Ethical violation redesign
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Ethical violation redesign

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Redesign study

Redesign study

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Ethical violation redesign Ethical violation redesign Presentation Transcript

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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