Day 3

Certificate in Health Profession Education

at SZABMU

Research Methodology and Ethical Issues

Dr Juneda Sarfraz
MBBS, MSPH, MSP, PhD.

Assistant Professor Public Health,

Deputy Registrar (Academics)

Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.

 Agenda for this Session
Certificate in Health Profession Education at SZABMU
1. Ice breaking session with “Round of Introductions”
2. Expectations from the participants
3. What is Research?
4. Methodology Vs Methods
5. Categories of Research
6. Qualitative Vs Quantitative
7. The meaning and significance of “Synopsis” in Research
8. Problem Analysis (briefly)
9. Synopsis Writing and its Components
10. Trouble Shooting: Study Methodology

11. Ethics in Research and Publications

12. Official Requirements (Discussion)

13. Wrapping Up Session

14. Questions and answers including Feedback

• Group Photo
 What is Research
• Research in common parlance refers to a search for knowledge.
• Once can also define research as a scientific and systematic search for pertinent
information on a specific topic. In fact, research is an art of scientific investigation.

• The Advanced Learner’s Dictionary of Current English lays down the meaning of
research as “a careful investigation or inquiry specially through search for new facts
in any branch of knowledge.” Redman and Mory define research as a “systematized
effort to gain new knowledge.”

• Some people consider research as a movement, from the known to the unknown.

• It is actually a voyage of discovery.

• According to Clifford Woody research comprises defining and redefining problems,

formulating hypothesis or suggested solutions; collecting, organising and evaluating
data; making deductions and reaching conclusions; and at last carefully testing the
conclusions to determine whether they fit the formulating hypothesis.

• D. Slesinger and M. Stephenson in the Encyclopaedia of Social Sciences define

research as “the manipulation of things, concepts or symbols for the purpose of
generalising to extend, correct or verify knowledge, whether that knowledge aids in
construction of theory or in the practice of an art.”
 Research
• Research is a quest for knowledge through diligent search or investigation
or experimentation aimed at the discovery and interpretation of new
knowledge.

• Scientific method is a systematic body of procedures and techniques

applied in carrying out investigation or experimentation targeted at
obtaining new knowledge.

• In context, research and scientific methods may be considered a course of

critical inquiry leading to the discovery of fact or information which
increases our understanding of human health and disease.
 Categories of Research

• Basic on certain understandings

• No water tight compartments

• Choice based on careful thought and purpose of enquiry

• Coexistence?
 Descriptive vs. Analytical
• Descriptive research includes surveys and fact-finding enquiries of different
kinds. The major purpose of descriptive research is description of the state
of affairs as it exists at present. In social science and business research we
quite often use
• The main characteristic of this method is that the researcher has no control
over the variables; he can only report what has happened or what is
happening. The methods of research utilized in descriptive research are
survey methods of all kinds, including comparative and correlational
methods.
• In analytical research, on the other hand, the researcher has to use facts or
information already available, and analyze these to make a critical
evaluation of the material.
 Conceptual vs. Empirical
• Conceptual research is that related to some abstract idea(s) or theory. It is generally
used by philosophers and thinkers to develop new concepts or to reinterpret existing
ones.
• On the other hand, empirical research relies on experience or observation alone, often
without due regard for system and theory. It is data-based research, coming up with
conclusions which are capable of being verified by observation or experiment.
Experimental type of research.
• In such a research it is necessary to get at facts firsthand, at their source, and actively to
go about doing certain things to stimulate the production of desired information.
– working hypothesis or guess as to the probable results.
– works to get enough facts (data) to prove or disprove his hypothesis.
– sets up experimental designs as to bring forth the desired information.

