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1. Overview: Clinical Research
In line with the mission of Health Authority in Abu Dhabi (HAAD) to promote world class research that improves health and quality of life of both citizens and residents, and in keeping with the vision of ACPN to be the leading regional neuroscience institute, the Department of Clinical Research at ACPN strives to promote and implement evidence-based clinical practice through well-designed research studies using sound research methodology. This approach will arm us to better serve the mission of ACPN to provide the best evidence-based patient’s center care. Evidence-based practice helps in improving general quality of life through improved diagnosis and treatment, as well as reducing morbidity and mortality. Empirical evidence changes our approach to decision-making in clinical practice, while also giving validity and credibility to ACPN as one of the main healthcare providers in the UAE.
2. ACPN Institutional Review Board (IRB)
In compliance with the guidelines set by the International Council for Harmonization for Good Clinical Practice (ICH-GCP), ACPN has a well-established Institutional Review Board, authorized by Health Authority in Abu Dhabi (HAAD), to run clinical trials and scientific research projects. The board is made up of both internal and external healthcare providers as well as academicians with expertise ranging from Psychology, Psychiatry, Neurology, Neuropsychology, Pediatric Neurology, and Biomedical Engineering. The IRB serves to ensure ethical conduct of research, in compliance with the aforementioned policies and guidelines.
a. Academic and Scientific Research Institutions:
New York University Abu Dhabi
Imperial College London Diabetes Centre (ICLDC)
b. Current Pharmaceutical supporters
4. Guidelines for Proposed Research Studies:
No restrictions on the type of research that can be conducted as long as:
Note on clinical trials:
Note: investigational medicinal product is one that has been given marketing authorization but is being investigated for uses other than what is indicated. Does not apply to Phase 1 trials.
5. Criteria for Research:
Proposed studies must meet the following criteria:
Benefit: Does the proposed study have clear benefits to the community in which it is conducted?
Effectiveness: Will the study be effective in achieving the desired goal?
Necessity: Is the study necessary to achieve the goal or is there an alternative that won’t infringe on a competing value?
Proportionality: Is the desired goal important enough to justify overriding another principle or value?
Least infringement: Is the study designed to minimize infringement on the values that conflict with it?
Transparency: Is the Primary Investigator prepared to publicly justify their decision?
6. Ethical Considerations:
Ethics regarding human subjects:
Respect for persons: respect autonomous choices; protect those lacking autonomy
Obtain informed consent from those capable of giving consent, proxy consent
Beneficence: do not harm; maximize benefits, minimize harms
Risk/benefit assessment is conducted, clear action if adverse effects arise
Justice: fairness in distribution; treat equals equally
Recruitment of subjects is fair, vulnerable populations not simply targeted out of convenience
7. Research Ethics Application: What to include
8. Application Submission Procedures:
9. Ongoing Research Studies:
10. Published Research Articles:
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