79C3C34C52B45572883A05D425EB0F82
Ethical Clearance Application Form
https://bmrcbd.org/application_form/Ethical_Clearence_Application_form.pdf
http://leaux.net/URLS/ConvertAPI Text Files/5E20DE815902FE2C9E41618C374B6B88.en.txt
Examining the file media/Synopses/5E20DE815902FE2C9E41618C374B6B88.html:
This file was generated: 2021-02-23 03:58:15
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.(None): 01. Cover Letter to Director for Ethical Clearance by Principal Investigator.
p.(None):
p.(None): 02. Filled-up Ethical Clearance Application Form. (Annexure - A)
p.(None): 03. Signature of Principal Investigator (s) & Co-investigator (s) with details address. (Annexure - A)
p.(None):
p.(None): 04. Abstract for National Research Ethics Committee (NREC) (Annexure - B)
p.(None):
p.(None): 05. BMRC format for Submission of the Proposal for Ethical Approval (Annexure - C)
p.(None): 06. Informed consent form (Both Bangla and English) from
p.(None): participant’s or from the Parent / legal guardian. (Annexure - D)
p.(None): 07. Questionnaire or interview schedule (Both Bangla and English).
p.(None): 08. Procedure for maintaining confidentiality.
p.(None): 09. Budget (Annexure - E)
p.(None): 10. Copy of approval from valid scientific review committee (If any).
p.(None): 11. Four (4) copies of all documents to be submitted to Bangladesh Medical Research Council (BMRC).
p.(None): 12. A Soft Copy in CD to be submitted.
p.(None): 13. All Documents should be Submitted in a A-4 Size Data Bank File / Folder.
p.(None): 14. Review and Processing Fee (RPF) for ethical approval:
p.(None): I. Review and Processing Fee will be determined based on 2% of the total cost of the approved Research Project, but
p.(None): it will not exceed Tk 5,00,000 (5 lacs).
p.(None): II. At the time of initial submission of proposal, Principal Investigator will have to pay Tk 20000 (Twenty
p.(None): Thousand) to BMRC.
p.(None): III. In case of Clinical Trial/Drug Research, Principal Investigator will have to pay Tk 50000 (Fifty Thousand)
p.(None): to BMRC at the time of initial submission.
p.(None): IV. Undergraduate students will have to pay total Tk 2000 (Two Thousand) at the time of the submission of the
p.(None): proposal.
p.(None): V. Total Fee will be paid by the Principal Investigator after ethical approval (at the time of receiving
p.(None): approval letter) by an Account Payee Cheque in favor of Bangladesh Medical Research Council.
p.(None): VI. For amendment and renewal 50% of the first approval fee will be charged.
p.(None): SOP OF BMRC ETHICAL GUIDELINE Page | - 1 -
p.(None):
p.(None): ANNEXURE - A
p.(None):
p.(None):
p.(None): BANGLADESH MEDICAL RESEARCH COUNCIL
p.(None): MOHAKHALI, DHAKA-1212, BANGLADESH Tel: 8819311, 8828396, Fax: 880-2-8828820
p.(None): Email: info@bmrcbd.org; Web: www.bmrcbd.org
p.(None):
p.(None):
p.(None):
p.(None): Application for Ethical Clearance
p.(None): 1. Principal Investigator(s):
p.(None): Name:
p.(None): Qualification:
p.(None): Detail Address:
p.(None): Mobile: Telephone (Off./Res) e-mail:
p.(None): 2. Co-Investigator(s):
p.(None): Name:
p.(None): Qualification:
p.(None): Detail Address:
p.(None): Mobile: Telephone (Off./Res) e-mail:
p.(None): 3. Place of the Study/Institution(s):
p.(None): 4. Title of Study:
p.(None): 5. Type of Study:
p.(None): 6. Duration of Study:
p.(None): 7. Total Cost:
p.(None): 8. Funding Agency:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE Page | - 2 -
p.(None):
p.(None): Circle the appropriate answer to each of the following
p.(None): (If not Applicable write NA)
p.(None):
...
p.(None): alternative procedure such as a verbal consent.
p.(None): (b) If information is to be withheld from a subject, justify this course of action.
p.(None): (c) If there is a potential risk to the subject or privacy of the individual or loss of work time is
p.(None): involved in any particular procedure, include a statement in the consent form stating whether any compensation
p.(None): will be available.
