EthicsIRBEthics Conducting ResearchEthical Projects and PracticeSocial Media Ethics in the Workplace

Tuskegee Experiment 1932-1972

PHS Syphilis Study Disclosed 1972

1932, Public Health Service study, in collaboration with the Tuskegee Institute in Macon County, Alabama, undertook a study of untreated syphilis in hopes of justifying treatment programs for blacks.

600 black men (399 with syphilis, 201 without) were told they had "bad blood," a local term used to describe syphilis, anemia, and fatigue.

Penicillin, treatment of choice, was discovered in 1940s but was withheld.

In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years.

PHS Syphilis StudyTo entice their continued participation, PHS doctors sent them a letter titled, “Last Chance for Special Free Treatment.” The men submitted to painful and dangerous spinal taps.

The fact that autopsies would eventually be required was also concealed.

The Surgeon General of the United States participated in enticing the men to remain in the experiment, sending them certificates of appreciation after 25 years in the study.

By end of study in 1970s, 28 men were dead of syphilis, 100 were dead of related complications, 40 of their wives were infected, and 19 of their children were born with congenital syphilis.

PHS Syphilis Study

“Sometimes, with the best of intentions, scientists and public officials and others involved in working for the benefit of us all, forget that people are people. They concentrate so totally on plans and p rog rams , expe r imen ts , s ta t i s t i cs – on abstractions – that people become objects, symbols on paper, figures in a mathematical formula or impersonal ‘subjects’ in a scientific study.”

Atlanta Constitution, July 27, 1972

PHS Syphilis Study, formerly “Tuskegee Study”

Significant Events

Nuremberg Code 1947 U.S. Scandals Henry Beecher: "Ethics and Clinical Research" Public Health Service Policy Adopting IRBs Declaration of Helsinki Stanford Prisoner Study (1971) PHS “Tuskegee Study” Revealed (1972) National Research Act & 45 CFR 46 Belmont Report (1979)

1930 1940 1950 1960 1970 1980

Nazi physician Carl Clauberg (l) performed medical experiments on prisoners in Block 10 of the Auschwitz camp. Poland, between 1941 and 1944.

Nazi War Crimes - WWII

Nuremberg Trials Led to the Enduring Nuremberg Code

• Voluntary consent

• Anticipate scientific benefits

• Benefits must outweigh risks

• Animal experiments first

• Avoid suffering

• No intentional death or disability

• Do no harm

• Subject may withdraw at any time

• Investigators must be qualified

• Investigation will stop if harm occurs

Nuremberg Code - 1947

Classic Ethical Problem: Stanley Milgram's Electric Shock Experiments (1963-1965) at UC-Berkeley.

Obedience to Authority Studies – 1960s

1961-1962: Stanley Milgram, Yale University researcher

The Milgram Study: “A lesson in depravity, peer pressure, and the power of authority”

I observed a mature and initially poised business man enter the laboratory poised and confident. Within 20 minutes he was reduced to a twitching, stuttering wreck, who was rapidly approaching nervous collapse. He constantly pulled on his ear lobe and twisted his hands. At one point he pushed his fist into his forehead and muttered ‘Oh God, lets stop it’. And yet he continued to respond to every word of the experimenter, and obeyed to the end.

“Ethics and Clinical research”New England Journal of Medicine 1966

○ Created the prospective, double-blind, placebo-controlled clinical trial (gold standard of clinical research)

○ Published landmark article about 22 published medical studies presenting risk to subjects without their informed consent

○ Beecher’s revelations were the impetus for creation of Institutional Review Board system and informed consent standards

Henry K. Beecher, Father of IRB - 1966

Public Health Service Adopts IRBs - 1960

o 1964: World Medical Association adopts Helsinki Declaration, establishing basic ethical principles for human research.

o 1966: The Office for Protection from Research Risks (OPRR) was established in National Institutes of Health, and Institutional Review Boards were required.

Classic Ethical Problem: Laud Humphrey’s Early and Controversial Study of Gay Men

Classic Ethical Problem: The Philip Zimbardo Prison Experiment (1971) at Stanford.

