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Application For Approval of Research Proposal

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0% found this document useful (0 votes)
144 views36 pages

Application For Approval of Research Proposal

Uploaded by

ranjit makaju
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Application for Approval of Research Proposal

Research Title:

Demographic and Clinical Characteristics of the patients admitted in the

covid hospital, BPKIHS, Dharan: A Cross-Sectional Study.

Institutional Review Committee

B. P. Koirala Institute of Health Sciences

Dharan, Nepal

Telephone no: 2212

Note: Please submit the same as a soft copy to [email protected]


Section A
(To be retained in IRC office)
1. Name and Designation of
i. Principal investigator (PI)
Name:
Designation:
Department:
ii. Co-investigator(s) (Add if more co-investigators)
Name
Designation
Department
2. Departments involved:
i. School of Public Health and Community Medicine.
ii.
3. Expected duration of the research project:
4. Tentative date of initiating the project:
5. Research site: Covid Hospital, BPKIHS, Dharan.
6. Amount of grant-in-aid asked for:
7. Has the PI received a grant from BPKIHS earlier? If yes, mention the
number of research grants received in previous years and what is the status
of last proposal grant received?
Has the PI received grant from other sources? If yes mention the name of
agency.
8. Is this a new project, or an extension of a project for which a grant has been
received from BPKIHS/other sources?
If an extension, has the interim report of the previous project been
submitted?

For Official Use Only


(Please see the check list before registration of the application form)

Institutional Review Committee Research Committee


Registration No.& Date: Registration No.& Date:

Date and number of time modified: Approval status: Approved/ Approved

1
with minor modification/ Not approved
Ethical Clearance Date: Approval date:

Name of Reviewer 1: Amount of budget approved:

Name of Reviewer 2: Tentative date of starting the research :

Signature of Member Secretary: Signature of Member Secretary:

Data Sheet

1. Name and Title of Principal Investigator responsible for the proposed

research:

…………………. ………….…….. .………………..

…………………

Last (Surname) Middle (if any) First name Title (Mr. Ms. Dr.)

(Please attach a copy of your curriculum vitae and list of publications


relevant to the proposed research)
Designation: Passport size
photograph
Department: …………………………………………………………………
(Compulsory)

Telephone No.: ……………………….. Email:

………………………………………….

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: ….

…………………………………………………………………….

Telephone No.: ………………… Email: …………...

……………………

3. Name and Title of Co-Investigator (if any) for the proposed research:

…………………. ………….…….. .………………..

…………………

Last (Surname) Middle (if any) First name Title (Mr. Ms.

Dr.)

(Please attach a copy of the curriculum vitae and list of publications


relevant
to the proposed research)
Designation: …………………………………….

Department:

…………………………………………………………………….

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

……………………

ACCEPTANCE OF GENERAL CONDITIONS AND DECLARATION

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.

Signatures (with seal and date):

a) Principal Investigator: Signature _____________ Date:

___________

b) Co-investigator (s): Signature ____________ Date:

___________

Signature ____________ Date: ___________

Remarks from the HOD of the Principal Investigator:

_______________________

Date: Signature & seal of the HOD

4
Remarks from the HOD of the Co-Investigator:

_______________________

Date: Signature & seal of the HOD

(All signatures should be on the same sheet)

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.:

Research Proposal Description

(To be sent for review)

1. Research Title:

Demographic and Clinical Characteristics of the patients admitted in the

covid hospital, BPKIHS, Dharan: A Cross-Sectional Study.

2. Summary of the Research Proposal (maximum 500 words):

7
Rationale: BPKIHS is one of the biggest tertiary centers in Nepal. Since

the beginning of covid pandemic BPKIHS is providing health services to

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

the demographic and clinical characteristics of covid patients admitted in

BPKIHS, Dharan from.

Aim: A descriptive study regarding the demographic and clinical

characteristics among the patients admitted in covid hospital, BPKIHS,

Dharan from .

General Objectives:

Specific Objectives:

 To study the demographic and clinical characteristics of the


admitted patients.

 To show the association between the demographic and clinical

characteristics of admitted covid patients and number of hospital

stay.

Research Hypothesis (if relevant): not relevant

Materials & Methods:

(a) Whether study involves humans/animals or both : Human

(b) Population/ participants: Patients admitted in the covid hospital

8
(c) Type of study design: Cross-Sectional Study.

(d) Human study :

(i) Inclusion Criteria : Patients admitted with

(PCR/RDT/GENE-XPERT) positive at the covid

hospital.