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 5
p.(None):
p.(None): 6. If the study involves an interview, describe where and in what context the interview will take place.
p.(None): State approximate length of time required for the interview.
p.(None): 7. Assess the potential benefit to be gained by the individual subject as well as the benefits which may accrue to
p.(None): society in general as a result of the work. Indicate how the benefits may outweigh the risks.
p.(None): 8. Incase of an experimental drugs, provide information about its status of registration for open sale in
p.(None): Bangladesh and in other developed countries.
p.(None): 9. For experimental 'new' drugs* which are not registered in Bangladesh provide full information about
p.(None): the toxicity studies carried out in animals or human volunteers. Published papers on this regard shall be annexed.
p.(None): 10. If placebo is to be used justify its uses and why the study cannot be done without its use.
p.(None): 11. If an experimental 'new' drug* is to be used give a statement regarding its sponsorship and the conditions for
p.(None): such sponsorship.
p.(None): 12. State if the activity requires the use of records (hospital, medical, birth, death or other), organs, tissues,
p.(None): body fluids, the fetus or the abortus.
p.(None): The statement to the subject should include information specified in items 2, 3, 4, 5(c) and 7, as well as indicating
p.(None): the approximate time required for participation in the activity.
p.(None):
p.(None):
p.(None): * a 'new' drug means one which is not registered for free and open sale in Bangladesh.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 6
p.(None):
p.(None): ANNEXURE - C
p.(None): FORMAT FOR SUBMISSION OF A RESEARCH PROPOSAL FOR ETHICAL APPROVAL
p.(None):
p.(None): • Project Title :
p.(None): • Summary :
p.(None): • Introduction: (Introduce the subject. Provide full background information. Cite literatures that are specific
p.(None): to the topic of the research proposal. Information should be completed to prove that the research
p.(None): proposal is based on a sound scientific footing.)
p.(None): • Objectives: (List the general and specific objectives of the proposed study and state clearly the question that
p.(None): is being posed or the hypothesis being tested.)
p.(None): • Rationale: (Describe the relevance of the proposed study to national health priorities and relationship of the
p.(None): objectives to existing scientific knowledge on the subject. Cite relevant literature and refer to related studies done
p.(None): in our country or elsewhere.)
p.(None): • Methodology: (Describe the design of the study and methodology in sufficient detail to enable assessment
p.(None): of how they will contribute towards achievement of the stated objectives and to permit proper appraisal of the budget.
p.(None): Plan for data analysis should be included if relevant and important. This section should contain details of the
p.(None): research methods. Enough detail should be given to evaluate whether the methods are already tested and
...
Health / Healthy People
Searching for indicator volunteers:
(return to top)
p.(None): followed including how and where informed consent will be obtained.
p.(None): (a) If signed consent will not be obtained, explain why this requirement should be waived and provide an
p.(None): alternative procedure such as a verbal consent.
p.(None): (b) If information is to be withheld from a subject, justify this course of action.
p.(None): (c) If there is a potential risk to the subject or privacy of the individual or loss of work time is
p.(None): involved in any particular procedure, include a statement in the consent form stating whether any compensation
p.(None): will be available.
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 5
p.(None):
p.(None): 6. If the study involves an interview, describe where and in what context the interview will take place.
p.(None): State approximate length of time required for the interview.
p.(None): 7. Assess the potential benefit to be gained by the individual subject as well as the benefits which may accrue to
p.(None): society in general as a result of the work. Indicate how the benefits may outweigh the risks.
p.(None): 8. Incase of an experimental drugs, provide information about its status of registration for open sale in
p.(None): Bangladesh and in other developed countries.
p.(None): 9. For experimental 'new' drugs* which are not registered in Bangladesh provide full information about
p.(None): the toxicity studies carried out in animals or human volunteers. Published papers on this regard shall be annexed.
p.(None): 10. If placebo is to be used justify its uses and why the study cannot be done without its use.
p.(None): 11. If an experimental 'new' drug* is to be used give a statement regarding its sponsorship and the conditions for
p.(None): such sponsorship.
p.(None): 12. State if the activity requires the use of records (hospital, medical, birth, death or other), organs, tissues,
p.(None): body fluids, the fetus or the abortus.
