Credit- 6

Scientific Writing and

Communication

Shripad B. Deshpande
Professor of Physiology
Institute of Medical Sciences
Banaras Hindu University

Components

Protocol writing
Paper presentation in a conference
Poster presentation in a conference
Thesis presentation and writing
Paper writing
Ethical considerations

Plan of Lectures
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.

Protocol writing
Common requirements for paper writing
Paper writingTitle, Authors and Abstract
Paper writingIntroduction
Paper writingMethods
Paper writingResults
Paper writingDiscussion
Paper writingReferences, Acknowledgements and others
Submission online/offline and Response to Reviewers
Proof reading
Abstract preparation and Paper presentation in a conference
Abstract preparation and Poster presentation in a conference
Writing Thesis
1.
3.
5.
7.
9.

Organization
2. Introduction
Review
4. Making Chapters
General discussion
6. Summary and Conclusions
Abstract preparation8. Bibliography
Other components

14. Ethics in writing

Resource materials
T. M. Georges , 1996. A Course in Analytical Writing
for Science and Technology.

mywebpages.comcast.net/tgeorges/write
/les17.htm
Biomedical Research: from ideation to
publication, Jagadeesh et al 2010, Wolters
and Kluvers publication
Email: desh48@yahoo.com

Shripad B Deshpande
Professor of Physiology
Institute of Medical Sciences
Banaras Hindu University

What is a protocol
Webster Dictionary a set
of rules that explain the
correct conduct and
procedures to be followed
in formal situations

Examples of
protocol

Protocol for Presidents visit

Military conduct protocol
Treatment protocol
Experimental protocol
REASEARCH PROTOCOL

Crystallization of
ideas, selection of
topic, literature
study, identifying
lacuna ,
Hypothesis, study
design selection

What is a Research
Protocol
A research protocol is a document
that describes the background,
rationale, objectives, design,
methodology, statistical evaluation
of the data, and organization of a
research project- i.e. The research
protocol is the detailed plan of
the research study

When you require to write

the research Protocol?
Before starting of every research study,

you should have a research protocol.

When you have already made proper and
complete planning of the study, the
protocol should be written.
When you are going to write the synopsis
of your thesis work
When you are going to submit a
research project proposal to a funding
agency.

What is the purpose of a

written protocol?
It helps the investigators to clarify their

thoughts and to consider all aspects of

the study
It is an essential guide for a team
working on the same research problem.
It is an indispensable component of a
research proposal submitted for
funding.

Criteria for well-written

protocol
It should be adequate to answer the

research question and achieve the

study objectives.
It should be feasible in the particular
set-up for the study.
There should be sufficient detail, so
that another investigator is able to
repeat the study.

Format of a Research Protocol

Title (Problem statement)
Summary (Summarizes all elements)
Description of the research project with
Rationale
Objectives
Methodology

Data management and analysis

Ethical considerations
Gender issues
References

Title
The title should be descriptive and

concise.
It describes what your research is
about.
It should reflect more closely the sense
of the study.
This may need revision after the study.

Title of a protocol
Study of visual and auditory evoked
potentials in children with
neurological disorders due to
congenital Rubella syndrome with
visual and auditory impairment and
its incidence in northern India.

Title of a protocol
Study of visual and auditory
evoked potentials in children with
neurological disorders due to
congenital Rubella syndrome with
visual and auditory impairment
and its incidence in northern
India.

Title bad to good

Study of visual and auditory
evoked potentials in children
with congenital Rubella
syndrome.

Project summary
[ Though comes in the beginning, this
may probably last thing you write]
The summary should concisely summarize

all the elements of the protocol.

Summary includes the key points: what,
why, how and when.
Include a brief description of the aims of
the study, research subject matter, the
methods to be used and the time frame.
Indicates also why this research is
needed, and its potential uses.

Rationale
Rationale puts the proposal/question in

context.
It should answer why the research
needs to be done and what will be its
relevance.
A brief description of the most relevant
studies published on the subject should
be provided to support the rationale for
the study.

Objective(s)
Specific objectives are statements of the

research question(s).
Objectives should be simple and specific
(not complex an vague).
After statement of the primary objective,
secondary objectives may be mentioned.
There should not be too many objectives
or over-ambitious objectives.

