NHRC has published National Ethical Guidelines for health Research in Nepal 2022

1. National Ethical Guideline for Health Research in
Nepal 2022
Namita Ghimire
Lead, Ethical Review M & E Section
member, IRC Acrediation Sub Committe
Nepal Health Research Council, Ministry of Health & Population
Government of Nepal 1

2. • National Ethical Guidelines for Health Research
in Nepal- 2001, 2005, 2011, 2019 and 2022
• National Health Care Waste Management
Guidelines, 2005
• Ethical Guidelines for the Care and Use of
Animals in Health Research in Nepal, 2005
• National Guidelines on Clinical Trials with
the Use of Pharmaceutical Products, 2005, and
• Guidelines for Institutional Review Committees
for Health Research in Nepal, 2016.
2

3. Table of Content
• Foreword
• Preface
• Abbreviations
• List of Boxes
Sections:
Section 1. Introduction
Section 2. Ethical Principles
Section 3. Responsible Conduct of Health Research
Section 4. Ethical Issues in Health Research
Section 5. Informed Consent Process in Health Research
Section 6. Ethical Review Process
Section 7. Specific requirements for Specialized Research
Section 8. Establishment of the Institutional Review Committees
Bibliographic References
Glossary
Annexes 3

4. Section 1. Introduction
1.1 Historical Background
• Nepal Medical Research Committee (NMRC) in 1982
• Nepal Health Research Council in 1991 an Act of Parliament
• National Ethical Guidelines for Health Research in Nepal- 2001, 2005, 2011, 2019 and
2022
1.2 Scope of the Guideline
• Researchers while developing research proposals;
• Review committee and reviewers while reviewing research proposals for approval,
monitoring of ongoing research and dissemination and utilization of research funding;
• Sponsors while approving, funding and utilizing the findings from research;
• Regulatory authorities while reviewing the proposals and monitoring the research
process to assess the comprehensiveness of their guidelines.
• Policy makers to review the research funding and possible use of research funding in
policies and programs.
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5. Section 2. Ethical Principles .
2.1 Basic Ethical Principles
2.2 General Ethical Principle
Individual researcher or the research team is required to abide by 4 basic and 13 general
ethical principles while undertaking health research in Nepal
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6. Section-2 Ethical Principles
1. Basic Ethical Principles
• Principle I: Respect for the Autonomy of Participant
• No researches should take precedence over respect for human rights, fundamental freedom
and human dignity, and practices contrary to human dignity should be prohibited
• Informed Consent
• Principle II: Beneficence and Non- maleficence
• Maximize possible benefits and to minimize possible harms
• Principle III: Justice
• The protection of persons in vulnerable situations is of special importance
• Principle IV: Respect for the Environment
• Special precautions that must be exercised for the protection of the environment in the
conduct of research
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7. 2. General Ethical Principles:
• Principle of essentiality
• Principle of voluntariness
• Principle of non-exploitation
• Principle of social responsibility
• Principle of ensuring privacy and confidentiality
• Principle of risk minimization
• Principle of professional competence
• Principle of maximization of benefit
• Principle of institutional arrangements
• Principle of transparency and accountability
• Principle of totality of responsibility
• Principle of environmental protection
• Principle of dissemination of research findings
The PI/Co-PI and research team should take accountability and responsibility in
obeying and maintaining the above outlined principles, while conducting the research.
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8. Section 3. Responsible Conduct of Health Research
3.1 Social Values of Research
3.2 Policies and Priorities Influencing Health Research
3.3 Specific Issues that Emerge during Research Planning and Conduction
3.3.1. Identifying, Mitigating and Managing Conflict of Interest
3.3.2. Data Acquisition, Management, Sharing and Ownership
3.4 Professional, Legal and Moral Responsibilities of Researchers and Sponsors
3.4.1 Roles and Responsibilities of the Researchers/Investigators
3.4.2 Roles and Responsibilities of the Sponsor
3.5 Research Reporting
3.6 Authorships in Research Publications
3.7 Handling of Research Misconduct
3.8 Clinical Trials Registration
3.9 Collaboration and Networking in Research
3.9.1 Externally Sponsored Research
3.9.2 Institutional Research Arrangements
3.9.3 Special Considerations in Collaborative Research 8