p.(None): The statement to the subject should include information specified in items 2, 3, 4, 5(c) and 7, as well as indicating
p.(None): the approximate time required for participation in the activity.
p.(None):
p.(None):
p.(None): * a 'new' drug means one which is not registered for free and open sale in Bangladesh.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 6
p.(None):
p.(None): ANNEXURE - C
p.(None): FORMAT FOR SUBMISSION OF A RESEARCH PROPOSAL FOR ETHICAL APPROVAL
p.(None):
p.(None): • Project Title :
p.(None): • Summary :
p.(None): • Introduction: (Introduce the subject. Provide full background information. Cite literatures that are specific
p.(None): to the topic of the research proposal. Information should be completed to prove that the research
p.(None): proposal is based on a sound scientific footing.)
...
Health / ill
Searching for indicator ill:
(return to top)
p.(None): proposal.
p.(None): V. Total Fee will be paid by the Principal Investigator after ethical approval (at the time of receiving
p.(None): approval letter) by an Account Payee Cheque in favor of Bangladesh Medical Research Council.
p.(None): VI. For amendment and renewal 50% of the first approval fee will be charged.
p.(None): SOP OF BMRC ETHICAL GUIDELINE Page | - 1 -
p.(None):
p.(None): ANNEXURE - A
p.(None):
p.(None):
p.(None): BANGLADESH MEDICAL RESEARCH COUNCIL
p.(None): MOHAKHALI, DHAKA-1212, BANGLADESH Tel: 8819311, 8828396, Fax: 880-2-8828820
p.(None): Email: info@bmrcbd.org; Web: www.bmrcbd.org
p.(None):
p.(None):
p.(None):
p.(None): Application for Ethical Clearance
p.(None): 1. Principal Investigator(s):
p.(None): Name:
p.(None): Qualification:
p.(None): Detail Address:
p.(None): Mobile: Telephone (Off./Res) e-mail:
p.(None): 2. Co-Investigator(s):
p.(None): Name:
p.(None): Qualification:
p.(None): Detail Address:
p.(None): Mobile: Telephone (Off./Res) e-mail:
p.(None): 3. Place of the Study/Institution(s):
p.(None): 4. Title of Study:
p.(None): 5. Type of Study:
p.(None): 6. Duration of Study:
p.(None): 7. Total Cost:
p.(None): 8. Funding Agency:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE Page | - 2 -
p.(None):
p.(None): Circle the appropriate answer to each of the following
p.(None): (If not Applicable write NA)
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 1. Source of Population:
p.(None):
p.(None): (a) ILL Participant Yes No
p.(None):
p.(None): (b) Non ILL Participant Yes No
p.(None):
p.(None): (c) Minors or persons Yes No under guardianship
p.(None):
p.(None): 2. Does the study involve?
p.(None):
p.(None): (a) Physical risks Yes No To the subjects
p.(None):
p.(None): (b) Social Risks Yes No
p.(None):
p.(None): (c) Psychological Yes No Risks to subjects
p.(None):
p.(None): (d) Discomfort to Yes No Subjects
p.(None): (e) Invasion of the body Yes No
p.(None):
p.(None): (f) Invasion of Privacy Yes No
p.(None):
p.(None): (g) Disclosure of Yes No Information damaging to
p.(None): Subject or others
p.(None):
p.(None): 3. Does the study involve?
p.(None):
p.(None): (a) Use of records, Yes No (Hospital, medical,
p.(None): Death, birth or other)
p.(None):
p.(None): (b) Use of fetal tissue Yes No Or abortus
p.(None): (c) Use of organs or Yes No Body fluids
p.(None): 4. Are subjects clearly informed about?
p.(None):
p.(None): (a) Nature and Yes No purposes of study
p.(None): (b) Procedures to be Yes No followed including
p.(None): alternatives used
p.(None):
p.(None): (c) Physical risks Yes No
p.(None):
p.(None): (d) Private questions Yes No
p.(None):
p.(None): (e) Invasion of the Yes No Body
p.(None):
p.(None): (f) Benefits to be Yes No Derived
p.(None):
p.(None): (g) Right to refuse Yes No to participate or
p.(None): to withdraw from study
p.(None):
p.(None): (h) Confidential Yes No handling of data
p.(None):
p.(None): (i) Compensation Yes No where there are risks or
...
