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IRB Application Required Materials
All submissions for IRB review must include:
Original, fully completed and typed application for review by the IRB.
A complete application includes:
- Investigator's signature (please see procedures for who can serve as PI)
- For Capstone projects — faculty sponsor's signature, student signature
- All applicable attachments (recruitment materials, consent or permission forms, institutional approval letters, research instruments, and any other additional materials)
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:
- Assisting in the recruitment of subjects
- Providing space for meeting with potential/actual subjects
- Access to records of individuals or the organization
Investigators who are planning work with any organization that has an Institutional Review Board must apply to that IRB for review and approval. They then must provide written approval from that IRB to the NYUAD IRB before final approval by the NYUAD IRB may be granted. Investigators should take into account when planning their research that IRBs vary widely in the time required for review and approval.
- Assisting in the recruitment of subjects
This statement is provided to potential participants by the investigator prior to obtaining informed consent and carrying out the proposed work. It explains in more detail than the recruitment materials, the purpose(s) of the research and what the subject will be asked to do if s/he agrees to participate.
The statement is generally provided as a response by the investigator to interest generated through a recruitment effort. It may be written or verbal, and may be delivered in person, by phone, by mail, or by email. In some cases, the recruitment material and statement to the subjects may be combined in one document.
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.
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. The information that is given to the subject or the representative must be in language understandable to the subject or the representative.
The following information must be included in all consent forms and permission forms:
- A statement that the study involves research and an explanation of the purpose(s) of the research
- Names and contact information of the investigator(s) and faculty sponsor, including institutional affiliation and status
- Contact information for the IRB(s) or Ethics Committee(s) involved in review and approval
- A description of the procedures to be followed, what the subject will be expected to do, and whether there are any procedures which are experimental
- How long participation will take, including how many sessions will be held if more than one will be needed
- A description of any benefits to the subject or to others, which may reasonably be expected from the research, or, more commonly, since the benefits of research to the subjects are usually tenuous at best, a statement that there will be no direct benefit to the subjects
- A description of any reasonably foreseeable risks or discomforts to the subject, including any intervention which may be offered, OR the statement that there are no risks beyond those of everyday life
- For research involving more than minimal risk, a clear description of the risks and where further information may be obtained.
- If audio or videotaping is involved, a statement that the subjects will be taped and that they have the right to review the tape and request that all or any portion of the tape be destroyed (parental permission forms, however, should not offer parents the right to review their child's tapes).
- If subjects might be quoted by name or in any way that might make them identifiable, an attribution statement authorizing (or refusing) this use of their names and/or verbatim responses.
- If the research is sponsored by or associated with a commercial enterprise, e.g. product evaluations or clinical trials, the name(s) of the research sponsors.
All surveys, questionnaires, and other data collection instruments must be submitted for review.
Surveys, questionnaires, demographic data sheets, interview questions, and observation guides are among the instruments commonly used by researchers at NYUAD. When experiments are conducted, investigators must submit complete descriptions of the differing conditions for each condition being studied.
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.
Educational Training Requirements
Under the University's Federalwide Assurance with the HHS (PDF), all investigators (i.e., principal investigators, co-investigators, faculty sponsors, as well as other research personnel who have involvement with human subjects need to demonstrate a basic knowledge of human research ethics, regulations, laws, and local policies prior to initiating research with human subjects. At NYUAD, educational training has been assured for all research personnel who are involved with human subjects research. All NYUAD investigators are required to review the human subjects tutorial and may be required to take and pass the CITI Certification Exam before submitting materials for review to the NYUAD IRB.
Human Subjects Tutorial
The human subjects tutorial provides training in the following areas:
- Relevant ethical principles
- Relevant federal regulations
- Written IRB procedures
- Office of Human Research Protections (OHRP) guidance
- Other applicable guidance
- UAE and Abu Dhabi laws
- NYUAD policies for the protection of human subjects
Please note that the tutorial is the minimum requirement to conduct research with human subjects.