Starting September 2019, all human research submissions to the IRB/REC will need to be done through Cayuse IRB. The IRB office will no longer accept PDF forms.
This is likely because you are not registered as a user in the system. If you are student, please complete the student user registration form. This will allow us to register you in the Cayuse system with access via your NYU NetID and password. If you are not a student, please reach out to our office at email@example.com.
The finance department may require copies of approval letter(s) issued for your study as a supporting document for processing payment related to your protocol, such as participant payments or payment to a survey company.
First, locate your study from the dashboard, to go to the study details page. Go to the initial submission by clicking on the ‘submissions’ heading.
On the submission details page, click on the ‘Letters’ option to access and download the PDF copy of your letter. You can also check our Cayuse manual for detailed instructions.
NOTE: Please submit a modification request if you wish to add investigators to protocols that has already secured an IRB approval. In case you are not able to locate the profile under ‘FIND PEOPLE’ button, please get in touch with us at firstname.lastname@example.org
Once you complete each section of the IRB form, a check-mark will appear next to it. If you are not able to see the ‘complete submission’ option, it is likely that you have missed answering some questions. Please locate sections missing the check-mark to answer any questions you have missed responding.
Yes, we provide multiple options for Cayuse IRB training every semester. The dates for in-person sessions will be posted on the IRB website, and included in the Al Sho'la newsletter once the schedule has been finalized. If you have missed these sessions, we also provide individual consultations; please feel free to let us know at email@example.com.
Yes, the application form has ‘ATTACH’ buttons that enables you to upload documents as well as share links.
Once you have submitted your application, the PI must ‘certify’ the submission for our office to initiate the review process. It’s highly likely that your submission is awaiting certification from your PI. You can log in the system to check the status of your application.
Both New York and Abu Dhabi campuses use different instances of Cayuse. A reason you are seeing an empty screen may be that you have logged into the New York instance of the system. Please try again by clicking on this link. If you are still seeing the same screen, please reach out to us at firstname.lastname@example.org.
If your research involves human subjects, it is likely that your study would require IRB review and that both of the following conditions must apply:
If you are unsure about determining if an IRB approval is required for your study, please email us to schedule a meeting. Our IRB reviewers will consult on your IRB requirements.
Principal Investigator (PI) on IRB protocols has to be a standing faculty or a PI in an institute center. Full time faculty would have this status by default, however if you have a visiting title, please apply for PI status. Our office can assist you in the application process, please email us at email@example.com to assist with this process.
Note: For students working on project(s) supervised by a faculty with visiting title, please ensure your supervisor has secured PI status.
Yes, all investigators conducting Human Subject Research must demonstrate a basic knowledge of human research ethics, regulations, laws and local policies prior to initiating research with human subjects. At NYUAD, such training is assured for all research personnel involved with human research subjects by completing an online program through CITI. If you've completed CITI training through an NYU or NYUAD subscription then your training status should be linked through Cayuse. We will accept your CITI training if it’s completed within the last three years under another institution's subscription. If you have not completed a CITI training, please refer to the Human Research Training Program page on our website for detailed instructions.
This would mainly depend on the nature of your research study. Please choose the Social & Behavioral Educational course if you are conducting social and behavioral research. For research involving a collection of human tissue samples or any bio specimens, please enroll for the Biomedical Research course. We also accept the CITI training in Investigators Conducting Exempt Research where your research study present no greater than minimal risk to subjects and fit into one or more exempt categories. Please email us at firstname.lastname@example.org to see if your research qualifies for an exempt review.
The purpose of the consent form is to give potential subjects a single document that includes all the information they need to make an informed decision about participating in research and to indicate their agreement to participate under the stated conditions.
Please refer to the ‘Required elements of consent’ document from our Guides and Resources Library. There is also a template available in the same section that can help you design a consent form tailored to the needs of your research project.
An IRB review process looks at how an investigator complies with the ethical principles and human subject research regulatory requirements while conducting their research. Some elements of an IRB review would include ensuring recruitment strategies implemented in the project are free of coercion, risks associated with the study are mitigated/minimized, a reasonable compensation is offered to participants (if any), principles of confidentiality and anonymity (wherever required) are maintained appropriately, informed consent is sought from potential participants, data storage and maintenance are appropriate, etc.