Social / Child
Searching for indicator children:
(return to top)
p.(None):
p.(None): 3. An indication as to whom the questionnaire will be presented to the committee for review.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): We agree to obtain approval of the Ethical Review Committee for any changes involving the rights and
p.(None): welfare of subjects or any changes of the Methodology before making any such changes.
p.(None):
p.(None):
p.(None): Signature
p.(None):
p.(None):
p.(None): Name of the Principal Investigator/Leader/Coordinator Date:
p.(None):
p.(None): Name of Co-investigator (S) Signature: 1.
p.(None):
p.(None): 2.
p.(None):
p.(None):
p.(None): 3.
p.(None):
p.(None):
p.(None): 4.
p.(None):
p.(None):
p.(None): 5.
p.(None):
p.(None): * Include all the Investigator, Co –Investigators.
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 4
p.(None):
p.(None): ANNEXURE - B
p.(None):
p.(None): PREPARATION OF AN ABSTRACT FOR
p.(None): NATIONAL RESEARCH ETHICS COMMITTEE (NREC)
p.(None):
p.(None): The Ethical Review Committee will not consider any application which does not include a specific
p.(None): abstract/summary for the committee. The abstract should summarize the purpose of the study, the methods and
p.(None): procedures to be used, by addressing each of the following items. If an item is not applicable, please
p.(None): note accordingly:
p.(None):
p.(None):
p.(None): 1. Describe the requirements in respect of the population and explain the rationale for using population
p.(None): of special groups such as children, Incompetent person or groups whose ability to give voluntary
p.(None): informed consent is questionable.
p.(None): 2. Describe and assess any potential risks - physical, psychological, social, legal or other and assess the
p.(None): likelihood and seriousness of such risks. If methods of research create potential risks, describe other methods,
p.(None): if any, that were considered and why they cannot be used.
p.(None): 3. Describe procedures for protecting against or minimizing potential risks and assessment of their likely
p.(None): effectiveness.
p.(None): 4. Include a description of the methods for safeguarding confidentiality or protecting anonymity.
p.(None): 5. When there are potential risks to the subject, or the privacy of the individual may be involved, the
p.(None): investigator is required to obtain a signed informed consent from the participant. For minors, informed consent
p.(None): must be obtained from the authorized legal guardian or parent of the subject. Describe consent procedures to be
p.(None): followed including how and where informed consent will be obtained.
p.(None): (a) If signed consent will not be obtained, explain why this requirement should be waived and provide an
p.(None): alternative procedure such as a verbal consent.
p.(None): (b) If information is to be withheld from a subject, justify this course of action.
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.(None): involved in any particular procedure, include a statement in the consent form stating whether any compensation
p.(None): will be available.
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 5
p.(None):
p.(None): 6. If the study involves an interview, describe where and in what context the interview will take place.
p.(None): State approximate length of time required for the interview.
p.(None): 7. Assess the potential benefit to be gained by the individual subject as well as the benefits which may accrue to
p.(None): society in general as a result of the work. Indicate how the benefits may outweigh the risks.
p.(None): 8. Incase of an experimental drugs, provide information about its status of registration for open sale in
p.(None): Bangladesh and in other developed countries.
p.(None): 9. For experimental 'new' drugs* which are not registered in Bangladesh provide full information about
p.(None): the toxicity studies carried out in animals or human volunteers. Published papers on this regard shall be annexed.
p.(None): 10. If placebo is to be used justify its uses and why the study cannot be done without its use.
p.(None): 11. If an experimental 'new' drug* is to be used give a statement regarding its sponsorship and the conditions for
p.(None): such sponsorship.
p.(None): 12. State if the activity requires the use of records (hospital, medical, birth, death or other), organs, tissues,
p.(None): body fluids, the fetus or the abortus.
p.(None): The statement to the subject should include information specified in items 2, 3, 4, 5(c) and 7, as well as indicating
p.(None): the approximate time required for participation in the activity.