– Such research is thus characterised by the experimenter’s control over the variables under
study and his deliberate manipulation of one of them to study its effects.
– Empirical research is appropriate when proof is sought that certain variables affect other
variables in some way.
– Evidence gathered through experiments or empirical studies is today considered to be the
most powerful support possible for a given hypothesis.
 Applied vs. Fundamental Research
• Applied (or action) research or fundamental (to basic or pure) research.
• Applied research aims at finding a solution for an immediate problem facing a society
or an industrial/business organisation, whereas fundamental research is mainly
concerned with generalisations and with the formulation of a theory.
• “Gathering knowledge for knowledge’s sake is termed ‘pure’ or ‘basic’ research.”
Research concerning some natural phenomenon or relating to pure mathematics are
examples of fundamental research. Similarly, research studies, concerning human
behaviour carried on with a view to make generalisations about human behaviour, are
also examples of fundamental research,
• Research aimed at certain conclusions (say, a solution) facing a concrete social or
business problem is an example of applied research. Research to identify social,
economic or political trends that may affect a particular institution or the copy research
(research to find out whether certain communications will be read and understood) or
the marketing research or evaluation research are examples of applied research.
• Thus, the central aim of applied research is to discover a solution for some pressing
practical problem, whereas basic research is directed towards finding information that
has a broad base of applications and thus, adds to the already existing organized body
of scientific knowledge.
Qualitative and Quantitative Research
• Quantitative research is based on the measurement of quantity or amount. It is
applicable to phenomena that can be expressed in terms of quantity.
• Qualitative research, on the other hand, is concerned with qualitative
phenomenon, i.e., phenomena relating to or involving quality or kind.
• For instance, when we are interested in investigating the reasons for human
behaviour (i.e., why people think or do certain things), we quite often talk of
‘Motivation Research’, an important type of qualitative research. This type of
research aims at discovering the underlying motives and desires, using in depth
interviews for the purpose.
• Attitude or opinion research i.e., research designed to find out how people feel
or what they think about a particular subject or institution is also qualitative
research.
• Qualitative research is specially important in the behavioural sciences where
the aim is to discover the underlying motives of human behaviour. Through
such research we can analyse the various factors which motivate people to
behave in a particular manner or which make people like or dislike a particular
thing.
 Some Other Types of Research
• Variations of one or more of the above stated approaches, based on either the purpose of
research, or the time required to accomplish research, or the environment in which research
is done, or on the basis of some other similar factor.

• Form the point of view of time, one-time research or longitudinal research. In the former
case the research is confined to a single time-period, whereas in the latter case the research
is carried on over several time-periods.
• Field-setting research or laboratory research or simulation research, depending upon the
environment in which it is to be carried out.
• Clinical or diagnostic research. case-study methods or indepth approaches to reach the
basic causal relations. Go deep into the causes of things or events that interest us, using very
small samples and very deep probing data gathering devices.
• Exploratory (development of hypotheses rather than their testing) or it may be formalized
(substantial structure and with specific hypotheses to be tested).
• Historical research is that which utilizes historical sources like documents, remains, etc. to
study events or ideas of the past, including the philosophy of persons and groups at any
remote point of time.
• Conclusion-oriented (a researcher is free to pick up a problem, redesign the enquiry as he
proceeds and is prepared to conceptualize) and decision-oriented (for the need of a decision
maker and the researcher in this case is not free to embark upon research according to his
own inclination) e.g Operations research
 What is a Synopsis??
• Synopsis is the gist of your planned project submitted
for approval from competent authorities.
• It gives a panoramic view of your research for quick
analysis by the reviewers.
• Forms an integral part of a research project or a thesis
 Word derived from…
• Literally, protocol (Greek word, protokollon - first page)
means a format procedure for carrying out a scientific
research.
• Synopsis (Greek word, sun - together, opsis - seeing)
means brief summary of something.
• Frequently, both the terms are used as synonyms but the
term 'synopsis' is used more often.
Betkerur J. Guidelines for writing a research project synopsis or protocol. Indian J Dermatol
Venereol Leprol 2008;74:687-90
 Constructed in a manner that facilitates the
Reviewer
to understand the research project at a glance

• Title
• Statement of the problem and hypothesis
• Aims and objectives
• Review of literature
• Research methodology
• References
• Official requirements
 Title
• Brief but informative;
• Sensationalisation of the title is best avoided. neither be too short nor too
long.
• Name of the institution, the number of cases to be studied should not be
included.
• Hypothesis to be studied can be included.

