Page 9 - Standard Operating Procedures (SOPs)

6. If the study involves an interview, describe where and in what context the
interview will take place. State approximate length of time required for the interview.

7. Assess the potential benefit to be gained by the individual subject as well as
the benefits which may accrue to society in general as a result of the work. Indicate
how the benefits may outweigh the risks.

8. Incase of an experimental drugs, provide information about its status of
registration for open sale in Bangladesh and in other developed countries.

9. For experimental 'new' drugs* which are not registered in Bangladesh provide
full information about the toxicity studies carried out in animals or human volunteers.
Published papers on this regard shall be annexed.

10. If placebo is to be used justify its uses and why the study cannot be done
without its use.

11. If an experimental 'new' drug* is to be used give a statement regarding its
sponsorship and the conditions for such sponsorship.

12. State if the activity requires the use of records (hospital, medical, birth, death
or other), organs, tissues, body fluids, the fetus or the abortus.

The statement to the subject should include information specified in items 2, 3, 4, 5(c)
and 7, as well as indicating the approximate time required for participation in the
activity.

* a 'new' drug means one which is not registered for free and open sale in
Bangladesh.

SOP OF BMRC ETHICAL GUIDELINE Page 8