CUNY Researcher Definition
CUNY defines a researcher as anyone who serves as either the PI or co-investigator, ii) interacts directly with research subjects for research purposes; or iii) has access to identifiable private information about the human subjects for research purposes.
CUNY is considered engaged in a particular human subjects research project when CUNY employees, staff or students obtain, for the purposes of the research project, (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; OR (3) the informed consent of human subjects.
CUNY HRPP or IRB review is required when ALL of the following criteria are met:
- The investigator is conducting research or clinical investigation;
- The proposed research or clinical investigation involves human subject; AND
- CUNY is engaged in the research or clinical investigation involving human subjects. See above regarding engagement definition
Please note that these policies apply regardless of funding. For more information regarding Researcher responsibilities please click here. For guidance on activities requiring CUNY HRPP or IRB Review please click here.
CUNY students and postdoctoral scholars
CUNY students and postdoctoral scholars may serve as PIs on IRB applications ONLY with the supervision and permission of their faculty advisor or research program director. The faculty advisor or research program director who signs off on the given project is ultimately responsible for the protection of human subjects, for compliance with applicable regulations and CUNY policies, and for adherence with CUNY UI-IRB stipulations.
CUNY students and postdoctoral scholars must submit their research protocols involving human subjects research to the HRPP Office at the CUNY College with which their faculty advisor has his/her primary affiliation. This applies to new AND open protocols. Thus, any PI with an open IRB protocol must submit continuing review applications, amendments, and/or closure forms to the advisor's primary campus irrespective of where he/she submitted the original application.
This policy applies to ALL CUNY students (undergraduate, graduate, doctoral students).
Full Time CUNY Faculty/Staff Members
Full time CUNY Faculty and Staff may serve as PIs on IRB applications. The faculty or staff member listed as the PI on the application form is ultimately responsible for the protection of human subjects, for compliance with applicable regulations and CUNY policies, and for adherence with CUNY UI-IRB stipulations.
Full-time CUNY Faculty and Staff members must submit their applications to the campus HRPP Office where they have their primary affiliation. Primary Affiliation pertains to where a full-time faculty or staff member has their full-time appointment.
If a PI wishes to conduct research at the Graduate Center but their primary affiliation is Baruch College, they would submit their applications to the Baruch College HRPP Office.
If a full-time faculty member is teaching a course, any student human subjects research from that course (even if the course is taught at another CUNY campus) would be submitted to the HRPP Office where that faculty member has their primary affiliation or full-time appointment.
This applies to new AND open protocols. Thus, any PI with an open IRB protocol must submit continuing review applications, amendments, and/or closure forms to the primary campus irrespective of where he/she submitted the original application. This includes all protocols previously approved by the CUNY-Wide IRB.
This policy applies to all FULL-TIME CUNY faculty and staff. There is no distinction between RF-paid faculty/staff and CUNY faculty/staff- as long as they are full-time within CUNY, they can serve as a PI.
CUNY Adjunct Faculty
Adjuncts can only serve as PI on HRPP/IRB applications at Baruch College if they are receiving a multi-semester appointment. CUNY Adjunct Faculty members also must obtain written approval from the Provost to serve as PIs on HRPP/IRB applications and IF submitting an expedited or full board proposal must obtain approval from the Vice Chancellor for Research as well. A request to serve as PI must be made using the CUNY Adjunct Faculty Request to Serve as a Principal Investigation (PI) on an IRB Application form.
Please note that in order for Adjuncts to serve as PI's on IRB/HRPP protocols they must obtain permission documentation before an HRPP/IRB application is submitted for review. Documentation of approval from the Provost and if applicable the Vice Chancellor for Research must be attached to the IDEATE Application.
This policy only applies to whether a current CUNY adjunct faculty member can serve as a PI on research studies. This DOES NOT apply to whether a current CUNY adjunct faculty member can serve as faculty advisor to a CUNY student. This role is determined by each college and academic department.
All CUNY adjunct faculty wishing to serve as a PI on IRB Application must fill out the Adjunct PI Permission Form and send it via email to Farida Lada (firstname.lastname@example.org), University Director for Research Compliance. For exempt studies please contact the HRPP Coordinator at email@example.com.
When approved to serve as a PI, the Adjunct Faculty member is ultimately responsible for the protections of human subjects, for compliance with applicable regulations and CUNY policies, and for adherence with CUNY UI-IRB stipulations.
Non-Affiliated Researchers and Key Personnel
Non-Affiliated Researchers and Key Personnel who collaborate with CUNY employees, staff, or students must provide the IRB with an approval letter from their institution's IRB in order to participate in research. This IRB approval letter will also serve as documentation of completion of human subjects training. See CITI Training Guidance Document for details.
Non-Affiliated Researchers and Key Personnel who are affiliated with an institution that does not have an IRB must submit a Letter of Support from their Supervisor. This letter should be on institutional stationary.
Non-Affiliated Researchers and Key Personnel who are not affiliated with an institution must provide the IRB with a signed Compliance Letter submitted via IDEATE attached to the application. PI's listed on the package must submit a Letter of Responsibility as well. Student PI's must also have their faculty advisor sign their letters.
If Non-Affiliated Researchers and Key Personnel are conducting analysis of de-identified or anonyomous data ONLY then this policy does not apply.
Note that these policies apply to Non-Affiliated Researchers conducting research at CUNY ONLY. If this a multi-site study, please click here for CUNY's Multi-Site Policy.
For information regarding Non-Affiliated Researchers who are not collaborating with CUNY personnel, please click here.
Multi-CUNY-College Human Subjects Research (Section 7.6.8)
When a research project is to be conducted in collaboration between two or more CUNY colleges, the human subjects research protocol should be submitted to the HRPP Office at the CUNY college with which the Principal Investigator of the project has primary affiliation. For Student PI's, applications should be submitted to the HRPP Office where their faculty advisor has their primary affiliation. The human subjects protocols should only be submitted to one CUNY HRPP Office regardless of the number of CUNY campuses collaborating on the project. Please note that this change ONLY concerns multi-site research involving multiple CUNY colleges. Please refer to the CUNY Human Research Protections Program Policies and Procedures and MultiSite Research Guidance for information regarding the review of multi-site protocols involving collaborations with non-CUNY institutions or investigators.
Applications can be submitted by CUNY Affiliated persons ONLY. CUNY Affiliated persons are full-time CUNY/ RF-CUNY faculty and staff or CUNY students.
If you have any questions, regarding these policies, please contact the HRPP Office at 646-312-2217 or firstname.lastname@example.org.