Institutional Review Committee (IRC)

Nobel College
Pokhara University
Sinamangal, Kathmandu, Nepal

Research Proposal Approval 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:
 Approval Form IRC NOBEL COLLEGE

Part – I
Photo
Administrative Information

1. Research Title:

2. Name and Title of Principal Investigator responsible for the proposed research:

Last (Surname) Middle (if any) First name

Nationality:
Citizenship Number with district name from where it was obtained (only for
Nepali)
Passport Number (only for non Nepali citizen):
Signature: Date:

Postal Address:
Telephone No.:
Mobile No.:

Fax No.:
e-mail:
Alternate e-mail:
3. Full name of the Institution associated with the Principal Investigator (if
applicable) :
Designation:
Postal Address (if different from the address given above):

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Telephone No.:
Fax No.:
e-mail:
Website:
4. Declaration of the head of the Institution (if applicable)
If the proposed research is approved, we will allow him/her to conduct the research
in this institution.
Signature: Date:

Last (Surname) Middle (if any) First name

Designation:
Name of the Institution
Contact/Postal Address:
Telephone No.:
Fax No.:
Institutional e-mail:
Website:
5. Name and Title of Co-investigators responsible for the proposed research (Use the
similar format if more than one): Passport size
photograph

Last (Surname) Middle (if any) First name

Nationality:
Citizenship Number with district name from where it was obtained (only for
Nepali)
Passport Number (only for non Nepali citizen):
Affiliated Institution (if applicable):
Designation:
Signature: Date:

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Postal Address (if different from the address given above):

Telephone No.:
Fax No.:

e-mail:

(Use additional sheet if necessary)

6. 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)

7. 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)

8. Is this research part of your Thesis?

Yes No
If yes,
For what degree and in which subject?
From which university?
From which country?

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Part – II
Financial Information
9. Research Title:

10. 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)

Part – III

Research Proposal Description

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11. Research Title:

12. Proposal Summary (maximum 500 words):

Background:

Methodology:

Expected Outcome:

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13. Introduction:
13.1 Background of Study (maximum 500 words):

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

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13.3 Conceptual framework

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13.4 Research Objectives / purpose / aim of the study:

General

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Specific

14. Research Design and Methodology

Research Method
Qualitative  Quantitative Combined
Study Variables:
Independent Variable:

Dependent Variable:

Type of Study (Specify):

Study Site and Its Justification:

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Study site:

Justification:

Study Population (Specify):

Study Unit:

Sampling Methods / Techniques (Specify):

Sample size (with justification):

Criteria for Sample Selection:

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Inclusion criteria

Exclusion criteria

Data Collection Technique / Methods (Specify):

Data Collection Tools: (please attached in annex)

Pre-testing the Data Collection Tools (if applicable):

Validity and Reliability of the Study Tools:

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Potential Biases (if applicable):

Limitation of the Study:

15. Plan for Supervision and Monitoring:

.

16. Plan for Data Management and Analysis:

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17. Expected Outcome of the Research:

18. Plan for Dissemination of Research Results:

19. Plan for Utilization of the Research Findings (optional):

How is the research project going to strengthen the research capability of the host
institution: Nepali Researcher (if submitted from abroad):

20. Work Plan (should include duration of study, tentative date of starting the project
and work schedule / Gantt chart):
Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 Apr-23 May-23
S
. Respon
N sible
. Activities Person 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
A Conceptu Resea

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al Phase rcher
Problem
Resea
Identificati
rcher
1 on
Literature Resea
2 Review rcher
Topic
finalizatio
Resea
n and
rcher
presentatio
3 n
Identified Resea
4 Variable rcher
Develop
Conceptua
Resea
l
rcher
Framewor
5 k
Methodolo Resea
6 gy rcher

Develop Resea
7 tools rcher

Internal Resea
Proposal rcher
8 Defense
Proposal
Resea
share with
rcher
B Donor
Share Resea
9 proposal rcher
Request
for
Resea
donation /
rcher
1 investment
0 in research
Proposal
presentatio Resea
1 n with rcher
1 Donor
C Enum
Empirical muret
Phase or/
Super
visors/

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Resea
rcher
Enum
muret
or/
Data
Super
Collection
visors/
1 Resea
2 rcher
Enum
muret
Data or/
Preparatio Super
n visors/
1 Resea
3 rcher
Statist
ician/
Enum
muret
Analytical
or/
Phase
Super
visors/
Resea
D rcher
Statist
ician/
Enum
muret
Data
or/
Analysis
Super
visors/
1 Resea
4 rcher
Statist
ician/
Enum
Interpretati muret
on of or/
results Super
visors/
1 Resea
5 rcher
Dissemina Resea
E tion Phase rcher
1 Report Resea

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Presentatio
rcher
6 n

1 Internal Resea
7 Defense rcher

Correction
by Resea
1 incorporat
rcher
8 e feedback

1 External Resea
9 Defense rcher

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Part – IV
Ethical Consideration
22. Regarding the human participants:
Are human participants required in this research? If yes, provide justification.

