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Institutional Review Board for Human Research (IRB) Human Subject Protections

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Institutional Review Board for Human Research (IRB) Human Subject Protections Susan Sonne, PharmD, BCPP Chair, MUSC IRB II Nuremberg Code first major control on ... – PowerPoint PPT presentation

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Title: Institutional Review Board for Human Research (IRB) Human Subject Protections


1
Institutional Review Board for Human Research
(IRB)Human Subject Protections
  • Susan Sonne, PharmD, BCPP
  • Chair, MUSC IRB II

2
Nuremberg Code
  • first major control on research in any
    nation
  • prescribed 1948 as part of trial of a Nazi
    Physician
  • willfully harmful research on unwilling human
    subjects

3
Jewish Chronic Disease Hospital Study
  • July 1963
  • Injection of live cancer cells into 22
    patients
  • No written consent
  • Some verbally informed involved in
    experiment
  • Never told being given live cancer cells
  • Guilty of fraud, deceit, unprofessional
    conduct

4
The Declaration of Helsinki
  • Produced 1961, adapted 1964
  • Informed consent ethical research
  • Basis for FDA policy

5
Willowbrook State School
  • Study began 1956
  • Institution for mentally defective children
  • Study designed to contribute to
    understanding etiology of infectious
    hepatitis and test effects of gamma globulin
    in preventing disease.
  • First subjects fed extracts of infected
    stool
  • Public attention 1971

6
National Research Act of 1974
Created National commission for the protection of
Human Subjects of Biomedical and Behavioral
research. Charge was to Identify basic ethical
principles that should underlie conduct of
biomedical and behavioral research involving
human subjects
7
More specifically, consider
Boundaries between research and practice Role of
assessment of risk-benefit Selection of
subjects Nature and definition of informed
consent Result was 1976 Belmont report
8
Good Clinical Practice Why have this training?
9
The Tuskegee Syphilis Study
  • 1932 to 1972
  • 399 African American Males were denied treatment
    for syphilis
  • Study conducted by U.S. Public Health Service

10
From President Clinton
  • "Although these regulations Protection of Human
    Subjects, Code of Federal Regulations, Title 45,
    Part 46 provide the framework for protecting
    human subjects in research, we must exercise
    constant care and ensure that these regulations
    are strictly enforced by departments and
    agencies. Therefore, I direct each department and
    agency of Government to review present practices
    to assure compliance with the Federal Policy for
    the Protection of Human Subjects and to cease
    immediately sponsoring or conducting any
    experiments involving humans that do not fully
    comply with the Federal Policy." -Bill Clinton,
    1994
  • The people who ran the study at Tuskegee
    diminished the stature of man by abandoning the
    most basic ethical precepts. They forgot their
    pledge to heal and repair. They had the power to
    heal the survivors and all the others and they
    did not. Today, all we can do is apologize.
    Bill Clinton, 1997

11
OHRP Suspensions
  • During the last 6-7 years, OHRP has suspended all
    human research at the following institutions
  • University of Illinois, Chicago Campus
  • University of Colorado
  • Duke University
  • Johns Hopkins
  • University of Pennsylvania
  • And others

12
General Rule for Human Subject Protection
Any element of research? ? Yes ? Undergo review
13
IRB Purpose
  • To protect the rights and welfare of human
    research subjects
  • Authority to approve, require modification and
    disapprove any research involving human subjects

14
  • Institutional Review Board
  • responsible to verify
  • Safety
  • Integrity
  • Human rights
  • Public reassurance
  • Scientific content

15
The Belmont Report
  • 3 Basic Principles for Protection of Human
    Subjects
  • Respect
  • voluntary informed consent
  • privacy
  • protections for vulnerable populations
  • Beneficence
  • Justice

16
Beneficence
  • Persons treated in an ethical manner
  • Protecting them from harm
  • Helping to secure their well being

17
Justice
  • Who ought to receive the benefits of
    research and bear the burden of research?
  • Equals ought to be treated equally
  • Fairness in distribution
  • What is deserved




18
Criteria for Approval
  • Risks are minimized
  • Reasonable riskbenefit ratio
  • Equitable selection of subjects
  • Informed consent obtained appropriately
  • Informed consent adequately documented
  • Monitor data to insure safety
  • Protect confidentiality
  • No coercion

19
  • Informed Consent
  • Essential to ethical conduct of clinical
    investigation
  • Potential subject chooses whether or not they
    will participate
  • Obtained after full information is given and
    understood
  • Explanation of study objective, potential
    benefits, risks, inconveniences, subjects
    rights and responsibilities

20
  • Informed Consent
  • Introduction
  • Purpose of the Study
  • Procedures
  • Potential Risks and Discomforts
  • Anticipated Benefits to Subjects
  • Anticipated Benefits to Society
  • Alternative to Participation
  • Emergency Care and Compensation for Injury
  • Payment for Participation
  • Financial Obligation
  • Privacy and Confidentiality
  • Participation and Withdrawal
  • Rights of Research Subjects
  • Signatures

21
The Mountain of Responsibility
FDA
Sponsor
Investigator
  • Protecting Participants
  • Implementing Study
  • Reporting Accurately

Research Team Coord, RA, etc
22
  • Investigator Obligations
  • Conducts a clinical investigation
  • Responsible for
  • All procedures conducted
  • All data collected
  • May delegate work in conducting study but
    they retain responsibility

23
  • Investigators and by delegation all study staff
    responsibilities
  • To protect the rights of participants
  • To obtain informed consent from each participant
  • To keep specific records and issue specific
    orders
  • To assure that the IRB is provided information
    for initial and continuing review of the study

24
Useful Regulatory/Policy Material
  • MUSC IRB
  • http//research.musc.edu/ori/irb/home
  • Office for Human Research Protections
  • http//www.hhs.gov/ohrp/
  • Food Drug Administration
  • http//www.fda.gov/oc/ohrt/irbs/default.htm
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