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writing on boardAvoiding Common Mistakes in a General Request for Exemption Determination

Failure to Identify the Proper Exemption Category:

In order for a research project to be considered exempt, all research activities must fall into one or another of the exemption categories. The General Request for Exemption Determination form guides you through the process of establishing which of those categories your project falls into. In filling out that form you are presenting evidence for an exemption claim. Don’t forget to explicitly indicate which specific exemption(s) you are requesting near the end of the form in the section entitled Jointly Attesting to Exemption.

Failure to Consider the Risks to Participants:

The IRB forms that you complete for your study include sections in which you are asked about the risks to participants that your study presents. For some reason, many people who fill out these forms fail to understand the purpose of that section, and write things like "The risk is that the participants will not agree to be in my study." That is, of course, not a risk to participants, but rather a risk to the researcher, which is largely irrelevant to the purpose of this section. What we need to hear about is the extent to which participation in your research project raises risks to the participants’ physical or mental health, reputation, future opportunities, right to privacy and so on.

It may seem odd to talk about reasons not to do your study on a form whose purpose is to apply for permission to do your study, but you should notice that after identifying the risks, you are invited to identify the things you plan to do in order to eliminate or at least minimize those risks. Your goal here is not to hide risks to participants, but to demonstrate that you understand them, and that you’re planning in advance to take appropriate precautions. Even research that might otherwise contain fairly significant risks can be approved if effective procedures for reducing those risks are put in place. But if you fail to identify risks to your participants, you can be sure that the IRB reviewers will identify them, and send you back to the form to revise your proposal before it can be approved.

Misunderstanding of the De-identification Standard and When it Applies:

You may be surprised at how strict the de-identification standard is (as you read Appendix B of the General Request for Exemption Determination form). It only makes more sense when you understand the larger context of when and why it applies. For exemption Category 2 (for specific procedures), it becomes a standard for determining that a research project can still have no more than minimal risk even when it involves sensitive data that would be sensitive if disclosed. For exemption Category 4 (archival research), it becomes a standard for demonstrating that privacy is still guaranteed even though the collected archival information is not publicly available.

If you are requesting exemption category 2 or 4, here more specifically is the de-identification question you will be asked: "Will information obtained be recorded in such a manner that participants CAN be identified directly or through identifiers linked to the participants?

This question is not only about whether or not participants can be identified in the reports or presentations that you do on your study after it is completed. Instead, the higher standard you say you are meeting—when you answer "no" to this question—is that the data itself as collected and recorded by you do not have information by which the participants can be identified. A common mistake is not to include yourself as person who might identify the participant.

  • The standard means that neither you, yourself, nor anyone else would be able to identify a particular participant from the recorded data.

Obviously, if your forms include a space for the participants to write their names or if you write down their names in your observational notes, you have not met the de-identification standard, even if those names never appear in the papers you write or the presentations that you do with your research results. But also, the standard is much higher. You only meet the de-identification standard if the data as collected and recorded are truly anonymous. For this reason, you need to read Appendix B on the form carefully, and review the list of direct and direct identifiers it notes. A common mistake is to overlook that you have to think about your research setting in order to to be able apply the standard. For example even knowing someone is a male might become an obvious indirect identifier if there is only one male in an organization!

Even if you do not need to fully meet the standard as an explicit requirement for a particular exemption, Appendix B still helps you think about how to maintain confidentiality and avoid inadvertent disclosure of information, especially when you are reporting your results

MINIMAL RISK: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [Federal Policy 45 CFR 46.102(i)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
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