Page 36 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

10.2.2 Special Concern

i. The participant should be informed about that some vaccines
that contain active or live attenuated micro-organisms can
possibly possess a small risk of producing that particular
infection.
ii. In case of the participants in control groups or when
subjected to ineffective vaccines run a risk of contracting the
disease, free treatment for the disease should be given and
where lifelong treatment is required then this should be
insisted upon by NREC.

iii. For all the recombinant vaccines/ products the Guidelines
issued by the National Institute of Health (NIH), Food and
Drug Administration (FDA) and Guidelines issued by the
authorities of Bangladesh should be strictly followed as the
risks associated with these vaccines are not known.

iv. Post-trial access to the vaccine should be given first to the
community from which the participants were drawn as well
as to the control group. This should be done only if the
vaccine is found to be safe and effective. But if the vaccine is
for pediatric age group and by the time the study gets over
the children in the control arm may cross the age when the
vaccine is supposed to be protective. In such instances the
control arm could be some other alternative vaccine for that
pediatric age group although this does not restore clinical
equipoise. EC may examine the feasibility and ethical
aspects on a case-to-case basis.

v. For choosing vulnerable group like children, care should be
taken to choose the particular age with regard to gender,
ethnic background and health profile for testing vaccines for
this age especially if they are from over-researched
community.

vi. In RCTs if no effective vaccine exists as comparator then
placebo can be used. The community should be involved to
decide on the choice of comparator.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 32