Science and Institutionalized Ethics: The Johns Hopkins Lead Paint Study and its Implications for Protecting Human Subjects

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Science and Institutionalized EthicsThe Johns
Hopkins Lead Paint Study and its Implications for
Protecting Human Subjects

• Barry Bozeman
• and
• Paul Hirsch
• Research Value Mapping Program
• School of Public Policy
• Georgia Tech
• Atlanta, Georgia USA

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• Acknowledgements
• Georgia Institute of Technology Sub-Contact for
  W.K. Kellogg Foundation Grant No. P0099263
  entitled, ST Policy and Social Capital Project
  Proposal for W.K. Kellogg Foundation

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• Analyzing the decision effectiveness
• of Institutionalized Science Ethics
• Do they protect vulnerable populations?
• Do they protect scientists?
• Do they account for the larger social impacts of
  research?

Scientific Progress
Science Ethics
ISE
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First, do no harm a selected history
Crisis Innovation Values (cumulative) Strategy
WWII Crimes against humanity 1946 - 1948 Nuremberg Trial Nuremberg Code -Benefits of research must outweigh risks -Informed consent Hold researchers responsible
1954 / 1964 Declaration of Helsinki -Respect for the individual Independent ethics panel
Tuskegee Syphilis Study 1974 National Research Act (rev. 1991) Belmont Report -Justice -Protect vulnerable populations IRB approval for all HS research
Hopkins / KKI lead paint study Ethics of crowds -Empathy -Social impact Representative science jury
a series of innovations, catalyzed by crises
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Hopkins / KKI Lead Paint Study

• Objective Find the lowest cost method of
  reducing the lead paint exposure of children.
• Method 3 types of lead abatement performed on
  Baltimore rental houses. Frequent measurement of
  blood lead levels in children living in those
  houses
• Results Maryland Appeals Court Slams
  Researchers Participants in Study on Lead Paint
  Weren't Informed of Risks, Judge Says
• The Maryland Court of Appeals' sweeping
  condemnation of lead paint researchers at
  Baltimore's Kennedy Krieger Institute has
  reinforced the rights of research subjects to
  know the risks they face, while tainting the
  prestigious research center by comparing its work
  to the infamous Tuskegee, Ala., experiments that
  withheld treatment to black men infected by
  syphilis.
• -Washington Post, August 21 2001.

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Fallout of Hopkins / KKI study

• Kennedy Krieger cannot understand how a study
  funded by the federal government and in
  compliance with federal regulations can be said
  to be unethical in its design or comparable to
  the atrocities cited in the Courts Opinion i.e.
  Tuskegee.
• -Attorney for KKI
• The impression of everyone doing the study was
  that everyone understood the situation.
• -Gary Goldstein, CEO of KKI

• The IRB is a non-objective house organ
• The researchers intended that the children be
  the canaries in the mines but never clearly told
  the parents.
• Judge Dale R. Cathell and 6 of the 7 judges,
  Maryland Court of Appeals
• The plaintiff, signed the informed consent, but
  no one ever told her, theres lead in this
  house, and it can cause brain damage.
• -Attorney for the Plaintiff

