Page 51 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

carefully evaluation of some population based data from the
starting of the study.

VI. During investigation it is important to prevent any social / cultural
disturbance and should be made to minimize harm to the
individuals and society at large.

VII. Research proposal should prepare in such a way to ensure that the
benefits of the study are maximized for the individuals and the
communities taking part. In some instances it may also be
necessary to inform the concerned family members about the
results, for instance, as in AIDS, STD etc.

VIII. In studies where there may be a conflict of interest like
surveillance, outbreaks, epidemics, disasters and calamities, and
epidemiological studies, the interest of the individuals involved in
the study should be protected and may need relief and
rehabilitation.

IX. Honesty and impartiality should be maintained at all stages of the
study. Withholding of selective data and similar practices are
unethical.

X. Benefits: The findings of prospective longitudinal studies should be
released in timely manner to fellow researchers and policy makers
and health care delivery authorities to take measures accordingly in
prevention & control of program.

XI. Ethical Review Procedures: Ethical Committees should be
independent and included at least one or two individuals with an
understanding of the principles of epidemiology.

XII. Program evaluation and research: Ethical review would be required
if program evaluation falls within the definition of research or
serves as a component of a research project. The determination of
whether an evolution study is research and therefore requires
NREC review should be made on a case by case basis and should be
guided by the definition of research.

XIII. Use of information for the purpose of research if it was originally
collected for another purpose: Information originally collected for a
purpose other than the current research purpose is considered
secondary use of information. Secondary use of information has the
potential to avoid duplication of primary data collection and the
associated burdens on participation, An NREC must review the
ethical acceptability of the research involving secondary use of
information; including issues of privacy. The requirement for NREC
review applies to information that may have been collected for a
specific research purpose and is later proposed for a new research
purpose.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 47