Page 15 - Standard Operating Procedures (SOPs)

GUIDELINES ON RESEARCH ETHICS AS PER NATIONAL HEALTH
RESEARCH STRATEGIES:

➢ The National Research Ethics Committee (NREC) will set standards, advice
the Departments and the Ministry of Health & Family Welfare on the
management of research ethics for Bangladesh and arbitrate on matters of
Ethics.

➢ 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:

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.

➢ Any health research to be conducted in Bangladesh has to be registered with
the BMRC.

➢ 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 should 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)
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.

➢ At least 2 (two) members shall be included from NREC during formation of
DSMB.

➢ Principal Investigator should report Serious Adverse Events (SAE) as well as
Adverse Events (AE) to the NREC.

➢ Approval is given subject to several conditions.

SOP OF BMRC ETHICAL GUIDELINE Page 14