Regulatory Compliance

International Ethics

Declaration of Helsinki
World Medical Association (1964, amended 2013)
Core principles: respect for individuals, subject wellbeing takes precedence, special protection for children, informed consent, ethics review.

Belmont Report (1979)
Three principles: Respect for Persons, Beneficence, Justice.

UN Convention on Rights of the Child
Articles 3, 12, 16, 19, 28: Best interests, right to express views, privacy, protection, education.

Data Protection

India: DPDP Act 2023 — Primary Regulation
• Lawful processing with consent
• Purpose limitation
• Data minimization
• Security safeguards
• Data principal rights

Children's data: Verifiable parental consent via our Longitudinal Consent Architecture.

GDPR Alignment
For international collaboration: lawfulness, fairness, transparency, purpose limitation, minimization, accuracy, storage limitation, integrity, accountability.

Other Indian Regulations
• IT Act 2000: Reasonable security practices
• POCSO Act 2012: Child protection, mandatory reporting
• ICMR Guidelines 2017: Research ethics

IRB Equivalence

Ethics Advisory Committee = IRB Equivalent

Our EAC performs all core IRB functions:
• Protocol review before data collection
• Continuing oversight
• Adverse event review
• Modification approval
• Documentation

For institutions requiring IRB approval for collaboration, our EAC approval satisfies this requirement.

Compliance Documentation

• Consent records for all participating families
• EAC meeting minutes
• Protocol review records
• Data processing logs
• Training records
• Annual compliance self-assessment