NEW CAYUSE Evisions IRB SUBMISSION PROCESS
Effective Fall Semester 2015, all Washington Square Schools will be transitioned to an online IRB submission process. This new process, encompassing creation, submission, and review for all human subjects protocols, including initial, continuing reviews, and amendments, will replace the current email-based IRB submission system.
Go to the description of the roll-out process and timeline for Instructions for registering and using the new system, Cayuse IRB. You can also download a PowerPoint presentation, introducing the new system.
The NYU office that oversees the IRB process is called the University Committee on Activities Involving Human Subjects (UCAIHS). The UCAIHS website contains all of the forms needed to download in order to submit an IRB application. It also provides documents with guidelines about how to address a range of issues related to conducting research with human subjects. Here is a list of some of the guideline documents they provide:
- Collaborative research involving human subjects
- Prisoner Guidance
- Undergraduate Student (Classroom) Research
- Language for Consent Forms
- Language for Parental Permission Forms
- Language for Child Assent (under age 12)
- Sample Language for Consent Forms
- International Research
- Instructions for Events Requiring Prompt Reporting to the IRB (UPIRSO)
- Summary Guidance on Certificates of Confidentiality
The SSSW Office for Research will provide assistance in navigating the IRB process for funded research.
Submission Deadlines and Procedures for IRB Review
In the interest of standardizing reviews and reducing submission-to-review turnover times, OFR strongly suggests that all applications for Human Subjects approval be submitted for internal review prior to submission to the NYU IRB.
Proposals and required attachments should be submitted to email@example.com two weeks prior to the applicable NYU deadline and will be reviewed by one of the School’s IRB liaisons. PIs should also complete an Additional NYU Co-Investigators & Personnel Form, which authorizes OFR staff to follow up on submitted applications with UCAIHS administrators.
Note: If extenuating circumstances prohibit OFR review of an application, PIs can submit directly to UCAIHS via one of their email aliases. However, in these cases, OFR cannot be responsible for tracking the status of an proposal it has not reviewed and will not be able to assist with any follow up and/or revisions.
Completion of Tutorials and Certification
Up to May 25th, 2015, NYU IRB applicants must complete the NYU tutorial on human subjects research as well as a certification exam. Go to the web page for the tutorial and the web page for the certification exam.
Starting May 25th, NYU will transition to Collaborative Institutional Training Initiative (CITI) training modules for Human Subjects, available at www.citiprogram.org.
PIs, Faculty Sponsors and Key Personnel--all individuals responsible for the design and conduct of a research study--who have not completed the UCAIHS administered certification exam prior to the transition will be required to take and pass the NYU CITI training modules, with an 80 or above as per the University's Federal Wide Assurance.
If you have already taken the CITI training at another institution, you may check to confirm that what you have taken includes all the modules required by NYU. If so, you may add NYU to your profile.
Is IRB Review Needed for My Research?
Some projects involving human subjects do not need IRB approval. For example, class projects that are non-intrusive, do not focus on risk populations, and that are not intended to be published often do not require IRB review. Determine if your project requires review.
Types of Review
Once you have determined that your research requires review, there are three types of review you can request:
Exempt review is sought for minimum risk studies. Exempt research falls into one of six categories and requires answering “no” to a set of explicit questions. Download a description of the categories and relevant questions. If your research is exempt, you still must submit an application form to get confirmation from the NYU IRB that exempt status is warranted. For the application form, see below.
Expedited review also must be minimal risk, however there can be mild deception. These applications are not reviewed by the full board, but instead by single or double reviewers from the board. The process is not necessarily faster than exempt but usually faster than full board review. Download a description of criteria to determine expedited status.
Full board review is required for research on sensitive topics with minor children, research on prisoners, pregnant women, impaired adults, research on illegal activities such as drug use, research on private activities such as sexual behavior, research on FDA approved drugs and devices presenting more than minimal risk, non-FDA approved drugs and devices, and research that employs deception or withholding of complete information during initial consent.
Types of Applications
Once you have determined that your research requires review and the type of review that is appropriate, there are four types of applications you can pursue:
New Applications (also called Initial Reviews): New applications that have never been reviewed by the UCAIHS before. Submit new applications to firstname.lastname@example.org.
Revisions: Revisions in response to the IRB’s initial review. These use the same form as the new applications but are a revised version. Submit revisions to email@example.com.
Amendments: Amendments to existing research protocols. These are not in response to an IRB request for change, but are initiated by the researcher (for instance, due to changes in sample size, etc). Submit amendments to firstname.lastname@example.org.
Continuing Review: Applications for previously approved and seeking renewed approval. Submit continuing review applications to email@example.com.
For Exempt Status, submit applications to firstname.lastname@example.org.
Download the following application forms:
Affirmation from UCAIHS that you do not need human subjects review for your project.
Application for expedited review. This form is a checklist and is submitted with the general form for an initial review (below).
It typically is necessary to submit copies of recruitment materials, consent forms, and research instruments/surveys with the application. Investigators should submit copies of their protocols in MS Word and attach a scanned PDF copy of the signature page.
Contact with UCAIHS
Key contact persons in the NYU IRB office are:
Alison Dewhurst, Human Research Compliance Director, email@example.com
Gretchen Borges, Senior IRB Administrator, firstname.lastname@example.org
Marguarette Bolton-Blatt, CIP, IRB Administrator, email@example.com
Brenda Rodriguez, IRB Coordinator, firstname.lastname@example.org
Barbara Johnson, IRB Coordinator, email@example.com
DROP-IN CONSULTATION HOURS WITH UCAIHS
See the drop-in hours for UCAIHS for one-on-one, face-to-face consultation for IRB projects or IRB issues.
SSSW Contact Person
Dr. Trudy Festinger, a member of the IRB and a faculty member in SSSW, has kindly offered to answer questions about IRB issues if you encounter unusual circumstances or need advice on how to address an IRB matter.
UCAIHS offers workshops on selected topics. OFR staff have attended the workshops and taken brief notes on key points within them. These notes are available here. These seminars and the notes reproduced herein do NOT necessarily represent formal policies on the part of the UCAIHS:
Notes on avoiding collaborating organizations from having to obtain their own IRB review. The Health and Human Services webpage for guidelines NYU uses to determine if collaborating organizations are "engaged in research."