To apply for IRB or REC approval, researchers must complete the Application Form, along with any other applicable checklists, found under Forms and Guidance, and send the application package to email@example.com. All applications must be completed in full and should include the following components:
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.
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:
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.