Page 6 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects
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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
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