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History of Research Protections for Individuals and Communities


Medical profession changed, to prevent anti-research groundswell ... experimental medical research. ... observational behavioral research (not medical) ... – PowerPoint PPT presentation

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Title: History of Research Protections for Individuals and Communities

History of Research Protections for Individuals
and Communities
  • Northern Plains Tribal Epidemiology Center
  • Aberdeen Area Tribal Chairmens Health Board
  • May 2, 2004

William L. Freeman, MD, MPH, CIP
  • Director of Tribal Community Health Programs,
  • Human Protections Administrator
  • Northwest Indian College
  • 360-392-4284 fax 360-647-7084 wfreeman_at_nwic.edu

  • with material by
  • Warren Ashe (Howard University)
  • Jeffrey Cohen (formerly, Office for Human
    Research Protection--OHRP)
  • Dale Hammerschmidt (University of Minnesota)

Hyshqe siam -Thank you, respected teachers
  • Community members, community IRB members
  • Sam Deloria, Lisa Preston, and others
  • IRB members
  • Dr. Francine Romero, and others
  • IRB staff
  • Helen McGough, Moira Keane, Susan Kornetsky, and
  • Researchers
  • Participants
  • Carolyn Robbins - Wife

  • To know the basic chronology of the development
    of the ethics and regulations of protection for
    individuals in research
  • To understand the basic intent, nature, and
    limitations of those regulations
  • To discuss 3 controversies concerning the
  • To understand protection of communities in
    research, and how it can be accomplished

Early problematic research
  • Infected prostitutes and children with syphilis
    to test immunity by serum from syphilitic
    patients, without consent (Germany, 1892)
  • BCG (TB vaccine) disaster--77 of 256 children
    died (Germany, late 1920s)
  • Poor children, especially orphans (1800s-early
    1900s, USA others)
  • Hebrew Infant Asylum, no orange juice to orphans
    to study development of scurvy (NYC)
  • Medical profession changed, to prevent
    anti-research groundswell
  • Susan Lederer Subjected to Science Human
    Experimentation in America Before the Second
    World War 1997.

Research atrocities by Nazis, WWII
  • In concentration camps (Dachau) and killing camps
  • Immerse prisoners in cold water
  • until they died the intent of the research
  • Decompress prisoners in high-altitude chambers
  • until they died the intent of the research
  • Inject many prisoners with typhus
  • many died
  • Nuremberg Medical Trial, 1946-47
  • tried 23 defendants (20 physicians)
  • convicted 15

The Nuremberg Code, Aug. 19, 1947
  • 10 rules for Permissible Medical Experiments
  • voluntary consent, without coercion,
  • good science, done by good scientists,
  • potential benefits justify experiment,
  • harms minimized,
  • degree of risk less than potential benefit,
  • subjects can end their participation, and 4
  • A start, but with limited applicability
  • medical research only, only on normal subjects
  • asked "When is research criminal?"
  • http//www.hhs.gov/ohrp/references/nurcode.htm

After WWII
  • Radiation experiments (1950s)
  • consent absent, or inadequate deceptive
  • Willowbrook (1950s)
  • deliberately infected mentally retarded children
    with hepatitis virus
  • coercion of parents
  • Jewish Chronic Disease Hospital (1960s)
  • injected live cancer cells into 22 elderly
    patients, some with dementia, some spoke only
  • consent deceptive, inadequate, not translated
  • guardians not asked for permission
  • Lerner BH. Sins of omission cancer research
    without informed consent. NEJM 2004

Henry Beecher
  • 1966 article summarized 22 recent unethical
    medical experiments (out of 50 examples
  • in major medical centers, by prominent
    researchers, funded by respected sources,
    published in prestigious journals (including
  • perform heart catheterizations on patients
    getting a bronchoscopy look at breathing
    passages through a tube
  • placebo control groups in life-threatening
    diseases with known effective treatments --
  • randomize soldiers with strep throat to
    penicillin vs. treatments known-to-be-ineffective
    ineffective treatment may lead to rheumatic
    heart disease
  • I.E., ethical problems were mainstream, not
  • "Ethics and clinical research" NEJM 1966 vol 274,
    p. 1354-60

