Mount Kenya University – Thika Campus

Medical School
Department of Medical Biochemistry

MBCU001: RESEARCH METHODOLOGY AND PROPOSAL WRITING

Contact Hours: 42 Hours

Program: MBChB; Credits: Lecture 3 hrs/ week.
Year 3 Semester 2: January - April 2025; Meetings: Wednesdays 7-10 AM; Room: CT 1.4A
Lecturer: Dr Paul Sifuna; Email address: poshule@[Link] Office: Room CT 2.2B

COURSE OBJECTIVE
To equip the learner with knowledge and skills in research proposal writing, data
collection, analysis and dissemination of results.

Expected Learning Outcome

By the end of the course unit, the learner will be able to:
i. Conduct scientific enquiry through pertinent literature
ii. Identify necessary resources, design and write a research plan and conduct a study or
an experiment.
iii. Be able to collect data in a systematic, organized method in response to research
questions.
iv. Analyze collected data, interpret and present a report in form of a manuscript, poster,
abstract, etc.

Course Description
Introduction to Research and Research Methods: Definition, concepts, use and application of
research; Classification of research: Participatory, Operational, Evaluative, Basic, Applied,
Empirical, Formal and Informal research. Research methods: Rational methods, Mystical
methods, Scientific methods, Methods based on authority, Qualitative and Quantitative methods.
Research proposal Development: Selection and formulation of a research problem and steps in
proposal and protocol development; Problem identification, formulation of objectives and
variables; Literature review and identification of gaps in knowledge. Research project design and
implementation: Factors determining the selection of a research design; Types of research study
designs, purposes and pitfalls; Factors determining the selection of a research design; Simple
experimental study design and complex experimental designs. Observational, cross-sectional,
and longitudinal study design, Quasi-experimental, Single-Subject, Qualitative and
Developmental Research and Surveys Designs. Sampling and Data collection methods:

1
 Sampling and sampling strategies or plans; Measurement and scaling techniques and
Questionnaires; Sampling and sampling strategies or plans; Questionnaire designs and extraction
of information. Research and Ethics in Biomedical Sciences: Application of ethics and
regulation of research Application of ethics and regulation of research; Fundamental ethical
principles; respect of persons and justice; Risks and benefits of research: physical, psychological,
social and economic; minimization of risk; maximization of benefits and justification of risk,
Helsinki declaration; Good clinical and laboratory practice. Writing Research Report:
Dissemination and presentation of results - printed, electronic, oral; Features of scientific writing
- publication, articles, perspectives, reviews, editorials, books; Title, Author, abstract,
introduction, literature, results, discussion, conclusions, references, acknowledgements; Seminar
and publications; Posters: Development and presentation.

COURSE OUTLINE

Week Topic Sub-topic

 Definition, concepts, use and application of research
1 Introduction to  Classification of research: Participatory, Operational, Evaluative,
Research and Basic, Applied, Empirical, Formal and Informal research
Research  Research methods: Rational methods, Mystical methods,
Methods Scientific methods, Methods based on authority, Qualitative and
Quantitative methods
Research  Selection and formulation of a research problem and steps in
 2 -3 proposal proposal and protocol development
Development  Problem identification, formulation of objectives and variables
 Literature review and identification of gaps in knowledge

 Factors determining the selection of a research design

4- 5 Research  Types of research study designs, purposes and pitfalls
project design  Simple experimental study design and complex experimental
and designs
implementation
 Observational, cross-sectional, and longitudinal study design,
 Quasi-experimental, Single-Subject, Qualitative and
Developmental Research and Surveys Designs

Sampling and  Sampling and sampling strategies or plans

6-7 Data collection  Measurement and scaling techniques and Questionnaires
methods  Questionnaire designs and extraction of information

8 Assessment CAT I

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 9 Research and  Application of ethics and regulation of research
Ethics in  Fundamental ethical principles; respect of persons and justice
Biomedical  Risks and benefits of research: physical, psychological, social
Sciences and economic; minimization of risk; maximization of benefits
and justification of risk, Helsinki declaration
 Obtaining informed consent

10  Good clinical and laboratory practice

 Features of scientific writing - publication, articles, perspectives,

11-12 Writing reviews, editorials, books
Research  Components of a research article: Title, Author, abstract,
 Report introduction, literature, results, discussion, conclusions,
and Research references, acknowledgements
results
dissemination  Dissemination and presentation of results - printed, electronic,
oral
 Posters: Development and presentation

13 Assessment End Term Examination

Learning and teaching methodologies: Lectures, tutorials, Assigned project.

Assessment: Continuous Assessment Test

REFERENCE MATERIALS

1. Kothari C. K. (2004). Research Methodology: Methods and Techniques 2nd Ed., New Age
International Ltd, New Delhi.

2. Olive M. Mugenda (1999). Research Methods: Quantitative and Qualitative Approaches,

ACTS Press; Nairobi.

3. Kumar, R. (2005). Research Methodology A Step to Step Guide for Beginners, 2nd ed., Sage
Publications Ltd, London. U.K.

4. Hammersley, M. and Traianou, A. (2012). Ethics in Qualitative Research: Controversies and

Contexts, Sage Publications Ltd, Los Angeles. USA.

3
 Why all medical students need to experience
research
Prof Christine Bennett AO
Saturday, June 4th, 2016

Professor Christine Bennett AO

MBBS, FRACP
Dean, School of Medicine, Sydney, the University of Notre Dame Australia

Professor Bennett is the Dean of Medicine at the University of Notre Dame Australia (Sydney); Chair of
Research Australia – an alliance of over 170 member organisations promoting health and medical research in
Australia; The Sydney Children’s Hospitals Network in NSW; and the Bupa Health Foundation Steering
Committee.

Prof Christine Bennett AO

Medical students are very busy. The demands of studying medicine are extraordinary.
Why then is it so important, on top of all there is to learn, to bother engaging in health
and medical research? It is particularly important to consider this question at a time
when, nationally and internationally, medical schools are including a research project as
either a requirement of their program or a highly encouraged option. In fact, the
Australian government is now supporting research by medical students with a specific
category of scholarship funding from the National Health and Medical Research Council
(NHMRC) available to students undertaking in a combined MBBS/PhD or MD/PhD
program. [1]

As a Dean of Medicine, and passionate advocate of health and medical research (HMR)
in Australia, I support the inclusion of research in medical programs. Research training
1
and experience are not just ‘nice to have’ but a ‘must’ for our doctors of the future.
Increased research training in medical programs is beneficial for a student’s
professional pathway, their evolving practice and, most importantly, for the health of the
patients and communities they serve. [2,3]

Demonstrated research experience at medical school is increasingly important in

obtaining positions in training programs post-graduation. [4] Recognition of the
importance of HMR in developing and applying the skills and knowledge acquired in
their medical studies has seen many of the specialist colleges including research
training and productivity (for example publications) in their approach to selection of
trainees. Competition for vocational and advanced training places is fierce, and a
professional resume that includes research productivity and qualifications is and will
continue to be important. Some colleges may even move to requiring a PhD for entry
into advanced training.

A research experience may be the first time a student has had to write and record what
they do, think, and find coherently, concisely and precisely. This can contribute to
developing lasting habits of critical thinking. In a landmark and classic essay, C. Wright
Mills commented that there was never a time he was not thinking, reflecting, analysing,
and writing – he was always working on an idea. [5] This is the mindset that research
can build up, and this is surely the mindset we want in clinical medicine and population
health, where continuing critical appraisal of new evidence and engagement with new
ideas is vital. In addition to stimulating ongoing interest in learning, this intellectually
curious mindset contributes to a sense of personal satisfaction and eagerness to
engage in discovery and learning as part of a team. [3,6] Research achievements are
rarely made by individuals in isolation. Developing a mindset of critical inquiry in
individuals and teams clearly encourages research productivity in grants and
publications in the longer term, [3] which can ‘future-proof’ careers at a time when
research performance is important in professional esteem and progression. Even more
importantly, involvement in research appears to improve clinical practice. Research-
active healthcare providers appear to provide better care and achieve better patient
outcomes, [7] making the investment of time in research training for medical students
potentially very important to building a healthier society in the long term. Given the
potential benefits to early career clinicians and to patients, it is important to expose
recent medical graduates to research as well, and successful postgraduate training
programs are also taking steps to include research training. [3,8]

So, what is the best way for medical schools and postgraduate training programs to
provide research training that maximises these benefits? It is clear from the literature
that the most important thing is to have protected time to pursue research. Whether the

2
research is a programmed experience as part of a course (as is increasingly the case),
or something pursued independently by the individual student or trainee, giving as much
time as possible is key to getting the best quality outcomes. For recent graduates,
hospitals need to allow time to do research. [8] For students, time should be set aside
within the program. [4] Students and trainees also need to be mentored by experienced
researchers to get the best results. [3] Research experiences for students and trainees
that combine mentorship and protected time can deliver the biggest benefits to our
future clinical leaders and society as they are most likely to result in high quality outputs
that are published and improve knowledge and practice. Where possible, trainees
without research degrees should try to enrol in these at the same time as pursuing their
research experiences, through a university that offers flexible research training and
options to submit theses by publication, as earning a research degree such as a PhD is
increasingly becoming a prerequisite for obtaining research funding that can support a
clinical research career.

In summary, more than ever before, being a doctor in the 21st century is a career of
lifelong learning. The combination of continued, rapid growth in knowledge and
advancing technology bringing that information to your fingertips, have brought both a
richness to the practice of medicine as well as a challenge. There is a growing
appreciation that researchers make better clinicians. Research exposure increases
understanding of clinical medicine; facilitates critical thinking and critical appraisal;
improves prospects of successful application for post graduate training, grants, and high
impact publications; develops teamwork skills; and increases exposure to the best
clinical minds. The government is lifting its investment in health and medical
researchers like never before. The establishment of the Medical Research Future Fund
by the Australian Government, for example, offers the promise of continued durable
investment in HMR and innovation, and the NHMRC’s substantial investment in
research training scholarships for current students and recent graduates signals the
Government’s commitment to developing clinician researchers for the future.

