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Centre of Studies & Research
Directorate General of Planning & Studies

Quality Care, Sustained Health




Submission of Research Proposal for Registration, Review and Approval

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1. Proposal Particulars

Role Name Job Title Telephone Email Act.

Principal Investigator (PI)
Co-Principal Investigator (Co-PI)



3. Planned Contribution of Research team members [e.g. Conception of idea, Research design, Data collection/field work, Data management, Analysis, Report writing, Interpretation of results, Critical reviewing with intellectual input]

S. No. Name of Researcher Location Contribution of Researcher Signature / Initials

1
2

In case this is supervised work or (Bachelor’s/Master’s/PhD or other academic programme thesis):



4. Research Proposal Summary (Not more than 500 words in a structured format)

4.1 Research Proposal Summary: [Please fill in this form only after completing your detailed proposal]
It must include the statement and importance of the research problem, objective(s), sample, sampling method, sample size, data collection tool(s) and technique (s), statistical analysis methods, indicators and implications for the expected major results

5. Steps and Description of Research Proposal

5.1 Literature Review (not more than 1500 words, please restrict to information directly pertaining to the research)
Citation Search Strategy: How did you search for the background and foreground information on your research topic? State the search terms / MeSH headings / Keywords and the internet search engines used to acquire the reference material. (E.g.: PubMed, Google Scholar, MedlinePlus, UpToDate, Embase, Cochrane Collaboration etc.) - Do not list individual web addresses from where references are cited.

*Please include copies of protocol approval, ethical approval and other available documents from the parent academia. This application form should also be signed for approval (or attach a covering letter to that effect) by the research guide / supervisor of the parent academia.


 
 
 
 
 
 
 



7.7 What kind of research will be conducted ? (The Applicant is advised to fill up the appropriate form. Click here to view the algorithm to help guide you in the choosing the right Form. If still in doubt, the applicant is encouraged to preview each of the forms so that the most appropriate form that will elicit suitable responses from the study to most of the items in the form can be used. )
 
6.8 Will the study group be subjected to an intervention as part of the research?
e.g.: any therapy including medication, surgery, training, instruction etc. as part of the research intervention?
6.9 Is your study a Case-control study or a Cohort Study?
Case-control study (retrospective observational) or Cohort study (prospective observational)?

FORM C: Non-Clinical Quantitative

Please fill in all the responses that are applicable to your specific study. If any of the items are not applicable to your study, please mention “NA” to indicate Not Applicable in the corresponding response box. You should also add any additional information that is pertinent or specific to your study in the section provided for it.

9.1 Define and briefly describe the population you plan to study (the source population who have the characteristic of interest that is to be studied and not the general / national population).

9.2 Who are the accessible participants (to be drawn from the source / reference / target population) who are under consideration for the study?

9.3 How will the potential study participants be accessed / invited to participate in the study from the accessible population? (e.g.: Outpatient visits, home visits, telephone / letter /e-mail invitation, web site announcement etc.)

10.1 Specify the inclusion criteria

10.2 Specify the exclusion criteria
11.1 What is the proposed sample size?
11.2 What is the basis for sample size calculation and how was it calculated? Indicate the anticipated variability, margin of error, confidence level, effect size or other measures to justify sample size.
11.3 Describe in detail the sampling process (e.g.: sampling method, sample cluster, sample frame, sampling unit etc. as applicable).
12.1 How will the eligible participants be enrolled / allocated to the study?

12.2 Describe briefly the sampling technique.
13.1 Will there be a control / comparison group? If yes, how will they be selected?
13.2 How will the potential control / comparison participants be selected from the accessible population?

13.3 Specify the inclusion criteria for controls.

13.4 Specify the exclusion criteria for controls.
13.5 How will the accessible control / comparison participants be enrolled / allocated to the study?
MEASURING INSTRUMENT
Note: Please include a copy of the Data collection pro forma/ Instrument along with this proposal ( in ‘Attachments’ section)
14.1 How will the required data / information be collected with details? (e.g.: Interviewer administered, self-administered, case records, other documents etc.)
14.2 Give details on who will collect the data / information?
14.3 Where (setting / location) and when (time-period) will the data be collected?
14.4 Specify how the instrument will be evaluated for Validity and Reliability?
15. Will there be a Pilot Study or Pre-test of the instrument? If yes, describe how it will be done (please include target, number, purpose, what will be done with the results, and whether it will be included or not in main study).
16. Will the data collectors be trained on data collection? If yes, explain the process.
INFORMED CONSENT
17.1 Explain briefly how, when and by whom informed consent will be taken? How will it be ensured that the consenter / participant has fully understood all the rights, duties and privileges of consenting including the right to withdraw at any time and other inalienable rights that has to be granted on account of the nature and process of the study?
Note: Please attach a copy of the consent form (in ‘Attachments’ section)
17.2 Is there likely to be any perceived coercion / undue pressure (direct or indirect) or incentive (material or otherwise) that may influence the participation including retention in the study? Briefly explain how this issue is addressed.
18.1 Attrition and Non-Compliance: Indicate the measures to reduce attrition / non-participation (drop outs / loss to or incomplete data procured) or non-compliance or non-response that may happen after allocation of the participant to the study. How will these instances be dealt with?
18.2 Adjustment for potential bias: Identify potential bias (if any) that could affect the study. How will they be avoided or reduced at the various stages in the study? (e.g.: Selection bias, Measurement bias, Recall bias, etc.).
DATA SYNTHESIS AND MANAGEMENT
19.1 Indicate the computer program that will be used for data entry and data analysis.
19.2 Indicate the likely statistical tests that will be performed (descriptive and analytical tests as appropriate to the study and the nature of the collected data).
19.3 Quality Control Of Data: What steps will be taken to ensure quality control of the data (data is properly collected, data entry is accurate, transcribed and decoded correctly, managed appropriately etc.)?)
20.1 Please describe your work plan / timetable / Gantt chart. (Alternatively, it can be attached in ‘Attachments’ section)
20.2 What is the anticipated conclusion that may result from the study and how can it be used to improve / enhance scientific knowledge, professional or administrative practice or influence policy making?
20.3 Beneficiaries of the research: Who will be the potential beneficiaries of the study and its application?
20.4 What are the potential shortcomings / limitations of the study?
20.5 Dissemination of the study findings and recommendations: How will the outcome of the study be disseminated for the benefit of the scientific and professional communities?
21.1 Indicate the Priority and Importance of the study / research topic.
21.2 Is your chosen research topic part of the ‘Health Research Priorities’ as listed in the booklet by the Ministry of Health? ( Refer the booklet on the Home Page)
 

