79C3C34C52B45572883A05D425EB0F82
Standard Operating Procedures
https://bmrcbd.org/application_form/SOPs.pdf
http://leaux.net/URLS/ConvertAPI Text Files/1F6DBCA3F8D0E2C23099BE1E77F92E7F.en.txt
Examining the file media/Synopses/1F6DBCA3F8D0E2C23099BE1E77F92E7F.html:
This file was generated: 2021-02-23 03:57:33
| 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:
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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):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 3
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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 4
p.(None):
p.(None): Circle the appropriate answer to each of the following (If not Applicable write NA)
p.(None):
p.(None):
p.(None):
p.(None): 1. Source of Population:
...
p.(None): (b) If information is to be withheld from a subject, justify this course of action.
p.(None):
p.(None): (c) If there is a potential risk to the subject or privacy of the individual or loss of work time is involved in
p.(None): any particular procedure, include a statement in the consent form stating whether any compensation will be available.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 7
p.(None):
p.(None): 6. If the study involves an interview, describe where and in what context the interview will take
p.(None): place. 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
p.(None): to 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
p.(None): in Bangladesh and in other developed countries.
p.(None): 9. For experimental 'new' drugs* which are not registered in Bangladesh provide full information about the
p.(None): 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
p.(None): conditions for such sponsorship.
p.(None): 12. State if the activity requires the use of records (hospital, medical, birth, death or other), organs,
p.(None): tissues, 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
p.(None): indicating the approximate time required for participation in the activity.
p.(None):
p.(None):
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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 8
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):
p.(None): • Summary :
p.(None):
p.(None): • Introduction: (Introduce the subject. Provide full background information. Cite literatures that are
p.(None): specific to the topic of the research proposal. Information should be completed to prove that the research proposal is
p.(None): 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 is
p.(None): being posed or the hypothesis being tested.)
p.(None): • Rationale: (Describe the relevance of the proposed study to national health priorities and relationship
p.(None): of the objectives to existing scientific knowledge on the subject. Cite relevant literature and refer to
p.(None): related studies done 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 feasible.
...
Health / Healthy People
Searching for indicator volunteers:
(return to top)
p.(None): 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):
p.(None): (c) If there is a potential risk to the subject or privacy of the individual or loss of work time is involved in
p.(None): any particular procedure, include a statement in the consent form stating whether any compensation will be available.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 7
p.(None):
p.(None): 6. If the study involves an interview, describe where and in what context the interview will take
p.(None): place. 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
p.(None): to 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
p.(None): in Bangladesh and in other developed countries.
p.(None): 9. For experimental 'new' drugs* which are not registered in Bangladesh provide full information about the
p.(None): 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
p.(None): conditions for such sponsorship.
p.(None): 12. State if the activity requires the use of records (hospital, medical, birth, death or other), organs,
p.(None): tissues, 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
p.(None): indicating the approximate time required for participation in the activity.
p.(None):
p.(None):
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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 8
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):
p.(None): • Summary :
p.(None):
p.(None): • Introduction: (Introduce the subject. Provide full background information. Cite literatures that are
p.(None): specific to the topic of the research proposal. Information should be completed to prove that the research proposal is
p.(None): based on a sound scientific footing.)
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None):
p.(None): • The proceedings of the meeting should be prepared within 3 working days after the meeting.
p.(None):
p.(None):
p.(None): • All decisions will be communicated in writing to the Principal Investigator.
p.(None):
p.(None):
p.(None): • NREC should have following documentation:
p.(None):
p.(None):
p.(None): - Copy of all study protocols with enclosed documents, progress reports, and Serious Adverse Effect (SAEs).
p.(None):
p.(None):
p.(None): - Minutes of all meetings.
p.(None): - Copy of all existing relevant national and international guidelines on research ethics and laws along with
p.(None): amendments.
p.(None):
p.(None):
p.(None): - Copy of all correspondence with members, researchers and other regulatory bodies.
p.(None):
p.(None):
p.(None): - Final report of the approved projects.
p.(None): - All documents should be archived.
p.(None): • Updating NREC members:
p.(None): -All relevant new guidelines should be brought to the attention of the members.
