Human Subjects

About Human Subjects:

If you are planning to conduct research involving human subjects, whether funded or not, the CUNY assurance with the U.S. Department of Health and Human Services requires the Graduate Center Institutional Review Board (IRB)- also known as the Committee for the Protection of Human Subjects- to review your research design for compliance with human subjects regulations. This requirement is mandated by federal law and is given further impetus by the ethical standards set by professional societies (see Links below) and those of the Graduate Center.

Important Advisory: CITI: COMPUTER-BASED HUMAN SUBJECTS TRAINING

All Principal Investigators must complete the CITI Human Subjects Training prior to applying for IRB approval. It is not necessary to take this training if you are submitting a Dissertation Proposal Clearance: Human Participants form, when the third option on the form is selected: "No, this dissertation does not involve the use of human participants or data from human participants."

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. Also, documentation of human subjects training is often requested with grant applications.

NOTE: A HARD COPY OF THE COMPLETION CERTIFICATE NEEDS TO BE SUBMITTED TO KAY POWELL. WE DO NOT HAVE ACCESS TO THE CITI DATABASE.

IRB Frequently Asked Questions

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 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 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.

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 P.I.s look at the Research Determination Form.

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.

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; and Exempt Review (low or no risk) and is reviewed by the Chair of the IRB.

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.

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.

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 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.

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.

Please contact Kay Powell, IRB Administrator, with any suggestions for the FAQ.

The Committee generally meets the last Monday of each month, with the submission deadline two weeks prior to the meeting date. In order to be placed on the Committee's agenda for a given month, all material for review must be submitted to Kay Powell (IRB Administrator, CUNY Graduate Center, 365 Fifth Avenue, Room 8309, New York, NY 10016-4309, 817-7525) by the "Upcoming deadline dates" at left.

Approximately one week after the meeting, applicants will be notified in writing of the Committee's decision. This letter will either 1) grant approval to proceed with the proposed work or 2) detail the reasons why approval was not granted and describe what must be done to allow the proposal to receive final approval.

Investigators should allow at least two months for the review process, since the Committee may request revisions or additional information before granting final approval. Most revisions are reviewed at the next Committee meeting; however, substantive issues may take more than one additional meeting to be resolved. Please also allow at least two months for Continuation Reviews.

For further information and the submission of applications, contact: Kay Powell, IRB Administrator(kpowell@gc.cuny.edu), Room 8309, 817-7525.

Richard G. Schwartz, Chair (Speech & Hearing Sciences)	Kay Powell IRB Administrator
Dee Clayman Deputy Chair (Classics)	Martin Ruck (Urban Education/Psychology)
Cindi Katz (Environmental Psychology)	Sabrica Barnett (Social-Personality Psychology) Student Representative
Carolyn Fisher (Anthropology) Student Representative	Donald Robotham (Anthropology)
Liza Pappas (Urban Education) Student Representative	Carolyn Stapleton Community Representative (Associate Pastor, Chinese United Methodist Church)
Beth Posner Head of Interlibrary Loan Service The GC Library	Rafi Torruella (Social Personality-Psychology) Student Representative

*2009 Fall Meeting Dates Deadline for Materials**


9/21 8/31
10/26 10/5
11/16 10/26
12/14 11/23
*Important: Expedited & Exempt reviews are not reviewed at Committee meetings, and do not have to meet the deadlines dates. They can be submitted at any time. Exempt or Expedited applications are reviewed as they are received. Exempt applications are reviewed within 7-10 days and Expedited applications are reviewed within 3-4 weeks. (The Chair of the Committee determines the review category for all applications.)