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?

Advertising and Promotion of Health Products and Medical Services

Philippine laws and regulations regulate the advertising and promotion of medical devices and medical services. 

Under the rules and regulations of the FDA Act ("FDA Act IRR"), a manufacturer, owner, distributor, advertiser, and its agents are mandated to strictly adhere to the standards, guidelines, and rules and regulations prescribed by the FDA, including the following: 

• No health product that has not been registered or authorized shall be advertised, promoted, or subjected to any marketing activities.
• No claim in the advertisement, promotion, sponsorship, or other marketing activities shall be made other than those contained in the approved label or packaging of the health product, or as duly approved by the FDA.
• No claims, therapeutic, scientific, or otherwise, shall be made that have not been duly approved by the FDA.

On the other hand, DOH Administrative Order 2015-0053 or the Implementing Guidelines on the Promotion and Marketing of Prescription Pharmaceutical Products and Medical Devices (“PPPMD Guidelines“) provide detailed rules and guidelines on the advertising and promotion of medicines and medical devices for the public and healthcare professionals. 

Under the PPPMD Guidelines, all advertising, promotional, or other marketing materials, whether written, audio, or visual, for products within the scope of such guidelines, may be subjected to a post-audit by the FDA and if any should be found to violate any FDA provisions, a cease-and-desist order and/or penalties and/or fines shall be issued by the FDA. Responsibility to ensure compliance with the PPPMD Guidelines belongs to the Prescription Pharmaceutical Company. 

Republic Act. No 7392, as amended, otherwise known as the Consumer Act of the Philippines ("Consumer Act"), also regulates advertising in the Philippines. Under the Consumer Act, advertising is defined as "the business of conceptualizing, presenting or making available to the public, through any form of mass media, fact, data or information about the attributes, features, quality or availability of consumer products, services or credit."

The Consumer Act also provides that advertisements must comply with the Code of Ethics of the Ad Standards Council ("ASC Code of Ethics"). The ASC Code of Ethics and Guidebook have specific provisions dealing with the advertisement of pharmaceutical products and devices. The ASC Code of Ethics mirrors the provisions in the FDA Act IRR. 

Under the ASC Code of Ethics, print advertisements, merchandising materials, and internet/digital/mobile advertisements involving medical devices are subject to post-screening by the ASC, except when they include leadership, exclusivity, absolute, comparative, and superiority claims, testimonials, or direct comparisons. ASC clearance or pre-screening is required when the advertisement is published in the form of broadcast materials, cinema advertisements, or out-of-home material.

Under the ASC Code of Ethics, out-of-home advertisements are essentially those that intend to reach consumers while they are outside the home. They include:

• Billboards
• Indoor or outdoor digital displays (e.g. malls, shopping centers)
• Transit ads
• Street furniture/fixtures (e.g. sheds, walkways, garbage bins, street signs, lamp posts, lighted signage)
• Blimps

The ASC Code of Ethics also includes rules on advertising of or by healthcare professionals:

• Endorsements by a medical practitioner shall be subject to the Code of Ethics and applicable laws and regulations to their profession.
• Advertisements or endorsements may state only the professional’s name, address, office hours, and licensed area of practice or specialization.
• Endorsements, direct or implied, are prohibited by the Code of Ethics of the profession and applicable laws, endorsements by actors portraying the medical practitioner shall not be allowed. 

The use of digital technologies, including telemedicine platforms to advertise services rendered by medical professionals and/or health products must comply with the foregoing regulations and guidelines.

https://practiceguides.chambers.com/practice-guides/digital-healthcare-2023/philippines/trends-and-developments

For further information regarding ethics in clinical trials in the Philippines, please see the National Ethical Guidelines 2017. For more information regarding advertising in the Philippines, refer to the ‘Overview of Philippine Advertising Regulation’.

9.2 Vulnerable Subjects 

Vulnerability of Research Participants 

Vulnerable participants shall require special protection because of certain characteristics or situations that render them as such. Vulnerable participants are those who are relatively or absolutely incapable of deciding for themselves whether to participate in a study for reasons such as physical and mental disabilities, poverty, asymmetric power relations, and marginalization, among others and who are at greater risk for some harm. 

Vulnerable groups shall not be included in research unless such research: 

1. Is necessary to promote the welfare of the population represented; and 
2. It cannot be performed on non-vulnerable persons or groups. 

Researchers, sponsors, or RECs shall not arbitrarily exclude women of reproductive age from biomedical research. The potential for becoming pregnant during a study shall not, in itself, be used as a reason for precluding or limiting women’s participation in research. 

Competent advice and assistance shall be provided to participants who, by virtue of social, economic, political, or medical disadvantages, are liable to give consent under duress or without the benefit of adequate information. Caution shall be exercised in obtaining informed consent for a research project if the research participant is in a dependent relationship with the researcher (e.g., as a research participant) to ensure that the consent is not given under duress or undue influence. 

http://49.231.15.21/deptw13/upload/files/hercF256312041721022781.pdf 

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

Consent is required from at least one parent. 

ETHICAL GUIDELINES FOR RESEARCH INVOLVING MINORS OR CHILDREN 

“Minors” are persons under 18 years of age and the term may be used interchangeably with the term “children.” 

