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Presented by Georgia Institute of Technology Institutional Review Board Presented by Melanie Clark, CIP Associate Director Office of Research Integrity Assurance. Nuremberg Code 1947 U.S. Scandals Henry Beecher: "Ethics and Clinical Research" Public Health Service Policy Adopting IRBs

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Presented byGeorgia Institute of TechnologyInstitutional Review BoardPresented byMelanie Clark, CIPAssociate DirectorOffice of Research Integrity Assurance

significant events

Nuremberg Code 1947

U.S. Scandals

Henry Beecher: "Ethics and Clinical Research"

Public Health Service Policy Adopting IRBs

Declaration of Helsinki

Stanford Prisoner Study (1971)

PHS “Tuskegee Study” Revealed (1972)

National Research Act & 45 CFR 46

Belmont Report (1979)

Significant Events

PHS Syphilis Study, formerly “Tuskegee Study”

1930 1940 1950 1960 1970 1980

military tribunal led to nuremberg code
Military Tribunal led to Nuremberg Code
  • Voluntary consent
  • Anticipated scientific benefits
  • Benefits outweigh risks
  • Animal experiments first
  • No intentional death or disability
  • Subjects may withdraw at anytime
  • Investigators must be qualified
  • Investigators will stop if harm occurs
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1950s:

Willowbrook State School

Staten Island, New York

1960s:

Jewish Chronic Disease Hospital

Cancer Experiments

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1932, Public Health Service study, in collaboration with the Tuskegee Institute in Macon County, Alabama, undertook a study of untreated syphilis in hopes of justifying treatment programs for blacks.
  • 600 black men (399 with syphilis, 201 without) were told they had "bad blood," a local term used to describe syphilis, anemia, and fatigue.
  • Penicillin, treatment of choice, was discovered in 1940s but was withheld.
  • In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years.
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Ethical Principles and Guidelines for the Protection of Human Subjects of Research
  • Respect for Persons
    • Individual autonomy
    • Protection of individuals with reduced autonomy
  • Beneficence
    • Maximize benefits and minimize harms
  • Justice
    • Equitable distribution of research costs and benefits

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

April 18, 1979

significant events1

Common Rule 1991

Nicole Wan dies at Rochester 1996

President Clinton apologizes to PHS Syphilis study survivors

Jesse Gelsinger dies at U Penn

VCU Twins Study

OPRR shuts down LA VA Medical, Duke, U Ill, U Colo, U Penn

OPRR shuts down VCU, UAB, U Okla OPRR reorganized as OHRP, moved to Cabinet level

and Director replaced, June 2000

Ellen Roche dies at Johns Hopkins; OHRP suspends JH federally funded research

Secretary\'s Advisory Committee on Human Research Protections replaces National Human Research Protections Advisory Committee

Significant Events

1990 1996 1997 1999 2000 2001 2002

1999 jesse gelsinger university of pennsylvania
1999: Jesse Gelsinger & University of Pennsylvania

18-year old volunteer in U Penn’s gene therapy study of partial omithine transcarbamylase deficiency (OTC)

2001 ellen roche johns hopkins
2001: Ellen Roche & Johns Hopkins
  • Healthy lab technician volunteered for asthma study of hexamethonium bromide.
  • Respiratory effects of hexamethonium bromide were not known to investigator prior to study.
  • Previous participant had respiratory problems, solution was changed without IRB being informed.
  • Johns Hopkins forced to halt $300 million in medical research
  • Ellen Roche died. Compensation for her participation: $365. Johns Hopkins settled out of court with her family.
what happens when the research enterprise is shut down
What Happens When the Research Enterprise is Shut Down
  • All federal research funding involving human subjects suspended (payroll, operations, etc.)
    • All experiments halted (except to treat enrolled subjects on a case-by-case basis)
  • IRB must re-review all protocols
  • Millions of dollars in lost revenue and expenses to bring institution into compliance
what is an irb
What is an IRB?

Faculty committee with the purpose of reviewing research activities involving human participants

Constituted in accordance with federal law:

Minimum of five members

Community representation

Scientific and non-scientific members

Adequate expertise to review the proposed work

Consultants, when needed

what is a human subject
What is a human subject?
  • As defined by 45 CFR 46 Is a living individual about whom an investigator obtains either:
    • Data through intervention or interaction with the individual; or
    • Identifiable private information
what is research
What is research?
  • Research: As defined by 45 CFR 46, "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge"
categories of research
Categories of Research
  • Exempt
  • Expedited
  • Full
what you need to submit
What you need to submit
  • IRB application
    • IRBWISE
  • Project description
  • Consent/Assent/Parental Permission
  • All recruitment flyers & scripts
  • Human Subjects Training Certificate
  • Questionnaire, surveys or interview guides
46 116 general requirements for informed consent
§46.116 General requirements for informed consent
  • Statement that it is research
  • Purpose & procedures
  • Health and financial risk
  • Compensation/costs
  • Confidentiality
  • In case of injury
  • Subjects rights
  • Appropriate reading level
anything else
Anything Else?
  • All Amendments must be submitted to IRB for review and approval prior to commencement.
    • Any change to the protocol or consent form
  • All Adverse Events must be submitted for IRB review even if they are not study related.
principal investigator s responsibilities
Principal Investigator’s RESPONSIBILITIES
  • Obtain approval prior to start of research
  • Inform IRB of:
    • Adverse events
    • Changes in protocol
    • Violations
  • Continuing review request
  • Obtain consent prior to enrolling subjects
case study
Case Study

“Check List”

  • Johns Hopkins University
  • Intensive Care Units in State of Michigan
  • Office for Human Research Protections
important information
Important Information
  • http://www.researchintegrity.gatech.edu
  • IRBWISE information
    • Human Subjects Training (CITI)
    • Policy and Procedures
    • Consent templates
contact information
Contact Information
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