The information below provides context and guidance for our most Frequently Asked Questions. If you don’t find what you’re looking for, please reach out to an IRB staff member!
If you have a research question, and are engaged in a systematic investigation intended to contribute to generalizable knowledge, you are engaged in Research as defined by the regulations.
If you are conducting Research that involves the collection or analysis of information about living individuals, or uses people in a manipulation or intervention, those individuals are considered Human Subjects.
Duke University’s Federalwide Assurance (FWA) with the US Department of Health and Human Services mandates that all Research with Human Subjects must be approved by the IRB before any interaction with human participants can may begin.
Protocol forms for submission should be uploaded directly from our website, and submitted by email to campusIRB@duke.edu.
The time between protocol submission and IRB approval depends on several factors including: the level of risk imposed on participants, necessary approvals or agreements by external parties/data providers, and whether your protocol application requires clarification or revision. In general, the IRB process can take 4-6 weeks. However, amendment requests are given priority, and very low-risk projects and “exempt” studies are often reviewed in less time.
Please note that the IRB approval process includes assistance from an IRB specialist, whose primary goal is to help you get your protocol in as “approvable” a state as possible before review. This “pre-review” process begins upon receipt of your IRB submission to campusIRB@duke.edu.
The “Exempt” category of research review is a bit of a misnomer. Federal regulations allow research that carries negligible risk to participants to be reviewed as Exempt. Exempt studies still need IRB review and approval; however, they are exempt from federal regulations that require the mitigation of risk to participants, as there are no risks.
Nuance and interpretation are inherent to applying federal regulations to social, behavioral, and educational research. For example, data scraped from social media sites may be categorized as Exempt, or require an Expedited review, or may not even qualify as research with human subjects. If your research involves a data security plan, vulnerable population, or the use of deception, the IRB will not categorize your project as Exempt.
Please allow the IRB to make this determination for you. If you are unsure about which form to submit, or whether your project qualifies as research with human subjects, please contact the IRB.
Review categories as defined by federal regulations, but a general guideline can be explained by considering the level of risk imposed on research participants.
Exempt Studies impose negligible risk to participants and can be reviewed and approved by the IRB Director or Assistant Director.
Expedited Review (most common) is offered to studies that carry minimal risk to participants, and are approved by an IRB member, typically on Duke faculty.
Full Board Review (least common) is required for studies that involve greater than minimal risk to participants. Studies that go to Full Board are discussed at length and voted upon by a diverse membership, and often result in minor requests to the research team to include better mitigation of risk to subjects. Please see the Full Board Review schedule to plan for submission deadlines.
If your project involves identifiable and sensitive data, you will need a plan for the safe collection, keeping, and analysis of that data. Projects that require a data security plan are forwarded to the Information Technology Security Office (ITSO) as part of the IRB approval process. You may need to reach out to your departmental IT staff person for technical questions about your data security plan before submitting your protocol to the IRB.
I am collaborating with non-Duke researchers. Can I include them on my IRB protocol? Can they include me on theirs?
The Campus IRB provides oversight of Duke affiliated researchers only, and typically expects collaborators to obtain their own IRB approvals at their respective institutions. However, a single IRB approval can be less burdensome for researchers working in close collaboration.
Depending on how and by whom the data are collected, stored, and analyzed, the Campus IRB may enter into an IRB Authorization Agreement (IAA) with a collaborator’s IRB, whereby one institution extends oversight of a researcher from the other institution, if both IRBs agree this is an appropriate arrangement. External researchers who rely on the Campus IRB will be expected to complete Research with Human Subjects training at their own institution and furnish certification before signing an IAA.
Research participants should always consent to their involvement in your project, but documenting their consent can be difficult, and sometimes even inappropriate. For research involving video conferencing, the IRB suggests emailing participants consent language ahead of the scheduled Zoom to give them time to think about whether they want to sign on. Once the meeting begins, researchers should confirm participants have had a chance to read the consent form and reiterate key points, allow them to ask questions, and then obtain verbal consent. It’s a good idea to document the date verbal consent was given and to whom.
Please check with your department manager about any required documentation if you plan to compensate research participants. If funds are being managed by Duke, you may need to collect social security numbers from participants. Your IRB specialist can help guide you with planning for the consent and safekeeping of obtaining such sensitive information.