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IRB Standards, Tuskegee, and Hopkins/KKI
Standard Tuskegee Hopkins Comments
Informed consent
Respect for individual
Benefits gt risks
Justice
Protect vulnerable populations
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IRB Standards, Tuskegee, and Hopkins/KKI
Standard Tuskegee Hopkins Comments
Informed consent No Yes, but maybe inadequate How much information? Level of comprehension? Volunteering? Informed consent for children?
Respect for individual
Benefits gt risks
Justice
Protect vulnerable populations
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IRB Standards, Tuskegee, and Hopkins/KKI
Standard Tuskegee Hopkins Comments
Informed consent
Respect for individual Not by todays standards Possibly Recognition of the personal dignity and autonomy of individuals is not easily operationalized perspective matters
Benefits gt risks
Justice
Protect vulnerable populations
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IRB Standards, Tuskegee, and Hopkins/KKI
Standard Tuskegee Hopkins Comments
Informed consent
Respect for individual
Benefits gt risks Judgment call - syphilis was a real problem Judgment call - need for real-life studies Risks and benefits are anticipated Level of analysis? individual subject or larger social groups
Justice
Protect vulnerable populations
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IRB Standards, Tuskegee, and Hopkins/KKI
Standard Tuskegee Hopkins Comments
Informed consent
Respect for individual
Benefits gt risks
Justice Probably not (but affected pop.subject) Possibly, lead paint disproportionately affects low-income children Fair distribution of burdens and benefits hard to measure
Protect vulnerable populations
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IRB Standards, Tuskegee, and Hopkins/KKI
Standard Tuskegee Hopkins Comments
Informed consent
Respect for individual
Benefits gt risks
Justice
Protect vulnerable populations No (but did not infect subjects) Met EPA standards but included active exposure of children Research done against an inequitable background - does the fact that exposure wouldve occurred justify the methods?
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Standard Tuskegee Hopkins Comments
Informed consent No Yes, but maybe inadequate How much information? Level of comprehension? Volunteering? Informed consent for children?
Respect for individual Not by todays standards Possibly Recognition of the personal dignity and autonomy of individuals is not easily operationalized perspective matters
Benefits gt risks Judgment call - syphilis was a real problem Judgment call - need for real-life studies Risks and benefits are anticipated Level of analysis? individual subject or larger social groups
Justice Probably not (but affected pop.subject) Possibly, lead paint disproportionately affects low-income children Fair distribution of burdens and benefits hard to measure
Protect vulnerable populations No (but did not infect subjects) Met EPA standards but included active exposure of children Research done against an inequitable background - does the fact that exposure wouldve occurred justify the methods?
Additional values Empathy? Personal Consequence?
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• The Key to the KKI Case- Recruiting Landlords to
  rent to families with children in order to ensure
  lead paint exposure. This implies..
• The need for empathy and consequence
• But we do not have science ethics institutions
  that insure empathy or that promote trust
• What would such an institution look like?

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All Rules are Behavior Forecasts

• Can we patch things up with more rules? A simple
  example
• Assume there is a desire to protect the
  confidentiality of research subjects. Rule all
  subjects records must be destroyed at the end of
  a research study.
• The causal reasoning in this case seems simple
  enough The study ends two years after the
  final collection of the data (providing
  sufficient time to write papers and
  dissertations) At the end of that period,
  research assistants will be ordered to destroy
  the centrally housed data, as will all persons
  who have possession of the data.
• Behavior Forecast
• Researchers will know the rule and abide by it,
• 2. The records will be destroyed
• Therefore,
• 3. Confidentiality will be preserved.

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Just a few possibilities
Confidentiality pertains to more than subjects
records for example, it may also pertain to
researchers and subjects willingness to talk to
others about their experiences. Confidentiality
may be inferred from studies, whether or not the
records are reported or otherwise used the
context of use may identify individuals Is two
years use after the data are collected
sufficient protection? When does the data
collection end? What constitutes and
end? What were the rules about data
distribution? Is it known who has the data? Will
those who have the data comply with the edict to
destroy the data? How will we know if they have
complied? Will data destruction be technically
adequate? Will data continue to survive on the
sectors of hard drives or in computer recycle
bins? What exactly is the study data? What is
part of the study data and what is not part of
it?
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A Decision Perspective on Science Ethics
Institutions
Mass Participation
Referendum
Political Demonstration
Numbers Of Participants
Institutional Review Board
2005 Principle Investigator
1950s Principle Investigator
Unitary
Rule Governance
Rule Bound
Spontaneous (no fixed rule)
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A Decision Perspective on Science Ethics
Institutions
Mass Participation
Referendum
Political Demonstration
Ethics of Crowds Science Jury
Numbers Of Participants
Institutional Review Board
2005 Principle Investigator
1950s Principle Investigator
Unitary
Rule Governance
Rule Bound
Spontaneous (no fixed rule)
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The Ethics of Crowds
This is Not an IRB
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James Surowiecki, The Wisdom of Crowds, New York
Random House, 2004
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• Appropriate concept from Surowieckis (2004)
  Wisdom of Crowds,
• argues that very large groups of people are
  likely to make better decisions and better
  forecasts than small groups of experts
• We do not agree that large groups necessarily
  make better forecasts. Our case is that a large
  representative group makes better ethical
  decisions due to its legitimacy. The source of
  the legitimacy is empathy and consequence.