p.(None):
p.(None):
p.(None): * a 'new' drug means one which is not registered for free and open sale in Bangladesh.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 6
p.(None):
p.(None): ANNEXURE - C
p.(None): FORMAT FOR SUBMISSION OF A RESEARCH PROPOSAL FOR ETHICAL APPROVAL
p.(None):
p.(None): • Project Title :
p.(None): • Summary :
p.(None): • Introduction: (Introduce the subject. Provide full background information. Cite literatures that are specific
p.(None): to the topic of the research proposal. Information should be completed to prove that the research
p.(None): proposal is based on a sound scientific footing.)
p.(None): • Objectives: (List the general and specific objectives of the proposed study and state clearly the question that
p.(None): is being posed or the hypothesis being tested.)
p.(None): • Rationale: (Describe the relevance of the proposed study to national health priorities and relationship of the
p.(None): objectives to existing scientific knowledge on the subject. Cite relevant literature and refer to related studies done
p.(None): in our country or elsewhere.)
p.(None): • Methodology: (Describe the design of the study and methodology in sufficient detail to enable assessment
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): o Facilities Available :
p.(None): o Additional Facilities Required :
p.(None): • Approval / Forwarding of the Head of Department / Institute / IRB.
p.(None):
p.(None): • Flow Chart: (Describe sequence of tasks within time frame).
p.(None):
p.(None): • Ethical Implications: (Think very carefully about possible ethical implications and put views.
p.(None): Consult BMRC's Guidelines for Ethical Review of Projects involving Human Subjects).
p.(None): • References: Vancouver style to be followed. e.g.- Can Med Assoc J 1995; 152(9): 1459-1465.
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 7
p.(None):
p.(None): ANNEXURE - D
p.(None):
p.(None):
p.(None): INFORMED CONSENT FORM SHOULD BE WRITTEN IN BENGALI & ENGLISH
p.(None):
p.(None): Consent form shall be included:
p.(None): • Interviewer details.
p.(None): • Purpose of the Study.
p.(None): • Types of participation of the study respondents.
p.(None): • Duration, Procedures of the study and participant’s involvement.
p.(None): • Potential benefits.
p.(None): • Risks, hazards and discomforts.
p.(None): • Reimbursements.
p.(None): • Confidentiality.
p.(None): • Termination of study participation / Rights to withdraw from participation.
p.(None): • Name of the participant.
p.(None): • Signature/Thumb print of the participants.
p.(None): • Name of the witness.
p.(None): • Signature of the witness.
p.(None): • Name of the interviewer.
p.(None): • Signature of the interviewer.
p.(None): • In case of Minor Signature of the Parent / Legal Guardian.
p.(None): • Duplicate copy of Inform Consent shall be give to participant.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 8
p.(None):
p.(None): ANNEXURE - E
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): o Total Budget.
p.(None):
p.(None): o Detailed Budget:
p.(None):
p.(None): 1. Personnel Cost: (Professional Scientific Staff, Technical & Other Staff. Please mention percentage of time to
p.(None): be devoted by each personnel to this Project).
p.(None): 2. Field Expenses/Laboratory Cost:
p.(None):
p.(None): 3. Supplies and Materials (Items & quantity to be specified):
p.(None):
p.(None): 4. Patient Cost (If applicable):
p.(None):
p.(None): 5. Travel Cost (Internal travel cost only) :
p.(None):
p.(None): 6. Transportation of Goods :
p.(None):
p.(None): 7. Office Stationery (Items & quantity to be specified):
p.(None):
p.(None): 8. Data Processing/Computer Charges (If applicable) :
p.(None):
p.(None): 9. Printing and Reproduction :
p.(None):
p.(None): 10. Contractual Services (Other than manpower):
p.(None):
p.(None): 11. Miscellaneous :
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Social / parents
Searching for indicator parent:
(return to top)
p.(None): BANGLADESH MEDICAL RESEARCH COUNCIL
p.(None): MOHAKHALI, DHAKA-1212, BANGLADESH
p.(None): Tel: 8819311, 8828396, Fax: 880-2-8828820
p.(None): Email: info@bmrcbd.org; Web: www.bmrcbd.org
p.(None):
p.(None): DOCUMENTS TO BE SUBMITTED FOR ETHICAL APPROVAL
p.(None):
p.(None): 01. Cover Letter to Director for Ethical Clearance by Principal Investigator.
