Updated September 25, 2018
Research Scientists and PI Eligibility for IRB
On this page, we provide guidance for Research Scientists who have questions about their eligibility as Principal Investigators (PIs) for IRB Review purposes. If you have general questions about the IRB process or how to get an application started, please turn to the Office of Human Research Administration (OHRA) website for more complete information: https://www.hsph.harvard.edu/ohra/submitting-a-protocol/.
All Research Scientists are eligible to serve as PI for projects that are determined as “non-human subjects research” or “exempt.”
The vast majority of Research Scientists are also eligible to serve as PI for projects that are determined as “Expedited” or “Convened.”
The policy is described on the OHRA website: https://www.hsph.harvard.edu/ohra/investigator-manual/principal-investigator/.
A summary of the relevant text is: A Principal Investigator (PI) for non-exempt Human Research must be a Harvard LMA School faculty member, e.g., professor, associate professor, assistant professor, instructor, lecturer, PI-eligible research scientist. This requirement does not preclude any non-faculty member from being listed as a Co-Investigator on the project, or having certain research responsibilities delegated to them, but they are not eligible to be named as PI nor assume ultimate responsibility for the assurances listed in Appendix C.
The specific criterion for being PI-eligible at the Harvard TH Chan School of Public Health is being employed at 25% or more FTE. A list of such Research Scientists is provided monthly by the Office of Faculty Affairs (OFA) to the IRB team in OHRA.
If you do not meet the eligibility criteria, you can still become a PI by completing an exception form. More about this process is available here: https://www.hsph.harvard.edu/ohra/investigator-manual/principal-investigator/.
ONSITE REVIEWS for PIs
Research Scientists who are PIs do not face any special requirements for onsite visits or other reviews, as separate from faculty or other PIs. However, if conducting non-exempt human subjects research, ALL first-time PIs and ALL PIs who went through the exception process must participate in an onsite review done by the Quality Improvement Program (QIP) within OHRA. For more information about onsite reviews, click here: https://www.hsph.harvard.edu/ohra/quality-improvement-program-qip/investigator-portal/
COMMON QUESTIONS & MORE HELP
If you have questions or concerns, we provide starting points for contacting the right person to get more help.
|…whether or not you meet the criterion of employed 25% or more through Harvard TH Chan School of Public Health||Philip Kret/Office of Faculty Affairs (firstname.lastname@example.org)|
|…notices from OHRA about PI eligibility, PI exceptions, or IRB review||Your OHRA IRB Review Specialist: https://www.hsph.harvard.edu/ohra/department-assignments/|
The OHRA IRB team receives regular training on this topic, but if you are having trouble, you can always reach out to Kim Serpico, Assistant Director of IRB Operations. To contact Kim, please email her at email@example.com or call 617-432-7434.