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Acting Chair: Prof. Thomas Kucharski
Administrator: Carina M. Quintian
Room 336-12 T
Office Hours:
Monday-Friday, 9:30 am to 5:00 pm.
Telephone: (212) 237-8961
Email: jj-irb@jjay.cuny.edu
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Welcome to the John Jay Institutional Review Board (IRB)!
The Board consists of 14 members, 12 of whom are full-time faculty at John Jay.
The IRB Office is charged with administering the College’s IRB operations.
If you are unfamiliar with the IRB process, click here.
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All applications must be filed electronically as MS Word documents attached to an email. All email to the John Jay IRB must be sent to: jj-irb@jjay.cuny.edu.
In addition, an ink-signed copy must be delivered to the IRB Office, 336-12 T.
Submission deadlines are posted on this web page.
An application will be considered timely filed if the IRB Office receives either
the electronic or ink-signed version by 4:00 pm of the deadline day.
Note that application deadlines apply only to Full Review submissions.
All other review processes are on a “rolling” basis and have no deadlines.
Note: Applications frequently have problems with Informed Consent forms. We strongly recommend use of the Consent Form Template. |
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For the July 31, 2008 Board meeting:
July 10, 2008 (4:00 p.m.)
For the August 28, 2008 Board meeting:
August 7, 2008 (4:00 p.m.)
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Those unfamiliar with the IRB process should read the following:
“IRB” stands for Institutional Review Board. Throughout the United States, institutions that conduct or facilitate research with human subjects – such as universities, hospitals and pharmaceutical companies – have created committees, known as IRBs, to review and clear research projects. These IRBs are mandated by federal law or are established pursuant to voluntary agreements between the institution and the U.S. Department of Health & Human Services. CUNY has such an agreement.
The purpose of the IRB system is to ensure
that researchers adopt protocols that protect the health, privacy and
autonomy of the research subjects. In the past, subjects have been injured physically and psychologically by researchers insufficiently sensitive to their needs and interests.
IRBs are tasked with reviewing the relevant research to ensure compliance with federal regulations. These regulations may be found at 45 CFR 46.101-409 and 63 FR 60364-60367. The complexity of the IRB process is largely attributable to the complicated nature of these regulations.
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| 1. Who must file with the JJ IRB? |
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Faculty, staff, students, or other member of the John Jay community conducting covered research must seek JJ IRB approval. Also, anyone who uses the College’s facilities or uses John Jay community members as research subjects must file.
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2. What kind of research is covered? |
According to federal regulations, covered research means “a systematic investigation . . . designed to develop or contribute to generalizable knowledge.” (45 CFR 46.102(d)) In addition, this research must involve interaction with living human beings or individually identifiable private information about living individuals. A classroom exercise for educational purposes is not “research.” The Research Determination Form may help you determine if your project involves covered research. If you need assistance, you may call (212) 237-8961 or email jj-irb@jjay.cuny.edu, the IRB Office.
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| 3. If my research requires IRB review, how do I apply for it? |
Fill out the Application Form. File this form electronically as a MS Word document attached to an email addressed to: jj-irb@jjay.cuny.edu. In addition, an ink-signed copy must be delivered to the IRB Office, 336-12 T. Please include your CITI certificate (Human Research Subjects Training Modules) with each protocol. Submission deadlines for Full Review (see question 4) are posted on this web page.
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| 4. How does the review process work? |
If the research is covered (see question 2), the type of review is determined by the nature of the research. There are three types of review: Exempt, Expedited and Full. Only Full review requires a decision of the Board. Exempt and Expedited reviews are conducted by the Chair and the Deputy Chair.
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| 5. Which of the three types of review applies to my project? |
Within one week of the submission of an application, the IRB Chair and Deputy Chair will determine the appropriate type of review, i.e., Exempt, Expedited or Full. Researchers must indicate, on the Application, the type of review they think appropriate. Due to the complexity of governing federal regulations, however, the IRB Chair and Deputy make the final decision.
a. Exempt Review is covered research that falls into certain categories established by federal regulations (45 CFR 46.101). These include projects involving certain types of interviews, observations of public behavior, or the collection or study of existing data.
b. Expedited Review is for research that involves no more than minimal risk to subjects and falls into certain categories established by the Secretary of Health & Human Services (63 FR 60364-60367).
c. Full Review applies to all other covered research.
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| 6. How long does the review process take? |
Full Review by the John Jay Board takes place three weeks after the submission deadline. Applicants will be informally notified by email within two days of the decision. Formal notification letters will be issued one week after the Board meeting. Exempt or Expedited Review ordinarily will be completed within two weeks of submission.
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| 7. What are the possible decisions of the IRB? |
There are four possible decisional outcomes: Approved, Approved with Conditions, Deferred or Disapproved. They are defined as follows:
1. Approved: As of the date of the letter of approval, the project may proceed without modification.
2. Approved with Conditions: The project may not proceed until the researcher makes relatively minor revisions, such as changing the informed consent form, or clarifying that the research does not access private information. The Chair or Deputy, not the Board, will review the revisions.
3. Deferred: The project may not proceed until the researcher makes significant revisions, such as major changes in the research protocol, or large numbers of smaller revisions. If timely resubmitted, the full Board, at its next scheduled meeting, will review the revised proposal.
4. Disapproved: The project requires such substantial changes that it is unlikely to receive approval even after revision. In essence, the researcher needs to completely revise the project and resubmit anew.
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| 8. May a decision of the John Jay IRB be appealed? |
Yes, but this is usually not necessary as proposals with deficiencies generally are Approved with Conditions or Deferred. Appeals first must be filed with the John Jay IRB, subject to the submission deadlines for Full Review. After an appeal to the John Jay IRB, a dissatisfied applicant may further appeal to the CUNY Central IRB. A project disapproved by the CUNY Central IRB, i.e., for the third time, may not go forward.
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