Yes (provide justification) No

How many participants are required for the research? Explain.

What is the frequency of the participant’s involvement in the research? Explain.

Clearly indicate the participant's responsibilities 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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23. 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 participants 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?
Data enumerator will be 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?
No-
-If yes, explain
……………………………………………………………………………

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

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……………………………………………………………………………
Is health insurance (if applicable) being made available to the research
participants? If yes, please provide the necessary insurance data.
……………………………………………………………………………
(Include in consent form)

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 Nepal Health Research Council (NHRC), 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 Nobel College 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
shall provide the Council with three copies of any such articles.

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

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INFORMED CONSENT:

􀂃Describe the manner in which informed consent will be obtained.

􀂃Indicate what kind of consent (e.g. parental, child, adult, etc) will be used.

􀂃If the subjects are children/adolescents ages 7-18 years, an Assent Form must be included
with the IRB application. The signed Assent Form along with the Parental/Guardian
Consent Form must be retained on file for at least three years after completion of the
research project.

􀂃If prisoners / pregnant women, or fetuses are to be included in the research sample, it is
likely that a full IRB review will be required and additional human subjects' protections
will be expected.

􀂃If the subjects do not read or comprehend English, you must provide a consent form in their
language as well as in English for IRC review and approval.

􀂃If you are requesting a waiver of written consent (i.e. a signature on an informed consent
form) from the subjects, you MUST justify this request by providing an explanation of
why obtaining written consent would add additional risk to the subjects and your
alternative provisions for informing them about the study.

􀂃If consent documents from another site will be used, you will have to indicate this and
provide a copy of the authorized consent document and IRC approval with your
application.

􀂃You will have to provide any other relevant information if necessary. Please be aware that
the PI is legally required to retain all signed Informed Consent forms for at least three
years after the project terminates

􀂃The Informed Consent form must be written at a level that the subjects will understand.
Please use simple language, and avoid clinical jargon.

􀂃Attach a copy of the written informed consent form (assent or parental consent where
applicable). Consent documents MUST be in format requested. See examples on line.

􀂃If the study uses database or archival data the use of informed consent is not applicable.

CONFIDENTIALITY OF DATA: Confidentiality of data MUST be address for all studies.

􀂃Indicate the extent to which confidentiality of records identifying subjects will be

maintained.

􀂃Describe the storage and disposal of information where applicable.

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Check List

For all applicants

1. Covering letter addressed to the Member secretary indicating the submission of the
approval of proposal.
2. Proposal will only be accepted if submitted in IRC format.
3. Both printed and electronic version of the proposal should be submitted.
4. Curriculum Vitae of the Principal Investigator & Co-Principal Investigator of the
study team should be submitted.
5. If the Principal Investigator is a non Nepali citizen, at least one Co-investigator should
be a Nepali citizen.
6. Submission of the application processing fee to IRC.(According to NHRC rules and
regulations)
7. Source of funding for the proposed project.
8. The proposal should have institutional ethical clearance from his/her own country if
submitted from academic and related institution.
9. If the research study is to be conducted in any hospitals/organization or
institution/community, a letter of approval from the related hospital/organization or
institution/district authority should be provided.
10. Consent form should be in Nepali & local language (if necessary).
11. Data collection tools should be in Nepali & local language (if necessary) including
interview guideline, observation checklist, questionnaires etc.
12. Style of referencing should be in Harvard style.
13. List of abbreviations / acronyms should be provided.

For students' applicants

1. Approval letter from concern Institute/University.
2. Recommendation letter from Academic Supervisor.

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Annex I: Informed Written Consent Form

Information Sheet
Study Title:

Investigators:

Background and Purpose:

Procedure:

Confidentiality:

Possible Risk and Benefit:

Withdrawal of participation:

Payment:

Request for more information:

Volunteer Agreement:

……………………………
Signature of witness/participant/family members
Date: …………………………..

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I certify that the nature and purpose, the potential benefits and risk associated
with participating in this research has been explained to the above individual.

………………………

Signature of investigator ……………………

Date…………………………………

………………………… ………
Signature of respondent Date

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Annex II- DATA COLLECTION TOOLS

QUESTIONNAIRE

Participant ID Number ……………

QUESTIONNAIRE…………………..

THANKYOU FOR YOUR COOPERATION

GOOD LUCK
Institutional Review Committee
Nobel College

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