Page 32 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

individual centre should publish any data till
appropriate authorities accept the combined report.
ix. If severe adverse reactions occur during the
conduct of a double blind trial, the code of the
administered drug could be broken.
x. It is advisable to establish communication
between ECs reviewing multicenter studies in
Bangladesh to discuss ethical concerns of the trial,
preferably under the guidance of NREC. This is
particularly important if any EC does not grant
approval for a study at a site for ethical reasons.

10.1.5.2 Contraceptives

i. In case of contraceptives, all steps for clinical trials
are applicable including informing participants clearly about
the alternatives available. Basic health check to ensure that
the subjects are healthy must be undertaken prior to the
study.

ii. Where implant has been used as a contraceptive
method for women, a proper follow up for removal of the
implant should be done after the trial is over or the
participant has withdrawn from the trial. If failures of
contraceptives occur, the children who born should be
followed up for any abnormalities.

10.1.5.3 Randomized Controlled Trial (RCT):

This is the most appropriate study design to reduce bias but
ethical problems can arise when placebo is used in the
control arm. Hence a proper justification should be provided
for using the placebo. Standard therapy should be used in
the control arm according to the Declaration of Helsinki. In
some situations placebo can be used, for examples, self-
limiting disease, and where no proven prophylactic,
diagnostic or therapeutic method exists.

Superiority and Non-inferiority trials – Newer
statistical analyses are applied recently in RCTs. When a
trial is conducted to test if a new drug is superior to the
existing one such a trial is termed superiority trial and when
the trial is conducted to examine if the drug is as good as the
existing one then it is called non-inferiority or active control
equivalence trial (ACET).Sometimes clinically small
difference in beneficial effect is expected. Previously in such

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 28