Originally Published MX July/August
2002

GOVERNMENTAL &
LEGAL AFFAIRS

Human-Subject
Protection in Congress Today

The safety of human
research subjects is getting congressional attention again, with both houses
considering the tightening of existing protections.

On April 23, 2002,
the Senate Committee on Health, Education, Labor, and Pensions held a hearing
entitled "Protecting Human Subjects in Research: Are Current Safeguards
Adequate?" Witnesses suggested many potential improvements to the systems
in place, including:

• Preempting state
  and local human-subject protections by a single, uniform federal standard.
  
  
• Requiring investigators
  to fully disclose financial and other conflicts of interest to IRBs and prospective
  study subjects.
  
  
• Imposing higher
  standards of accountability on IRBs, and stronger requirements for certification.
  
  
• Considering
  a new framework for research review based on the risk of the research.
  
  
• Centralizing
  responsibility for the federal oversight of human-subject protection in a
  single independent office.

The House of Representatives