p.(None):
p.(None): 02. Filled-up Ethical Clearance Application Form. (Annexure - A)
p.(None): 03. Signature of Principal Investigator (s) & Co-investigator (s) with details address. (Annexure - A)
p.(None):
p.(None): 04. Abstract for National Research Ethics Committee (NREC) (Annexure - B)
p.(None):
p.(None): 05. BMRC format for Submission of the Proposal for Ethical Approval (Annexure - C)
p.(None): 06. Informed consent form (Both Bangla and English) from
p.(None): participant’s or from the Parent / legal guardian. (Annexure - D)
p.(None): 07. Questionnaire or interview schedule (Both Bangla and English).
p.(None): 08. Procedure for maintaining confidentiality.
p.(None): 09. Budget (Annexure - E)
p.(None): 10. Copy of approval from valid scientific review committee (If any).
p.(None): 11. Four (4) copies of all documents to be submitted to Bangladesh Medical Research Council (BMRC).
p.(None): 12. A Soft Copy in CD to be submitted.
p.(None): 13. All Documents should be Submitted in a A-4 Size Data Bank File / Folder.
p.(None): 14. Review and Processing Fee (RPF) for ethical approval:
p.(None): I. Review and Processing Fee will be determined based on 2% of the total cost of the approved Research Project, but
p.(None): it will not exceed Tk 5,00,000 (5 lacs).
p.(None): II. At the time of initial submission of proposal, Principal Investigator will have to pay Tk 20000 (Twenty
p.(None): Thousand) to BMRC.
p.(None): III. In case of Clinical Trial/Drug Research, Principal Investigator will have to pay Tk 50000 (Fifty Thousand)
p.(None): to BMRC at the time of initial submission.
p.(None): IV. Undergraduate students will have to pay total Tk 2000 (Two Thousand) at the time of the submission of the
p.(None): proposal.
p.(None): V. Total Fee will be paid by the Principal Investigator after ethical approval (at the time of receiving
p.(None): approval letter) by an Account Payee Cheque in favor of Bangladesh Medical Research Council.
p.(None): VI. For amendment and renewal 50% of the first approval fee will be charged.
p.(None): SOP OF BMRC ETHICAL GUIDELINE Page | - 1 -
p.(None):
p.(None): ANNEXURE - A
p.(None):
p.(None):
p.(None): BANGLADESH MEDICAL RESEARCH COUNCIL
...
p.(None):
p.(None): (d) Discomfort to Yes No Subjects
p.(None): (e) Invasion of the body Yes No
p.(None):
p.(None): (f) Invasion of Privacy Yes No
p.(None):
p.(None): (g) Disclosure of Yes No Information damaging to
p.(None): Subject or others
p.(None):
p.(None): 3. Does the study involve?
p.(None):
p.(None): (a) Use of records, Yes No (Hospital, medical,
p.(None): Death, birth or other)
p.(None):
p.(None): (b) Use of fetal tissue Yes No Or abortus
p.(None): (c) Use of organs or Yes No Body fluids
p.(None): 4. Are subjects clearly informed about?
p.(None):
p.(None): (a) Nature and Yes No purposes of study
p.(None): (b) Procedures to be Yes No followed including
p.(None): alternatives used
p.(None):
p.(None): (c) Physical risks Yes No
p.(None):
p.(None): (d) Private questions Yes No
p.(None):
p.(None): (e) Invasion of the Yes No Body
p.(None):
p.(None): (f) Benefits to be Yes No Derived
p.(None):
p.(None): (g) Right to refuse Yes No to participate or
p.(None): to withdraw from study
p.(None):
p.(None): (h) Confidential Yes No handling of data
p.(None):
p.(None): (i) Compensation Yes No where there are risks or
p.(None): loss of working time or privacy is involved in any particular procedure
p.(None): 5. Will signed consent form/verbal consent be required?
p.(None): (a) From Subjects Yes No
p.(None): (b) From parent or Yes No guardian (if subjects
p.(None): are minors)
p.(None): 6. Will precautions be Yes No
p.(None): taken to protect anonymity of subjects
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE Page | 3
p.(None):
p.(None): Note: If the final instrument / questionnaire is not completed prior to review, the following information
p.(None): should be included in the abstract.
p.(None): 1. A description of the areas to be covered in the questionnaire or interview which could be
p.(None): considered either sensitive or which would constitute an invasion of privacy.
