Policy on Data Privacy and Confidentiality

Policy on Data Privacy and Confidentiality

  1. Purpose

To safeguard the privacy of research participants and ensure the confidentiality of all personal, medical, and sensitive data collected during healthcare research. This policy aligns with national regulations and international standards on data protection.

  1. Scope

This policy applies to all research studies involving human participants conducted under the auspices of [Institution/Organization Name], including clinical, biomedical, and behavioral research where identifiable or sensitive data is collected, stored, analyzed, or shared.

  1. Guiding Principles
  • Respect for Privacy
    Participants have a fundamental right to privacy. Researchers must limit data collection to what is necessary and relevant.
  • Confidentiality
    All identifiable data must be treated as confidential and secured against unauthorized access or disclosure.
  • Transparency
    Participants must be clearly informed about what data will be collected, how it will be used, who will access it, and how it will be protected.
  • Compliance
    Research must comply with applicable laws and regulations, including:
    • The Information Technology Act, 2000 (India)
    • ICMR Guidelines (2017)
    • GDPR (if applicable for international collaboration)
  1. Data Handling Requirements
  • Data Collection
    • Collect only data that is necessary for research objectives.
    • Use coded or anonymized identifiers wherever possible.
  • Informed Consent
    • Consent forms must include specific clauses regarding data use, storage, sharing, and publication.
    • Participants should be able to withdraw their data without penalty, where feasible.
  • Data Storage
    • Store data on secure, access-controlled servers or physical environments.
    • Maintain encryption and regular backups for digital data.
    • Paper records must be stored in locked cabinets with restricted access.
  • Data Sharing and Transfer
    • Data may only be shared with authorized personnel or collaborators named in the protocol.
    • Any sharing with third parties must be pre-approved by the Ethics Committee and covered by appropriate data-sharing agreements.
  • Retention and Disposal
    • Data must be retained only as long as necessary for the research purpose.
    • Secure destruction of records must be ensured once retention requirements expire (e.g., shredding, secure deletion).
  1. Breach of Confidentiality
  • Any suspected or actual breach must be reported immediately to the Ethics Committee.
  • Investigations will be conducted, and corrective actions will be required.
  • Breaches may result in disciplinary action and revocation of ethical approval.
  1. Responsibilities of Researchers
  • Maintain strict confidentiality of all participant data.
  • Train team members on data privacy practices.
  • Report data-related incidents promptly.
  • Implement data protection measures as described in the approved protocol.