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
Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
Why?
All agencies receiving federal funds (all public universities) are required to have an Institutional Review Board
Protection of:Research participants ResearcherUniversity
Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
Committee for the Protection of Human Subjects
Covers research done with human subjects <by people at CSUF>What is research?What are human subjects?
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
Research is not
Data collected for classroom evaluation, illustrative purposes, or educational purposes
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)
Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
Risk Categories
No risk research Minimal risk research At risk research
<risk = equivalent to daily life>
No Risk Research
Study of existing anonymous data Study of existing documents Study of publicly observable, legal
behavior
Minimal Risk Research
Study of “normal adults’” attitudes opinions, cognitions, personality, etc.
Study of “normal adults’” moderate exercise
Study of “normal adults’” biological specimens
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
At Risk Research
Study of protected populationsThose younger than 18 years oldThose with psychological, cognitive,
and/or physical impairments Incarcerated individualsPregnant women
Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
Levels of Review
Departmental Chair Departmental Committee University Committee
No Risk Research
Unfunded:Memo to Departmental Chair
Funded:Departmental Committee, then
University Committee (Expedited)
Minimal Risk Research
Unfunded:Departmental Committee
Funded:Departmental Committee, then
University Committee (Expedited)
At Risk Research
Unfunded:Departmental Committee, then
University Committee Funded:
Departmental Committee, then University Committee (Full)
Overview
Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining
Human Subjects Approval CSUF Paperwork for Obtaining
Human Subjects Approval
CPHS Webpage
Checklists Example memos Example Informed Consent Forms Training modules
Paperwork / Timing Problems
No departmental review No training certificate Missing instruments Missing informed consent forms Premature submission of grants
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