The document summarizes a 1963 study at the Jewish Chronic Disease Hospital that injected live cancer cells into patients without fully informing them. This led to allegations of fraud and deceit against the investigators. It sparked reforms that established modern research ethics regulations, including requiring proper informed consent and review by institutional review boards. Key results were the Nuremberg Code, Declaration of Helsinki, and regulations from the Department of Health and Human Services and Food and Drug Administration.
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Ethics presentation may 26 2011
1. The Jewish Chronic
Disease
Hospital Study
Ethics in Clinical Research
Presented By
Linda Burak Paula Fasano-Piectrazak Phylis Rusinko Janice Titano
2.
3. Ethics in Clinical Research
• The Study In 1963, studies were undertaken at
New York City’s Jewish Chronic Disease
Hospital to develop information on the nature
of the human transplant rejection process.
• The studies involved the injection of live cancer
cells into patients who were hospitalized with
various chronic debilitating diseases.
4. Ethics in Clinical Research
• Indigent elderly patients were not told they would
receive cancer cells because, in the view of the
investigators, this would frighten the patients.
• Allegations of fraud and deceit were demonstrated
by the investigators , Drs. Southam and
Mandel, upon the group of 22 patients and their
families involved based upon: (a) Inadequate
consents having been obtained, and (b) The
assumption the injections were harmful and may
produce cancer.
5. What Happened in the Research
World?
Cumulative Affect prior to The Jewish Chronic Disease
Hospital
Nuremberg Doctor’s Trial
Nuremberg Code
Declaration of Helsinki
International Ethical Guidelines for Biomedical Research
Involving Human Subjects
Researchers found guilty of fraud, deceit, and
unprofessional conduct
Resignations
Probations
6. What Followed the Jewish Chronic
Disease Study?
Establishment of the current U.S. regulatory
standards
National Research Act of 1974
National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
Belmont Report of 1979
Department of Health and Human Services in 1981
Food and Drug Administration and the IRB
7. Safeguards
Prior to the research
study:
-- Nuremberg Code –
1947
•Voluntary consent
•Benefits outweigh
risks
•Ability to withdraw
8. Safeguards
• Post research study:
– Declaration of Helsinki – 1964
•Concern for the interest of the participant must
prevail
– National Research Act - 1974
•Regulatory protection for human subjects
•Creation of the National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research
10. Safeguards
•1980 - Food and Drug Administration –
established regulations for clinical
research
•Code of Federal Regulations, Title 21,
Part 50
11. Safeguards
• 1981 - Department of Health and Human
Services (DHHS) and Food and Drug
Administration (FDA) regulations
– Main Elements
•Compliance with regulations
•Obtaining and documenting informed consent from
all study participants
•IRB membership, function, operations, and review of
research
•Record keeping
•Subparts that provide protection for vulnerable
subjects
12. Safeguards
• 1982 - Council for International Organization of
Medical Research (CIOMS)
• Published “International Ethics Guidelines for
Biomedical Research Involving Human Subjects”
• Designed to guide researchers from more
technologically advanced countries in conduction
research in developing countries
13. Safeguards
• 1989 - Office of Scientific Integrity (OSI) –
established within the National Institute of
Health
• Purpose – investigate charges of scientific
misconduct and determine instances of
honest errors versus actual misconduct
14. Safeguards
•1991 – The Common Rule
•Protection of human rights
•Covered research supported by the
Depts. of
Agriculture, Energy, Commerce, HUD, J
ustice, Defense, Education, VA, Transpo
rtation, EPA, NASA, SSA, CIA, plus more
15.
16. Safeguards
• 1994 – Advisory committee on human
radiation experiments
• Examined cases where radiation was
released into the environment for
experimental purposes
17. Safeguards
• 1995 – National Bioethics Advisory
Commission (NBAC) – is established
• 2000 – Office of Human Research
Protections (OHRP) is established
18. How are safeguards monitored?
• Institutional Review Board (IRB)
– Requires the researcher to include clear, detailed
information that addresses the regulatory requirements
– Before starting a research study – review and approval
by the IRB is required (unless there is minimal risk and
fits one of the defined categories).
20. Common Rule - DHHS
• Definition of Human Subject:
– a living individual about whom an investigator
obtains data through intervention or interaction
or obtains identifiable private information, and
research as a systematic investigation designed
to develop or contribute to generalizable
knowledge
21. DHHS
Regulations
• Human research?
Focuses on:
– Type of information
collected
– Manner in which it is
collected
– Procedures that guide
the collection of
information
– How the information
will be shared
22. FDA Regulations
• Definition of Human Subject:
– An individual, either healthy or a patient, who or
becomes a participant in research, either as a
recipient of the test article or as a control
• Uses “clinical investigation” rather than
research
– Any experiment that involves a test article and
one or more human subjects, and that either
must meet the requirements for prior
submission to the FDA.
23. Exemptions from IRB
• Observation of public behavior
• Evaluation of teaching methods
• Collection of anonymous surveys of
no vulnerable individuals in which the
information is not sensitive
24. Institutional Review Board
• Integral to ensure
regulatory
compliance and
ethical conduct of
research involving
human subjects
25. Preparing Materials for IRB Submission
• Institution –specific submission form
• Research protocol
• Full grant application (if one is available)
• Informed consent
• All subject recruitment materials
26. Consequences of Scientific
Misconduct
• Public retraction
• Harder to get funding
in the future
• Harder to get future
articles published
• Adverse media
attention
• Possible license
suspension
27.
28. Progression of the
Research
• Research not hindered
• New York Board of Regents placed
Southam & Mandel on probation only,
citing lack of informed consent
unacceptable (1966)
• Soon after, Southam elected
president of the American
Association for Cancer Research
35. The Principle of Justice
The Right
to Privacy
The Participant Can
Review the
Information and Agree
to the Accuracy of the
Content
36. The Principle of Justice
The Right to Privacy
All Persons Involved
in Research Must
Maintain
Confidentiality
37.
38. Informed Consent for a Research Study…
ESSENTIAL ELEMENTS
• Presence of a written • Benefits
document
• Contact information for
• The purpose of the research questions
• Expectations from the • Other treatment options
participant including time
commitment • States that participant may
choose to leave and receive
• The known and the unknown standard treatments
about the research
• Protection of privacy
• Risks
In 1964, Southam published his paper in the Annals of the New York Academy of Sciences WITH NO MENTION OF INFORMED CONSENT
What is informed consent? A CONTRACT BETWEEN RESEARCHER AND PARTICIPANT IRB ASKS IF APPROPRIATE INFORMED CONSENT PROCEDURES HAVE BEEN FOLLOWED & HAVE ETHICAL PRINCIPLES OF BENEFICENCE, RESPECT FOR HUMAN DIGNITY AND JUSTICE BEEN ESTABLISHED
Study must not have the surprise after element. All untoward as well as beneficial effects needs to be disclosed prior to starting the research.
Balancing risks and benefits. Area of study needs to have an expected beneficial outcome, meaningful. No hidden agendas that could harm patient without explaining this first in the informed consent.
