PUBH 6012 Exam 1 Questions and Answers |Complete Solutions Graded A+ |100% Correct
____________________ are defined by state law, part of the state network and shared
responsibility Local government
Created by referendum or legislation resolution
75% at a county level Local Public Health Agencies (LPHA)
Principles underlying health regulations •Always a balancing of interests (When and how
should government be able to regulate for the benefit of public's health?When are restrictions
on individual liberties too great?)
•Common bases for regulations
•Preventing harm to others (third parties)
•Protection of incompetent persons
•Risk to self
Doing nothing Nonintervention
Provide information (inform), Exhort (implore) Persuasion
Tax and/or subsidize Incentive
Grant/contract (buy), Produce (make) Procure
Require or prohibit Regulate
•Increase access to primary care providers
•Increase physical activity levels of children Policy Goals
,•Loan forgiveness programs for primary care physicians
•Laws expanding nurse practitioners' scope of practice
•State law increasing physical education requirements in schools
•Media campaign aimed at parents Specific Policies
Mechanisms used by policymakers to make change Policy levers
Common policy levers in US health policy •Attaching/changing conditions of funding
•Attaching/changing conditions of participation in programs
•For beneficiaries and providers
•Attaching/changing conditions of licensure and certification (barriers to entry in the market)
•Taxes and tax code penalties or credits to influence individual behavior or a market
•Can make something more or less expensive to affect supply/demand
•Using the power of the government as a purchaser to influence the market
•Direct regulation, such as a ban or mandate
The principles and values that help guide actions designed to promote health and prevent
injury and disease in the population Public Health Ethics
The voluntary consent of the human subject is absolutely essential Nuremberg Code (1948)
•Required drug manufacturers to prove to FDA effectiveness of their products before
marketing them
•Response to Thalidomide disaster in late 1950s in which sedative not approved in the U.S. was
given to pregnant women and later found to cause birth defects. Approximately 12,000 babies
were born with severe deformities. Kefauver Amendments to the Food, Drug and Cosmetic
Act (1962)
, •Research project conducted by the U.S. Public Health Service from 1932 to 1972. "Six hundred
low-income African American males, 400 of whom were infected with syphilis, were monitored
for 40 years. Free medical examinations were given; however, subjects were not told about
their disease. Even though a proven cure (penicillin) became available in the 1950s, the study
continued until 1972 with participants being denied treatment. In some cases, when subjects
were diagnosed as having syphilis by other physicians, researchers intervened to prevent
treatment. Many subjects died of syphilis during the study." Stopped only after study was made
public. Tuskegee Syphilis Study (1932-1972)
Codified protection of human subjects in research in law; created the National Commission for
the Protection of Human Subjects of Biomedical and Behavioral to develop guidelines for
research. National Research Act (1974)
Established three basic ethical principles—respect for persons (informed consent), beneficence
(assessment of risks and benefits), and justice (selection of subjects)—for regulations involving
human subjects Belmont Report (1979)
1981: Federal regulations based on the Belmont Report
•The Department of Health and Human Services (DHHS) issued Code of Federal Regulations
(CFR) Title 45 (public welfare), Part 46 (protection of human subjects). The Food and Drug
Administration (FDA) issued CFR Title 21 (food and drugs), Parts 50 (protection of human
subjects) and 56 (Institutional Review Boards)
.
1991: Common Rule
The core DHHS regulations (45CFR Part46,SubpartA) were formally adopted by more than a
dozen other departments and agencies that conductor fund research involving human subjects
as the Federal Policy for the Protection of Human Subjects Common Rule (1991)
Main elements of the Common Rule •Requirements for researchers obtaining and
documenting informed consent
•Requirements for Institutional Review Board (IRB) membership, function, operations, review
of research, and record keeping
____________________ are defined by state law, part of the state network and shared
responsibility Local government
Created by referendum or legislation resolution
75% at a county level Local Public Health Agencies (LPHA)
Principles underlying health regulations •Always a balancing of interests (When and how
should government be able to regulate for the benefit of public's health?When are restrictions
on individual liberties too great?)
•Common bases for regulations
•Preventing harm to others (third parties)
•Protection of incompetent persons
•Risk to self
Doing nothing Nonintervention
Provide information (inform), Exhort (implore) Persuasion
Tax and/or subsidize Incentive
Grant/contract (buy), Produce (make) Procure
Require or prohibit Regulate
•Increase access to primary care providers
•Increase physical activity levels of children Policy Goals
,•Loan forgiveness programs for primary care physicians
•Laws expanding nurse practitioners' scope of practice
•State law increasing physical education requirements in schools
•Media campaign aimed at parents Specific Policies
Mechanisms used by policymakers to make change Policy levers
Common policy levers in US health policy •Attaching/changing conditions of funding
•Attaching/changing conditions of participation in programs
•For beneficiaries and providers
•Attaching/changing conditions of licensure and certification (barriers to entry in the market)
•Taxes and tax code penalties or credits to influence individual behavior or a market
•Can make something more or less expensive to affect supply/demand
•Using the power of the government as a purchaser to influence the market
•Direct regulation, such as a ban or mandate
The principles and values that help guide actions designed to promote health and prevent
injury and disease in the population Public Health Ethics
The voluntary consent of the human subject is absolutely essential Nuremberg Code (1948)
•Required drug manufacturers to prove to FDA effectiveness of their products before
marketing them
•Response to Thalidomide disaster in late 1950s in which sedative not approved in the U.S. was
given to pregnant women and later found to cause birth defects. Approximately 12,000 babies
were born with severe deformities. Kefauver Amendments to the Food, Drug and Cosmetic
Act (1962)
, •Research project conducted by the U.S. Public Health Service from 1932 to 1972. "Six hundred
low-income African American males, 400 of whom were infected with syphilis, were monitored
for 40 years. Free medical examinations were given; however, subjects were not told about
their disease. Even though a proven cure (penicillin) became available in the 1950s, the study
continued until 1972 with participants being denied treatment. In some cases, when subjects
were diagnosed as having syphilis by other physicians, researchers intervened to prevent
treatment. Many subjects died of syphilis during the study." Stopped only after study was made
public. Tuskegee Syphilis Study (1932-1972)
Codified protection of human subjects in research in law; created the National Commission for
the Protection of Human Subjects of Biomedical and Behavioral to develop guidelines for
research. National Research Act (1974)
Established three basic ethical principles—respect for persons (informed consent), beneficence
(assessment of risks and benefits), and justice (selection of subjects)—for regulations involving
human subjects Belmont Report (1979)
1981: Federal regulations based on the Belmont Report
•The Department of Health and Human Services (DHHS) issued Code of Federal Regulations
(CFR) Title 45 (public welfare), Part 46 (protection of human subjects). The Food and Drug
Administration (FDA) issued CFR Title 21 (food and drugs), Parts 50 (protection of human
subjects) and 56 (Institutional Review Boards)
.
1991: Common Rule
The core DHHS regulations (45CFR Part46,SubpartA) were formally adopted by more than a
dozen other departments and agencies that conductor fund research involving human subjects
as the Federal Policy for the Protection of Human Subjects Common Rule (1991)
Main elements of the Common Rule •Requirements for researchers obtaining and
documenting informed consent
•Requirements for Institutional Review Board (IRB) membership, function, operations, review
of research, and record keeping
