Regulatory Training Requirements
All students engaged in any research activities must complete a set of Duke-mandated training courses. These should be done as early as possible and are required before participating in any type of research.
Required:
- Biomedical Research with GCP - Basic/Refresher
- Vulnerable Subjects - Research Involving Children
- Vulnerable Subjects - Research Involving Prisoners
- Vulnerable Subjects - Research Involving Pregnant Women, Fetuses, and Neonates
Recommended:
- Race in Clinical Research: Ethics and IRB Decision Making
Responsible Conduct of Research (RCR) training
Required:
- RCR requirements administered by The Graduate School
Recommended:
- Online CITI RCR (instructions)
All students should have completed all modules by October 31 of the first semester
LMS Annual HIPAA Privacy and Security Training module
LMS New Workforce Member Policy Acknowledgement module
Institutional Review Board (IRB) Approval
All research for students in DPHS is governed by the requirements of the Duke Health IRB. For research assistant work, this is typically an IRB owned by the advisor or other principal investigator.
All students must receive Duke Health IRB approval before beginning any research activities. This includes projects related to the advisor’s work. Students are expected to complete the IRB process themselves, with support from their advisor. For IRB approval, students need to make sure their email address registered with the CITI Training site is in the format NETID@duke.edu. The iRIS Support Page FAQs have detailed instructions.
Other Institutional Approvals and Research Requirements
Students must follow the same research requirements as other faculty and staff. It is not possible to anticipate the requirements for every situation, but common approvals are related to data security plans, contracts between institutions, and clinical quality management plans.
Students should work closely with their advisors to ensure they are meeting all requirements. My Research Path should serve as a primary resource to identify needed approvals.
Departmental Resources
In addition to their advisors, students can direct questions about the IRB process to the department’s Research Practice Manager (RPM), Brian Perry (brian.perry@duke.edu).