US Public Health Service Syphilis Study
  • Natural history of untreated syphilis in
  • 405 African American men
  • impoverished sharecroppers around Tuskegee, AL
  • Researchers lied to the men
  • said they treated them for "bad blood"
  • Highly "successful"
  • dropout rate only 1 over 40 years
  • Why was it so successful?
  • The reason it was "culturally sensitive"
  • paid for funeral, African American nurse some
  • Not secret!
  • Updated results published about every 5 years

National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
  • By the 1974 National Research Act
  • First, it proposed regulations
  • required Institutional Review Boards (IRBs)
  • for research done or conducted by HEW (now DHHS)
  • 45 CFR 46 (Title 45 Code of Federal Regulations
    Chapter 46)
  • http//www.hhs.gov/ohrp/humansubjects/guidance/45c

Then issued The Belmont Report
  • Basic ethical principles underlying its proposed
    regulations ( - and their application)
  • Respect for persons
  • Informed Consent
  • Beneficence
  • Assessment of potential risks harms and
  • Justice
  • Selection of people to be in the research
  • http//www.hhs.gov/ohrp/humansubjects/guidance/bel

Principle Beneficence
  • "Do no harm" - "Do benefit"
  • Assessment of risks harms and benefits
  • Minimize harms to participants
  • Use least harmful methods to achieve the
    scientific end
  • Favorable Benefit-to-Risk comparison
  • maximize Benefit-to-Risk ratio
  • maximize benefits to participants and society

Principle Justice
  • "Treat individuals fairly"
  • Selection of subjects / participants
  • Equitable distribution of research harms and
  • Equitable selection of subjects / participants
    within a population
  • Equitable selection of population

Principle Respect for Persons
  • "Individual autonomy"
  • Informed consent
  • full information
  • full comprehension
  • voluntary
  • without coercion
  • Protect individuals with reduced capacity to
    exercise autonomy

CONTROVERSY 1 "The regulations are designed
only forexperimental medical research."
  • A common complaint of some behavioral or
    non-experimental researchers.
  • Many ethically problematic studies were medical
  • Lets examine the sentence
  • experimental research
  • medical research.

"The regulations are for 'experimental research'
  • Tuskegee was not an experiment.
  • It was observational research.

Definition of research
  • "a systematic investigation, including research
    development, testing and evaluation, designed to
    develop or contribute to generalizable
    knowledge.... (S)ome demonstration and service
    programs may include research activities."
  • 45 CFR 46.102 (d)
  • The definition is not limited to "experimental."
  • Nevertheless, were the ethically problematic
    studies primarily medical research?

Behavioral research with problematic ethics - 1
  • Milgram (1963)
  • Behavioral study of obedience
  • a few participants still quite distressed when
    queried well after the experiment
  • not medical
  • Humphries (1970)
  • Tearoom Trade Impersonal Sex in Public Places
  • concerns of confidentiality and privacy
  • neither medical nor experimental

Behavioral research with problematic ethics - 2
  • The Monster Study
  • so named by people who stutter researchers of
  • by Mary Tudor Wendell Johnson (1939,
  • Randomized trial 12 normal-speaking orphans in
    IA orphanage
  • Researcher purposefully criticized the speech of
    6 orphans--to induce stuttering
  • Some may have developed stuttering, a few for
  • Another example of orphan kids used in research
  • Franklin Silverman "The monster study" Journal
    of Fluency Disorders 1988 vol. 13, p. 225-231

Behavioral research with problematic ethics - 3
  • Social science in the service of eugenics
  • In the state of Vermont VT, the first third of
    20th century
  • Surveys of "dumb" or "delinquent" children and
    their families
  • Dumb or delinquent families were usually poor
  • Catholic French Canadians, Abenaki Indians, or
  • Led to VT sterilizing some of the identified
    dumb or delinquent children -- "to protect
    the gene pool"
  • Poor science did not measure "dumbness" or
  • Nancy L. Gallagher Breeding Better Vermonters
    The Eugenics Project in the Green Mountain State
  • Please do not turn the page of the handout until
    asked to do so

Non-experimental behavioral research - 4
  • What do you think has been the general kind of
    research that has caused the most harm to the
    most people in 20th century America?
  • USPHS syphilis study in Tuskegee?
  • radiation experiments?
  • eugenics?
  • other?

