Principal investigators (PIs) bear full responsibility for the conduct of human subjects research studies and for the safety of subjects participating in them. PIs and their study teams must comply with international, federal, state, and local laws and regulations, UMES policies, and the determinations of the UMES IRB and other IRBs/ERB involved in the study. PIs are responsible for submitting research staff and students’ CITI certifications and for properly training research staff and students in activities and procedures.
UMES requires that individuals who serve as PIs of human subjects research studies meet certain criteria:
- A principal investigator must be an employee of UMES (Professor, Associate Professor, Assistant Professor, Adjunct Professor, Professor Emeritus, Instructor, Independent Research Associate, Lecturer, Part-Time faculty, Center Director, Administrator). If your title is not referenced in this policy, please contact the UMES IRB. The UMES IRB has the authority to determine if a person in a position not referenced within meets the requirements for service as a principal investigator. Students (graduate, undergraduate, post-doctoral, or faculty/staff/administration functioning as a student), are not permitted to serve as the principal investigator of a human subjects research study.
- Faculty members must possess the required CITI training certificates. The minimal training required is:
- Responsible Conduct of Research for Human Subjects; and
- Biomedical Research Investigator if you are involved primarily in Biomedical research with human subjects; or
- Social & Behavioral Investigator if you are involved primarily in Social and Behavioral research with human subjects.
External individuals seeking access to the UMES student, faculty, and or staff population for a human subjects research study must be employed in a capacity referenced above at their institution. Students from other institutions may not serve as a PI on a submission to the UMES IRB. Additionally, external individuals must meet the UMES CITI training requirements or have their training deemed equivalent by the UMES IRB.
