Page 24 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

➢ The NREC will be responsible to review all clinical trials of both
non-registered medicinal substances in Bangladesh and new
indication of already registered medicinal substances.

➢ Research issues having religious or social sensitivity should be
approved by NREC

➢ International collaborative research involving Bangladeshi
population will have to get ethical approval by the NREC, while
the administrative approval shall be given by the Government

Registration of Health Research as per National Health Research
Strategy:

❑ Any health research to be conducted in Bangladesh has to be
registered with the BMRC.
❑ BMRC has developed a Registration Form for registration of
research studies. BMRC is developing electronic submission system
for health research registration.

❑ There is a specific section in this system for Clinical Trial Registry.

❑ Within short period Clinical Trial Registry will be in operation in
Bangladesh through the BMRC web site.
❑ The Clinical Trials Protocol should be reviewed and approved by the
NREC.

❑ Clinical Trials should be registered in the Clinical Trial Registry in
the BMRC.

❑ Clinical Trials be well monitored.

❑ Clinical Trials be conducted following ethical standard (Social or
Scientific Value, Scientific Validity, Fair Subject Selection,
Favorable Risk-Benefit Ratio, Independent Review, Informed
Consent & Respect for Potential and Enrolled Subjects)

Monitoring of Clinical Trial

❑ The NREC conducts post-approval monitoring of Clinical Trial.

❑ It is mandatory to form Data Safety Monitoring Board (DSMB) for
conducting Clinical Trial.
❑ Principal Investigator should report Serious Adverse Events (SAE)
as well as Adverse Events (AE) to the NREC.

❑ Approval is given subject to several conditions.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 20