Components of a Research

protocol

Dr. Uttam Bharati

1st year resident
Department Of Clinical Pharmacology
MMC, IOM
Date: 20/04/2078
04/08/2021
 Outline

• Definition of research.
• History of research.
• Research process.
• Components of research protocol.

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 What is Research?

• Origin from Middle French “recherché” meaning “to go about

seeking”.
• “Systematic inquiry to describe, explain, predict and control
the observed phenomenon.”
• Systematic investigation designed to contribute to
generalizable knowledge.

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Research cont..

Human research: Any systematic investigation involving living

humans.
Biomedical research, Health research or Clinical research:
Research for promotion of health and prevention of disease.
methodological investigation
Systematic investigation
data collection & analysis

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 Human Subject Research

Human subject:
A living individual about whom a research investigator obtains
data through investigation or interaction with the individual or
from individually identifiable information.

“Any social science, biomedical, behavioral, or epidemiological

activity that entails systematic collection or analysis of data
with the intent to generate new knowledge.”-WHO

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 History of Healthcare research

• 506 BC Biblical Period:

 “Book of Daniel”-Earliest recorded clinical trial
 King Nebuchadnezzar: Experiment on two groups of
people, One: meat and wine, other: vegetarian diet; Result:
Vegetarian diet appeared healthier than non-veg.
(uncontrolled human experiment)

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 History of Healthcare research cont…

• 11th century China- trial of ginseng (control group)

• 1747 AD James Lind’s Trial in British Navy
 Treatment of scurvy with citrus fruits.
 12 affected soldiers into 6 groups; each group receiving
different supplement. Remarkable improvement with citrus
fruit.
(First documented controlled clinical experiment.)

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 History of Healthcare research contd..

• Early 1800s AD Introduction of Placebo.

“An epithet given to any medicine more to please

than benefit the patient.”
• The 1940s and Afterward Modern concepts

After world war II: PTB trial

First Properly conducted RCT

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 Healthcare Research in Nepal

• 1951 Malaria Survey: First recorded research

• 1965-66 Nepal Health Survey
• 1976 Nepal Fertility Survey
• 1979-80 Nepal Blindness Survey
• 1988-90 Nepal Nutrition Intervention Project
 NHRC- 1991 (Autonomous Body)

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 Types of Research

• Basic versus Applied Research

• Biomedical versus population versus Health policy Research
• Quantitative versus Qualitative Research
• Action Research
• Dual Use Research

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 Types of research cont..

Basic Research Applied Research

o Focuses on fundamental o Testing theoretical concepts
principal & testing theories in actual problem situation

o No immediate or planned o Done to improve product or

application process

eg; A study assessing role of eg; An investigation to identify

the side effects of using a
drug in treatment.
particular drug.
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 Types of research cont..

• Biomedical Research: all biological, medical, and clinical

research in addition to biomedical product development and
evaluation.
• Population Research: study on epidemiological, demography
and socio-behavioral sciences.
• Health Policy Research: encompasses the health system and
service and health economic research.

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 Types of research cont..
Quantitative Qualitative
Focuses on theories and testing Focuses on exploring ideas
hypothesis
Assumes a fixed and measurable Assumes a dynamic and
reality negotiated reality
Statistical analysis for Analysis done largely by
interpretation concepts and images
Expressed in number, graphs Expressed in words
and charts
Large sample size Fewer participants
Closed questions Open ended questions
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 Types of research cont..

• Action Research: Style of research rather than sub type.

Relies on Qualitative method for its completion
• Dual Use Research: conducted for legitimate use but can
potential be exploited for harmful purposes.
– eg; research on toxins, pesticides, vaccines

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 Research Process

Identifying
problem

Reporting Reviewing
results literature

Research Setting
cycle research
Analyzing
questions,
data
objectives
hypothesis

Choosing
Collecting
research
data
design
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 Components of Research Protocol

1. Project title 6. Research

2. Project summary questions/hypothesis

3. Introduction 7. Research methodology

4. Rationale and justification 8. Data management and

of study statistical analysis
5. Objectives 9. Biases

10. limitations
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 Components of Research Protocol

11. Safety considerations 16. Work plan

12. Plan for supervision and 17. Ethical considerations
monitoring 18. Informed consent
13. expected outcome of the 19. Budget
study 20. References
14. Dissemination of research 21. Annexes
findings
15. Plan for utilization of the
research finding
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 Project Title
• Informative, accurate, clear, concise, and attention commanding.
• FINER CRITERIA:
F = Feasible
- adequate subjects, adequate expertise, affordable.
I = Interesting
- to health policy managers and researcher.
N = Novel
- fill the gap in existing knowledge.
E = Ethical
- ethically justifiable.
R = Relevant

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 Project Title cont..
• Acronyms avoided unless obvious- WHO, ICU
• No. of words restricted to 10-15
• Avoid question mark (?), semicolon (;) and slash (/)
• Avoid phrases like ‘a study of’ or ‘observations on’.
• Revisit or reevaluate at the end.

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 Example

“Pharmacotherapy for hospitalized patients with

COVID-19 at a tertiary care hospital .”

