IRB Advisor – December 1, 2003
December 1, 2003
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New HHS research committee plans to clarify and define some regulations
IRBs and the research community soon may have new guidance in defining and clarifying some of the gray areas in regulations of human subject protection. -
Committee looking at 407 review process
IRBs and research institutions may have some disagreement and confusion over when its appropriate to send a pediatric research proposal to the Department of Health and Human Services (HHS) for a 407 review. -
Advocates say, ‘Give back to community that gives’
For more than two centuries, the small communities that make up the Canadian province of Newfoundland and Labrador, on the countrys most northeastern coast, were largely isolated from the rest of the world. -
Institutional, QI projects may require IRB review
As awareness of IRBs and human subjects research protection increases among the public and staff at institutions, IRB members sometimes are asked to consider new gray areas regarding studies that typically havent made it to the IRBs radar screen. -
Secondary subjects still need IRB consideration
It has been five years since a complaint from the father of a study subject was lodged about a longitudinal study at Virginia Commonwealth University (VCU) in Richmond a complaint that precipitated a shutdown of all research involving human subjects. -
IRB members should be knowledgeable, diverse
Question: Does the Food and Drug Administration require that an IRB have a certain number of members? -
Biotech ethics focus of President’s Council
A document exploring the implications of using biotechnical powers for reasons beyond therapy takes up controversial issues such as the prospect of creating designer babies and questions whether such scientific advances are possible and ethical.