I encourage all students to make the most of research opportunities in medical school
and beyond, not only for the personal and professional benefits, but in contributing to
the health of their patients and to the Australian community.

3
References

[1] NHMRC Funding Rules 2015: Postgraduate Scholarships – 6 Categories of Award – 6.2. Clinical
Postgraduate Scholarship. 2015. [Link] (accessed Nov 2015).

[2] Laidlaw A, Aiton L, Struthers J, Guild S. Developing research skills in medical students: AMEE guide no. 69.
Med Teach. 2012;34:754–71.

[3] Lawson PJ, Smith S, Mason MJ, Zyzanski SJ, Stange KC, Werner JJ, Flocke SA. Creating a culture of
inquiry in family medicine. Fam Med. 2014;46(7):515–521.

[4] Collier AC. Medical school hotline: importance of research in medical education. Hawai’i Journal Med Public
Health. 2012;71(2):53-6.

[5] Mills, CW. On intellectual craftsmanship. In: Seale, C. Editor. Social research methods: A reader. London:
Routledge, 2004.

[6] von Strumm S, Hell B, Chamorro-Premuzic T. The hungry mind: intellectual curiosity is the third pillar of
academic performance of university. Perspect Psychol Sci. 2011;6(6):574-88.

[7] Selby P, Autier P. The impact of the process of clinical research on health service outcomes. Ann Oncol
2011;22(Suppl 7):vii5-vii9.

[8] Chen JX, Kozin ED, Sethi RKV, Remenschneider AK, Emerick KS, Gray ST. Increased resident research
over an 18-year period – a single institution’s experience. Otolaryngol Head Neck Surg. 2015;153(3):350-6.

4
Lecture 2

Research proposal
development
 Lecture outline

I. Define a research proposal

II. Components of a research
proposal
III. Do’s and Don'ts when writing a
research proposal
IV. Define a concept note
 Some basic ideas
Question

Doubt

Confidence

Four Questions
What data / evidence do I need?
What will be the source of that data / evidence?
How will I collect that data / evidence?
How will I analyze that data / evidence?
 What is a Research Proposal?

“A research proposal is a document that

describes the essential features of a study
to be conducted in the future, as well as the
strategy whereby the inquiry may be
logically and successfully accomplished.”

Busha & Harter, Research Methods in Librarianship, p. 343.

Research Proposal Writing

• Research Proposal Basics

• Writing a Good Proposal

• Tips and Common Errors

 What Makes a Good Proposal?

• A good idea or compelling project

• Research addresses a significant problem

• Clear description of the research activities

• A good fit with funding agency’s priorities

 Factors We Can’t Control

• Internal politics within the funding agency

• Stiff competition from other applicants

• Limited availability of funds for certain

program areas within funding agency

*This applies to funded research proposals

 Factors We Can Control

• Quality of our own proposal

– Requires careful research and planning

– Requires meticulous execution

 Common Components of a
Research Proposal

• Summary / Abstract • Data Analysis

• Introduction / • Bibliography
Statement of the
• Timeline
Problem
• Budget/Cost
• Review of the
Effectiveness
Literature
• Appendices
• Methodology
 Cover/Title Page
• Use sponsor agency form if applicable
• Use required guidelines (MLA, APA, EEE, for
title page

– Project title
– Organization name
– Sponsor agency name (if applicable)
– Submission date
Project Summary / Abstract

• One page

• State problem

• Propose solution

• State project objectives and significance

 The Introduction
• What specific need or problem does your
research address?

• How was the need identified and its

significance?

• Who will benefit from the proposed research

project?

• What are the research questions and/or

objectives of the proposal
Project Research Questions / Objectives

• Bullet list research questions or objectives

• Should be action-oriented

• Relate to identified needs

• Relate objectives to sponsor agency’s goals

and priorities
 Developing Research Questions

• Clear and concise

• Feasible

• Should drive the research

methodology
 Developing Conceptual
Framework
• The definition of a conceptual framework.

• Where the conceptual framework appears in the

research.

• Developing the conceptual framework.

• The presentation of the conceptual framework.

• The good and bad of conceptual frameworks.

 What is a Conceptual
Framework?
A written or visual presentation that:

– “explains either graphically, or in narrative

form, the main things to be studied – the key
factors, concepts or variables -

– and the presumed relationship among them”.

(Miles and Huberman, 1994, P18)

 Where does the conceptual framework fit in -
quantitative?
• Research problem: The issue of theoretical or practical interest.

• Paradigm: The philosophical assumptions about the nature

of the world and how we understand it -
positivism.
• Aims and objectives: What we want to know and how the answer may
be built up.
• Literature review: A critical and evaluative review of the thoughts
and experiences of others.
• Conceptual framework: Provides the structure/content for the whole
study based on literature and personal
experience
• Research questions: Specific questions that require answers.
• Data collection and analysis: Methodology, methods and analysis.
• Interpretation of the results: Making sense of the results.
• Evaluation of the research: Revisit conceptual framework.
 How to develop theoretical framework or
conceptual framework
1. Select Concepts:
 A concept is an image or symbolic representation of an
abstract idea, e.g: health pain, intelligence

2. Identify the interrelationships among concepts (Logical

propositions about the relations among the concepts).

3. Formulating clear definitions (Conceptual and

operational definition).
 Some concepts are easily defined, e.g: BP

4. Formulating the theoretical rationale.

 Theoretical connections between variables can identified and
confirmed.
What general forms might a conceptual framework
take?

• Flow charts.
• Tree diagrams.
• Shape based diagrams – triangles, concentric
circles, overlapping circles.
• Mind maps.
• Soft systems.
Why are conceptual frameworks useful?
• Conceptual frameworks provide researchers with:

– The ability to move beyond descriptions of ‘what’ to

explanations of ‘why’ and ‘how’.

– A means of setting out an explanation set that might be used to

define and make sense of the data that flow from the research
question.

– An filtering tool for selecting appropriate research questions

and related data collection methods.

– A reference point/structure for the discussion of the literature,

methodology and results.

– The boundaries of the work.

 Limitations of a conceptual framework?

• Conceptual frameworks, however, also have problems in

that the framework:

– Is influenced by the experience and knowledge of the

individual – initial bias.

– Once developed will influence the researcher’s

thinking and may result in some things being given
prominence and others being ignored – ongoing bias.

• The solution is to revisit the conceptual framework,

particularly at the end when evaluating your work.
 Testing theories
• Testing theory is about comparing between the
observed results with what hypothesized.
• Theories and conceptual model might be
discredited or revised.
• “Hypotheses and theories cannot be confirmed or
proven, no matter how much evidence ….they
may be falsified”
(Pedhazur & Schmelkin,1991, p:184).

Theory testing studies:

• 1. logical deduction
• 2. design study avoiding any other explanation
Review of the Literature
Review of Related Literature – Important Information

• Information concerning theory – findings

• Information concerning methods

• Information concerning data analysis

• Strengths and weaknesses

[Research summary note for each study]

 Purposes of Literature Review - 1

• Familiarity with the field of inquiry

• Provides a context for the proposed study

• Generation of research questions or

hypotheses for further studies

• Knowledge of the methodologies common

to the field
 Purposes of Literature Review - 2
• Can reveal sources of data that you may not
have known existed

• Demonstrates why it is important and timely

• To avoid or solve problems others have

encountered in their research (Limitations)

• Increase your confidence in your topic because

others have invested considerable time, effort,
and resources in studying it.
Steps in Conducting Literature Review - 1
1. Identify a research topic

2. Identify keywords/descriptors that are useful in locating

relevant information material

3. Develop a search strategy for the literature review

4. Search preliminary sources

5. Select relevant primary and secondary sources

6. Search the library for identified primary and secondary

sources
 Steps in Conducting Literature Review - 2
7. Establish a computer and paper trail including research
summaries that will be used in the literature review
8. Repeat step 4–7 as needed to refine search

9. Develop themes/concepts that synthesize the literature

10. Relate the themes/concepts to one another through an

outline of the literature review, or a literature map
11. Produce a final literature review organizes the literature
thematically or by important concepts
12. Use the literature review to develop or refine the
research objectives, questions, and hypothesis
 Methodology
• Subjects – Describe Sample

• Design – Type of Design Used and

Sequence of Events

• Data Collection – Description of variables,

control, measurements
 Data Analysis
• Describe how collected data will be
analyzed

• What are the effects to be analyzed

• Analysis should meet project objectives or

• Should be linked to the hypotheses and clear

how each hypothesis will be tested
 Data Analysis…
Mertler and Charles (2005) identified a number of different purposes
for using statistics. Specifically, statistics can:
1. Summarise data and reveal what is typical and atypical within a group;
2. Identify the relative standing of individuals within an identified cohort;
3. Show relationship between and among variables;
4. Show similarities and differences among groups;
5. Identify error that is inherent in a sample selection;
6. Test for significance of findings;
7. Support the researchers in making other inferences about population
8. Condense a vast body of data into an amount of information that the
mind can more easily understand.
9. Identify patterns and relationships within the data that they may
otherwise go unnoticed.
Statistical software:
• Refers to tools that assist in collecting and analyzing data
to provide science-based insights into patterns and trends.
• They often use statistical analysis theorems and
methodologies to perform data science, such as
regression and time series analysis.
 Time Frame & Work Schedule
• The proposal should include the sequence of tasks
to be performed, the anticipated length of time
required for its completion and the personnel
required.

