Transcript Ethical Principles and Guidelines for Research Involving

DO NO
HARM
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IRRB Presentation
Purposes
Responsibilities
Processes
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IRRB Purposes
Assure that research follows ethical
principles and guidelines.
Assist the investigator in examining
ethical implications of their research.
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Nuremberg Code
Voluntary consent of the human subject
absolutely essential.
Risk should never exceed benefits.
The Doctors Trial
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Belmont Report
Practice - Interventions that enhance
well-being of an individual and are likely
to be successful.
Research - Activities designed to
contribute to generalizable knowledge
and/or interpretive understanding.
The Belmont Report
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Basic Ethical Principles
Respect for Persons - informed consent
Beneficence - do no harm
Justice - fair distribution of burdens & benefits
The Tuskegee Syphilis Study
U.S. Dept of Health and Human Services
Office for Human Research Protections
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Federal Definition of
“Human Research Subject”
A living individual about whom an
investigator (whether professional or
student) conducting research obtains:
• Data through intervention or interaction
with individual, or
• Identifiable private information.
Title 45, Part 46
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When does research not
meet federal definition?
Study of private information about dead people;
Study of public information about living
persons;
Observation of public behavior;
Study of publicly available information in which
persons are not identifiable.
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Federal Requirements
Institutions conducting research will create:
A statement of ethical principles,
An institutional research review board
(IRRB),
Written procedures for conducting reviews of
research and reporting actions to
investigators.
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IRRB Actions
Review and approve or disapprove all
research activities.
Require informed consent and
documentation of informed consent.
Notify investigators of its decision in
writing.
Conduct continuing review of research at
appropriate intervals.
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Elements of Informed Consent
(Sample forms available at NLU)
 Purpose of the research
 Participants’ right to see your study
 Contact for further information
 Advisor’s/chair’s address, telephone, and e-mail
 Affiliation with the university
 Signatures—you and the participant
 Two copies: for you and the participant
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Informed Consent
(Do no harm!)
Participant must…
 Be informed, and
 Give consent
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Be Informed
Answer these questions:
Who do I contact for information?
What is the purpose of the study?
How will data be used?
How long will my participation take?
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Be Informed (cont.)
Answer these questions:
How will confidentiality be protected?
Who will have access to transcripts, field notes?
What are the risks and benefits?
How will you report the research findings?
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Give Consent
Include the following elements:
Participation is voluntary
Right to withdraw
Free of coercion and undue influence
Consent of parent or guardian when required
Consent cannot be assumed, but must be
explicit and written
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Who Applies?
Those engaged in research:
Faculty and staff
Doctoral Students: Dissertation
Masters Students: Thesis
IDS Students: Action Research
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Who Does Not Apply?
Students conducting research as part
of a class
Faculty and staff collecting institutional
data for self study and accreditation
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Designated Category
Exempt
Expedited
Full Review
Criteria Standards
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Disposition of Application
Sent to Office of the Provost
Checked for completeness
Reviewed
Database updated
Proposal filed
Researcher notified
THANK YOU!
For additional information:
Visit
NLU IRRB Home page
or contact the
Office of the Provost
(312) 261-3683