Ethical Review process of Ethical Review Board of Nepal Health Research Council

1. NHRC Overview
Defining a clinical trial
Namita Ghimire
Ethical Review M & E Section,
Nepal Health Research Council (NHRC)
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Ethical Review Process of
ERB,NHRC

2. NHRC Overview
Defining a clinical trial
Health Research Regulation in Nepal
 NHRC is mandated to provide the ethical review, approval
and monitoring of the research project to be conducted all
over the country
 FERCAP recognized National Ethical Review Board within
the NHRC (http://nhrc.gov.np/ethics/ethical-review-
board/)
 56 IRCs at health care facilities, academic institutions and
research institutions throughout the country
(http://nhrc.gov.np/ethics/irc/)
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3. NHRC Overview
Defining a clinical trial
NHRC Publications
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Ethical Review Process of ERB

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NHRC website : www.nhrc.gov.np

6. Online proposal submission
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7. Researcher Log
Admin log
Reviewer Log
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8. Submission of proposal
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9. Proposal format
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10. Screening information:
Research related to health, national or international
researcher and thesis or self-funded study
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Researcher should prepare the followings

11. • CV, Photos, Scanned signature of the PI, Co-investigators and
other team members
• Investigators academic qualification and research
experiences and research related training
• GCP Certificate/ basic research Ethics Training
• Incase of Collaborative research , Nepali PI
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Administrative information

12. Human resource cost, field expenses, transportation cost,
laboratory cost, data management cost, report writing and
dissemination cost, logistic cost, monitoring and evaluation cost,
miscellaneous cost, ethical approval cost
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Financial details

13. Technical Details
• Title of Research,
• Research area,
• Background,
• Rationale/justification,
• Conceptual Framework,
• General Objective,
• Specific Objective,
• Research Hypothesis,
• Study Variables,
• Research Method,
• Research Design,
• Description of Research Design,
• Study site and its Justification,
• Study Population,
• Sampling unit,
• Sample Size,
• Number of participants and Justification,
• Sampling Technique,
• Criteria for Sample Selection,
• Data Collection Technique,
• Data Collection Tools, Pretesting,
• Validity and Reliability of Tool,
• Potential Biases,
• Limitation of the Study,
• Plan for Supervision and Monitoring,
• Plan for Data Management and Analysis,
• Expected Outcome of the Research Results
• Plan for Utilization of Research Findings
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14. Ethical consideration
• Number of human participants to be involved,
• Frequency,
• Responsibility,
• Vulnerability,
• Risks and benefits,
• Responsible person for taking consent
• Types of informed consent, etc.
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15. Documents
• Data collection tools including interviews and Focused Group Discussion guideline,
observation checklist, questionnaires etc.
• The consent form
• A letter of acceptance from the respective hospital/organization or institution
• Agreement letter with the sponsor, incase of funded study.
• MTA, CVs of the bio-sample/specimens handling person, and the commitment letter
from the PI. Only extracted bio-samples will be allowed to transfer.
• Other centre's ethical approval letter, in case of multi-centric study
• List of abbreviations /acronyms
• References
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16. • Original Protocol including detail description of the study design, screening and eligibility assessment
including randomization and blinding process (if followed)
• The phase of the trial, and a detail description of the safety of the product or procedures
• Investigational Product (IP) (IP description, labelling, supply, its storage, etc.)
• Investigators brochure
• DSMB Chatter
• Pharmacovigilance safety report including the pharmacological, pharmaceutical, and toxicological data
• Insurance documents
• The signed final copy of the previously conducted clinical trial documents
• Permission letter from the DDA
• Clinical Trial Registration (CTR) number
• Detail of CRO
• SoP
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Additional documents in case of trials

17. • Approval Letter from concern Institute/University
• Recommendation letter from the academic supervisor
• In the case of the foreign student working for an academic thesis
in Nepal, the local Nepali supervisor
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Student Application

18. The researcher can deposit the ethical approval processing fee at NHRC
Office or at Standard Chartered Bank Nepal Ltd. Kathmandu, Nepal
Swift code: SCBLNPKA
A/C Name: Nepal Health Research Council
Saving A/C Number: 18-0018546-06
Global IME Bank Ltd
Saving A/C Number : N307010001852
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Ethical approval processing fee

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Process of Ethical Review of NHRC
Online application for Ethical Clearance
Communicate with Reviewer & investigator to Complete Review/Revision process
Assign proposal to Secretariat Staff
Screening of the proposal based on checklist
If the proposal satisfies all column of checklist, in consultation with ERB Chair
Once the PI response is agreed by Reviewer, for further process
Present proposals and reviewers comments in ERB Meeting
Prepare agenda for ERB Meeting and proposals forward to ERB member at least
48 hrs. before meeting

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Discuss during ERB Meeting
Approved
Notify the decision and documents to
Principle Investigator
Monitoring of implementation of approved research proposal
Progress report and Dissemination of report
Submission of monitoring report to ERB through ERB Chairs consent ERB
Decision on Amendment/Stop
Approved with
minor revision
Resubmission Disapproved
Start from
beginning
Appeal within 35
days to NHRC
Final Report Submission
Archive in NHRC archive and Library of NHRC
Process of Ethical Review of NHRC……………

21. Type of risk
• Less than minimal : Probability of harm or discomfort is nil or not expected.
(Exemption from Review )
• Minimal risk : Probability of harm or discomfort anticipated in the research is not
greater than encountered in routine life activities/ serious harm or adverse event
is unlikely (Expedited Review )
• Low risk: Increment in probability of harm or discomfort is only a little more than
the minimal risk threshold. Such research should have a social value. Social risks,
psychological harm and discomfort may also fall in this category. (Expedited
Review )
• More than Minimal/high risk : Probability of harm or discomfort anticipated in the
research is invasive and greater than minimal risk or interventional study. (Full
Board Review )
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22. • Documentation of the ERB decision
 Minuting and communicating the decision
• Monitoring and supervision of approved study
• Reporting of SAE,AE
• PD /PV
• Amendments
– Progress report
– Summary of changes with rationale
– Updated proposal in track changes version
– Documents will be asked based on the amendments requests
• Submission of the progress and final report
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Post approval process

23. For more details go through these reference
 Nuremberg Code 1947 [Full text]
 The Belmont report 1979 [Full text]
 Council for International Organizations of Medical Sciences (CIOMS) 1982-2016 [Full text]
 WHO Global Health Ethics [Full text]
 Guidelines for IRCs for Health Research in Nepal [Full text]
 National Ethical Guideline for Health Research in Nepal and Standard Operating Procedure 2011
 National guideline for Clinical Trial with the use of Pharmaceutical products 2005
 National Guideline for Care and Use of Animals in Health Research in Nepal 2005
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