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. Potential trial subjects may be recruited:

1. by advertisements in a newspaper or magazine,
2. on a noticeboard in places such as a university or hospital,
3. on the radio or television, or
4. on a website or any other social media platform.

All study-specific advertisements must be approved by the relevant IRB/IEC. Advertisements should say that the trial involves research and that the advertisement has been approved by an IRB/IEC and should give a contact name and phone number and some of the selection criteria. In addition, advertisements may give the purpose of the trial, where it will take place, and the name of the company or institution carrying it out. 

However, advertisements must never overstress payment, use IRB/IEC approval as an inducement, name and promote the product, or claim that it is safe.

An ethics committee should review general advertising and screening procedures. General screening constitutes non-invasive procedures that are undertaken to evaluate a subject’s eligibility to join a trial unit’s volunteer panel. The creation and maintenance of such a database should comply with the Personal Data Protection Act.

Subjects must be recruited of their own free will irrespective of the method used for recruitment. They should not be made to feel obliged to take part in a trial, nor should they suffer in any way if they do not take part.

9.2 Vulnerable Subjects

According to local requirements:

"Investigators must be wary of recruiting vulnerable trial subjects, such as the homeless, employees of the company, or students of the institution that is sponsoring or carrying out the trial. Employees and students are or may feel, vulnerable to pressure from someone who can influence their careers. Should such subjects decide to take part in the trial, they must be dealt with like other subjects in the trial, and not be allowed to let their normal work interfere with the trial. The investigator should forewarn employees, in a written agreement, of the possible implications of having their personal data processed at work by their colleagues. Employees and students may need to get permission from their employer or institution beforehand. Some sponsors bar the use of employees from trials of IPs."

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

Consent from one parent is considered sufficient.

https://mmc.gov.my/wp-content/uploads/2019/11/Consent_Guideline_21062016.pdf

9.4 Financial Disclosures

Yes, investigators are required to disclose any financial arrangements impacting the trial as well as any other perceived or actual conflicts of interest.

9.5 ICF translations – Are Certificates Required?

No, translation certificates are NOT required.

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?

Special provisions should apply to providing compensation to volunteers involved in healthy volunteer studies and patient studies. The nature of the compensation policy should be clear from the information and consent form, and subjects should be invited to seek an explanation of any aspect of the undertaking that is not clear to them. Compensation should be related to the time involved and the inconvenience that the volunteer is subjected to. 

The procedure for reimbursement and compensation should be clearly defined in the volunteer information form.