• It can be presented in tabular or graphic form

(Gantt chart)

• Flow charts and other diagrams are often useful

for highlighting the sequencing and
interrelationship of different activities in the study.
 What about Facilities?
The proposal should also include the important
facilities required / available for the study namely
computers, laboratories, special equipment, etc.

Personnel needed?
• Proposal should include who are the primary investigators
and co- investigators, their qualifications, research
experience, etc.
• The proposal may also include the Major roles to be taken
up by different investigators.
 Role of Budget
• The budget translates project activities into monetary terms
• It is a statement of how much money will be required to
accomplish the various tasks.

• Major items in the budget

– Salary for staff
– Travel
– Purchase of equipment
– Printing / Xeroxing
– Consultancy charges
– Institutional overheads
 Summary of a Good Proposal . . .
1. Starts with a good idea 6. Describes need for
research, objectives,
2. Is carefully researched plan of operation,
expected outcomes,
3. Matches a particular
evaluation plan,
sponsor’s priorities
sustainability and
4. Is neat and well written timeline

5. Follows guidelines 7. Demonstrates cost-

carefully effectiveness
 Common, easy-to-avoid mistakes

• Don’t follow directions (font, margins, pages,

appended material, etc.)
• Format
• Not allowing enough time
• Careless criticism of other scholars in the field
• Don’t include all who, what, where, when, why,
and how info., up front
 Other common problems…

• Research problem itself

• Scholarly background to the problem—uneven or
inadequate or erroneous
• Writing is unclear—too much jargon, not
accessible, or not well organized
• Methods and work plan unclear or undefended
• Lack of specificity
What is a concept note?
• A concept note is a brief outline of
the project you have in your mind.
• A simple version of it will include
an introduction, a background,
proposed objectives and results
and a budget overview.
• Ideally, it should not be more than
2-3 pages
Next lecture

Research project design

and implementation
Lecture 3

Research project design

and implementation
 Lecture outline

I. Study designs
II. Experimental designs
 Study design: Definition

A study design is a specific plan or

protocol for conducting the study,
which allows the investigator to
translate the conceptual hypothesis
into an operational one.
 Study Designs: Types
1. Qualitative
2. Quantitative
– Experimental

– Observational
» Basic
» Hybrid
» Incomplete
Qualitative Quantitative
 Methods  Methods
 Focus Groups
 Observational
 Interviews  Experimental
 Surveys  Mixed
 Self-reports  Sampling: Random
 Observations (simple, stratified,
 Document analysis cluster, etc) or
purposive
 Sampling: Purposive

 Quality Assurance:  Quality Assurance:

 Trustworthiness: Credibility,  Reliability: Internal
Confirmability, Dependability, and External
Transferability  Validity: Construct,
 Authenticity: Fairness, Content, Face
Ontological, Educative, Tactical,
Catalytic
 Qualitative Research Techniques
• Participant observation (field notes)
• Interviews / Focus group discussions
with key informants
• Video / Text and Image analysis
(documents, media data)
• Surveys
• User testing
Qualitative research techniques
involves skills of:
• Observing

• Conversing

• Participating

• Interpreting
 Quantitative designs
• Observational: studies that do not
involve any intervention or
experiment.

• Experimental: studies that entail

manipulation of the study factor
(exposure) and randomization of
subjects to treatment (exposure)
groups
 Study populations
 Cross-sectional: where only ONE set of
observations is collected for every unit in the
study, at a certain point in time, disregarding the
length of time of the study as a whole.
 Study populations…
Longitudinal: where TWO or MORE sets
of observations are collected for every unit
in the study, i.e. follow-up is involved in
order to allow monitoring of a certain
population (cohort) over a specified period
of time. Such populations are AT RISK
(disease-free) at the start of the study.
What kinds of research questions require longitudinal methods?

Questions about systematic change over time Questions about whether and when events occur

• Espy et al. (2000) studied infant neuro- • South (2001) studied marriage duration.
development. • 3,523 couples.
• 20 infants exposed to cocaine, 20 controls. • Followed for 23 years, until divorce or until the
• Each observed daily for 2 weeks. study ended.
• Infants exposed to cocaine had lower rates of • Couples in which the wife was employed
neuro-development. tended to divorce earlier.

1. How does an infant’s neuro-functioning 1. Does each married couple eventually divorce?
change with time? 2. If so, when are couples most at risk of
2 What’s the rate of development? divorce?
3 How does the rate of development vary by 3. How does the risk of divorce vary by couple
child characteristics? characteristics?

Individual Growth Model/ Discrete- and Continuous-Time

Multilevel Model for Change Survival Analysis
 Types of Longitudinal studies…
• Panel study: a sample of people from a more significant
population and is conducted at specified intervals for a
more extended period.

• Cohort Study: a cohort (a group of people who typically

experience the same event at a given point in time).
Medical researchers tend to conduct cohort studies. Some
might consider clinical trials similar to cohort studies.

• Retrospective study: A retrospective study uses already

existing data, collected during previously conducted
research with similar methodology and variables.
 Case - Control Studies
Characteristics: two source populations;
assumption that non-cases are representative
of the source population of cases.
Merits: least expensive; least time-
consuming; suitable for study of rare
diseases (especially NCDs)
Limitations: not suitable for rare exposures;
liable to selection bias and recall bias; not
suitable for calculation of frequency measures.
 Cohort Studies
• Characteristics: follow-up period
(prospective; retrospective)

• Merits: no temporal ambiguity; several

outcomes could be studied at the same time;
suitable for incidence estimation

• Limitations (of prospective type): expensive;

time-consuming; inefficient for rare diseases;
may not be feasible
 Ecological studies
 These are studies where exposure data relating to a
place (say hardness of water, which could be
collected on individuals) are correlated with health
data collected on individuals but summarised by
place (say CHD rates).

 Conceptually, the ecological component in this

kind of study is an issue of data analysis and not
study design.

 What is missing: relationship b/n exposure and

outcome at the individual level (incomplete design)
Experimental Designs
 Experimental Study Design

A study in which a population is

selected for a planned trial of a
regimen, whose effects are measured
by comparing the outcome of the
regimen in the experimental group
versus the outcome of another
regimen in the control group.
 Why it is Performed ?
1. Provide stronger evidence of the effect (outcome)
compared to observational designs, with maximum
confidence and assurance
2. Yield more valid results, as variation is minimized
and bias controlled
3. Determine whether experimental treatments are
safe and effective under “controlled environments”
(as opposed to “natural settings” in observational
designs), especially when the margin of expected
benefit is doubtful / narrow (10 - 30%)
 Types of trials
Diagramtitel

Trial

Controlled Not controlled

Randomised Not randomised

Blinded Not blinded

 Blind trials
• The people taking part don't know which
treatment they are getting. They could be one of
the following:
• the new treatment
• the standard treatment
• a placebo
• This depends on the design of the trial. All
patients have identical injections or tablets, so
they can't tell which treatment they are having.
 Double-blind trials
• Neither the researchers nor the patients know
what they are getting.
• The computer gives each patient a code number.
And the code numbers are then allocated to the
treatment groups. Your treatment arrives with
your code number on it. Neither you nor your
doctor knows whether it is the new treatment or
not.
• The list of patients and their code numbers are
kept secret until the end of the trial.
How should an RCT
be designed?
Check out reference by A. Bhide et al. sent to class email
Random Controlled Trial (RCT)
• Type of scientific (often medical) experiment that
aims to reduce certain sources of bias when testing
the effectiveness of new treatments.
• Experimental group - receiving the intervention
that is being tested
• Comparison group or control - receiving an
alternative (conventional) treatment.

• The two groups are followed up to see if there are

any differences between them in the outcome.
Random Controlled Trial (RCT) - advantage

– The “gold standard” of research designs. They

thus provide the most convincing evidence of
relationship between exposure and effect.

Example:
Trials of hormone replacement therapy in
menopausal women found no protection
for heart disease, contradicting findings
of prior observational studies.
 RCT - disadvantages

• Large trials (may affect statistical power)

• Long term follow-up (possible losses)

• Compliance

• Expensive

• Public health perspective ?

• Possible ethical questions

Overlap in the conceptual basis of quantitative study designs
• The cross-sectional study can be repeated
• If the same sample is studied for a second time i.e. it is
followed up, the original cross-sectional study now
becomes a cohort study.
• If, during a cohort study, possibly in a subgroup, the
investigator imposes an intervention, a trial begins.
• Cohort study also gives birth to case-control studies, using
incident cases (nested case control study).
• Cases in a case-series, particularly a population based one,
may be the starting point of a case-control study or a trial.
• Not every epidemiological study fits neatly into one of the
basic designs.
 Conclusion
• Qualitative designs are complementary to
quantitative designs, are important in study of
social determinants of health problems

• Quantitative designs have a common goal to

understand the frequency and causes of
health-related phenomena

• Seeking causes starts by describing

associations between exposures (causes) and
outcomes
Next lecture

Sampling and Data collection tools

Lecture 4

Sampling and Data

collection tools
 Lecture outline

I. Sample size determination

II. Sampling

III. Data collection tools

 Sample size
• This is the minimum sample size you need to
estimate the true population proportion with the
required margin of error and confidence level.
• Note that if some people choose not to respond
they cannot be included in your sample and so if
non-response is a possibility your sample size will
have to be increased accordingly.
• In general, the higher the response rate the better
the estimate, as non-response will often lead to
biases in your estimate.
 Determining Sample Size
• What data do you need to consider?
– Variance or heterogeneity of population
– The degree of acceptable error (confidence
interval)
– Confidence level

– Generally, we need to make judgments on all

these variables
 Determining Sample Size…
• Variance or heterogeneity of population
– Previous studies? Industry expectations?
Pilot study?

