Pokhara University

Pokhara University Research Centre (PURC)

Institutional Review Committee (IRC)
Lekhnath-12, Kaski, Nepal
E-mail: [email protected], Website: http://www.pu.edu.np

Ethical Approval Research Proposal Format

Research Title:

For Official Use Only

(Please see the check list before Registration of the application form)
Registration No.:
Registration Date:
Approved Date:
Name of PI:
Total Budget of the Project:
IRC Processing Fee:
Research Site:
Tentative Date of Initiating the Project:
Duration of the Research Project:
Name of Internal Reviewer:
Name of External Reviewer:
Signature & Seal of IRC:
Passport size
IRC/ETHICAL-RES/PROP/Approval
Part – I photograph

Administrative Information
1. Research Title: ……………………………………………………………………………
………………………………………………………………………………………………
Name and Title of Principal Investigator responsible for the proposed research:
……… …………………………………………………………………….
Last (Surname) Middle (if any) First name
Nationality: ……………………………………….
Citizenship Number & place of issue (only for Nepali): …………………………………
Passport Number & country (only for non Nepali citizen):
………………………………..
Signature: …………………………. Date: ………………………………….
Telephone No./ Mobile No.: ……………………………Email…………………………….
Full name of the Institution associated with the Principal Investigator (if applicable) :
…………………………………………. Designation:……………………………
Telephone No.: ........................................... Website:……………………………….
2. Declaration of the head of the Institution (if applicable)
If the proposed research is approved, we will allow him/her to conduct the research.
Signature: ………………………….. Date: …………………………………..
………………………………………………………………………..
Last (Surname) Middle (if any) First name
Designation: ………………………………………………………………………..
Name of the Institution ……………………………………………………………..
Contact/Postal Address: ……………………………………………………………..
Telephone No.: ………………………………………………………………………
Institutional e-mail: …………………………………………………………………..
Website:……………………………………………………………………………….
3. Name and Title of Co-investigators responsible for the proposed research (Use the similar
format if more than one):
………………………………………………………………………
Last (Surname) Middle (if any) First name
Nationality: …………………………………………………………..

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IRC/ETHICAL-RES/PROP/Approval
Citizenship Number with district name (only for Nepali) …………………………………
Passport Number (only for non Nepali citizen): …………………………………………..
Affiliated Institution (if applicable):
Designation: ………………………………………………….
Signature: ………………………………. Date: ……………………………………….
Telephone No.: ..................................................................
E-mail: ...............................................................
(Use additional sheet if necessary)
4. List the name(s) and institutional affiliation to the researcher(s) (other than co-
investigator) to assist your project in Nepal and abroad (if any)
Name Institution and Address
(a) ……………………………………………………………………………………
(b) ……………………………………………………………………………………
(Use additional sheet if necessary)
5. List the name(s) of Nepali researcher(s) (other than co-investigator) or Nepalese
Institution/hospital/NGO(s) etc. from whom you may seek co-operation (if any)
(a) ……………………………………………………………………………………….
(b) …………………………………………………………………………..
(Use additional sheet if necessary)
7. List major equipment(s) in relation to your research project you plan to bring/import to
Nepal (if applicable)
(a) ……………………………………………………………………………………….
(Use additional sheet if necessary)
7.1 List details of all specimen(s) (if any) that you may transport from Nepal in relation to
your research.
(a) ……………………………………………………………………………………..
7.2 Country of Destination: …………………………………………………………..
Name of Institution: ……………………………………………………………….
7.2 Mode of Transportation of Specimen:……………………………………………..
7.3 Is this research part of your Thesis? Yes……….. No ………
If yes, mention the degree and subject/program.................................................................
Name of the university …………………………………………………………….
Name of the country………………………………………………………

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IRC/ETHICAL-RES/PROP/Approval

Part – II
Financial Information
8 Research Title:
……………………………………………………………………………………………
9 Name of the funding organization:
………………………………………………………………………………………………
………………………………………………………………………………………….
Contact information of funding organization or agency:
Postal Address: …………………………………………………………………………

Telephone No.: ……………………………………………………………………..

Fax No.: …………………………………..E-mail: …………………………..

