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  • BioEdge: Do prisoners have a right to participate in clinical trials?
    trial were conducted on prisoners The substances to which they were subjected ranged from perfume soap and cosmetics to dioxin psychological warfare agents and radioactive isotopes In the wake of a number of scandalous abuses attitudes have changed so dramatically say the authors that current guidance governing research in prisons nowadays in the UK is too protectionist and restrictive The strongest argument for prisoner participation in research they say is equity prisoners should have access to the same healthcare and research opportunities as other citizens They also cite a moral argument participants may benefit through the moral satisfaction of contributing to society Research contribution can be regarded as a public good As such excluding prisoners denies them the opportunity to make the same moral contribution as free members of society disengaging them from the wider moral community Moreover prisoners may particularly value this as a way to redeem atone and reconcile It no accident that the words to redeem atone and reconcile strike a religious note in an otherwise utilitarian essay They ultimately came from a 1996 article in a journal called Catholic Lawyer in which they were used ironically Prisoners are a highly vulnerable group and in the past they were sometimes horribly exploited by researchers Will this happen again The authors are optimists Times have changed Research is now subject to strict regulations research governance and review all of which act as safeguards against unethical research Surveys have shown that although prison life does influence a decision to participate it is questionable whether such influences constitute coercion MORE ON THESE TOPICS clinical trials informed consent prisoners This article is published by Michael Cook and BioEdge under a Creative Commons licence You may republish it or translate it free of charge with attribution for non commercial purposes following these

    Original URL path: http://www.bioedge.org/bioethics/do_prisoners_have_a_right_to_participate_in_clinical_trials/11036 (2016-02-18)
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  • BioEdge: the latest news and articles about bioethics
    politicians have discovered how to reconcile punishment and compassion allow prisoners on death row to donate their organs Belgium s new death row Michael Cook 19 October 2013 Comments tags Belgium euthanasia prisoners Ten prisoners in Belgian jails have asked for euthanasia Search BioEdge Subscribe to BioEdge newsletter Subscribe to BioEdge RSS feed Recent Posts Dutch psychiatric patients may get euthanasia too easily says US study 14 Feb 2016 A

    Original URL path: http://www.bioedge.org/bioethics/tag/prisoners (2016-02-18)
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  • BioEdge: Were Irish orphans of the 30s used in clinical trials?
    in the files relating to the Department of Local Government and Public Health the Municipal Health Reports relating to Cork and Dublin or the Wellcome Archives in London suggests that vaccine trials would not have been acceptable to government municipal authorities or the general public However the fact that reports of these trials were published in the most prestigious medical journals suggests that this type of human experimentation was largely accepted by medical practitioners and facilitated by authorities in charge of children s residential institutions A spokesman for GlaxoSmithKline the drug conglomerate which has absorbed Burroughs Wellcome said The activities that have been described to us date back over 70 years and if true are clearly very distressing We would need further details to investigate what actually took place but the practices outlined certainly don t reflect how modern clinical trials are carried out We conduct our trials to the same high scientific and ethical standards no matter where in the world they are run The revelations have added fuel to a firestorm of criticism of the Catholic Church s role in Irish society However the truth of the allegations remains to be established Headlines about 800 baby corpses have provided fodder for the speeches of hostile politicians but the more that is known about it the less sinister it appears Something similar could be said about Mr Dwyer s iceberg Drug tests like this were not illegal at the time in Ireland And they were conducted before World War II and the Nuremberg code for human experimentation when governments and doctors were less sensitive to the need for informed consent The notorious Willowbrook hepatitis trials in the US in the 1950s and 1960s were conducted on hundreds of intellectually disabled children an even more vulnerable population long after the

    Original URL path: http://www.bioedge.org/bioethics/were_irish_orphans_of_the_30s_used_in_clinical_trials/11013 (2016-02-18)
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  • BioEdge: Unpublished trial results are “ethical failure”
    authors say that non publication constitutes a failure to honor the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation They point out that ethical standards such as the US government s Common Rule and the Declaration of Helsinki stress the importance of making results available When trial data remain unpublished the societal benefit that may have motivated someone to enroll in a study remains unrealized The study authors examined the outcomes of 585 large randomized trials with at least 500 participants registered with ClinicalTrials gov and completed before January 2009 ClinicalTrials gov is a website that provides easy access to information on clinical studies on a wide range of diseases and conditions Of these 29 had not been published by November 2012 Non publication was more common among trials that received industry funding 32 compared to those without industry funding 18 MORE ON THESE TOPICS clinical trials research ethics This article is published by Michael Cook and BioEdge under a Creative Commons licence You may republish it or translate it free of charge with attribution for non commercial purposes following these guidelines If you teach at a university we ask that

    Original URL path: http://www.bioedge.org/bioethics/unpublished_trial_results_are_ethical_failure/10758 (2016-02-18)
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  • BioEdge: the latest news and articles about bioethics
    central government to ensure that the informed consent of any patients in clinical trial be videotaped Search BioEdge Subscribe to BioEdge newsletter Subscribe to BioEdge RSS feed Recent Posts Dutch psychiatric patients may get euthanasia too easily says US study 14 Feb 2016 A Dutch report applies the brakes on completed life euthanasia 13 Feb 2016 Celebrating 15 years of Dutch euthanasia 13 Feb 2016 Canada s euthanasia courts 13

