Human Subjects Research (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.

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 staffat the Campus IRB office are happy to answer any questions via email, phone, or in-person.

Why is IRB approval important?

To uphold the safety and well-being of human participants
To guarantee adherence to the ethical values and principles underlying research
To ensure that only ethical and scientifically valid research is implemented
To alleviate concerns about the responsible conduct of research

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.

Research with Human Subjects

There are three relevant definitions: research, human subject and documentary. A study needs IRB review and approval when it meets definitions for research and human subjects; a participant release waiver is needed when producing a documentary.

Defining research is relatively straightforward. Research, according to the federal regulations, paraphrased, is a systematic investigation designed to produce generalizable knowledge.

Defining human subjects is more complex. Even though a project involves interviews, focus groups, and other research methods associated with research with human subjects, it may not, in fact, constitute research with human subjects. Determining whether human subjects are involved depends on the questions asked.

In some cases, students do not intend to conduct research, but rather produce a documentary about a specific subject. A documentary is a non-fictional accounting of an issue, either in writing or video, that is intended to document reality, primarily for the purposes of instruction, education or maintaining a historical record.

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:

“What are some of the barriers to the acceptance of pollution-free cook stoves?
“When did the energy efficiency program take effect?”
“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?”

If you ask people in the community how the programs have affected their livelihood, decisions about recreation, their opinions about the role of the US government in administering land trust programs, these are “about whom” question. This type of research would require IRB review.

If you ask fishermen if they know about the regulations regarding illegal by catch, that is an “about whom” question. If you ask members of a conservation organization for data about illegal bycatch, that is not an “about whom” question.

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

Work done solely for the purpose of learning a research instrument or method is not considered research and does not require IRB approval.
Work done solely for the purpose of a program evaluation or program improvement is not considered research and does not require IRB approval.

Ethical Issues

Even if research does not constitute research with human subjects there are still ethical issues to consider. When a researcher asks someone to do something, such as carving out time for an interview, they need to provide that participant with some information.

Prospective informants need to know who you are, who you represent, what you will ask of them, and what you will do with the information they provide, including whether or not quotations will be attributed to them. In reality this looks a lot like an informed consent form, but does not need to be signed or reviewed by the IRB office. Securing signatures would be at the discretion of the researcher.

In the case of documentary production, the act of filming or recording information from an individual can create vulnerabilities for that individual. If you intend to release information into the public domain it is advisable to work with the Duke Center for Documentary Studies to ensure protection of participants and obtain a consent for release waiver, and to consult with Duke Campus IRB on dissemination plans for resulting products.

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, found on the IRB Forms Page.
If you will be analyzing data collected by someone else, you should complete the Request for the Secondary Analysis of Existing Data form, found on the IRB Forms Page.
In some cases, you may be able to submit a Screening for Exemption request, found on the IRB Forms Page. 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.

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. To schedule a consultation, contact an IRB staff member or email Renee McQuaig at campusIRB@duke.edu. Staff can meet with researchers by phone or video conferencing (Zoom, WebEx, Teams).