How to write a research protocol

Corlia van Vuuren

February 2011

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.

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.pdfRetrieved on 2 March 2010)

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_.pdfRetrieved on 2 March 2010)

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.pdfRetrieved on 2 March 2010)

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?

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)

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

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”

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

Methodology

Research (study) design

• Appropriate study (research design) to answer research question

• Substantiate your choice

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

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

Methodology

Methodological errors/ethical aspects

• Confidentiality

• Describe potential difficulties and limitations

• Validity

• Reliability

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

Methodology

Data analysis

• Biostatistics will handle the data analysis.

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

Other information

• Time schedule

• Budget

References

• A set method throughout

• Make sure about differences between referencing in the text and in the bibliography

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)

Thank you