Literature DB >> 12834317

The rise of litigation in human subjects research.

Michelle M Mello1, David M Studdert, Troyen A Brennan.   

Abstract

Owing to widespread public concern about the adequacy of protections for human research subjects and recent instances of serious injury to subjects at several major research institutions, lawsuits against investigators, institutional review boards, and academic institutions are becoming increasingly common. Several claim-promoting conditions are ripe to promote the further growth of this litigation and raise the stakes for research institutions. While this litigation may serve a valuable compensation function for injured subjects, it will also have profound effects on institutional review boards, leading to a more legalistic, mechanistic approach to ethical review that does not further the interests of human subjects or scientific progress.

Entities:  

Keywords:  Biomedical and Behavioral Research; Legal Approach

Mesh:

Year:  2003        PMID: 12834317     DOI: 10.7326/0003-4819-139-1-200307010-00011

Source DB:  PubMed          Journal:  Ann Intern Med        ISSN: 0003-4819            Impact factor:   25.391


  13 in total

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Review 3.  Evidence-based ethics for neurology and psychiatry research.

Authors:  Scott Y H Kim
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5.  Addressing risks to advance mental health research.

Authors:  Ana S Iltis; Sahana Misra; Laura B Dunn; Gregory K Brown; Amy Campbell; Sarah A Earll; Anne Glowinski; Whitney B Hadley; Ronald Pies; James M Dubois
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6.  Confronting the therapeutic misconception.

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7.  Legal and ethical values in the resolution of research-related disputes: how can IRBS respond to participant complaints?

Authors:  Kristen Underhill
Journal:  J Empir Res Hum Res Ethics       Date:  2014-02       Impact factor: 1.742

8.  Why are peer review outcomes less favorable for clinical science than for basic science grant applications?

Authors:  Michael R Martin; Teresa Lindquist; Theodore A Kotchen
Journal:  Am J Med       Date:  2008-07       Impact factor: 4.965

Review 9.  Managing incidental findings in human subjects research: analysis and recommendations.

Authors:  Susan M Wolf; Frances P Lawrenz; Charles A Nelson; Jeffrey P Kahn; Mildred K Cho; Ellen Wright Clayton; Joel G Fletcher; Michael K Georgieff; Dale Hammerschmidt; Kathy Hudson; Judy Illes; Vivek Kapur; Moira A Keane; Barbara A Koenig; Bonnie S Leroy; Elizabeth G McFarland; Jordan Paradise; Lisa S Parker; Sharon F Terry; Brian Van Ness; Benjamin S Wilfond
Journal:  J Law Med Ethics       Date:  2008       Impact factor: 1.718

Review 10.  The law of incidental findings in human subjects research: establishing researchers' duties.

Authors:  Susan M Wolf; Jordan Paradise; Charlisse Caga-anan
Journal:  J Law Med Ethics       Date:  2008       Impact factor: 1.718

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