9. 3.3.1 Identifying, Mitigating and Managing CoI
1. At the level of researchers: Researcher must identify and dis close if there is any financial
and/or non-financial conflict between the interests of the researcher and the interests of those
bodies representing the ethical oversight. Researcher should also express his/her commitment to
time and resource investment in conducting the research.
2. At the level of reviewers: Reviewer should declare CoI during review process if any of
his/her close friends, family members and/or students have submitted the research proposal for
obtaining research grants and approval. Reviewer should declare CoI if any of his/her close
friends, family members and/or students are directly or indirectly involved in the research study.
3. At the level of research institutions: Institution must declare CoI during research process and
develop SOP to manage and mitigate CoI, if any. It should be communicated in a transparent
way. Particularly when the institutions like NHRC are involved in research implementation, CoI
should not interfere in any process of the ethical review, implementation monitoring, data
analysis and recommendation to the government for policy making. The process of managing
CoI should be clearly documented in the SoP.
4. At the level of ECs: ERB members must declare their CoI (if any) and take appropriate
actions to recuse themselves from the review and decision-making process on the protocol(s)
related to their CoI; and, follow directives from the ERB. 9

10. Roles and Responsibilities
Ethics
Committees
 During review, determine whether the prospective participants for a particular research are
vulnerable.
 Examine whether inclusion/exclusion of the vulnerable population is justified.
 Ensure that CoI do not increase harm or lessen benefits to the participants.
 Carefully determine the benefits and risks to the participants and advise risk minimization
strategies wherever possible.
 Suggest additional safeguards, such as more frequent review and monitoring, including site
visits.
 Only the full committee should do initial and continuing review of such proposals. It is
desirable to have empowered representatives from the specific populations during
deliberations..
 ERB should have SOPs for handling proposals involving vulnerable populations.
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11. Section 4. Ethical Issues in Health Research
4.1 Research among Vulnerable Populations
4.2 Assessment of Risks and Benefits
4.3 Privacy and Confidentiality
4.4 Equitable Distribution
4.5 Compensation and Payment
4.5.1 Payment for Participation
4.5.2 Compensation for Research related Harm
4.6 Qualification of the Researcher
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12. Section 4. Ethical Issues in Health Research (Contd…)
4.5 Compensation and Payment
4.5.1 Payment for Participation
4.5.2 Compensation for Research related Harm
4.6 Qualification of the Researcher
4.7 Transparency and Conflict of Interest
4.8 Data/Bio-sample Collection, Storage, Bio-security, Transfer and Bio-banking
4.8.1 Data Collection, Storage, Security and Transfer
4.8.2 Biological Specimen Collection, Storage, Security and Bio-banking
4.8.2.1 Bio-bank and Types of Biological Specimens
4.8.2.2 Key aspects in maintaining Confidentiality and Privacy of Donors related to
Biological Specimens and /or Data
4.8.2.3 Biological Specimen Transfer
4.9 Research Benefit Sharing
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13. Section 4: Ethical issues in Health Research-
• Research among vulnerable populations
• Additional safeguards/protection mechanisms
Box 4.1 Characteristics of vulnerable
individuals/populations/group
Individuals may be considered to be vulnerable if they are
• Socially, economically or politically disadvantaged and therefore
susceptible to being exploited;
• Incapable of making a voluntary informed decision for
themselves or whose autonomy is compromised temporarily or
permanently, for example people who are unconscious, differently
abled;
• Able to give consent, but whose voluntariness or understanding
is compromised due to their situational conditions; or
Unduly influenced either by the expectation of benefits or fear of
retaliation in case of refusal to participate which may lead them to give
consent
Box 4.2 Vulnerable populations or
groups
• Economically and socially disadvantaged (unemployed
individuals, orphans, abandoned individuals, persons below the
poverty line, ethnic minorities, sexual minorities–lesbian/
gay/bisexual and transgender (LGBT), etc.;
• Unduly influenced either by the expectation of benefits or fear
of retaliation in case of refusal to participate which may lead
them to give consent;
• Children (up to 18 years);
• Women in special situations (pregnant or lactating
women, or those who have poor decision-making powers/poor
access to healthcare);
• Tribal and marginalized communities;
• Refugees, migrants, homeless, persons or populations in
conflict zones, riot areas or disaster situations;
• Afflicted with mental illness and cognitively impaired
individuals, differently abled mentally and physically disabled;
• Terminally ill or are in search of new interventions having
exhausted all therapies; suffering from stigmatizing or rare
diseases; or have diminished autonomy due to dependency or
being under a hierarchical system (students and employees,
subordinates, defense services personnel, healthcare workers,
institutionalized individuals, under trials and prisoners)
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14. Benefit-risk assessment
The ERB/IRC should assess the inherent benefits and risks, ensure a favorable balance of benefits and risks,
evaluate plans for minimizing the risk and discomfort and decide on the merit of the research before approving
it.
Type of risk Definition/Description
Less than
minimal risk
Probability of harm or discomfort anticipated in the research is nil or not
expected. For example, research on anonymous or non-identified data/samples,
data available in the public domain, meta-analysis, etc.
Minimal risk Probability of harm or discomfort anticipated in the research is not greater than
that ordinarily encountered in routine daily life activities of an average healthy
individual or general population or during the performance of routine tests where
occurrence of serious harm or an adverse event (AE) is unlikely. Examples
include research involving routine questioning or history taking, observing,
obtaining body fluids, hair, saliva, urine, etc. without invasive intervention.
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15. Benefit-risk assessment
Type of risk Definition/description
Minor increase
over minimal
risk or Low risk
Increment in probability of harm or discomfort is only a little more than the minimal
risk threshold. This may present in situations such as routine research on children and
adolescents; research on persons incapable of giving consent; delaying or withholding
a proven intervention or standard of care in a control or placebo group during
randomized trials; use of minimally invasive procedures that might cause no more than
brief pain or tenderness, small bruises or scars, or very slight, temporary distress, such
as drawing a small sample of blood for testing; trying a new diagnostic technique in
pregnant and breastfeeding women, etc. Such research should have a social value. Use
of personal identifiable data in research also poses indirect risks such as social risks,
economic risk, psychological harm and discomfort.
More than
minimal risk or
High risk
Probability of harm or discomfort anticipated in the research is invasive and greater
than minimal risk. Examples include research involving any interventional study using
a drug, vaccine, device or invasive procedure such as lumbar puncture, lung or
liver biopsy, endoscopic procedure, intravenous sedation for diagnostic
procedures, etc. 15