– Sequential sampling

– Rule of thumb: the value of standard

deviation is expected to be 1/6 of the
range.
 Determining Sample Size - STAGES

1. Consider your sample size variables

–Population size
–Margin of Error
–Standard deviation

2. Calculate the sample size

Find your Z- score
Use the sample size formula
 How to find your Z- score
• You need to turn your confidence level into a Z-
score. Here are the Z-scores for the most common
confidence levels:

90% – Z Score = 1.645

95% – Z Score = 1.96
99% – Z Score = 2.576
*Sometimes a Z-score table can also be applied
 Determining Sample Size - Example

Assuming you chose

a 95% confidence
((1.96)2 x .5(.5)) / (.05)2
level, .5 standard (3.8416 x .25) / .0025
deviation, and a .9604 / .0025
margin of error 384.16
(confidence interval) 385 respondents needed
of +/- 5%.
 Determining Sample Size…
Formulas:
Means n = (ZS/δ) 2
Proportions n = Z2 pq/ δ2
Percentiles n = pc (100 – pc) Z2/ δ2

Z at 95% confidence = 1.96

Z at 99% confidence = 2.58
Determining Sample Size…
 Sample Size (Mean)
Exercise 1
• We are about to go on a recruitment drive to hire some
auditors at the entry level. We need to decide on a
competitive salary offer for these new auditors. From
talking to some HR professionals, I’ve made a rough
estimate that most new hires are getting starting salaries in
the 138,000/- - 162,000/- range and the average (mean) is
around 149,000/-. The standard deviation seems to be
around13,000/-.
• I want to be 95% confident about the average salary and
I’m willing to tolerate an estimate that is within 5000/-
(plus or minus) of the true estimate. If we’re off, we can
always adjust salaries at the end of the probation period.
• What sample size should we use?
 Sample Size (Proportion)
Exercise 2
• We’ve just started a new educational TV program that
teaches viewers all about research methods!!
• We know from past educational TV programs that such a
program would likely capture 2 out of 10 viewers on a
typical night.
• Let’s say we want to be 99% confident that our obtained
sample proportion of viewers will differ from the true
population proportions by not more than 5%.
• What sample size do we need?
 Sample size (Percentage)

Exercise 3

• We wish to determine the required sample size

with 95% confidence and 5% error tolerance that
the percentage of citizens preferring the Party A.

• A recent poll showed that 40% of Citizens

questioned preferred party B.

• What is the required sample size?

 A look at how
sampling is carried
out
Reference was sent your class email

Chapter 7. Sampling Techniques

 Sampling
• A sample is “a smaller (but hopefully representative)
collection of units from a population used to determine
truths about that population” (Field, 2005)
• Why sample?
– Resources (time, money) and workload
– Gives results with known accuracy that can be
calculated mathematically
• The sampling frame is the list from which the potential
respondents are drawn
– Registrar’s office
– Patients records
– Class register
– Must assess sampling frame errors
 Sampling…
• What is your population of interest?
• To whom do you want to generalize your
results?
–All doctors
–School children
–Indians
–Women aged 15-45 years
–Other

• Can you sample the entire population?

 Sampling……
• Three factors that influence sample
representative-ness
• Sampling procedure
• Sample size
• Participation (response) (attrition rate)

• When might you sample entire population?

• When your population is very small
• When you have extensive resources
• When you don’t expect a very high response
 What do you want Theoretical
to generalize to? Population
What population can The study
you get access to? population
How can you get What is your
access to them? sampling frame?

Who is in your
study? The sample

SAMPLING BREAKDOWN 19
 Sampling Frame
• It is possible to identify and measure every
single item in the population and to include
any one of them in our sample.
• As a remedy, we seek a sampling frame
which has the property that we can identify
every single element and include any in our
sample .
• The sampling frame must be representative
of the population
Sampling Frame

STUDY POPULATION

SAMPLE

TARGET POPULATION
 The sampling process
Comprises several stages:
– Defining the population of concern
– Specifying a sampling frame, a set of items or
events possible to measure
– Specifying a sampling method for selecting
items or events from the frame
– Determining the sample size
– Implementing the sampling plan
– Sampling and data collecting
– Reviewing the sampling process 23
 Types of Sampling
• Probability (Random) Samples
• Simple random sample
– Systematic random sample
– Stratified random sample
– Multistage sample
– Multiphase sample
– Cluster sample

• Non-Probability Samples
• Convenience sample
• Purposive sample
• Quota
 Simple Random Sampling…
• Estimates are easy to calculate.
• Simple random sampling is always an “equal
probability selection” (EPS) design, but not all EPS
designs are simple random sampling.

• Disadvantages
• If sampling frame large, this method impracticable.
• Minority subgroups of interest in population may
not be present in sample in sufficient numbers for
study.
 Systematic Sampling……
All elements have same probability of selection (in the
example, one in ten). It is not 'simple random sampling'
because different subsets of the same size have different
selection probabilities - e.g. the set {4,14,24,...,994} has
a one-in-ten probability of selection, but the set
{4,13,24,34,...} has zero probability of selection.
 Stratified Sampling…….

Draw a sample from each stratum

 Cluster Sampling
• Cluster sampling is an example of 'two-stage
sampling'
• First stage a sample of areas is chosen;
• Second stage a sample of respondents within
those areas is selected.
• Population divided into clusters of homogeneous
units, usually based on geographical contiguity.
• Sampling units are groups rather than individuals.
• A sample of such clusters is then selected.
• All units from the selected clusters are studied.
 Cluster Sampling…
Freq cf cluster • XVI 3500 52500 17
• I 2000 2000 1 • XVII 4000 56500 18,19
• II 3000 5000 2 • XVIII 4500 61000 20
• III 1500 6500 • XIX 4000 65000 21,22
• IV 4000 10500 3 • XX 4000 69000 23
• V 5000 15500 4, 5 • XXI 2000 71000 24
• VI 2500 18000 6 • XXII 2000 73000
• VII 2000 20000 7 • XXIII 3000 76000 25
• VIII 3000 23000 8 • XXIV 3000 79000 26
• IX 3500 26500 9 • XXV 5000 84000 27,28
• X 4500 31000 10 • XXVI 2000 86000 29
• XI 4000 35000 11, 12 • XXVII 1000 87000
• XII 4000 39000 13 • XXVIII 1000 88000
• XIII 3500 44000 14,15 • XXIX 1000 89000 30
• XIV 2000 46000 • XXX 1000 90000
• XV 3000 49000 16 • 90000/30 = 3000 sampling interval
 Multistage Sampling
• Complex form of cluster sampling in which two or
more levels of units are embedded one in the other.
• First stage, random number of districts chosen in all
states.

• Followed by random number of locations, villages.

• Then third stage units will be houses.

• All ultimate units (houses, for instance) selected at

last step are surveyed.
 Multi Phase Sampling
• Part of the information collected from whole
sample & part from subsample.

• In Tb survey MT in all cases – Phase I

• Xray chest in MT +ve cases – Phase II
• Sputum examination in Xray +ve cases - Phase III

• Survey by such procedure is less costly, less

laborious & more purposeful
 Quota Sampling
• The population is first segmented into mutually
exclusive sub-groups, just as in stratified sampling.
• Then judgment used to select subjects or units from
each segment based on a specified proportion.
• For example, an interviewer may be told to sample 200
females and 300 males between the age of 45 and 60.
• It is this second step which makes the technique one of
non-probability sampling.
• In quota sampling the selection of the sample is non-
random.
• For example interviewers might be tempted to interview
those who look most healthy. The problem is that these
samples may be biased because not everyone gets a
chance of selection. This random element is its greatest
weakness and quota versus probability has been a matter
of controversy for many years
 Convenience Sampling
• Sometimes known as grab or opportunity sampling or accidental
or haphazard sampling.
• A type of nonprobability sampling which involves the sample being
drawn from that part of the population which is close to hand. That
is, readily available and convenient.
• The researcher cannot scientifically make generalizations about the
total population from this sample because it would not be
representative enough.
• For example, if the interviewer was to conduct a survey at a
shopping center early in the morning on a given day, the people that
he/she could interview would be limited to those given there at that
given time, which would not represent the views of other members
of society in such an area, if the survey was to be conducted at
different times of day and several times per week.
• Most useful for pilot testing.
• In social science research, snowball sampling is a similar technique,
where existing study subjects are used to recruit more subjects into
the sample.
Judgmental or Purposive sampling
The researcher chooses the sample based
on who they think would be appropriate
for the study. This is used primarily
when there is a limited number of
experts in the area being researched
34
 Panel Sampling
• Method of first selecting a group of participants through
a random sampling method and then asking that group for
the same information again several times over a period of
time.
• Each participant is given same survey or interview at two
or more time points; each period of data collection called
a "wave".
• This sampling methodology often chosen for large scale
or nation-wide studies in order to gauge changes in the
population with regard to any number of variables from
chronic illness to job stress to weekly food expenditures.
• Can also be used to inform researchers about within-
person health changes due to age or help explain changes
in continuous dependent variables like spousal interaction.
35
Data collection Tools
 What is Data Collection?
• The methodical process of gathering and
analyzing specific information to offer solutions
to relevant questions and evaluate those results.

