Introduction to

Methods of
Research
Presented by

Prof. Dr. Hanan Abdel Aziz Mubarak

M.B.B.Ch, M.Sc., M.D., D.H.P.E.

Professor of Physiology

Faculty of Medicine, Cairo University

 Content

Title Page
Meaning of the Research and 2
Scientific base of the research
The Purposes of Nursing Research 3
Criteria of a good research 3
Classification of the research 5
Steps of the Research 12
Ethical Principles in Clinical Research 15

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 Meaning of the Research

 Research is a formal work undertaken systematically to increase

the volume of knowledge or to refine an existing knowledge.

 It is also defined as a scientific process of systematic

collection, analysis and interpretation of data to find an answer
or solution of a problem.

Scientific base of the research

Scientific
truths True Beliefs
[Hypothesis]
[Knowledge]

Justified true beliefs

Research: is the Process of justification of true beliefs (hypothesis)

to make them part of the knowledge to increase the volume of
knowledge.

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 The Purposes of Nursing Research
 The main goal of nursing research is to achieve better care
standards and applications for patients and families.

 The general purpose of nursing research is to answer questions

or solve problems of relevance to the nursing profession.

 The specific purposes of nursing research include identification,

description, exploration, explanation, prediction, and control of
the problem.

 Another specific purpose of research is an ongoing process of

correcting and refining hypotheses, which should lead to the
acceptance of certain scientific truths.

Criteria of a good research

Whatever may be the types of research studies, they all have to
satisfy the following criteria:

1. Originate with a novel question or problem.

2. The main purpose of the research should be clearly defined.

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3. The study or the procedure design of the research should be
carefully planned to produce results related to the purpose as
possible.

4. The procedure used should be described in sufficient details to

permit other researchers to repeat the research for further
progression of what has already been achieved.

5. The research requires collection and interpretation of data

6. The analysis of data should be sufficiently adequate to reveal its

significance and the methods of analysis used should be
appropriate.

7. High ethical standards should be applied and reported frankly.

8. Conclusion should be on the basis of data analysis and not on

guessing or intuition.

9. The research should describe the limitations (restrictions) of the

study.

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 10. Greater confidence in research is warranted if the researcher is
experienced, has a good reputation in research and is a person
of integrity

Classification of the research

A starting point in trying to understand the collection of information
for research purposes is that there are broadly two approaches:
 Qualitative research
 Quantitative research
It may be combined quantitative and qualitative research

Qualitative Research
 Definition

 What is Qualitative Research?

No one definition, however main features include:
- Qualitative research methods originated in the social and behavioral
sciences: sociology, anthropology and psychology.
- Qualitative research is aimed at gaining a deep understanding of a
specific organization or event, rather than surface description of a large
sample of a population.
- It is more flexible in that it can adjust to the setting. Concepts, data
collection tools, and data collection methods can be adjusted as the
research progresses.

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  Types of methods:
- Some common methods include focus groups (group discussions),
individual interviews and observations.

Types of qualitative methods

 Problems with qualitative studies include:

- Generates large amount of data difficult to be analyzed
- Achieved results have general approximate characters.
- More difficult to code data
- Not applicable to widely dispersed social setting

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 Quantitative Research
 Definition:
 Quantitative Research refers to the systematic investigational
study.
 Where the researcher collects the data from the different
respondents that are based on numerical figures
 Then data obtained is then analyzed for obtaining the results
using different mathematical, statistical and computational
tools.

 Types of methods:
Some common Quantitative research methods include: Survey
research, correlation research, comparative research and
experimental research.

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 Types of qualitative methods

 Advantages of quantitative research:

1. Quantitative research is not based on the thinking.

2. The data in the Quantitative research is collected and presented
in the numbers.
3. Quantitative research is based on the numbers; thus, it removes
the risk of personal biases.
4. It involves the statistics, so it is extremely accurate.
5. The data collected in the Quantitative research is quite
straightforward, thus less time-consuming.

