human research ethics: issues and procedures dr. constance jones chair, committee for the protection...
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Human Research Ethics: Issues and Procedures
Dr. Constance Jones
Chair, Committee for the Protection of Human Subjects
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Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
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Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
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Why?
All agencies receiving federal funds (all public universities) are required to have an Institutional Review Board
Protection of:Research participants ResearcherUniversity
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Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
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Committee for the Protection of Human Subjects
Covers research done with human subjects <by people at CSUF>What is research?What are human subjects?
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Research is
Any systematic investigation or collection of data intended for scientific presentation or publication
Researchers may be undergraduate students, graduate students (projects or theses), faculty, staff, administrators
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Research is not
Data collected for classroom evaluation, illustrative purposes, or educational purposes
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Human Subjects Research can involve:
Contact with humans via telephone, mail (paper or electronic), or in-person interaction
Study of records of human behaviors or attitudes (e.g., case files, police records, hospital records)
Study of specimens collected from humans (e.g., blood, urine)
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Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
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Risk Categories
No risk research Minimal risk research At risk research
<risk = equivalent to daily life>
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No Risk Research
Study of existing anonymous data Study of existing documents Study of publicly observable, legal
behavior
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Minimal Risk Research
Study of “normal adults’” attitudes opinions, cognitions, personality, etc.
Study of “normal adults’” moderate exercise
Study of “normal adults’” biological specimens
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At Risk Research
Study involving possibility of physical or psychological harm
Study involving collection of reports of illegal / embarrassing behavior
Study using deception and debriefing
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At Risk Research
Study of protected populationsThose younger than 18 years oldThose with psychological, cognitive,
and/or physical impairments Incarcerated individualsPregnant women
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Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
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Levels of Review
Departmental Chair Departmental Committee University Committee
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No Risk Research
Unfunded:Memo to Departmental Chair
Funded:Departmental Committee, then
University Committee (Expedited)
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Minimal Risk Research
Unfunded:Departmental Committee
Funded:Departmental Committee, then
University Committee (Expedited)
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At Risk Research
Unfunded:Departmental Committee, then
University Committee Funded:
Departmental Committee, then University Committee (Full)
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Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
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CPHS Webpage
Checklists Example memos Example Informed Consent Forms Training modules
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Paperwork / Timing Problems
No departmental review No training certificate Missing instruments Missing informed consent forms Premature submission of grants
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Proposal Problems
Lack of clarity in terms of:Who will be studiedHow they will be studiedWhen they will be studiedContext of study
Minimization of risk Incorrect classificationToo brief consideration and/or
description of risk