Revolution or reform in human subjects research oversight

J Law Med Ethics. 2012 Winter;40(4):922-9. doi: 10.1111/j.1748-720X.2012.00721.x.

Abstract

The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review-and-comment, to the current review-and-approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Confidentiality / legislation & jurisprudence
  • Cost-Benefit Analysis
  • Efficiency, Organizational
  • Ethics Committees, Research / economics
  • Ethics Committees, Research / organization & administration*
  • Guideline Adherence / economics
  • Guideline Adherence / organization & administration
  • Human Experimentation / ethics*
  • Humans
  • Informed Consent / legislation & jurisprudence
  • Models, Organizational
  • United States