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 Project Summary

• Brief one page description (~250 words).

• All the central elements of the proposal like rationale,
objectives, methods, populations, time frame and expected
outcomes.
• Purpose of study achieve objectives expected outcome
• Should stand alone without need to refer to description.

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 Introduction

• Brief and appropriate historical backdrop followed by a

general statement of the problem
• Should describe the magnitude, frequency, affected
geographical areas, ethnic and gender considerations etc.
followed by a brief description of the most relevant studies
published on the subject.

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 Rationale and justification of the study

• Should specify the reasons for conducting the research.

• Should include a well-documented statement of the problem,
the cause of this problem and its possible solutions.
• Should strive to answer the question of why and what:
• Why the research needs to be done?
• What will be its relevance?

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 Research Objectives
• Clear, concise, declarative statements.
• Closely related to statement of problem.
• Summarize what is to be achieved.
• Characteristics:
 S = Specific

 M = Measurable

 A = Achievable

 R = Relevant

 T = Time Bound

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 Research Objectives cont..

• Use action verbs:

To determine, to compare, to verify, to describe, to

establish, to assess, to calculate, to demonstrate, to prove etc.
• Avoid vague non-action verbs:

to help, to assist, to appreciate, to understand, to

develop, to discover or to study.

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 Type of objectives

• General objective: what is to be accomplished by the

research project
• Specific objectives: relate to specific research questions the
investigator wants to answer through the purposed study

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 Type of objectives-Example
• General objective
 To access the use of medicines for hospitalized patients

with COVID-19.

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 Type of objectives-Example

• Specific Objective
 To identify medicine used for COVID-19 pneumonia
according to severity in past 6 months in TUTH.
 To determine the therapeutic class of different medicines
used for COVID-19 pneumonia in past 6 months in TUTH.

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 Research Questions
• Formulated based on FINER criteria
• Direct re-wording of General Objectives.

Example:
General objective: To access use of medicines for hospitalized
patients with COVID-19.
Question: what are the medicines used for hospitalized
patients with COVID-19 in a tertiary care hospital?

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 Research Hypothesis

• Prediction of a relationship between one or more variables

and the problem under study.
• Realistic, specific, clear, and testable.
• Not needed in descriptive studies.
• Null Hypothesis (H0): no association/relation
• Alternative Hypothesis(HA): association exists between
predictor and outcome variables.

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 Example

• There is no association between hospitalization and

pharmacotherapy with recovery of patients from
COVID-19 -Null
• There is association between hospitalization and
pharmacotherapy with recovery of patients from
COVID-19 - Alternative

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 Research Methodology

• Include complete description of the methods utilized.

• Should be replicable by another independent investigator.
• Should be well written and logically organized.
• Should describe in detail “where”, “who”, “how”, and “when”
of the research.

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 Research design

• Based on research questions, available resources, time and

natural history and prevalence of the disease.
• Research method: the strategies, processes or techniques
utilized in the collection of data or evidence for analysis in
order to uncover new information or create better
understanding of a topic. Qualitative, quantitative or a
combined study?
• Types of Study: Observational or interventional study?
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 Observational Experimental / intervention

Descriptive Analytic Controlled Non-controlled

case-control cohort Randomized Non-randomized

Retrospective
Prospective Retrospective

• Cross-sectional Single occasion

• Longitudinal Over a period of time
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 Study population

• What is the target population?

• What is the sampling frame?

Example: Target Population: All hospitalized patients with

COVID-19 in a tertiary care hospital
Sampling Frame: COVID 19 Patient hospitalized within past 6
months.

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 Study sites and Justification

• A study site is a place where study/research is conducted.

• Common research sites includes; geographic area, universities,
hospital..
• Justification: rationale for selecting the site for study. e.g High
prevalence of disease, high case load..

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 Sampling method

Non-Probability Probability
(Non-Random Sampling) (Random sampling)

Purposi
ve or Conveni Simpl
Quota
Judgme ence Snow e Syste Strati Clust Multi
Samplin
ntal Samplin ball rand matic fied er stage
g
samplin g om
g

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 Sample size
• Basis and method of determination including power of the
study, level of significance etc.
• Formula

• n=Sample size
• Z=abscissa of the normal curve that cuts off an area of tails
(desired confidence level)-e.g Z value for 95% confidence
limits=1.96
• p=prevalence
• q=1-p
• d= desirable error (0.05)

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 Sample size cont..

• Simplified formula for proportions

• n=sample size
• N=Known population of the study area
• e=allowable error

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 Inclusion and Exclusion criteria
• Inclusion criteria: the key features of the target population
that the investigators will use to answer their research
question.

• Exclusion criteria: the features of the potential study

participants who meet the inclusion criteria but present with
additional characteristics that could interfere with the success
of the study or increase their risk for an unfavorable outcome.

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 Study variables

• A characteristic under study of which an identity or value

changes or is possible to change per unit is called variable.
• A variable is a characteristic that varies in the context of its
value or identity e.g. height, weight, age, blood pressure
• Types
 Dependent
 Independent
 Qualitative
 Quantitative

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 Study variables cont..

