Class notes
NURS 5366 Assignment 4 MODULE 5 ETHICS
- Institution
- University Of Texas - Arlington
NURS 5366 Assignment 4 MODULE 5 ETHICS Introduction To Clinical Research
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Introduction To Clinical ResearchContents
1
. Contents
1
. Course Objectives and Contents
2
. What Is Clinical Research?
3
. How Does Clinical Research Differ From Standard Care?
4
. Why Do We Perform Clinical Research?
1
. Why Do We Perform Clinical Research?
5
. Introduction: Key Points To Remember
6
. What Are The Main Principles Of Research Ethics?
1
. What Are The Main Principles Of Research Ethics?
7
. What Is Informed Consent And Why Is It Needed?
1
. What Is Informed Consent And Why Is It Needed?
2
. What Is Informed Consent And Why Is It Needed?
3
. What Is Informed Consent And Why Is It Needed?
4
. What Is Informed Consent and Why Is It Needed?
8
. Why Do People Participate In Clinical Research And What Are The Benefits And Risks
Involved?
1
. Why Do People Participate In Clinical Research And What Are The Benefits And Risks
Involved?
9
. Research Ethics: Key Points To Remember
10
. Study Designs
11
. Cohort Studies
12
. Case Control Studies
13
. Cross Sectional Surveys
14
. Case Reports
15
. Clinical Trials
1
. Clinical Trials
16
. Study Designs: Key Points To Remember
17
. Maintaining High Ethical Standards, Data Quality And Uniformity In A Study
1
. Maintaining High Ethical Standards, Data Quality And Uniformity In A Study
18
. Key Points To Remember
19
. References And Resources
20
. Quiz
Course Objectives and Contents
Objectives
Upon completion of this course, you will have an understanding of:
the basic concepts of clinical research e.g. what it is, how it differs from standard care and
why it is undertaken
the purpose of ethics in research, what informed consent is and why it is necessary
five of the most commonly used study designs
how high ethical standards, data quality and uniformity are maintained in a study
Contents
- Introduction: this section provides an overview of:
A definition of clinical research
How does clinical research differ from standard care
Why is clinical research carried out - Research Participants and Ethical Practices: this section provides an overview of:
The main principles of research ethics
Informed consent and why we need it
Why people participate in research and the benefits and risks
- Types of Clinical Studies: this section provides an overview of:
Cohort studies
Case control studies
Cross sectional surveys
Case reports
Clinical trials
- Maintaining high ethical standards, data quality and uniformity in a study: this section provides
an overview of:
Standard operating procedures
- Key points to remember
- References and Resources
This section provides the references used in this course and resources that you may find useful
for further reading.
- Quiz
This section provides questions that will allow you to test what you have learned from the
course.
What Is Clinical Research?
Clinical research is scientific study that involves people. Individuals volunteer to
participate in carefully conducted studies which ultimately uncover improved
methods and knowledge on screening, diagnoses, treatment and prevention of
disease and on the promotion of health and health care.
Clinical research can be interventional or observational. Observational studies
are projects where there is no investigational product assigned to participants, e.g. research on
how therapies work, health economic research and qualitative clinical research such as
understanding patients' experiences, etc. Interventional studies are controlled experiments, like clinical trials, where every participant is
allocated to the treatment or control group at the start of the study. The WHO's International
Clinical Trials Registry Platform states that ‘interventions can include drugs, cells and other
biological products, surgical procedures, radiologic procedures, devices, behavioural
treatments, process-of-care changes, preventive care, etc
’.
Studies can be run in just one location and are referred to as ‘single centre studies’, or they can
be run across many sites, and these are called ‘multi-centre studies’. Whether a study is single
or multi-centred will depend upon the type and scale of the research being undertaken.
How Does Clinical Research Differ From Standard Care?
The difference between clinical research and standard care is that clinical research:
involves human volunteers, these may be patients or can all be healthy individuals who are
not suffering from an illness or condition.
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