5. Investigator and Investigational Product

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?

Yes. Federal Law No. 5 of 2019 Regulating the Practice of Human Medicine regulates the medical profession in the UAE. Article 4 requires any person who practices the profession in the UAE (including within the free zones, according to Article 1) must be licensed to do so by a Health Authority, which is the Department of Health for Abu Dhabi. Article 5 provides that, in order to obtain a license to practice in the UAE, a medical practitioner:

• must hold a Bachelor’s degree or equivalent in human medicine, including dentistry, which is accredited in the State;
• must have completed an internship;
• must be of good character and conduct;
• must be medically fit to perform their duties, and
• any other conditions or controls prescribed.

Federal Law No. 8 of 2019 on Medical Products, Profession of Pharmacy and Pharmaceutical Institutions defines a Healthcare Practitioner as a “person who is scientifically and technically qualified and licensed to practice any of the healthcare professions in the State as set out by the Implementing Regulation of this Law”.

The DOH’s “Standard on Human Subject Research” provides the following definition of a PI:

“3.23.1 Principal investigator (PI): Principal Investigator is the primary individual responsible for the preparation, conduct, and administration of a research project at a study/trial site in compliance with applicable laws and regulations and facility policy governing the conduct of research.

• 3.23.1.1 A PI is preferably to be from one of the following health specialties: physician, dentist, nurse, or pharmacist.
• 3.23.1.2 Where research projects involve collaboration among many individuals, one person must be designated as the principal investigator (PI).
• 3.23.1.3 The PI will be the investigator responsible for the research site in a multi-site study. There should also be one PI for each research site.
• 3.23.1.4 In the case of a single-site study, the PI and the key investigator will normally be the same person.
• 3.23.1.5 The PI is the “point person” for communicating with the REC and all applications for review by the REC should be submitted by the PI.”

5.2 Does local regulation require any specific documents if PI/CI is based outside the country?

As per the current guidance, it is our interpretation that only locally authorized entities can apply for clinical trials. PIs participating in a clinical trial must be registered with the DOH.

5.3 Does local authority allow electronic ICF administration, including electronic signatures?

The HAAD’s “Guidelines for Patient Consent” contains provisions on electronic consent applicable under the Tele-Medicine interventions. However, the current Telemedicine Standards available are applicable to standard medical care and not clinical research.

The Department of Health is embracing innovation, and electronic consent may be one of the decentralized elements that may be considered during a clinical trial. However, it is not currently supported under any published policy/guideline or standard applicable to clinical research.

We recommend discussion with the DOH if eConsent and eSignatures are planned to be used in a clinical trial in Abu Dhabi.

5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded?

The HAAD’s “Guidelines for Patient Consent” indicate the following:

“Recording and Reviewing Decisions:

• The physician and/or allied health care professional should make use of the patient’s medical records or Consent form to record the key elements of the decision made with the patient. This should include any specified patient requests, visual, audio, or written material provided to the patient and any decisions that were made”.

Under Appendix B - Duties of Physicians, Allied Health Care Professionals, and Health Care Providers:

“3. Communication, partnership and teamwork

3.5 Give patients the information they want or need in a way that they can understand to make informed decisions; 

3.5.1 Information may be provided using written information, visual, or other aids and the physician shall ensure this information is accurate and up to date and documented in the patient record.”

5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)?

The Health Data Protection Law No. 2 of 2019 Regarding the Use of ICT [information and communication technology] in the Health Fields (Health Data Law), amended by Ministerial Resolution No. 51 of 2021 (“the Resolution”), is based on the EU GDPR law and regulates the use of information and communications technology in the health sector in the UAE. 

The Resolution provides a set of exceptions to the restriction on cross-border and the processing of UAE Health Data under Article 13 of the Health Data Law. The exceptions are set out in Article 2 of the Resolution. UAE Health Data can be exported from the UAE in the following circumstances: 

1. Treatment of overseas patients
2. Medical testing
3. Scientific research
4. Insurance claims and coverage
5. Organizations cooperating with the UAE
6. Wearables or healthcare monitoring devices
7. Pharmacovigilance reporting
8. Data approved by a Health Authority
9. Telemedicine
10. Formal request

These topics are mentioned in more detail as relevant to the topics discussed in Section 8 of this guidebook.

5.6 If a clinical study involves the study product as OTC and this is provided via pharmacy/amazon, etc., are there any specific regulations for IP management that need to be followed?

The DOH’s “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” contain the following provisions regarding study products:

“15. The Sponsor should ensure that the tested medicinal product(s) and all articles required for its administration are free of charge for any case of interventional design.”

The Department of Health is embracing innovation, and the distribution of IP directly to study participants may be one of the decentralized elements that may be considered during a clinical trial. However, this is not currently supported under any published policy/guideline or standard applicable to clinical research.

We recommend discussion with the DOH if the distribution of investigational or auxiliary medicinal products is planned to be used in a clinical trial in Abu Dhabi.

5.7 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs. Interventional Study)?

The DOH’s “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” contain the following provisions regarding study products:

“15. The Sponsor should ensure that the tested medicinal product(s) and all articles required for its administration are free of charge for any case of interventional design.”

5.8 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range?

The DOH’s “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” provide that clinical trials on minors or adults unable to give consent may be undertaken provided that:

“21.7 & 22.2.6 No financial or other incentives are provided.”

5.9 Specific labeling requirements for clinical study product

From the research conducted, this could not be determined. It may be assumed that these requirements will follow those in the Emirate of Dubai if approved by the ADHRTC.

5.10 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics?

Approval must be obtained from the Ministry of Health and Prevention in order to import investigational/study products into the UAE. Advice may be sought from the Ministry of Health and Prevention in relation to the import and export of drugs and biological specimens via Import.Export@mohap.gov.ae.

An official import permit should be obtained through MOHAP licensed medical warehouse per each shipment after attaching the below documents in the import application for officer review:

• The regulatory committee approval for the clinical trial.
• The regional research ethics committee approval for the clinical trial.
• Authorization letter from the manufacturer/clinical trial sponsor for the appointment of the local agent (MOHAP licensed medical store).
• Declaration letter from the local agent (MOHAP licensed medical store) that the imported items will be used in the relevant investigational/clinical study only.

Import license permits are obtained via the MOHAP website or smart app using the UAE PASS.

Process and documentation for obtaining a Permit to import medicines from a local agent are identified within the MOHAP website.

5.11 What is the turn-around time to get an import permit?

Within a period of 3 working days of filing an import request.

5.12 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required?

From the research conducted, this could not be established. It may be assumed that this will be permitted, as it is in the Emirate of Dubai if approved by the ADHRTC.