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Columbia University IRB IRB 101

Columbia University IRB IRB 101. July 14, 2005 George Gasparis, Executive Director, CU IRB Asst. V.P. and Sr. Asst. Dean for Research Ethics. Objectives . Today’s session will provide information on: History and Trends in Human Research Ethics and Regulations

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Columbia University IRB IRB 101

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  1. Columbia University IRBIRB 101 July 14, 2005 George Gasparis, Executive Director, CU IRB Asst. V.P. and Sr. Asst. Dean for Research Ethics

  2. Objectives • Today’s session will provide information on: • History and Trends in Human Research Ethics and Regulations • Introduction to Relevant Regulations • Introduction to Operation of the CUMC IRB • Understanding of IRB Review Criteria • Submitting to the IRB Successfully

  3. Well Known Major Cases Involving Unethical Research Nazi Experimentation in Concentration Camps World War II 1939-44

  4. THE NUREMBERG CODE • Became the first widely recognized ethical code of conduct for human research • First Tenet - The voluntary consent of the human subject is absolutely essential. • [from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington, D.C.: U.S. G.P.O, 1949–1953.]

  5. Nuremberg Code and Voluntary Consent (Continued) • The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

  6. Not Well Publicized Ethical Tragedies • Chemical and Biological warfare experimentation in Asia – 1920s • -Documented by Dr. Sheldon Harris’ book: “Ethics of Biological Warfare Research” • -The Big Three: Ishii Shiro, Katano Masaji, and Wakamatsu Ywiro conducted biological warfare (bw) and chemical warfare (cw) research on thousands of subjects in China, Indonesia, New Guinea, and the Philippines (and possibly Korea). • -Ishii used a minimum of 10-12,000 subjects in Northern Mantsuria

  7. Not Well Publicized Ethical Tragedies (cont’d) • Chemical and Biological warfare experimentation in Asia – 1920s • -Research was done on slaves, prisoners, and citizens in dozens of chemical factories; Units 731 (headed by Ishii Shuro; and the largest unit), Unit 100, and Unit 555 were the most famous. • -Research was also done on frostbite (by freezing subjects), gangrene, decompression (exploding subjects), cholera, dysentery, and virtually every known pathogen. • -About 250,000 people were killed in China alone.

  8. Not Well Publicized Ethical Tragedies (cont’d) • Chemical and Biological warfare experimentation in Asia – 1920s • -Subjects were referred to as “monkeys” or “marutas” (“logs”). • -American POWs were not tested at major centers, but were tested, including surgical excision of livers while alive. • -Every Japanese officer above Major and every Minister of Office, and the Imperial family knew of the experiments.

  9. Declaration of Helsinki, 1964 • A more developed research code of conduct expanding to address clinical research • -Developed by the World Medical Assembly • Has undergone 8 revisions; the most recent in October 2000

  10. SUCH CONDUCT COULD NOT OCCUR IN THE U.S., • RIGHT?

  11. Well Known Major Cases Involving Unethical Research in the U.S. • Tuskegee Syphilis Study 1932-1972 • U.S. Radiation Experiments 1940s • Willowbrook Study, NY 1956-1972 • Milgram Study, 1961 • Jewish Chronic Disease Hospital, 1963 • U.S. Army LSD studies/National Airport, 1963-4 • Stanford Prison Study, 1971

  12. Not Well Publicized Ethical Tragedies • Dr. Albert Kligman’s research at the Holmesburg prison – 1951 - 1970’s • -Documented by Dr. Allen Hornblum’s book: “Acres of Skin” • -Conducted chemotherapy, psychotropic drugs, and burn studies in Ohio • -Came to the prison in 1951 to study athlete’s foot; earlier he performed ringworm studies on retarded children. • -Total of 1,200-1,400 patients; 70-80% were in studies.

  13. Not Well Publicized Ethical Tragedies (cont’d) • Dr. Kligman’s research at the Holmesburg prison – 1951 - 1970’s • -One Example: -Dow Chemical sponsored study of diazanon • -he was paid $10,000/pt. • -increased dose 480x and left patients untreated • -no adverse events reported • -Other Examples: -Tested benzylates, atropine, and other psychotropic drugs • and chemical warfare agents

  14. Not Well Publicized Ethical Tragedies (cont’d) • Dr. Kligman’s research at the Holmesburg prison – 1951 - 1970’s • -In 25 years of studies, he only received a handful of lawsuits. • -Subjects were given waivers to sign (not consent); if subjects accepted a payment, they would waive rights to suit the investigator, University of Pennsylvania, or jail. • -At the time, Pennsylvania only had a 2 year statute of limitations from time one knew or should have known.