• Independent: It is a variable that stands alone and isn't

changed by the other variables you are trying to measure.
• Dependent: the variable that is being measured or tested by
the researcher in the research.
• E.g; Pharmacotherapy for hospitalized patients with COVID-
19 at a tertiary care hospital. Here the independent variable
is Pharmacotherapy and the dependent variable is COVID
19

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 Study variables cont..

• Qualitative variable:

Example; gender: male/female, disease: present/absent,

vaccine: vaccinated/ not vaccinated, smoker/non smoker, pain:
none/ mild/moderate/severe
• Quantitative variable: Discrete variable- finite number/whole

Continuous variable- fractional

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 Study procedures

• Interventions, procedures, measurements, observations clearly

mentioned.
• Expected time and duration of the study.
• Plan for follow up.
• RCT- randomization, blinding, stopping rules etc. should be
described.
• A graphic outline of the study design and procedures using a
flow diagram including the timing of assessments.
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 Data collection method and instruments
used
• Instruments:

- Manufacturing company, city, country name.

-Validity and reliability of the instrument.
- Person performing interventions/ observations.
• Tools/ techniques used to collect data:

- Clinical examination, laboratory tests

- Chart review
- Questionnaires, interview
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 Data management and statistical
analysis

• Provide information on data management, including data

coding for computer analysis, monitoring and verification.
• Procedures for accounting for any missing or spurious data
etc.
• Statistical tests used should be clearly outlined.
• Mention the software and version of computer programs.

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 Bias

• All studies are potentially subject to bias.

• Mention the potential biases

(selection, measurement, recall, observer)

• Methods to address such biases.

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 Limitations

• Influences beyond the researchers’ control.

• Potential weakness of the study.
• Each limitation duly acknowledged and described.
• Explain why it is inevitable.

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 Expected outcome of the study

• Indicate influence of results in advancement of existing

knowledge.
• How the results will affect health care, health systems, or
health policies in a broader sense.

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 Dissemination of research findings

• Planned process involving target audience.

• Specify how and to whom (journals, conferences, university
research committee)
• Clear description of publication policy (number and order of
authorship) for scientific journal.

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 Work plan

• Should describe how researcher intend to complete the project

on a realistic and achievable timescale.
• Should include duration of the study, tentative date of starting
the project and work schedule.
• Gantt chart is commonly used for this purpose.

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 Gantt Chart
Activities Aug Sep Oct Nov Dec Jan Feb
Literature Review
Topic Selection
Proposal Devlopment
Proposal Presentation
Data Collection
Data Analysis
Report Drafting
Dissemination of
Findings
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 Ethical considerations

• Safety of participants should be ensured.

• Special emphasis on selection of human participants.

• Informed consent and participants responsibilities clearly

indicated.
• Any risks (physical, social, psychological) should be justified.

• Mention any benefits (direct and indirect).

• Separate information sheet provided to the participants should

be included.
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 Ethical considerations contd..

• Approval by ethics review committee:

 For studies in humans:

Local, institutional or equivalent ethics committee and/or

national ethics committee.
 For animal studies:

Animal welfare committee of the institute or its equivalent.

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 Informed consent
• (Informed consent form along with an information sheet should
be submitted in English and Nepali language and also in the
language of the research participants if s/he does not understand
Nepali and English)
• Information required in the informed consent form include but
is not limited to:
 Consent by patient/subject/legal guardian.
 Declaration that participants have understood all the
information in the consent form and are willing to volunteer.
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 Informed consent cont.
 Participants can withdraw from the study at any time without
giving reason and without fear. State clearly how the
participants can opt out the study.
 Guarantee of confidentiality of the research participants.
 Any compensation that might be given to the research
participants and or their community (if applicable).
 Signature space for the research participants, a witness, and
the date.
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 Budget

(Should include financial provision necessary for carrying out the

research up to dissemination of research findings.)
• Budget table
• Budget justification
• Source of budget
• Sponsor, if any

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 References

1. Sharma MR. Principles of Health Science Research. First.

Kathmandu: Samiksha Publication Pvt Ltd; 2021. 155 p.
2. Patino CM, Ferreira JC. Inclusion and exclusion criteria in research
studies: Definitions and why they matter. J Bras Pneumol.
2018;44(2):84.
3. Goyal R. Research Methodology for Health Professional including
proposal, thesis and article writing. First. New Delhi: Jaypee Brothers
Medical Publishers; 2013. 288 p.
4. Pant PP. Biostatistics. First. Kathmandu: Vidyarthi Pustak Bhandar;
2012. 309 p.
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 References

5. Hunter DJ. Evidence-based management: a practical guide for

health professionals. Vol. 3, International Journal of Integrated
Care. 2003.
6. IOM-IRC Research Proposal Format - 2020.

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 Annexes

a. Pro forma sheet

b. Data collection instruments including questionnaires
c. Information to participant sheet
d. Informed consent form
e. List of abbreviations
f. Recently updated CV of principal investigator (PI) and
other investigators.

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 Thank you

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