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 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 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