FINER Criteria
• Feasibility
• Interest
• Novelty
• Ethics
• Relevance
 Problem Analysis
• Recognition as a problem
• “But Why” Technique
• Causes and Consequences
• “Problem Tree”
• Feasibility/ Importance Matrix
• Research question
 Hypothesis

• Statement of probable outcome

• Should not be a haphazard guess but should reflect the
knowledge, imagination, and experience of the
investigator.
• Can be formulated by understanding the problem,
reviewing the literature on it, and considering other
relevant factors.
• State the problem and hypothesis in about 200 words
covering all the aspects described above.
 Aim and Objectives
• Mandatory
• Aim is broad area in which this study would contribute

• Objectives are statements of things that must be

achieved within the research.

• How to make SMART objectives

 Methodology
• The research methodology forms the core/ roadmap of the research
project, and has the following aspects:

• Study design
• Study settings
• Sampling
• Variables
• Controls
• Study methods - examinations or investigations
• Data collection
• Data analysis
• Ethical clearance
 Methodology and Methods

• Mackenzie, N., & Knipe, S. (2006). Research dilemmas: Paradigms,

methods and methodology. Issues in educational research, 16(2), 193-205.
• http://iier.org.au/iier16/mackenzie.html (scinapse.io)

• Research as a problem to be solved or a dilemma to be lived with?

• Interlocking choices
• Several phases
• No true method
• Series of choices is directional
• Set of choices is circular-come back to the problem
• Some sketches to make my point clear
• McGrath-1981-ABS-Dilemmatics-1.pdf (cebma.org)
• McGrath, J. E. (1981). Dilemmatics: The study of research choices and dilemmas. American Behavioral
Scientist, 25(2), 179-210.
 Study Methods

Here the researcher will have to describe the tool and

technique for data collection, which may be in the form of:
• Topic Guide (qualitative)
• Questionnaire (quantitative)
• Interviews
• Data extraction Form
– Medical examination record
– Laboratory investigations
– Screening procedures
• Observation Checklist

• Varying levels of participation

 Data Collection

A brief note on how data are collected

• Methods (Tools and Techniques)

• The organizational setup
• Training to data collecting team
• Logistic support
• Plans for collaboration with other organisation should be
included
 Variables
• Variables are the factors that can change. These changes can affect the outcome of a
research project. Thus, it is important to identify the variables at the planning stage.
They should be quantified with a measurable unit. Knowledge of the various
variables in a research project will assist in refining the objectives. Usually, objectives
of a research will be to see the effect of independent variables on dependent variables.
There are four types of variables.

Independent variables

These are the variables that can be manipulated by the researcher and the effects of
that are observed on the other variables. For example, predisposing factors, risk
factors and cause.

Dependent variables

The changes occur as a result of independent variables. For example, disease and
outcome.

Intervening variables

These may influence the effect of independent variables on the dependent variables.
For example, while studying the response of HIV-AIDS to HAART the outcome may
be influenced by the presence of antitubercular drugs.
 Data Analysis
• Important part of a research project.
• A good analysis leads to good results.
• The plans for data analysis should be mentioned under
the following heads
– Statistical methods,
– Computer program used, and
– Data sorting method.
– A general statement "appropriate statistical methods will be
used." must be avoided.
 Ethical clearance
• Wherever necessary, ethical committee clearance from
the institute should be obtained.
• The certificate must be attached when manuscript sent
for publication.
• Ethical clearance is required in all human and animal
studies.
 Referencing

• All references quoted in review of literature and anywhere else in

the synopsis should be listed here.
• There are two styles for writing references, Vancouver style and
Harvard style.
• Vancouver style depends on the numbers as quoted in text, while
Harvard shows the author’s name and year of publication.

