Research Methods Lecture 1 Dr.

Yassir Abdulkadhim Yassir

RESEARCH METHODS

The following topics will be discussed in the research method lectures

Introduction

Ethics in Health Research

Stages of the Scientific Research Process

• Identifying a Research Topic

• Review of Literature

• Defining and Refining the Research Question

• Generating the Research Hypothesis

• Types of Research (Methodologies)

• Populations and Samples

• Data Collection

• Data Analysis

• Interpreting the Results

Writing a Research Protocol

Writing a Scientific Paper

Evaluating a Scientific Paper

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Research Methods Lecture 1 Dr. Yassir Abdulkadhim Yassir

INTRODUCTION

Research can be defined as the systematic collection, description, analysis and interpretation of data
to answer a certain question or solve a problem. In health researches, the data can be used to
improve the health of individuals or groups.

The research process changes “information” into “knowledge”, through critical assessment and
relating it to other existing human knowledge.

Example from our daily life, when we want to buy a car in a proper way, we collect information
about models and dealers, analyze it, then try to reach a “scientific” conclusion on which car to buy.
The use of complex instrumentation is not a necessary requirement for good research. Key attributes
of good research are proper planning, accuracy in data collection and proper unbiased interpretation.

There is only one type of research: good research. Bad research does not deserve the name of
research. Badly done research is not only a waste of time, money and effort. It can be considered
unethical if it exposes research subjects to the inherent risks of experimentation with no reward to
them, to others or to their communities.

Research is not a method of “proof”. In other words, research does not “prove” anything. Rather, it
provides supportive evidence for or against the existence or nature of relationships among or
between variables of interest.

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Research Methods Lecture 1 Dr. Yassir Abdulkadhim Yassir

ETHICS IN HEALTH RESEARCH

As researchers, we are unable to conduct our projects successfully if we do not receive the help of
other people. Many people are willing to disclose a lot of personal information during our research, so
we need to make sure that we treat both the participants and the information they provide with
honesty and respect. This is called research ethics.

General Ethical Principles

Where research involves experimentation on human subjects, the basic principles include:

1. Beneficence: Every effort should be made to maximize the benefits to the subjects.

• If the topic is about testing a new therapy or procedure, evidence should already be available
to suggest that it can be superior to currently available alternatives.

2. Non-maleficence: The subjects should suffer no harm.

• Adequate data must be available from animal studies and from studies on a small number of
human subjects to confirm safety and to suggest effectiveness, before subjecting patients to a
new drug or procedure.

3. Respect: Which includes that:

• Participation in the research should be completely voluntary and based on informed consent

• Where research involves collection of data on individuals, privacy should be protected by

ensuring confidentiality

• The research should respect the society’s cultural, moral, religious and legal values.

4. Justice: No population group should carry an undue burden of research for the benefit of another
group.

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Research Methods Lecture 1 Dr. Yassir Abdulkadhim Yassir

Apart from the basic principles, other principles also apply. Where research involves
experimentation on animals, mercy is an ethical imperative. For research in general, medical or
nonmedical, honesty is an indispensable value.

Research involving experimentation on animals should be justified. In-vitro biological systems or

computer simulation models should be considered, wherever possible, as substitutes to animal
research. The animal experiments must be relevant to the advancement of knowledge or are an
essential step before human experimentation.

Responsibility for Ethics in Health Research

Responsibility for ensuring that ethical standards are observed in research rests collectively with
different parties. Ethical approval by one does not relieve the others of responsibility.

1. Investigators: The primary and ultimate responsibility rests with the investigators who should, as a
part of their training, be made aware of the ethical imperatives in research.

2. Research Institution: The research institution is responsible for the ethical quality of the research
performed by its staff and in its facilities by the institutional ethics review committee. The
committee should be completely independent from the investigators and with no direct interest
in the proposal.

3. Funding Agencies and Organizations: No research proposal should be funded unless it has clearly
outlined the ethical aspects of the study and has gained the approval of the institutional review
committee. It is unjustifiable to do clinical trials on therapies that are unlikely to become available
to people in the country or community (non-affordable or non-marketable).

4. National Drug Regulatory Agency: New drugs or devices that are not yet approved in the country
should not be used on human subjects without approval being obtained for their use under the
conditions of the study.

5. Editors of Medical Journals: Reports of research not complying with ethical standards should not
be accepted for publication.

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Research Methods Lecture 1 Dr. Yassir Abdulkadhim Yassir

Ethical Considerations throughout the Research Process

Approval by ethics review committees: For studies in the biomedical field (involving human subjects
or animals), the protocol must be approved by the institutional ethics review committee.

Informed decision-making: A consent form, where appropriate, must be developed and attached to
the protocol. The consent form has two parts:

1. A participant/patient information sheet describing the study.

2. A certificate indicating the subject’s consent to participate in the study.

Both parts should be written in the subjects’ mother language, in a simple way so that the subject can
easily understand the contents. As much as possible, the use of medical terminology should be
avoided. Special care is needed when subjects are illiterate.

The participant/patient information sheet should:

3. Explain why the study is being carried out and why the subject has been asked to participate.

4. Describe, in sequence, what will happen in the course of the study, giving enough detail for the
subject to gain a clear idea of what to expect.

5. Clarify whether or not the study associated with any benefits or adverse effects to the subject or to
others.

6. Indicate that the subject has the right to withdraw from the study at any time without, in any way,
affecting her/his further health care.

Note: The World Medical Association, in 1964, developed, adopted the Helsinki Declarations which
today provide guidance to the medical research. International ethical guidelines for biomedical
research involving human subjects have been issued by the Council for International Organizations of
Medical Sciences (CIOMS) in collaboration with the World Health Organization. The latest edition was
issued in 2002 (for more information, see Supplementary Materials for Lecture 1).