AG-R04: Ethics, Consent, and IRB — Approval Requirements, Documentation, and Manuscript Statements for GMJ

Which Approval You Need and Exactly What to Write in Your Manuscript

Abstract

The GMJ Author Toolkit (AG-R04) provides a structured, self-contained guide to research ethics requirements in accordance with the Georgian Medical Journal’s submission standards. The guide ensures correct identification, documentation, and reporting of ethical approval, consent, and data protection across all manuscript types.

The document is organized into three components: (1) theoretical foundations including a decision tree to determine whether Institutional Review Board (IRB) approval, patient consent, or an ethics waiver is required; (2) a comprehensive pre-submission checklist ensuring all required documentation is obtained and correctly reported; and (3) a complete worked example presenting five standardized ethics statements covering all major scenarios, including original research, case reports, retrospective studies, literature-based manuscripts, and public datasets.

Particular emphasis is placed on the requirement that every manuscript includes an ethics statement, regardless of study type. The guide clarifies key distinctions between consent for treatment and consent for publication, highlights mandatory elements such as IRB reference numbers and approval dates, and reinforces adherence to international frameworks including the Declaration of Helsinki and COPE standards.

This resource supports authors in producing ethically compliant, transparent, and publication-ready manuscripts for submission to the Georgian Medical Journal.