My vote
  • IQ research comparing blacks and others
  • observational behavioral research (not medical)
  • contributed to and reinforced racial
    stigmatization of African Americans and others,
    including American Indian, Alaska Native,
    Canadian First Nation, and Inuit students and
  • harmed primarily those communities, and all
    people in those communities
  • What will historians 40 years from now say about
    our research today?
  • Please turn page of handout

  • All types of research, both experimental and
    non-experimental, both medical and behavioral,
    has caused (and can cause) major harms
  • Harms to communities when community members
    not in the original research are directly harmed
    by the results of the research
  • The IRB should have the expertise to assess all
    potential harms, including harms to communities,
    in the research it reviews
  • behavioral research may require special expertise
  • e.g., qualitative, ethnographic

CONTROVERSY 2 The place of regulations in human
research protection
  • 1900 - Germany, Prussian Minister of Religious,
    Educational, and Medical Affairs
  • Directive - included consent "unequivocally"
  • 1930 - Germany, Reich Minister of the Interior
  • "Regulations on New Therapy and Human
  • had almost all points in Nuremberg Code
  • Nazis did ethically atrocious research despite
  • Michael Grodin "Historical origins of the
    Nuremberg Code," in George Annas Michael Grodin
    (eds) The Nazi Doctors and the Nuremberg Code
    1992 p. 121-144 Paul Weindling "The origins of
    informed consent the International Scientific
    Commission on Medical War Crimes, and the
    Nuremberg Code" Bulletin of the History of
    Medicine 2001 vol. 75, p. 37-71.

USA Medical University IRB - 1
  • 1994 - MU IRB reviewed the Prenatal Clinic policy
  • to test pregnant women with a urine drug screen
  • without fully informing the women that a
    positive test would be reported to the court, and
  • that the court likely would jail test-positive
    women and could take their newborn and other
  • Most were poor black women.
  • Preliminary outcome results were reported in
    state medical journal final results were
    promised soon
  • planned to send final results to a major
    obstetrical journal
  • "Was this research?"

Medical University IRB - 2
  • A few members voted that, by 1994, it had become
    prospective research, and would have disapproved
    the protocol, because
  • the consent process was incomplete and deceptive,
  • the potential harm to the women by the procedures
    outweighed the potential benefit of the research
    to each woman and society.
  • The majority voted that it was not research.

Medical University IRB - 3
  • Many IRB members felt that, even if it was
    research, and for all other research on those
  • Drug-abusing pregnant women were harming their
  • And the women were doing illegal behavior ...
  • thus the women did not deserve to be protected
  • What is wrong with this picture?
  • From the investigation by OPRR in 1994, and
    discussion with an IRB member, and Edgar O Horger
    et al "Cocaine in pregnancy confronting the
    problem" Journal of the South Carolina Medical
    Association Oct 1990 vol. 86, p. 527-531.
  • Also the US Supreme Court, March 22, 2001,
    reviewed a legal case from this project (not
    about the research), and ruled against the city
    and MU (Ferguson v. City of Charleston et al).

  • Good regulations are necessary, but are not
    sufficient, for human research protection.
  • Also necessary are that researchers and IRB
  • understand and agree with the purpose of the
  • and apply the regulations to everyone,
  • especially to people whom society or the IRB
    members consider to be morally or socially
  • or even despise.

CONTROVERSY 3 What were the good, the bad,
the ugly in AI/AN research and how to avoid the
bad ugly?
  • Research with AI/AN people/communities/tribes is
    not listed in the catalog of problematic research
  • A common feeling among many tribal people
    research has harmed AI/AN people
  • What is behind that feeling?

