The Academic Exchange What constitutes an IRB review?

Professor Karen Hegtvedt The principal investigator (PI) completes the application form and attaches some documents: a research protocol, describing the work and methodology; data collection instruments, such as questionnaires and interview questions; consent documents. We recognize that in much of that research the PI is not submitting every possible question, but it gives us at least a flavor of the general categories. Consent documents allow us to understand the study and assess the benefits and risks. We also want to make sure the PI understands what he or she must do to protect the rights of the study participants. The PI gives the application and documents to the department or division human subjects review coordinator. That person looks through all the materials for completeness and consistency and then recommends to the IRB whether the project should receive exempt, expedited, or full board review. If it’s exempt or expedited, as most humanities research is, it comes directly to me. If it’s full board review, then all board members see it.

We want to figure out ways for the PI to achieve standards demanded by federal regulations without compromising the integrity of their approach. I think one of the challenges is that humanists don’t think of their research participants as subjects because they are not being acted upon [as in biomedical research]. But the regulations say that a human subject is anyone from whom an investigator obtains information for the purpose of research.

AE Why is informed consent so critical?

KH The consent form tells the subject about the study so he or she can make an informed choice about participating. The consent document is key to protecting the participant’s rights through statements of voluntariness, confidentiality, benefits, risks, etc. The participant has the right to know what types of questions will be asked and to say, “I’m not going to answer this,” especially if it makes him or her uncomfortable. Although the typical way to get consent is by having the subject read a written document and sign it, other means achieve the same end without a written form. If the PI can convince us it’s reasonable and appropriate to deviate from the standard consent procedures, we are likely to approve it.

AE If a federal audit found problems with non-federally-funded research or even unfunded research, could federal funding get pulled?

KH Yes, although that scenario may have a low probability. It would depend upon the severity of the consequences of the non-compliance and the frequency of it. We’ve had a couple of instances of non-compliance. For example, somebody started collecting data before getting approval and then applied to a granting agency that wanted evidence of IRB approval. The board reported the non-compliance to the [Federal] Office of Human Research Protection, who in turn allowed the board to determine the punishment. We could have asked the PI to destroy his data. But in this instance, we informed the granting agency that the researcher did not follow proper procedures.

AE One common concern is that a scientific model is being forced on non-scientific research.

KH I do admit that in some ways, we’ve gotten more like the committees that review invasive, biomedical research involving human subjects. But I also think that claims that we are following biomedical standards are overstated. We do have flexibility. We see ourselves there to facilitate the mission of research, rather than to hinder it. The committee is very sensitive to different forms of research. I’m having to learn about humanities research. Are they trying to create generalizable knowledge? Not in the same sense as sociologists trying to make statements about society. But oral histories, for example, are in some ways generalizable knowledge. More people in the humanities are adopting social science methods—questionnaires and interviews—but they know little about the methodologies because it’s not part of their training. So the IRB requirements came as a big surprise.

AE What of the fears that this process infringes on academic freedom, that it’s controlling?

KH I’d rather not think of it as controls on research, but as a means to make us more responsible researchers. There are definitely costs in time and energy. But going through this process gives the PI help in thinking through some of the issues to ensure protection. Sometimes researchers don’t realize the implications of their data collection approaches. IRB approval is one more hurdle to undertaking research. But as employees of a university that receives federal funds, we’ve got to be in compliance with the law. From my understanding, those laws trump the custom of academic freedom.