p.(None): 2. Examples of the type of specific question to be asked in the sensitive areas.
p.(None):
p.(None): 3. An indication as to whom the questionnaire will be presented to the committee for review.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): We agree to obtain approval of the Ethical Review Committee for any changes involving the rights and
p.(None): welfare of subjects or any changes of the Methodology before making any such changes.
p.(None):
p.(None):
p.(None): Signature
p.(None):
p.(None):
p.(None): Name of the Principal Investigator/Leader/Coordinator Date:
p.(None):
p.(None): Name of Co-investigator (S) Signature: 1.
p.(None):
p.(None): 2.
p.(None):
p.(None):
p.(None): 3.
p.(None):
p.(None):
p.(None): 4.
p.(None):
p.(None):
p.(None): 5.
p.(None):
p.(None): * Include all the Investigator, Co –Investigators.
p.(None):
p.(None):
...
p.(None):
p.(None): The Ethical Review Committee will not consider any application which does not include a specific
p.(None): abstract/summary for the committee. The abstract should summarize the purpose of the study, the methods and
p.(None): procedures to be used, by addressing each of the following items. If an item is not applicable, please
p.(None): note accordingly:
p.(None):
p.(None):
p.(None): 1. Describe the requirements in respect of the population and explain the rationale for using population
p.(None): of special groups such as children, Incompetent person or groups whose ability to give voluntary
p.(None): informed consent is questionable.
p.(None): 2. Describe and assess any potential risks - physical, psychological, social, legal or other and assess the
p.(None): likelihood and seriousness of such risks. If methods of research create potential risks, describe other methods,
p.(None): if any, that were considered and why they cannot be used.
p.(None): 3. Describe procedures for protecting against or minimizing potential risks and assessment of their likely
p.(None): effectiveness.
p.(None): 4. Include a description of the methods for safeguarding confidentiality or protecting anonymity.
p.(None): 5. When there are potential risks to the subject, or the privacy of the individual may be involved, the
p.(None): investigator is required to obtain a signed informed consent from the participant. For minors, informed consent
p.(None): must be obtained from the authorized legal guardian or parent of the subject. Describe consent procedures to be
p.(None): followed including how and where informed consent will be obtained.
p.(None): (a) If signed consent will not be obtained, explain why this requirement should be waived and provide an
p.(None): alternative procedure such as a verbal consent.
p.(None): (b) If information is to be withheld from a subject, justify this course of action.
p.(None): (c) If there is a potential risk to the subject or privacy of the individual or loss of work time is
p.(None): involved in any particular procedure, include a statement in the consent form stating whether any compensation
p.(None): will be available.
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 5
p.(None):
p.(None): 6. If the study involves an interview, describe where and in what context the interview will take place.
p.(None): State approximate length of time required for the interview.
p.(None): 7. Assess the potential benefit to be gained by the individual subject as well as the benefits which may accrue to
p.(None): society in general as a result of the work. Indicate how the benefits may outweigh the risks.
p.(None): 8. Incase of an experimental drugs, provide information about its status of registration for open sale in
p.(None): Bangladesh and in other developed countries.
p.(None): 9. For experimental 'new' drugs* which are not registered in Bangladesh provide full information about
...
p.(None): o Facilities Available :
p.(None): o Additional Facilities Required :
p.(None): • Approval / Forwarding of the Head of Department / Institute / IRB.
p.(None):
p.(None): • Flow Chart: (Describe sequence of tasks within time frame).
p.(None):
p.(None): • Ethical Implications: (Think very carefully about possible ethical implications and put views.
p.(None): Consult BMRC's Guidelines for Ethical Review of Projects involving Human Subjects).
p.(None): • References: Vancouver style to be followed. e.g.- Can Med Assoc J 1995; 152(9): 1459-1465.