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 Disadvantages of quantitative research:

1. The Survey instruments used for the research are vulnerable to

errors like the mistakes in measurement or sampling techniques
as the numerical data is involved. If the error occurs, the
research will not give the correct results for which the research
is conducted.
2. Generally, the Quantitative research method requires the
extensive statistical analysis that becomes difficult to perform,
especially if the person conducting the research is from the non
– statistical background.
3. In this method, a structured questionnaire is involved, which has
close-ended questions; the respondents of the research have
limited options for their responses as their responses will be
based on the selection of the question and their options as
made by the researcher. Due to this, limited outcomes can only
be derived from the research.

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 Comparing qualitative versus quantitative research

Research

Qualitative scope Quantitative

Discover ideas or Common purpose Test hypothesis or
understand human specific research
behavior question
Observe and interpret Method Approach Measure and test
Non-statistical Data analysis Statistical data
usually in form of
tables or charts
Researcher is Researcher Researcher
intimately involved, independence uninvolved observer,
results are subjective results are objective
Small number of non- Samples Large number of
representative cases cases representing
population of interest
Focus group, Examples Survey, experimental,
individual depth comparative,
interview, group correlation
discussion,
observations

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 Exercise

As regards internet research, state the quantitative or qualitative

example. Identify the methods or tools.

 Q1: How many are using the PubMed website?

 Q2: What motivates the target group to visit the website?
 Q3: What are colors preferred by the target group?

Answers:

Q1: Quantitative research. The method/tool is: google analytics

combined with survey for the representative users.

Q2&3: Qualitative research. The method / tool is: observation and

focus group

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 Steps of the Research

Step Requirements

[1] Developing a  Critical thinking

research idea  Clinical background
 Being a keen observer during clinical
practice
 Reading clinical research

[2] Reviewing the  Finding the keywords of the research

literature question
 Developing the search strategy
 Searching Medical Electronic
databases (PubMed, Cochrane,
Google Scholar, EBSCO, EMBASE,
SCOPUS, Web of Knowledge, etc.)
 Using key words

[3] Formulating the  Being aware of the types of

hypothesis hypotheses

[4] Planning for the  Discussing the study details with your
study team
 Writing the study protocol according

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 to the template of the institution

[5] Piloting the study  Piloting the process of data

collection, data entry, and data
analysis to find potential problems
that were not considered in the study
protocol.
[6] Gaining Ethical Complying with the requirements and
approval guidelines of your institution Ethics
Committee (EC) or Institutional Review
Board (IRB).

[7] Study Clinical skills if the interventional study:

implementation  Screening
 Subjects enrollment
 Implementation of intervention
 Data collection
 Data entry

[8] Data collection  Data collection tools e.g. google form

online survey, mails, phone ... etc

[9] Data entry Using MS Excel, Google sheets, etc.

[10] Data analysis  Interpretation of the statistical
analysis results

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  Running the basics statistical tests on
some statistical analysis software,
e.g., SPSS, R, STATA,SAS, etc.
[11] Writing manuscript  Following the standard reporting
checklists
 Following the scientific writing rules
 English language proficiency
[12] Publication  Presentation skills
 Experience in Journal selection
 Experience in addressing reviewers’
comments

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 Ethical Principles in Clinical Research

 What is Ethics, Bioethics?

Ethics are ways of understanding and examining the moral life, or right and
wrong human conduct.
Bioethics is a way of understanding and examining the moral
aspects of biomedical research and Practice.

 Definition of Clinical Research

Patient-oriented research:
- Research conducted with human subjects (or on material of human origin
such as tissues, specimens and cognitive phenomena) for which an
investigator (or colleague) directly interacts with human subjects.
- Excluded from this definition are in vitro studies that utilize human tissues
that cannot be linked to a living individual.

Patient-oriented research includes:

- Mechanisms of human disease,
- Therapeutic interventions,
- Clinical trials,
- Development of new technologies.

 Ethics Principles
- Respect for Persons: The principle of respect requires that subjects
participating in the research should be fully aware of the nature of such

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research and assured that such participation is voluntary, with no pressure
or threats.

- Beneficence: Beneficence requires researchers to maximize the potential

benefits to the subjects and minimize the potential risks.

- Justice: The principle of justice requires fair selection of subjects and a

fair and equitable distribution of risks and benefits of research.