p.(None): - Members should be encouraged to attend national and international training programs in research ethics for
p.(None): maintaining quality in ethical review and be aware of the latest developments in this area.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 13
p.(None):
p.(None): GUIDELINES ON RESEARCH ETHICS AS PER NATIONAL HEALTH RESEARCH STRATEGIES:
p.(None): ➢ The National Research Ethics Committee (NREC) will set standards, advice the Departments and the Ministry
p.(None): of Health & Family Welfare on the management of research ethics for Bangladesh and arbitrate on matters
p.(None): of Ethics.
p.(None): ➢ The NREC will be responsible to review all clinical trials of both non registered medicinal substances
p.(None): in Bangladesh and new indication of already registered medicinal substances.
p.(None): ➢ Research issues having religious or social sensitivity should be approved by NREC
p.(None): ➢ International collaborative research involving Bangladeshi population will have to get ethical approval by the
p.(None): NREC, while the administrative approval shall be given by the Government
p.(None): Registration of Health Research as per National Health Research Strategy:
p.(None): BMRC has developed a Registration Form for registration of research studies. BMRC is developing
p.(None): electronic submission system for health research registration. There is a specific section in this
p.(None): system for Clinical Trial Registry.
p.(None): ➢ Any health research to be conducted in Bangladesh has to be registered with the BMRC.
p.(None): ➢ The Clinical Trials Protocol should be reviewed and approved by the NREC.
p.(None): ➢ Clinical Trials should be registered in the Clinical Trial Registry in the BMRC.
p.(None): ➢ Clinical Trials be well monitored.
p.(None): ➢ Clinical Trials should be conducted following ethical standard (Social or Scientific Value, Scientific
...
Health / ill
Searching for indicator ill:
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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):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 3
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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 4
p.(None):
p.(None): Circle the appropriate answer to each of the following (If not Applicable write NA)
p.(None):
p.(None):
p.(None):
p.(None): 1. Source of Population:
p.(None):
p.(None): (a) ILL Participant Yes No
p.(None): (b) Non ILL Participant Yes No
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): (b) Social Risks Yes No
p.(None): (c) Psychological Yes No Risks to subjects
p.(None): (d) Discomfort to Yes No Subjects
p.(None): (e) Invasion of the body Yes No
p.(None): (f) Invasion of Privacy Yes No
p.(None): (g) Disclosure of Yes No Information damaging to Subject or others
p.(None): 3. Does the study involve?
p.(None): (a) Use of records, Yes No (Hospital, medical, 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): (a) Nature and Yes No purposes of study
p.(None): (b) Procedures to be Yes No followed including alternatives used
p.(None): (c) Physical risks Yes No
p.(None): (d) Private questions Yes No
p.(None): (e) Invasion of the Yes No Body
p.(None): (f) Benefits to be Yes No Derived
p.(None): (g) Right to refuse Yes No to participate or
p.(None): to withdraw from study
p.(None): (h) Confidential Yes No handling of data
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
...
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 welfare of
p.(None): 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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 6
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):
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
p.(None): methods and procedures to be used, by addressing each of the following items. If an item is not
p.(None): applicable, please note accordingly:
p.(None):
p.(None):
p.(None): 1. Describe the requirements in respect of the population and explain the rationale for using
p.(None): population of special groups such as children, Incompetent person or groups whose ability to give voluntary informed
p.(None): 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, if
p.(None): 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 must be
p.(None): obtained from the authorized legal guardian or parent of the subject. Describe consent procedures to be followed
p.(None): 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):
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.(None): any particular procedure, include a statement in the consent form stating whether any compensation will be available.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 7
p.(None):
p.(None): 6. If the study involves an interview, describe where and in what context the interview will take
p.(None): place. 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
p.(None): to 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
p.(None): in Bangladesh and in other developed countries.
p.(None): 9. For experimental 'new' drugs* which are not registered in Bangladesh provide full information about the
p.(None): 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
p.(None): conditions for such sponsorship.
p.(None): 12. State if the activity requires the use of records (hospital, medical, birth, death or other), organs,
p.(None): tissues, 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
p.(None): indicating the approximate time required for participation in the activity.
p.(None):
p.(None):
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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 8
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):
p.(None): • Summary :
p.(None):
p.(None): • Introduction: (Introduce the subject. Provide full background information. Cite literatures that are
p.(None): specific to the topic of the research proposal. Information should be completed to prove that the research proposal is
p.(None): 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 is
p.(None): being posed or the hypothesis being tested.)
p.(None): • Rationale: (Describe the relevance of the proposed study to national health priorities and relationship
p.(None): of the objectives to existing scientific knowledge on the subject. Cite relevant literature and refer to
p.(None): related studies done in our country or elsewhere.)
p.(None): • Methodology: (Describe the design of the study and methodology in sufficient detail to enable assessment
...
