Table of Contents
The NHRC developed the “National Ethical Guidelines for Health Research in Nepal 2022” to ensure ethical practices in health research involving human participants. These guidelines are for researchers, reviewers, sponsors, and regulatory authorities. They build on earlier versions from 1995, 2001, 2011, and 2019. The NHRC has organized workshops to educate researchers on ethical standards and address compliance issues. The 2022 guidelines focus on new ethical concerns, such as the informed consent process, the creation of Institutional Review Committees (IRCs), and issues in emerging research areas like public health emergencies and biobanking. Overall, these guidelines represent an important step forward in managing health research ethically, protecting participants’ rights and welfare while supporting valuable research.
2. Ethical Principles of Health research in Nepal
2.1 Basic Ethical Principles
2.2 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 Benefit Maximization
- Principle of Professional Competence
- Principle of Institutional arrangements
- Principle of transparency and accountability
- Principle of the totality of responsibility
- Principle of environmental protection
- Principle of dissemination of research findings
3. Roles and Responsibilities of the Researchers/Investigators (NHRC)
- Researchers are individuals or groups who plan and conduct studies, with a Principal Investigator leading the team and taking full responsibility.
- Co-Investigators assist but do not have full authority; all share the duty to protect participants’ rights and ensure data credibility.
- Investigators must be qualified through education and experience, and provide proof of their qualifications.
- They need to ensure enough resources, including staff and facilities, are available for the study.
- Medical care for participants must be managed by a qualified health worker, ensuring they receive care for any health issues.
- Investigators must communicate with the Ethics Review Board (ERB) for proposal development and ethical approvals.
- They must follow the approved study protocol and submit any changes to the ERB for approval.
- For studies with investigational products, investigators must keep track of these products and ensure they are used correctly.
- Informed consent from participants is crucial, and investigators must follow regulations for obtaining it.
- They should maintain accurate study records and keep them safe for at least five years after the study ends.
- Investigators must report study progress and any serious adverse events to the ERB and sponsor promptly.
- All study-related documents must be submitted on time, and investigators are accountable for their content.
4. Ethical Issues in Health Research
• Ensuring participant safety, especially vulnerable groups.
• Assessing risks and benefits.
• Maintaining transparency, privacy, and confidentiality.
• Managing conflicts of interest (CoI).
• Fair benefit-sharing.
4.1 Research Involving Vulnerable Populations
- Vulnerable individuals may lack autonomy, decision-making ability, or be socially/economically disadvantaged.
- Categories include:
- Social status: Refugees, immigrants, sex workers, prisoners, LGBTQ+, students, etc.
- Physical/Mental condition: Children, elderly, pregnant women, mentally ill, terminally ill, disaster victims, etc.
- Ethical safeguards:
- Justification for inclusion.
- Risk-benefit assessment.
- Ensuring voluntary participation and informed consent.
- Addressing CoI between participants and legal representatives.
- Providing necessary medical and social support.
4.1.2 Research Involving Children
- Only justified when adult studies are insufficient.
- Requires parental or legal guardian consent, plus child assent when possible.
- Conditions for inclusion:
- Pediatric-specific diseases.
- Unique physiological responses in children.
- Drug testing for pediatric safety.
4.1.3 Research Involving Pregnant & Lactating Women
- Only justified if necessary for maternal health.
- Requires informed consent, cultural sensitivity, and reproductive risk awareness.
- Must allow withdrawal from trials if desired.
4.1.4 Research on Sexual Minorities & Sex Workers
- Research must protect against stigma, discrimination, and confidentiality risks.
- Outcomes should not reinforce negative biases.
4.1.5 Research on Tribal & Indigenous Populations
- Justified if beneficial for their health.
- Community engagement and consent required, especially for knowledge commercialization.
4.1.6 Research on Individuals with Mental Illness or Cognitive Impairment
• Permitted if directly related to their condition.
