rapidly remediate harms, the IRB should have the right to say no. If, however, the prospect of harm can be minimized, the institution should be willing to share responsibility for the research (just as they will share the credit).

If, on the other hand, there is no reasonable prospect that a piece of research will result in harm, the IRB should not be involved unless its review is formally required under the terms of Federal or other funding. The research cited by Phil Backlund appears to be a classic case of research that should not need IRB approval, as the funding sources are local and there does not appear to be any reasonable prospect of harm associated with the research. In my last post I proposed that a small number of questions should be sufficient to free the IRB from formally reviewing a broad range of research. I propose an amended version of that list of questions here:

  1. Does this research require Human Subject Review under the terms of Federal or other funding?
  2. Does this research involve manipulation of subjects (as opposed to observation of subjects or manipulation of content), whether physically, socially, or psychologically?
  3. Is there any reasonable prospect that this research will result in harm to subjects?

If the answer to all three of these questions is no, the IRB should simply collect the paperwork and remind the researcher that they are personally/organizationally responsible for any harms that result from their research. This reminder could easily take the form of a signed statement of responsibility on the same piece of paper that the questions are on. If the answer to any of these questions is yes, then the IRB should act as a resource to help review and minimize the prospects for harm associated with the study.

Davis Foulger (
Visiting Associate Professor
Oswego State University