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Governance and Organizational Structure
Research involving human participants at NYUAD is governed by the principles outlined in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, "Ethical Principles and Guidelines for the Protection of Human Subjects of Research" (the Belmont Report). The Belmont Report identifies three basic principles, which are described in this document for informational purposes:
- Respect for Persons
The principle of respect for persons means respecting an individual's autonomy, i.e., a person's right to make decisions for him/herself. This means that individuals should participate in research voluntarily and be given sufficient, accurate, clear, and understandable information to make an informed decision about whether or not to participate. The Belmont Report further specifies that persons with diminished autonomy (e.g., children, cognitively impaired persons) are entitled to additional protections.
The principle of beneficence requires that the researcher not only protect individuals from harm but make efforts to secure their well-being. Complementary expressions of beneficent actions are: (1) do no harm, and (2) maximize possible benefits and minimize possible harms. Risks to subjects may be balanced against the potential benefits to the subjects directly, or to society as a whole.
The principle of justice means that the benefits and burdens of the research are fairly distributed. For example, it is a violation of the principle of justice to select a class of subjects (e.g., the poor, an ethnic disadvantaged minority, institutionalized persons, etc.) simply because of easy availability, rather than for reasons directly related to the research topic being studied. The principle of justice requires that there be fair procedures and outcomes in the recruitment and selection of research subjects.
The NYUAD IRB is bound by the regulatory requirements of the United Arab Emirates, United States and other countries where research is conducted, and by NYUAD policies.
NYUAD has filed an assurance of compliance, called a Federalwide Assurance (FWA) (PDF), with the Office for Human Research Protections (OHRP) in the US Department of Health and Human Services (DHHS). An FWA is a binding written agreement between the University and DHHS. It states that the University is guided by the ethical principles of the Belmont Report, and will comply with federal regulations (45 Code of Federal Regulations Part 46, or simply 45 CFR 46) (PDF) for all federally-funded human subjects research.
NYUAD, through its written policies and procedures governing the conduct of research involving human subjects, assures that the research complies with the applicable laws of the United Arab Emirates and Abu Dhabi, and when required, the regulations of the DHHS, pertinent US laws, and requirements of other applicable agencies and funding sources, as necessary.
The Federalwide Assurance requires that the Institution has written policies and procedures that describe the responsibilities of the Institution, the Institutional Official, the HRPP, the IRB, and the investigator. All investigators at NYUAD are expected to conduct research in accordance with the provisions of the Federalwide Assurance, regardless of the funding source for their research, and including unfunded research or research funded using NYUAD resources.
Other federal agencies have additional HS regulations, e.g. the Departments of Education, Energy, and Defense. Research sponsored by these agencies must also comply with the agency's regulations.
The Institutional Official (IO) is the person ultimately responsible for the development and implementation of the Human Research Protection Program (HRPP) plan and the coordination of its various components. The Vice Provost for Research Administration and University Partnerships serves as IO at NYUAD, and has the authority to sign federal assurances, and place limitations on an investigator's or staff's privilege to conduct human research if such activities are deemed inappropriate for conduct at NYUAD. The IO is responsible for approving the HRPP plan.
The IO is responsible for assuring that the written policies and procedures that implement the HRPP are compliant with any and all policy development and approval procedures dictated by NYUAD.
The IO cannot overturn the decision of the IRB to suspend or disapprove a protocol.
The Institutional Review Board (IRB) Administrator is a professional staff member who is responsible for supporting the IRB activities, facilitating understanding and interpretation of IRB policies and procedures, and assuring that protocol submission and review procedures are conducted according to HRPP/IRB policies and procedures. The IO may delegate certain human research oversight administrative activities to the IRB Administrator, as appropriate. At NYUAD, the IO has delegated the determination of Exempt from Review status for proposed research projects to the IRB Administrator.
Institutional Review Board
The Institutional Review Board (IRB) is the board formally designated in an institution to review the conduct of research involving human subjects, unless specifically exempted from IRB review, in accordance with the requirements of DHHS 45 CFR 46 (PDF).
The written policies and procedures of the NYUAD HRPP plan fully describe the IRB membership and operations, IRB administrative support, and other matters pertinent to the conduct of research involving human subjects at NYUAD.