Harmonization of the UAE Clinical Trial regulation and ethical

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Transcript Harmonization of the UAE Clinical Trial regulation and ethical

Harmonization of the UAE Clinical
Trial Regulation and Ethical
Dr. Mahera Abdulrahman, MD, MSc, PhD
Research Support Section
Dubai Health Authority
Institutional Review Board (IRB)
• The International Council on Harmonization (ICH) defines an
institutional review board (IRB) as:
“ A group formally designated to protect the rights, safety and
well-being of humans involved in a clinical trial by reviewing
all aspects of the trial and approving its startup. IRBs can
also be called independent ethics committees (IECs)”
Evolution of Research Ethics
• 1932
• 1947
• 1948
• 1964
• 1979
• 1993
• 1997
"Tuskegee Study of Untreated Syphilis“
Nuremburg Code
UN Universal Declaration of Human Rights
Declaration of Helsinki
Belmont Report
CIOMS: International Ethical Guidelines
for Biomedical Research (Updated 2002)
ICHTR: The International Conference on
Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for
Human Use
Nuremburg Code, 1947
• Voluntary consent is absolutely essential
• Good study design
• Avoid unnecessary suffering
• Death or serious injury should not be expected
• Risk weighted against importance of the problem
• Facilities and means to protect subject
• Scientific qualification of researcher
• Subject must be free to withdraw at any time
• Be able to stop the study at any time
The Belmont Report, 1979
Autonomy, Respect for Persons:
Each individual: Has the right and capacity to decide; Has
value and dignity; and Has the right to informed consent.
Beneficence/ Do Good & Non-Maleficence/ Do No
Researchers must Protect the physical, mental &
social well-being of each research participant
Minimizes physical and social risks
Maximize the possible benefits
The research should generate more good than harm
Optimizing IRB Review:
Principles and Potential Models
• Historically IRBs
• Large academic institutions conducted human research
• Established as a local, institutional body
• Single-site research predominated
• Evolving research landscape
• Research increasingly a collaborative enterprise
• Growing prominence of multi-site trials
• Central and other models of IRB review increasingly attractive
• Efficiency
• Consistency
Optimizing IRB Review:
Principles and Potential Models
• UK:
• One multicentre IRB/REC would review the protocol and the
local IRBs would limit their review to locality issues, with an
aim to communicate the decision to the applicant within
three weeks (1998)
• France:
• A single IRB/REC opinion has been in place since 1988
• Spain:
• 133 RECs (local and regional) on 2005
Optimizing IRB Review:
Principles and Potential Models
• EU, the Directive 2001/20/EC2 :
To ensure legally the implementation of the principles of
good clinical practice in clinical trials on medicinal products
in Europe. This Directive does not apply to noninterventional trials. The whole process should take no
longer than 60 days.
• US:
The Common Rule is a rule of ethics regarding biomedical and
behavioral research involving human subjects in the United
States. These regulations governing IRBs for oversight of human
research came into effect in 1981
IRB Guidelines in Middle East
Ministry of Health
Ministry of Health
Ministry of Health
Kuwait Institute for medical Specialization
Saudi Arabia
Saudi Food & Drug Authority
Saudi Council for Health Specialties
Prime Ministers Council
Ministry of Health
Perlman Council
Alahmad et al. BMC Medical Ethics 2012, 13:34 Page 4 of 10
UAE Medical Liability Law No.
10 (2008)
• It shall be prohibited to conduct medical research or
experiments on humans unless after obtaining the
necessary license from one of the following bodies, as
per their jurisdiction:
1. Dubai Health Authority
2. Dubai Healthcare City Authority
3. Ministry of Health
4. Health Authority – Abu Dhabi
5. Public universities
‫”يحظر إجراء أبحاث أو تجارب طبية على اإلنسان إال بعد الحصول على ترخيص بذلك من‬
“‫الجهة التي تحددها الالئحة التنفيذية و تبعا للشروط التي تقررها تلك الالئحة‬
 Each established research policies & standards
 These regulatory activities are designed to:
 Ensure patient safety and the protection of research
 Maintain the highest standards of ethical research conduct
consistent with international principles.
 Comply by all UAE laws, policies and regulations
 Conform to ICH-GCP standards
 Investigational New Drugs must be registered with The
Ministry of Health Drug Control Department and Each
organization Drug and Medical Products Regulation
 Health Authority – Abu Dhabi :
 Governance structure to oversee regulation of
human subjects research
 Be limited to those licensed facilities that have
been authorized to conduct research
Harmonizing the IRBs in UAE
• Heterogeneity in terms of requirements and evaluations, patient
information and consent document, and investigator qualifications.
• The application requirements and processes are different, which
results of loads of paper work and consumes time of researchers
• There are some discrepancies in the approaches of different ethics
committees as regards inclusion and exclusion criteria
• Some ethics committees require applicants to have certificates in
research (e.g. GCP)
• Some require payments
• Administrative burden is one main bottleneck in the process of
seeking ethics approval: 4 weeks to sometimes months to get the
Harmonizing the IRBs in UAE
• This multiplication of effort is expensive, time consuming, and has
resulted in too much variety in response among the IRBs involved
• There is a need for a common regulatory framework
• There is a need for formal training of ethics committee members
• Crucial need for specific training on innovative research and on
highly specialized fields of research (somatic cell therapy, gene
therapy, tissue bioengineering)
Harmonization should be sought intensively, in order to make the
procedure more predictable and even quicker.
• Endorse effective and coordinated policies and regulations
for the conduct and oversight of clinical research
• Establishing, at the national level, a single electronic
submission of the documents for clinical trials
• Maintain the integrity and enhance the effectiveness of
institutional system
• Build partnerships and develop new mechanisms of
interaction: regular meetings in a federal level
“Formally Establishing Central IRB in UAE”