Example of ObjectivesTitle- Use of X drug in patients with

nausea and/or vomiting from gastro
paresis
Hypothesis to be tested: The drug X
improves symptoms of gastro paresis
Primary objective

Secondary objective

To determine the

To determine the time

treatment response of X in
gastroparetic patients with
nausea and/or vomiting
(What percentage of
patients treated with X
that have improved
symptoms of nausea,
vomiting)

course of symptom
improvement with X for
symptoms of gastroparesis
To determine symptomatic
responses in both diabetic
and idiopathic
gastroparesis

Methodology
It is the most important part of the

protocol.
The methodology section has to be thought
out carefully and written in full detail.
It should include information on the
Research design
Selection of research subjects
Interventions to be introduced
Data collection and observations to be made
Sample size.

Methodology-Research
design
The study design should be stated
Why a particular type of the

design is chosen should be

explained in relation to the study
objectives.

Study design-types

Methodology- Human
Research
If the research involves human subjects or
participants following should be answered:
What are the criteria for inclusion or selection?
What are the criteria for exclusion?
In intervention studies, how will subjects be
allocated to index and comparison groups will be
made?
What will be the criteria for discontinuation if
intervention is not tolerated?
All the parameters for evaluation to be clearly
stated.

Methodology- Animal
Research
Detailed experimental protocol should be outlined
Outline the experimental design
Animals to be used and maintained, sources etc.
Details of Drugs and doses/ intervention to be
carried out
Experimental groups and controls to be clearly
defined
State parameters to be evaluated, recording and
data collection methods clearly narrated
Mention all recording devices or biochemical
estimation procedures to be used

MethodologyObservations
Information should be provided on how and

how frequently the observations to be made.

If the observation is made by a questionnaire,
this should be appended to the protocol.
Laboratory or other diagnostic and
investigative procedures should be described.
For established procedures, reference to

appropriate published work will suffice.

For new or modified procedures, an adequate
description is needed, with a justification for
their use.

Methodology- Sample size

The protocol should provide information and

justification about sample size.

An unnecessary larger sample size
increases cost, duration and unethical- risk
without additional benefit.
A smaller sample size - unethical if it exposes
human subjects to risk with no benefit to
scientific knowledge.
The basis on which sample size is calculated
should be explained
Computer software programs can be used

Data management and analysis

The protocol should provide information

on how the data will be managed

Statistical tests to be used.
Help of a statistician may be useful
Even if computer software is used,
principles should be well understood.

Ethical considerations
Ethical considerations apply to all types of

health research
therapeutic or diagnostic patients may not have

any benefit
Epidemiological, field and qualitative- encroachment
of individuals privacy and even on communities

Written approval of the appropriate ethics

review committee required.

A written form for informed consent required

Ethical considerations
All research protocol (involving human

or animal) must be approved by ethics

review committees at the local,
institutional and/or national ethics
committee.
The protocol must be written in
accordance with the World Medical
Association Declaration of Helsinki on
Ethical Principles.

Gender issues
Gender-related differences can influence the

outcome of the research for men and

women (due to genetic, hormonal and
behavioral difference)
Women were often excluded from clinical
trials
A drug proved safe and effective for men
may not be true for women.

References
The protocol should end with relevant
references on the subject
Vancouver style-References -with number,
appears in order of citation.
Harvard Style- (References Author and year),
arranged in alphabetical order.

Checklist for a Research

Protocol
Title
Summary
Description of the research project with
Rationale, Objectives, Methodology

Data management and analysis

procedures
Ethical considerations and clearance
Gender issues
References
Appendix (Questionnaire, consent form, registration
of clinical trial, etc)

Further reading &

Sources
Mahmoud F. Fathalla A Practical Guide for Health
Researchers WHO Regional Publications Eastern
Mediterranean, Cairo, 2004: 65-71.
Kendall MJ and Hawkins C. Planning and protocol

writing. In: Hawkins C, Sorgi M, eds. Research: How

to plan, speak and write about it. Berlin, SpringerVerlag, 1985: 1228.

Thank
You
Before next lecture
Prepare a Research protocol of your
study and mail it to me
We will pick some and discuss them in
the next class
Then we will take up the next topic
Common requirements for paper
writing