Lead Undergraduate Researcher
For IRB purposes, undergraduate students working on a team protocol will need to identify a Lead Undergraduate Researcher on the Undergraduate Student Request for Protocol Approval application. The purpose of identifying a Lead is to help the IRB staff know who will be the primary contact on IRB-related communication.
Other members of the team and the faculty advisor(s) will still receive emails and notices.
The Lead Undergraduate Researcher is not a fixed role on a protocol. Research teams can identify a new Lead Undergraduate Researcher if the student currently listed graduates.
All researchers at Duke must complete the research with human subjects certification requirement before the IRB can approve a protocol submission.
Note that undergraduate students conducting summer research have different certification requirements than students carrying out research throughout the school year.
As described in our policy on advisors, Duke undergraduate will need to identify a faculty advisor on their Undergraduate Student Request for Protocol Approval application. The IRB cannot appove an undergraduate student protocol without a faculty advisor. While a student may be the primary researcher on a protocol, the IRB considers the faculty advisor the responsible investigator. The faculty advisor will need to attest that they will take responsibility for the conduct of the research by signing the assurance section of the protocol application.
Students should meet with their advisor to go over drafts of the protocol before submitting it to the IRB.
The listed advisor on the protocol application does not need to be the undergraduate’s major advisor.
Collection of Sensitive Identifiable Information
The Campus IRB takes very seriously the privacy and confidentiality concerns of undergraduate students, especially when researchers intend to collect sensitive and identifiable information about them.
Examples of sensitive information about undergraduates include but are not limited to: financial aid status, illegal or unlawful behavior (e.g. drug use, underage drinking), medical history (e.g. prescription medication), sexual history, violations to the Duke Community Standard (e.g. cheating), and other sensitive topics (e.g. suicidal ideation, sexual assault).
To protect the privacy of undergraduate students participating in studies that collect sensitive information, undergraduate student researchers should avoid, to the greatest extent possible, collecting identifiable information about students.
Examples of information that could identify undergraduate student participants include their names, contact information (e.g. email addresses), Unique ID or NetID, and sharing unique information about themselves, such as specific experiences or any number of individual characteristics that, when combined, could lead to the deductive identification of who they are (e.g., gender, race/ethnicity, year in school, and major).
When the collection of sensitive and identifiable information is unavoidable, undergraduate student researchers may be required to enlist the involvement of a non-undergraduate student (e.g., graduate student member of the team, faculty advisor, or another third party) to strip the identifying information from the study data before it is made available for analysis.
Research applications made by undergraduate students that involve the collection of sensitive and identifiable data about their fellow undergraduate students will be considered on a case-by-case basis.
Periodic Check-in of an Approved Protocol
Generally, approved protocols are assigned an expiration date that is 364 days from the approval date.
Undergraduate students who intend to continue conducting research under an approved protocol must submit a Periodic Check-In form before the protocol’s expiration date. The Campus IRB will accept this form only if a student listed on the protocol is still enrolled at Duke.
If the research will continue after the Lead Undergraduate Researcher has graduated from Duke, the research team will need to identify a new Lead Undergraduate Researcher.
Once all students listed on a protocol have graduated, the protocol must be closed.
The only exception to this policy is if a faculty advisor listed on the protocol informs the IRB that he or she will assume primary investigator responsibilities before the protocol is closed. At that time, the protocol is no longer considered an undergraduate student protocol.
Retention of Research Records
Undergraduate students who have graduated from Duke can take their research data with them, only if the research data has been completely de-identified. Students cannot take any identifiable data from Duke upon graduation.
Research records that will not be taken with the student must be destroyed or retained by the faculty advisor.
Other Resources for Undergraduate Researchers
For information about research opportunities, visit the Undergraduate Research Support Office.
For help on survey design and methodology, visit the Duke Initiative on Survey Methodology.
For help on qualitative and ethnographic research, visit SSRI’s Initiative on Qualitative, Ethnographic, and Mixed-Methods Research.