  15. Belmont Report, 1979 • National Commission for the Protection of Human Subjects of • Biomedical and Behavioral Research • Basis of federal regulations regarding the protection of human subjects in research • http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

  16. Belmont Report, 1979 • Applies to Social and Behavioral Research, as well as Biomedical Research

  17. Belmont Report, 1979 • Articulates 3 Basic Ethical Principles: Respect For Persons – Autonomy of the Individual Beneficence – Risk Minimization Justice – Burdens and Benefits of Research are Equitably Distributed

  18. Relevant Regulations • Federal Regulations: • Department of Health and Human Services (HHS) • Food and Drug Administration (FDA, agency of HHS) • State Law: • New York State

  19. DEPARTMENT OF HEALTH & HUMAN SERVICES

  20. Federal Regulations for the Protection of Subjects from Research Risks45 CFR Part 461981

  21. 45 CFR 46 • Subpart A -- Basic Protections • Subpart B -- Pregnant Women, Neonates and Fetuses • Subpart C -- Prisoners • Subpart D -- Children

  22. 45 CFR 46 – Subpart B • Revised Subpart B issues on November 13, 2001 • (effective date December 13, 2001) • Changes: • -introduces the term neonate; removes references to in-vitro fertilization; • -changes when paternal consent is required; • -strengthens the protection for the fetus by requiring that the parents are fully informed regarding the impact of the research on the fetus or neonate

  23. COMMON RULEFederal Policy for the Protection of Human Subjects(45 CFR 46 Subpart A) • June 18, 1991 • 17 Departments and Agencies

  24. http://www.hhs.gov/ohrp/ Check website for guidance on many different ethical and regulatory considerations. OHRP Website

  25. Other Relevant Federal Regulations • FDA Regulations: • Code of Federal Regulations • Title 21, Parts 50, 56, 312, 812 • Applicable to research that involves testing of FDA regulated drugs, devices, biologics • http://www.fda.gov/oc/ohrt/irbs/

  26. Trends from 1970s - Present • 1970 to mid 80s – Protectionists era • 1985 - ?

  27. Trends from 1970s - Present • 1970 to mid 80s – Protectionists era • 1985 -1995 – Inclusion era: • -HIV epidemic

  28. Trends from 1970s - Present • 1970 to mid 80s – Protectionists era • 1985 -1995 – Inclusion era: • -HIV epidemic • -NIH and FDA Guidance for Inclusion of Women and Minorities in Research

  29. Trends from 1970s - Present • 1970 to mid 80s: Protectionists era • 1985 -1995: Inclusion era: • 1995 - Present: Pendulum has swung back towards protectionism

  30. Well Known Major Noncompliance Cases • Continued incidence of unethical research • Gulf War, 1991 • OPRR/OHRP Shutdowns of Academic Medical Centers: • Duke University • Rush Presbyterian • UCLA • Univ. of California at Irvine • University of Oklahoma • + others

  31. Even More Recently and Closer to Home • Continued incidence of unethical research/noncompliance: • Nicole Wan, Univ. of Rochester, 1996 • Jesse Gelsinger, Univ. of Penn., 1999 • Ellen Roche, Johns Hopkins, 2001 Ethical Research, but serious noncompliance: • Columbia University Medical Center, 2005 – Current OHRP investigation

  32. What are the implications of noncompliance? • 1. Affects the Public Trust in our research enterprise • -affects recruitment • -affects sponsors’ decisions to bring studies to an institution • 2. Affects economics of the research enterprise locally • 3. Creates significantly more work to ensure regulatory compliance

  33. IRBManagement of Noncompliance Cases • Total case load: • 43 open cases involving 21 investigators • Sources of noncompliance cases: • 12 studies – Federal regulatory agencies or NIH • 18 studies – CUMC IRB • 8 studies – CUMC employees or staff • 5 studies – External to CUMC • 1 study – Self-reporting • 15 closed cases involving 12 investigators

  34. All Human Research at Columbia University • Governed by Ethical Principles and the Requirements of HHS and FDA Regulations and NY State Law

  35. Columbia University • Each performance site needs: • Assurance of Compliance Approved by OHRP (not required by FDA regulations) • B. Board Approval (i.e., IRB, REB, ethics cmte.) • Consent Obtained from Each Subject, Unless Waived by the IRB

  36. Columbia University Medical Center • Federalwide Assurance (FWA) • FWA00002636 • -Applies the Belmont Report and • 45 CFR 46 to all of its Human Subjects • Research Regardless of Support

  37. New York Presbyterian Hospital • Federalwide Assurance (FWA) • FWA00002635 • -Applies the Belmont Report and • 45 CFR 46 to all of its Human Subjects • Research Regardless of Support

  38. When does Human Subjects Research Need IRB Review?Not Human Research (No IRB Review) • Oral History Evaluation • Polling QA Gray Area Human Research IRB Review EthnographyPedagogical Res.

  39. Definition of Human Subject • A Living Individual about who an investigator (whether • professional or student) conducting research obtains: • Data through intervention or interaction with the individual, • or 2. Identifiable private information

  40. Types of IRB Review • 1) Determination if human subjects research • 2) Exempt • 3) Expedited Review • 4) Full Committee Review

  41. Definition of Research • -A systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge

  42. Types of IRB Review • 1) Determination if human subjects research • 2) Exempt • 3) Expedited Review • 4) Full Committee Review

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