IRBs

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IRBs Tribal Research IssuesCan research be
good for tribes? How can tribes protect
themselves in research?

• MT WY Tribal Leaders Council
• April 6
• William L. Freeman, MD, MPH, CIP
• Director of Tribal Community Health Programs,
• Human Protections Administrator
• Northwest Indian College
• 360-758-2175 (360-392-4284) fax [phone]
  wfreeman_at_nwic.edu

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Hy'shqe siam

• Thank you respected mentors teachers
• Francine Romero
• Laura Arbour
• Wylie Burke
• Sam Deloria
• Roger Gollub
• Ann Macaulay
• Alex McComber
• Jerry Mohatt
• Terry Powell
• and many others
• Thank you respected wife, Carolyn M. Robbins

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Objectives

• Discuss characteristics of good bad research
  among MT WY tribes
• Describe some good bad research in Indian
  Country
• Describe history, basic concepts, weaknesses of
  human research protection in majority society
• Define Community-Based Participatory Research
  CPBR, an approach to minimize harms and
  maximize benefits
• Propose additional ways to protection Indian
  individuals tribes in research

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Older good research in Indian Country

• Research to treat trachoma eye infection
• major cause of blindness for AI/AN, 1st half
  20th century
• Sulfa antibiotics invented 1930s, clinical trial
  of sulfa among White Mountain Apache, 1937
• Saved the eyesight of many AI/AN people
• Tuberculosis was a killer, major cause of AI/AN
  death
• last half 19th, first half of 20th, centuries
• Clinical trial of INH isoniazid Navajo
  Reservation in early 1950s -- Annie D. Wauneka,
  a major leader
• Proved INH was an effective treatment for TB
• Saved the lives of many AI/AN people

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Older bad research in Indian Country

• 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
  migrants
• Led to VT sterilizing some of the
  identifieddumb or delinquent children -- "to
  protect the gene pool
• The problem was the basic plan of the research
• Poor science did not measure "dumbness" or
  "delinquency
• Use of science for plain political power
• Nancy L. Gallagher Breeding Better Vermonters
  The Eugenics Project in the Green Mountain State
  1999.

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Recent good research in Indian Country

• 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, an
  important topic
• - Kahnawake Schools Diabetes Prevention
  Project
• Community-Based Participatory Research, both an
  important and a very sensitive topic
• - People Awakening Project with Alaska
  Native groups, about resiliency and strengths in
  dealing with alcoholism

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Recent bad research in Indian Country - 1

• Congenital syphilis epidemic, 1980s
• reservation not named in publication
• gave precise 1980 US Census pop.
• Reservation children taunted "Your mama's ..."
• Gas stations refused to let reservation people
  use restrooms
• The problem was the way the release of the
  research results

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Recent bad research in Indian Country - 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
  nutrition
• 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
  KAuthor
• Paul Rubin personal communication

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Recent both good bad research

• Hantavirus, summer 1993
• 50 of infected people died
• first recognized on the Navajo Reservation
• 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
  Chapters
• where the people lived who were infected first
• where the deer mice and other animals were
  trapped
• Navajo approved no research for gt13 months

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Recent bad research summary

• Major community harm was disruption
• Major individual harm was internal
  self-stigmatization
• All subsequent research in most of those
  communities was adversely affected
• Usual problem was publication-dissemination
• Sharing genetic specimens, anonymized for
  individual ID, is no longer appropriate--an NIH
  researcher practice
• Tribal approval of research extends to future
  uses of genetic and biological specimens, of
  data, etc.
• The values and relationships of the tribes and
  researchers are changing

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Current ugly research in Indian Country

• Havasupai there is more
• with the diabetes study was also a schizophrenia
  study
• apparently researchers told neither tribe nor
  individuals
• 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
  Country
• major adverse publicity in Arizona, major law
  suit by Havasupai
• Better tribal IRB review could have prevented
  this!
• - not blaming the victim, not blaming the
  tribe

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Research atrocities in western societies 1

• Nazis in WWII - in concentration camps (Dachau)
  and killing camps (Auschwitz)
• Immersed prisoners in cold water
• until they died the intent of the research
• Decompressed prisoners in high-altitude chambers
• until they died the intent of the research
• Injected many prisoners with typhus
• many died
• Nuremberg Medical Trial, 1946-47
• tried 23 defendants (20 physicians)
• convicted 15

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Research atrocities 2 USPHS Syphilis Study

• Public Health Service studied natural history of
• untreated syphilis in 405 African American men --
• impoverished sharecroppers around Tuskegee, AL
  1932-72
• Researchers lied to the men
• said they treated them for "bad blood"
• Highly successful (defined as the men stayed
  with it)
• 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
  doctors
• Not secret!
• Updated results published about every 5 years

