IRB Members

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.

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.

Richard G. Schwartz, Chair (Speech & Hearing Sciences)	Kay Powell IRB Administrator
Dee Clayman Deputy Chair (Classics)	Martin Ruck (Urban Education/Psychology)
Madeline Perez (Urban Education) Student Representative	Martin Gitterman (Speech & Hearing Sciences)
Carolyn Fisher (Anthropology) Student Representative	Donald Robotham (Anthropology)
David Jones (Political Science)	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

*2008 Fall Meeting Dates Deadline for Materials**


8/25 8/11
9/22 9/1
10/27 10/6
11/17 10/27
12/15 11/14
*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.)

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.

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

Forms:

It is strongly suggested that PIs refer to the Information Sheet and Sample Consent Form pages listed below for guidance in submitting applications and consent forms.

A CITI certificate for the P.I., and when applicable his/her advisor, must be included with the submission of all IRB applications.

The following forms are available in Adobe Acrobat format (PDF), and you must have the latest version of Acrobat Reader to view and print the PDF versions. Acrobat Reader can be downloaded free of charge from Adobe's site; GC computers have Acrobat Reader preinstalled.

Note: Applicants must submit the original and 10 copies for Full Committee reviews, 1 original copies for Expedited, Exempt and Continuing reviews. In addition to the hard copies of your application, please email your application as an attached file to Rachel Verni at rverni@gc.cuny.edu.

Downloadable Forms

PI Manual (DOC)

Application Form (DOC) Interactive

Information Sheet (PDF) (hints, requirements, etc. for application submission)

Sample Consent Form

Request for Amendments or Modifications for Approved Protocol

Adverse Event Report Form

Subject Information Confidentiality Agreement

All non-CUNY personnel working on CUNY related research need to submit the attached form.

Unanticipated Adverse Event and Unanticipated Problem Report Form

Continuing Review only:

Continuing Application and Final Report Form
***Click the "Insert" key before filling in the form fields

Information Sheet (for submission of continuing applications)

12/2003 Oral History Interviews: Message from Gillian Small
University Associate Dean for Research

Multi-Campus Review Policy (PDF)

Effective April 14th, 2003, new federal regulations were issued under the Health Insurance Portability and Accountability Act (HIPPA) that deal with the privacy of individually identifiable health information.

For more information: HIPAA (Health Insurance Portability and Accountability Act)

Important Information for Students

Dissertation Requirement [Download Dissertation Clearance Form]

CUNY Policy for Student Research With Human Subjects

Links: For More Information Concerning Human Subject Research

Please visit the Research Foundation website at www.rfcuny.org for more information and additional links on Research Conduct
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. Please see information at: http://schools.nyc.gov/daa/guides/Doing_Research_in_NYC_Schools.pdf

Certificate of Confidentiality for information on Applying for a Certificate of Confidentiality.

Proposal Guidelines for Conducting Research in New York City Public Schools.

Information on HIPAA (Health Insurance Portability and Accountability Act)

Office for Human Research Protections (OHRP)

National Bioethics Advisory Commission

American Anthropological Association "Ethics"

American Psychological Association "Ethics Information"

American Sociological Association "Code of Ethics"

Office of Human Subjects Research (OHSR)

American Political Science Association

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