MEDICAL DECISIONS EXAM 1 | QUESTIONS AND 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
, MEDICAL DECISIONS EXAM 1 | QUESTIONS AND ANSWERS | 2026 UPDATE | WITH
COMPLETE SOLUTION
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
Data Safety Monitoring Board (DSMB) - (answer)committees of experts w/ no bias permitted to
periodically view unblinded data and conduct interim analysis
HHS (Department of Health and Human Services) - (answer)provide general criteria for IRB approval and
research
investigators consider protections against risks, potential benefits to individual participants, and the
importance of the knowledge being gained
Office of Human Research Protection - (answer)established in 2000 replacing OPRR
regulatory authority for the protection go human subjects in research
privacy - (answer)free from unwanted intrusion
Confidentiality - (answer)the act of holding information in confidence, not to be released to
unauthorized individuals
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
, MEDICAL DECISIONS EXAM 1 | QUESTIONS AND ANSWERS | 2026 UPDATE | WITH
COMPLETE SOLUTION
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
Data Safety Monitoring Board (DSMB) - (answer)committees of experts w/ no bias permitted to
periodically view unblinded data and conduct interim analysis
HHS (Department of Health and Human Services) - (answer)provide general criteria for IRB approval and
research
investigators consider protections against risks, potential benefits to individual participants, and the
importance of the knowledge being gained
Office of Human Research Protection - (answer)established in 2000 replacing OPRR
regulatory authority for the protection go human subjects in research
privacy - (answer)free from unwanted intrusion
Confidentiality - (answer)the act of holding information in confidence, not to be released to
unauthorized individuals
