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PRIMER: Human Subjects, Past, Present, and Future

PRIMER: Human Subjects, Past, Present, and Future. Susan Metosky, Arizona State University Debra Murphy, Arizona State University. Objectives. Overview Historical Perspective IRB at Arizona State University (ASU) Questions and Answers.

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PRIMER: Human Subjects, Past, Present, and Future

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  1. PRIMER: Human Subjects, Past, Present, and Future Susan Metosky, Arizona State University Debra Murphy, Arizona State University

  2. Objectives • Overview • Historical Perspective • IRB at Arizona State University (ASU) • Questions and Answers

  3. Areas and committees supported by Office of Research Integrity and Assurance (ORIA) Human Subjects IRB Responsible Conduct in Research RCR Animal Care IACUC Export Controls Security Research Integrity and Assurance Biosafety IBC Scientific Diving DCB Conflict of Interest IPIRC Ensuring support for compliance with Local, State, and Federal Regulations through responsible conduct of research.

  4. Who are our stakeholders? • Researchers • Federal Government • Participants in Research Studies • Sponsored Projects and Grants Staff • Research Administrators • Administrators at Arizona State University • Committee members

  5. ORIA’s roles Follow Regulations Protect researchers/university Protect participants

  6. Institutional Review Board (IRB) • Reviews all proposed research involving human subjects • Ensures that participants are treated ethically • Diverse membership • At least 5 members • Males and Females • One unaffiliated member

  7. History “Those who cannot remember the past are condemned to repeat it ." - George Santayana

  8. 20th Century Research Clinton Apology 1997 Common Rule 1991 Consolidated HHS/FDA Regulations 1981 Belmont Report 1979 1972 Syphilis Study Exposed 1966 The Beecher Article (NEJM) Declaration of Helsinki 1964 Milgram Study Kefauver-Harris Amendments Food, Drug and Cosmetic Act 1962 Nuremberg Code 1947 Nazi Experiments 1932 Tuskegee Syphilis Study begins

  9. Tuskegee Syphilis Study • Images taken from: https://www.msu.edu/course/hm/546/tuskegee.htm and • http://alondranelson.wordpress.com/2012/07/25/tuskegee-and-the-black-panther-party/

  10. Nazi War Crimes World War II The image is from been the website: http://fcit.usf.edu/holocaust/resource/gallery/n1945.htm

  11. 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

  12. Belmont Report:Principles and Applications

  13. 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

  14. Rules that apply to all universities • Approval must be in place prior to initiating research activities or grant expenditure • There are 3 types of reviews • Full Board • Expedited • Exempt

  15. Where was ASU? 4 Federal Audits in recent years

  16. Where is the ASU IRB today? /

  17. Criteria that the IRB Uses to Evaluate Protocols for Approval • Compliance with Federal Regulations and University Policy • No risks or risks are minimized • Acceptable risk: benefit ratio • Equitable selection of subjects • Adequate informed consent process • Privacy and confidentiality protections • Additional safeguards for vulnerable populations

  18. Ways the ASU IRB Works to Minimize Risk To Researchers • Document Everything • Follow study procedures • Submit any changes to the IRB in writing • Must be approved before implementing • Report unexpected events • Ask questions To Participants • Alternatives • Other procedures that are less risky • Precautions • Procedures to decrease the likelihood that harms occur • Safeguards • Procedures to deal w/harms if they occur

  19. Program Enhancements at ASU • Culture of service in addition to culture of compliance • Director and IRB Administrator serve as trained IRB alternates • Approve minor changes that do not increase risk • Approve continuations that are closed to enrollment • Exempt protocols reviewed by trained staff • Increased emphasis on outreach • Increase in the number of affiliation agreements

  20. Program Enhancements at ASU • Classroom research guidance document • Guidelines regarding subject pools • Exempt and expedited “grid” documents • Special review of “geographic” issues

  21. What are some human subjects issues today? • Gene Therapy Trials • International Research • Nanotechnology • Internet Research • Chemical and Biological Terrorism • Suspension of human subjects programs at universities

  22. Looking to the Future: Advanced Notice of Proposed Rule Making

  23. Questions and Contact Information • Susan Metosky (480) 727-0871 Susan.metosky@asu.edu • Debra Murphy (480) 965-2179 Debra.Murphy@asu.edu

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