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Overview of Protocol Development, Objective, Introduction

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Overview of Protocol Development, Objective, Introduction

Uploaded by

Anika Tahsin
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Protocol Development

Dr Md. Habibur Rahman, MBBS, MPH, PhD


Course Coordinator, Basic Course on Epidemiology and Biostatistics
Technical Training Unit, icddr,b
Email: [email protected]

Solving public health problems through innovative scientific research www.icddrb.org


What is a Protocol?

Clinical research/health research is conducted according to a


plan (a protocol) or an action plan.

• A protocol is a formal document that demonstrates the


guidelines for conducting the study.

• Illustrates what will be made in the study by explaining each


essential part of it and how they will be carried out.

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Why to write a research protocol?

• Allows the researcher to plan and review the project's steps


• Serves as a guide throughout the research
• Forces time and budget estimates
• Ensures scientific integrity
• Complies with ethical issues and regulatory requirements

A study protocol must be approved by an IRB


before undertaking research activities!!!

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Key points of a protocol
A protocol should include justification for the need of the project and
a detailed plan for the investigation:

• What is the question? (Hypothesis) What is it to be investigated?


• Why is the study important? (Significance)
• Where and when it will take place?
• What is the methodology? (Procedures and methods to be used).
• How are you going to do it? (Research design)
• Proposed time table and budget.
• Resources required (technical, scientific, and financial)
• Ethical issues (IRB approval)

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Components of a Research Protocol

1. Title of the study


2. Administrative details
3. Project summary
4. Introduction to the research topic, background
5. Preliminary studies
6. Study objectives and/or questions. Statement of the problem.
7. Methodology: Study design, study population and methods of
recruitment, variables list, sample size, methods of data collection, data
collection tools, plan of analysis (analysis of data)
8. Project management: Work plan (Timeline - proposed schedule)
9. Strengths and limitations of the study
10. Issues for ethical review and approvals

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Components of a Research Protocol

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Points to remember
• Developing a protocol is a team effort
• Ample time and many drafts are required
• Involve your mentor, statistician, medical writer, data analyst,
peer group from the start
• Review all relevant literature critically
• Expect multiple reviews from IRB and sponsors/donors (may
be)
• Draft version and date are very important, use footer with
short title and date
• If any amendments to the protocol needed, ask for IRB review
and approval
• Use the prescribed template

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Title

• The fewest possible words that adequately


indicate the contents of the paper
• Important in literature searching
• Should not include extra words, such as “A Study
of” or “Observations on”
• Should be specific enough
• Generally should not include abbreviations
• (Running title: short version of title—appears at
tops of pages)
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4. Introduction (Background)
• Why? Justify your Research Proposal!
• Build up the rationale and arguments in a logical step-by-step
manner.

• Describe the problem/situation/characteristic as per the hypothesis/objective


• Definition, Magnitude, Distribution, Significance, Importance, Control
strategies

• Are there knowledge gaps?


• Are there shortcomings/limitations/difficulties in understanding/formulation/
implementation/acceptance of the current control strategies?
• Are there scopes for innovations/improvements? How important will those
be – what is the potential impact?

• What is the basis of your approach – provide the supporting evidence.


• How the data generated by this proposal is going to help in
advancing/enhancing these strategies?

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An Amorphous Introduction

Ed, a postgraduate student, proudly shows his


mentor the introduction he has drafted for his
protocol. The mentor perceives that this
introduction includes some good content but that
it is at least twice the appropriate length for the
target journal and that it has no discernible
structure. The mentor decides to give Ed some
guidance on writing an introduction. What points
about content and structure might be good to
include?

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Purposes of the Introduction

• To provide background
• In order to help readers understand the paper
• In order to help readers appreciate the importance
of the research
• To identify the question(s) the research
addressed
• Sometimes stated as a hypothesis or hypotheses

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Structure of the Introduction

• Introduction typically should be funnel-shaped,


moving from general to specific
• A common structure:
• Information on importance of topic
• Highlights of relevant previous research
• Identification of unanswered question(s)
• Approach you used to seek the answer(s)
• (In some cases, the main findings)

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Research aim
• Usually refers to the main goal or overarching purpose
of a research project.

• Sentences stating the aim of a project are usually quite brief


and to the point.

An example: To investigate factors associated with partner


violence.

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Research objectives
• Research objectives indicate in more detail the
specific research topics or issues the project plans
to investigate, building on the main theme stated in
the research aim.

• It is good practice to put these in a numbered list


so they can be clearly identified later in a proposal or
report.

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Research objectives (cont.)
Example

Objective 1: To examine whether alcohol consumption is


associated with increased partner violence.

Objective 2: To examine whether labour force status


(employment, unemployment, not in the labour force) is
associated with variations in the incidence of partner violence.

Objective 3: To explore differences between couples with an


extended history of partner violence and couples with only a
brief, recent history of partner violence.

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Research questions
In some situations, rather than stating research objectives,
researchers will prefer to use research questions.
Example:

Question 1: Is alcohol consumption associated with


increased partner violence?

Question 2: Is labour force status (employment,


unemployment, not in the labour force) associated with
variations in the incidence of partner violence?

Question 3: Are there differences between couples with


an extended history of partner violence and couples with
only a brief, recent history of partner violence?

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Hypothesis
It is a statement based on sound scientific theory that
recognizes the predicted correlation between two or
more variables

• For example, a research project might hypothesize that


higher consumption of alcohol (an independent variable)
is associated with more incidents of partner violence (the
dependent variable).

• Data would then be gathered and analyses statistically to


see whether the results support the hypothesis or not.

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Thank you

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icddr,b thanks its core donors for their on-going support

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