“Ethical Clearance for Researches/studies involving Human Participants“
The Institutional Review Board (IRB) has been established in the Khesar Gyapo University of Medical Sciences of Bhutan (KGUMSB) mainly to facilitate ethical clearance for research1 involving human subjects/participants2. In addition, IRB anticipates to protect human subjects/participants in any research or study.
Since its establishment in July 2021, students, faculties of KGUMSB and its affiliated institutes, must obtain Ethical Approval from the IRB prior conducting the research/study. Any health or medical related study/research carried out without prior Ethical Approval will be considered void or nullified. In the interest of the human participants’ protection, IRB may take actions for such incident.
The IRB is a Human Research Ethics Committee, established under the auspices of KGUMSB responsible for reviewing an ethical acceptability of research. It has a special responsibility for oversight of the conduct of ethical reviews so that quality and consistency of its processes are maintained in compliance with professional and ethical standards of SIDCER-FERCAP3.
The primary role of IRB is to safeguard the rights, safety, dignity and well-being of all actual and potential research participants. This also includes protecting participants from physical, psychological, social/cultural, economic and legal risks of harm.
The guiding principles in making this decision are those of:
- R=Respect for persons;
- B=Beneficence; and
The Board Meets 4 times (January, March, July & November) in a year. All documents pertaining ethics application must reach the IRB Secretariat at least two weeks before the scheduled meetings. Full-Board reviews takes about a month and the expedited review process takes about two weeks duration, on average.
- The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge through a systematic investigation. Generalizable knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context “research” includes both medical and behavioural studies pertaining to human health.
- Research involving human subjects/participants includes:
- studies of a physiological, biochemical or pathological process, or of the response to a specific intervention – whether physical, chemical or psychological – in healthy subjects or patients;
- controlled trials of diagnostic, preventive or therapeutic measures in larger groups of persons, designed to demonstrate a specific generalizable response to these measures against a background of individual biological variation;
- studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures; and
- studies concerning human health-related behaviour in a variety of circumstances and environments.
The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) was founded in 2001 by the World Health Organization under the Special Programme for Research and Training in Tropical Diseases (WHO-TDR), in an effort to address the fundamental ethical gaps and challenges encountered in global health research.
The Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP) was conceived in Bangkok, Thailand on 12 January 2000 after much thought and deliberation among a group of bioethicists and medical experts with the objective of fostering an improved understanding and better implementation of ethical review of behavioral and biomedical researches in the region. FERCAP is the result of the realization that ethics requires collective wisdom and there is need for a systems approach to address important health research issues in Asia and the Western Pacific.