Details: Go to Zimbardo’s web site and click on Prison Experiment http://www.prisonexp.org/

National Research Act - 1974• Upgraded Office for Protection from Research Risks’ policies

to REGULATION• Established a National Commission for Protection of Human

Subjects of Biomedical and Behavioral Research

o Identify basic ethical principleso Develop guidelines to assure research is carried out according to

those principleso Required institutions receiving HEW (PHS) funding for human

research to establish Institutional Review Boardso 1975: HHS promulgates Title 45 of Federal Regulations, “Protection

of Human Subjects”o 1976: Held the now famous conference at Smithsonian’s Belmont

Conference Center

The Belmont Reporto Respect for Persons

o Individual autonomyo Protection of individuals with

reduced autonomyo Beneficence

o Maximize benefits and minimize harms

o Justiceo Equitable distribution of research

costs and benefits

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

April 18, 1979

Significant Events

1990 1996 1997 1999 2000 2001 2002

Common Rule 1991 Nicole Wan dies at Rochester 1996 President Clinton apologizes to PHS Syphilis study survivors Jesse Gelsinger dies at U Penn OPRR shuts down LA VA Medical, Duke, U Ill, U Colo, U Penn

OPRR shuts down VCU, UAB, U Okla OPRR reorganized as OHRP, moved to Cabinet level and Director replaced, June 2000 Ellen Roche dies at Johns Hopkins; OHRP suspends JH federally funded research Secretary's Advisory Committee on Human Research Protections replaces National Human Research Protections Advisory Committee

Jesse Gelsinger & U Penn - 1999

o 18-year old volunteer in U Penn’s gene therapy study of partial omithine transcarbamylase deficiency (OTC), which interferes with liver’s ability to metabolize ammonia.

o Jesse died at U Penn Hospital after being injected with genetically altered adenovirus.

o U Penn researchers had financial conflict of interest. http://www.sskrplaw.com/gene/jessieintent.html

Universities, Hospitals Shut Down

Mar 1999 West Los Angeles Veterans Administration Medical CenterMay 1999 Duke University Medical CenterAug 1999 University of IllinoisSep 1999 University of ColoradoSep 1999 University of PennsylvaniaJan 2000 Virginia Commonwealth UniversityJan 2000 University of Alabama at BirminghamJun 2000 University of Oklahoma – TulsaJun 2001 Johns Hopkins Medical University

What is a “Human” Subject?o Is a living individual about

whom an investigator obtains either:o Data through intervention

or interaction with the individual; or

o Identifiable private information

Willowbrook State School, Staten Island, New York, 1950s • Children at this institution for the retarded were fed extracts of stools from individuals infected with the hepatitis virus.

• Justification by Willowbrook’s Research Director, Dr. Saul Krugman, was that children in the crowded facility would likely contract hepatitis anyway.

• Parental “permission” was obtained through misleading them about lengthy admission process for non-participating children.

Jewish Chronic Disease Hospital Cancer Experiments - 1960s

• Twenty two chronically ill, debilitated, non-cancer patients injected with live human cancer cells • They were not told about the cancer cells because doctors (researchers) "did not wish to stir up any unnecessary anxieties in the patients" who had "phobia and ignorance" about cancer. • Research funded by U.S.P.H.S. and American Cancer Society. • Two years later, the American Cancer Society elected the principal investigator to be their Vice-President.

Mid 20th Century Scandals

Twins Study & VA Commonwealth - 2000o Dad opened college-aged

daughter’s mail and found VCU survey from ongoing twin study.

o Family members would have become research subjects without giving consent.

o 1000 VCU studies with human subjects were shut down by Office for Human Research Protections (OHRP).

o Living individuals become research subjects when investigators obtain private, identifiable information about them.

o Healthy lab technician volunteered for asthma study of hexamethonium bromide.

o Respiratory effects of hexamethonium bromide were not known to investigator prior to study.

o Previous participant had respiratory problems, solution was changed without IRB being informed.

o Johns Hopkins forced to halt $300 million in medical research

o Ellen Roche died. Compensation for her participation: $365. Johns Hopkins settled out of court with her family.

