Ethical issues in selection of research subjects Bernard Lo, M.D. July 28, 2001.
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Transcript of Ethical issues in selection of research subjects Bernard Lo, M.D. July 28, 2001.
Is it care rather than research?
Potentially life-saving intervention
Liver transplant is standard care in
other clinical settings
Transplant may be available outside
trial
Different selection priorities
In clinical care Well-being of individual patient paramount Priority to those in greatest medical urgency
In research Benefits/risks uncertain Generalizable knowledge also a goal Priority to most appropriate to answer research
question
Proof of concept
Is intervention efficacious in optimal
circumstances?
Negative study is definitive
Positive study needs follow-up in
broader population
Generalizability
Is intervention effective in ordinary
practice?
Need larger sample size
Positive study is definitive
Negative study may be due to selection
Subject selection for different research questions
If proof of concept Select those with best prognosis after Tx Exclude those with poorer or uncertain
prognosis
If generalizability Select those representative of population
Risk to health care workers?
Persons with high viral titers whose
liver disease precludes HAART
If no resistance, likely to respond to
HAART after Tx
Risk to health care workers?
Needlesticks during operation
Risk to HCWs is greater if higher titer
Ethical obligation to provide standard
care, even at risk to self, but not
experimental care?
Characteristics of ethical dilemma
Strong arguments for different
positions
Reasonable people may disagree
Should HIV+ persons be given a scarce resource?
How should scarce organs be allocated?
Bernard Lo, M.D.
July 29, 2001
Reaction to Mickey Mantle
“With each crack of the bat, Mickey
Mantle allowed us to dream. For one
moment forget about everything else.”
Reaction to Mickey Mantle
“Had my sister been a start baseball
player perhaps she would be alive
today… Unfortunately, her only claim
to fame was that she was a loving wife
and mother.”
Reaction to Mickey Mantle
“I have lost three relatives to liver failure
… None were given the preferential
treatment he received… My only hope
is that he doesn’t take advantage of his
brand-new liver and revert to his old
ways.”
Principles of “fair” allocation
Those with greatest medical urgency
Those most likely to benefit Exclude those unlikely to benefit
Those with greatest medical urgency
Rescue those in greatest need Probability of death Likelihood of good outcome after Tx
Those most likely to benefit
Help the greatest number of patients
Groups with similar outcomes should
have similar priority Need outcomes data
Arguments over data, not principle
May conflict with medical urgency
Exclude those unlikely to benefit
Medical Too sick: sepsis, other organ failure Too healthy: survive without Tx
Poor adherence Active substance abuse Poor social support Possibility of bias
Principles of “fair” allocation
Those with greatest medical urgency
Those most likely to benefit Exclude those unlikely to benefit
Those who waited longest
Exclude those who cannot pay
Those who are “unworthy”?
Favor those who are “worthy”?
Past contributions to society
Future contributions to society
Traditional social/cultural values
Exclude those who are “unworthy”?
Behaviors that lead to illness
Groups stigmatized or marginalized
Public willingness to donate organs
History of early renal dialysis