Governance

Research involving human subjects at NYU Abu Dhabi is governed by the Ethical Principles embodied in the Belmont Report (PDF), by the regulatory requirements of the United Arab Emirates, United States and other countries where research is conducted, and by the policies of NYUAD and NYU.

Ethical Principles

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
Beneficence
Justice

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.

Regulatory Requirements

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 Health Authority of Abu Dhabi regulates research involving human subjects in the Emirate of Abu Dhabi. Policies can be found on the Health Authority of Abu Dhabi website, under useful resources.

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