 Ethical requirements in clinical research aim to:

- Ensure that the rights and welfare of subjects are respected while they
contribute to the generation of knowledge.

 What makes research ethical?

Fulfilling all 7 requirements is necessary and sufficient to make clinical
research ethical. These requirements are universal, although they must be
adapted to the health, economic, cultural, and technological conditions in
which clinical research is conducted.
1. Valuable scientific question
2. Valid scientific methodology
3. Fair subject selection
4. Favorable risk-benefit evaluation
5. Independent review
6. Informed consent
7. Respect for enrolled subjects

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1. Valuable scientific question
Ethical clinical research should answer a valuable question, i.e., one that
will generate new
knowledge or understanding about human health or illness, i.e. a socially,
clinically, or scientifically useful question.

2. Valid scientific methodology

Ethical clinical research should be designed in a methodologically rigorous
manner (design, methods, statistical power and methods, etc.) that will
yield valid, reliable, generalizable, and interpretable data, and that is
feasible.

3. Fair subject selection

- No exclusion without justification
- Informed consent
- Respect for enrolled subjects

4. Favorable Risk benefit ratio

- Are risks to subjects necessary and minimized?
- Are risks justified by benefit to individual subjects and/or the importance of
the knowledge to society?
- Compensation for participation in research is not considered to be a
benefit but, rather, compensation for research-related inconveniences.

5. Independent Review
 Independent review allows evaluation of the research for adherence to
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established ethical guidelines by individuals with varied expertise and no
personal or business interest in the research. For most clinical research,
this independent review is carried out by an Institutional Review Boards
(IRB) or research ethics committee (REC).

6. Informed consent
For all biomedical research involving human subjects, the investigator must
obtain the informed consent of the prospective subject or authorized
representative.
Informed consent ensures that individuals have the opportunity to decide
whether they want to participate in research or continue participation and
whether it is compatible with their goals, values and interests.

 In seeking informed consent, the following information shall be

provided to each subject:

Essential Elements of Informed Consent Form

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 Who can consent?
– A competent adult, or
– The patient’s legally authorized representative.

 Vulnerable (or Potentially Vulnerable) Research Subjects

Vulnerable subjects frequently are individuals who are unable to consent
(e.g. unable to understand the research in question).
- Comatose people
- Critically ill people
- Mentally retarded people
- People with dementias/some psychiatric diseases
- Children
- Educationally/economically deprived people
- Prisoners
- Seriously/terminally ill people.

 Consent and Children in Research

- Children may be required to “assent,” but they cannot legally “consent” to
participate in research.
- Generally, permission of both parents, and his or her legal guardian, is
required
for a child to participate in research.

7. Respect for enrolled subjects

Ethical research requires continued respect for the rights of participants
throughout research, including:
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- Protecting confidentiality
- Recognizing right to withdraw
- Informing participants of findings

Excercise

Are these studies ethical? (Group Discussion)

1. High-Altitude Experiments. Experiments were conducted to
investigate the limits of human existence at extremely high altitudes.
The experimental subjects were placed in a low-pressure chamber
and after that the simulated altitude there was raised.

High-Altitude experiments

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 2. Freezing Experiments: Experiments were conducted to investigate
the most effective means of treating persons who had been severely
chilled or frozen. In one series of experiments the subjects were
forced to remain in a tank of ice water for periods up to 3 hours. In
another series of experiments, the subjects were kept naked outdoors
for many hours at temperatures below freezing.

Freezing Experiments

3. Experiments with Poison: Experiments were conducted to investigate

the effect of various poisons upon human beings. The poisons were
secretly administered to experimental subjects in their food. The victims

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 died as a result of the poison or were killed immediately in order to
permit autopsies.

Experiments with Poison

4. A medical device for corneal transplantation surgery: In 1994, eye

surgeon James Rowsey invented a medical device that he thought would
revolutionize corneal transplantation surgery and make millions of dollars. It
did neither. Instead, it cost him a high paying university job and led to
federal findings that he performed unapproved research on more than 60
people, including children.

Hands on Activity
A study will be conducted to assess the effects of a new drug treatment for
diabetic patients.
Prepare an informed consent form that includes required information, as
described in the part of informed consent.
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