Low-risk trial offers and assessment sessions for parents

Parents can look for low-risk trial offers and assessment sessions by focusing on studies that involve minimal additional procedures, clear informed consent, and transparent information about costs, risks, and benefits. In Singapore, clinical trials involving minors generally require minimal risk and burden when there is no direct benefit, and parental consent is required when the child cannot consent for themselves.

What to ask before agreeing to a trial or assessment session:

• What is being assessed? Ask whether it is an actual treatment trial, a screening/assessment visit, or a study using existing care with no new treatment.
• How much extra risk is involved? Good low-risk studies minimise added procedures and separate study risks from routine treatment risks.
• What will my child need to do? Ask about blood draws, scans, questionnaires, follow-up visits, and whether anything can be done during routine care.
• Will there be any fees? Trials usually do not charge participation fees, though families may still have expenses; many studies reimburse travel, meals, parking, or hotel costs.
• Can I take time to decide? Parents are typically given information sheets and time to consider participation and ask questions before consenting.

Signs that a trial or assessment session is designed to be low-risk:

• It uses minimal additional procedures beyond usual care.
• It focuses on information collection or observation rather than new or invasive treatment.
• Risks are described separately from the child’s underlying medical condition or routine operation.
• The study team explains how they will monitor safety and what happens if you withdraw.

Questions that help parents judge whether an offer is suitable:

• Who is running the study, and is the team independent from the child’s regular doctor?
• What are the possible benefits, and are they personal benefits or mainly benefits for future patients?
• What happens if my child does not want to continue?
• Are there reimbursements or compensation, and what costs are not covered?

If you want, I can turn this into a parent-friendly checklist for evaluating low-risk trial offers and assessment sessions in Singapore.