Older current good history / research
  • Tuberculosis was a killer, major cause of AI/AN
  • last half 19th, first half of 20th, centuries
  • Clinical trial of INH isoniazid in the Navajo
    Rez in early 1950s proved INH was an effective
    treatment, saved many AI/AN lives
  • Diabetes is a killer
  • - Diabetes Prevention Program DPP proved
    that intense counseling for lifestyle change
    could prevent type 2 diabetes reduce calories,
    especially fats moderate exercise 30 minutes a
    day 5 times a week reduce weight by 7
  • Community-Based Participatory Research
  • - Kahnawake Schools Diabetes Prevention
  • - People Awakening Project with Alaska
    Native groups, about resiliency and strengths in
    dealing with alcoholism

Older bad history - 1
  • Research with radioactive iodine (I131)
  • early 1950s, USAF
  • "Do ANs survive the cold by having higher
  • Gave I131 to Alaska Native people
  • same amount as then used for thyroid scan
  • almost all ANs did not speak English
  • 3 AN women in research were breast feeding
  • Long term effects of thyroid scan not then known
  • (ANs not higher metabolism know how to dress
    and eat)
  • Involved radiation a feared modern hazard

Older bad history - 2
  • Navajo uranium miners, 1950s
  • Dust in U mines known to cause lung cancer
  • AEC refused to regulate mining
  • PHS study, natural history
  • health exam Q2Yrs, tracked deaths
  • "pile up bodies at the door"
  • did not inform participants of known health
    effects or reason for study
  • Bodies piled up by 1960s -gt regulation started

Implications of older bad history
  • I131 and uranium studies have complex issues
  • children who were breast feeding may not have
    been followed up
  • so what would you do to get the US to establish
    health regulations for mining, against the power
    of the AEC?
  • The problem was basic protocol design

Recent bad history - 1
  • Barrow, Alaska study on alcoholism
  • 1970s, researchers from northeastern US
  • announced findings in press conference
  • held at their northeastern university
  • Internal stigmatization by people from Barrow
    nearby communities
  • Bonds on Wall Street adversely affected
  • Impact of research results?
  • no positive change in/by Barrow

Recent bad history - 2
  • Haida Gwai anthropologic research, 1970s?
  • PhD student -gt worked as a schoolteacher
  • Documented effects of alcohol
  • incest, murder, etc.
  • instances not widely or legally known in the
  • Book published 1990s, names hidden
  • to outsiders -- but not to community members!
  • Author almost physically assaulted in next visit

Recent bad history - 3
  • Congenital syphilis epidemic, 1980s
  • Rez not named in publication
  • gave precise 1980 US Census pop.
  • Rez children taunted "Your mama's ..."
  • Gas stations refused to let Rez people use

Recent good bad history - 4
  • Hantavirus, summer 1993
  • 50 of infected people died
  • first recognized on the Navajo Rez
  • CDC found cause lt10 days--a virus from deer mice
  • Good helped NNDOH develop prevention programs
  • NNDOH asked CDC not to give Navajo place names in
    scientific articles
  • Bad 1st 2 articles, CDC named the Navajo
  • where the people lived who were infected first
  • where the deer mice and other animals were
  • Navajo approved no research for gt13 months

Implications of recent bad history
  • Major community harm was disruption
  • Major individual harm was internal
  • All subsequent research in many of those
    communities was adversely affected
  • The problem was publication-dissemination

Current bad research 1
  • Nuu-chah-nulth First Nations western Vancouver
    Island, BC, Canada, severe unusual arthritis
  • early 1980s, UBC rheumatology genetic
    researchers studied their problem, took blood
  • geneticist kept specimens with him UBC -gt U
    Utah -gt Oxford U, report migration genetic
    research results
  • Community found out 3 years ago
  • major adverse publicity across Canada
  • Community wanted the specimens back to finish the
    arthritis research
  • geneticist died early 2004, had stated to return

Current bad research 2
  • Havasupai
  • early 1990, tribe approved a diabetes study
    including genetic analysis, by ASU researchers
  • no NLM-listed journal articles on genetic
    analysis of T2DM among Havasupai, one article on
  • HLA, inbreeding, migration genetic research
    also done using the specimens
  • sources
  • Rubin P. Indian givers. Phoenix New Times 2004
    May 27
  • Dalton R. When two tribes go to war. Nature
    2004 430500-2
  • Editorial. Tribal culture versus genetics.
    Nature 2004 430489
  • Pubmed Havasupai OR Markow TAuthor OR Martin
    JFAuthor OR Benyshek DAuthor OR Zuerlein
  • Paul Rubin personal communication

