NCPA - National Center for Policy Analysis

Report Recommends Better Protections for Human Subjects in Clinical Trials

October 4, 2002

The Institute of Medicine, part of the National Academy of Sciences, wants more safeguards for people involved in clinical trials of new prescription drugs. It favors strengthening the oversight of federal regulators in trials conducted by both public and private institutions.

Specifically, it recommends:

  • Extending federal patient-protection standards to any research on human subjects.
  • Establishing a compensation system for research participants if they are injured during a study.
  • Revising consent forms presented to research participants to focus on communicating risks of the trial -- rather than focusing on protecting the institution or the researchers from potential liability.
  • Passing legislation requiring all research to abide by what is known as the Common Rule -- a set of patient-protection principles currently only used in federally funded research.

The report was commissioned by the Department of Health and Human Services after the death of an 18-year-old subject in a 1999 gene therapy trial at the University of Pennsylvania, an incident that heightened concern about oversight of research involving humans.

Source: Sarah Lueck, "Humans in Clinical Trials Need Better Protections, Report Says," Wall Street Journal, October 4, 2002; Daniel D. Federman, Kathi E. Hanna and Laura Lyman Rodriguez, Editors, "Responsible Research: A Systems Approach to Protecting Research Participants," Committee on Assessing the System for Protecting Human Research Participants, Institute of Medicine.

For text (WSJ subscribers)

http://online.wsj.com/articles/SB1033666248887494713.djm

For report

http://www.nap.edu/books/0309084881/html/

 

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