Page 6 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects
P. 6
3. Review of preliminary and final research reports and give advice on
strategic implications of completed research projects and send
review reports to the Directorate General of Health Services and
Directorate General of Family Planning.
4. Provide advice on all health research related matters to government
departments and international agencies.
5. Facilitate co-ordination among the organizations and institutions at
various levels so that the health research strategy operates in a
coherent manner rather than a collection of fragmented and
uncoordinated activities.
6. Any health research to be conducted in Bangladesh has to be
registered with BMRC as a pre-requisite for any funding (national
or international).
7. BMRC would advise Government on the gaps, synergies and
overlaps that exist as well as on the appropriateness of the research
work, its budget, achievements and emphases.
8. The National Research Ethics Committee-NREC (functioning under
the BMRC & previously named as Ethical Review Committee),
should set standards, advise the Departments and the Ministry of
Health and Family Welfare on the management of research ethics
for Bangladesh and arbitrate on the matters of ethics.
9. The NREC will be responsible to review all clinical trials of both
non-registered medicinal substances in Bangladesh and new
indications of already registered medicinal substances.
10. The NREC will advice the Drug Administration in ensuring that
the drugs available in the country fulfill the necessary
requirements for safety, quality and efficacy and that the decision
to register a drug is in the interests of public health.
11. Research issues having religious or social sensitivity should be
approved by NREC.
12. 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.
13. BMRC will sponsor and co-ordinate multicentric commissioned
research on areas of national importance.
14. Establishment and further strengthening of BMRC sponsored
research institutions and centers for conducting research studies on
national priority research areas.
BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 2