Informed Concent Policy

1. Policy Statement

IJMHS requires that all research involving human participants be conducted in accordance with the Declaration of Helsinki. Valid informed consent is a fundamental requirement.

2. Scope of Application

This policy applies to any manuscript involving:

Direct human participation (clinical trials, interviews, surveys, etc.)
Use of personal medical or genetic data
Use of human biological specimens
Use of identifiable images, audio, or video recordings

3. Core Requirements for Valid Informed Consent

Participants must be provided with all essential information about the research.
Consent must be documented (typically written and signed).
Consent must be given voluntarily by competent individuals.
For vulnerable populations, additional safeguards and appropriate proxy consent are required.

4. Special Considerations

Clinical Trials: Consent forms must include specific trial-related information.
Genetic/Biobank Research: Consent must cover future use of samples/data.
Identifiable Images: Separate, specific consent for publication is required.
Deceased Individuals: Ethical and legal requirements for use of data/tissue must be met.

5. Manuscript Submission Requirements

Manuscripts must include in the Methods:

A statement confirming informed consent was obtained.
The name of the approving Ethics Committee/IRB and approval number.
For clinical trials, the registration number.
For identifiable images, a statement confirming consent for publication.

6. Waiver of Informed Consent

A waiver is only acceptable with formal ethics committee approval, typically for retrospective studies with minimal risk where obtaining consent is impracticable.