Obtaining approval for educational research

Residency Program Insider, February 28, 2006

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Obtaining approval for educational research

There are many exciting opportunities for educational research. While many people involved in GME choose to conduct educational research for presentation at national meetings or for resident educators in their specialty, many would be more likely to do such research if not intimidated by the Institutional Review Board (IRB) approval process.

Before beginning educational research, be aware that there are special considerations that often simplify the process. Educational research is different than biomedical research conducted at medical schools and hospitals, but both types need approval from the IRB, a rigorous and sometimes daunting prospect for potential researchers. However, because educational research generally poses a lower risk to human subjects, special provisions can simplify the process of IRB approval. The Code of Federal Regulations makes provisions for educational research (among other types) to be exempt from IRB approval.

Be aware that exemption from IRB approval does not mean that the research can proceed without submission to the IRB. The individual(s) planning to conduct the research must apply to the IRB for the exemption. Only after written exemption has been granted by the IRB are research activities allowed to proceed.

Most institutions have a straightforward process for granting exemption, such as a simple form that acknowledges the nature of the exemption for which the individual has applied. Educational research usually falls into one of the following categories of exemption:

1. Research conducted in established or commonly accepted educational settings involving normal practices, such as research on regular and special education strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving educational tests and surveys, as long as the subjects are not identifiable.

Research where subjects are identified can usually be approved by the IRB without review by the entire committee, a process known as "expedited review," provided there is minimal risk to the subjects.

When doing research that involves residents or students, remember that these are vulnerable subjects and that they are entitled to special protections. The IRB is especially adamant that residents are not involved in research through coercion or against their will. The research cannot jeopardize the research subjects' employment, and protections put in place to minimize or eliminate these risks must be presented to the IRB. When possible, participation should be anonymous and appropriate compensation for these subjects' time should be provided.

In most cases, the IRB requires a letter of support from the program director. If the program director is the person conducting the research, a department chair, dean, or designated institution official for education should write the requisite letter of support, provided that individual is not a co-investigator or otherwise have a potential conflict of interest in the research.

Finally, be aware that there is no mechanism for the IRB to grant retroactive exemptions or approvals. The investigator must apply for the exemption prior to beginning any research-related activity. Data initially collected strictly for educational purposes can be used for research, provided IRB approval is sought as soon as the decision is made to conduct research with the data.

If there is ever any doubt about the course of action to take, call your IRB office and ask for guidance. Your IRB will also likely have other resources to assist you in the application process.

All the best,

David Chelmow, MD, FACOG

Director of OB/GYN residency program
IRB Chairman for the Tufts-NEMC/Tufts University Health Sciences Campus
Tufts New England Medical Center
Boston, MA

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