9. Subject Considerations

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them?

From the research conducted, it is clear that there are no regulations that deal directly with the use of digital advertisement in order to recruit clinical trial subjects. As an indication of what the Dubai Health Authority and DSREC are likely to permit, in relation to an application for a clinical trial, reference may be made to existing legislation and policy.

• Healthcare and medical advertising is regulated by government authorities, with a focus on ensuring transparency and honesty, and requires governmental pre-approval before publication.
• Advertisements may not violate public morals, decency, UAE customs, or Islamic values and traditions. 
• Medical advertising may not mislead potential patients/participants regarding the effectiveness of any therapy, treatment, or protocol, or that it will have no side effects.
• It is prohibited to target children via medical or healthcare advertising.
• Incentives to healthcare workers are not permitted for the sale of specified medications, via medical or healthcare advertisements.

Federal Law No. 8/2019 on Medical Products, Profession of Pharmacy, and Pharmaceutical Institutions governs the advertising of medicines and medical devices in the UAE. 

The 2019 Law provides a thorough framework that governs areas such as: (i) import, export, distribution, warehousing, and manufacturing; (ii) pricing; (iii) registration; (iv) advertising and promotion; (v) pre and post-clinical trials; and (vi) safety reporting and product recalls.

With regard to advertisement specifically, the 2019 Law sets out clear conditions around how various categories of Medical Products can be advertised in the UAE. Failure to adhere to the requirements will be considered a criminal offense resulting in fines or imprisonment.

The Publications Law states that advertisements on medicines or pharmaceutical products may only be published after having obtained a special license from MOHAP and also imposes various additional specific obligations/conditions on the advertisement of medical products. Where the subject matter of advertising is specifically related to Medical Products and services, advertisers must comply with special requirements. For example, the advertisement shall contain true and balanced statements that should not deceive public opinion and must include genuine facts and contents. It is prohibited to publish any advertisements which advertise medicine or pharmaceutical products without the approval of MOHAP. Such approval shall only be granted if the relevant advertisement complies with the requirements of the applicable regulations.

Any recruitment and/or advertising material intended to be used in a clinical trial must be submitted for approval to the DSRC and the MOHAP.

In the UAE, the law regulating media is the Federal Decree-Law No.55 of 2023. As per the decree, all media individuals and institutions operating in the UAE are required to comply with the national standards for media content.

UAE Government has a Media Regulation Page, where all related laws and guidelines on media can be found.

9.2 Vulnerable Subjects

Paragraph 2.42 of the “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices_2017” defines “Vulnerable Subjects” as: 

“Paragraph 2.42 ‘Vulnerable Subjects’ are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.”

Article 22. 

Paragraph 22.1 Clinical trials on individuals under Article 16, Paragraphs 16.4 and 16.5, who are not able to give informed consent, shall be carried out in accordance with the requirements of Article 11. 

Paragraph 22.2 Other than the requirements under Paragraph 22.1, the participation of adults who are not able to give informed consent in clinical trials shall be allowed, provided that: 

22.2.1. the respective Ethics Committee, involving specialists with competence in respect to the disease concerned or to the group of patients, has approved the protocol after discussing the clinical, moral and psycho-social aspects of relevance to the particular disease and to the group of patients; 

22.2.2. it may be expected that taking the medicinal product tested would bring benefits exceeding the risks or that risks have been fully eliminated; 

22.2.3. the purpose of the trial is to check data obtained through clinical trials on humans who are able to give informed consent or of data obtained through other research methods; 

22.2.4. the trial is directly connected to a life-threatening or disabling disease of which the adult person concerned who is not able to give informed consent suffers;

22.2.5. the clinical trials have been planned so that pain, inconvenience, fear, and other foreseeable risks associated with the disease have been reduced to a minimum and the level of risk and the degree of physical pain have been set in advance and are constantly monitored during the trial; 

22.2.6. no financial and other incentives are provided, except for compensation. 

Article 23. 

No clinical trials of a medicinal product may be conducted on pregnant and breast-feeding women, unless the medicinal product concerned is required for their treatment and may not be tested on any other group of patients.

9.3 Pediatrics (including whether consent from a single parent is sufficient vs. requiring both parents to sign)

Both parents or legal guardians, see below Art. 17.

Articles 16, 17, and 21 the “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices_2017” sets forth the requirements for clinical trials with vulnerable groups of patients. Articles 17 and 21 apply specifically to minors: 

“Article 17. 

Paragraph 17.1 Clinical trial on a minor shall be carried out after obtaining written informed consent from both parents or from the legal guardians of the individual, subject to Article 16, Paragraphs 16.1 and 16.3. They should be involved in the process if they are able to “assent” by having a study explained to them and/or by reading a simple form about the study, and then giving their verbal choice about whether they want to participate or not. 

Paragraph 17.2 The consent of the parents and legal guardians must represent the presumed will of the minor and may be withdrawn at any time without any penalty for him. 

Paragraph 17.3 The declared wish of the minors to refuse taking part or to withdraw at any time from the clinical trial must be taken into account by the investigator.”

Article 21. Clinical trials on minors may be undertaken provided that: 

Paragraph 21.1 the protocol has been approved by the relevant Ethics Committee after discussion of the clinical, moral and psycho-social aspects of childhood, in which at least two pediatricians have taken part; 

Paragraph 21.2 a direct benefit is expected from the clinical trial for the group of patients that will be included in it; 

Paragraph 21.3 the clinical trial is directly related to the clinical condition of the suffering minor; 

Paragraph 21.4 the medicinal product tested is intended to be used for diagnosis, treatment, or prevention of diseases that are specific to minors; 

Paragraph 21.5 the trial is intended to be carried out on minors; 

Paragraph 21.6 the purpose of the trial is to verify data obtained from clinical trials on individuals that are able to give informed consent or data obtained through other research methods; 

Paragraph 21.7 the results obtained from clinical trials on adults and their interpretation may not also be considered valid for minors and young persons; 

Paragraph 21.8 the trial is planned in a way to minimize pain, inconvenience, fear and other foreseeable risks associated with the disease, and the level of risk and physical pain have been predefined and are constantly controlled during testing; 

Paragraph 21.9 no financial or other incentives are provided, other than compensation. 

9.4 Financial Disclosures

It is a requirement for the Financial Disclosure of the Principal investigator to be submitted to the MOHAP. However, there is no template available.

9.5 ICF translations – Are Certificates Required?

The national law is silent on whether or not a translation certification is required. However, under normal practice, Certificates of Translations (CoTs) are not required to be submitted; relevant CoTs should be filed within the Trial Master File.

9.6 Subject Compensation: Is there a need for a local sponsor to be listed on the insurance certificate, the insurance certificate to cover the duration of the study, and specific minimum amounts of coverage to be specified, both for individual events occurring and in aggregate?

Article 12 of the Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” states that:

“Article 12. The sponsor and the investigator shall make a local insurance covering their liability available to the trial subjects in the event of any trial-related injury or death during the course of the trial.