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References

Council for International Organizations of Medical Sciences. (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva

World Medical Association. (2013). Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.

World Health Organization. (2011). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.

United Nations Educational, Scientific and Cultural Organization. (2005) Universal Declaration on Bioethics and Human Rights.

International Conference for Harmonisation. (1996). Good Clinical Practice.

INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2) Current Step 4 version dated 9 November 2016.

PNHRS National Ethical Guidelines for Health and Health-Related Research 2022.