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 7
p.(None):
p.(None): ANNEXURE - D
p.(None):
p.(None):
p.(None): INFORMED CONSENT FORM SHOULD BE WRITTEN IN BENGALI & ENGLISH
p.(None):
p.(None): Consent form shall be included:
p.(None): • Interviewer details.
p.(None): • Purpose of the Study.
p.(None): • Types of participation of the study respondents.
p.(None): • Duration, Procedures of the study and participant’s involvement.
p.(None): • Potential benefits.
p.(None): • Risks, hazards and discomforts.
p.(None): • Reimbursements.
p.(None): • Confidentiality.
p.(None): • Termination of study participation / Rights to withdraw from participation.
p.(None): • Name of the participant.
p.(None): • Signature/Thumb print of the participants.
p.(None): • Name of the witness.
p.(None): • Signature of the witness.
p.(None): • Name of the interviewer.
p.(None): • Signature of the interviewer.
p.(None): • In case of Minor Signature of the Parent / Legal Guardian.
p.(None): • Duplicate copy of Inform Consent shall be give to participant.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 8
p.(None):
p.(None): ANNEXURE - E
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): o Total Budget.
p.(None):
p.(None): o Detailed Budget:
p.(None):
p.(None): 1. Personnel Cost: (Professional Scientific Staff, Technical & Other Staff. Please mention percentage of time to
p.(None): be devoted by each personnel to this Project).
p.(None): 2. Field Expenses/Laboratory Cost:
p.(None):
p.(None): 3. Supplies and Materials (Items & quantity to be specified):
p.(None):
p.(None): 4. Patient Cost (If applicable):
p.(None):
p.(None): 5. Travel Cost (Internal travel cost only) :
p.(None):
p.(None): 6. Transportation of Goods :
p.(None):
p.(None): 7. Office Stationery (Items & quantity to be specified):
p.(None):
p.(None): 8. Data Processing/Computer Charges (If applicable) :
p.(None):
p.(None): 9. Printing and Reproduction :
p.(None):
p.(None): 10. Contractual Services (Other than manpower):
p.(None):
p.(None): 11. Miscellaneous :
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.(None): (a) If signed consent will not be obtained, explain why this requirement should be waived and provide an
p.(None): alternative procedure such as a verbal consent.
p.(None): (b) If information is to be withheld from a subject, justify this course of action.
p.(None): (c) If there is a potential risk to the subject or privacy of the individual or loss of work time is
p.(None): involved in any particular procedure, include a statement in the consent form stating whether any compensation
p.(None): will be available.
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 5
p.(None):
p.(None): 6. If the study involves an interview, describe where and in what context the interview will take place.
p.(None): State approximate length of time required for the interview.
p.(None): 7. Assess the potential benefit to be gained by the individual subject as well as the benefits which may accrue to
p.(None): society in general as a result of the work. Indicate how the benefits may outweigh the risks.
p.(None): 8. Incase of an experimental drugs, provide information about its status of registration for open sale in
p.(None): Bangladesh and in other developed countries.
p.(None): 9. For experimental 'new' drugs* which are not registered in Bangladesh provide full information about
p.(None): the toxicity studies carried out in animals or human volunteers. Published papers on this regard shall be annexed.
p.(None): 10. If placebo is to be used justify its uses and why the study cannot be done without its use.
p.(None): 11. If an experimental 'new' drug* is to be used give a statement regarding its sponsorship and the conditions for
p.(None): such sponsorship.
p.(None): 12. State if the activity requires the use of records (hospital, medical, birth, death or other), organs, tissues,
p.(None): body fluids, the fetus or the abortus.
p.(None): The statement to the subject should include information specified in items 2, 3, 4, 5(c) and 7, as well as indicating
p.(None): the approximate time required for participation in the activity.
p.(None):
p.(None):
p.(None): * a 'new' drug means one which is not registered for free and open sale in Bangladesh.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE P a g e | 6
p.(None):
p.(None): ANNEXURE - C
p.(None): FORMAT FOR SUBMISSION OF A RESEARCH PROPOSAL FOR ETHICAL APPROVAL
p.(None):
p.(None): • Project Title :
p.(None): • Summary :
p.(None): • Introduction: (Introduce the subject. Provide full background information. Cite literatures that are specific
p.(None): to the topic of the research proposal. Information should be completed to prove that the research
p.(None): proposal is based on a sound scientific footing.)
p.(None): • Objectives: (List the general and specific objectives of the proposed study and state clearly the question that
p.(None): is being posed or the hypothesis being tested.)
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| children | Child |
| drug | Drug Usage |
| fetus | Fetus/Neonate |
| ill | ill |
| minor | Youth/Minors |
| parent | parents |
| placebo | participants in a control group |
| volunteers | Healthy People |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
protect
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input