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 could not be established whether digital advertisements that are specifically aimed at clinical trial subject recruitment are permitted in Abu Dhabi. Regulations exist in relation to medical and healthcare advertisements in a general sense. It may be inferred that these may be extended to apply to subject recruitment, in the absence of specific regulations to address the latter, and hence they are discussed below.

• 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. It 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 should 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 local Ethics Committee and the Department of Health.

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.

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

9.2 Vulnerable Subjects

The DOH’s Standard on Human Subject Research provides the following definition of vulnerable persons:

“3.38 Vulnerable persons: Vulnerable persons include, but are not limited to:

• The mentally ill
• Prisoners and young offenders
• Children under 18
• People of determination
• Those in an overtly dependent situation (for example those in care)
• Patients with incurable diseases
• Persons in nursing homes
• Patients in emergency situations
• Those incapable of giving consent
• Also include individuals whose decision may be influenced by the expectation of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g. 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)."

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

“18. Obtaining informed consent in the event the subject is unable to do so himself or herself: the information given to the subject or, to his or her legally acceptable representative for the purposes of obtaining informed consent in the event the subject is unable to do so himself or herself, should:

• 18.1 Enable the subject or his or her legally acceptable representative to understand:
  • 18.1.1 The nature, objectives, benefits, implications, risks, and inconveniences of the clinical trial;
  • 18.1.2 The subject's rights and measures regarding his or her protection, in particular, his or her right to refuse to participate and the right to withdraw from the clinical trial at any time without any resulting penalty and without having to provide any justification;
  • 18.1.3 The conditions under which the clinical trial is to be conducted, including the expected duration of the subject's participation in the clinical trial; and the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical trial is discontinued;
• 18.2 Be kept comprehensive, concise, clear, relevant, and understandable to a layperson and should be in his or her vernacular language.
• 18.3 Be provided in a prior interview with a member of the investigating team who is a physician and appropriately qualified.”

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

A) The DOH guidance on “Human Subject Research” contains the following provisions regarding pediatric participants in clinical research:

“6.7. Children and Adolescents as Research Subjects:

Special considerations apply when children or adolescents are the research subjects.

• 6.7.1. Minors (less than 18 years of age) cannot give legal permission to participate in research. In these instances, the researcher must prepare an Informed Consent form for parents (or legal guardians) to sign on their child’s behalf.
• 6.7.2. Additionally, children must be assessed by the PI before obtaining consent and they must also agree (assent) to participate in the research study, either in writing or verbally.
• 6.7.3. Written assent will typically be appropriate for children aged 8 and above.”

B) The Department of Health-Abu Dhabi’s “HAAD-Guidelines-Patient-Consent-V1” contains the following provisions:

“7. CONSENT GIVER

Patient

Consent can be signed directly by the patient if the patient is 18 years of age or older unless there is evidence to verify incompetence regarding the decision to be made.

Substitute Consent Giver

Situations requiring a Substitute Consent Giver:

• When the patient is less than 18 years of age
• When the patient is deemed incompetent
• In accordance with the Law and cultural tradition, only procedures involving reproductivity and fertilization in a female patient require Consent to be obtained from the patient and the husband and/or Substitute Consent Giver regardless of their age
• When the patient is deemed incompetent

Legal Guardian

A legal guardian may give Consent for a minor under his/her guardianship. This may include cases where the child lives with grandparents or other family members who have legal guardianship status by an authorized competent Court of Law. An authorized competent Court of Law is one that has jurisdiction in the child's country where the decision was approved.

Zayed High Organisation for Humanitarian Services in Abu Dhabi or its delegate or successor (or equivalent entities in UAE, if applicable) is the properly authorized entity to give Consent if the child resides in a permanent ward/home”.

C) The DOH’s “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” contain the following provisions regarding minors and consent:

“17. Information and Consent

• 17.1 To carry out a clinical trial on a minor, written informed consent should be obtained from both parents or from the legal guardian(s) of the minor. The minor should be involved in the process if he/she is able to “assent” by first having the study explained to him/her and/or by reading a simple form about the study, followed by giving verbal consent on whether he/she wants to participate or not. Where one of the parents is unknown, deceased, or deprived of parental rights or, in case of divorce no such rights have been given to him/her, the written informed consent should be given by the minor and by the parent exercising parental rights.
• 17.2 The consent of the parents and legal guardians represents the presumed will of the minor and may be withdrawn at any time without any penalty for him.
• 17.3 The investigator should take into consideration the declared wish of minors to refuse to take part or to withdraw at any time from the clinical trial.
• 17.4 The assent of the minor and the consent of the parents or of the legally acceptable representative may be withdrawn at any time without any penalty for the minor.
• 17.5 The minor should be given information about the trial and about the possible risks and benefits in a way that will ensure understanding by a physician who has experience with minors.”

9.4 Financial Disclosures

It is a requirement for the Financial Disclosure of the Principal investigator to be submitted to the local ethics committees and DOH. 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?

Chapter 2 of Federal Law No. 8 of 2019 on Medical Products, Profession of Pharmacy and Pharmaceutical Institutions sets out provisions in relation to Clinical and Non-clinical Studies in the UAE.

Article 16 requires “the entity for whose interest” a clinical study is conducted to commit to concluding “an insurance contract with any insurance company operating in the State, to cover the damage that may arise from the study.”

The DOH’s “Standard on Human Subject Research” requires the following documentation to be submitted to the ADHRTC or REC/IRB on the application for approval to conduct a clinical trial, as specified in Appendix 2:

“f. Data about funding and the administrative organization of trials

1. Insurance covering the liability of the Sponsor and the Principal investigator(s) in case of property or non-property damages caused to the subjects related to their participation in the trial.
2. Provision for compensation or a sample agreement between the Sponsor and study subjects, when such compensation is considered.
3. Sample Agreement between Sponsor, Institution, and Investigator, defining terms and conditions of conducting the clinical trial.
4. Written approval as outlined in items I, 8.2 of the “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” document– Statement by the Director of the Institution regarding permission for conducting the study (if applicable).
5. Information about a clinical trial finance resource in case the Sponsor is a non-profit organization.
6. Pre-site assessment report signed by the Sponsor or its representative.
7. Evidence for payment of the required fee.”