16. Section 5. Informed Consent Process in Health Research
5.1 Requisites
5.2 Information
5.3 Comprehension
5.4 Voluntariness
5.5 Process for obtaining an Informed Consent
5.6 E-consent
5.7 Re-consent
5.8 Waiver of the Consent
5.9 Obtaining consent in Special Situations
5.10 Consent for Studies using Deception
5.11 Procedures after the Consent Process
5.12 Documentation of the Consent
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17. Section 5: Informed consent process in Health Research
• Requisites
• Essential information for research
participants
• Comprehension
• Voluntariness
• Documentation of informed consent
process
• Electronic consent
• Re-consent
• Waiver of Consent
• Special situations
• Gatekeepers
• Community consent
• Consent from vulnerable groups
• Consent for studies using deception
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18. Assent
• In addition to consent from parents/LARs, verbal/oral or written assent, as approved by the ERB, should be
obtained from children of 7–18 years of age.
Considerations for assent
• There is no need to document assent for children below 7 years of age.
• For children between 7 and 12 years, verbal/oral assent must be obtained in the presence of the parents/LAR and should be
recorded.
• For children between 12 and 18 years, written assent must be obtained. This assent form also has to be signed by the
parents/LAR.
• Adolescents may have the capacity to give consent like adults. However, as they have not attained the legal age to provide
consent, it is termed as assent and the consent of the parents/LAR should be obtained. If the latter will affect the validity of the
study, waiver of consent from the relevant adult should be taken and recorded with the approval of the ERB, for example, in
behavioral studies in IV drug users where parental consent may not be possible.
• Research involving sexual minorities and sex workers
• Research among tribal population
• Research involving individuals with mental illness or cognitively impaired/affected individuals
• Individuals who have diminished autonomy due to dependency or being under a hierarchical system
• Patients who are terminally ill
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19. Section 6. Ethical Review Process
6.1 Formation and Terms of Reference of Ethical Review Board (ERB)
6.1.1 Formation of the ERB
6.1.2 Appointment of the ERB Chair/Members and Conditions of Appointment
6.1.3 Qualification of the ERB Chair/Members
6.1.4 Dis-qualification, Resignation, Cancellation, and Renewal of the ERB Chair/Members
6.1.5 Responsibilities of Ethical Review Board
6.2 Office of the ERB Secretariat and its Functions and Responsibilities
6.2.1 Office of ERB Secretariat
6.2.2 Functions and Responsibilities of ERB Secretariat
6.2.3 Capacity building of ERB and its Secretariat
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20. Section 6. Ethical Review Process (Contd…)
6.3 Submission and Review Procedures
6.3.1 Application Submission
6.3.2 Elements of the Review Process
6.3.3 Joint Review
6.3.4 Exemption from Review
6.3.5 Expedited Review
6.3.6 Re-submitted Proposal Review
6.3.7 Review of Amendment of the Approved Proposal
6.3.8 Review of the Final Report
6.4 ERB Meetings
6.4.1 Quorum requirements for ERB
6.5 Decision Making
6.6 Communicating a Decision
6.7 Continuing Review
6.8 Site Monitoring Visit
6.9 Documentation and Archiving
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21. Section 6: Ethical review process
• Formation, and Terms of Reference for the Ethical Review Board, NHRC
• Appointment of the Ethical Review Board Chair, members and conditions of appointment
• ERB Composition, qualifications, trainings, member specific roles and responsibilities, disqualification
resignation, cancellation and renewal
• Submission and review
procedures
• List of documents
required in hand before
embarking online
proposal submission
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22. Types of Review
No Types of review
1 Exemption
from
review
Conditions:
• Research which involves accessing and analyzing data available in public
domain;
• Research on anonymous or non-identified data/samples;
• Observation of public behavior when information is recorded without any
link and disclosure of the person under observation; and
• Quality assurance and quality control audits in the institution.
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23. Types of Review
No Types of review
2 Expedited
review
Proposals that pose no more than minimal risk may undergo expedited review, for
