PHIG Policy Framework v1.2 · Policy 49 · Adopted 1 September 2026 · References: Declaration of Helsinki; CIOMS International Ethical Guidelines; 45 CFR Part 46 (US Common Rule) for US-funded research; EU MGA Art. 14 and ethics appraisal; WHO Research Ethics Review Committee requirements; Georgian law on health care (research)
1. Purpose and scope
To protect the rights, safety, dignity and wellbeing of people who take part in PHIG’s research, surveys, assessments and training evaluations. Applies to the Board, the Director, staff, consultants, volunteers, experts, partners and suppliers of PHIG and all platforms of its network.
2. Policy
- Any research involving human participants or identifiable personal data is reviewed and approved before it starts by a recognised research ethics committee — the committee of David Tvildiani Medical University, the national committee, a partner institution’s IRB registered with the US Office for Human Research Protections where US funding requires, or the WHO Research Ethics Review Committee for WHO-supported research; PHIG keeps the approval on file.
- Informed consent, freely given and documented, in a language and form the participant understands; assent plus guardian consent for children; additional safeguards for refugees, migrants, detainees, patients and others in situations of dependence or vulnerability; the right to withdraw at any time without consequence.
- Risks minimised and reasonable in relation to benefits; privacy and confidentiality protected under the Data Protection Policy; compensation fair and not coercive.
- Investigators trained in research ethics (e.g., CITI or TRREE) before starting; training records kept.
- Adverse events and protocol deviations reported to the ethics committee and, where required, the sponsor and donor; serious events immediately.
- For US-funded research, PHIG holds or obtains a Federalwide Assurance (FWA) as required and complies with 45 CFR 46; for EU-funded research, the ethics self-assessment and any ethics deliverables are completed.
- Community engagement and feedback of results to participants and communities are planned from the start.
3. Procedures
- Ethics checklist in every protocol; consent form templates; adverse-event form; training register.
Responsibilities
Project leads; Director; Scientific Committee advises.
Review
Every two years.
Part of the PHIG Policy Framework. Breaches and concerns may be reported under the Whistleblowing Procedure to info@accreditation.ge (subject “Confidential — integrity”).