If Yes, kindly mention to which priority topic your research is related to.
22. Highlight the ethical issues in the study and how they have been addressed. (Refer the ‘Ethical Checklist’ for relevant particulars)
23. Will the research take up any additional resources of the department / hospital / health facility, including but not limited to human resource, time, equipments, consumables, reagents, investigations, bed occupancy, finances etc. If yes, list them. Has due permission been obtained from the appropriate authority? (Please include letter of approval(s) in ‘Attachments’ section)
Any other additional information (if applicable)?
25. Are you planning to apply for a research grant through the Centre of Studies & Research of the Ministry of Health?


Budget Form :

Categories

Sub-categories

First year

Second year

Total
Salaries, stipends, etc. Consultants

Research assistants

Technicians

Others

Equipment & Facilities Screening / Clinical exam. /Measurement equipment’s

Computer/ Printer

Materials & Supplies Lab Supplies, Reagents, etc.

Conference& Local travel Local transportation/rent cars

Conference

Dissemination & Publication of research results Reports

Flyers for important results

Workshop

Result & recommendations

Policy brief

Publications

Training Data collection

Sample collection

Measurements

Data entry

Research sample

Administrative costs Printing

Stationary

Use of MoH facilities

Miscellaneous

TOTAL



Budget Form :

Categories

Sub-categories

First year

Second year

Total
Salaries, stipends, etc. Consultants

Research assistants

Technicians

Others

Equipment & Facilities Screening / Clinical exam. /Measurement equipment’s

Computer/ Printer

Materials & Supplies Lab Supplies, Reagents, etc.

Conference& Local travel Local transportation/rent cars

Conference

Dissemination & Publication of research results Reports

Flyers for important results

Workshop

Result & recommendations

Policy brief

Publications

Training Data collection

Sample collection

Measurements

Data entry

Research sample

Administrative costs Printing

Stationary

Use of MoH facilities

Miscellaneous

TOTAL

If Yes, please submit / attach the Budget Form. (For more details about research grants, refer to the Health Research Funding Guideline)

Attachments:


Kindly attach all additional documents in this section:
1. List of Abbreviations (if applicable)      No applicable abbreviation.pdf

2. Curriculum Vitae of the P.I.      CV asara.pdf

3. Curriculum Vitae of the Co-P.I./s      CV saryia.pdf

4. Participation Information Sheet      Participation sheet.pdf

5. Informed Consent for Research Participants      project Consent t.pdf

6. Letter of Endorsement for the Study / Institutional Approval      https___www.mohcsr.gov1.pdf

7. Letter from Supervisor (for supervised studies)      Supervisor letter from institution-.pdf

8. Letter from Sponsor (for sponsored studies)      dean aproval.pdf

9. Data Collection Tools / Instrument      assesment tool for project.pdf

10. Sample spreadsheet for the Data entry      Data entry sheet.pdf

11. Work plan / Timetable / Gantt chart      Gantt chart7.pdf

12. Other Information relating to the study      Other information relating to the study.pdf

“ Declaration – To be signed by the Principal Investigator (P.I.) ”

If the application is accepted, I (we) declare that I (we) shall be actively engaged in, control the project and agree to provide progress reports and final report to the committee for revision before final dissemination of it.

I (we) confirm that the details of this proposal are a true representation of the research to be undertaken. I (we) will ensure that the research does not deviate from the protocol described. If significant protocol amendments are required as the research progresses, I (we) shall submit these to the Research and Ethical Review Committee for approval.

I (we) shall ensure that only the analysis specified in the protocol will be done on the samples. If I (we) send patients’ blood, body fluids or tissues outside the country for analysis, due permissions to do so will be obtained. Any unused or remaining samples will be disposed as per laboratory guidelines for specimen disposal.