Page 7 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

15. BMRC will take initiative to enhance its in-house human capacity,
create appropriate physical facilities & logistics and strengthen
linkages with all stakeholders involved in health research.

1.2. Objectives of the ethical approval:

As part of good research governance, research requires ethical approval.

a. To safeguarding the dignity, rights, safety and well being of all
potential research participants.

b. To protect the rights of a researcher to carry out legitimate
investigation, as well as the reputation of the institution.

c. To minimize potential for claims of negligence made against the
researchers, the institution concerned and any collaborating
individual or organization.

d. To require evidence of ethical approval in refereed journals.

e. To influence the research design with ethical consideration.

f. To avoid potential problems letter on, by trail to ensure that the
main ethical issues are address before the research starts

1.3. Research requires ethical approval if it involves:

a) Human participants (including of observation or questionnaires).
b) Accessing personnel, sensitive of confidential data.

1.4. Background:

Ethical Issues in Health Research is becoming more and more important
now-a-days. Several international documents are available in this area.
But due to cultural and socioeconomic diversity these international
guidelines need to be adopted by specific country. The World Health
Organization developed Operational Guidelines for Ethics Committees
that Review Biomedical Research in 2000. Many countries have developed
their own Ethical Guidelines for example in India, the Indian Council for
Medical Research (lCMR) has developed "Policy Statement on Ethical
Considerations Involved in Research on Human Subjects” in 1980. This
document was modified and published in 2000 as Ethical Guidelines for
Biomedical Research on Human subjects, this document further updated in
2006. Similarly Nepal health Research Council (NHRC) has recently
developed their own Guidelines “Nepal Health Research Council Ethical
Guideline” which was adopted in 1995 and revised in 2001, Sri Lanka
developed national Ethics Review Committee Guidelines in 2007. Other

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 3