History & Ethics Flashcards
Came out of trials of German officials in WWII; set foundation for regulation of human subjects research in US
Nuremberg Code (1947)
Voluntary participation, potential societal benefit, justified based on prior knowledge, don’t experiment when risks include disabling injury/death, hire trained & qualified staff, benefits outweigh risks, avoid undue harm/risk, implement systems to prevent risk/harm, participants can withdraw, stop experiments if continuation deemed dangerous
Tenants of Nuremberg Code
Conducted by US Public Health service; observed natural progression of untreated syphilis in 622 AA men in AL but marketed as free healthcare; lasted 40-years –> infected men not informed, funding lost for treatment but still continued, penicillin established in 1947 but not provided to participants
Tuskegee Syphilis Study (1932-1972)
Created in response to Tuskegee Study; created National Commission of Protection of Human Subjects of Biomedical & Behavioral Research –> formalized establishment & role of IRB
National Research Act (1974)
Created by National Commission for Protection of Human Subjects of Biomedical & Behavioral Research in response to Tuskegee Study (drafted at Belmont Conference 10 miles south of Baltimore); distinguished between medical treatment & research; 3 core principles = respect for persons (informed consent), beneficence (risk/benefit assessment), justice (selection of participants); crucial report underlying role of IRBs today
Belmont Report (1978)
Agreement/permission accompanied by full notice about care, treatment, or service that is subject of consent; patient apprised of nature, risks, & alternatives of medical procedure/treatment; patient either consents to or refuses treatment after receiving information
Informed Consent
Statement of study as research, explanation of purpose/duration/procedures, description of risks & benefits, disclosure of alternatives, statement on extent of confidentiality, discussion of compensation & safeguards/treatments for risks, contact information of study team, statement that participation is voluntary & can withdrawal at anytime; beneficence, justice, & respect for persons
Core Elements of Informed Consent
Non-exploitative research, protection of vulnerable populations, fair distribution of costs & benefits to research participants & benefitting population
Justice
Developed by World Medical Association following WWII; some overlap with Nuremberg Code but specifically for clinical research; additional tenets include duty to participant over society, ethics more important than laws, work must benefit population being studied, declare COIs, etc.
Declaration of Helsinki (1964, latest revision in 2013)
Built off Declaration of Helsinki; regulations & standards for IRBs –> assuring compliance by research institution, documentation of informed consent, criteria for establishment/operation/documentation of IRB, protection of vulnerable populations
Common Rule (1981, revised in 1991 & 2018)
Role to review & approve human subjects research (scientifically & ethically); composed of scientists, non-scientists, community members, & a non-affiliated party; review types include exempt, expedited, or full board
IRB
Enacted by Congress; 5 parts (4 regulating aspects of insurance & 1 focusing on protecting health information) –> restrictions on use of medical charts in research & increased focus on how privacy would be protected in studies
Health Insurance Portability & Accountability Act (1996)
Cervical cancer patient at JHU; cells used to establish immortal cell lines without her knowledge or consent; broadly disseminated to researchers & foundation of numerous ground-breaking projects
Henrietta Lacks
24-y/o healthy volunteer at JHU who inhaled experimental drug in asthma study & died of lung failure; study IRB approved but drug not FDA-approved; ICF only noted drop in BP as risk, didn’t note compound not FDA-approved, prior symptoms from other patients not reported to IRB; lead to suspension of Hopkins Medicine IRB
Ellen Roche (2001)
Developed early human & statistical census methods (life tables) that provided framework for modern demography; one of first experts in epidemiology
John Graunt (1662)
First clinical trial (treatise) for scurvy
James Lind (1754)
Established concept of competing risks (lives saved by eliminating small pox)
Daniel Bernoulli (1760)
Developed cowpox vaccine –> smallpox vaccine
Edward Jenner (1796)
Introduced SMR in annual report of Registrar General of GB to compare mortality & life expectancy across occupational groups (record cause of death in different groups)
William Farr (1840)
Identified source of cholera outbreak (contaminated water from Broad Street pump)
John Snow (1854)
Realized women were dying in childbirth because of contamination (doctors not washing hands between pathology & delivery)
Ignac Semmelweis (1860)
Involved in typhoid fever (ID are contagious); worked with John Snow cholera data & to protect London water supplies; nature, MOT, prevention
William Budd (1873)
Koch postulates, germ theory (anthrax causes disease), TB –> contributed to germ theory & causal relationships
Robert Koch (1870s)
Anthrax vaccines, rabies vaccines, germ theory of disease, pasteurization
Louis Pasteur (1885)
First connection of smoking with lung cancer (1950 case-control study); Bradford Hill criteria
Sir Austin Bradford Hill
1918
Foundation of Bloomberg School of Public Health
1919
Foundation of JHU Department of Epidemiology
Dean of Bloomberg 1916-1926; founder of JH School of Hygiene & Public Health (1918); bacteriologist & pathologist; discovered bacteria that causes gas gangrene (clostidium welchii); founding editor in chief of AJE
