How to write a research protocol

1. How to write a research protocol Corlia van Vuuren February 2011

5. Learning outcomes • At the end of this session the learners must understand: • the aim of writing a protocol; • the intend of each section of the protocol; • the possible pitfalls when writing a protocol; and • possible corrections to be made to their individual protocols.

6. What is a research protocol? • A research protocol is: • “a regulatory document describing a single study in detail”; • “organised around the objectives of the study”; • “informative, but focused on the specific details”. • (Dana-Farber/Harvard Cancer Center. 2008. Writing a research protocol. http://www.dfhcc.harvard.edu/fileadmin/DFHCC_Admin/Clinical_Trials/CTEO/downloads/Writing_a_Research_Protocol.pdf • Retrieved on 2 March 2010)

7. What is a research protocol? (cont’d) • A research protocol is: • “a detailed set of activities for the project you propose and these activities are supported by evidence from other research and from your preliminary investigations” • “It shows above all, evidence of planning, including anticipation of potential problems and how you intend to deal with them”. • (Society of Radiographers. 2009. How to write a research protocol. http://www.sor.org/public/pdf/How_to_write_a_protocol_29_5_09_2__2_.pdf • Retrieved on 2 March 2010)

8. Aims of writing a protocol • Help with the formulation of ideas and gain feedback from peer researchers • Obtain approval for the study from regulatory bodies/evaluation committees • Obtain ethical clearance • Obtain permission to execute the research from all parties involved • Obtain funding • (East of England Research Development and Support Unit. n.d. Writing a research protocol. • http://www.east-of-england-rdsu.org.uk/activity/docs/infosheet-1.pdf • Retrieved on 2 March 2010)

9. Where do I start? • Review the latest literature • Similar studies • Outcomes of those studies • Methodology used • Problems experienced • Limitations noted • Why another study in this field? • What will be different? • What will be the same? • How will I prevent the same problems and limitations? • What extra ground work did I do?

10. Title • Prerequisites • Must be “catchy” • Include the main area of research • May contain a brief description of the study design • (if not evident from the objectives) • Describe the central/main objectives of the study • Refer to the study population • (Preferably not more than 12-14 words)

11. Introduction • Prerequisites • Introduce the reader to what the research is all about • Background to and a rationale for the study • Create reader interest • Critical review of current literature (published and unpublished) • Identification of gaps in evidence • Potential value of furthering knowledge or to fill above mentioned gaps • Research hypothesis and reasons for undertaking the research

12. Introduction (cont’d) • “In the introduction, it should be clear that you have thoroughly reviewed the relevant literature and have developed your hypothesis or research question within that context” • “The introduction must include a convincing argument that your study will make a valuable contribution to knowledge” • Will it contribute to existing knowledge? • Will it fill a gap in knowledge? • Does it challenge existing knowledge? • Does it attempt to resolve an existing controversy? • “The introduction must justify the need to undertake the research”

13. Research question, aims and objectives • Prerequisites • Must be precise • Should follow on from the hypothesis • Brief, but specific description of aims and objectives • Directly related to the main research question, research problem and title of the study • Should be clearly and concisely formulated • Must capture the essence of the study

14. Methodology • Research (study) design • Appropriate study (research design) to answer research question • Substantiate your choice

15. Methodology • Study participants/sampling • Detailed information regarding study participants • Detailed information regarding identification and recruitment • Inclusion/exclusion criteria • Justify sample size • Withdrawal/fall out criteria

16. Methodology • Measurement/Data collection • Which methods and why? • Measurement outcomes measures must support the hypothesis • Detailed information on the data collection method and data management • Detailed information on variables

17. Methodology • Methodological errors/ethical aspects • Confidentiality • Describe potential difficulties and limitations • Validity • Reliability

18. Methodology • Pilot study • Details regarding the participants • Are they comparable with the study participants • Will the data be included/excluded from the main study and when or why? • Reasons for conducting a pilot study

19. Methodology • Data analysis • Biostatistics will handle the data analysis.

20. Implementation of results • Substantiate why it was necessary to conduct the research • Must link with research question • Must link with hypothesis • Must link with research question, aims and objectives

21. Other information • Time schedule • Budget

22. References • A set method throughout • Make sure about differences between referencing in the text and in the bibliography

23. Appendices • All the documentation must be included • Questionnaires • Information letters • Recruitment letters • Informed consent • Data forms • Permission letters • Ethical clearance and approval letters (in script)

24. Thank you