Page 22 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

selected. Generally, early clinical phases of research, particularly
of drugs, vaccines and devices, should be conducted in communities
that are less vulnerable to harm or exploitation. However, for valid
scientific and public health reasons, if sufficient scientific and
ethical safeguards are ensured it may be conducted in any phase
after obtaining relevant regulatory clearances.

6. The nature, magnitude, and probability of all foreseeable harms
resulting from participation in a collaborative research programme
should be specified in the research protocol and explained to the
participants as fully as can be reasonably done. Moreover, the
modalities by which to address these, including provision for the
best possible nationally available care to participants who
experience adverse reactions to a vaccine or drug under study,
compensation for injury related to the research, and referral for
psychosocial and legal support if necessary, need to be described.

7. The research protocol should outline the benefits that persons /
communities / countries participating in such research should
experience as a result of their participation. Care should be taken
so that these are not presented in a way that unduly influences
freedom of choice in participation. The burden and the benefit
should be equally borne by the collaborating countries.

8. Guidelines, rules, regulations and cultural sensitivities of all
countries participating in collaborative research projects should be
respected, especially by researchers in the host country and the
sponsor country. These could be with reference to intellectual
property rights, exchange of biological materials (human, animal,
plant or microbial), data transfer, security issues, and issues of
socially or politically sensitive nature. (ICMR-2006)

08. RESEARCHER’S RELATIONS WITH THE MEDIA AND
PUBLICATION PRACTICES

Researchers have a responsibility to make sure that the public is
accurately informed about results without raising false hopes or
expectations. It should also not unnecessarily scare the people.
Researchers should take care to avoid talking with journalists or reporters
about preliminary findings as seemingly promising research that
subsequently cannot be validated or could lead to misconcepts if reported
prematurely. Or, the results of research may be reported in such a way
that it would seem that the human application is round the corner, only to
be told later by the researchers that considerable time has to pass before
these findings can be translated into tools for human use. In such

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 18