Human Subjects Research (IRB)

If you are conducting research with human subjects, you must secure approval from the Campus Institutional Review Board (IRB) before you collect information or access data. While this page is intended to provide basic information about the IRB process in regard to your MP, the staff at the Campus IRB office are happy to answer any questions via email, phone, or in-person.

The IRB

An Institutional Review Board, or IRB, is a committee designated to review and approve research with human subjects. At Duke, the Campus IRB is made up of Duke faculty and staff, as well as local community members.

Research with Human Subjects

A study is considered research with human subjects if it meets the definitions of both research AND human subjects:

Research: If you are conducting a pilot study or have designed a study to collect information in a systematic way to answer a research question, your project meets the definition of research.

Human Subjects: If you are collecting information from or about people, through an interaction, intervention, or observation, or you are using an existing dataset that includes identifiable information about people, then your project meets the definition of human subjects.

To meet the definition of research with human subjects, you must be conducting research and obtaining information from or about human subjects.

Because research is the gathering of information for the purpose of creating generalizable knowledge that can be applied to other similar situations, the Nicholas School treats all MP work as “research.” The question then becomes whether your MP involves “human subjects.”

“About what” VS. “About Whom”

To meet the definition of human subjects, you must ask “about whom” questions. If your data include responses only to “about what” questions, you do not have “human subjects” and will not need IRB approval.

Examples of “about what” questions:

  1. “What are some of the barriers to the acceptance of pollution-free cook stoves?
  2. “When did the energy efficiency program take effect?”
  3. “Does your organization support anti-fracking legislation?”

Examples of “about whom” questions:

  • “How often do you visit the Duke Forest?”
  • “Would you pay a fee in order to preserve this wetland?”
  • “What conservation organizations do you belong to?”

Questions about your respondents’ attitudes, opinions, preferences, behavior, experiences, or characteristics, are all considered “about whom” questions.

Gathering information from experts is often not research with human subjects if you are only interested in what they can tell you about an issue, a process, a policy, or an organization (“about what”) instead of the experts themselves. However, if you are also interested in the experts’ educational background or employment history (“about whom”), then you may be doing research with human subjects.

Other Distinctions
  1. Work done solely for the purpose of learning a research instrument or method is not considered research and does not require IRB approval. 
  2. Work done solely for the purpose of a program evaluation or program improvement is not considered research and does not require IRB approval.
Dual-use Project

Dual-use projects have both program evaluation/improvement and research components. They usually involve internships with non-governmental organizations, local government, associations, or consulting groups. In a dual use project, the data you collect will be given to the organization and also used for your MP.   When conducting dual-use projects it is very important that your subjects know you have two different roles. The IRB has a consent form model that shows how to describe dual roles.

Submitting a Protocol for IRB Review:
  • If your MP needs IRB review, you must submit a protocol application.
  • If you will be gathering your own data, you should complete the Request for Protocol Approval form.
  • If you will be analyzing data collected by someone else, you should complete the Request for the Secondary Analysis of Existing Data form.
  • In some cases, you may be able to submit a Screening for Exemption request. Please contact the IRB to determine whether your research meets the “exemption” criteria to avoid completing the wrong form.

Important note: If you are collaborating with a non-Duke organization then contact the IRB before completing a protocol application.

Certification

Before the IRB can approve a protocol, all members of the research team (including advisors) must complete training in the conduct of ethical research with human subjects. Advisors who have already gone through the IRB process are most likely certified. 

The IRB website provides more information about certification, including step-by-step instructions for completing the required training online.

Research Conducted Without Approval

The Campus Human Subjects Protections Program works with investigators to protect the rights and welfare of research participants as required by federal law and Duke policies.

In the event that you have conducted research without approval, it is imperative that you stop data collection or analysis and contact the IRB. If data collection or analysis has concluded, you must also contact the IRB before using the information in your MP.

Contacting the IRB

You can contact the IRB office at 919-684-3030 or campusirb@duke.edu. Their office is located at Erwin Square: 2200 W Main Street, Suite 710, Durham, NC 27705. The IRB also holds on-campus office hours. Appointments are recommended.