Statement of Informed Consent
 

International Journal of Pharma Insight Studies

The International Journal of Pharma Insight Studies is committed to upholding the highest ethical standards in biomedical, pharmaceutical, clinical, and health-related research. The journal strictly adheres to internationally accepted principles for research involving human participants, ensuring respect for human dignity, rights, safety, and privacy.

This Statement of Informed Consent has been developed in accordance with Scopus publication ethics expectations, COPE Core Practices, ICMJE Recommendations, and the Declaration of Helsinki.

This policy applies to all manuscripts submitted to the journal that involve:

1. Human participants
2. Identifiable human data
3. Human biological material
4. Clinical case reports or case series
5. Surveys, interviews, or questionnaires involving individuals

Manuscripts that do not comply with this policy will not be considered for publication.

All research involving human subjects must receive prior approval from a recognized Institutional Ethics Committee (IEC), Institutional Review Board (IRB), or equivalent ethical authority.

Authors must clearly state in the manuscript:

1. Name of the approving ethics committee
2. Approval or reference number
3. Date of approval

If ethical approval was not required, authors must:

1. Clearly justify the exemption
2. Confirm that the study complied with national and institutional ethical regulations

The editorial office may request supporting documentation.

Written informed consent must be obtained from all participants before their inclusion in the study.

The consent process must ensure that participants were informed about:

1. The purpose of the study
2. Study procedures
3. Potential risks and benefits
4. Voluntary participation and right to withdraw
5. Confidentiality and data protection measures

1. Minors: Consent must be obtained from a parent or legal guardian, and assent from the minor where applicable.
2. Vulnerable populations: Additional safeguards must be implemented, and consent must comply with ethical committee recommendations.

For manuscripts containing:

1. Identifiable personal information
2. Clinical images, photographs, or videos
3. Case reports where anonymity cannot be fully guaranteed

Authors must obtain explicit written consent for publication from the participant or legal representative.

A statement confirming consent for publication must be included in the manuscript.

All applicable manuscripts must include a dedicated section titled:

         “Ethics Approval and Informed Consent”

This section must clearly confirm:

1. Ethics committee approval
2. Informed consent for participation
3. Consent for publication (where applicable)

Data Privacy and Confidentiality

1. Personal identifiers such as names, initials, hospital numbers, or exact locations must not be disclosed unless scientifically essential and explicitly consented to.
2. Authors must ensure compliance with applicable data protection and privacy regulations.
3. Data should be anonymized or de-identified wherever possible.

Authors must:

1. Retain original signed informed consent documents
2. Provide documentation to the editorial office upon request during review or post-publication investigation

The journal does not require submission of consent forms but reserves the right to verify compliance.

Manuscripts may be:

1. Returned for clarification or revision
2. Withheld from peer review
3. Rejected

if ethical approval or informed consent statements are incomplete, unclear, or missing.

If ethical violations are identified after publication, the journal may issue:

1. Corrections
2. Expressions of concern
3. Retractions

in line with COPE guidelines.

This policy is fully aligned with:

1. Declaration of Helsinki
2. ICMJE Recommendations
3. COPE Core Practices
4. Scopus Publication Ethics and Malpractice Guidelines

This Statement of Informed Consent is reviewed periodically to ensure continued alignment with international ethical standards and indexing requirements.