CUNY is dedicated to compliant and ethical conduct of research. The information below describes CUNY’s research compliance organization, policies, and procedures that support the conduct of responsible research and also ensure compliance with applicable laws and regulations.
CUNY researchers are expected to conduct research in accordance with the highest ethical and professional standards. To promote responsible and ethical research, each CUNY college designates a research integrity officer (RIO). The RIO works in collaboration with the research compliance staff in the CUNY Office of Research, to provide training in responsible conduct of research and to implement relevant policies and procedures.
All CUNY researchers are required to complete on-line training in responsible conduct of research. Instructions for completing the on-line training are available at http://www.cuny.edu/research/compliance/training-education/citi-training.html. Ongoing training requirements for all researchers, and additional training requirements for student and post-doctoral researchers are described in CUNY’s Policy on Training in Responsible Conduct of Research. Upon completion of required training, researchers must submit their certificate of completion to their college’s research integrity officer, and provide a copy to the college grants officer.
Researchers should refer to the responsible conduct of research web page for current policies and procedures.
CUNY’s HRPP is designed to ensure the protection of the rights and welfare of human subjects participating in research projects conducted by CUNY faculty, students, and staff. The HRPP is also responsible for ensuring compliance with applicable laws and regulations. Each CUNY college has a dedicated HRPP Coordinator, who provides guidance to researchers and facilitates the required review of human subject research. CUNY’s HRPP currently includes four convened University Integrated Institutional Review Board (UI-IRB) panels and one University integrated expedited review panel.
All researchers engaged in human subject research are required to complete on-line training in protection of human subjects. Instructions for completing the on-line training are available at http://www.cuny.edu/research/compliance/training-education/citi-training.html. Upon completion, researchers must attach their certificate of completion to their profile in the on-line IRB application system.
Researchers should refer to the CUNY HRPP web site for current policies, procedures and IRB information.
a. IRB Related Research Agreements
CUNY may enter into a number of agreements related to human subject research. Signatory authorities for each of the agreements are defined in the Signatory Authority for Research-related Agreements memorandum and webpage. IRB related agreements include:
i.IRB Authorization Agreements
Collaborative research projects involving human subject research generally require review by the Institutional Review Board (IRB) of record for each collaborating institution. IRB Authorization Agreements (IAA) are required for cases in which CUNY and its institutional collaborators have agreed to rely on either CUNY’s, or the collaborating institution’s, designated IRB for review of specified federally funded human subject research. These agreements include, at a minimum:
- institution name, Federalwide Assurance number, and IRB Registration number of the institution providing IRB review;
- institution name, Federalwide Assurance number, and IRB Registration number of the institution relying on the designated IRB;
- title of the research project in question;
- names of the principal investigators at each institution;
- compliance and record-keeping requirements for each institution.
ii. Independent Investigator Agreements
Independent Investigator Agreements (IIA) are required when CUNY agrees to allow an independent investigator to rely on CUNY’s designated IRB for his/her collaboration in federally funded human subject research. These agreements include, at a minimum:
- name of the independent investigator;
- title of the research covered by the agreement;
- description of the independent investigator’s role in the research;
- terms and conditions of relying on CUNY’s IRB.
Researchers should contact the research compliance staff for information on obtaining these agreements.
b. Privacy and Confidentiality Protections
CUNY may also request Certificates of Confidentiality and Privacy Certificates on behalf of a researcher.
i. Certificates of Confidentiality
Certificates of Confidentiality (CoC) are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. These certificates allow the investigator and others who have access to research records to refuse to disclose identifying information about research participants in any civil, criminal, administrative, legislative, or other proceeding, at the federal, state, and local levels.
The NIH application for a certificate of confidentiality includes assurances that must be signed by both the Principal Investigator and the Institutional Official (IO). The designated IO for CUNY is the Vice Chancellor for Research. All requests for an IO signature on CoC applications must be forwarded to a Research Compliance Administrator, who will conduct a congruency review between the IRB approved protocol and the CoC application. Once the congruency review is complete, the research compliance staff will obtain the required institutional signature and return the completed application to the principal investigator.
Researchers should refer to the NIH Certificates of Confidentiality Kiosk for additional information.
ii. Privacy Certificates
The National Institute of Justice (NIJ) has developed specific procedures to document applicants’ understanding of their obligations under confidentiality regulations. Privacy Certificates are required by the National Institute of Justice for all NIJ funded research. The Privacy Certificate is designed to assure that the applicant understands his/her responsibility to protect the confidentiality of research and statistical information.
