RESEARCH PROPOSAL/ PROTOCOL WRITING

Prof. & Vice Principal- Mrs. Veena M. Joseph

© 2010Chettinad College of Nursing

Research Proposal

Definition• It is the plan or the blue print of the study or

preview of the study

• It is a written document which outlines the plan of a research study.

Purposes1. Helps examine what the researcher intends to do2. Submitting a research proposal prior to conduct

of a study is mandatory as a requirement for student researchers

3. Research proposal can serve as a document of contract for the project

Components of a Proposal

1.Title2.Proposal summary • Main objective (main topic/question)• specific goals (operationalize the question into

specific, testable questions)• Theoretical framework of project• brief description of method (number of subjects)

and design (procedure)• brief statement of potential significance

Proposal main body 3.Introduction / background of the study ( 1. to 1.5

pages )4.Study goals and objectives5.Study design6.Sponsor details7. Methodology8.Duration 9.Expected outcome10.Follow up

11. Data management and statistical analysis12.Ethical issues and how these issues will be

addressed13.Safety and confidentiality of data14. Quality assurance15.Publication policy16.Annexure / attachment / enclosures.

1. Title Should be • Short• Accurate• Descriptive• Concise• Readable font size to be used ( 12 ) • Avoid more than two fonts• Key words in the title should make a reader index• Should include what population study involves

2. Project summary• Summarizes all the central elements of the proposal• Should stand on its own and not refer the reader to

points in the project description• Should be written like the abstract of a research

paper, in not more than 300 words3. Introduction and background information• Introduction should be brief• Background information should be about what has

already been researched in the area with the description of the most relevant studies published and

• what is yet to be known in this topic which would further advance the knowledge

• A clear statement of the problem, its magnitude, affected population and the geographical areas, the causes of the problem and the possible solution which can be achieved by doing the study has to be discussed

• Should indicate why the research needs to be done and what will be its relevance

4. Study goals and objectives• Goals are general statements of what the study

intends to achieve• Objectives should be written for each goal because

the specify how one will accomplish the goal

• Goal can have many objectives• Objectives can be primary or secondary• Objectives should be simple and specific

5. Study design• Quality of a study depends mainly on the study

design and methodology• The design should include information on the type

of study approach, setting, study population,sample etc

6. Details of the investigator• Principal investigator & associate investigator• Name , institute, ph no, email address• Details of all the persons who will be involved in

the study7. Sponsor details • Details of the sponsor• Nature of sponsorship• What aspects of the research will be covered

should be stated

8.MethodologyShould describe how exactly one is going to

conduct the study8.1 design details8.2 sample8.3 inclusion / exclusion criteria8.4 sampling technique8.5 blinding details8.6 detailed information on the interventions,

procedures

8.8 measurements and observations• Details of how the observations are going to be

recorded• Instruments which are to be used to collect data8.9 limitations of the study

9. Duration of the projectthe proposal should specify the time that each

phase of the project is likely to take, along with a monthly time line for each activity to be undertaken.

1/22/10

10. Expected outcome• State what would be the expected outcome of the

study• How the study will contribute to the advancement

of knowledge• How the results will be utilized11. Follow up • The nature of follow-up that will be provided to

the research participants• For how long

12. Data management and statistical analysis• information on how the data will be collected• Duration of data collection• Data storage and management• Data handling and coding for statistical analysis• Sample size calculation• Plan for statistical analysis of data

13. Ethical issues• Information on how and from whom ethical

clearence will be obtained• Description of ethiocal considerations relating to

the study• How these issues will tackled• Informed consent process14. Safety considerations• Information on how the safety of the research

participants will be ensured• Procedures for recording and reporting adverse

events, their follow up and compensation ( if any )

15. Quality assuranceHow the quality assurance will be ascertained for the

conduct of the study16. Dissemination of findings and publication policy• Plans of publication17. Attachments• Curriculum vitae of investigator• Informed consent forms• Letters of confirmation from collaborating institutions• Research documents• Other supportive documents18. References