• Referencing Software
• Endnote
 Common Ethical Issues In
Research And Publication
• Research is expanding field of biomedical research, this has
improved the quality and quantity of life
• Researcher is in a privileged position
• “able to control “life and death” of patients and have free access to
their confidential information”
• “medical researchers have also enjoyed immunity from
accountability due to high public regard for science and medicine”

• Need oversight

• Five Common Areas to be aware of during research and publication

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4453117/
 Oversight for Ethical Controversies

• Declaration of Helsinki was established to inform biomedical

researchers the principles of clinical research.
• This declaration highlighted a tripartite guidelines for good
clinical practice which include respect for the dignity of the
person; research should not override the health, well-being and
care of subjects; principles of justice.
• Committee on Publication Ethics (COPE) was also founded in
1997 to address the breaches of research and publication ethics.
• Ethical Committee at the level of Country, educational
Institution etc

• Human, D., & Fluss, S. S. (2001). The World Medical Association’s declaration of Helsinki: Historical and
contemporary perspectives. World Medical Association.
 1. Study Design and Research Approval
• According to COPE, “good research should be well adjusted, well-planned,
appropriately designed, and ethically approved. To conduct research to a lower
standard may constitute misconduct.” This may appear to be a stringent criterion, but
it highlights the basic requirement of a researcher is to conduct a research
responsibly. To achieve this, a research protocol should be developed and adhered to.
It must be carefully agreed to by all contributors and collaborators, and the precise
roles of each team member should be spelled out early, including matters of
authorship and publications. Research should seek to answer specific questions,
rather than just collect data.

• It is essential to obtain approval from the Institutional Review Board, or Ethics

Committee, of the respective organisations for studies involving people, medical
records, and anonymised human tissues. The research proposal should discuss
potential ethical issues pertaining to the research. The researchers should pay special
attention to vulnerable subjects to avoid breech of ethical codes (e.g. children,
prisoners, pregnant women, mentally challenged, educationally and economically
disadvantaged). Patient information sheet should be given to the subjects during
recruitment, detailing the objectives, procedures, potential benefits and harms, as
well as rights to refuse participation in the research. Consent should be explained and
obtained from the subjects or guardians, and steps should be taken to ensure
confidentiality of information provided by the subjects.
 2. Data Analysis
• It is the responsibility of the researcher to analyse the data appropriately.
Although inappropriate analysis does not necessarily amount to
misconduct, intentional omission of result may cause misinterpretation
and mislead the readers. Fabrication and falsification of data do constitute
misconduct. For example, in a clinical trial, if a drug is found to be
ineffective, this study should be reported. There is a tendency for the
researchers to under-report negative research findings, and this is partly
contributed by pressure from the pharmaceutical industry which funds the
clinical trial.

• To ensure appropriate data analysis, all sources and methods used to

obtain and analyse data should be fully disclosed. Failure to do so may
lead the readers to misinterpret the results without considering possibility
of the study being underpowered. The discussion section of a paper
should mention any issues of bias, and explain how they have been dealt
with in the design and interpretation of the study.
 3. Authorship of Research Paper

• There is no universally agreed definition of authorship.

• It is generally agreed that an author should have made substantial

contribution to the intellectual content, including conceptualising and
designing the study; acquiring, analysing and interpreting the data. The
author should also take responsibility to certify that the manuscript
represents valid work and take public responsibility for the work. Finally,
an author is usually involved in drafting or revising the manuscript, as
well as approving the submitted manuscript. Data collection, editing of
grammar and language, and other routine works by itself, do not deserve
an authorship.

• It is crucial to decide early on in the planning of a research who will be

credited as authors, as contributors, and who will be acknowledged. It is
also advisable to read carefully the “Advice to Authors” of the target
journal which may serve as a guide to the issue of authorship.
 4. Conflict of Interest
• This happens when researchers have interests that are not fully apparent
and that may influence their judgments on what is published. These
conflicts include personal, commercial, political, academic or financial
interest. Financial interests may include employment, research funding,
stock or share ownership, payment for lecture or travel, consultancies and
company support for staff. This issue is especially pertinent in biomedical
research where a substantial number of clinical trials are funded by
pharmaceutical company.