If you need more guidance on how to better prepare your IRB application, please reach out to us on email@example.com for assistance in understanding the IRB requirements for your project.
Please allow us a timespan of three weeks to conduct the initial review of your submission. Should your study require a full board review, we would need more time, as it requires our committee to meet and review your submission. Please bear in mind that the review time may take longer especially around holidays, semester break periods or when the office is experiencing large number of submissions.
It is important that you are well prepared to start a submission. Having an understanding on your project aims, recruitment methods, and research design will help you get started. Some generic rules would be to:
These may differ from project to project depending on the research design used by the researchers. If you have any doubts, please email us at firstname.lastname@example.org.
Under the University's Federalwide Assurance (PDF), all research activities involving human subjects (funded or non-funded) must be approved by the IRB prior to the commencement of the research, if:
Any material (flyers, letters, etc.) used to inform potential participants of the opportunity to participate as a subject should clearly identify the investigator and institutional affiliation.
Materials should give a brief idea of the purpose of the research, what participation entails (including any important subject inclusion/exclusion criteria), and a way for potential participants to contact the investigator if interested in participating.
Recruitment materials should also include sample letters to potential subjects, and applications to organizations being asked to take part (or are taking part) in the project effort. This includes:
Please see Forms and Guidance for further information on recruitment materials requirements.
Informed consent is designed to provide potential subjects or those who must give permission for potential subjects, all the information they need to decide whether or not to participate in a research project.
Consent, permission, and assent materials must be written in language appropriate to the intended subjects. If an investigator plans to recruit subjects from non-English speakers or those who do not speak it well, certified translations should be provided once the English versions of the consent, permission, and assent materials have been approved by the IRB.
Any subjects over the age of 18 (or respective age of majority in other countries) must provide informed consent to participate in research. This is typically done by reading and signing a consent form. The IRB presumes that children ages four and older should be given an opportunity to provide assent. Generally, oral assent through the use of a script should be obtained from children four-seven years of age.
Please see Forms and Guidance for further information on the required elements of informed consent.
Surveys, questionnaires, demographic data sheets, interview questions, and observation guides are among the instruments commonly used by researchers at NYUAD and should be included with your application. When experiments are conducted, investigators must submit complete descriptions of the differing conditions for each condition being studied. This also includes any instructions for participation.
If the investigator will be using proprietary instruments that are well established and known in the field, the instruments should be named and briefly described in the application.
Research that does not involve more than minimal risk and meets specific criteria can be eligible for Exemption review. This means that once initially reviewed by the IRB administrative staff, a determination will be made indicating that the research is ‘exempt from continuing review’. This does not mean that any human subjects research is exempt from IRB review, but that after an initial review, the IRB can determine certain research as exempt from further oversight. See Forms and Resource Library for further details.
Non-Exempt Research that does not involve more than minimal risk and meets specific criteria can be eligible for expedited review. Such research will also be reviewed by the IRB administrative staff and will need to meet particular requirements for the participant recruitment plan, informed consent process, data confidentiality, and management, international. See Forms and Resource Library
for further details.
Research that involves more than minimal risk to participants requires review by the convened board. If your research involves any of the following, your application will most likely require full board review:
See Forms and Guidance for further details.
In addition, any Abu Dhabi-based biomedical research or research involving the collection of human tissue samples (such as hair, saliva, blood, etc.) which does not qualify for an exemption will likely require full board review under Abu Dhabi Department of Health Regulations. See Research Ethics Committee (REC) for further details.
Any changes to approved or exempt research must first be reviewed and approved by the IRB before implementation. Investigators can request an amendment to a protocol through an amendment request form. This should clearly describe the changes proposed and the reasons for them. See Forms and Resource Library for further details.
Non-exempt research (Expedited or full board reviewed) typically requires annual renewal of approval. In order to continue with human subjects work and renew approval, investigators must submit the Continuation request form. This serves as a progress report informing the IRB of the project’s status, any adverse or unanticipated events, or any changes to the protocol that might be needed. See Forms and Resource Library for further details.