Social / Religion
Searching for indicator religious:
(return to top)
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):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 11
p.(None):
p.(None): ANNEXURE - F NATIONAL RESEARCH ETHICS COMMITTEE (NREC)
p.(None): Bangladesh Medical Research Council (BMRC) is the Secretariat for the National Research Ethics Committee
p.(None): (NREC). According to BMRC Policy each and every Project Proposal approved by the Scientific Review Committee must
p.(None): get ethical approval before funding. Scientific validity should be approved by a valid Scientific
p.(None): Review Committee before submission of a research project to NREC.
p.(None):
p.(None):
p.(None): The Ethics Review Committee of BMRC was established in 1979. The Committee consists of 9-13 Members
p.(None): (Lawyer, Female Representative, Religious Leader, Research Methodologist / Bio-statistician are obligatory as
p.(None): member) including chairman and member secretary. The Committee is formed by the Council under Guidelines for formation
p.(None): of Ethics Review Committee for tenure of 3 Years. The NREC is multidisciplinary and multi-sectorial in
p.(None): composition and an independent Body.
p.(None): The Committee is registered in OHRP as an official IRB (lRB No. 0001494) and has FWA (#00006444). Usually every year
p.(None): the Ethics Review Committee evaluates around 100 Research Proposals. The Committee meets every month. The Committee
p.(None): has given ethical approvals to investigators of numerous International Agencies and Academic Institutions
p.(None): (e.g. WHO, UNICEF, UNFPA, Harvard, Johns Hopkins, Columbia, Cambridge Universities, Intl. NGOs etc.)
p.(None): • The NREC provides approval for:
p.(None):
p.(None): ➢ BMRC Funded Research Projects (Internal/Intramural)
p.(None):
p.(None): ➢ Projects funded by Organizations (National and International) other than BMRC (External/Extramural),
p.(None): including multicentric collaborative studies.
p.(None): ➢ Research studies leading to Postgraduate Degrees (Specifically PhDs).
p.(None):
p.(None):
p.(None): • The Chairperson will conduct all meetings of the NREC. In absence of the Chairperson, members of the NREC will elect
p.(None): a chairperson who will conduct the meeting.
p.(None):
p.(None):
p.(None): • The NREC will conduct meeting in every 2 (two) months. The agenda should not be so loaded that sufficient time
p.(None): is not available for discussion. The frequency of meetings may increase depending on the number of applications.
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 12
p.(None):
...
p.(None): amendments.
p.(None):
p.(None):
p.(None): - Copy of all correspondence with members, researchers and other regulatory bodies.
p.(None):
p.(None):
p.(None): - Final report of the approved projects.
p.(None): - All documents should be archived.
p.(None): • Updating NREC members:
p.(None): -All relevant new guidelines should be brought to the attention of the members.
p.(None): - Members should be encouraged to attend national and international training programs in research ethics for
p.(None): maintaining quality in ethical review and be aware of the latest developments in this area.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 13
p.(None):
p.(None): GUIDELINES ON RESEARCH ETHICS AS PER NATIONAL HEALTH RESEARCH STRATEGIES:
p.(None): ➢ The National Research Ethics Committee (NREC) will set standards, advice the Departments and the Ministry
p.(None): of Health & Family Welfare on the management of research ethics for Bangladesh and arbitrate on matters
p.(None): of Ethics.
p.(None): ➢ The NREC will be responsible to review all clinical trials of both non registered medicinal substances
p.(None): in Bangladesh and new indication of already registered medicinal substances.
p.(None): ➢ Research issues having religious or social sensitivity should be approved by NREC
p.(None): ➢ International collaborative research involving Bangladeshi population will have to get ethical approval by the
p.(None): NREC, while the administrative approval shall be given by the Government
p.(None): Registration of Health Research as per National Health Research Strategy:
p.(None): BMRC has developed a Registration Form for registration of research studies. BMRC is developing
p.(None): electronic submission system for health research registration. There is a specific section in this
p.(None): system for Clinical Trial Registry.
p.(None): ➢ Any health research to be conducted in Bangladesh has to be registered with the BMRC.
