Disclosure outside of the research team

Research oversight

Full access to research data is usually required by the following individuals:

• Research ethics committees
• Inspectors from regulatory authorities
• Auditors and monitors delegated by research sponsors

Other compulsory disclosures required by law

For example:

• Notifiable infectious diseases (e.g. HIV, viral hepatitis, tuberculosis) ⁽¹⁶⁾
  • Refer to the Malaysia Prevention and Control of Infectious Diseases Act 1988 (Section 10) (click to download).
• Child abuse ⁽¹⁷⁾
  • Refer to the Malaysia Child Act 2001 (Section 27 - 29).
• When ordered by court

Conscientious disclosures for the health and safety of subjects / other people

For example, interaction with research subjects may bring to your awareness:

• Serious crimes or security threats to the public
• Self-harm or suicide plans
• Health findings that will have significant impact on subject’s family or contacts (e.g. hereditary diseases, serious infectious diseases)

Continuation of clinical care

For example, you may want to inform subjects’ healthcare providers about any interventions that subjects have received as part of research to ensure a smooth transition to clinical care after the study ends. 

Billing of research / clinical costs

For example, the costs of emergency treatments provided during an adverse event may need to be billed to a subjects’ insurance company.