ANSWERS | 2026 UPDATE | WITH COMPLETE
SOLUTION
3 fundamental principles that guide ethical conduct involving human
participants Answer - respect for persons, beneficence, justice
Individual Justice Answer - benefits of participation in research are offered to a
diverse eligible population, risks of research are shared by a diverse population
social justice Answer - consideration is given to classes of subjects that ought,
and not ought, to participate in research
Nuremberg code Answer - 1947 - set forth 10 conditions to be met before
research could be deemed ethically permissible
first international standers for the conduct of research and introduced modern
era of protection for human research subjects
Jewish Chronic Disease Hospital Study Answer - 1963 - cancer cells injected
into chronically ill pts without their knowledge
Willowbrook Study Answer - 1963-1966 - mentally delayed children were
infected with HepA
, Decleration of Helsinki Answer - 1964 - world medical association drafted 1st
international agreement recommending ethical standards for clinical research
Federal protection for Human Subjects Answer - 1974 - Tuskegee syphilis study
ran 1932-1974
Belmont Report Answer - A 1979 National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research report that established
three basic ethical principles for the protection of human subjects, including
respect for persons, beneficence, and justice
Publication of FDA Regulations Answer - 1980
Health Insurance Portability and Accountability Act (HIPAA) Answer - 1996 -
issued by HHS, standards for privacy of individually identifiable health
information
four organizations that protect human participants Answer - IRBs, data and
safety monitoring boards, HHS, and the Office of Human Research Protections
(OHRP)
Institutional Review Board (IRB) Answer - specialized committees required by
HHS, determine acceptability of proposed research in terms of institutional
commitments and regulations, applicable law, and standards of professional
conduct and practice
initial review and approval, meets all requirements, progress reports and
protocols in ongoing studies