BANGLADESH MEDICAL RESEARCH COUNCIL
MOHAKHALI, DHAKA-1212, BANGLADESH
Tel: 8819311, 8828396, Fax: 880-2-8828820
Email: info@bmrcbd.org;  Web: www.bmrcbd.org

DOCUMENTS TO BE SUBMITTED FOR ETHICAL APPROVAL

01.      Cover   Letter   to   Director   for   Ethical   Clearance   by   Principal Investigator.

02.      Filled-up Ethical Clearance Application Form. (Annexure - A)
03.      Signature of Principal Investigator (s) & Co-investigator (s) with details address. (Annexure - A)

04.      Abstract    for    National    Research    Ethics    Committee    (NREC) (Annexure - B)

05.      BMRC format for Submission of the Proposal for Ethical Approval (Annexure - C)
06.      Informed    consent    form    (Both    Bangla    and    English)    from
participant’s or from the Parent /        legal   guardian. (Annexure - D)
07.      Questionnaire or interview schedule (Both Bangla and English).
08.      Procedure for maintaining confidentiality.
09.      Budget (Annexure - E)
10.      Copy of approval from valid scientific review committee (If any).
11.      Four  (4)  copies  of  all  documents  to  be  submitted  to  Bangladesh Medical Research Council (BMRC).
12.      A Soft Copy in CD to be submitted.
13.      All Documents should be Submitted in a A-4 Size Data Bank File / Folder.
14.      Review and Processing Fee (RPF) for ethical approval:
I.    Review and Processing Fee will be determined based on 2% of the total cost of the approved Research Project, but 
it will not exceed Tk 5,00,000 (5 lacs).
II.    At the time of initial submission of proposal, Principal Investigator will have to pay Tk 20000 (Twenty 
Thousand) to BMRC.
III.  In case of Clinical Trial/Drug Research, Principal Investigator will have to  pay  Tk  50000  (Fifty  Thousand)  
to  BMRC  at  the  time  of  initial submission.
IV.   Undergraduate students will have to pay total Tk 2000 (Two Thousand) at the time of the submission of the 
proposal.
V.   Total  Fee  will  be  paid  by  the  Principal  Investigator  after  ethical approval (at the time of receiving 
approval letter) by an Account Payee Cheque in favor of Bangladesh Medical Research Council.
VI.   For  amendment  and  renewal  50%  of  the  first  approval  fee  will  be charged.
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ANNEXURE - A


BANGLADESH MEDICAL RESEARCH COUNCIL
MOHAKHALI, DHAKA-1212, BANGLADESH Tel: 8819311, 8828396, Fax: 880-2-8828820
Email: info@bmrcbd.org; Web: www.bmrcbd.org



Application for Ethical Clearance
1.        Principal Investigator(s):
Name:
Qualification:
Detail Address:
Mobile:                                         Telephone (Off./Res) e-mail:
2.        Co-Investigator(s):
Name:
Qualification:
Detail Address:
Mobile:                                           Telephone (Off./Res) e-mail:
3.        Place of the Study/Institution(s):
4.        Title of Study:
5.        Type of Study:
6.        Duration of Study:
7.        Total Cost:
8.        Funding Agency:







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Circle the appropriate answer to each of the following
(If not Applicable write NA)




1.   Source of Population:

(a)   ILL Participant            Yes       No

(b)   Non ILL Participant    Yes       No

(c)   Minors or persons        Yes       No under guardianship

2.   Does the study involve?

(a)   Physical risks               Yes       No To the subjects

(b)   Social Risks                  Yes       No

(c)   Psychological                Yes       No Risks to subjects

(d)   Discomfort to                Yes       No Subjects
(e)   Invasion of the body     Yes       No

(f)    Invasion of  Privacy     Yes       No

(g)   Disclosure of                 Yes       No Information damaging to
Subject or others

3.   Does the study involve?

(a)   Use of records,              Yes       No (Hospital, medical,
Death, birth or other)

(b)   Use of fetal tissue         Yes       No Or abortus
(c)   Use of organs or           Yes       No Body fluids
4.   Are subjects clearly informed about?

(a)   Nature and                   Yes       No purposes of study
(b)   Procedures to be           Yes       No followed including
alternatives used

(c)   Physical risks               Yes       No

(d)   Private questions         Yes       No

(e)   Invasion of the             Yes       No Body

(f)    Benefits to be                Yes       No Derived

(g)   Right to refuse              Yes       No to participate or
to withdraw from study

(h)   Confidential                  Yes       No handling of data

(i)  Compensation                Yes       No where there are risks or
loss of working time or privacy is involved in any particular procedure
5.   Will signed consent form/verbal consent be required?
(a)   From Subjects              Yes       No
(b)   From parent or             Yes       No guardian (if  subjects
are minors)
6.   Will precautions be         Yes       No
taken to protect anonymity of subjects





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Note:  If  the  final  instrument  /  questionnaire  is  not  completed  prior  to review, the following information 
should be included in the abstract.
1.      A  description  of  the  areas  to  be  covered  in  the  questionnaire  or  interview which  could  be  
considered  either  sensitive  or  which  would  constitute  an invasion of privacy.
2.      Examples of the type of specific question to be asked in the sensitive areas.

3.      An   indication   as  to   whom  the   questionnaire   will  be   presented   to   the committee for review.




We  agree  to  obtain  approval  of  the  Ethical  Review  Committee  for  any changes  involving  the  rights  and  
welfare  of  subjects  or  any  changes  of the Methodology before making any such changes.


Signature


Name of the Principal Investigator/Leader/Coordinator Date:

Name of Co-investigator (S)                                                             Signature: 1.

2.


3.


4.


5.