Ellen Roche & Johns Hopkins - 2001

Fred Hutchinson Cancer Research Center 2001

o Patients died in two failed clinical trials at the center.

o The Center and its doctors had a financial interest in the trials.

Social Media and Identity•Privacy•Anonymity•Consent•Harm & Human Subjects (dignity)•Marginalizing Populations

Privacy

Case Studies: Implications

FacebookPrivacy changes over time

http://mattmckeon.com/facebook-privacy/

From http://royal.pingdom.com/2010/01/05/facebook-twitter-myspace-page-views/

Conflicts of Interest on SNS’s

• Faculty ‘friending’ students on Facebook.• Patients ‘friending’ doctors on Facebook.• College athletes ‘friending’ recruiters.• Judgles ‘friending’ lawyers who appear

before them.

T3 datasetnortheast college

• Approved by Harvard IRB • NSF mandated release of data • Researchers put protections in place –

delays

Can you protect anonymity in today’s big-data culture?

"But the data is already public": on the ethics of research in Facebook by Zimmer

Facebook Emotion Contagion Study

Cambridge Analyticahttps://www.nytimes.com/2018/03/19/technology/facebook-cambridge-analytica-explained.htmlhttps://en.wikipedia.org/wiki/Cambridge_Analytica

• control over information (Elgesem 1996)

• restricting access to information (Tavani 2007)

• contextual integrity (Nissenbaum 2004)

Privacy as Contextual Integrity by Nissenbaum

Open or Fragmented Communities

• Polarization• Communities supporting anorexia

Reasonable Expectation of Privacy ?

What was ephemeral….

• DejaNews• Twitter

What is freedom of speech? Terms of Service Common Sense? The Law

More examples at:

• http://www.michaelzimmer.org/2012/05/26/ica-2012-researching-social-media-ethical-and-methodological-challenges/

No policy or inadequate policy

• “Often, either no policies for conduct in these situations exist or existing policies seem inadequate. A central task of Computer Ethics is to determine what we should do in such cases, that is, formulate policies to guide our actions.”

-Jim Moor, “What is Computer Ethics

Ethics

• Virtue• Consequentialist• Deontological

• http://ethics.npr.org/tag/social-media/

Ethics in the workplace:

Reactions

• Ellen Simotetti posted images on her personal blog. Fired for misuse of uniform.

• Heather B. Armstrong, coined the term ‘dooced’ in 2002. “I started this website in February 2001. A year later I was fired from my job for this website because I had written stories that included people in my workplace. My advice to you is BE YE NOT SO STUPID.”

• Rachel Mosteller, under pseudonym, Sarcastic Journalist, fired from Durham Herald-Sun."I really hate my place of employment. Seriously. Okay, first off. They have these stupid little awards that are supposed to boost company morale. So you go and do something 'spectacular' (most likely, you're doing your JOB) and then someone says 'Why golly, that was spectacular.' then they sign your name on some paper, they bring you chocolate and some balloons. "Okay two people in the newsroom just got it. FOR DOING THEIR JOB.”

• Michael Hanscom, on his blog, Eclecticism, posted photos of Macs on the Microsoft campus. No longer allowed on campus.

• Blogger, Karsh, blogged about employees, employer on company time.

• Jeremiah Love, police officer from Wichita, Texas

• Princeton Nude Olympic photos posted on Flickr and Facebook

• Stacy Snyder, drinking from plastic cup. Supervisor at high school called photo unprofessional. What does it mean to be a public employee? First amendment rights?What can you do after hours?

• 16 year old girl in Britain fired for Facebook comment “I’m so totally bored!!”

• 66 yr. old Canadian barred permanently from visiting the U.S. After guard found article from 30 years ago documenting experiments with L.S.D.

• Stephen Fowler, “worst husband” on wife-swap

• Kitten Lady

Closer to home.

• http://suffenus.wordpress.com/2014/01/29/twitter-outrage-charted-the-partial-anatomy-of-the-fuckphyllis-trend-and-why-i-dont-trust-buzzfeed/

Ethics

• Virtue• Consequentialist• Deontological