Page 21 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

suggests an interest in a humane and civil society, while on the other it
could give the impression of experimentation on the population of one
country by another. Different levels of development in terms of intellectual
property rights etc; necessitate an ethical framework to guide such
collaboration. The same concerns are applicable even when there is no
formal collaboration between countries, but the research is undertaken
with assistance from international organizations as sponsors
(Governmental like National Institutes of Health, USA, non-Governmental
like Bill & Melinda Gates Foundation, Ford Foundation or others like
WHO, UNICEF, UNAIDS, etc. ). (ICMR-2006)

Special Concerns

1. Given the magnitude and severity of the health problems in
different countries, capacity building to address ethical issues that
arise out of collaborative research must be promoted on a priority
basis. Strategies should be implemented so that various countries
and communities can practice meaningful self-determination in
health development and can ensure the scientific and ethical
conduct of research.

2. The collaborating investigators, institutions and countries can
function as equal partners with sponsors even when in a
vulnerable position by building appropriate safeguards.
Community representatives should be involved early enough while
designing the protocol and in a sustained manner during the
development, implementation, monitoring and dissemination of
results of research.

3. Careful consideration should be given to protect the dignity, safety
and welfare of the participants when the social contexts of the
proposed research can create foreseeable conditions for exploitation
of the participants or increase their vulnerability to harm. The
steps to be taken to overcome these should be described and
approval taken from NREC.

4. Every adult participant in the research should voluntarily give
informed consent and child her/his assent as may be applicable.

5. As different kinds of research (epidemiological studies, clinical
trials, product development, behavioral and social science oriented
research etc.) have their own particular scientific requirements and
specific ethical challenges, the choice of study populations for each
type of study should be justified in advance in scientific and ethical
terms regardless of the place from where the study population is

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 17