Types of Data Collection

Secondary data collection

Primary data collection • Involves gathering of second-hand
data collected by an individual who
1. Qualitative
is not the original user
2. Quantitative
• From published books, journals,
online portals.
 Data Collection Methods
Primary: where the investigator is the first to
collect the data. Sources include: medical
examinations, interviews, observations, etc.
Merits: less measurement error, suits objectives of
the study better. Disadvantage: costly, may not be
feasible.
Secondary: where the data is collected by
OTHERS, for other purposes that those of the
current study. Sources include: individual records
(medical / employment); group records (census
data, vital statistics)
 Quantitative data collection
• Quantitative data collection tools collect
data that can be counted and subjected
to statistical analysis

• Examples of common quantitative tools are:

i. Surveys
ii. Questionnaires
iii. Observation checklists
iv. Physical tests.
 Quantitative data collection…
• Questions from quantitative data collection tools
are most often closed-ended questions and are
asked in a pre-planned logical order

• Closed-ended questions require respondents to

reply using a limited number of answers

• Question types include numerical, two-option

response, multiple choice, and rating/Likert scales.
Commonly Utilized Data Collection
Approaches in Clinical Research
1. Questionnaire Surveys and Patient
Reported Data

2. Proxy/Informant Data

3. Review of Ambulatory or Hospital Medical

Records

4. Collection of Biologic Material

Am J Med. 2013 November ; 126(11): . doi:10.1016/[Link].2013.04.016.
Factors affecting the use of
anti-malaria preventive
measures among Taiwan
immigrants returning to
malaria-endemic regions.
Travel Medicine and Infectious Disease
Wen-Shin Hung et [Link] 12, Issue 4, July–August 2014, Pages
370-377

([Link]
 Three Key Reminders

1. Develop a data collection and training plan as

needed

2. Follow your IRB/ ERC protocol!

- Study retention/closeout of data

3) Keep data secure

- Protected Health Information (PHI) and
stewardship of your data.
Lecture 6

Ethics in Biomedical
Research
• Application of ethics and regulation in
research

• Fundamental ethical principles;

respect of persons and justice

• Risks and benefits of research

• Good clinical ad Laboratory Practice

 Introduction
• The term ‘ethics’ broadly describes the way
in which we look at and understand life, in
terms of good and bad or right and wrong.

• Moral theories are the frameworks we use

to justify or clarify our position when we
ask ourselves “what should I do in this
situation?” or “what is right or wrong for
me?’’
 Introduction….
There are many moral theories and there is no one
right theory. They converge and often borrow from
one another.

Three theories will be described here.

• Consequentialism
• Deontology
• Bioethics, a common morality theory, is a recent
theory that dominates current thinking in health
care settings.
 Consequentialism
“The End Justifies the Means”

In consequentialism, the consequence of an

action justifies the moral acceptability of the
means taken to reach that end. The results of
actions outweigh any other consideration; in
other words, ‘the end justifies the means.’
 Consequentialism….
“The End Justifies the Means”

Jeremy Bentham was an early and influential

advocate of utilitarianism, the dominant
consequentialist position.

A utilitarian believes in ‘the greatest happiness

for the greatest number.’ The more people
who benefit from a particular action, the
greater its good.
 Deontology
Deontology or Kantianism is an obligation-based theory
whose chief author was Immanuel Kant, who lived in the
18th century. This theory emphasizes the type of action
rather than the consequences of that action.
Deontologists believe that moral decisions should be made
based on one’s duties and the rights of others. According
to Kant, morality is based on pure reason. As people have
the innate ability to act rationally, they therefore must act
morally, irrespective of personal desires.
Another way of stating Kant’s theory is
“Act morally regardless of the consequences.”
 Bioethics
• Common morality theories are usually based on
principles that are used to guide ethical thinking,
based on a shared moral belief. One of these
theories is Bioethics, the ethics of biology,
biological research and the applications of that
research.
• It is an ethical theory that brings together
medicine, the law, social sciences, philosophy,
theology, politics and other disciplines to address
questions related to clinical decision making and
medical research.
 Principles of Bioethics
Some of the early founders of bioethics put forth four
principles which form this framework for moral reasoning.
These four principles are:
Autonomy – one should respect the right of individuals to
make their own decisions

Nonmaleficence – one should avoid causing harm

Beneficence – one should take positive steps to help others

Justice – benefits and risks should be fairly distributed

Beneficence
• Common definition – acts of kindness or charity
that go beyond strict obligation
• To do good
• Endeavor to benefit where possible
• In health care; an obligation to improve health
• In research; Maximize benefits and minimize risks
of possible harms
• Balance risks and benefits
• Promotes risk benefit analysis
 Types of Benefits
• Individual benefit
• Social benefits
• Community benefits

• Types of community benefits

– Provision of health care in resource poor communities
– Salaries, infrastructure, incentives to research
participants, etc.
– Sustaining health care improvements by planning for
gradual phase-out with the community and local
authorities
 Types of Community Benefits in Health Research
• Post study benefits include:
– Appropriate training and technology transfer.
– Access to trial products, infrastructure and knowledge
by the research participants, the community and the host
country.

• Post study benefits may also include:

– disseminating the study results with the study
participants, the community and health authorities;
– presenting results -simple, understandable language;
– establishing personal contacts and attendance of
community meetings.
 Non Maleficence

• Prevent evil or harm

• Ought to remove evil or harm

Examples of risks
• Physical harm

• Psychological harm

• Legal harm

• Social harm

• Economic harm

• Harm to ones reputation

 Justice
• To each his or her due
• Equal treatment – Different treatment requires
justification (experience, age, deprivation,
competence, merit, position, etc.)
• What is deserved – People should be treated fairly,
and given what they deserve in the sense of what
they have earned (Beauchamp and Childress)
• Promotes issues on subject selections, what is
owed them, how they are treated during and after
research
• Fair distribution
 Principles of Bioethics -Justice
• This principle states that we have an obligation to
treat all people equally, fairly and impartially.
• An injustice occurs when some benefit to which a
person is entitled is denied without good reason or
when a burden is imposed unduly.
• By placing some people at the risk of harm for
the good of others, clinical research has the
potential of exploiting patient volunteers.
 Principles of distribution of
burden and benefits
• To each person an equal share

• To each person according to individual need

• To each person according to individual effort

• To each person according to societal contribution

• To each person according to merit

 Application to health research
• Recruitment of charity ward patients while benefits
of health care enjoyed by private patients
• Nazi use of war prisoners perceived as grave
injustice
• Tuskegee patients deprived of treatment when it
was already available
• Recruitment of vulnerable population because they
are available, easier to manipulate and not because
they manifest any condition related to the study
 Application to health research…
• Applicant should not be selected due to
social characteristics such as socioeconomic
class or race, unless justified by study
objectives
• Women have been underrepresented in
certain research studies
• Counselor client relationship
• Teacher student relationship
Definition of terms
• Research – systematic investigation designed
to discover generalisable information/widely
applicable
• Bioethics – Set of moral principles or system
of rules that guide bio-medical research
• Participant – The individual about whom
information is collected
• Researcher – Person who undertakes a study
especially in order to discover new facts or
information
 Guidelines on Ethics of Biomedical
• Nuremberg code - Nuremberg Military Tribunal,
1947

• Declaration of Helsinki – World Medical

Association, 1964, 1975, 1983, 1989, 1996

• Belmont Report – National Commission for the

Protection of Human Subjects of Biomedical and
Behavioural Research, 1979
 Research with human subjects
• Guidelines for Good Clinical Practice for trials on
pharmaceutical products – World Health
Organisation, 1995

• Good Clinical Practice – International Conference

on Harmonization of Technical requirements for
registration of pharmaceuticals for human use
(ICH), 1996
 The Nuremberg code
• During World War II, criminal medical
experiments were carried out on non-German
nationals, both prisoners of war and civilians,
including Jews and others.

• Code written during the Trials of War Criminals

before the Nuremberg Military Tribunal in 1949,
to provide the basis for putting the criminal
doctors on trial.
 Provisions of the Nuremberg Code-1
1. Certain types of medical experiments on human beings,
when kept within reasonably well-defined bounds,
conform to the ethics of the medical profession generally,
2. Protagonists -human experimentation yield results for the
good of the society that are unprocurable by other
methods or means of study.
3. All agreed -that certain basic principles must be observed
in order to satisfy moral, ethical and legal concepts.
4. Ten principles of the code were then drawn.
5. This code later gave way to the Declaration of Helsinki by
the World Medical Association in 1964.
World Medical Association Declaration of Helsinki -1

• Ethical Principles for Medical Research Involving

Human Subjects
• Adopted by the 18th WMA General Assembly
Helsinki, Finland, June 1964
• The Declaration of Helsinki is an official policy
document of the WMA, the global representative
body for physicians.
 World Medical Association Declaration of Helsinki-2

Amended by the:
• 29th WMA General Assembly, Tokyo, Japan, October
1975
• 35th WMA General Assembly, Venice, Italy, October 1983
• 41st WMA General Assembly, Hong Kong, September
1989
• 48th WMA General Assembly, Somerset West, Republic of
South Africa, October 1996
• 52nd WMA General Assembly, Edinburgh, Scotland,
October 2000
 World Medical Association Declaration of Helsinki-3

• The Helsinki Declaration consists of 32 articles which are

divided into three sections:

• A. INTRODUCTION: Articles 1-9,

• B: BASIC PRINCIPLES FOR ALL MEDICAL

RESEARCH: Articles 10-27,

• C: ADDITIONAL PRINCIPLES FOR MEDICAL

RESEARCH COMBINED WITH MEDICAL CARE:
Articles 28-32.
 Ethical Norms
• Ethical norms are statements that some
activities of certain types ought, or ought not,
to be done.
• E.g. “Research should be conducted only by
scientifically qualified persons”.
• Ethical norms are aimed at indicating how the
requirements of the fundamental ethical
principles may be met in the conduct of
research involving human subjects.
Types of Ethical Norms

1. Good research design

2. Competent investigators

3. A favorable balance of harm and benefit

4. Informed consent

5. Equitable selection of subjects

6. Compensation for research-related injury

 1. Good research design
• The experiment should be so designed and based on
results of animal experimentation and a knowledge of the
natural history of the disease or other problem under study,
that the anticipated results will justify the performance of
the experiment (Nuremberg 3).