William H. Welch
Dean of Bloomberg 1926-1931; physiologist; pioneered use of heparin; worked closely with Welch to establish curriculum
William H. Howell
Dean of Bloomberg 1931-1934 & chair of epi 1919-1938; first resident lecturer at school of public health & first professor of epidemiology; studied poliomyelitis, influenza, diphtheria, & TB; “father of modern epi” (index case, life table methods, age cohorts, epi curve, SIR models); established Eastern Health District Research Area in Baltimore
Wade H. Frost
Dean of Bloomberg 1934-1937; expanded school’s MPH program
Allen W. Freeman
Dean of Bloomberg 1937-1946; professor of biostatistics (came up with “biostatistics”)
Lowell J. Reed
Dean of Bloomberg 1946-1967; focused on environmental medicine & chronic disease; founded Department of International Health (1961); promoted health aid in foreign policy
Ernest L. Stebbins
Dean of Bloomberg 1967-1977; expanded health services research & integrated social/behavioral sciences; expanded student body; trained first EIS (1951)
John C. Hume
Dean of Bloomberg 1977-1990; lead WHO efforts on smallpox eradication; first director of Office of Public Health Emergency Preparedness
Donald A. Henderson
Dean of Bloomberg 1990-2005; known for work on vitamin A deficiency
Alfred Sommer
Dean of Bloomberg 2005-2017; focused on cardiovascular & kidney disease
Michael J. Klag
Dean of Bloomberg 2017-present; expert on trauma care systems
Ellen J. MacKenzie
Chair of epi 1938-1954; first formally trained in epi; virologist; recommendation adding fluoride to drinking water; first polio lab
Kenneth Maxcy
Chair of epi 1954-1970; established CDC’s Epidemic Intelligence Service & trained first class (1951); first president of MD Public Health Association; worked on incubation periods of different IDs, vaccination effectiveness against polio & influenza, harms of occupational radiation
Philip Sartwell
Chair of epi 1970-1975; expanding epi to include chronic disease; father of “contemporary chronic disease epi”; worked on link between smoking & lung cancer; trained first EIS (1951)
Abraham Lilienfeld
Chair of epi 1975-1993; epidemiology textbook; helped establish vision for Welch Center
Leon Gordis
Interim chair of epi 1993-1994; focus on international health (disasters & wars)
Haroutune Armenian
Chair of epi 1994-2008; focus on health risks of environmental pollutants; current chair of Clean Air Scientific Advisory Committee (EPA) & Tobacco Products Scientific Advisory Committee (FDA)
Jonathan Samet
Chair of epi 2008-present; Inaugural Charles Armstrong Chair (2009); initial work on cancer & alcohol; started working on HIV/AIDS & STIs (1980s) in ALIVE & MACS; international collaborations with Thailand
David Celentano
Professor in 1960s; micronutrient deficiency, TB, & CVD (ran first trials for BCG vaccine –> early use of cluster randomized design); known for engagement in community-based research & early cohort studies; Comstock Center
George Comstock
Put vitamins forefront in nutrition
Elmer V. McCollum
Professor; MACS & ALIVE studies; advocate for patients with HIV/AIDS; reinvigorated ID research
B. Frank Polk
Faculty; contributed to elimination of polio in US; father of “shoe leather epi”; established EIS (1940s)
Alexander Langmuir
Worked on lead poisoning in children & pioneered lead poisoning prevention guidelines
Emanuel Kaplan
Mean age at death as summary measure to compare health conditions of sanitary districts in London
Sir Edwin Chadwick
Chair of biostatistics; use of OR exposure to approximate OR disease in case-control studies (invariance of OR)
Jerome Cornfield
Basis for Cox PH model to evaluate time-to-event analyses with censoring
Sir David R. Cox
Regression fallacy
Milton Friedman
Nonparametric estimation from incomplete observations –> intended to deal with problem of right censoring; take intervals as short & numerous as possible so each event occupies own interval
Paul Meier
Mortality increases with age so areas with older populations will have higher mean age at death; direct & indirect standardization; use of standard populations
Francis G.P. Neison
“When you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind”
William Thomson, 1st Baron Kelvin
Regression to the mean (children’s height vs. height of parents); need to distinguish real change from expected change due to natural variation
Sir Francis Galton
Baltimore City Health Commissioner 2019-present
Letitia Dzirasa
Director of CDC
Rochelle Walensky
Director of FDA
Janet Woodcock
Director of WHO
Tadros Adhanom
Director of NIH Allergy & Infectious Disease; chief medical advisor to president
Anthony Fauci
Director of NIH
Francis Collins
First female faculty (1932); beginning of racial disparity work
Miriam Brailey
Established genetic epi program in 1979
Bernice Cohen
Establishment of Framingham Cohort Study
1947
Doll & Hill, smoking & lung cancer study
1950
Cornfield, case-control study; Framingham/CVD
1951
Pasteur, vaccines (rabies, anthrax)
1885
Fleming, penicillin vaccine
1928
Watson & Crick, DNA
1953
Smallpox eradication
1980
Salk, polio vaccine (inactivated)
1955
Sabin, oral polio vaccine
1961
Sanitary statistics, miasma vs. ID era, germ theory
19th Century Epi
ID era, germ theory vs. chronic disease, black box/risk factors
20th Century Epi
Statistician that demonstrated that mammography screening for breast cancer saves lives
Sam Shapiro
Demonstrated HPV precedes cervical cancer in 95% cases
Keerti V. Shah
Diagnosed first case of AIDS in India
Suniti Solomon
Epi IDEAS diversity recognition award; first group from JHU to win award
2019
Bloomberg Distinguished Professor of Epidemiology & Oncology; represents Department at school level to IDARE Efforts, chaired by Joel Bolling
Otis Brawley
