Ethical approval from Nepal Health Research Council

In the realm of advancing healthcare and wellness, research stands as the bedrock upon which innovation and progress are built. Recognizing this, Nepal established the Nepal Health Research Council (NHRC) with a distinct mission to promote and regulate health-related research within the country. In this blog, we delve into the core functions, objectives, and ethical review process of the NHRC, shedding light on its pivotal role in shaping the landscape of health research in Nepal.

Empowering Responsible Research

The NHRC, an institution of paramount significance, was founded with a clear mandate - to oversee and guide the responsible conduct of health research across Nepal. Through rigorous ethics review, the council ensures that research initiatives not only align with scientific rigor but also uphold the highest ethical standards. This screening process, conducted by the Ethical Review Board (ERB), serves as a crucial filter, allowing only scientifically and ethically robust research to proceed.

A Triad of Objectives

The NHRC's objectives are intricately woven to meet the evolving needs of Nepal's health landscape:

• Exploration and Understanding: The council commits itself to studying prevailing health challenges and prospective issues. This includes research on ongoing and anticipated health problems, laying the groundwork for informed policy decisions.
• Consultancy and Information: NHRC pioneers programs aimed at providing consultation services and disseminating information. By enhancing the utility of health-related research, the council catalyzes informed decision-making within Nepal's healthcare sphere.
• Evidence-Based Policy: As a vanguard of health-related evidence, the NHRC not only accumulates global and national data but also liaises with the Government of Nepal to drive evidence-based policies and strategic planning.

Functions

The NHRC's operational framework encompasses diverse functions, including:

• Conducting research in alignment with the priorities outlined in Nepal's National Health Policy.
• Enabling a policy framework for the promotion, regulation, and utilization of health research.
• Identifying health research needs and establishing research priorities.
• Monitoring and evaluating health-related research endeavors, offering recommendations as needed.
• Sharing research outcomes at national and international levels to foster collaboration and growth.
• Collaborating with foreign researchers and institutions to expand research capabilities.
• Facilitating global information exchange to support Nepal's healthcare advancements.

Ethics: The Pillar of Review

The NHRC's Ethics Review Process rests on multiple pillars:

• Technical Review: Proposals undergo meticulous screening for completeness and scientific merit. External experts then review the proposal's scientific and technical content.
• Communication and Response: Feedback from reviewers is communicated to researchers, who must address the comments.
• Ethical Review: Proposals deemed scientifically sound are presented to the Ethical Review Board (ERB) for ethical deliberation.
• Decision Making: ERB strives for consensus-based approvals. Conditional approvals may carry suggestions, while disapprovals necessitate clear justifications.
• Decision Communication: The ERB's decision is conveyed in writing to researchers within two weeks of the meeting.
• Ongoing Oversight: ERB monitors approved studies from initiation to conclusion.

The Ethical Review Board (ERB) cannot possibly review and monitor all research being conducted in the country. Thus, the ERB has delegated its power to Institutional Review Committees (IRCs) established at health care facilities, academic institutions and research institutions throughout Nepal.

Every IRC team is multidisciplinary, having at least one female member and one external member not affiliated with the institution. IRCs hold regular meetings and submit semiannual progress reports to the NHRC. The NHRC has developed guidelines for the Institutional Review Committees for health research in Nepal. The guidelines regulate the conduct and define the operating procedures of the IRCs. An IRC is authorized to provide ethics clearance to research proposals from researchers from within the institution associated with a specific IRC, but are not authorized to provide approval to the following research proposals:

• Research proposed intended for studies at the national or international level
• Externally sponsored/funded research (the term “externally” indicates not only outside of the country but also outside of the particular health care facility or institution)
• Clinical trials involving human and/or animal participants.

Ethical review process of NHRC 

NHRC Approval Processing Fee 

(Effective from 07 March 2018 (2074-11-23)

A) For Nepalese student studying inside Nepal (Thesis) -Self funded: 

NRs. 1,000

B) For Nepalese student studying outside Nepal (Thesis) -Self funded:  

NRs. 10,000

C) For Nepalese Researchers- For proposals with budget below NRs. 2,00,000 (<$2,000):

NRs. 5,000 ($50)

D) For proposals with budget between 2,00,000 (%2000) to Nrs. 10,00,000 ($10000): 

NRs. 10,000($100)

E) For international students (Thesis), international researchers and international researcher involvement in any health researches with budget up to $10,000: 

 $200

F)For proposal with budget upto $500000 for national and international researcher:

First first $5,00,000) 3%of total budget.

For second (5,00,000-10,00,000) 1.5% of the total budget

G) For proposal with budget upto $10,00,000 for national and international researcher:

First first $5,00,000) 3%of total budget.

For second (50,00,00-10,00,000) 1.5% of the total budget.

For third above ($10,00,000) 1% of the total budget (additional) 

[These fee structures contribute to the sustainable operation of NHRC and support its critical role in overseeing ethical health research in Nepal.]

Online system for Ethical approval 

You can go to link : https://erb.nhrc.gov.np/ for submission of ethical approval.

Approved list of Researches

To see the approved list of research that are  approved by NHRC can be visualized from the portal: https://nhrc.gov.np/ethics/irc/

Key Inclusions for a Comprehensive Research Proposal

Crafting a compelling research proposal requires meticulous attention to detail. Here's a rundown of essential components to ensure your proposal is well-rounded and comprehensive:

1. Research Team Information:

Include Curriculum Vitae (CV) of the Principal Investigator, Co-Principal Investigator, and other team members. Formats accepted are PDF or Word. Alongside, attach photos of team members in JPG format and scanned signatures of the Principal Investigator and Co-Principal Investigator.

2. Principal Investigator's Nationality:

For non-Nepali Principal Investigators, ensure there's a Nepali citizen on the team, related to the research, as co-investigator.

3. Data Collection Tools:

Provide data collection tools in Nepali and local languages, if applicable. This includes interview and Focused Group Discussion guidelines, observation checklists, questionnaires, and more.

4. Consent Forms:

Incorporate consent forms in both Nepali and local languages, as needed, ensuring ethical considerations are covered.

5. Conceptual Framework (If Relevant):

If your research lends itself to a conceptual framework, include it to provide a structural overview.

6. Acceptance from Affiliated Institutions:

If your study is conducted within a hospital, organization, or institution, attach an acceptance letter from the relevant entity.

7. Institutional Ethical Clearance:

Proposals from academic and related institutions should possess institutional ethical clearance from their home country.

8. Work Plan:

Lay out a detailed work plan, clearly delineating the timeline by months and years, ensuring a systematic approach.

9. Abbreviations/Acronyms:

For clarity, present a list of abbreviations or acronyms used throughout the proposal.

10. References:

Cite sources and references to give your proposal a solid foundation of existing knowledge.

11. Donor Agreement (If Applicable):

If your study is funded, include an agreement letter with the donor to outline the terms of funding.