• Medical research involving human subjects must conform

to generally accepted scientific principles, be based on a
thorough knowledge of the scientific literature, other
relevant sources of information, and an adequate
laboratory and, where appropriate, animal
experimentation. (Helsinki 11)
2. Competent investigators
• The experiment should be conducted only by
scientifically qualified persons. The highest degree of
skill and care should be required through all stages of the
experiment of those who conduct or engage in the
experiment. (Nuremberg 8)

• Medical research involving human subjects should be

conducted only by scientifically qualified persons and
under the supervision of a clinically competent medical
person. The responsibility for the human subject must
always rest with a medically qualified person and never
rest on the subject of the research, even though the
subject has given consent.(Helsinki 15)
3. A favorable balance of harm and benefit
• The degree of risk to be taken should never exceed that
determined by the humanitarian importance of the problem
to be solved by the experiment. (Nuremberg 6)

• Medical research involving human subjects should only be

conducted if the importance of the objective outweighs the
inherent risks and burdens to the subject. This is especially
important when the human subjects are healthy
volunteers.(Helsinki 18)

• Medical research is only justified if there is a reasonable

likelihood that the populations in which the research is
carried out stand to benefit from the results of the research.
(Helsinki 19)
 4. Informed consent
• The voluntary consent of the human subject is absolutely
essential. (Nuremberg 1)

• The subjects must be volunteers and informed participants

in the research project.(Helsinki 20)

• When obtaining informed consent for the research project

the physician should be particularly cautious if the subject
is in a dependent relationship with the physician or may
consent under duress. In that case the informed consent
should be obtained by a well-informed physician who is
not engaged in the investigation and who is completely
independent of this relationship.(Helsinki 23)
 5. Equitable selection of subjects
• This requirement derives from the principle of justice,
which requires equitable distribution of both the burdens
and the benefits of research.

• The right of research subjects to safeguard their integrity

must always be respected. Every precaution should be
taken to respect the privacy of the subject, the
confidentiality of the patient's information and to minimize
the impact of the study on the subject's physical and mental
integrity and on the personality of the subject.
6. Compensation for research-related injury

• Sponsor statements regarding research-related

injury must be considered as part of the informed
consent process.

• All offers to compensate subjects for research-

related injuries must be placed on separate sponsor
letterhead.
 Purpose of an Ethical Committee

• The ethical review in biomedical research is a

system of quality control in the operationalization
of research involving human subjects.

• It safeguards the dignity of living things in general

and human subjects in particular

• Their rights, safety and well-being.

 1. The role of the Ethical Committee

• Composition - multidisciplinary and multi-

sectoral.

• Balanced for demographic characteristics of

population e g experts, laypeople, age and gender.
 2. The role of the Ethical Committee
• Should be consistent
• laws and regulations of the country

• values and traditions of the community

• The EC should establish its standard

operating procedures (SOPs):
> its establishment,
> functions and duties,
> membership,
> appointments and secretariat.
 Function of Ethical Committee
To review research protocols and supporting
documents with particular attention to:
• i. The informed consent process,
• ii. Documentation of the protocol,
• iii. Suitability and feasibility of the protocol,
• iv. Any legal matters concerning the study.
The following areas should be
considered in an ethical review:
 1. Scientific design and conduct of the study

• The elements of scientific design,

– relevant background literature review
– Justification
– Objectives
– Methodology
– data management

• Recommendations of prior scientific committee

review.
 2. Recruitment of research subjects

• An evaluation of the description of study subjects

in the protocol
– Gender
– Age
– Culture
– Ethnicity, etc.
 3. Care and protection of research subjects

• Suitability of the investigators’ qualifications and

experience

• Adequacy of medical supervision

• Appropriate clinical care

• Psycho-social support for study subjects;

4. Protection of confidentiality of the study subject

• Access to the personal data, records and samples;

• Measures to ensure the confidentiality and security

of personal information
 5. The informed consent process – 3 STAGES

a) A full description of the process for

obtaining informed consent, including the
identification of those responsible for
obtaining consent;
b) Obtaining consent from others on behalf of
minors or similar category of persons;
c) Appropriate levels of communication with
study subjects.
 6. Community considerations

• Impact and relevance of the research on the local

community

• Desired communication with the study site

communities and the influence on the consent of
individuals;

• Public engagement - communicating research

results to the study subjects.
 7. Expedited reviews

• Appropriate procedures for expedited reviews

should be developed by the Ethical Committee.
8. Communication of the EC’s decision

• The EC’s decision should be given to the

investigator
– On time
– In writing

• Mechanism for follow-up of all approved research

protocols up to the end of their implementation.
Next lecture

Good Clinical Laboratory Practice

Lecture 7

Good Clinical and

Laboratory Practice
(GCLP)
Good Clinical Laboratory Practice (GCLP)
is a quality system for laboratories
designed to provide a strong framework to
those individuals and organisations that
undertake the analyses of samples from
clinical trials, specifically on the facilities,
systems and procedures that should be
present to assure the quality, reliability and
integrity of the work and results generated
during the organisation’s/ individual’s
particular contribution to a clinical trial.
Good Clinical Practice (GCP) is an
international ethical and scientific
quality standard for designing,
conducting, recording and
reporting trials that involve the
participation of human subjects,
provided by the International
Conference on Harmonization
(ICH).
• Analysing samples collected from
subjects is a key part of the clinical
trial process.
• To ensure that the data obtained are
accurate and reliable, that subject
safety is not compromised, and that
test results from multiple
laboratories are comparable, good
practices must be followed.
What standard applies to the analysis
of clinical samples?
• Good Clinical Practice
• So why do we need another standard?

What ICH GCP says that relates to the

laboratory
‘Systems with procedures that assure the
quality of every aspect of the trial should be
implemented’.
Essential Documents:
- certification or accreditation of laboratories
Why not GLP?

• Good standard for work at the bench

• However some conflicts in organisation, roles

& responsibilities and the reporting of results.
GLP Study Director
• Single point of control -responsibility for the
overall conduct of study and final report
• Approves the study plan & ensures
procedures specified are followed
• Ensures data is fully documented and
computer systems validated
• Signs/dates final report to indicate acceptance
of responsibility for validity of data and GLP
compliance.
GCP Sponsor
• Initiates the trial
• Ensures compliance with protocol and GCP
• Selects Investigator (s)
• Monitoring of procedures to verify conduct of
trial is in compliance and data verifiable
• QA and QC
• Provides final report
 GCLP
• Provides a bridge between GCP and GLP

• Provides framework to organisations on

facilities, systems and procedures

- to ensure the reliability, quality and integrity

of the work and results

- to satisfy GCP expectations.

SCOPE
• All laboratories where tests are done on
biological specimens for diagnosis, patient care,
disease control and research such as:
1) Microbiology & Serology
2) Hematology & Blood Banking
3) Molecular Biology and Molecular Pathology
4) Clinical Pathology
5) Clinical Biochemistry
6) Immunology (Immunohematology and
Immunobiochemistry)
7) Histopathology/Pathology and Cytology
Organisation & Personnel

• Facility management

• Analytical Project Manager

• Analytical staff

• Archivist

• Quality Audit personnel

Facility Management
• Ensures that the principles of GCP,GCLP are
complied with
• Provide sufficient, trained staff
• Appropriate & available facilities, equipment &
materials
• SOPs are approved and in place
• Ensure Analytical Plan exists
• Quality audit and QC programs are in place
 Facility Management…
• Key Appointments
 Analytical Project Manager
& if necessary document replacement

 Archivist (individual or organisation)

 Quality Audit personnel

• Retain all records that support the work conducted

• Retain responsibility for any work subcontracted

Analytical Project Manager
• Responsible for the overall conduct of the analytical
work

• Approve analytical plan & ensure plan is followed

• Ensure authorisation for any modification is obtained

& documented

• Ensure results are accurately recorded

• Approve the issue of analytical results

• Ensure data are archived

Analytical Staff
• Maintain awareness of GCP, GCLP which apply to
their work

• Perform trial requirements in accordance with Trial

Protocol, Analytical Plan & Standard Operating
Procedures.

• Maintain prompt, accurate and complete records

• Responsible for the quality of their work & data

Quality Audit Staff

• Independent monitoring of facility

• Performs quality audits

– review all aspects of the facility and work

performed

• Reports findings to Analytical Project Manager

and Facility Management
Facilities, Equipment & Reagents
• Demonstrably fit for purpose

• Requirements for Facilities

– suitable size, structure and location
– space to avoid sample mix-up or contamination
• separation of activities
– limited access?
– storage areas
• temperature controlled, monitored, limits set, alarmed,
back up
– good housekeeping*
Facilities, Equipment & Reagents…
• Equipment
– acceptance testing prior to use

– appropriately maintained & calibrated

• with records to demonstrate this
• trend analysis of calibration checks?
– validated computer systems in use

– may need to keep records of usage

• Reagents -suitably labelled and stored

Standard Operating Procedures
• Function of SOPs
– To establish standard procedures which will
ensure quality and integrity of the data
– To communicate these procedures to those
who will undertake them and underpin
training
– To leave a permanent record of the
methodology employed.
 Standard Operating Procedures…
• Approved by Management
• Controlled with historical file maintained
• To cover areas such as:
– Format, control and review of SOPs
– Sample handling- receipt, chain of custody,
storage, repeat analysis, etc
– Methods or control of methods
– Equipment use and maintenance
– Record keeping
– QC procedures & Audit procedures
 Planning
• Documented and approved plan for the work
• May form part of the contractual agreement
with the sponsor
• Should reflect the requirements of the clinical
protocol
• Should contain sufficient detail to provide clear
instruction to staff
• Amendments and deviations documented
Conduct
• In accordance with the plan
• Data and results recorded
– promptly, indelibly, legibly, signed & dated

• Methods validated
• Uniform analytical platforms
• Definition of raw (source) data
• Documented procedure for repeat analysis
 Conduct…
• Samples
– procedures for receipt, handling, storage,
management designed to prevent mix-ups and
maintain integrity
– adequately labelled at all times
– chain of custody- traceability at all times
• from shipment schedule to post analysis

• Quality Control
– external proficiency schemes
– internal in-process checks
Reporting
• Two types of report
– Analytical report
– Analytical results
• Contain information as required by GCLP,
Analytical plan and Sponsor
– clinical trial number, identity of the facility and
APM, dates, results etc.