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

• Established by the 1974 National Research Act.
• First, it proposed regulations.
• The regulations were a restriction on the federal
  government (HEW, now DHHS)
• it could not do or fund human research that had
  not been
• approved by an Institutional Review Board (IRB)
• and whose review complied with 45 CFR 46 (Title
  45 Code of Federal Regulations Chapter 46).
• http//www.hhs.gov/ohrp/humansubjects/guidance/45c
  fr46.htm

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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
  benefits
• Justice
• Selection of people to be in the research
• http//www.hhs.gov/ohrp/humansubjects/guidance/bel
  mont.htm

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Principle Beneficence

• Do no harm to individuals - "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

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Principle Justice

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

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Principle Respect for Persons

• "Individual autonomy"
• Informed consent
• Full information
• Full comprehension
• Voluntary
• without coercion
• Protect individuals with reduced capacity to
  exercise autonomy

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Values present in the regulations

• Minimize harms to individuals, and maximize
  benefits to society
• Justice for individuals
• Respect for individuals
• But the regulations 45 CFR 46 do not cover
• Minimize harms and maximize benefits to
  communities and tribes
• Justice for communities and tribes
• Respect for communities and tribes

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Native values not explicit in the regulations

• Protection of communities
• except obliquely
• Respect for elders knowledge of community
• ethnographic interviews published or archived by
  outsiders
• Respect Native communities, strengths, and
  survival
• 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

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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

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Minimize harms maximize benefits to Indian
people tribes Community- Based Participatory
Research (CBPR)

• Also called "Participatory Action Research"
• Research to deal with directly, solve,
  community-based problems
• Community is highly involved
• Tends to be "problem-focussed" "action- /
  solution- focussed"

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CBPR in Native communities

• Research related not just to identified
  community-based problems (as in other
  communities)
• Related also to generic issue of tribal
  communities that are distinct, and partially
  separate, from general US society
• research that supports promotes the tribes
  maintenance and survival
• research that respects incorporates the tribes
  strengths

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Potential problems with CBPR

• Will community involvement hurt the quality of
  the science in the research project?
• "contaminate data" by some community members
  knowing interim results
• Will researcher bend results to favor what
  community people want?
• Will community impose censorship?
• My assessment is that
• - these questions are serious,
• - should be addressed by CBPR researchers
  tribes, and
• - can be addressed by CBPR researchers tribes

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Should CBPR be the usual research in tribal
communities?

• The opposite questions, "Why not CBPR?"
• May non-CBPR researchers ask the wrong questions?
• May non-CBPR researchers enroll the wrong people?
• May non-CBPR researchers misinterpret their
  results?
• May non-CBPR researchers have a higher chance of
  harming the Native community?
• My assessment is that these opposite questions
• - are serious, and
• - should be addressed by non-CBPR researchers
  working in tribal communities

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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
  boards."
• New England Journal of Medicine Vitamin C and
  acute illness in Navajo school children 1976,
  vol 295, p. 973-977.
• No Bad or ugly research since 1967 -
  hantavirus
• Before the publication, the Navajo Area IHS IRB
  asked CDC to change the Hantavirus articles -gt no
  change
• The IHS Research Program Director Chair of its
  IRB demanded deletion of the place names -gt no
  deletion

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Is review approval by tribal government enough
protection?

• Sometimes, but not always
• Limits of legal jurisdiction of tribal
  governments
• Institutional Review Boards (IRBs) have
  jurisdiction power of federal government and
  its regulations
• moral power with editors of medical journals
• legal power of IRB regulations in non-tribal
  courts
• legal power of IRB regulations over researchers
  grant
• A tribe with its own IRB, recognized by the
  federal government, thus expands the power
  influence of the tribe over research beyond the
  tribes borders

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Summary of the evidence 1 Research

• Much research has been good for AI/AN individuals
  and tribes
• Some research has been bad
• Some research has been both good and bad, and
• Rare research has been ugly
• Human research protections in majority society
  include some important Native concerns, but do
  not include others
• Tribes and TCUs need to protect themselves and
  actively promote their own interests

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Summary of the evidence 2 CBPR

• CBPR can promote tribal interests and produce
  good research
• CBPR is a true partnership a research team with
  tribal and outside communities as
  Co-Investigators
• Such research teams can minimize or avoid the
  chance of possible harms of research in tribal
  communities
• Such research teams can maximize and promote the
  benefits of research for tribal communities
• CBPR is a spectrum more (or fewer) components
  of the research process involve the communities

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Summary of the evidence 3 Tribal IRBs

• A Tribe can promote tribal interests, produce
  good research, stop bad research, and protect
  tribal interests by
• Forming its own IRB
• Getting official federal recognition as an IRB
• Learning the IRB regulations how to use them
• Building beyond the floor of the IRB regulations
  include tribal concerns and values in the IRB
  reviews
• Having a formal active process for the tribal
  government to review research
• Model Tribal Research Code
• Solicit allies from IRBs researchers with
  goodwill