The blog of the Presidential Commission for the Study of Bioethical Issues

Panel recommends compensation for research injuries

An international expert panel today issued five recommendations to the Presidential Commission for the Study of Bioethical Issues on the effectiveness of current federal rules and international standards for research involving human subjects. One of the five was a recommendation that the U.S. government should implement a system to compensate research subjects for research-related injuries. No system currently exists.

The International Research Panel, whose recommendations are advisory and will help inform the Commission’s report to President Obama expected late this year, did not recommend a specific model of compensation, although it did mention the U.S. National Vaccine Injury Compensation Program, a no-fault alternative to the traditional tort system that compensates people found to be injured by vaccines.

“The international panel felt strongly that the U.S. was an outlier in not specifying any system of compensation for research subjects, other than you get a lawyer and you sue,” said Dr. Amy Gutmann, Chair of the Commission and President of the University of Pennsylvania. Gutmann chaired the international panel.

Many European countries legally require sponsors and investigators to carry indemnity insurance for research-related injuries. In India, bioethics committees ensure that research sponsors pay compensation for participants injured in research. Brazil’s regulations similarly ensure that research sponsors pay such compensation.

The Panel’s other recommendations were:

  • Researchers must demonstrate respect for human subjects and their communities in all phases of clinical trial design and implementation. One important part of this is through community engagement to achieve a “partnership in achieving research goals.” Community engagement  “is a microphone from the community to the researchers” on issues related to the research, said Dr. Nelson Michael, Director of the Division of Retrovirology at the Walter Reed Army Institute of Research and Director of the U.S. Military HIV Research Program.
  • Funders of human subjects research should support ethics training for investigators and others, including members of Institutional Review Boards. Training should address rules, standards, and practices, as well as the ethical principles underlying them.
  • Greater efforts are needed to enhance transparency, monitor ongoing research, and hold researchers and institutions responsible and accountable to violations of applicable rules, standards, and practices. Governments should consider requiring all greater than minimal risk research to be registered and results reported.
  • Continued efforts to harmonize and guide interpretation of rules should be made a priority over creating new rules. Clear, sound, and streamlined rules can produce efficiencies and promote quality.

The Panel, which was formed in March, was established to advise the Commission on the effectiveness of current federal rules and international standards for research involving human subjects. It met three times in Philadelphia, London, and Washington.

The Panel members included experts on medical ethics, science and clinical research and hailed from 10 countries, including Argentina, Brazil, China, Egypt, Guatemala, India, Russia, Uganda, Belgium, and the United States.

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2 Comments to Panel recommends compensation for research injuries

  1. August 30, 2011 at 7:20 pm | Permalink

    In 1947, The Journal of the American Medical Association published the Nuremberg Code requiring patients’ consent—a response to Nazi experiments. “We had enough ethics in the air and in society that would have instructed the Guatemala researchers to do differently than they did,” said commission member Anita Allen, a law professor at Penn…’

    What kind of ethics are in the air and in society today? I think the panel should take along hard look at what’s going on in Baltimore: Hastings Bioethics Center Forum:

  2. s s narayanan's Gravatar s s narayanan
    September 1, 2011 at 5:04 am | Permalink

    Also the indemnity & Insurance protection must be available to the subject at the time of occurrence of the adverse event, irrespective of the fact whether the trial in question is current or already completed, and the validity of the insurance policy should not affect the entitlement.

    We also need to ensure that, in the event of an Injury resulting from the clinical trial, the compensation computed is realistic and is related to the economic potential / prospects of the subject. In other words, apart from making insurance protection mandatory (ie., NO FAULT) for all subjects opting for clinical trials the economic damage caused by the injury as well as the loss of quality of life to the subject as well as to the dependents should be adequately compensated.

  1. By on August 30, 2011 at 10:38 pm

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