• QC to ensure accuracy
• Approved for issue
 Storage and Retention of Data
• Trial data, Analytical plan & Analytical
results/reports
• Supporting data or information
• Organisation charts
• Staff records (training, job descriptions, CVs)
• Equipment records( maintenance & calibration)
• System validation records
• Historical file of SOPs
• Quality Audit reports
• Stored in appropriate facilities
 Summary

• GCLP is concerned with producing

reliable results which can be supported
and are reconstructable.

• To meet the challenge of GCP

compliance
Further reference documents on GCLP

1. GCLP – World Health Organization

(2009)

2. GCLP- Indian Council of Medical

Research (2008)

3. SANAS- South African National

Accreditation System
 checklist for GCLP
Next lecture

Research Data presentation

Lecture 7

Good Clinical and

Laboratory Practice
(GCLP)
Good Clinical Laboratory Practice (GCLP)
is a quality system for laboratories
designed to provide a strong framework to
those individuals and organizations that
undertake the analyses of samples from
clinical trials, specifically on the facilities,
systems and procedures that should be
present to assure the quality, reliability and
integrity of the work and results generated
during the organization's/ individual’s
particular contribution to a clinical trial.
Good Clinical Practice (GCP) is an
international ethical and scientific
quality standard for designing,
conducting, recording and
reporting trials that involve the
participation of human subjects,
provided by the International
Conference on Harmonization
(ICH).
• Analysing samples collected from
subjects is a key part of the clinical
trial process.
• To ensure that the data obtained are
accurate and reliable, that subject
safety is not compromised, and that
test results from multiple
laboratories are comparable, good
practices must be followed.
What standard applies to the analysis
of clinical samples?
• Good Clinical Practice
• So why do we need another standard?

What ICH GCP says that relates to the

laboratory
‘Systems with procedures that assure the
quality of every aspect of the trial should be
implemented’.
Essential Documents:
- certification or accreditation of laboratories
Why not GLP?

• Good standard for work at the bench

• However some conflicts in organisation, roles

& responsibilities and the reporting of results.
GLP Study Director
• Single point of control -responsibility for the
overall conduct of study and final report
• Approves the study plan & ensures
procedures specified are followed
• Ensures data is fully documented and
computer systems validated
• Signs/dates final report to indicate acceptance
of responsibility for validity of data and GLP
compliance.
GCP Sponsor
• Initiates the trial
• Ensures compliance with protocol and GCP
• Selects Investigator (s)
• Monitoring of procedures to verify conduct of
trial is in compliance and data verifiable
• QA and QC
• Provides final report
 GCLP
• Provides a bridge between GCP and GLP

• Provides framework to organisations on

facilities, systems and procedures

- to ensure the reliability, quality and integrity

of the work and results

- to satisfy GCP expectations.

SCOPE
• All laboratories where tests are done on
biological specimens for diagnosis, patient care,
disease control and research such as:
1) Microbiology & Serology
2) Hematology & Blood Banking
3) Molecular Biology and Molecular Pathology
4) Clinical Pathology
5) Clinical Biochemistry
6) Immunology (Immunohematology and
Immunobiochemistry)
7) Histopathology/Pathology and Cytology
Organisation & Personnel

• Facility management

• Analytical Project Manager

• Analytical staff

• Archivist

• Quality Audit personnel

Facility Management
• Ensures that the principles of GCP,GCLP are
complied with
• Provide sufficient, trained staff
• Appropriate & available facilities, equipment &
materials
• SOPs are approved and in place
• Ensure Analytical Plan exists
• Quality audit and QC programs are in place
 Facility Management…
• Key Appointments
 Analytical Project Manager
& if necessary document replacement

 Archivist (individual or organisation)

 Quality Audit personnel

• Retain all records that support the work conducted

• Retain responsibility for any work subcontracted

Analytical Project Manager
• Responsible for the overall conduct of the analytical
work

• Approve analytical plan & ensure plan is followed

• Ensure authorisation for any modification is obtained

& documented

• Ensure results are accurately recorded

• Approve the issue of analytical results

• Ensure data are archived

Analytical Staff
• Maintain awareness of GCP, GCLP which apply to
their work

• Perform trial requirements in accordance with Trial

Protocol, Analytical Plan & Standard Operating
Procedures.

• Maintain prompt, accurate and complete records

• Responsible for the quality of their work & data

Quality Audit Staff

• Independent monitoring of facility

• Performs quality audits

– review all aspects of the facility and work

performed

• Reports findings to Analytical Project Manager

and Facility Management
Facilities, Equipment & Reagents
• Demonstrably fit for purpose

• Requirements for Facilities

– suitable size, structure and location
– space to avoid sample mix-up or contamination
• separation of activities
– limited access?
– storage areas
• temperature controlled, monitored, limits set, alarmed,
back up
– good housekeeping*
Facilities, Equipment & Reagents…
• Equipment
– acceptance testing prior to use

– appropriately maintained & calibrated

• with records to demonstrate this
• trend analysis of calibration checks?
– validated computer systems in use

– may need to keep records of usage

• Reagents -suitably labelled and stored

Standard Operating Procedures
• Function of SOPs
– To establish standard procedures which will
ensure quality and integrity of the data
– To communicate these procedures to those
who will undertake them and underpin
training
– To leave a permanent record of the
methodology employed.
 Standard Operating Procedures…
• Approved by Management
• Controlled with historical file maintained
• To cover areas such as:
– Format, control and review of SOPs
– Sample handling- receipt, chain of custody,
storage, repeat analysis, etc
– Methods or control of methods
– Equipment use and maintenance
– Record keeping
– QC procedures & Audit procedures
 Planning
• Documented and approved plan for the work
• May form part of the contractual agreement
with the sponsor
• Should reflect the requirements of the clinical
protocol
• Should contain sufficient detail to provide clear
instruction to staff
• Amendments and deviations documented
Conduct
• In accordance with the plan
• Data and results recorded
– promptly, indelibly, legibly, signed & dated

• Methods validated
• Uniform analytical platforms
• Definition of raw (source) data
• Documented procedure for repeat analysis
 Conduct…
• Samples
– procedures for receipt, handling, storage,
management designed to prevent mix-ups and
maintain integrity
– adequately labelled at all times
– chain of custody- traceability at all times
• from shipment schedule to post analysis

• Quality Control
– external proficiency schemes
– internal in-process checks
Reporting
• Two types of report
– Analytical report
– Analytical results
• Contain information as required by GCLP,
Analytical plan and Sponsor
– clinical trial number, identity of the facility and
APM, dates, results etc.

• QC to ensure accuracy
• Approved for issue
 Storage and Retention of Data
• Trial data, Analytical plan & Analytical
results/reports
• Supporting data or information
• Organisation charts
• Staff records (training, job descriptions, CVs)
• Equipment records (maintenance & calibration)
• System validation records
• Historical file of SOPs
• Quality Audit reports
• Stored in appropriate facilities
 Summary

• GCLP is concerned with

producing reliable results which
can be supported and are
reconstructable.

• To meet the challenge of GCP

compliance
Further reference documents on GCLP

1. GCLP – World Health Organization

(2009)

2. GCLP- Indian Council of Medical

Research (2008)

3. SANAS- South African National

Accreditation System
 checklist for GCLP
Next lecture

Research Data presentation

Lecture 8

Presenting research
data
Dissemination of research findings:
• Dissemination is defined as the sharing
of formatted data with users.

• There are several levels and modes of

sharing formatted data. Data can be
shared at Global, National and Local
levels all targeting users of different
socio-economical backgrounds.
Dissemination is Good!
• Expands available knowledge about a
subject
• Benefits colleagues, patients, others
• Enhances your understanding of the project
• Credentials you in academia
• Raise morale in unit/program
• Enhances reputation of program, campus,
medical school
• Can lead to: Fame? Fortune? Ego?
Dissemination Techniques
1. Publication
2. Oral presentation
3. Poster presentation
4. Abstract
5. Web
6. Other
Process of getting your work published
Process of getting your work published…
1. Findings
What are your results? What do they mean?
2. Audience
Who would be interested in these results -who is your
audience?
3. Target publication
What publications is you audience interested in? What
publications would be interested in your results –where
do they fit? What types of articles does the journal
accept?
4. Contact journal/editor
Contact the journal/editor of your target publication to see
if there is interest in your article.
5. Adhere to instructions
READ the instructions for submitting to that publication.
Adhere religiously to the instructions –not following
instructions is an easy way to reject a manuscript
6. Review and revise
After you have written the article, set it aside for a few days
then go back and edit it.
7. Save, search
If it is rejected, save it and submit to other publications.
Continue to search for other articles about your topic.
How to write a good article
• Talk to the typical reader
• Anticipate reader/reviewer questions
• Use correct format
• Follow the instructions
• Keep It Simple
• Watch out for simple grammar/spelling mistakes
• Get help
Article format
• Title
• Abstract
• Materials and Methods
• Results
• Discussion
• Acknowledgements
• References
Referencing your publication
1. In-text citation

2. List of references
– Book
– Journal article
– Website
Types of Referencing Styles:
1. APA Style (American Psychological Association)

2. Harvard Style

3. MLA Style (Modern Language Association)

4. Chicago Style

Write down one example in each case.

