Application For Approval of Research Proposal
Application For Approval of Research Proposal
Research Title:
Dharan, Nepal
1
with minor modification/ Not approved
Ethical Clearance Date: Approval date:
Data Sheet
research:
…………………
Last (Surname) Middle (if any) First name Title (Mr. Ms. Dr.)
………………………………………….
2. Name and Title of Co-Investigator (if any) for the proposed research:
…………………
Last (Surname) Middle (if any) First name Title (Mr. Ms. Dr.)
2
(Please attach a copy of the curriculum vitae and list of publications
relevant
to the proposed research)
Designation: …………………………………….
Department: ….
…………………………………………………………………….
……………………
3. Name and Title of Co-Investigator (if any) for the proposed research:
…………………
Last (Surname) Middle (if any) First name Title (Mr. Ms.
Dr.)
Department:
…………………………………………………………………….
……………………
3
1. I/we hereby certify that the above mentioned statements are true.
2. I/we have read and understood the guidelines for submission of research
proposal.
3. I/we agree to accept responsibility for the scientific conduct of the
research project.
4. I/we shall provide progress reports 6 monthly and agree to submit final
report to Research Committee, BPKIHS within three months from the
date of completion of the project.
5. If a grant is awarded as a result of this application, I/we agree to
maintain a stock book for purchases made for the project and I/we shall
submit the complete statement of account within three months of the
termination of the project, and at any other time as required by the
accounts section. I/we also agree to acknowledge the grant in any
publication resulting from the project if it is approved for financial
assistance.
6. I/we declare that the project will be conducted as per the highest ethical
standards applicable to animal/human experiments.
7. If the research is terminated, for any reason, I/we will notify Research
Committee, BPKIHS of this decision and provide the reasons for such
actions.
___________
___________
_______________________
4
Remarks from the HOD of the Co-Investigator:
_______________________
5
Recently updated Curriculum Vitae of Principal Investigator & Co-
investigators
Format for
CURRICULUM VITAE OF THE INVESTIGATOR(S)
1. Name :
2. Designation :
3. Address for correspondence :
4. Date of birth :
5. Educational qualifications :
6. Research experience in the related field (if any)
7. List of important recent publications related to the subject of the present
project (if any).
6
Section B Reg no.:
1. Research Title:
7
Rationale: BPKIHS is one of the biggest tertiary centers in Nepal. Since
the covid patients through a separate 100 bedded covid hospital. It is the
main referral center for covid patients for Eastern region of Nepal. There
has been less study regarding the demographic and clinical characteristics
of covid patients in the tertiary centers. Our research aims to study about
Dharan from .
General Objectives:
Specific Objectives:
stay.
8
(c) Type of study design: Cross-Sectional Study.
hospital.
(ii) Exclusion Criteria : those who did not give consent for
research.
9
required/Received/ Applied on date __________
b. Safety measure
c. Plan to withdraw
from the sputum of these patients, which was on February 11, 2020
10
two (SARS-CoV-2) by the International Committee on Taxonomy of
The first case in Nepal was confirmed on 23 January 2020 when a 31-
January, tested positive for the disease. It was also the first recorded
control. From mid April, India was hit severely by 2nd wave of
11
Covid-19. Cases continued to rise in Nepal as well and country wide
lockdown was implemented from April 29, 2021. As of 21st July 2021,
of 672,871 cases with 9,637 death and 636,402 cases has recovered. In
Bagmati Province and Kathmandu being the worst hit province and
district respectively.
words)
BPKIHS, Dharan is the biggest tertiary and the main referral center in the
Eastern region of Nepal. There has been very less study regarding the
12
3.3 Research Aims & Objectives: It should be precise and should include
3.3.1 General
3.3.2 Specific
Not relevant
13
4. Literature Review (not exceeding 1000 words – please make it brief and
history and clinical symptoms of 925 survivors and 353 fatal cases with
(27.6%) died and 925 recovered. Mean (SD) age for confirmed patients
was 56.9 (18.7) years, for deceased cases 67.1 (15.9) years and for
recovered cases 53.0 (18.3) years. The most frequent co-morbidities were
16.3%). Dyspnea (929, 72.7%), cough (870, 68.1%), and fever (815,
Similarly, a study about the demographic and clinical profile of patients
May 25, 2020 shows 114 patients with SARS-CoV-2 infection were
was available in 75 (65.8%) patients. The median age of the patients was
33.5 yr (13-79 yr), and there were 66 (58%) males. Of the total enrolled
14
patients, 48 (42%) were symptomatic. The common presenting
complaints were fever (37, 77%), cough (26, 54%) and shortness of
15
Days of hospital stay.
Cross-sectional study
16
5.4 Study Site and Its Justification:
XPERT) positive.
Purposive sampling.
Open Epi
17
5.9 Data Collection Technique / Methods (Specify):
Not relevant.
5.12 Validity and Reliability of the Research (if relevant): Mention, how
Information bias.
Selection Bias
Missing data
18
Collection of data was challenging as all the data was secondary and
was taken from the patient’s hospital files. There was difficulty isn
accessing all the files as they were located in different places during
our research. Face to face interview was difficult. All the data
provided in the files were given by the patient’s close relatives and not
some doubt.
test.
19
9. Plan for Dissemination of Research Results:
11. Work Plan (should include duration of study, tentative date of starting the
20
12. Address the following for clinical trial
21
12.3 The trial treatment
12.5 The potential or direct benefits (if any) for the research participants.
12.7 The risks, discomforts, and inconveniences associated with the study.
22
12.10 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.
23
Section C
Ethical Consideration
justification.
Yes No
Justification
13.2 How many participants are required for the research? Explain.
Explain.
