1. What does "exempt" mean?
2. What regulations and policies govern exempt research?
3. What kinds of research are eligible for exemption?
4. What kinds of research are not eligible for exemption at Duke?
5. Who makes the decision about whether research is exempt?
6. Can research with children be considered for exemption?
7. How do I apply for an exemption?
8. How long does it take to secure an exemption?
9. I plan to use my own students as research subjects. Can I get an exemption?
10. I am asking sensitive questions, but I will not record names of my subjects. Can I get an exemption?

Q. What does “exempt” mean?

A. Exempt research is research with human subjects, but once approved, it is “exempt” from ongoing review, unless the research is amended in such a way that it no longer meets the eligibility requirements. Also, while exempt research does requires an informed consent process, it is not subject to the same exacting consent requirements as is research reviewed through the expedited and full processes.

Q. What regulations or policies govern exempt research?

A. Exempt research is subject to the ethical principles outlined in the Belmont Report, a statement of principles adopted by the University. Thus, for example, the principle of respect for persons require a consent process that includes full disclosure in manner understandable to subjects and voluntary participation.

Q. What kinds of research are eligible for exemption?

A. There are six categories of activity, defined in the federal regulations that are often risk free and eligible for exemption. The use of exemptions is limited by Duke Policy and subject population. Follow the links for a complete response.

Q. What kinds of research are not eligible for exemption at Duke?

• Research that does not fit in one of the eligible categories of research activity
• Research involving students or employees of the investigator
• Research involving deception
• Research using experimental manipulations of subjects and/or their environments
• Research involving people whose decision-making capacity is impaired

Q. Who makes the decision about whether research is exempt?

A. In accordance with Duke Policy, the determination that research is eligibility for exemption must always be made by the administrative staff of the IRB, rather than by the investigator. This determination must be made regardless of the source of funding and when the research is unfunded. Currently, Lorna Hicks makes the determination. She can be reached at lorna.hicks@duke.edu or at 681-8773.

Q. How long does it take to get an exemption approved?

A. It depends. It can take just a day or two if the application is complete and the investigators (students and their advisors, too) are certified to conduct research with human subjects. It may take longer if there are issues to resolve, for example, the staff may need consultation about assessing risk in a foreign country. Also, 50% of reviews are screenings for exemption, and at times, there may be a backup. It is always advisable not to wait until the last minute.

Q. Can research with children be considered for exemption?

A. The following activities will children are eligible for exemption: 1) research involving normal educational practices in commonly accepted educational institutions, 2) educational testing, and 3) observation in public settings. Research involving interviews, surveys, and participant observation will be considered on a case-by-case basis

Q. How do I apply for an exemption?

A. Submit the form called Request for Protocol Approval, unless your research is limited to the analysis of secondary data. In that case, submit the form called Request for Protocol Approval for Secondary Analysis of Existing Data. The same forms are used for all three types of review, including screenings for exemption, expedited review, and full review. Questions in the forms may not apply to your research. Just respond to the ones that do.

Q. I plan to use my own students as research subjects. Can I get an exemption?

A. Duke Policy requires full review when the subjects are students or employees of the researcher.

Q. I am asking sensitive questions, but I will not record names of my subjects. Can I get an exemption?

A. Probably not. While anonymity will prevent the inadvertent disclosure of the subjects’ responses, asking sensitive questions may pose other kinds of risks, such as emotional distress in research about trauma. When the subjects will be exposed to risk, the IRB or an expediting reviewer needs to assess the risk management strategy.