What is Ethical Approval & How to Get One in Nepal?

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As a young researcher or an undergraduate students, you may wonder how to initiate research or complete your thesis.Research of social sciences and health sciences involves human participant so a ethical approval is needed . In this section, we will cover all the aspects of ethical approval , process , fee / charges and steps for obtaining one for your research.

 

What is An Ethical Approval?

Ethical approval is an integral part of the research process that  aims to protect both researchers and participants in research Participants should have enough details to make informed, autonomous decisions in research.  Research involving human participant must be regulated so that it’s impact could be controlled. Through the ethics review process, research that is not scientifically and ethically sound will not be approved. The NHRC has developed the National Ethical Guidelines for Health Research in Nepal and formed Ethical Review Board (ERB) to regulate research conduct in Nepal.

 

How to get an Ethical Approval in a Nepal?

Whether you are a student or a young researcher, it is unlikely for you to encounter a name ” Nepal Health Research Council “. Nepal Health Research council established in 1998 is the apex body that controls, moderate, regulate and monitor all the research activities and planning in Nepal.

The Nepal Health Research Council is a national apical body responsible for providing scientific study and quality health research in the country with the highest level of ethical standards. It started as a Nepal Health Research Committee under the Ministry of Health, chaired by the Secretary of Health in 1982 AD (BS 2039). On 11 April 1991 (29 Chaitra 2047 BS), the committee was developed as the Nepal Health Research Council (NHRC), a statutory and autonomous body as promulgated by the Nepal Health Research Council Act No. 129 of the year 1991 of Government of Nepal. With the consent of the Council of Ministers under Article 129 of the constitution of the Government of Nepal, 1990 enacted the NHRC.

 

Ethical Review Process

Ethical Review Process is initiated as the researcher submits his/her research proposals via online. NHRC have updated their system and accepts only online submissions.

Processing Charge

NHRC charges certain percentage of the total budget of the research. Processing fee also depends upon the type of research, nationality of Principal Investigator,

Processing Charge is as follows:

• For Nepalese students studying inside Nepal (Thesis) – Self Funded : Rs: 1000
• For Nepalese students studying outside Nepal (Thesis) – Self Funded : Rs. 10,000.00
• For Nepalese Researchers – For proposals with budget below Rs. 2,00,000 (<$2,000): Rs. 5,000 ($50)
• For proposals with budget between Rs. 2,00,000 ($2,000) to Rs. 10,00,000 (<$10,000) : 10,000 ($100)
• For international students (Thesis), international researchers and international researchers involvement in any health researches with budget up to $10,000: $00
• For proposals with budget upto $5,00,000 for national and international researchers : 3% of total budget
• For proposals with budget upto $10,00,000 for national and international researchers: For first ($5,00,000) 3% of total budget For second ($5,00,000 – $10,00,000) 5% of the total budget (additional)
• For proposals with budget above ($10,00,000) for national and international researchers : 1% of the total budget (additional)

What should you include in Proposal?

1. Curriculum Vitae of Principal Investigator, Co-Principal Investigator and other team members in pdf format or Word format.
2. Photos of Principal Investigator and Co-Principal Investigator and other team members in jpg format.
3. Scanned Signature of Principal Investigator and Co-Principal Investigator and other team members in jpg format
4. If the Principal Investigator is a non Nepali citizen, one principal Investigator should be a Nepali citizen who is related to that research
5. Data collection tools should be in Nepali and local language (if necessary)including interviews and Focused Group Discussion guideline, observation checklist, questionnaires etc
6. Consent form should be in Nepali and local language(if necessary)
7. Conceptual framework, If applicable
8. If the research study is to be conducted in a hospital/organization or institution a letter of acceptance from the related hospital/organization or institution should be provided
9. The Proposal should have Institutional ethical clearance from his/her own country if submitted from academic and related institution
10. work plan with clearly mentioning month and year
11. List of abbreviations /acronyms
12. References
13. Agreement letter with donor, if it is a funded study.

• When the research involves a study product (such as pharmaceutical or device under investigation), an adequate summary of all safety, pharmacological, pharmaceutical and toxicological data available on the study product, together with a summary of clinical experiences with the study product to date(e.g recent investigator’s brochure, published data, summary of product’s characteristics).
• For clinical trial of new drug or medical product, approval letter from Department of Drug Administration

 

 

Does NHRC only provide ethical approval in Nepal?

Beside from NHRC, various IRC’s (Institutional Review Committee) has been established throughout the countries to supervise and moderate the internal research of students and teachers. A total of 52 Institutional Review Committee are established on various institution all over the country. However, a limited power is vested to these IRC’s. IRC’s cannot provide ethical approval to national and international researches, research funded by external parties and research involving clinical trials.

 

A section of All IRC’s in Nepal

 

Ethical Approval Certificate

Note : Certain details of Ethical certificate have been removed/blurred to maintain research integrity and prevent misuse

 

After the ethical review of research proposal has been completed, a certificate will be provided from NHRC stating all the decisions and all the rules that researchers have to abide during research.