• If they pose harm to themselves/others, confidentiality may be breached for safety.
4.1.7 Research on Hierarchical Groups (Prisoners, Military, Employees, etc.)
• Participation must be voluntary, with no coercion or penalties for withdrawal.
4.1.8 Research on Terminally Ill Persons
- Special consent procedures needed.
- Extra monitoring for adverse effects.
- Post-trial access to beneficial treatments should be reviewed.
- This section emphasizes safeguarding participants’ rights, ensuring ethical conduct, and minimizing risks in health research.
5. Informed Consent Process in Health Research
Requisites
The informed consent process must include information, comprehension, and voluntariness
Information
Researchers must provide all necessary information to potential participants.
Comprehension
Researchers must ensure participants understand the information provide.
Voluntariness
Participation must be voluntary and free from coercion
Obtaining Informed Consent
- Explain the study’s purpose, procedures, risks, and benefits
- Allow time for questions and decision-making
- Obtain consent in the participant’s preferred language
- Use simple, non-technical language
- Provide a copy of the signed consent form to the participant]
E-consent
Electronic consent is acceptable if it meets certain criteria.
Re-consent
Re-consent is required in specific situations, such as protocol changes or new information affecting participation.
Waiver of Consent
Consent may be waived in certain circumstances, such as minimal risk studies or when consent is impractical].
Special Situations
Special considerations apply for obtaining consent from vulnerable populations or in emergency research.
Deception Studies
Specific procedures are outlined for studies involving deception
Post-consent Procedures
Researchers must ensure ongoing consent and provide relevant new information to participants
Documentation
Proper documentation of the consent process is required
This section emphasizes the importance of a thorough, ethical, and well-documented informed consent process in health research, ensuring participants’ rights and welfare are protected.
Section 6: Ethical Review Process by NHRC
This section describes the formation, roles, and responsibilities of the Ethical Review Board (ERB) and its processes:
Formation and Composition of ERB
- The ERB is formed to ensure ethical oversight in health research.
- Members include experts from diverse fields, appointed based on qualifications and experience1.
Responsibilities of ERB
- Review research proposals for ethical compliance.
- Monitor ongoing research and ensure adherence to ethical standards.
- Address potential conflicts of interest1.
Submission and Review Procedures
- Proposals must be submitted with detailed documentation.
- Reviews can be exempted, expedited, or conducted through full board meetings depending on the study’s nature.
- Amendments to approved proposals and final reports are also reviewed1.
Continuing Oversight
- ERB conducts periodic reviews, site visits, and monitors compliance throughout the research lifecycle1.
Section 7: Specific Requirements for Specialized Research
This section outlines additional guidelines for specialized types of research:
Key Requirements
- Adequate human resources, infrastructure, and insurance coverage for participants are mandatory.
- Conflict of interest must be declared and mitigated1.
Clinical Trials
- Covers trials involving drugs, vaccines, devices, surgical interventions, and traditional medicine.
- Special considerations are required for trials involving vulnerable populations or high-risk interventions1.
Emerging Areas of Research
- Includes guidelines for synthetic biology, radioactive materials, bioavailability/bioequivalence studies, and public health research.
- Community engagement is emphasized in community trials1.
Section 8: Establishment of Institutional Review Committees (IRCs) of NHRC
This section focuses on setting up IRCs at institutional levels:
Formation of IRCs
- Institutions conducting health research must establish IRCs to oversee ethical compliance locally.
- IRCs function under NHRC guidelines but operate independently within their institutions1.
Roles and Responsibilities
- IRCs review proposals from their institutions, ensuring alignment with ethical standards.
- They monitor research activities and provide feedback to researchers1.
Capacity Building
- Regular training is encouraged to enhance the expertise of IRC members in reviewing specialized research proposals1.
These sections collectively emphasize a robust ethical framework for health research in Nepal, ensuring participant safety and adherence to international standards.
Links :
NHRC : https://nhrc.gov.np
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