    Original URL path: http://www.bioedge.org/bioethics/tag/human+research+ethics (2016-02-18)
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  • BioEdge: Another unethical study – this time in NY’s Bowery
    necessarily prolong their lives The failure to provide full informed consent and exposing a vulnerable population to undue risk are disturbing Yet the research was published in leading medical journals and frequently cited joining the long list of unethical studies performed in full public view says Robert Aronowitz the author of a highly critical essay in the American Journal of Public Health The study was started in 1951 by a young urologist Dr Perry Hudson and ran for more than a decade Now 96 and living in Florida Dr Hudson told the New York Times that he believed that the treatments would prolong their lives Even at the time some doctors objected to the research on ethical grounds Among urologists I got called a collection of really fancy names Dr Hudson told Aronowitz I didn t pay any attention to them The people Hudson admired understood what I was doing So I paid no attention to it A retrospectoscope is a clear lens for ethical mistakes But Dr Aronowitz s real target is contemporary screen and treat programs for prostate cancer He says that they too are a mass experiment conducted on ill informed men Ethical tragedies are difficult to recognize in the present They do not necessarily appear in the same guise as past ones Dr Aronowitz writes Future observers may view the massive evidence challenged expansion of our screen and treat paradigm in prostate cancer in the same way as we now view the Bowery series practices See also a similar article in the Bulletin of the History of Medicine MORE ON THESE TOPICS clinical trials informed consent This article is published by Michael Cook and BioEdge under a Creative Commons licence You may republish it or translate it free of charge with attribution for non commercial purposes

    Original URL path: http://www.bioedge.org/bioethics/another_unethical_study_this_time_in_nys_bowery/10730 (2016-02-18)
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  • BioEdge: the latest news and articles about bioethics
    years after the calamitous release of the sedative Thalidomide by the German company Gruenenthal the company has finally issued an apology India wants more compensation for victims of clinical trials Michael Cook 24 August 2012 Comments tags clinical trials India research ethics New rules in India will force pharmaceutical companies to pay higher compensation if patients in clinical trials die or are injured Startling admissions in IVF journal Michael Cook 04 August 2012 Comments tags clinical trials IVF Robert Edwards Some IVF patients are being offered risky unsafe techniques which have not been developed ethically and which offer dubious benefits according to an extraordinary article in the journal Reproductive BioMedicine Online RBO Justice needed for injured research subjects says bioethicist Michael Cook 06 July 2012 Comments tags clinical trials research ethics University of Minnesota bioethicist Carl Elliott has composed a handy primer on how to exploit a research subject in his blog Step 1 Design a risky deceptive or scientifically worthless study Step 2 Injure subjects Step 3 Bankrupt the injured subjects by forcing them to pay for their medical care Panel gives US govt funded clinical research clean bill of health Michael Cook 17 December 2011 Comments tags clinical trials Guatemala US Current rules and regulations provide adequate safeguards to mitigate risk in clinical trial says the Presidential Commission for the Study of Bioethical Issues After a survey of federally sponsored research involving human volunteers after a scandal over highly unethical treatment of Guatemalan patients in the late 1940s by doctors in the Public Health Service Commission basically gave American research a clean bill of health US mothers participate in clinical trials to make ends meet Jared Yee 25 November 2011 Comments tags clinical trials US More cash strapped mums are signing up for clinical trials Questions over clinical trials in India Jared Yee 24 November 2011 Comments tags clinical trials India research Western pharmaceutical companies have pinpointed India as a prime candidate for outsourcing clinical trials due to its population and lax regulations which help slash research costs Panel urges ethics study of testing anthrax vaccine on children Jared Yee 03 November 2011 Comments tags children clinical trials informed consent terrorism Informed consent and the possible threat of terrorist attack have clashed in a debate over whether an anthrax vaccine should be tested on children Are we morally obliged to participate in research Michael Cook 22 October 2011 Comments tags autonomy bioethics clinical trials informed consent Bioethics debates are often robust but it s not every day that they make a reader sick This was the reaction of Professor Bill Gleason of the University of Minnesota Medical School a columnist for the Chronicle of Higher Education He had just attended a seminar at his university Do people have a moral obligation to participate in research The contrarian views of Rosamund Rhodes of Mt Sinai School of Medicine in New York were so unsettling that he needed three beers to come back to earth Interview John D Arras on

    Original URL path: http://www.bioedge.org/bioethics/tag/clinical%20trials/P20 (2016-02-18)
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  • BioEdge: the latest news and articles about bioethics
    trials human rights interviews An interview with the author of The Professional Guinea Pig Nerve wracking times for stem cell investors Michael Cook 04 September 2010 Comments tags clinical trials Geron stem cells Geron prepares for Phase 1 clinical trial Should clinical trials be used as marketing exercises Michael Cook 04 September 2010 Comments tags Big Pharma clinical trials informed consent Death in anti psychotic trial raises disturbing questions UK doctor censured over callous and dishonest trial on children Michael Cook 13 February 2010 Comments tags clinical trials GMC vaccination Andrew Wakefield saga draws to close Should patients be forced to participate in clinical trials Michael Cook 10 December 2009 Comments tags autonomy clinical trials Stem cell scientst calls for mandatory participation DRUG WAS CULPRIT NOT TRIAL DESIGN SAYS REPORT Michael Cook 25 April 2006 Comments tags clinical trials CONSENT FORM FOR DRUG TRIAL DISASTER FLAWED SAY CRITICS Michael Cook 11 April 2006 Comments tags clinical trials DRUG TRIAL CHANGES MOOTED Michael Cook 04 April 2006 Comments tags clinical trials TWO LEAVE HOSPITAL AFTER DRUG TRIAL DISASTER Michael Cook 28 March 2006 Comments tags clinical trials HEALTHY YOUNG MEN NEAR DEATH AFTER DRUG TRIAL Michael Cook 21 March 2006 Comments

    Original URL path: http://www.bioedge.org/bioethics/tag/clinical%20trials/P40 (2016-02-18)
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