Human Subjects/IRB

 

Human Subjects/IRB

Information concerning the submission of IRB applications will hereafter be generated by CUNY’s Central Office, under a newly organized Human Research Protections Program (HRPP)

The Graduate Center submissions will continue to be facilitated by HRPP Coordinator
Kay Powell
Room 8309
kpowell@gc.cuny.edu
212 817-7525

Please go to:
http://www.cuny.edu/research/compliance.html
for information on the following issues and much more:
How to register on IRBNet
How to download and transfer documents from IRBManager to IRBNet
How to create your user profile

Forms and Templates
All forms and templates are located on IRBNet (www.irbnet.org):
Select the Forms and Templates Section, select Library Documents and select “documents for researchers.”

Important Information for Student P.I.s Concerning Submissions
CUNY graduate students 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 P.I. 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. 

Registering on IRBNET
All P.I.s, Co-P.I.s and key personnel must register on IRBNet (www.irbnet.org), attaching their CITI Certificates. CITI Certificates can be attached under User Profile. It is imperative that all key personnel register on IRBNet as each person materially involved in a study must be “shared” on each application. Please note that if you are attaching a refresher course certificate, also attach a copy of your original basic CITI certificate for record keeping purposes. See the IRBNet Training Energizer on the link above.

PI Training and Resources
IRBNet training resources are available on-line. Please go to www.irbnetresources.org and click on the resource link for researchers. Type in “cuny” as the username and “resources” as the password.

Some Useful Definitions
Research - A systematic investigation (the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.

Human Subject - A living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information.

Risk - The probability of harm or injury (physical, psychological, social or economic) occurring as a result of participation in a research study.

Computer Based Human Subjects Training

All Principal Investigators and their advisors need to complete the CITI Human Subjects Training prior to applying for IRB approval.

We urge everyone to keep a copy of their CITI completion certificate. A hard copy needs to be included with the submission of IRB applications for researchers, advisors, and key personnel. We do not have access to the CITI database.

Conducting Research in NYC Public Schools

P.I.s planning to conduct research in New York City Public Schools need to receive approval from the DOE Education Accountability Assessment Office before research can begin. Read more about Conducting_Research_in_NYC_Schools.

Dissertation and Clinical Research Form Requirements

Dissertation Proposal Clearance: Human Participants

CUNY has an ongoing agreement with the federal Office for Human Research Protection (OHRP) of the Department of Health & Human Services concerning all research involving human participants (including interviews, oral history, and database research). That agreement requires prior approval of all research proposals and, if applicable, an annual continuing review by an official CUNY Institutional Review Board (IRB).

To assure compliance with this agreement, the Graduate Center has a requirement that all Ph.D., D.M.A., and D.S.W. students must submit a Dissertation Proposal Clearance: Human Participants Form or Clinical Research Project Clearance Form. The Registrar’s Office at the Graduate Center sends the forms to all Ph.D., D.M.A. and D.S.W. students when they advance to Level 3 and the form is distributed to all Clinical Doctoral (Au.D., DPH, DPT, and DNS degrees) students in class. Students should submit this form and, if applicable, an IRB application to the office indicated below after their dissertation topic and methodology are approved by their committee and before research begins. If there are substantial methodological changes that affect human subjects, you must notify the IRB.

  • If human participants are involved in your research:  Before you begin your research, submit a human subjects application to CUNY’s IRB. Applications and guidance information are also available at the Office for Research and Sponsored Programs and in Room 8309. 

After your research has been approved by the IRB, complete the Clearance Form and attach a copy of CUNY’s IRB approval. Submit the form to the Office for Research and Sponsored Programs (address below).

  • If human participants are not involved in your research: Complete the form and attach your project abstract and methodology and submit to: Kay Powell, IRB Administrator, The Graduate Center, Room 8309, 365 Fifth Avenue, New York, NY 10016.

If you are uncertain about the classification of your dissertation research, or have any questions, please contact Kay Powell, IRB Administrator, The Graduate Center (212) 817-7525, kpowell@gc.cuny.edu

FAQ Human Subjects/IRB

What is the IRB?

An IRB (Institutional Review Board for human participants) is a group of at least five individuals with varying backgrounds to promote complete and adequate review of research studies. An IRB conducts the initial and annual reviews of a research study.

What is research?

Research is defined as a systematic investigation, including pilot research, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research that needs to receive IRB approval before the research can begin.

What is a human participant?

A human participant is a living individual about whom a researcher obtains data through intervention or interaction (interviews) with the individual, or through identifiable private information (data with identifiers).

What is exempt research?

Exempt does not mean exempt from IRB review. The IRB, rather than the researcher, determines when research is exempt. Researchers proposing exempt research should submit an IRB application requesting exempt review. Examples of exempt research include educational tests, surveys, or interviews without individual identification or the use of existing data, documents, or other records without individual identifiers.

How do I know if I should submit a research application to the IRB?

If an investigator's (faculty and students) research project involves any human participants (including observation, interviews, surveys, and data collection), an IRB application must be submitted. (IRB approval cannot be given retroactively.)

It is recommended that PIs look at the Research Determination Form.

At times it is difficult to determine if a project constitutes research under the federal definition of research. The purpose of this form is to solicit sufficient preliminary information from the project staff for the IRB to provide a determination regarding whether the federal human subjects protection regulations apply to the project.
Research involving the use of existing data may not need an Exempt IRB approval. Researchers should submit a Research Determination Form and provide as much information as possible on how thoroughly the data have been de-identified.

Do I need to take training to conduct research with human participants?

Human participant training must be completed by the principal investigator, faculty advisor, and key personnel before an IRB application can receive approval. CUNY uses the Collaborative IRB Initiative Training (CITI) program. The CITI program is a web-based human subjects training program designed and updated by a number of IRB professionals and is housed at the University of Miami. It is used by hundreds of institutions to satisfy the federal regulations training requirement. The direct link is www.citiprogram.org.

What are the review categories of an IRB application?

There are three review categories depending on the potential risk to the participants:
Full Review (high risk) needs full IRB review
Expedited Review (minimal risk) needs two IRB members to review
Exempt Review (low or no risk) and is reviewed by the Chair of the IRB

What criteria do reviewers apply when looking at my research project?

Purpose, methodology, adequate handling of the informed consent, whether the research deals with high risk or sensitive issues and, if so, whether the benefits outweigh the risks, and the degree to which confidentiality is both assured and protected.

What is the difference between anonymity and confidentiality with research subjects?

Anonymity means the researcher has no record of the identity of the participants. For example, having participants mail back questionnaires or hand them back in a group, without names or other unique identifiers. Or working with data where all the identifiers have been removed.

Confidentiality means the researcher knows the identity of the participants but will keep the participants' identity and all identifying characteristics confidential.

What should my application say about risk?

Research participants may be exposed to physical, psychological, social, and economic risks. Very few studies involve no risk.

Do I need IRB approval for oral history interviews?

Yes.

Useful Links

Please visit the Research Foundation website at www.rfcuny.org for more information and additional links on Research Conduct.