Harmonization of the UAE Clinical Trial Regulation and Ethical Approval Dr. Mahera Abdulrahman, MD, MSc, PhD Research Support Section Dubai Health Authority.

Harmonization of the UAE Clinical Trial Regulation and Ethical Approval

Dr. Mahera Abdulrahman, MD, MSc, PhDResearch Support SectionDubai 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 "Tuskegee Study of Untreated Syphilis“• 1947 Nuremburg Code• 1948 UN Universal Declaration of Human Rights• 1964 Declaration of Helsinki• 1979 Belmont Report• 1993 CIOMS: International Ethical Guidelines

for Biomedical Research (Updated 2002)• 1997 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

outcome• 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 Harm:

Researchers must Protect the physical, mental & social well-being of each research participant Minimizes physical and social risks Maximize the possible benefits

• Justice/Non-Exploitation 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

• 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

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 non-interventional 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 EastCountry Entity Year/

Guidelines

UAE Ministry of Health 2006

Qatar Ministry of Health 2009

Bahrain Ministry of Health 2009

Kuwait Kuwait Institute for medical Specialization 2001

Saudi Arabia Saudi Food & Drug AuthoritySaudi Council for Health Specialties

20051998

Jordan Prime Ministers Council 2001

Egypt Ministry of Health 2003

Lebanon Perlman Council 1994

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 Authority2. Dubai Healthcare City Authority3. Ministry of Health 4. Health Authority – Abu Dhabi 5. Public universities

بعد” إال اإلنسان على طبية تجارب أو أبحاث إجراء يحظرالالئحة تحددها التي الجهة من بذلك ترخيص على الحصول

“ الالئحة تلك تقررها التي للشروط تبعا و التنفيذية

IRB in UAE

Each established research policies & standards

These regulatory activities are designed to: Ensure patient safety and the protection of research

subjects. 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 Section.

IRB in UAE 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 approval

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.

FUTURE SCOPES• 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”

THANKS!

Any Questions?