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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

Columbia University IRBIRB 101

July 14, 2005

George Gasparis, Executive Director, CU IRB

Asst. V.P. and Sr. Asst. Dean for Research Ethics

objectives
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
well known major cases involving unethical research
Well Known Major Cases Involving Unethical Research

Nazi Experimentation in

Concentration Camps

World War II

1939-44

the nuremberg code
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.]
nuremberg code and voluntary consent continued
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.
not well publicized ethical tragedies
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
not well publicized ethical tragedies cont d
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.
not well publicized ethical tragedies cont d8
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.
declaration of helsinki 1964
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
well known major cases involving unethical research in the u s
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
not well publicized ethical tragedies12
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.
not well publicized ethical tragedies cont d13
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
not well publicized ethical tragedies cont d14
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.
belmont report 1979
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
belmont report 197916
Belmont Report, 1979
  • Applies to Social and Behavioral Research, as well as Biomedical Research
belmont report 197917
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

relevant regulations
Relevant Regulations
  • Federal Regulations:
  • Department of Health and Human Services (HHS)
  • Food and Drug Administration (FDA, agency of HHS)
  • State Law:
  • New York State
slide19

DEPARTMENT OF

HEALTH & HUMAN SERVICES

45 cfr 46
45 CFR 46
  • Subpart A -- Basic Protections
  • Subpart B -- Pregnant Women, Neonates and Fetuses
  • Subpart C -- Prisoners
  • Subpart D -- Children
45 cfr 46 subpart b
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
common rule federal policy for the protection of human subjects 45 cfr 46 subpart a
COMMON RULEFederal Policy for the Protection of Human Subjects(45 CFR 46 Subpart A)
  • June 18, 1991
  • 17 Departments and Agencies
slide24
http://www.hhs.gov/ohrp/

Check website for guidance on many different ethical and regulatory considerations.

OHRP Website
other relevant federal regulations
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/
trends from 1970s present
Trends from 1970s - Present
  • 1970 to mid 80s – Protectionists era
  • 1985 - ?
trends from 1970s present27
Trends from 1970s - Present
  • 1970 to mid 80s – Protectionists era
  • 1985 -1995 – Inclusion era:
  • -HIV epidemic
trends from 1970s present28
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
trends from 1970s present29
Trends from 1970s - Present
  • 1970 to mid 80s: Protectionists era
  • 1985 -1995: Inclusion era:
  • 1995 - Present: Pendulum has swung back towards protectionism
well known major noncompliance cases
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
even more recently and closer to home
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
what are the implications of noncompliance
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
irb management of noncompliance cases
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
all human research at columbia university
All Human Research at Columbia University
  • Governed by Ethical Principles and the Requirements of HHS and FDA Regulations and NY State Law
columbia university
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
columbia university medical center
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
new york presbyterian hospital
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
when does human subjects research need irb review not human research no irb review
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.

definition of human subject
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

types of irb review
Types of IRB Review
  • 1) Determination if human subjects research
  • 2) Exempt
  • 3) Expedited Review
  • 4) Full Committee Review
definition of research
Definition of Research
  • -A systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge
types of irb review42
Types of IRB Review
  • 1) Determination if human subjects research
  • 2) Exempt
  • 3) Expedited Review
  • 4) Full Committee Review