 Authorship
• Author, Co-author and Corresponding author??
• Every author listed on a publication/ journal
article should have made a significant
contribution to the work reported
• This could be in terms of research conception or
design, or acquisition of data, or the analysis and
interpretation of data
• As an author or co-author, you share
responsibility and accountability for the content
of your article.
 Plagiarism
• “When somebody presents the work of others
(data, words or theories) as if they were his/her
own and without proper acknowledgment.”

• When citing others’ (or your own) previous work,

please ensure you have:
1. Clearly marked quoted verbatim text from another source with
quotation marks.
2. Attributed and referenced the source of the quotation clearly
within the text and in the Reference section.
3. Obtained permission from the original publisher and rights
holder when using previously published figures or tables.
2. Oral Presentation
• Confidence
• Passion
• Knowledge
• Naturalness
• Organization
• Time sensitive
• Clarity
Style Things during a presentation
• Dress - comfortable, no distracters
• Voice - clear, conversational, vary pitch & tone to
match content
• Language - appropriate to audience, no ums,
ahs, okays?”
• Eye contact - “sweep and click”, watch blind
spots and potential trouble seats (front of room
and back of room)
• Body - confident, moves & gestures for
emphasis, avoid distractions
3. Poster Presentation
• A poster combines text and graphics to
present your project in a way that is visually
interesting and accessible
• At scientific meetings – a poster enables you
to share research with your colleagues
• A poster gives you an opportunity to:
 organize your data
 get experience presenting your data
 discuss your findings in one-on-one situations
 get feedback from your colleagues
 Poster Format
• Title
• Abstract
• Background/Introduction – why did you do it?
• Methods – how did you do it?
• Results – what did you find?
• Discussion/Conclusion – why is this important?

 Methods and results sections should make up

the bulk of the abstract.
The Introduction and Conclusion should be
about 2-3 sentences each.
 Making a Poster
• Choose software
– PowerPoint – easiest and commonly used
– Publisher
– Adobe Illustrator
– Photoshop
• Design
– Layout – template, font size is critical!
– Visuals
• Review
• Print – save as a PowerPoint, Jpeg or PNG
Do not forget Acknowledgements and Citations
An effective poster
1. Catches the readers attention – very descriptive title
2. Make your poster visually pleasing
– Large, easy to read font
– Prominent section headings
– Clear and effective visuals

3. Poster layout and format are critical

– Create a logical organizational flow of information
4. Content is key, but keep it concise
4. Conference Abstract
• A conference abstract is different from an abstract for
a research article

• Conference abstracts are designed to summarize a

short presentation, while article abstracts must cover
more ground as they are synthesizing full-length
articles

• Conference abstract is evaluated as a standalone

piece – the promise of a paper while an article
abstract is evaluated alongside its accompanying
paper.
5. Web
• Disseminating information on an
organization's website
• Blogs
• Social media sites
6. Other dissemination techniques
• Press Briefings, flyers, pamphlets
• Electronic and Mass Media
 News papers
 Radio
 Television
 DVDs, etc
Next lecture

Writing Research report

Lecture 9

Writing research report

What do scientist write?
a) Abstracts
b) Research papers
c) Perspectives
d) Reviews
e) Books
f) Book chapters
g) Grant applications
h) Theses (and assessment reports)
 Clarity is essential
• All documents need to read swiftly

• No room for ambiguity

• English may not be the readers 1st language

 Rules for clarity
• Everyone will acquire his or her own style
• However, there are some general rules:
– Use short sentences which express single
concepts
• I worry if my sentences exceed three lines

– Use short paragraphs

– Avoid clever clauses and parentheses
– Use good grammar and punctuation
– If in doubt, keep it simple
 A useful tips
• You will annoy your friends, but please try to
read your own work out loud.

• If you find it hard to speak then something is

wrong with the text

• When correcting text try little and often rather

than long boring sessions

• Get a friend to read your work

Common writing errors
• Keep track of singular and plural forms
– Remember data is the plural of datum!
– Hence, “these data suggest…”

• Keep track of tense

– Most experiments and procedures will be
described in the past tense
 More on tense
• A good way to separate what you have shown
from what others have reported is to mix tenses
in your writing
– This is common in a discussion section

• For example:
The protein was non-functional after modification
of the terminal residue. This result is consistent
with those from other groups (references) and
indicates….
 “Instructions to authors”
• Read these before you start writing!

• All journals have a house style

– Examples:
• The BMJ insists all papers are written in first person
– I demonstrated that….

• Most pure science journals tend to require third

person
– These data demonstrate that….
What is an
Abstract?
 A brief synopsis of writing an abstract

• It is a minipaper:
– Introduction (usually 1-2 sentences)
– Methods (often longest part)
– Results
– Discussion is limited to concluding statement

• Like a paper, requires many drafts, most

oriented to presenting argument concisely
 For Conference abstracts
Problems

• You often need to describe work in progress

months before the meeting
• Acceptance is highly competitive

and
• You want to be accepted as your travel grant
depends on giving a presentation!
More on abstracts…
• Follow the rules
– Strict word or (even character) counts etc

• Make whatever you hope to present sound

as good and positive as possible

• Avoid empty statements like:

– These data will be discussed
– This work is still in progress
 Even more on abstracts….
• Choose a punchy title

• Write a brief introduction. May be only 2

sentences

• Very briefly describe the methods

• Show ‘solid’ data (with statistics if needed)

• The conclusion should show how you have

answered your original question.
Types of scientific papers

1. Original Research
2. Short reports or Letters
3. Review Articles
4. Case Studies
5. Methodologies or Methods
Choose your journal
• Look carefully at a JAMA: Journal of the American Medical
Association
selection 1. JAMA Cardiology
– Which is most 2. JAMA Dermatology
appropriate? 3. JAMA Internal Medicine
4. JAMA Network Open
5. JAMA Neurology
• Talk to your 6. JAMA Oncology
supervisor(s) 7. JAMA Ophthalmology
8. JAMA Pediatrics
9. JAMA Psychiatry
10. JAMA Surgery
 Writing the paper
• Read the instructions to authors
• What sections should the text be divided
into?
• Often:
– Title
– Abstract
– Introduction
– Methodology
What do you do first?
– Results
– Discussion
– References
– Figure legends
 Some writing tips
• On a 1000 mile journey, the hardest thing is
the first step.
– Make the first step easy!

• The methodology is often easiest to write

as is simply descriptive.
– Order this in the same way as you will present
your results
 Some writing tips…
• You can write the results text next
• This is also descriptive as you simply describe
your data (figures and tables)
– “These data show that something is
higher/faster/larger than something else (p<0.001)”.

• A common error is to add discussion and

interpretation to this section
– This leaves nothing for the discussion section!
Some writing tips – the home stretch
• Then you can write the introduction
– Details why you did you did the study (not
what you found)

• Then the discussion interprets your results

and places into context with the literature.
– End with a nice ‘take home’ message in the
final paragraph.
Some writing tips – crossing the line
• Figure legends should be ‘stand alone’
• The title should be clear and attract
attention
– You need to lure readers to your paper
amongst all the others

• Similarly, the abstract should be very clear

with simple messages, clear results and
snappy conclusions
References
• Use Endnote (or similar) to output the references
in the correct format

• But, which references do you cite?

– High impact factor journals in your study field
– Avoid over citation of yourself
– Write what you know and then reference the text or
you will need to stop every few words to find a paper
in the heap on your floor!
 A knotty problem
• Who will be included as authors (and in what
order)

• This can cause some dispute!

• Some journals have a clear policy

• Some supervisors or research groups also have a

policy (ask)

• All authors carry full responsibility for the content

 The mechanics of publication
• Submission
– You may need to learn how to use an on-line system
like ‘Manuscript Central’

• The decision
– Rejection. Learn from the referees comments and try
again
– Revision. This is common. Answer the referees
questions carefully (maybe generate some more data)
and you’ll be OK
– Immediate acceptance. This is rare!
 The mechanics of publication
• Submission
– You may need to learn how to use an on-line
system like ‘Manuscript Central’
• The decision
– Rejection. Learn from the referees comments
and try again
– Revision. This is common. Answer the referees
questions carefully (maybe generate some
more data) and you’ll be OK
– Immediate acceptance. This is rare!
 Errors and glitches
• Check proofs VERY CAREFULLY!

• Make necessary corrections clearly

• Answer all the editorial questions

– You must not re-write the text at this stage

• Don’t hurry this process or errors will get

through!
 Authorship
If you have more than seven authors, list the
first six authors followed by an ellipsis and
ending with the last author listed.

Example:
Johnson, M. C., Carlson, M., Hanover, L. E., Chan, X.
H., Smith, J. N. H., Kim, H. B., ... Watson, J. M.
 Why Authorship is Important
• Certification of public responsibility for truth
of a publication

• Equitable assignment of credit

• Productivity, promotion and prestige

 Authorship Problems
• Failure to involve potential collaborators

• Failure to credit contributors

• Undeserved (gift) authorship

• Poor judgment about relative contributions

• Ambiguity about process

Conventions for Assigning Authorship
• Alphabetical order
• Reverse alphabetical order
• Relative contributions
– main author first
• Corporate authorship
• Contributorship
 Authorship in medicine
Designation as an author must satisfy four
conditions. The author must have:
1. Contributed substantially to the conception and design
of the study, the acquisition of data, or the analysis and
interpretation
2. Drafted or provided critical revision of the article
3. Provided final approval of the version to publish
4. Agreed to be accountable for all aspects of the work in
ensuring that questions related to the accuracy or
integrity of any part of the work are appropriately
investigated and resolved.
• In the medical discipline, the first and the
last authors are the most contributed
authors and the middle author is the least
(in a curve).

• In contrast, in the Engineering discipline, contribution

level goes from the who contributed the most to the
least: first (most contribution), second, third, fourth.....
last author (least contribution).