p.(None): ➢ The Clinical Trials Protocol should be reviewed and approved by the NREC.
p.(None): ➢ Clinical Trials should be registered in the Clinical Trial Registry in the BMRC.
p.(None): ➢ Clinical Trials be well monitored.
p.(None): ➢ Clinical Trials should be conducted following ethical standard (Social or Scientific Value, Scientific
p.(None): Validity, Fair Subject Selection, Favorable Risk- Benefit Ratio, Independent Review, Informed Consent & Respect
p.(None): for Potential and Enrolled Subjects)
p.(None): Clinical Trial
p.(None): ➢ The NREC conducts post-approval monitoring of Clinical Trial.
p.(None): ➢ It is mandatory to form Data Safety Monitoring Board (DSMB) for conducting Clinical Trial.
p.(None): ➢ At least 2 (two) members shall be included from NREC during formation of DSMB.
p.(None): ➢ Principal Investigator should report Serious Adverse Events (SAE) as well as Adverse Events (AE) to the NREC.
p.(None): ➢ Approval is given subject to several conditions.
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): o Facilities Available :
p.(None): o Additional Facilities Required :
p.(None):
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): • Ethical Implications: (Think very carefully about possible ethical implications and put views. Consult BMRC's
p.(None): 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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 9
p.(None):
p.(None): ANNEXURE – D
p.(None):
p.(None): INFORMED CONSENT FORM SHOULD BE WRITTEN IN BENGALI & ENGLISH
p.(None):
p.(None): Consent form shall be included:
p.(None):
p.(None): • Interviewer details.
p.(None):
p.(None): • Purpose of the Study.
p.(None):
p.(None): • Types of participation of the study respondents.
p.(None):
p.(None): • Duration, Procedures of the study and participant’s involvement.
p.(None):
p.(None): • Potential benefits.
p.(None):
p.(None): • Risks, hazards and discomforts.
p.(None):
p.(None): • Reimbursements.
p.(None):
p.(None): • Confidentiality.
p.(None):
p.(None): • Termination of study participation / Rights to withdraw from participation.
p.(None):
p.(None): • Name of the participant.
p.(None):
p.(None): • Signature/Thumb print of the participants.
p.(None):
p.(None): • Name of the witness.
p.(None):
p.(None): • Signature of the witness.
p.(None):
p.(None): • Name of the interviewer.
p.(None):
p.(None): • Signature of the interviewer.
p.(None):
p.(None): • In case of Minor Signature of the Parent / Legal Guardian.
p.(None):
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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 10
p.(None):
p.(None): ANNEXURE - E
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
p.(None): time to 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):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 11
p.(None):
...
Social / parents
Searching for indicator parent:
(return to top)
p.(None): care.
p.(None): • Protocol deviation, if any, should be informed with adequate justifications.
p.(None): • Any amendment to the protocol should be resubmitted for renewed approval.
p.(None): • Any new information related to the study should be communicated to NREC.
p.(None): • Change of investigators / place of study need to be approved by NREC.
p.(None): • Safety and confidentiality of participant shall be maintain.
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.(None): Page 2
p.(None):
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):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 3
p.(None):
p.(None): ANNEXURE - A
p.(None):
p.(None):
p.(None): BANGLADESH MEDICAL RESEARCH COUNCIL
...
p.(None):
p.(None): 2. Does the study involve?
p.(None):
p.(None): (a) Physical risks Yes No To the subjects
p.(None): (b) Social Risks Yes No
p.(None): (c) Psychological Yes No Risks to subjects
p.(None): (d) Discomfort to Yes No Subjects
p.(None): (e) Invasion of the body Yes No
p.(None): (f) Invasion of Privacy Yes No
p.(None): (g) Disclosure of Yes No Information damaging to Subject or others
p.(None): 3. Does the study involve?
p.(None): (a) Use of records, Yes No (Hospital, medical, 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): (a) Nature and Yes No purposes of study
p.(None): (b) Procedures to be Yes No followed including alternatives used
p.(None): (c) Physical risks Yes No
p.(None): (d) Private questions Yes No
p.(None): (e) Invasion of the Yes No Body
p.(None): (f) Benefits to be Yes No Derived
p.(None): (g) Right to refuse Yes No to participate or
p.(None): to withdraw from study
p.(None): (h) Confidential Yes No handling of data
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 are minors)
p.(None): 6. Will precautions be Yes No taken to protect
p.(None): anonymity of subjects
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.(None): Page 5
p.(None):
p.(None): Note: If the final instrument / questionnaire is not completed prior to review, the following information should be
p.(None): included in the abstract.