* Include all the Investigator, Co –Investigators.


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ANNEXURE - B

PREPARATION OF AN ABSTRACT FOR
NATIONAL RESEARCH ETHICS COMMITTEE (NREC)

The  Ethical Review  Committee  will not consider any  application  which  does not include  a  specific  
abstract/summary   for  the  committee.  The  abstract  should summarize the purpose of the study, the methods and 
procedures to  be used, by addressing  each  of  the  following  items.  If  an  item  is  not  applicable,  please  
note accordingly:


1.      Describe  the  requirements  in  respect  of  the  population  and  explain  the rationale for using population 
of special groups such as children, Incompetent person   or   groups   whose   ability   to   give   voluntary   
informed   consent   is questionable.
2.      Describe and assess any potential risks - physical, psychological, social, legal or other and assess the 
likelihood and seriousness of such risks. If methods of research  create  potential  risks,  describe  other  methods,  
if  any,  that  were considered and why they cannot be used.
3.      Describe procedures for protecting against or minimizing potential risks and assessment of their likely 
effectiveness.
4.      Include  a  description  of  the  methods  for  safeguarding  confidentiality  or protecting anonymity.
5.      When there are potential risks to the subject, or the privacy of the individual may  be  involved,  the  
investigator  is  required  to  obtain  a  signed  informed consent from the participant. For minors, informed consent 
must be obtained from the authorized legal guardian or parent of the subject. Describe consent procedures to be 
followed including how and where informed consent will be obtained.
(a) If  signed  consent  will  not  be  obtained,  explain  why  this  requirement should be waived and provide an 
alternative procedure such as a verbal consent.
(b)  If  information  is  to  be  withheld  from  a  subject,  justify  this  course  of action.
(c)  If there  is a  potential risk  to  the  subject or privacy  of the  individual or loss  of  work  time  is  
involved  in  any  particular  procedure,  include  a statement in the consent form stating whether any compensation 
will be available.


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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.






















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ANNEXURE - C
FORMAT FOR SUBMISSION OF A RESEARCH PROPOSAL FOR ETHICAL APPROVAL

•     Project Title :
•     Summary :
•     Introduction: (Introduce the subject. Provide full background information. Cite  literatures  that  are  specific 
 to  the  topic  of  the  research  proposal. Information  should  be  completed  to  prove  that  the  research  
proposal  is based on a sound scientific footing.)
•     Objectives: (List the general and specific objectives of the proposed study and state clearly the question that 
is being posed or the hypothesis being tested.)
•     Rationale: (Describe the relevance of the proposed study to national health priorities and relationship of the 
objectives to existing scientific knowledge on the subject. Cite relevant literature and refer to related studies done 
in our country or elsewhere.)
•     Methodology:  (Describe  the  design  of  the  study  and  methodology  in sufficient detail to enable assessment 
of how they will contribute towards achievement of the stated objectives and to permit proper appraisal of the budget. 
Plan for data analysis should be included if relevant and important. This section should contain details of the 
research methods. Enough detail should  be  given  to  evaluate  whether  the  methods  are  already  tested  and 
feasible.  The  following  scheme  is  suggested:  Factors  in  study  (variables), Study design, Study Population, 
Sampling, Statistical basis of the sample size,    Procedures,    Methods    of    Data    Collection,    Pretesting,   
 Data Interpretation,    Statistical    Analysis    (Correlation,    Significance    Test, Coefficient of Variation, 
Evaluation Methods, wherever applicable).
•     Utilization  of  Results:  (Describe  in  brief  how  you  perceive  that  the results  from  this  study  may  
contribute  to  health  development  of  the Country.)
•     Facilities  :  (Resources,  equipment,  chemicals,  subjects  (human,  animal) etc. required for the study):
o  Facilities Available :
o  Additional Facilities Required :
•     Approval / Forwarding of the Head of Department / Institute / IRB.

•     Flow Chart: (Describe sequence of tasks within time frame).

•     Ethical   Implications:   (Think   very   carefully   about   possible   ethical implications and put views. 
Consult BMRC's Guidelines for Ethical Review of Projects involving Human Subjects).
•     References: Vancouver style to be followed. e.g.- Can Med Assoc J 1995; 152(9): 1459-1465.


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ANNEXURE - D


INFORMED CONSENT FORM SHOULD BE WRITTEN IN BENGALI & ENGLISH

Consent form shall be included:
•     Interviewer details.
•     Purpose of the Study.
•     Types of participation of the study respondents.
•     Duration, Procedures of the study and participant’s involvement.
•     Potential benefits.
•     Risks, hazards and discomforts.
•     Reimbursements.
•     Confidentiality.
•     Termination   of   study   participation   /   Rights   to   withdraw   from participation.
•     Name of the participant.
•     Signature/Thumb print of the participants.
•     Name of the witness.
•     Signature of the witness.
•     Name of the interviewer.
•     Signature of the interviewer.
•     In case of Minor Signature of the Parent / Legal Guardian.
•     Duplicate copy of Inform Consent shall be give to participant.




















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ANNEXURE - E




o  Total Budget.

o  Detailed Budget:

1.      Personnel Cost: (Professional Scientific Staff, Technical & Other Staff. Please mention percentage of time to 
be devoted by each personnel to this Project).
2.      Field Expenses/Laboratory Cost:

3.      Supplies and Materials (Items & quantity to be specified):

4.      Patient Cost (If applicable):

5.      Travel Cost (Internal travel cost only) :

6.      Transportation of Goods :

7.      Office Stationery (Items & quantity to be specified):

8.      Data Processing/Computer Charges (If applicable) :

9.      Printing and Reproduction :

10.    Contractual Services (Other than manpower):

11.    Miscellaneous :

























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