Privacy Certificates include assurances that must be signed by both the Principal Investigator and the individual with primary responsibility for ensuring compliance. The individual holding this primary responsibility at CUNY is the Vice Chancellor for Research or his/her designee. All requests for signatures on Privacy Certificates must be forwarded to a Research Compliance Administrator, who will obtain the required signatures.
Researchers should refer to the NIJ Privacy Certificate Guidance for additional information.
CUNY’s conflict of interest policies and procedures are designed to ensure, to the extent possible, that any financial interests and/or conflicts of commitment are managed in a manner that prevents bias in the design, conduct, reporting, or regulatory review of research.
Each CUNY college has an appointed college conflicts officer (CCO). The CCO works in collaboration with the research compliance staff in the Office of Research to implement CUNY’s conflict of interest policies and procedures.
Researchers are expected to disclose any financial conflicts of interest using the significant financial interest disclosure and supplement forms. Completed forms must be submitted to the college conflicts officer and copied to the college grants officer. Researchers are also expected to disclose any conflicts of commitment to the research integrity officer at their college. In addition, conflicts related to research involving human subjects should be disclosed to the HRPP, and conflicts related to research involving animal subjects should be disclosed to the IACUC.
Researchers should refer to the conflict of interest web page for current policies, procedures and disclosure forms.
Researchers may be affected by US export control regulations when they are:
- in possession of export controlled materials or data in hard or soft (digital) copy;
- giving access to laboratories containing export controlled materials, equipment, and data to non-US persons;
- participating in international collaborations with individuals or organizations in embargoed countries;
- teaching and/or traveling abroad;
- hosting foreign nationals.
Researchers are encouraged to use the Preliminary Evaluation Form to assess whether they may be affected by export control regulations.
High-risk areas include: computer science (including high performance computing); cryptography; material science; electro-mechanical engineering; semiconductor research; space science & launch related research; oceanographic research; atmospheric research; astronomy; bio-engineering; robotic research, sensors & detectors; nuclear physics & engineering; infectious diseases, microbiology & pathology; and antiquities research.
Each CUNY college has an appointed export control administrator who works in collaboration with the research compliance staff in the Office of Research to ensure compliance with export control regulations.
Researchers should refer to the export control web page for current policies, procedures and guidance documents.
CUNY colleges with animal facilities have institution-specific policies and procedures that allow for the humane treatment of animals; local Institutional Animal Care and Use Committees (IACUC); and adequate resources to support the animal programs. CUNY faculty, staff and students who plan to use animals for any research or educational activities must contact their college animal facility staff to learn about the local animal program policies and procedures.
CUNY researchers engaged in research involving animals in the wild are also required to comply with applicable animal welfare policies and procedures. Researchers at CUNY colleges without an animal program, who are engaged in research involving animals in the wild, should contact the research compliance staff in the University Research Office to obtain guidance and appropriate IACUC approval.
a. Institutional Biosafety Committee
CUNY Researchers engaged in research utilizing recombinant or synthetic nucleic acid molecules must contact their college Institutional Biosafety Committee (IBC) for information on local policies and procedures to ensure compliance with NIH Guidelines and all other applicable laws and regulations.
Researchers who engage in activities involving infectious agents, other hazardous agents (e.g. carcinogens), radioactive materials, or transgenic animals are required to contact their respective college’s research administration office to obtain information on college-level oversight of such activities.
b. Select Agents and Toxins
Select agents and toxins are those biological agents and toxins that are identified as having the potential to pose a severe threat to public health and safety, animal health and safety, plant health and safety, or to the safety of animal or plant products. Select biological agents or toxins are listed in the following regulations:
- US Department of Agriculture regulations at 7 CFR 331.3 and 9 CFR 121.3
- US Department of Health and Human Services regulations at 42 CFR 73.3
Possession, use, or transfer of select agents or toxins requires prior registration with the Centers for Disease Control and Prevention, the Animal and Plant Health Inspection Service of the US Department of Agriculture, or both. Researchers who plan to work with any select agents or toxins are required to contact their respective college’s Environmental Health and Safety (EHS) Officer prior to possessing, using, or transferring select agents or toxins.
Researchers should refer to the Federal Select Agent Program for additional information.
c. Dual Use Research of Concern
The United States Government has issued a Dual Use Research of Concern policy that establishes regular reviews of federally funded life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel or national security.
Federal regulations require ongoing institutional review and oversight for such research. Each CUNY college administration is responsible for ensuring compliance with this policy, as it pertains to the research being conducted at the respective college. College administration may contact the research compliance staff in the Office of Research for guidance.