Human Subjects Research
Donna K. Palivec, Ed.D
Department of Physical Education, Health, & Sport
BSU Human Subjects Committee Member
HOPR 1105 Presentation
February 15, 2006
A Historical Perspective
History of scandal & abuse
The present
*Privacy & confidentiality issues are focus
*System of oversight
*Appreciation for protection requirements
*Public expectations for research & protection
Historical Events & Documents
Nuremberg War Crimes Trials
*Nuremberg Code (1947)
**Voluntary consent
**Benefits outweigh risks
**Ability of subject to terminate participation
Declaration of Helsinki (1964)
*Biomedical research – human subjects
Social/Behavioral Science Research
Wichita jury (1953)
*Tape recording
*1956 federal law to ban recording
Simulated prison research
*Zimbardo, 1973 – Stanford
*Male student volunteers
**Prisoners, guards
**Physical & psychological abuse
Twin Study
*Questionnaire opened by subject’s father
National Research Act (1974)
National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research.
Institutional Review Boards (IRBs)
*Required at institutions supported in human subjects research by HEW.
Belmont Report (1979)
Respect for Persons
*Treat individuals as autonomous agents
Beneficence
*Acts of kindness that go beyond duty
Justice
*Treat people fairly
Federal Regulations
45 CFR 46 – DHHS Policy for Protection of Human Subjects – Subpart A
*Adopted 1981; revised 1991
*Document known as “Common Rule”
Subpart B
*pregnant women, fetuses, neonates
Subpart C
*Biomedical/Behavioral – prisoners
Subpart D
*Children
Subpart E
*Mentally incapacitated
IRB (Institutional Review Board)21 CFR 56.10745 CFR 46.107
At least 5 members
*Varied backgrounds
*Faculty & lay members
Roles
Review Continuum
Level of risk determines route of review
Exempt---Expedited---Full
Low---Minimal---Higher
--------RISK--------
Exemption Categories*
Sue Fish, PharmD, MPH
Director, Institutional Review Board
Associate Director, Office of Clinical Research, Boston University Medical Center
Educational settings or tests
Survey procedures
Interview procedures
Observation of public behavior
Research use of existing data
Public benefit or service programs
Taste & food quality
*Summary provided by presenter - suggested to check with regulations documents
Exempt UNLESS
Human subject can be identified
AND
Disclosure could place subject at risk
Expedited Review
BSU policy: Review by chair of HSC + 1 other member
Minimal risk
*Assessment of minimal risk: Sue Fish
“The probability & magnitude of harm or discomfort anticipated in the research are not greater in & of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
Human Subjects Approval Form
Bemidji State University
*Subject recruitment requirements
*Subject Risk
*Debriefing
*Materials
Subject Recruitment
Selection Considerations
Informed consent – Attachment B
Respect for persons
*U of M uses “Consent Form”
3 elements to consent
*Information
*Comprehension
*Voluntariness
Subject Risk
Committee can look to see if risks are justified
Risk = possibility that harm might occur
Benefit = something of positive value related to health or welfare
Risks & benefits “balanced”
*Principle of beneficence
Debriefing & Materials
Debrief – Attachment C
*Feedback about study
Materials
*Questionnaires, inventories, tests, instruments
Human Subjects Protection Program
Education Summit - Fall, 2005
IRB = a peer review body
*Flexibility
Issues
*Confidentiality
*Deception - unintentional
*Study design
*Informed consent
Student Research
Human Subjects Protection Program
Educational Summit at the U of Minnesota – Fall, 2005
3 variables – risk, benefits, training
*No risk, no benefit; students learn from process
*Training – students learn
*Rigor of review is the same
*At U of M, all student research must have a faculty advisor
U of M has 3 different boards
*IRB for student research
*IRB for faculty research
*IRB for medical research
Trends
In school research
Clinical focused web training
Students serve on IRB panels
Department of Physical Education, Health, & Sport
BSU Human Subjects Committee Member
HOPR 1105 Presentation
February 15, 2006
A Historical Perspective
History of scandal & abuse
The present
*Privacy & confidentiality issues are focus
*System of oversight
*Appreciation for protection requirements
*Public expectations for research & protection
Historical Events & Documents
Nuremberg War Crimes Trials
*Nuremberg Code (1947)
**Voluntary consent
**Benefits outweigh risks
**Ability of subject to terminate participation
Declaration of Helsinki (1964)
*Biomedical research – human subjects
Social/Behavioral Science Research
Wichita jury (1953)
*Tape recording
*1956 federal law to ban recording
Simulated prison research
*Zimbardo, 1973 – Stanford
*Male student volunteers
**Prisoners, guards
**Physical & psychological abuse
Twin Study
*Questionnaire opened by subject’s father
National Research Act (1974)
National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research.
Institutional Review Boards (IRBs)
*Required at institutions supported in human subjects research by HEW.
Belmont Report (1979)
Respect for Persons
*Treat individuals as autonomous agents
Beneficence
*Acts of kindness that go beyond duty
Justice
*Treat people fairly
Federal Regulations
45 CFR 46 – DHHS Policy for Protection of Human Subjects – Subpart A
*Adopted 1981; revised 1991
*Document known as “Common Rule”
Subpart B
*pregnant women, fetuses, neonates
Subpart C
*Biomedical/Behavioral – prisoners
Subpart D
*Children
Subpart E
*Mentally incapacitated
IRB (Institutional Review Board)21 CFR 56.10745 CFR 46.107
At least 5 members
*Varied backgrounds
*Faculty & lay members
Roles
Review Continuum
Level of risk determines route of review
Exempt---Expedited---Full
Low---Minimal---Higher
--------RISK--------
Exemption Categories*
Sue Fish, PharmD, MPH
Director, Institutional Review Board
Associate Director, Office of Clinical Research, Boston University Medical Center
Educational settings or tests
Survey procedures
Interview procedures
Observation of public behavior
Research use of existing data
Public benefit or service programs
Taste & food quality
*Summary provided by presenter - suggested to check with regulations documents
Exempt UNLESS
Human subject can be identified
AND
Disclosure could place subject at risk
Expedited Review
BSU policy: Review by chair of HSC + 1 other member
Minimal risk
*Assessment of minimal risk: Sue Fish
“The probability & magnitude of harm or discomfort anticipated in the research are not greater in & of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
Human Subjects Approval Form
Bemidji State University
*Subject recruitment requirements
*Subject Risk
*Debriefing
*Materials
Subject Recruitment
Selection Considerations
Informed consent – Attachment B
Respect for persons
*U of M uses “Consent Form”
3 elements to consent
*Information
*Comprehension
*Voluntariness
Subject Risk
Committee can look to see if risks are justified
Risk = possibility that harm might occur
Benefit = something of positive value related to health or welfare
Risks & benefits “balanced”
*Principle of beneficence
Debriefing & Materials
Debrief – Attachment C
*Feedback about study
Materials
*Questionnaires, inventories, tests, instruments
Human Subjects Protection Program
Education Summit - Fall, 2005
IRB = a peer review body
*Flexibility
Issues
*Confidentiality
*Deception - unintentional
*Study design
*Informed consent
Student Research
Human Subjects Protection Program
Educational Summit at the U of Minnesota – Fall, 2005
3 variables – risk, benefits, training
*No risk, no benefit; students learn from process
*Training – students learn
*Rigor of review is the same
*At U of M, all student research must have a faculty advisor
U of M has 3 different boards
*IRB for student research
*IRB for faculty research
*IRB for medical research
Trends
In school research
Clinical focused web training
Students serve on IRB panels
posted by Louise Mengelkoch at
9:52 AM
