Page 27 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

iii. On completion of the clinical trial, if the drug is found to be
effective, the sponsoring agency should give the drug to the patient
till its availability in the local market and after that at a reduced
price for the participants wherever possible. A suitable a priori
agreement should be done on post trial benefits.

iv. The criteria for termination of a trial must be defined a
priori in the proposal of the trial and plan of interim analysis must
be clearly presented. This is important that if the test drug is found
more effective or less effective than the standard drug on interim
analysis, the trial can be discontinued thereafter and better drug
should be given to patient receiving less effective drug.

v. Issues of partner notification and discordant couples should
be taken care of before initiating any HIV/ AIDS related trial.

vi. For new drug substances discovered in Bangladesh, clinical
trials are required to be carried out in Bangladesh right from Phase
I through Phase III and data should be submitted as required under
regulations. Generally permission to carry out these trials are given
in stages, considering the data found in earlier Phase(s).

vii. For new drug substances discovered in countries other than
Bangladesh, Phase I data as required under regulations, from other
country(ies) should be submitted along with the application. After
Phase I data submission to the Licensing Authority, permission
may be granted to conduct Phase II and Phase III trials
concurrently with other global trials for that drug.

viii. In case of amendment or deviation in the protocol not only
the approval of NREC may be obtained but also the Licensing
Authority has to be notified of the same.

ix. Published and unpublished data regarding the drug
concerned must be submitted along with the research proposal.

For accelerating drug development, which are indicated in life
threatening/ serious diseases or specific diseases of relevance to
Bangladesh – the toxicological and clinical data requirements shall
be decided on a case by case basis. In such cases, particular studies
may be abbreviated, deferred or omitted, as believed appropriate by
the Licensing Authority and not by NRECs.

Common Principles of Good Clinical Practices (GCP) based on the
international guidelines issued by World Health Organization
(WHO) and International Committee on Harmonization (ICH)
provide operative guidelines for ethical and scientific standards for
the designing of a trial protocol including conduct, recording and

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 23