Science and Institutionalized Ethics: The Johns Hopkins Lead Paint Study and its Implications for...

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”

ISE

Scientific ProgressScience Ethics

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?

“First, do no harm”: a selected history

a series of innovations, catalyzed by crises

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”

Hopkins / KKI Lead Paint StudyObjective: 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

IRB Standards, Tuskegee, and Hopkins/KKIStandard Tuskegee Hopkins CommentsInformed consent

Respect for individual

Benefits > risks

Justice

Protect vulnerable populations


No Yes, but maybe inadequate

How much information? Level of comprehension? “Volunteering”? Informed consent for children?


Benefits > risks

Justice




Not by today’s standards

Possibly “Recognition of the personal dignity and autonomy of individuals” is not easily operationalized; perspective matters

Benefits > risks

Justice




Benefits > 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




Benefits > 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




Benefits > risks

Justice


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 would’ve occurred justify the methods?

Standard Tuskegee Hopkins CommentsInformed consent

No Yes, but maybe inadequate

How much information? Level of comprehension? “Volunteering”? Informed consent for children?


Not by today’s standards

Possibly “Recognition of the personal dignity and autonomy of individuals” is not easily operationalized; perspective matters

Benefits > 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


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 would’ve occurred justify the methods?

Additional values: Empathy? Personal Consequence?

• 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 ForecastsCan 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:

1. Researchers will know the rule and abide by it,

2. The records will be destroyed;

Therefore,

3. Confidentiality will be preserved.

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?

Just a few possibilities:

NumbersOfParticipants

MassParticipation

Unitary

Rule Governance Spontaneous(no fixed rule)

Rule Bound

PoliticalDemonstration

Referendum

InstitutionalReview Board

1950’s Principle Investigator

2005Principle Investigator

A Decision Perspective on Science Ethics Institutions

NumbersOfParticipants

MassParticipation

Unitary

Rule Governance Spontaneous(no fixed rule)

Rule Bound

PoliticalDemonstration

Referendum

“Ethics of Crowds”Science Jury

InstitutionalReview Board

1950’s Principle Investigator

2005Principle Investigator

A Decision Perspective on Science Ethics Institutions

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)

(1) Before the research is authorized , develop an initial statement about the project, its ethical suitability, its procedures and benefits (much as an IRB form).

(2) “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.

(3) 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].

Science Jury Procedures

• 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.

Science and Institutionalized Ethics: The Johns Hopkins Lead Paint Study and its Implications for...

Documents

Transcript of Science and Institutionalized Ethics: The Johns Hopkins Lead Paint Study and its Implications for...