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• The Ethics of Crowds Approach A Science Ethics
  Jury
• Objective Develop valid assessment of (1)
  acceptability of threat to a population
  (vulnerable or not) (2) risk-benefit from a
  study or project.
• Assumptions
• The results will be valid because of the
  representativeness and participation of the
  science jury
• The deliberations will mimic the proceedings of
  a trial, including both a plaintiff (advocate)
  team and a defense (opponent) team of experts.
• The jurys decision will be binding (but a
  retrial with a different jury is an option after
  one year has elapsed)

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Science Jury Procedures

• Before the research is authorized , develop an
  initial statement about the project, its ethical
  suitability, its procedures and benefits (much as
  an IRB form).
• The Court uses the initial statement to develop
  a science jury. The science jury is a group
  of people, about 25-30, who could be subjects for
  they study. The group should be as
  representative as possible of the putative study
  population. Either random of stratified sampling
  could be used depending of the nature of the
  population.
• A science jury is recruited using pay incentives
  and appeals to group and public interest.
  Sampling adjustment techniques can be used to
  minimize selection effects.

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• A designated advocate for the study is
  identified, either nominated or approved by the
  studys PI
• A designated opponent of the study is appointed
  by the court
• The comparison group is instructed that the
  overarching criterion is would I participate in
  this study or would I permit a loved-one to
  participate in this study
• Let the games begin! The advocate makes the best
  case possible for the conduct of the research,
  including bringing witnesses if desired. The
  opponent makes the best case against the
  research, using witnesses if desired. Cross
  examination is permitted. Unlike normal juries,
  the science jury can directly ask questions of
  all witnesses, advocates and opponents.

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Results

• The science jury decides whether the research
  is permissible as proposed, whether it would be
  permissible with modification, or whether it is
  in some respect sufficiently objectionable as to
  not be permissible. These decisions are reached
  by discussion and, if necessary, multiple votes.
  A court official observes and writes the
  opinion of the jury.

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The Spirit of the Ethics of Crowds

• A recognition that scientists have less authority
  to make value judgments about harm and benefit
  than does a group of people having attributes
  identical to or similar to the intended human
  subjects
• A recognition that the most important decisions
  about research ethics will be improved by
  deliberation and, in some cases, by dialectic,
  rather than the erratic application of
  necessarily general rules
• A recognition that standards and judgments are
  fluid and changeable
• A recognition of the intrinsic authority of
  communities, at least when persons from a
  recognizable community are intended to either
  suffer a differential burden or sustain a
  differential benefit.

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Questions? Yes!

• Q What about the cost!?!
• A This is not a procedure to be used with
  ever study. Perhaps some of the costs can be
  offset by limiting the more ridiculous IRB
  reviews being undertaken for studies that have
  near zero likelihood of harm.
• Q But how would one know when to use these
  extraordinary measures?
• A Wise researchers could request them when they
  are undertaking controversial work. So could
  government agencies and research institutions.
• Q How will poorly educated, economically
  disadvantaged people have the knowledge to make
  sound decisions?
• A A Ph.D. does not make anyone more ethical and
  it does not make ones values more sensitive and
  refined. An appropriate crowd, that is, one in
  the same environment and potentially facing the
  same risks as the would-be subjects, can provide
  the most valid answer to the should this harm be
  permitted for this benefit? question. Moreover,
  if they do not understand the study, then
  informed consent is not possible.

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Finally,

• The science jury system will not be perfect. But
  it will endow decisions with greater legitimacy
  and it may promote trust.
• Ordinary people will learn something about what
  often seems a black art, and scientists will
  learn something about ordinary people- outside
  the courtroom, that is.