example;
 Research involving non-identifiable specimen and human tissue from sources like
blood banks, tissue banks and left-over clinical samples;
 Research involving clinical documentation materials that are non-identifiable (data,
documents, records);
 Modification or amendment to an approved protocol including administrative changes
or correction of typographical errors and change in researcher(s);
 Revised proposals previously approved through expedited review, full review or
continuing review of approved proposals;
 Minor deviations from originally approved research causing no risk or minimal risk;
 Progress/annual reports where there is no additional risk, for example activity limited
to data analysis. Expedited review of SAEs/unexpected AEs will be conducted by SAE
subcommittee; and
 For multi-center research where a designated main ERB among the participating sites
has reviewed and approved the study, a local ERB may conduct only an expedited
review for site specific requirements in addition to the full committee common review.
 Research during emergencies and disasters
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24. No Types of review
3 Full
Board
Review
All research proposals presenting more than minimal risk that are not covered under exempt or
expedited review should be subjected to full committee review, some examples are;
 Research more than minimal risk
 Research involving vulnerable populations,
 Studies involving deception of participants (see section 5.11 for further details);
 Research proposals that have received exemption from review, or have undergone expedited
review/undergone subcommittee review should be ratified by the full committee, which has the
right to reverse/or modify any decision taken by the subcommittee or expedited committee;
 Amendments of proposals/related documents (including but not limited to informed consent
documents, investigator’s brochure, advertisements, recruitment methods, etc.) involving an
altered risk;
 Major deviations and violations in the protocol;
 Any new information that emerges during the course of the research for deciding whether or not
to terminate the study in view of the altered benefit–risk assessment;
 Research during emergencies and disasters either through an expedited review/ scheduled or
unscheduled full committee meetings. This may be decided by Member Secretary depending on
the urgency and need;
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25. Types of Review (Contd…)
• Re-submitted Proposal Review
• Review of Amendment of the Approved Proposal
• Review of the Continuing Review Report
• Review of the Protocol Deviation Report
• Review of the SAE Report
• Review of the Final Report
Joint Review
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26. Decisions by ERB
An ERB can give one of the following decisions:
• Approved – (to start the study as presented, with no changes required)
• Approve with minor modification (requiring minor changes/corrections to the item(s)
noted at the convened meeting; to be followed-up by the ERB Chair and Member
Secretary after the researcher makes changes/corrections/modifications as per the
suggestions).
• ERB can ask for the resubmission of the proposal (requiring major changes/corrections to
the items and full committee review of the materials)
• Disapprove the proposal (rejecting the study, stating the reason for disapproval).
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27. Section 7. Specific requirements for specialized research
7.1 Basic Requirements:
7.1.1 Human resources and infrastructure
7.1.2 Contract Research Organization (CRO)
7.1.3 Declaration of conflict of interest and mitigation measures
7.1.4 Insurance, Indemnity and Medical Coverage of the Participants
7.1.5 Independent Data and Safety Monitoring Board (DSMB)
7.1.6 Trial Steering Committee
7.1.7 Community Engagement
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28. 7.2. Clinical Trials of Investigational Products (Drugs, Vaccines, Devices and other
Investigational Products in Traditional Medicine)
7.2.1 Clinical Trial involving Vulnerable Participants
7.2.2 Clinical Trial Involving Devices/Instruments/Implants
7.2.3 Surgical Intervention/Trial
7.2.4 Community trials
7.2.5 Traditional and Complementary Medicine Clinical Trials
7.2.6 Research in an Area of Synthetic Biology
7.2.7 Research in an Area of Radioactive Materials including X-rays
7.2.8 Research for Bioavailability and Bioequivalence Study
28
Section 7. Specific requirements for specialized research (Contd…)

