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?

Yes, digital advertisement is allowed as long as the appropriate message is explicitly communicated to the audience in the form of text or sound depending on the type of advertising.

https://www.regdesk.co/thailand-direct-advertising-labeling/

9.2 Vulnerable Subjects 

These participants may include hospitalized patients, prisoners, children, the mentally impaired, critically ill and psychotic patients, pregnant women, and the disadvantaged. Other vulnerable participants may include drug company employees, soldiers, prisoners, patients with incurable diseases, emergency patients, unemployed or poor people, members of minority groups, the homeless, immigrants, and young people who are unable to give consent on their own.

Pregnant Women, Fetuses & Neonates

Any Thai clinical studies involving pregnant women and fetuses require additional safeguards to ensure that the research conforms to appropriate ethical standards and upholds societal values. Adequate information on the safety and impacts on the fetus should also be made available.

In addition, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) indicates that the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

Prisoners

Prisoners are considered vulnerable because incarceration could affect their ability to make voluntary decisions regarding participation in research. A research study involving prisoners should ensure that these prospective participants are informed, and are given the opportunity to make their own decisions without any interference from a higher authority.

Mentally Impaired

Per G-ResEthics, informed consent should be obtained from the legal representatives or guardians of participants for studies involving psychiatric or mentally incapacitated patients.

As further explained in the Mental Health Act, any research to be conducted with patients who are mentally impaired needs to respect their right to:

• Receive treatment according to medical standards that protect human dignity.
• Have information about their illness and treatment kept confidential other than what is required to be disclosed by law.
• Sign an ethics committee (EC) approved consent form prior to participation.
• Receive equal access to state health insurance and social security systems.

The Mental Health Act prohibits disclosure of health information of mentally impaired participants in a manner that may damage the individual, except in the event that the patient or others may be in danger, for public safety, or specific laws require this information to be disclosed.

The Act also states that any research involving patients who are mentally impaired can only be performed after obtaining their consent as well as EC approval and approval from other relevant authorities to conduct the study. The patient’s approval may be revoked at any time. Treatment may only be administered once the patient has been informed as to why the treatment is necessary and provided with the details and benefits prior to giving his/her consent. In the case of a patient under 18 years old, or one who lacks the ability to make decisions, the patient’s legal representative(s) or guardian(s) should provide consent. If the patient is to be admitted to a public hospital or treatment facility, his/her signed consent is necessary. Research is permitted in the case of patients with mental impairments who are either facing dangerous conditions or compulsory treatment is required.

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

According to the National Ethical Guidelines (2007), a minor is someone under 18 years of age.

When a research participant is a minor, informed consent should be obtained from both parents, guardians, or legal representatives. Additionally, precautions against possible physical and mental harm should be exercised. Furthermore, the rights of minors should be respected for their voluntary decision to participate in a clinical study.

The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) states that when a clinical trial includes minors, the minor should be informed about the trial to the extent compatible with his or her understanding and, if capable, he or she should sign and personally date the written informed consent.

Assent is required for minors aged 7 until they reach 18. Different assent forms should be created for the following age groups: 7 to 13 and over 13 until 18. The CREC requires children aged 13 years and older to sign an assent form.

9.4 Financial Disclosures 

Researchers must disclose any financial activity prior to the commencement of the trial which may be considered a real or perceived conflict of interest.

9.5 ICF translations – Are certificates required?

Yes, where the ICF is provided in Thai, a certified translation into English should be provided.

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?

The National Ethical Guidelines (2007) state that the sponsor should provide insurance or indemnify the investigator/institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence, if required by applicable regulatory requirements. Therefore, the local sponsor should be included on the insurance certificate.