(ii) Exclusion Criteria : those who did not give consent for

research.

(e) Expected sample size :

(i) Sample size calculation- via Epi-one

(f) Control groups :

(g) Probable duration of study:

(h) Setting: Covid Hospital, BPKIHS, Dharan.

(i) Parameter/Variables to be applied/measured:

(j) Outcome measures: Disease outcome, Number of hospital stay.

(k) Rationale for statistical methods to be employed :

(l) Ethical clearance :

(m) Permission to use copyright questionnaire/Pro forma

(n) Maintain the confidentiality of subject

(o) Whether available resources are adequate:

(p) Other resources needed:

(q) For Intervention trial

a. Permission from Drug Controller of Nepal required/ Not

9
required/Received/ Applied on date __________

b. Safety measure

c. Plan to withdraw

3. Details of Research Proposal

3.1 Background of Study (maximum 500 words):

• In December 2020, the city of Wuhan, Hubei Province, China

became the center of an unusual pneumonia-like disease of an

unknown cause. In January 2020, Chinese scientists realized that this

condition was caused by a novel Coronavirus, first called 2019-nCOV.

On January 7, 2020, scientists isolated this novel type of Coronavirus

from the sputum of these patients, which was on February 11, 2020

classified as Severe Acute Respiratory Syndrome Coronavirus type

10
two (SARS-CoV-2) by the International Committee on Taxonomy of

Viruses. On the same date, the World Health Organization (WHO)

named the disease caused by this virus coronavirus disease 2019

(Covid-19) in the International Classification of Diseases. Public

Health Emergency of International Concern (PHEIC) was declared on

January 30, 2020 and pandemic on March 11, 2020.

As of 21st July 2021, about 192,840,803 cases were reported

globally with 4,142,679 deaths. About 175,357,704 cases recovered,

USA reported the highest number of cases (35,146,476, 625,808

deaths) followed by India (31,257,720 cases and 419,021 deaths).

SAARC region comprises of over 21% of the world's population which

remains vulnerable towards COVID-19. As of 21st July 2021, the

Member States have reported 3,44,11,825 cases, a total of 4,74,388

deaths in the region, and 3,32,09,311 recovered cases.

The first case in Nepal was confirmed on 23 January 2020 when a 31-

year-old student, who had returned to Kathmandu from Wuhan on 9

January, tested positive for the disease. It was also the first recorded

case of COVID-19 in South Asia. Nepal's first case of local

transmission was confirmed on 4 April in Kailali District. The first

death occurred on 14 May. A country-wide lockdown came into effect

on 24 March 2020, and ended on 21 July 2020 as the cases came in

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,

the Ministry of Health and Population. (MoHP) has confirmed a total

of 672,871 cases with 9,637 death and 636,402 cases has recovered. In

the meantime, 3495069 real-time RT-PCR (RT-qPCR) tests have been

performed in 40 laboratories across the country. The viral disease has

been detected in all provinces and districts of the country, with

Bagmati Province and Kathmandu being the worst hit province and

district respectively.

The COVID-19 pandemic has emerged as a major public health

emergency affecting the healthcare services all over the world. It is

essential to analyze the epidemiological and clinical characteristics of

patients with COVID-19 in different parts of our country.

3.2 Statement of the Problem and Rationale / Justification (maximum 500

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

demographic and clinical characteristics in the tertiary centers in Nepal.

Our aim is to study the demographic and clinical characteristics of

patients in BPKIHS COVID hospital, Dharan.

12
3.3 Research Aims & Objectives: It should be precise and should include

following information - Participant, Intervention/exposure,

Comparison /control & Outcome).

3.3.1 General

3.3.2 Specific

 To study the demographic and clinical characteristics of the


admitted covid patients.

 To show the association between the clinic-demographic

characteristics of admitted covid patients and disease outcome

along with number of hospital stay.

3.4 Research Hypothesis (if relevant)

Not relevant

13
4. Literature Review (not exceeding 1000 words – please make it brief and

relevant to current proposal)

A recent cross-sectional study from Mashhad University of Medical

Sciences, Iran studied the demographic and clinical characteristics severe

Covid-19 infection, between 5 March and 12 May 2020 in Mashhad,

Iran, 1278 of 4000 suspected Covid-19 patients were confirmed positive

by real-time reverse-transcriptase–polymerase-chain-reaction assay of

upper respiratory specimens. It compared the demographic, exposure

history and clinical symptoms of 925 survivors and 353 fatal cases with

confirmed disease. Of the 1278 confirmed Covid-19 patients, 353

(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

cardiovascular disorders (268/1278; 21.0%) and diabetes (208/1278;

16.3%). Dyspnea (929, 72.7%), cough (870, 68.1%), and fever (815,

63.8%) were the most frequent clinical symptoms. Overall, 1251/1278

(97.9%) of the cases had at least one clinical symptom. 

