Part of the PHIG policy framework. Download the full manual (PDF). To raise a concern: admin@accreditation.ge.
All PHIG research involving people or their data receives independent ethics approval before it starts, and all findings are reported honestly, whatever the result. Owner: Research Integrity Officer (Tamar Talakvadze).
Framework: the World Medical Association Declaration of Helsinki, the CIOMS International Ethical Guidelines for Health-related Research, the European Code of Conduct for Research Integrity, Georgian law and funder requirements.
Ethics review
- Research with human participants or identifiable data is approved by an independent, properly constituted research ethics committee before recruitment starts. PHIG uses an accredited committee in Georgia under a written agreement, or the committee of a partner institution.
- Service evaluations and surveys with anonymous data are screened by the Research Integrity Officer, who decides whether full review is needed and records the decision.
- Amendments, adverse events and protocol deviations are reported to the committee.
Protecting participants
- Informed, voluntary consent in a language the person understands, with the right to withdraw at any time.
- Extra protection for children, patients, migrants, prisoners and others in dependent positions.
- Confidentiality and pseudonymisation of data (Policy 16).
- No payment that could unduly influence participation; reimbursement of reasonable costs is allowed.
Research integrity
- Misconduct: fabrication, falsification and plagiarism are prohibited. Questionable practices — selective reporting, undisclosed changes to outcomes, honorary authorship — are also breaches.
- Registration: clinical trials are registered before enrolment in a public registry.
- Authorship: follows ICMJE criteria; contributions are declared.
- Funders: have no right to suppress, delay or alter findings; this is written into every research contract.
- Data: kept for at least five years after publication and shared openly where ethics and consent allow.
Allegations
Allegations of research misconduct go to the Research Integrity Officer and are handled under Policy 14, with an external reviewer where the Officer is conflicted.