• Such interests, where relevant, should be discussed in the early stage of

research. The researchers need to take extra effort to ensure that their
conflicts of interest do not influence the methodology and outcome of the
research. It would be useful to consult an independent researcher, or Ethics
Committee, on this issue if in doubt. When publishing, these conflicts of
interest should be declared to editors, and readers will judge for themselves
whether the research findings are trustworthy.
 5. Redundant Publication and Plagiarism

• Redundant publication occurs when two or more papers, without full cross
reference, share the same hypothesis, data, discussion points, or conclusions.
However, previous publication of an abstract during the proceedings of meetings
does not preclude subsequent submission for publication, but full disclosure
should be made at the time of submission. This is also known as self-plagiarism.
In the increasing competitive environment where appointments, promotions and
grant applications are strongly influenced by publication record, researchers are
under intense pressure to publish, and a growing minority is seeking to bump up
their CV through dishonest means.

• On the other hand, plagiarism ranges from unreferenced use of others’ published
and unpublished ideas, including research grant applications to submission
under “new” authorship of a complete paper, sometimes in different language.

• Therefore, it is important to disclose all sources of information, and if large

amount of other people’s written or illustrative materials is to be used, permission
must be sought.
 Official requirements

A synopsis is incomplete if it does not contain the following

information:

• Name of the researcher, designation and department

• Name and designation of the supervisor
• Name and designation of head of department\institution
• Name of the institution
• Signatures of all with official seal
• Other documents
 Researcher’s Responsibility
• It is the duty of the researcher to ensure that research is conducted
in an ethical and responsible manner from planning to publication.
• Researchers and authors should familiarise themselves with these
principles and follows them strictly.
• Any potential ethical issues in research and publication should be
discussed openly within the research team.
• If in doubt, it is advisable to consult the respective institutional
review board (IRB) for their expert opinions.

• Case Scenarios (depending on time)

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4453117/
 Synopsis writing is an important step in a research project

• Gives maximum information in minimum words.

• A well-conceived synopsis will go a long way in convincing the
reviewer about the ability of the researcher to conduct the project.
• In cases of need for financial assistance, the request will be
considered favourably.
• All researchers should make efforts to prepare a well-structured
synopsis.
 Each question requires a definitive “Yes”

• Does my synopsis give a producer an accurate view of my story?

• Based on my synopsis, could a producer easily pitch my screenplay
to others?
• Can my synopsis be easily understood or is it too complicated of a
read?
• Is my synopsis bogged down with too many unimportant or
unnecessary details?
 Management of Research

• Planning Skills
• Experience
• Time Management
• Self and Peer Review

• Reflection and Reflexive thinking

• Gantt Chart

• Exercise
 Alignment Essential

• Research question/objectives
• Research hypothesis
• Research Design
• Methodology
• Data Collection
• Data Analysis
• Policy Implications

• Armchair Review
 Thank you

• Questions and comments welcome.

• Kindly fill in the feedback form (anonymous).
• Four aspects only
– What I learnt today,
– what I liked,
– what I did not like,
– what I would have done differently

• Also indicate if you would like to be kept informed

about future workshops.
 Some easily available references
for further reading
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4453117/
• https://www.pdfdrive.com/research-methodology-methods-and-techniqu
es-e170503040.html
• World Medical Association. (2013). World Medical Association Declaration
of Helsinki: ethical principles for medical research involving human
subjects. Jama, 310(20), 2191-2194.
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5037952/
• Yip, C., Han, N. L. R., & Sng, B. L. (2016). Legal and ethical issues in
research. Indian journal of anaesthesia, 60(9), 684.
• samples.jblearning.com/9781284144185/9781284267051_FMxx_Pozgar.pdf