Literature DB >> 22497093

Recovering from research: a no-fault proposal to compensate injured research participants.

Elizabeth R Pike1.   

Abstract

National advisory committees have considered the obligations owed to research participants in the event of research-related injuries. These committees have repeatedly concluded that injured research participants are entitled to compensation for their injuries, that the tort system provides inadequate remedies, and that the United States should adopt no-fault compensation. But because the advisory committees have made no concrete proposals and have taken no steps toward implementing no-fault compensation, the United States continues to rely on the tort system to compensate injured research participants. This Article argues that recent legal developments and a transformation in the global research landscape make maintaining the status quo morally indefensible and practically unsustainable. Recent legal developments exacerbate the longstanding difficulties associated with the tort system as a method of compensation; nearly every injured research participant will have difficulty recovering damages, and certain classes of injured research participants--those in federal research and those abroad--are prevented from recovering altogether, resulting in substantial unfairness. In the past ten years, many of the countries substantially involved in research have mandated systematic compensation. By not mandating compensation, the United States has become a moral outlier and risks having its noncompliant research embargoed by foreign ethics committees, thereby delaying important biomedical advances. This Article examines alternative compensation mechanisms and offers a concrete no-fault compensation proposal built on systems already in place. The proposed system can be implemented in the United States and countries around the world to help harmonize various national compensation systems and to more equitably and effectively make those injured by research whole.

Entities:  

Mesh:

Year:  2012        PMID: 22497093     DOI: 10.1177/009885881203800101

Source DB:  PubMed          Journal:  Am J Law Med        ISSN: 0098-8588


  11 in total

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Authors:  Matt Lamkin; Carl Elliott
Journal:  J Law Med Ethics       Date:  2018-03-27       Impact factor: 1.718

2.  Finding Fault? Exploring Legal Duties to Return Incidental Findings in Genomic Research.

Authors:  Elizabeth R Pike; Karen H Rothenberg; Benjamin E Berkman
Journal:  Georgetown Law J       Date:  2014

3.  Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics.

Authors:  Susan M Wolf; Pilar N Ossorio; Susan A Berry; Henry T Greely; Amy L McGuire; Michelle A Penny; Sharon F Terry
Journal:  J Law Med Ethics       Date:  2020-03       Impact factor: 1.718

4.  The unintended implications of blurring the line between research and clinical care in a genomic age.

Authors:  Benjamin E Berkman; Sara Chandros Hull; Lisa Eckstein
Journal:  Per Med       Date:  2014       Impact factor: 2.512

5.  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

6.  Research-related injury compensation policies of U.S. research institutions.

Authors:  David B Resnik; Efthimios Parasidis; Kelly Carroll; Jennifer M Evans; Elizabeth R Pike; Grace E Kissling
Journal:  IRB       Date:  2014 Jan-Feb

7.  Food and beverage policies and public health ethics.

Authors:  David B Resnik
Journal:  Health Care Anal       Date:  2015-06

8.  Injury and death in clinical trials and compensation: Rule 122 DAB.

Authors:  Ravindra B Ghooi
Journal:  Perspect Clin Res       Date:  2013-10

9.  Insurance in clinical research.

Authors:  Ravindra B Ghooi; Deepa Divekar
Journal:  Perspect Clin Res       Date:  2014-10

10.  Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa.

Authors:  George Rugare Chingarande; Keymanthri Moodley
Journal:  BMC Med Ethics       Date:  2018-02-17       Impact factor: 2.652

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