Republic Act No. 6809 places the age of majority at 18 years of age at which time the person is emancipated from parental authority and is considered “qualified and responsible for all acts of civil life”, and can enter into contracts on their own, or sign the ICF. 

Pediatric practice, on the other hand, includes patients who are more than 18 years though under 19 years old. The practice means that pediatric research may include patients who can already sign the ICF on their own, without requiring parental consent. 

Assent is the manifestation of the agreement of a minor to participate in a research or clinical trial. The assent may be in the oral or written form. 

Minors are considered as belonging to a vulnerable population. 

1. Research involving minors is justified when: 

1. The research cannot be carried out equally well in adults. Examples include research on pediatric cancer, systemic lupus erythematosus, adolescent depression, childhood abuse, and Down’s syndrome, among others such that research among adults who had these illnesses in their childhood will not elicit accurate results. 
2. The purpose of the research is to obtain knowledge relevant to the health needs of children. 

Requirement for permission from a legally authorized representative 

2. A parent or legally authorized representative (LAR) of each child shall provide the necessary consent for the participation of the minor. In default of parents or judicially declared guardians, this order of authority shall be followed: 

• 2.1. Grandparents
• 2.2. Oldest sibling over 21 years of age, unless unfit or disqualified
• 2.3. Actual custodian over 21 years of age, unless unfit or disqualified

3. Where the parents are both of minor age or themselves incapacitated to enter contracts or give consent to their child’s participation in research, the guidelines on medical treatment of such a child may be followed whereby a third party may give the consent (i.e., the child’s grandparents, physician, or the hospital administrator, as in emergency cases). 

Requirement for assent 

4. Aside from the informed consent being required from LARs, assent from minors must also be obtained. Thus, the protocol must include the procedure for obtaining the minor’s assent. The minor’s assent to participate in the study shall be obtained without coercion. 

5. At any age, any sign of dissent shall be observed, and children who dissent must not be recruited to the study. 

6. The manner and form by which a minor provides his or her assent shall be as follows: 

• 6.1. If the minor is under 7 years old, no formal assent, whether verbal or written, is needed as long as there is no manifestation of dissent. 
• 6.2. If the minor is 7 to under 12 years old, verbal assent is acceptable. Documentation of the verbal assent is required. Documentation may be in the form of a written description of the process and witness. 
• 6.3. If the minor is 12 to under 15 years old, he or she shall sign a simplified Assent Form that is different from the Informed Consent Form which the parents or guardians sign. The Assent Form shall have been reviewed and approved by the REC. The decision to have an Assent Form for participants below 12 years old rests on the REC. (See Appendix M: Informed Assent Template) 
• 6.4. If the minor is 15 to under 18 years old, he or she can sign the same informed consent document signed by the parents. 

7. A minor’s refusal to participate or continue in the research shall be respected. 

8. Information on the study to which the child’s participation is sought, and terms such as “research,” “study design,” “procedures,” “adverse effect,” and “voluntary” shall be explained in a manner and language the child understands for purposes of assent and dissent. 

Determining the age of the child 

9. The age of the child shall be determined by documentary evidence as follows: 

• 9.1. Child’s birth certificate
• 9.2. Child’s baptismal certificate
• 9.3. Any other pertinent documents such as, but not limited to, the child’s school records, dental records, or travel papers.
• 9.4. In the absence of all the above, competent testimonial evidence may be used. 

10. In case of doubt as to the age of the child, after all measures are exhausted to determine it, the age shall be resolved in the best interest of the child. 

11. Assent presupposes that the child is mentally and physically capable of understanding what study participation entails. However, a competency examination of a child, motu proprio or by request of a party, shall be conducted when there exists substantial doubt regarding the ability of the child to understand the nature and consequences of giving assent. 

http://49.231.15.21/deptw13/upload/files/hercF256312041721022781.pdf 

9.4 Financial Disclosures 

To implement Section 35(b) of the Universal Healthcare Act ("UHC Act"), the Department of Health (DOH) has issued Administrative Order No. 2021-0036 entitled 'Guidelines on Compliance with Section 35(b) of [the UHC Act]: All Drug, Medical Device, Biological and Medical Supplies Manufacturers to Submit Reports on Disclosure of Financial Relationships with Health Care Providers and Health Care Professionals' ("Disclosure Guidelines").

The Disclosure Guidelines require covered drug and medical device companies to submit Disclosure Reports on their financial relationships with healthcare providers and healthcare professionals (collectively, HCP) to the Food and Drug Administration (FDA).

https://insightplus.bakermckenzie.com/bm/mergers-acquisitions_5/philippines-doh-issues-guidelines-on-disclosure-of-financial-relationships-between-fda-licensed-establishments-and-hcps-under-the-uhc-act 

9.5 ICF translations – Are Certificates Required?

The ICF should be presented in English.

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?

According to the National Ethical Guidelines:

Clinical care and compensation of participants 

Investigators shall ensure that research participants who suffer an injury as a result of their participation are entitled to free medical treatment for such injury, and to such financial or other forms of assistance that would compensate them equitably for any resultant impairment. 

http://49.231.15.21/deptw13/upload/files/hercF256312041721022781.pdf