Research Ethics
Learning outcomes
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Recognize the importance of IRB for research
Identify the components and types of IRB
Identify the components of informed consent form
for research that use human subjects
Recognize ethical issues in research
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Research participants must voluntarily consent to
research participation.
Research aims should contribute to the betterment of
society.
Research must be based on sound theory and prior
animal testing.
Research must avoid unnecessary physical and mental
suffering.
No research projects can go forward where serious
injury and/or death are potential outcomes.
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The degree of risk taken with research participants
cannot exceed anticipated benefits of results.
Proper environment and protection for participants is
necessary.
Experiments can be conducted only by scientifically
qualified persons.
Human subjects must be allowed to discontinue their
participation at any time.
Scientists must be prepared to terminate the experiment
if there is cause to believe that continuation will be
harmful or result in injury or death.
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Advice to avoid Plagiarism:
 A researcher preparing a written manuscript should
cite the original source if he or she: "Quotes another
person’s actual words”
 Paraphrases another person’s words.
What is an IRB?
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IRB stands for Institutional Review Board
The IRB is composed of at least 5 persons
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Chairperson
Community Member
University Faculty
Lay Person (non-affiliated)
Practitioner
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Each person listed as an author on an article should
have significantly contributed to both the research and
writing.
All listed authors must be prepared to accept full
responsibility for the content of the research article.
Plagiarism: is the act of passing off somebody else’s
idea, thoughts, pictures, theories, words, or stories as
your own.
Informed Consent:
 The researcher needs to lay out the protocol of the
experiment to the participant; inform them on the
benefits, obligations, and any potential risks
 Consent forms have to be extremely explicit in their
language, and must clearly state the roles in the study.
 Participants must to be informed of confidentiality
issues.
 The informed consent form is in fact a contract between
the participant and the researcher.
General Requirements for Informed Consent
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Legally effective informed consent shall:
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Be obtained from the subject or the subject's legally
authorized representative.
Be in a language understandable to the subject or the
representative;
Be obtained under circumstances that provide the
subject with the opportunity to consider whether or not to
participate,
Not include language through which subject is made to
waive any of his legal rights or which releases the
investigator, sponsor or institution from liability for
negligence.
Basic Elements of Informed Consent
1.Statement that study involves research;
2. Explanation of purpose(s) and expected duration
of participation;
3.Description of procedures and identification of
experimental procedures.
4.Description of risks or discomforts to subject.
5.Description of benefits to subject or to others.
6.Disclosure of alternative procedures, if appropriate.
7.Description of the extent to which confidentiality will
be maintained.
What does the IRB do?
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The IRB is responsible for protecting the rights and
welfare of human and animal research subjects
that participate in research activities conducted
under the protection or support of the University.
The IRB reviews and approves ALL research
involving human subjects BEFORE experimentation
begins. (This includes surveys, professional tests,
questionnaires, and studies in which the researcher
is the subject of his/her own research.)
The IRB determines the level of RISK involved in the
project.
Why Does we Need an IRB?
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To protect researchers from legal issues
To protect potential participants
To meet the requirements of the federal government
Ensure that the element of the consent form are
present.
To meet the requirements of external funding
agencies
May required by journal
Levels of Review
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There are three levels of review:
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Exempt Research
Expedited
Full review
Consent Form
All of the following information will be needed in
each consent form.
For early withdrawal from the study:
If you agree to be in this study, you are free to
change your mind. At any time you may withdraw
your consent to be in this study and for us to use
your data. If you withdraw from the study, you will
continue to have access to health care at …….