IRB Advisor – May 1, 2003
May 1, 2003
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Dana-Farber Cancer Institute goes beyond regs with its QA program
At the Dana-Farber Cancer Institute in Boston, human subjects protection is treated as a quality assurance issue. The institute takes steps to ensure that protections are extended throughout protocols through data monitoring and auditing and is working to improve informed consent through a validated questionnaire. -
IRB members face individual lawsuits
IRBs now have a new legal worry the recent emergence of lawsuits aimed squarely at individual IRB members, rather than just at the institution or the IRB as a whole. -
New FDA drug category proposed by military
A proposal to create a new category of Food and Drug Administration (FDA) licensure for drugs used by the Department of Defense (DoD) against nuclear, biological, and chemical threats has caused a stir in human research circles. -
Research OKs are tricky when dealing with neonates
Its no secret that the process of obtaining informed consent for research involving human subjects is never easy. The process is even more complicated, however, when the proposed study participant is a newborn. -
Spotlight on Compliance: HHS suggests analysis of conflicts of interest
The public is increasingly concerned about the integrity and ethical conduct of research. Now with the release of draft guidance Financial Relationship and Interests in Research Involving Human Subjects: Guidance for Human Subject protection, published on March 31, the discussion will take on greater urgency and importance.