Policy on Human Research Ethics

1. Purpose

This policy establishes the ethical principles and standards for conducting human research under the jurisdiction of [Institution/Organization Name]. It ensures that all research involving human participants upholds their rights, safety, dignity, and well-being.

2. Scope

Applies to all research involving human participants, including clinical trials, biomedical studies, behavioral research, and studies using identifiable personal data or human biological materials conducted within or affiliated with the institution.

3. Guiding Ethical Principles

All human research must adhere to the following ethical principles:

• Respect for Persons
  Recognizing the autonomy of individuals and the need for informed, voluntary participation.
• Beneficence
  Maximizing potential benefits while minimizing possible harm to participants.
• Non-Maleficence
  Ensuring that research does not intentionally or unintentionally cause harm.
• Justice
  Ensuring equitable selection of research participants and fair distribution of the benefits and burdens of research.
• Confidentiality and Privacy
  Protecting participants’ data, identity, and personal information at all stages of research.
• Transparency and Accountability
  Researchers must disclose funding sources, potential conflicts of interest, and research goals clearly.

4. Informed Consent

• Must be obtained in writing, using language understandable to the participant.
• Includes clear information on study purpose, procedures, risks, benefits, confidentiality, and the right to withdraw without penalty.
• Informed consent is mandatory for all participants, including special provisions for vulnerable populations (e.g., children, mentally incapacitated individuals).

5. Ethical Review and Approval

• All research proposals must be submitted to the Ethics Committee before initiation.
• The Committee evaluates scientific validity, risk-benefit ratio, participant protection, and ethical compliance.
• Research cannot commence without written ethical clearance.

6. Ongoing Oversight

• Approved studies are subject to periodic monitoring.
• Investigators must report adverse events, protocol deviations, and any changes for further review.

7. Responsibilities of Researchers

• Ensure ethical conduct throughout the research lifecycle.
• Maintain accurate records and submit progress/final reports to the Ethics Committee.
• Promptly report any ethical concerns or participant complaints.

8. Conflict of Interest

• Researchers and committee members must declare potential conflicts of interest.
• Management plans will be implemented where necessary to maintain objectivity.

9. Compliance and Sanctions

Non-compliance with this policy may result in suspension or revocation of ethical approval and/or disciplinary action as per institutional regulations.