IRB Advisor articles from March 2007

IRB Advisor archives from March 2007

OHRP has new guidelines for reporting unanticipated problems.
March 1, 2007... OHRP has new guidelines for reporting unanticipated problems AEs and UPs are separate entities The Office for Human Research Protections (OHRP) of Rockville, MD, published, on Jan. 18, 2007, its final version of new guidelines on...

Study participant discusses risks, benefits.
March 1, 2007... Study participant discusses risks, benefits She was diagnosed with rare, progressive disease Weighing risks and benefits in human subjects research can be an objective, clinical process, unless the person who is measuring is also a...

Improve management by using practice strategies.
March 1, 2007... Improve management by using practice strategies Expert offers tips in a nutshell IRB offices require skilled, dedicated, hard-working staff, and it's not always easy to find the right people for the available jobs. Through years...

IRBs combine to better use resources, expertise.
March 1, 2007... IRBs combine to better use resources, expertise Ensure social-behavioral researchers aren't in the cold As many IRBs rethink their organizational structure to provide for more efficient review, some decide the time is right to create a...

Placebo trials require special care by IRBs.
March 1, 2007... Placebo trials require special care by IRBs Standard of care, crafting informed consent are key Many IRBs rethink their organizational structure to provide for more efficient review; some decide the time is right to create a second IRB...

CE/CME objectives/questions.
March 1, 2007... CE/CME Objectives The CE/CME objectives for IRB Advisor are to help physicians and nurses be able to: *establish clinical trial programs using accepted ethical principles for human subject protection; *apply the mandated...