24
13.4 Clearly indicate the participant's responsibilities in the research. What is
13.5 Does your study involve vulnerable members like – pregnant women /
13.6 Are there any risks involved to the participants? If yes, identify clearly what are
the expected risks for the human participants in the research and provide a justification
13.7 Are there any benefits involved to the participants? If yes, identify clearly what
14. Informed Written Consent Form / Ethical Issues (please attach in annex):
25
It has two parts: a. Information sheet (to be explained and given to
(Informed Consent form should be submitted in Nepali & English and in the
26
Section D
(BUDGET)
Source: Self ( ), BPKIHS ( ), Other ( )
15. If BPKIHS, mention the total amount of funds (in Nepalese currency)
requested for proposed research project:
16. If, Other, please clarify the source.
Budget Items
Personnel Person(s) x Rate x Duration Total (NRs.)
Non consumable supplies (if relevant)
(Include major and minor equipment etc.)
Consumable and expendable supplies
(Include stationery, photocopying, etc.)
Clinical expenses (if relevant)
(Include Drugs, Special Clinical Investigations like Clinical Tests,
Patients Cost i.e. Transportation/Reimbursement of Travel Expenses
etc.)
Field / Community related costs (if relevant)
(Include refreshment cost for focus group discussion and other related
costs etc.)
Travel cost within the country (if relevant) for investigator.
(Include airfare, Bus fare, Vehicle hiring, Fuel etc.)
Report Writing (Include Printing and Binding)
Contingency (5 %)
GRAND TOTAL:
Other sources of supplementary funds (if any)
If yes, indicate the amount in Nepalese currency:
Name of funding organization / agency:
Address of funding organization / agency:
27
Telephone No.: Fax No.: Email:
Explanation and Justification of Budget Items
Annexure
Submit two hard copies of the all documents along with covering letter
addressed to the Member Secretary, Institutional Review Committee (IRC) in
the Office of the Dean Academics, BPKIHS, Phone ext. 2212, forwarded by
HoD/ Chief.
The soft copy of the documents should also be submitted as two PDF files
separately to the Member Secretary, Institutional Review Committee. email:
[email protected]
28
4. Scanned copy of section A of the Application for Approval of Research
Proposal.
5. Any other signed document/s
PDF file 2:
1. Soft copy of section B, C, D and E of the Application for Approval of
Research Proposal.
The researcher must submit the research proposal to the Member Secretary,
IRC after presentation in the department and the recommendation of the Head
of the department within stipulated date and time. The department must invite
all co-investigator/s for their input. The Principal investigator, co-
investigator/s and the Head must ensure that the project has been reviewed
both from the scientific and ethical point of view.
The submission should be made in the prescribed format with signatures of all
investigators and Head of the department. The submission must be
accompanied with Participant Informed Consent Form and Participant
Information Sheet in a simple layman’s language in a narrative form. Please
ensure that all documents are enclosed and the pages are numbered.
No research work will be/can be started unless ethical approval from IRC and
approval from Research Committee / Proposal Committee are obtained. Please
bear in mind that no retrospective approval will be provided to research
projects. Research proposal not submitted through proper channel will not be
considered for process and the researcher will be responsible for the delayed
process.
Letter of approval and Ethical clearance: Start your thesis work only after
getting ethical clearance and approval letters from Member Secretaries of IRC
and Research Committee respectively.
29
Amendment submission: While submitting amendments in proposals a
covering letter must be provided clearly listing the changes. A soft copy of the
same should also be submitted to IRC through proper channel.
Project Submission time: Submission will be received on all days for self
funded and funded by others. However, for BPKIHS funding, submission will
be received only after the request from BPKIHS. Proposals received by IRC
will be processed within a month..
General guidelines
1. Font size:12 (Arial Font); A4 size paper; Line spacing: Double space
2. Margins: 2.5 cm on all sides & justified.
3. Print NA in the fields not applicable to you.
30
k) Undertaking that the work has not started and that the work will be done as
per Good Clinical Practice Guidelines.
l) Either undertaking that the scales/ questionnaire/scores to be used are not
copyright or permission to use them has to be obtained.
m) Soft copy of all the documents in PDF as two separate files. Title page
together with section A as one file and rest as another file.
Note:
1. The IRC may call the researcher for discussions and to give suggestions as
and when necessary.
2. The IRC will send each proposal to two reviewers. The comments of both
the reviewers will be compiled and forwarded to the researcher.
3. Correspondence with the researcher will be done by email rather than on
paper.
4. The proposal will be forwarded to the Research Committee after the IRC
has finished reviewing the proposal.
5. Research can be started only after approval from the Research Committee.
Sheet addressed to the patient or participant or parent (in case of minor). This
a) Research Title:
f) Voluntary participation
l) Mention a statement that the human participants can withdraw from the
study at any time without giving reason and without fear. State clearly how
m) The potential or direct benefits (if any) for the research participants;
32
u) The provision of including the name and address, including telephone
Is the research sensitive to the Nepali culture and the social values? If yes
explain
Mention a statement indicating that the participant has understood all the
the research.
Mention a statement that the participant can withdraw from the study at any
time without giving reason and without fear. Also indicate if the participant
has to pay for any procedure or will be paid by PI/ Institute. Whether
voluntary.
Please indicate who is responsible for obtaining informed consent from the
Signature/ thumb space for the research participant, a witness, and the
date.
33
34
FLOW CHART SHOWING PROCEDURE FOR APPROVAL OF
RESEARCH PROPOSALS
Principal Investigator
Forwarded following
departmental meeting of that
particular department and
submitted to IRC
Interaction
Principal Investigator
IRC
Interaction and
ethical approval
Research Committee
Non-funded BPKIHS
Research Funded
Conduction and
completion
of Research
Report submission to
Research Committee and
IRC
35