Similarly, a study about the demographic and clinical profile  of patients

with COVID-19 at a tertiary care hospital in north India from April 1 to

May 25, 2020 shows 114 patients with SARS-CoV-2 infection were

admitted. The history of contact with COVID-19-affected individuals

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

breath (10, 20.8%). Nineteen (17%) patients had hypoxia (SpO2<94%) at

presentation and 36 (31%) had tachypnoea (RR >24). Thirty four

(29.8%) patients had an accompanying comorbid illness. Age more than

60 yr and presence of diabetes and hypertension were significantly

associated with severe COVID-19 disease. Mortality of 2.6 per cent (3

patients) was observed.

5. Research Design and Methodology

5.1 Research Method



Qualitative Quantitative Combined

5.2 Study Variables:

5.2.1 Predictor / baseline variables : age, sex, district,

5.2.2 Outcome variables

 Disease Outcome (Discharge, Expired, Transferred)

15
 Days of hospital stay.

5.3 Research Design (Specify):

5.3.1 Type of study

Cross-sectional study

5.3.2 Conceptual Frame work

16
5.4 Study Site and Its Justification:

Covid hospital, BPKIHS, Dharan

5.5 Study Population (Specify):

Patients admitted in covid hospital who were (PCR, RDT, GENE-

XPERT) positive.

5.6 Sampling Methods/Techniques (Specify):

Purposive sampling.

5.7 Sample size (with justification):

Open Epi

5.8 Criteria for Sample Selection:

Patients admitted in the covid hospital.

17
5.9 Data Collection Technique / Methods (Specify):

Secondary data via hospital files.

5.10 Data Collection Tools: (please attach in annexe along with

participant/case record form):

5.11 Pre-testing the Data Collection Tools (if relevant):

Not relevant.

5.12 Validity and Reliability of the Research (if relevant): Mention, how

will you assess validity and reliability?

5.13 Potential Biases (if relevant):

 Information bias.

 Selection Bias

5.14 Limitation of the Study (if relevant):

 Missing data

18

5.15 Possible Challenges of the Study:

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

by the patient’s himself/herself so validation of the information had

some doubt.

6. Plan for Supervision and Monitoring:

7. Plan for Data Management and Statistical Analysis:

The categorical data were summarized as frequencies and percentages.

Numerical variable were expressed as mean ± standard deviation (SD)

whereas the categorical variables were analyzed using chi-square and t-

test.

8. Expected Outcome of the Research:

19
9. Plan for Dissemination of Research Results:

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

11. Work Plan (should include duration of study, tentative date of starting the

project and work schedule / Gantt chart):

20
12. Address the following for clinical trial

12.1 Allocation of subjects

12.2 Mention who will be blinded / masked.

21
12.3 The trial treatment

12.4 A detailed explanation of the trial procedures including all invasive


procedures.

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

12.6. Alternative procedure(s) or treatments (s) that may be available.

12.7 The risks, discomforts, and inconveniences associated with the study.

12.8 Provisions for management of any adverse reaction including stopping


rules.

12.9 The provisions of insurance coverage for any permanent disability or


death caused directly by the investigational treatment or procedure.

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.

12.11 Is there going to be a transfer of any biological materials from the


country? Explain.

12.12. Is there a Data Safety Monitoring Board? If yes, mention.

12.13 Is this trial internationally registered?

23
Section C

Ethical Consideration

13. Regarding the human participants:

13.1 Are human participants required in this research? If yes, provide

justification.

Yes  No

Justification

13.2 How many participants are required for the research? Explain.

13.3 What is the frequency of the participants’ involvement in the research?

Explain.

What is the follow up schedule?

24
13.4 Clearly indicate the participant's responsibilities in the research. What is

expected of the research participants during the research?

13.5 Does your study involve vulnerable members like – pregnant women /

newborn / children below 12 years / physically or mentally challenged /

persons with HIV / AIDS / IV drug users? If yes, provide justification.

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

for these risks.

13.7 Are there any benefits involved to the participants? If yes, identify clearly what

are the expected benefits for the participants.

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

participants) and b. Consent form (consent by participant and retained by PI).