29. 7.3 Public Health Research
7.4 Implementation Research
7.5 Socio-behavioral Research
7.6 Research on Molecular Genetics
7.7 Molecular Testing on Biological and Environmental Samples related to Human
Health
7.8 Research in Humanitarian Emergencies and Disasters Situations
7.9 Stem Cell Research for Health
7.10 Use of Animals in Research for Health
29
Section 7. Specific requirements for specialized research (Contd…)

30. Section 8. Establishment of the Institutional Review Committees
8.1 Establishment and Functions of Institutional Review Committees (IRCs)
8.1.1 Renewal of Institutional Review Committees
8.1.2 Withdrawal of Institutional Review Committees
8.2 Networking and Regulation of Institutional Review Committees
30

31. Checklist for IRC Establishment
• Evidence of at least 10 health related researches in the year
• Cover letter clearly marking the list of the IRC Member(Gender, discipline, age balanced, affiliated / non-affiliated )
with designated IRC chair and member secretary along with their educational background and position in IRC
• Attached CV ( Consist of at least 7-15 members of sufficiently diverse backgrounds)
• Separate IRC office with administrative requirements
• Documentation and Archiving
• Commitment letter from the head of institute to run the IRC with provision of Dedicated HR, separate Office and
Logistic support
• Standard Operating Procedure based on IRC guidelines published by NHRC
• Declaration of Conflict of Interest declaration form, Commitment letter and Appointment letter to the IRC member
• Academic Institute
• Number of Approved research in Last One year
• Fund allocation for research activities & Capacity Building list of Published Article (IRC Chair/Member secretary) 1st
Author Corresponding Author Co-Author, IRC Chair (Fulltime faculty member)
• Inspection visit by ERB (If fulfill all the requirements having with good coordination between IRC & Institution and
positive environment of research culture
• Processing fee for Rs.20,000 for first time and during renewal Rs. 5000. 31

32. Do’s and Don’ts for IRCs
Do’s
• Proposal having less than minimal and
minimal risk that are self-funded by the
student, faculty and staff of same institute
(non commercial and national funding of
up to two lakhs)
• Single centered study/thesis submitted by
the students from any university of Nepal (
i.e. bachelor and master's)
• Single centered study submitted by another
institute faculty having less than minimal
and minimal risk can be reviewed, if there is
an academic collaboration.
Don’ts
• Research proposals in high risk
category (clinical trial involving
human)
• Externally sponsored/funded
multicentric studies at national and
international level (the term "externally
indicates sponsored from outside the
country")
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33. Special instructions to IRCs
• Research proposals (for the studies to be conducted in Nepal), reviewed and
approved by the ERB, do not require further review and approval or processing
fees from any IRC in the country. However, for multi-centric studies, IRCs must
send their recommendation to ERB for approval. For multi-centric studies, ERB
should also organize joint review.
• Institution may charge certain fees for the purpose of research promotion or
institutional support in case of collaborative studies
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