National Ethical Guideline For Health Research In Nepal 2022
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 3. Roles and Responsibilities of the Researchers/Investigators (NHRC) 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 4.1.2 Research Involving Children 4.1.3 Research Involving Pregnant & Lactating Women 4.1.4 Research on Sexual Minorities & Sex Workers 4.1.5 Research on Tribal & Indigenous Populations 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 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 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 Responsibilities of ERB Submission and Review Procedures Continuing Oversight Section 7: Specific Requirements for Specialized Research This section outlines additional guidelines for specialized types of research: Key Requirements Clinical Trials Emerging Areas of Research Section 8: Establishment of Institutional Review Committees (IRCs) of NHRC This section focuses on setting up IRCs at institutional levels: Formation of IRCs Roles and Responsibilities Capacity Building 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 Download Guideline pdf : Ethical-guideline-for-health-research-in-Nepal-2022.pdf अनुसूची २ : Download Downlod Other Guideline Links :https://bishtnabin.com.np/plans/