IRB Advisor – December 1, 2011
December 1, 2011
View Issues
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Some see including minorities in CR as an IRB/ethical CR responsibility
Research ethicists and others have long described the value of recruiting more minorities in clinical research (CR) trials, but the question is whether or not IRBs have a role to play in advancing this goal. -
Compliance Corner: IRB has CR sites correct errors with action plans
IRBs and research offices need a variety of procedures and tools to ensure compliance. One tool that sometimes is overlooked is requiring research sites to develop corrective action plans (CAPs) when they have problems. -
Lean process QI plan can work well for IRBs
Most major corporations and business sectors have adopted business quality improvement (QI) measures like Six Sigma, Lean Process, and others. But in human subjects research, this type of QI approach is fairly new, an expert says. -
IC experts advocate improvements to process
In the proposed revision of the Common Rule, the Department of Health and Human Services (HHS) responds to years of complaints about informed consent documents that they're too long, too complicated, too full of boilerplate and risk management language. -
AAHRPP says regulators need more information
In assessing the recent revisions to the Common Rule proposed by the Department of Health and Human Services (HHS), the accrediting agency for human subjects protection programs suggests that HHS may lack the necessary information to move forward with a final rule. -
Groups finding common ground on Common Rule
In the waning days of the comment period for the advance notice of proposed rule-making (ANPRM) for human subjects protection regulation, some of the IRB community's heavy hitters have weighed in. -
Dispatching CARs to inform the public
When investigators seek an exception from informed consent (EFIC) for emergency research, they must show that they have engaged in community consultation and public disclosure, informing the public that they may encounter an experimental intervention while being treated in an emergency setting.