How did the concern regarding the ethics of research involving human subjects devveloped?
As a result of Nazi regime's atrocities during World War II.
Performed medical experiments upon concentration camp inmates & human w/o consent.
The Nuremberg Code (1947)
Permissible Medical Experiment ruled by court
- Little direct impact on human research as origin in concern abt nazi Atrocities
- not adopted as law or as part of any professional ethical code
10 points constitute the Nuremberg code
1. Voluntary consent of human subject is absolutely essential
2. Experiment should yield fruitful results for good of society; unprocurable by other methods; not random & unnecessary
3. Experiment designed & based on results of animal experimentation & kn
1. Voluntary consent of human subject is absolutely essential
-Legal capacity to give consent
-Able to exercise free power of choice
-Sufficient knowledge & comprehension of the elements
-Made known to him the nature, duration, purpose of experiment; method and means by which it is conducted
-Inconveniences & hazard
U.S. Public Health Service (PHS) Study of Untreated Syphilis (1932 - 1972)
-Study of untreated Syphilis in Negro Males
- Examined the natural course of untreated syphilis in Black American men
-Were not told they had syphilis; not offered effective treatment (penicillin)
-Subjects not free to decline (not informed they were in a
Other Abuses
Willowbrook studies (1926 - 1970)
-Children w intellectual disabilites deliberately infected w hepatitis virus
Jewish Chronic Disease Hospital Study (1963)
-Live cancer cells injected into 22 cognitively imparired patients
-Publicity about extensive medic
National Research Act (1974)
-Response to ethics of PHS Syphilis Study, Prisoner research, willowbrook
- Hearing on "Quality of Health Care - Human Experimentation" held before the before the Subcommittee on Health of the U.S. Senate Committee on Labor & Public welfare (1973)
-Passed
The National Commission (1979)
- Identify basic ethical principles underlying human subjects research
- Develop guidelines for ensuing the conduct of human subjects research is conducted acc to guidelines
-Issued series of reports on vulnerable populations (fetuses, children, prinsoner
The Belmont Report
-Based on deliberations of National Commission
-Identified 3 basic principles: Respect for Persons, Beneficence, and Justice
BR:Respect of Persons
-Individuals should be treated as autonomous agents
-Individuals w diminished autonomy (age health cognitive ability) (poverty, lack of education, social status) need additional protections
- Extent of protection depend upon risk of harm/ likelihood of be
ROP: Informed consent
ROP requires subjects, to the degree that they are capable, be given opportunity to choose what shall or shall not happen to them.
-Information: Information should be sufficient so that a reasonable volunteer can decide whether to participate
-Comprehensi
ROP: Privacy
ROP involves respecting individual's right privacy
- Right to control access to one's self & info
- Protecting the confidentiality of private, identifiable info abt indiv
-Ensure subject's right of privacy is not violated & confidentiality of info protect
BR: Beneficence
-Obligation of researchers to strive to do no harm
-Maximize benefits & minimize harm
-Respecting decision; protect from harm; make efforts to secure well-being
-benefits should be foregone because of risk
- Applications: Systematic assessment of risks &
Beneficence: Systematic assessment of Risk & Benefits
- Risk is not harm, it is possibility of harm.
-Analysis of risks: take into account magnitude + possbility of harm
-Anticipated benefits: to individual subjects or in the form of advancement of scientific knowledge
- In balancing these different elements
Beneficence: Minimization of risk
-Investigators & IRBs should carefully consider alternative, less risky procedures / modifications to the procedures that reduce the magnitude / probability of possible harm to subjects
BR: Justice
-Requires selection of subjects is equitable
-Injustice = some benefit to which person is entitled is denied w/o good reason or when some burden is imposed unduly
-Application: Selection of Subjects
Justice: Selection of subjects
-Selection of research subjects needs to be scrutinized to determine if some classes are being systematically selected due to easy availability, compromised position, manipulability, rather than directly related to problem being studied
- Selection must b
Development of U.S. Regulations
-First imposed requirements on research involving human subjects: Kefauver-Harris Drug Amendments to the FDA (1962). FDA faced challenge controlling drug to prevent morning sickness in pregnant women that caused birth defects.
-Amendment: Evidence of safe
International Regulations
1964: 18th world medical assembly meeting in Helsinki, Finland; adopted "recommendation guiding medical doctors in Biomedical research involving human subjects" / declaration of Helsinki
1982: CIOMS adopted "international ethical guidelines for biomedical
Recent History
1974 to mid 1990s: concerns regarding ethical research had been addressed by the federal regulations
-most established IRBs and IRB review & approval required for federally funded research & research conducted under FDA regulations
BUT
-concerns on invest
Current Situation
-IRB not enough to protect human subjects in research
-Address problems w IRB system arose concept of human research protections program (HRPP).
-HRPP: comprehensive organized system of shared responsibility at an organization to ensure protection of huma