(Informed Consent form should be submitted in Nepali & English and in the

language appropriate to the research participants)

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

Principal Investigator: ..........……………………

Certified by Account Officer: ..........................................


Section E

Annexure

Annexes should include


a. References
b. Participant/Case record form
c. Data Collection Instruments including questionnaires
d. Participant Information Sheet and Participant Informed consent Form
e. List of abbreviations,

GUILDELINES FOR SUBMISSION OF RESEARCH PROPOSAL

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]

Scanned PDF file 1:


1. Covering letter (through the Head of the Department). The covering letter
must state that the proposal has first been discussed and approved in the
departmental meeting.
2. Dated undertaking that the work has not been started and that the work
will be done as per Good Clinical Practice Guidelines.
3. Dated undertaking that the scales/questionnaire/scores to be used are not
copyright or that the permission to use them has been/ to be obtained.

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.

Reply resubmission: While submitting replies to the questions raised by IRC,


the candidates are advised to mention the research reference number and also
attach a copy of the comments of IRC. The revised proposal must be submitted
through the Head to the Member Secretary, IRC. The changes should be
mentioned in the covering letter as well as incorporated in the hard and soft
copy of the proposal

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..

The Research Sub-committee will immediately proceed for non-funded


proposal on last Friday of every month after receiving ethical clearance letter.
The funded proposals will be reviewed only in the full house Research
Committee meeting.

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.

Checklist of the documents to be submitted:


a) Covering letter addressed to the Member Secretary, Institutional Review
Committee forwarded by concerned HoD/ Chief, stating that the proposal
has been discussed and approved in the departmental meeting.
b) Proposal to be submitted in BPKIHS format.
c) Copy of the detailed proposal (two hard copies and one soft copy). Title
page together with section A should be submitted separately.
d) Attach photograph of Principal Investigator.
e) Proposal signed by the Principal Investigator & Co-Investigator/s and the
HoDs of involved departments should be on a same sheet..
f) Curriculum Vitae of the Principal Investigator & Co-Investigator/s of the
study team.
g) Participant Information Sheet (PIS) in English, Nepali & local language (if
necessary)
h) Participant consent form in English, Nepali & local language (if
necessary)
i) Data collection tools (Questionnaire/ Participants Record Form) in English
or in Nepali & local language (if necessary) including interview guideline,
observation checklist, questionnaires etc.
j) Style of referencing in Vancouver style.

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.

Guidelines to develop Information sheet and Consent form

Statements required in the Participant Information Sheet include:

Logo of the institute

The research project must be accompanied by the Participant Information

Sheet addressed to the patient or participant or parent (in case of minor). This

sheet should be provided to the participants. While formulating the Participant

Information Sheet, investigator must include the following information in a

simple layman’s language and in a narrative form, directed to the participant.

a) Research Title:

b) Introduction of the candidate and guide and co-guide:

c) Importance of the research:

d) Purpose of this research:


31
e) Participant selection

f) Voluntary participation

g) Expected duration of the subject

h) Any benefits to be expected from the research to the subject or to others

i) Any risk to participation the subject associated with the study

j) Procedures and proposal

k) State, how you will guarantee confidentiality of the research participants.

storage and disposal of information.

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

the participants can opt out of the study.

If the study is a clinical trial a detailed explanation of the trial procedures

including all invasive procedures should be included as listed below:

m) The potential or direct benefits (if any) for the research participants;

n) Alternative procedure(s) or treatment(s) that may be available;

o) The risks, discomforts, and inconveniences associated with the study;

p) Provisions for management of any adverse reactions;

q) The provisions of insurance coverage for any permanent disability or death

caused directly by the investigational treatment or procedure;

r) Amount of the blood sample in quantity expressed in terms of teaspoonful,

to be taken should be mentioned.

s) Cost and source of investigations, drugs, surgery must be mentioned

t) Sharing the results

32
u) 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.

v) Self-certification should be given that translation to vernacular is accurate

Is the research sensitive to the Nepali culture and the social values? If yes

explain

Statements required in the Participant Consent Form include:

Logo of the institute

Name and department of PI

Title of the proposal

Mention a statement indicating that the participant has understood all the

information in the information form and is willing to volunteer / participate in

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

participant will receive any incentive for the participation or it will be

voluntary.

Please indicate who is responsible for obtaining informed consent from the

participants in this research study.

 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

Approved by Approved by full


Research Sub house Research
Committee Committee

Conduction and
completion
of Research

Report submission to
Research Committee and
IRC

35

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