Claim of IRB Exemption

Many research projects involve studying people but are exempt from IRB review. In some cases, these projects are exempt because the interview subjects – as human beings – are not the subject of the inquiry. Instead, the project deals with the public role of these individuals. In other cases, the questions being asked are simply not sensitive, and we can reasonably claim that the research does not pose a risk of harm to subjects. If you believe that your research project is exempt from IRB review, please elaborate on your claim below.

In submitting this form, you asking the appropriate IRB representative to grant your project an exemption from IRB review. The researcher can not make the determination herself or himself.

Principal Investigator:

Title of Project:

Brief Summary of Project Research Question:

Brief Summary of Research Design:

Justification for Exemption. Federal law lists the following forms of research as exempt from IRB review (indicate all that apply):

Research is on educational methods or evaluation in a normal educational setting.
Research involves tests, surveys, or observations of public behavior without collecting any information to identify the subjects.

Research involves no sensitive information (i.e., no physical, psychological, or social harm would come to the subject if he or she were identified with the information collected).
Research involves public (elected or appointed) officials in their public roles.

Research involves publicly available information or documents.
Research involves the collection or study of existing data, documents, records AND the information is recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects.

Research or demonstration projects evaluate, or otherwise examine public benefit or service programs.
Research involves taste and food quality consumer acceptance studies of wholesome food.

All the human subjects components of the research design fall into at least one of the above exempt categories. Yes No

Unit Designee, IRB Chair, or other IRB representative:

The proposed research is/ is not exempt from IRB review.

Signature:

Name:

Date:

Examples

Research is on educational methods or evaluation in a normal educational setting. You might introduce a “pre-test” teaching methodology in one section and compare the final exam test scores of students in and not in the pre-test section.
Research involves tests, surveys, or observations of public behavior without collecting any information to identify the subjects. You can observe and record how people passing a homeless person on a Washington street react to him or her.

Research involves no sensitive information (i.e., no physical, psychological, or social harm would come to the subject if he or she were identified with the information collected). You can ask people which brand of toothpaste they prefer and why.
Research involves public (elected or appointed) officials in their public roles. You can ask President Clinton how the Lewinsky issue is affecting his ability to govern.

Research involves publicly available information or documents. You can use Washington Post reports of leaks from the Kenneth Starr investigation.
Research involves the collection or study of existing data, documents, records AND the information is recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects. You have access to data someone else has collected, and all demographics that would provide unique identifiers have been stripped.

Research or demonstration projects evaluate, or otherwise examine public benefit or service programs. You can accept a contract from the USDA to set up a demonstration project to test a new model for delivering WIC benefits.
Research involves taste and food quality consumer acceptance studies of wholesome food. You can have people take the “Pepsi Challenge.”