Implications of current bad history
  • The old NIH policy and researcher practice, of
    sharing genetic specimens usually anonymized for
    identity of the individual is no longer
  • Tribal approval of research extends to future
  • of genetic biological specimens
  • of data
  • Tribes vary about their degree of favorable or
    unfavorable attitude toward research in general
  • extent to which they see research as an enemy of,
    or a friend of, the tribes future physical and
    cultural survival
  • The values and relationships of the tribes and
    researchers are changing

Current ugly research
  • Havasupai there is more
  • concurrently with T2DM study was schizophrenia
  • apparently researchers told neither tribe nor
  • apparently research team obtained information
    from clinic charts surreptitiously, after hours,
    with no approval
  • apparently the ASU IRB did not comply with own
    procedures requirements
  • Was this amateur night?
  • Now prime example of ugly research in Indian
  • major adverse publicity in Arizona, major law
    suit by Havasupai
  • Better tribal or IRB review could have prevented

Current good research and practices
  • Kennewick Man is an example of bad practice
  • skeleton found 08/96, 1st scientist said was
  • Kwaday Dan Tsinchi - Long Ago Man Found
  • Champagne-Aishihik First Nations FN, d.
  • glacier in Tatshenshini-Alsek Park, British
    Columbia BC
  • body found 08/99, plan developed, studied to
  • returned to the Champagne-Aishihik
  • cremated, potlatch, ashes scattered where found
  • head found 08/2003, studied, laid to rest 10/2004
  • final ceremonies being planned
  • FN community BC government set up a joint group
    to oversee the research within cultural limits
  • People Awakening Project

Values present in the regulations
  • Respect for persons
  • Minimize harms to persons
  • Maximize benefits to persons
  • Justice for persons
  • But the regulations 45 CFR 46 do not cover
  • Publication of private communal knowledge
  • CDC's Hantavirus articles
  • Desecration of bones in archaeologic remains
  • because archaeology is not human research of
    identifiable living human beings

Native values not explicit in the regulations
  • Protection of communities
  • except obliquely
  • Respect for elders knowledge of community
  • ethnographic interviews published or archived by
  • Respect Native communities, strengths, and
  • much research focuses on how bad things are
  • not on how/why people survived and do well
  • Promote resiliency, help activate the community
  • Respect and promote tribal sovereignty

Protect communities, respect elders, and
respect communities
  • Typical research on alcoholism or domestic
    violence document how bad things are
  • attacks the value of community
  • Rather, research how/why people stopped domestic
    violence, or became and stayed sober and thus
    promote resiliency, help activate the community
  • People Awakening Project

Rely on others to protect communities?
  • Yes
  • 1967 - Indian Health Service policy required
    approval by the tribal government of all research
  • 1976 - "Permission to conduct this investigation
    was granted by the Indian Health Service, the
    Bureau of Indian Affairs and appropriate Navajo
    tribal authorities, including local school
  • New England Journal of Medicine Vitamin C and
    acute illness in Navajo school children 1976,
    vol 295, p. 973-977.
  • No
  • Before the publication, the Navajo Area IHS IRB
    asked CDC to change the Hantavirus articles -gt no
  • The IHS Research Program Director Chair of its
    IRB demanded deletion of the place names -gt no

My summary of the evidence - 1
  • Some research has been good for AI/AN individuals
    and tribes
  • Some research has been bad for AI/AN individuals
    and tribes
  • Some research has been both good and bad
  • Some research has been ugly
  • The regulations do not include some important
    AI/AN concerns
  • Tribes and TCUs need to protect themselves
  • in addition to relying on others the

My summary of the evidence - 2
  • Researchers are more ethical
  • IRBs do protect individuals
  • The regulations are valuable
  • and should be understood and used
  • IRBs the regulations are a floor, not a ceiling
  • IRBs are necessary and quite valuable,
  • but they are not sufficient for tribes, tribal
    people, and TCUs.

Steps to protect tribal individuals,tribal
communities, TCUs
  • Establish an IRB
  • tribal, TCU, or combined TCU-tribal
  • Learn the regulations and how to use them
  • Tribal governments and TCUs maintain an active
    process to review research
  • Solicit allies from other IRBs and researchers
    with goodwill
  • Protect communities by building beyond the floor
    of the regulations
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