human subjects research at asu
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Human Subjects Research at ASU. An Overview. Overview. Definitions Historical Framework Federal Guidelines Human Subjects Research at ASU. Institutional Review Board (IRB). - PowerPoint PPT PresentationTRANSCRIPT
Human Subjects Research at ASU
An Overview
Overview• Definitions• Historical Framework• Federal Guidelines • Human Subjects Research at ASU
Institutional Review Board (IRB)• Reviews all proposed research involving human subjects to
ensure that subjects are treated ethically and that their rights and welfare are adequately protected
• Diverse membership– At least 5 members – Males and Females– Scientists– Non-scientists– At least one unaffiliated member
Human Subjects Research
Research “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”
Human Subject “a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information”
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102
Principal Investigator (PI)
Faculty or full-time staff member who assumes the following responsibilities:
• Submission of all required forms to the appropriate review committee
• Conduct of the research• Compliance with IRB decisions• Submitting proposed changes to previously approved
research
History• “Those who cannot remember the
past are condemned to repeat it.” ~ George Santayana
Tuskegee Syphilis Study
• Initiated by the US Public Health Service• Participants were told that they were being treated for “bad
blood” • Individuals were deceived by the officials that conducted the
study • In 1997, President Clinton apologized on behalf of the United
States Government to living survivors of the study
Nazi War Crimes World War II
• "Medical experiments" were performed on thousands of concentration camp prisoners
• Examples of tortures: – Forced killings– Injecting people with gasoline – Immersing people in ice water– Forcing people to ingest poisons
• 23 physicians and administrators were indicted before the War Crimes Tribunal at Nuremberg
Nuremberg Code (1947)
• Voluntary consent• Anticipate scientific benefits• Benefits must outweigh risks• Perform animal experiments first• Avoid suffering• No intentional death or disability• Do no harm• Subjects can withdraw at any time• Investigators must be qualified• Research will stop if harm occurs
Belmont Report (1979)
• The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issues a report: “Ethical Principles and Guidelines for the Protection of Human Subjects”
• Expanded upon Nuremberg Code
• Established 3 ethical principles for human subjects protection
http://www.hhs.gov/ohrp/policy/belmont.html
Federal Regulations
45CFR46 – Federal Policy for the Protection of Human Subjects
21CFR50 (Protection of Human Subjects)– Regulations about FDA-regulated clinical investigations
21CFR56 (Institutional Review Boards)– Regulations about responsibility of IRBs that review FDA-
regulated clinical investigations
What are the differences?
• Common Rule is based on funding • FDA regulations are based primarily on use of FDA regulated
products: drugs, devices, or biologics
The Office for Human Research Protections (OHRP) regulates
• Federally-supported research• Institutional Review Boards (IRB)• All research if a university chooses to apply 45CFR46 to
research
http://www.hhs.gov/ohrp/
ASU Human Subjects Review
All Human Subjects Research must be reviewed & approved prior to data collection
3 Types of Review
• Exempt Studies• Expedited Review• Full Board
Review time depends upon the type of study! Review takes approximately 1-6 weeks from receipt by the Office of Research Integrity and Assurance.
Exempt Studies• Research activities in which the only involvement of human
subjects will be in one or more of the exempt categories as defined by 45 CFR 46.101(b)
• For additional information about Exempt categories, please see http://researchintegrity.asu.edu/humans/exemptstatus
Studies that fall under an exempt category must be submitted for review!
Expedited Review
Studies are reviewed by the IRB Chair or a qualified member of the IRB. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research as defined by 45CFR46. To review the expedited review categories, see http://researchintegrity.asu.edu/humans/expeditedreview
Studies that fall under an expedited category must be submitted for review!
Full Board review
This type of review is carried out for studies that pose greater than minimal risk to subjects.
For more information, please see http://researchintegrity.asu.edu/humans/process
Making Changes to a ProtocolSubmit any proposed changes for review and approval before implementing the changes.
Examples of such changes include:• Alteration of study design, methodology, or recruitment• Changes to any instruments• Changes to informed consent documents• Alteration of project title• Addition of research sites• Addition/deletion of investigators
Changes to exempt studies do not need review unless the change makes the study non-exempt.
Study Approval• Non-exempt studies may be approved for up to 1 year• Study is complete when data analysis and data collection are
complete.
What happens if research lasts longer than 1 year?• Submit a Continuing Review/study closure application if the
project is to last longer than the approval period, which is typically 1 year
• If data analysis is continuing, submit a Continuing Review/study closure application
What happens when the research is done?• Submit a Continuing review/study closure application when
data analysis and data collection are complete• There is no expiration date for studies that were determined
to be exempt
The ASU ProcessStudies that fall under any category must be submitted for review!
• Use ERA-IRB to submit all:– New Studies (whether Exempt, Expedited, or Full Board),– Continuing Reviews/Study Closures– Modifications,– Reportable New Information, and
• For information on using ERA-IRB, see http://researchintegrity.asu.edu/humans
Conclusions• Treat human subjects ethically• Be aware of Federal, State, and Institutional regulations and
guidelines• Ask questions
Contact Information
ORIA staff are available to answer questions and assist you.• Susan Metosky, Assistant Director
– [email protected] (480) 727-0871
• Tiffany Dunning – [email protected] (480) 639-7396
• David Marin – [email protected] (480) 965-4796
• Debra Murphy, Director – [email protected] (480) 965-2179