information about changes to the Common Rule, CUNY HRPP policies and
procedures, and the IDEATE application -- effective July 19, 2018
The U.S. Department of Health and Human Services (HHS) and
fifteen other Federal Departments and Agencies have issued final revisions to
the Common Rule, which is the Federal Policy for the Protection of Human
Subjects. The changes will go into effect on July 19th 2018, and will result in a number of changes to CUNY HRPP policies, procedures and templates,
as summarized on the CUNY
HRPP website under "Common Rule Changes". Detailed information regarding changes to the Common Rule are
available on the OHRP ‘Final Revisions to the Common Rule’ webpage.
changes will also result in revisions to the IDEATE application, effective July
new applications that are pending (i.e., not yet approved by the CUNY HRPP/IRB)
on or after July 19 will be subject to review as per the revised Common Rule
and revised HRPP Policies and Procedures, and must adhere to the revised
policies, guidance and templates. As is normally recommended, please arrange to
have protocols submitted several months in advance to allow the CUNY
UI-IRB/HRPP sufficient time to conduct a proper review, particularly when
funding deadlines are forthcoming.
feel free to contact the Queens College Office of Regulatory Compliance (with
the IDEATE protocol number and title) with any questions or concerns, and stay
tuned for more information. Thank you for your patience as we become familiar
with the revised Common Rule and CUNY HRPP policies and procedures, and develop
guidance for the Queens College research community.
Human Research Protection Program at Queens College
The CUNY Human Research Protection Program (HRPP) is responsible for the protection of the rights and welfare of human subjects in research projects conducted at CUNY or by CUNY faculty, staff and students and Research Foundation CUNY staff. All research activities involving human subjects must be reviewed and approved by the CUNY HRPP or CUNY University Integrated-Institutional Review Board (CUNY UI-IRB) prior to implementation. The information below will provide Queens College researchers with the information needed to access CUNY policies and procedures, as well as the tools to submit a complete IRB application. Please refer to the CUNY HRPP website for full details and current information on CUNY's HRPP.
How to Apply:
All submissions to the HRPP/IRB must be made through IDEATE using your CUNY Portal credentials.
CUNY has provided a set of IDEATE Help documents to assist researchers navigate the system. These documents are proprietary and are password-protected. Please email the Office of Regulatory Compliance (firstname.lastname@example.org) to request the log-in credentials.
If you are unsure whether your project requires CUNY UI-IRB or HRPP review, please read the document When is CUNY HRPP or IRB Review Required? For further assistance in determining whether an activity constitutes human subjects research requiring review by the HRPP/IRB, or to set up a consultation to discuss your project, please attend one of our Cookies and Comments sessions or email the Office of Regulatory Compliance (email@example.com) to schedule an appointment.
Guidance and Development of the IRB Application:
- The complete list of CUNY HRPP Policies, Procedures Guidelines can be found in the CUNY HRPP website. Review the policy documents while designing your IRB protocol.
- A list of Informed Consent templates are available in the Informed Consent section of the CUNY HRPP website. Please use these templates when developing your informed consent process and creating consent documents.
- Before creating the IRB application in IDEATE, please review the IDEATE Tips & FAQs page/document for tips on how to properly use the IDEATE system.
- Before submitting the IRB application within IDEATE, please review the IRB-HRPP Checklist for a list of documents that should accompany your application.
First time CITI users should access the CITI website at www.citiprogram.org. For further information about the CUNY HRPP CITI Training in the Protection of Human Subjects, please see the CUNY policy: CITI Training in the Protection of Human Subjects
Human Subjects Protection Basic Course
All CUNY faculty members, postdoctoral scholars, graduate and undergraduate students involved in human subjects research as key personnel must complete the Basic Course in the protection of human subjects prior to Institutional Review Board (IRB) approval of their protocol. Certificate of completion of the basic course is valid for three years.
Human Subjects Research Refresher Course
Key personnel of human subjects' research protocols must complete a refresher course every three years.