Proposal Guidelines 2021
Proposal Submission

The proposal soft copy should be submitted via email to irb.nams.birhospital@gmail.com by Principal Investigator andCCed  to Co-investigators.

The Cover Page must have Study title, Name, Post/Designation, Department, Institutional affiliation, date and signature of Principal Investigator and Co-investigator(s).

Once the review is completed, a final hard copy should be submitted to IRB, NAMS to receive IRB approval letter.

Follow IRB proposal guidelines, include 15 headings mentioned below in proposal and send revisions as early as possible for early proposal processing.

In case of research involving multiple disciplines/specialties, a co-investigator from each concerned specialty can be included.

In case of intervention study (clinical trials), the trial registry is compulsory. The trial registry can be done at Nepal Clinical Trial Registry Platform (https://npctr.nhrc.gov.np/) and approval from Nepal Health Research Council.

In case of provision of biological samples (body fluids, swabs, blood etc.) to be transported outside Nepal for research, approval from Nepal Health Research Council is MUST.

For researchers from institutions outside National Academy of Medical Sciences, permission letter from Hospital Director, concerned Head of Department, PI/Co-PIs CV with photograph & Nationality (dated and signed), approval from affiliated institution (if applicable), funding source disclosure and budget details, NAMS fee payment voucher are must and approval from Nepal Health Research Council. In addition, for foreign researchers and researchers from institutions outside National Academy of Medical Sciences, local co-investigator from NAMS is must.

The research proposal should be written in Times New Roman font, letter size 12, margins of 2.5 cm. both sides and 1.5 spacing between lines. 

1. Title

This should be comprehensive, self-explanatory and concise.

2. Introduction

Introduction should focus upon the following points. (at least 1- 2pages)

1. What is known about the research problem and what are the lacunae in the knowledge about the problem?

2. Findings of relevant past studies (preferably within 5 years).

3. Importance of the research problem and justification for conducting the research.

4. Aim of research.

3. Literature Review

10 or more relevant and recent local, national, regional and global research.

Highlight the findings of previous studies (national, regional, global)

Provide citations

Do not provide unnecessary details and basic concepts and definitions.

3. Hypothesis / Research Question (if applicable)

5. General Objectives

 General objective- mention the broad aim of the research

6. Specific Objectives

 Specific objectives - mention the specific and measurable variables one is going to record.

7. Methods

Study design, Type of study, Study site, Study duration including data collection time.

Sampling technique

Sample size, sample size formula and calculation

Study variables

Inclusion and Exclusion criteria

Operational definitions

In case of observational study, “study details”

In case of intervention study, “intervention details”? What are the possible adverse events following intervention? What precautions will be taken to prevent or mitigate adverse events?

8. Data collection

Pretest (only if required in your research)

Data collection techniques ( Who will collect, where will data be collected, how will data be collected)

Follow up (drop outs only if required in your research)

Data collection tools

Dummy tables

9. Data analysis

Mention name of Statistical tests that will be used

10. Data safety and Management plan

Data storage

How collected data will be stored/ protected? (eg. Password protected computer, locked cabinets etc.)

Who will have access to data?

How will the data be stored? For how long the data will be stored ?

11. Ethical considerations

Information sheet and Written Consent form (in Nepali and English)

Research participant’s safety

Research participant’s information/data privacy. Avoid name, contact, address and personal details of research participants (that is not required for the research) in data collection form.

Study details including potential benefits and harms in Research Information Sheet along with Name and Contact details of researcher.

Sensitive to local culture and social values

12. Work plan chart/Gantt chart

13. Budget

Structure of the proposed budget

Unit breakdown of budget headings

Source of budget

Mention if Funding available

14. References

Modified Vancouver style

Provide DoI, PMID, google scholar or hyperlink (Pubmed/Full Text/Google Scholar/Weblink)

15. Proforma/Questionnaire/Check-list/Interview Guidelines ( as applicable)

Proposal Guidelines

Student Thesis/Research Proposal Submission

The proposal soft copy should be submitted via email to irb.nams.birhospital@gmail.com and CCed to Co-ordinator, Guide and co-guide.

Once the review is completed, a final hard copy should be submitted to IRB, NAMS to receive IRB approval letter.

Follow IRB proposal guidelines and include headings mentioned below .

Please submit your thesis/research proposal and subsequent revisions as early as possible for early processing

In case of intervention study (clinical trials), the trial registry is compulsory. The trial registry can be done at Nepal Clinical Trial Registry Platform (https://npctr.nhrc.gov.np/) and approval from Nepal Health Research Council.

The thesis proposal should be written in Times New Roman font, letter size 12, margins of 2.5 cm. both sides and 1.5 spacing between lines.

Title

This should be comprehensive, self-explanatory and concise.

Introduction

Introduction should focus upon the following points. (at least one- 2pages page)

1. What is known about the research problem and what are the lacunae in the knowledge about the problem?

2. Findings of relevant past studies

3. Importance of the research problem

4. Justification for conducting the research with a broad aim and in an inverted triangle format.

Literature Review

10 or more relevant and recent local, national, regional and global research.

Highlight the findings of previous studies (national, regional, global)

Provide citations

Do not provide unnecessary details and basic concepts and definitions.

Hypothesis / Research Question (if applicable)

Objectives

1. General objective- mention the broad aim of the research

2. Specific objectives - mention the specific and measurable variables one is going to record.

Methods

Study design, Type of study, Study site, Study duration (proposal design to thesis submission) including data collection time.

Sampling technique

Sample size, sample size formula and calculation

Study variables

Inclusion and Exclusion criteria

Operational definitions

In case of observational study, “study details”

In case of intervention study, intervention details? What are the possible adverse events following intervention? What precautions will be taken to prevent or mitigate adverse events?

Data collection

Pretest (only if required in your thesis)

Data collection techniques ( Who will collect, where will data be collected, how will data be collected)

Follow up (drop outs only if required in your thesis)

Data collection tools

Dummy tables

Data analysis

Mention name of Statistical tests

Data safety and Management plan

Data storage

How collected data will be stored/ protected ? (eg. Password protected computer, locked cabinets etc.)

Who will have access to data?

How will the data be stored? For how long the data will be stored ?

Ethical considerations

Information sheet and Written Consent form (in Nepali and English)

Research participant ‘s safety

Research participants information/data privacy

Potential benefits and harms

Assent ( only for 12-18 years) and written informed consent from legal guardian (eg. Parents)

verbal consent (7-11 years) and written informed consent from legal guardian (eg. Parents)

Sensitive to local culture and social values

If Human biological sample to be sent out of the country then approval from Nepal Health Research Council

Work plan chart/Gantt chart

Budget

Structure of the proposed budget

Unit breakdown of budget headings

Source of budget

Mention if Funding available

References

Modified Vancouver style

Provide DoI, PMID, google scholar or hyperlink(Pubmed/Full Text/Google Scholar/Weblink)

Proforma/Questionnaire/Check-list/Interview Guidelines

If you have any queries , please email at 

irb.nams.birhospital@gmail.com

membersecretary.irb@gmail.com