The CUNY Human Research Protection Program (HRPP) is responsible for the protection of the rights and welfare of human subjects in research conducted at CUNY or by CUNY faculty, staff and students and RF CUNY staff. CUNY applies the ethical principles and federal regulations to all human subjects research conducted at CUNY or by CUNY employees (faculty and staff) and students, regardless of funding or funding source. The program provides oversight, administrative support and educational training to ensure that CUNY research complies with Federal and State regulations, University policy, and the highest ethical standards. The CUNY HRPP comprises of University Integrated Institutional Review Boards (IRBs) and on-site HRPP offices. LaGuardia HRPP Office is one of them.
(Please note: During the pandemic when physical campus locations are not available, HRPP Coordinators are working remotely. If you have questions regarding IRB application or need assistance in IDEATE submission, please email Dr. Xiwu Feng. Consultations and trainings will be available remotely. )
The Institutional Review Board (IRB) for the Protection of Human Research Participants is an independent compliance committee mandated by the U.S. Department of Health and Human Services (DHHS). The role of the IRB is to protect the rights and welfare of persons recruited to participate in research activities conducted under the auspices of the University. The IRB reviews proposed research protocols to ensure that the proposed research follows federal guidelines and accepted ethical principles. The IRB has the authority to approve, require modifications, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution. However, those officials may not approve research if it has been disapproved by the IRB.
To assess the IDEATE system, please click HERE
Training Requirements All research personnel involved in human subjects research must complete the CUNY- required modules of the Collaborative Institutional Training Initiative's (CITI) online training in the protection of human subjects (basic course) prior to IRB approval of a new/continuing review application, or an amendment application. The following certificates must be attached with the submission:
Instructions for completing this training are available from CUNY Policies and Procedures
For the Collaborative Institutional Training Initiative, please click CITI Program to Register.
Organization – “City University of New York.”
Online training certificates will be valid for three years. Key personnel are required to take the CITI training in the protection of human subjects (Refresh Course) every 3 years following completion of the basic course.
Key Personnel are defined as the Principal Investigator, co-investigators and research personnel who interact directly with human subjects or who have access to private information related to human subjects during the course of a research project. Key personnel also include faculty sponsors / advisors who provide direct oversight of research with human subjects or research using private information about human subjects.
Please follow the instructions and then fill in Informed Consent Document Template. Click HERE
Does Your Project Warrant IRB Review? The study requires advance IRB approval if it meets the following: it is designed to develop or contribute to generalizable knowledge; it involves a systematic investigation to obtain information from or about living individuals; it is conducted by CUNY faculty, staff, and students. Such projects need IRB review: funded and non-funded questionnaire, interview, qualitative, secondary, experimental research, and pilot projects. However, In-class exercises done wholly for pedagogical purposes and institutional research (assessments) that are not disseminated externally do not require IRB approval.
Reviewing Processes Human Subjects Research Determinations: Submissions that require a determination of whether the Research is considered “human subjects research” and falls within the purview of IRB review, will be conducted by the campus HRPP Coordinator. The HRPP Coordinator confirms the researcher’s CITI training status, determines if the study involves vulnerable populations, and assesses any implications of external funding or other institutions’ involvement. The HRPP Coordinator will conduct an administrative review for all applications (also known as packages) submitted via IDEATE with the exception of continuing full board applications. The HRPP Coordinator will review exempt packages to determine if it meets the definition of research as defined by the federal regulations per 45 CFR 46.102 (d) (f). Once all requested information has been submitted by the PI, the Coordinator will forward the package to the Expedited Reviewer for review. If particular expertise is needed, the LaGuardia HRPP Office in consultation with the CUNY Office of Research will select a CUNY UI IRB Member with the required expertise.
Review of Exempt or Expedited protocols takes about two to three weeks. The review process for protocols submitted for Full Review can take up to a month or longer to complete.
This Q&A page addresses some of the most commonly raised issues pertaining to HRPP/IRB Review:
Does My Project Warrant UI IRB Review? If a study is designed to develop or contribute to generalizable knowledge, and if it involves obtaining information from or about living individuals, the project requires advance UI IRB approval. Such projects include funded and non-funded questionnaire, interview, qualitative, secondary, and experimental research. Pilot projects need review. In-class exercises done wholly for pedagogical purposes need not be submitted for prior UI IRB review, and institutional research that is not disseminated externally does not require approval. Research conducted by faculty, staff and students needs IRB approval.
What does the IRB look for in an application?
The IRB seeks:
What steps do I need to take if I want to submit something for the IRB to review? First, contact your campus HRPP Coordinator <firstname.lastname@example.org> for any necessary consultation on new and/or existing protocols. Second, review CUNY Policies & Procedures for step by step instructions on submitting a project for review.
What documents and information do I need to include for a new protocol? A continuation request? An amendment? Please refer to the “Submitting to the IRB” section within the “Policies, Procedures & Guidelines” section of the CUNY HRPP website for submission checklists on the required items for specific submissions. Click HERE.
Where do I submit my application? You can ONLY submit your application electronically by Logging in to IDEATE at the link - https://ideate.cuny.edu
How do I log-in to IDEATE? Investigators are to use at their CUNY Portal credentials to log-in to IDEATE.
Who do I contact for a status/update on my study I submitted? Log in to IDEATE and click on the protocol for which you need a status update. If you still have questions, please contact HRPP Coordinator <email@example.com> for information regarding your study.
I am a CUNY faculty member with multiple CUNY campus affiliations. How do I affiliate with CUNY campus in my user profile in IDEATE? CUNY Faculty must affiliate themselves with their primary campus and submit all human research proposals to the primary campus.
I am a faculty member and would like to conduct research at a CUNY campus other than my own or the one I am primarily affiliated with. Where do I submit the submission package for review? Researchers must submit their submission packages to the CUNY HRPP office of their primary campus, e.g. “LaGuardia Community College HRPP Office.”
What if I am an adjunct professor?
CUNY adjunct faculty who wish to conduct human subject research as part of their institutional responsibility at CUNY should obtain an approval from their Provost prior to submitting an IRB application. Please complete the form and attach it with your IDEATE submission and Current CV. See CUNY Adjunct Faculty as PI of IRB Application Form.
I would like to conduct research at an outside (non-CUNY) institution, is there anything I should know? Please contact your campus HRPP Coordinator for guidance on conducting research at non-CUNY institutions. If you are planning research at an international setting or multiple non-CUNY institutions, please refer to the policy on Collaborative Research.
How long does review take? Review of Exempt or Expedited protocols takes about two to three weeks. The review process for protocols submitted for Full Review can take up to a month to complete. You should include sufficient time in your research plan as allowance for any IRB-required changes to the research protocol.
I want to administer my study in a language other than English. What do I do? All consent documents and instruments, must be translated. The IRB must certify that the translated documents translate equivalently in English.
I'm working with other researchers on this project. What should I do? The protocol package in Ideate should specify these researchers and their CITI certificates must be attached to the package being submitted for review.
How do I know when my protocol has been approved? You can check the progress of your submission on your Ideate homepage. Once an approval letter has been issued, an email will be sent to you notifying you of this. My research is finished. Now what? You must complete a continuing review/final report form to inform the committee about your research. This form can be completed in the Ideate website.
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