40th Anniversary: past, present, future

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40th Anniversary past, present, future

• Third Annual Turtle Mountain Research Conference
• March 29, 2007
• William L. Freeman, MD, MPH, CIP
• Director of Tribal Community Health Programs
  Human Protections Administrator
• Northwest Indian College http//www.nwic.edu
• Lummi Nation http//www.lummi-nsn.gov
• 2522 Kwina Road
• Bellingham, WA 98226-9217
• 360-392-4284 fax [phone]
  wfreeman_at_nwic.edu
• home PO Box 5293 Bellingham, WA 98227-5293
  360-758-2175

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Hy'shqe siam

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

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What we will discuss

• The 40th anniversary
• The past What has happened since
• The past present What Tribes TCUs and
  partnerships of Tribes and researchers have
  done and are doing
• The future

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40 years ago

• 1967 Director of the Indian Health Service
  IHS developed implemented the policy that
  required approval by the tribal government of all
  research within the jurisdiction of that tribe
• and 31 years ago
• 1976 First article with any communitys
  approval of research "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.

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Recent past good research

• A true experiment using human beings
• many people dislike experimenting on human
  beings, especially American Indian / Alaska
  Native people
• The Diabetes Prevention Program (DPP)
• asked people at high risk to develop diabetes to
  volunteer
• assigned volunteers randomly (like a lottery)
  to usual care, or a diabetes medicine, or
  life-style change
• 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
• had American Indian 171 volunteers

6
Recent past bad research

• Barrow, Alaska study on alcoholism
• 1970s, researchers from northeastern US
• invited by one faction in the community
• announced findings in press conference
• held at their northeastern university
• Effects and outcomes
• internal stigmatization by people from Barrow
  nearby communities
• bonds on Wall Street adversely affected
• Impact of research results?
• no positive change in/by Barrow

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Recent past good bad research - 1

• Congenital syphilis epidemic, 1980s
• reservation not named in publication
• but gave precise 1980 US Census pop.
• Reservation children taunted "Your mama's ..."
• Gas stations refused to let reservation people
  use restrooms

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Recent past good bad research - 2

• 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 CDC helped Navajo Nation Dept. of Health
  (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
• NN approved no research for gt1 year, formed IRB

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Recent past implications of bad, and of good
bad, research

• Major community harm was disruption
• Major individual harm was internal
  self-stigmatization for most examples
• All subsequent research in many of those
  communities was adversely affected
• The problem was publication-dissemination
• NOTE most researchers were well-intentioned
  were trying to help the community

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Past present bad research

• 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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Past present UGLY research

• Havasupai there is more
• concurrently with T2DM study was 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 or IRB review could have prevented
  this!

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Present good research as partnership

• Kwaday Dan Tsinchi - Long Ago Man Found
• Champagne/Aishihik First Nations FN, d.
  1415-1445
• glacier in Tatshenshini-Alsek Park, British
  Columbia BC
• body found 08/99, plan developed, studied to
  12/2000
• returned to the Champagne-Aishihik
• cremated, potlatch, ashes scattered where found
  07/2001
• 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

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Present basic values of IRB regulations

• Respect for persons
• Minimize harms to persons
• Maximize benefits to persons
• Justice for persons
• But the regulations 45 CFR 46 do not cover
• Other Native values
• Other Native concerns

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Present Native values not explicit in the IRB
regulations

• Protection of communities
• Respect for elders knowledge of community
• 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
• tribes themselves should be involved in the
  research

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IRBs and the IRB regulations are good

• Most researchers are more ethical
• IRBs do protect individuals
• The IRB regulations are valuable
• and should be understood and used

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For tribal communities, people, and TCUs

• IRBs the IRB regulations are a floor, but they
  are not a ceiling
• They are necessary and quite valuable, but they
  are not sufficient
• The Havasupai experience shows that relying on
  only another institutions IRB may not protect
  tribes
• And thus, increasingly
• tribes and TCUs protect themselves
• tribes and TCUs promote good research

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Actions by Tribes TCUsto protect themselves

• Have an IRB (Tribal Review Board, per the regs)
• learn about the IRB regulations how to use them
• build beyond the floor of the IRB regulations
• solicit allies from IRBs researchers with
  goodwill
• Have active process to review approve research
• IRBs do not ask, Does the research fit the
  Tribes priorities? but Tribes need to ask
  answer that question
• e.g., Model Tribal Research Code, by the American
  Indian Law Center, Inc.

