History and Principles Flashcards
are moral principles that govern a person’s behavior or the conducting of an activity
Ethics
Inoculated 8-year-old James Phipps with cowpox, then smallpox 3 months later
Edward Jenner &
the smallpox
vaccine
Later led to the discovery of the smallpox vaccine
Edward Jenner &
the smallpox
vaccine
Represented the first scientific attempt to control an infectious disease by vaccination
Edward Jenner &
the smallpox
vaccine
US Army surgeon, Chairman of the Reed Commission
Major Walter Reed
& yellow fever
Utilized Spanish immigrant volunteers; paid more those who contracted the disease
Major Walter Reed
& yellow fever
Tested side effects of a popular cholera vaccine on 24 inmates in Bilibid Prison
Dr. Richard Strong
& a cholera vaccine
Eventually proved that yellow fever was spread by female Aedes Aegypti mosquitoes
Major Walter Reed
& yellow fever
Killed 13 people
Dr. Richard Strong
& a cholera vaccine
The Angel of Death
Josef Mengele
Notorious for selecting prisoners for execution and conducting human experiments on camp inmates, including sterilization experiments, unnecessary amputations, and intentional infections, including children
Dr. Josef Mengele
Established The Nuremberg Code
The Nuremberg Trials
23 leading German physicians and administrators tried for war crimes and crimes against humanity, among others
The Nuremberg Trials
Formed the World Medical Association (WMA) in 1947
The Nuremberg Trials
10 principles of ethical experiments involving humans
The Nuremberg Code
Formed the basis of almost all future guidelines
The Nuremberg Code
The first international document that advocated for voluntary participation and informed consent
The Nuremberg Code
aka Ethical Principles for Medical Research Involving Human Subjects
Declaration of Helsinki
Governs international research ethics and defines rules for research for clinical care and non-therapeutic research
Declaration of Helsinki
Formed the basis for the Good Clinical Practices guidelines used today
Declaration of Helsinki
Most recent revision was from October 2013
Declaration of Helsinki
defines human research and its necessity and emphasizes on the responsibility of the physician to prioritize participant health. This section stresses that special populations involved in research must be closely monitored
Section A
discusses basic principles for medical research and reiterates the points of the Nuremberg Code
Section B
discusses research combined with medical care and states that research can only be combined with clinical care if it has the potential to prevent, diagnose, or treat
Section C
Only 74 of 400 subjects remained alive
Tuskegee Syphilis Study (1932-1972)
Led to the first revision of the Declaration of Helsinki
Tuskegee Syphilis
Study (1932-1972)
Led to the passing of the National Research Act of 1974
Tuskegee Syphilis
Study (1932-1972)
A statement of basic ethical principles and guidelines addressing ethical problems in research with human participants
Belmont Report
3 BASIC PRINCIPLES OF CLINICAL RESEARCH ETHICS
- Respect for person
- Beneficence
- Justice
Individuals must be treated according to a shared and voluntary informed consent to participation, and persons with diminished autonomy must be protected
Respect for person
Human rights and safety should prevail over scientific and social benefit.
Beneficence
and non-maleficence
All patients must be treated fairly and not exploited while procedures should be properly performed and managed.
Justice
Government-mandated board of experts established at each institution that is engaged in the research process
Institutional Review Board (IRB)
Charged with monitoring the ethical conduct of research as outlined by the Belmont Report
Institutional Review Board (IRB)
A formal examination of a research protocol by a board composed of 5 to 20 individuals
Full
Only a selected subcommittee reviews the research protocol
Expedited
A study protocol is exempt from formal review from either the full board or its subcommittee; the IRB is still to approve but without future or annual review necessary
Exempt
It is just a standard not a law
Nuremburg Code
This was done because of the atrocities in Aushwitz, Germany
The Nuremberg Trial
GCP was formed by the
Declaration of Helsinki
Written by National Institutes of Health (NIH)
7 Guiding Principles of Ethical Research
Universal framework from research whether a research is ethical or not
7 Guiding Principles of Ethical Research
Evaluation of a diagnostic or therapeutic intervention leading to health improvement while increasing knowledge
Social or scientific value
The study should present with a scientifically sound design, ensuring research outcomes with accurate and reproducible end points
Scientific validity
Research subjects should be selected through fair inclusion and exclusion criteria
Fair subject selection
Risks to participants should be minimized while benefits should be maximized
Favorable risk/benefit ratio
Evaluation of adherence to ethical standards by a full committee of unaffiliated individuals with expertise
Independent review
Subjects must be accurately informed of benefits, harms, and alternatives to the proposed research
Informed consent
Individuals must be respectfully treated throughout the study
Respect for enrolled participants
