do no harm
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DO NO HARM. NLU IRRB Home page. IRRB Presentation. Purposes Responsibilities Processes. NLU IRRB Home page. IRRB Purposes. Assure that research follows ethical principles and guidelines. Assist the investigator in examining ethical implications of their research. NLU IRRB Home page. - PowerPoint PPT PresentationTRANSCRIPT
DO NO HARM
IRRB Presentation
Purposes
Responsibilities
Processes
NLU IRRB Home page
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 ReportPractice - 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
Who do I contact for information?
What is the purpose of the study?
How will data be used?
How long will my participation take?
Answer these questions:
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Be Informed (cont.)
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?
Answer these questions:
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Give Consent
Participation is voluntaryRight to withdrawFree of coercion and undue influenceConsent of parent or guardian when requiredConsent cannot be assumed, but must be
explicit and written
Include the following elements:
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Who Applies?
Those engaged in research:
Faculty and staffDoctoral Students: DissertationMasters Students: ThesisIDS 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 ProvostChecked for completenessReviewedDatabase updatedProposal filedResearcher notified
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THANK YOU!
For additional information:
Visit
NLU IRRB Home page
or contact the
Office of the Provost
(312) 261-3683