Contact person at the funding organization or agency:

………………………………………………………………………………………..
Last (Surname) Middle (if any) First name
Designation: ………………………………………………………

Total amount of funds (in NRs / US $) allocated for the proposed research project:
…………………………………………………………………..
Itemized budget (in detail) and justify the resources required for the proposed research
work (use additional sheet)

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IRC/ETHICAL-RES/PROP/Approval
Part – III
Research Proposal Description
10 Research Title:
…………………………………………………………………………………
…………………………………………………………………………………
11 Proposal Summary (maximum 500 words):

12 Introduction:
12.1 Background of Study (maximum 500 words):

12.2 Statement of the Problem and Rationale / Justification (maximum 500 words)

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IRC/ETHICAL-RES/PROP/Approval
13 Research Objectives / purpose / aim of the study:
General

Specific

14 Research Design and Methodology

Research Method
Qualitative Quantitative Mixed
Study Variables:

Type of Study (Specify):

Study Population, Site and Its Justification:

Study Unit:

Sampling Methods / Techniques (Specify):

Sample size (with justification):

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IRC/ETHICAL-RES/PROP/Approval
Data Collection Technique / Methods (Specify):

Data Collection Tools: (please attached in annex)

Validity and Reliability of the Study Tools:

Limitation of the Study:

15 Plan for Data Management and Analysis:

16 Plan for Dissemination of Research Results:

17 Work Plan (should include duration of study, tentative date of starting the project and
work schedule / Gantt chart):

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IRC/ETHICAL-RES/PROP/Approval
Part – IV
Ethical Consideration

18. Regarding the research participants:

Are research participants required in this research? Yes No

If yes, mention the type of participants: ……………………… (e.g. Human, Animal, etc)

How many participants are required for the research? Explain.

…………………………………………………………………………………
………………………………………………………………………………..

Clearly indicate the participant's responsibilities (if any) in the research. What is expected
of the research participants during the research?
………………………………………………………………………………………………
………………………………………………………………………………………………
Are vulnerable members of the population required for this research? If yes, provide
justification.
………………………………………………………………………………………………
………………………………………………………………………………………………
………………………………………………………………………………………………
Are there any risks involved for the participants? If yes, identify clearly what are the
expected risks for the human participants in the research and provide a justification for
these risks.

…………………………………………………………………………………
…………………………………………………………………………………
…………………………………………………………………………………
Are there any benefits involved for the participants? If yes, identify clearly what are the
expected benefits for the participants.

…………………………………………………………………………………
…………………………………………………………………………………
…………………………………………………………………………………

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IRC/ETHICAL-RES/PROP/Approval
19. Informed Consent Form / Ethical Issues:

Statements required in the Informed Consent Form include:

A statement that the human participants can withdraw from the study at any time without
giving reason and without fear. State clearly how the participants can opt out the study.

A statement guaranteeing the confidentiality of the research participants.

If required, a statement on any compensation that might be given to the research
participant and or their community.

A statement indicating that the participant has understood all the information in the consent
form and is willing to volunteer / participate in the research.

Signature space for the research participants, a witness, and the date.

(Informed Consent form should be submitted in English and in the language appropriate to
the research participants)

Obtaining the Consent

How informed consent is obtained from the research participants?

Verbal Written

Please indicate who is responsible for obtaining informed consent from the participants in this
research study?
…………………………………………..………………………………

Is there anything being withheld from the research participants at the time the informed
consent is being sought?
If yes, explain……………………………………………………………………………

Is the research sensitive to the Nepali culture and the social values?
Yes No Explain.
……………………………………………………………………………

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IRC/ETHICAL-RES/PROP/Approval

20. Regarding Clinical Trial:

In case of a clinical trial address the following:

The trial treatment
……………………………………………………………………………

A detailed explanation of the trial procedures including all invasive procedures.

……………………………………………………………………………

The potential or direct benefits (if any) for the research participants.
……………………………………………………………………………

Alternative procedure(s) or treatment(s) that may be available.

……………………………………………………………………………

The risks, discomforts, and inconveniences associated with the study

……………………………………………………………………………

Provisions for management of any adverse reactions

……………………………………………………………………………

The provisions of insurance coverage for any permanent disability or death caused
directly by the investigational treatment or procedure.
……………………………………………………………………………

The provision of including the name and address, including telephone numbers of person
to be contacted in case of adverse events or for any information related to the trial.
……………………………………………………………………………

Is there going to be a transfer of any biological materials from the country? Explain.

Is this trail internationally registered?

……………………………………..

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IRC/ETHICAL-RES/PROP/Approval
Part – V

ACCEPTANCE OF GENERAL CONDITIONS AND DECLARATION

BY THE PRINCIPAL INVESTIGATOR

I hereby certify that the above mentioned statements are true, I have read and understood the
regulation of the Institutional Review Committee (IRC) on the approval of research proposal
and will act in conformity with the said regulation in all respects.

If the research is terminated, for any reason, I will notify IRC of this decision and provide the
reasons for such actions. I will provide IRC with a written notice upon the completion of the
research as well as a final summary/full report of the research study. If I publish the results in
a journal, I shall acknowledge the IRC and submit at least one copy of any such articles to
IRC.

…………………………
Signature of Applicant Date:…………………

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