p.(None): 1. A description of the areas to be covered in the questionnaire or interview which could be considered either
p.(None): 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 welfare of
p.(None): 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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 6
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
p.(None): methods and procedures to be used, by addressing each of the following items. If an item is not
p.(None): applicable, please note accordingly:
p.(None):
p.(None):
p.(None): 1. Describe the requirements in respect of the population and explain the rationale for using
p.(None): population of special groups such as children, Incompetent person or groups whose ability to give voluntary informed
p.(None): 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, if
p.(None): 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 must be
p.(None): obtained from the authorized legal guardian or parent of the subject. Describe consent procedures to be followed
p.(None): 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):
p.(None): (c) If there is a potential risk to the subject or privacy of the individual or loss of work time is involved in
p.(None): any particular procedure, include a statement in the consent form stating whether any compensation will be available.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 7
p.(None):
p.(None): 6. If the study involves an interview, describe where and in what context the interview will take
p.(None): place. 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
p.(None): to 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
p.(None): in Bangladesh and in other developed countries.
p.(None): 9. For experimental 'new' drugs* which are not registered in Bangladesh provide full information about the
...
p.(None): o Additional Facilities Required :
p.(None):
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): • Ethical Implications: (Think very carefully about possible ethical implications and put views. Consult BMRC's
p.(None): 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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 9
p.(None):
p.(None): ANNEXURE – D
p.(None):
p.(None): INFORMED CONSENT FORM SHOULD BE WRITTEN IN BENGALI & ENGLISH
p.(None):
p.(None): Consent form shall be included:
p.(None):
p.(None): • Interviewer details.
p.(None):
p.(None): • Purpose of the Study.
p.(None):
p.(None): • Types of participation of the study respondents.
p.(None):
p.(None): • Duration, Procedures of the study and participant’s involvement.
p.(None):
p.(None): • Potential benefits.
p.(None):
p.(None): • Risks, hazards and discomforts.
p.(None):
p.(None): • Reimbursements.
p.(None):
p.(None): • Confidentiality.
p.(None):
p.(None): • Termination of study participation / Rights to withdraw from participation.
p.(None):
p.(None): • Name of the participant.
p.(None):
p.(None): • Signature/Thumb print of the participants.
p.(None):
p.(None): • Name of the witness.
p.(None):
p.(None): • Signature of the witness.
p.(None):
p.(None): • Name of the interviewer.
p.(None):
p.(None): • Signature of the interviewer.
p.(None):
p.(None): • In case of Minor Signature of the Parent / Legal Guardian.
p.(None):
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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 10
p.(None):
p.(None): ANNEXURE - E
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
p.(None): time to 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):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 11
p.(None):
p.(None): ANNEXURE - F NATIONAL RESEARCH ETHICS COMMITTEE (NREC)
...
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):
p.(None): (c) If there is a potential risk to the subject or privacy of the individual or loss of work time is involved in
p.(None): any particular procedure, include a statement in the consent form stating whether any compensation will be available.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 7
p.(None):
p.(None): 6. If the study involves an interview, describe where and in what context the interview will take
p.(None): place. 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
p.(None): to 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
p.(None): in Bangladesh and in other developed countries.
p.(None): 9. For experimental 'new' drugs* which are not registered in Bangladesh provide full information about the
p.(None): 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
p.(None): conditions for such sponsorship.
p.(None): 12. State if the activity requires the use of records (hospital, medical, birth, death or other), organs,
p.(None): tissues, 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
p.(None): indicating the approximate time required for participation in the activity.
p.(None):
p.(None):
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): SOP OF BMRC ETHICAL GUIDELINE
p.(None): Page 8
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):
p.(None): • Summary :
p.(None):
p.(None): • Introduction: (Introduce the subject. Provide full background information. Cite literatures that are
p.(None): specific to the topic of the research proposal. Information should be completed to prove that the research proposal is
p.(None): 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 is
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| children | Child |
| drug | Drug Usage |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| ill | ill |
| minor | Youth/Minors |
| parent | parents |
| placebo | participants in a control group |
| religious | Religion |
| volunteers | Healthy People |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
developing
ethics
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input