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Science and Institutionalized Ethics: The 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. Acknowledgements
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Science and Institutionalized Ethics:The 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
Acknowledgements Georgia Institute of Technology Sub-Contact for W.K. Kellogg Foundation Grant No. P0099263 entitled, “S&T Policy and Social Capital Project Proposal for W.K. Kellogg Foundation”
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? Science Ethics Scientific Progress ISE
“First, do no harm”: a selected history a series of innovations, catalyzed by crises
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.
Fallout of Hopkins / KKI study [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, ‘there’s lead in this house, and it can cause brain damage.’” -Attorney for the Plaintiff “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 Court’s 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 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?
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.
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 year’s 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?
A Decision Perspective on Science Ethics Institutions Mass Participation Referendum Political Demonstration Numbers Of Participants Institutional Review Board 2005 Principle Investigator 1950’s Principle Investigator Unitary Rule Governance Rule Bound Spontaneous (no fixed rule)
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 1950’s Principle Investigator Unitary Rule Governance Rule Bound Spontaneous (no fixed rule)
The Ethics of Crowds This is Not an IRB
James Surowiecki, The Wisdom of Crowds, New York: Random House, 2004
Appropriate concept from Surowiecki’s (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.
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 jury’s decision will be binding (but a retrial with a different jury is an option after one year has elapsed)
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].
A designated advocate for the study is identified, either nominated or approved by the study’s 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.
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.
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.
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 one’s 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.
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.
