Redesign study

2. Primary Focus & Who Benefits
 The primary focus of this study was to test skin care
lotions and creams for effectiveness
 Inmates’ skin was exposed to several untested
lotions/creams for 30 days
 Tested areas were exposed to sunlamps
 Because of the repeated exposures inmates developed a
“patchwork” design on their skin
 The general population were the intended
beneficiaries of the knowledge gained from this study

3. Ethical Violations
 Prisoners
 Do not have the ability to exercise free choice
 Self-determination
 Subjects did not have the ability to opt out of the study
 Coercion
 Inmates were offered substantial amounts of money that would
entice them to participate and overlook the risks involved
 Insufficient protection against harm
 It does not appear that the products were tested on animals first
to ensure that the products were safe for humans

4. Should this study have been
conducted?
NO!!!
 The subjects, prison inmates, are part of a vulnerable
population and without any safeguards there is a risk
of them being taken advantage of
 The risks of blisters and burns could eventually lead
to long-term healthcare risks for the subjects

5. Should the data be used?
NO!!!!
 This data was collected in an unethical manner
 Prisoners cannot give informed consent because they
cannot exercise free choice
 There was no evidence given - the risk of harm of this
study outweigh the benefits to the subjects

6. Implications for Professionals
 The ethics violations in this study brought criticism
upon the investigators involved
 Unethical studies shed a negative light on research
studies in general and can bring shame to other
professionals
 An unethical study could cause reduced participation in
future studies
 The American Civil Liberties Union proposed 11
guidelines for the recruitment of prisoners into medical
research

7. Implications for Professionals
ACLU Guidelines
 All consents obtained for the purposes of any form of experimentation
must be informed consents.
 It is the responsibility of the researcher to make sure that the
prospective volunteer is in the proper physical and (when relevant)
mental condition to undertake the experiment.
 Waiver forms or exculpatory language in the consent document must
be banned.
 Researchers must be required to carry insurance providing total
coverage for subjects adversely affected by the experiment, and for
compensation of the family or next of kin in case of death.
 Prisoner-volunteers must be paid at a scale commensurate with what
the researcher would offer “free world” volunteers as compensation.
 Prisoners should not be promised reduced sentences or favorable
consideration for parole in return for participation in a clinical
experiment.

8. Implications for Professionals
ACLU Guidelines Cont.
Assurances must be made and enforced that the experiment will
be carried out in a manner that does not necessarily threaten the
lives or safety of the prison-volunteers.
Subject to requirement number 6, no report or records of the
prisoners’ participation in the experiments should be released to
anyone by the researcher or by prison authorities without the
signed consent of the prisoners.
A supervisory committee, independent of prison authorities, the
researcher, and the sponsors of the research, must be established
to review and oversee all experimentation conducted in prisons.
The sponsors of prison research (drug companies, foundations,
or whoever) must pay reasonable sums for the privilege of having
access to the inmate population for research purposes.
Prison authorities' should immediately undertake to provide
greater opportunities to work and earn money

9. Implications for Subjects
 There was no therapeutic benefit to the subjects
 Subjects were faced with health risks, both physical &
emotional
 By allowing research to conducted in this manner it opens
the inmate population to possible future exploitation
 Sexual assaults increased in the prison system as a result of
the influx of money
 Prison administrators used removal from the study as a
means of control over the inmates
 Prisoners might not have access to timely healthcare
services

10. Study Redesign
 Do not use prison inmates as subjects; instead use
general population, using a post test only with random
assignment
 Make sure that subjects give informed consent
 Ensure that subjects are aware of all risks & dangers
 Ensure that subjects can opt out whenever they would
like