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Actions to promote good research - 1
science colleagues
science colleagues
science colleagues
science colleagues
science colleagues
Generate protocol
Identify problem
Diagnose problem
Develop plan
Get funds, approvals
science colleagues
science colleagues
science colleagues
science colleagues
science colleagues
Implement protocol
Collect data
Report results
Draft results
Analyze data
Usual process steps of research
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Process steps implement, data, report
science colleagues
science colleagues
science colleagues
science colleagues
science colleagues
Generate protocol
Identify problem
Diagnose problem
Develop plan
Get funds, approvals
science community colleagues
science community colleagues
science colleagues
science colleagues
science community colleagues
co-implement protocol
co-collect data
co-report results
Draft results
Analyze data
(usual, and now expected, process steps of
research in Indian Country)
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Process step co-fund, co-approval
science colleagues
science colleagues
science colleagues
science colleagues
science community colleagues
Generate protocol
Identify problem
Diagnose problem
Develop plan
co-fund, approvals
science community colleagues
science community colleagues
science colleagues
science colleagues
science community colleagues
co-implement protocol
co-collect data
co-report results
Draft results
Analyze data
tribes resources fitness center PXE, Inc
Pseudoxanthoma Elasticum http//www.pxe.org
how to consent before drawing bloods
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Process steps co-analyze data, co-draft results
science colleagues
science colleagues
science colleagues
science colleagues
science community colleagues
co-generate protocol
Identify problem
Diagnose problem
Develop plan
co-fund, approvals
science community colleagues
science community colleagues
science community colleagues
science community colleagues
science community colleagues
co-implement protocol
co-collect data
co-report results
co-draft results
co-analyze data
People Awakening - become healthy vs the way
life is supposed to be (not co-draft 1st 2
hantavirus articles outbreak of congenital
syphilis)
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Process step co-generate protocol
science colleagues
science colleagues
science colleagues
science community colleagues
science community colleagues
co-generate protocol
Identify problem
Diagnose problem
Develop plan
co-fund, approvals
science community colleagues
science community colleagues
science community colleagues
science community colleagues
science community colleagues
co-implement protocol
co-collect data
co-report results
co-draft results
co-analyze data
randomized clinical trial--tribe disapproved 1
arm of 4 analyses by tribes in Spirit of Eagles
led to new epi questions to answer
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Process step -- co-develop plan
science colleagues
science colleagues
science community colleagues
science community colleagues
science community colleagues
co-generate protocol
Identify problem
Diagnose problem
co-develop plan
co-fund, approvals
science community colleagues
science community colleagues
science community colleagues
science community colleagues
science community colleagues
co-implement protocol
co-collect data
co-report results
co-draft results
co-analyze data
Kahnawake--change foods in schools, do not try
to force change in members stores
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Process steps co-identify co-diagnose problem
science community colleagues
science community colleagues
science community colleagues
science community colleagues
science community colleagues
co-generate protocol
co-identify problem
co-diagnose problem
co-develop plan
co-fund, approvals
science community colleagues
science community colleagues
science community colleagues
science community colleagues
science community colleagues
co-implement protocol
co-collect data
co-report results
co-draft results
co-analyze data
social pathologies of alcoholism vs
resiliencies against alcoholism NARCH
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Actions to promote good research - 2
science community colleagues
science community colleagues
science community colleagues
science community colleagues
science community colleagues
co-generate protocol
co-identify problem
co-diagnose problem
co-develop plan
co-fund, approvals
science community colleagues
science community colleagues
science community colleagues
science community colleagues
science community colleagues
co-implement protocol
co-collect data
co-report results
co-draft results
co-analyze data
CBPR in Native communities
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Present-Future Community-Based Participatory
Research (CBPR) - 1

• Producing new knowledge by "systematic inquiry,
  with the collaboration of those affected by the
  issue being studied, for the purposes of
  education and taking action or effecting social
  change."
• Green LW, George MA, Daniel M, Frankish CJ,
  Herbert CJ, Bowie WR, et al. Study of
  Participatory Research in Health Promotion.
  Ottawa The Royal Society of Canada 1994. ISBN
  0-920064-55-8

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Present-Future CBPR - 2

• Based on a mutually respectful partnership of
  researchers and communities
• Involves collaboration, mutual education, and
  acting on results developed from
  community-relevant research questions
• Macaulay AC, Commanda LE, Freeman WL, Gibson N,
  McCabe ML, Robbins CM, Twohig PL, (for the) North
  American Primary Care Research Group.
  Participatory research maximises community and
  lay involvement. BMJ 1999 319774-778
  http//www.bmj.com/cgi/content/full/319/7212/774

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Present-Future CBPR - 3

• Not a dichotomous category -- "yes/no CBPR"
• Same continuum as that of community as Co-I
• Examples suggest CBPR steps are possible even in
  multi-center randomized clinical trials
• CBPR especially in research involving behavior,
  culture, values, beliefs, attitudes, sensitive
  issues
• sensitive pathologies alcoholism, genetics,
  violence ( core strengths resiliencies
  sobriety, relatedness who is family,
  maintaining Native-healthy families)
• including issues outsiders may not consider to be
  sensitive e.g., Navajo place names in
  hantavirus articles

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CBPR community as co-investigator (Co-I)

• CBPR is a continuum, from minimal to maximal
• A story of not listening / listening
• Communities being present vs. being Co-Is
• Possible measures of community as Co-I
• percent of time community Co-Is talk in all
  meetings
• number of times/day scientist Co-Is learn
  something new
• percent of plan/protocol/analysis/report is
  influenced or changed by community Co-Is
• Time consuming! for scientist community Co-Is
• Problem continuity of partner Co-Is and
  concerns
• Sometimes emotional, for both types of Co-Is

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Summary from 40 years past to present

• 1967 The policy was IHSs first action of a
  long-term movement of TCUs tribal communities
  having more control over research
• Since at least 1994, when the Navajo Nation
  formed its own IRB, Tribes TCUs have asserted
  more control in and of research
• More Tribes TCUs protect themselves
• establish their own, effective, IRBs, and
• implement their own code to review approve
  research
• More Tribes TCUs promote good research
• community-based participatory research (CBPR)

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Summary the future?

• My prediction that long-term trend will
  continue
• My prediction Tribes TCUs will drive that
  long-term trend

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Partial scientist bibliography

• Cornwall A, Jewkes R. What is participatory
  research? Soc Sci Med. 1995 41(12)1667-1676.
• Israel BA, et al. Review of community-based
  research assessing partnership approaches to
  improve public health. Annu Rev Public Health.
  1998 19173-202.
• Public Health Practice Program Office, CDC.
  Principles of Community Engagement. Atlanta
  Centers for Disease Control Prevention. 1997.
  http//www.cdc.gov/phppo/pce/index.htm