A. Research Involving Human Participants
All research involving human participants must be conducted ethically and approved by an appropriate ethics authority prior to initiation.
1. Institutional Review Board (IRB) / Ethics Committee Approval
- All studies involving human participants must have prior approval from an Institutional Review Board (IRB), Ethics Committee (EC), Research Ethics Board (REB), or equivalent authority.
- Authors must include the name of the ethics committee, approval number or ID, and date of approval.
- A statement confirming compliance with the Declaration of Helsinki is required.
When IRB Approval Is Required
- Clinical or behavioral studies.
- Human biological samples.
- Surveys, interviews, or questionnaires involving identifiable information.
- Retrospective studies involving identifiable data.
- Studies using patient medical records.
- Genetic studies.
When IRB Approval May Not Be Required
- Analysis of publicly available datasets.
- Anonymized secondary data with no identifiers.
- Studies formally exempted by an institutional board (documentation required).