-
Critics and supporters both have weighed in on recent standard of care guidance published by the Office for Human Research Protections (OHRP).
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
The way investigators, research institutions, and IRBs handle incidental findings has evolved in recent years, with a consensus now forming around the belief that research sites have an ethical responsibility when it comes to reporting certain incidental findings to research subjects.
-
Many research institutions now have quality assurance/improvement projects that include research site audits or quality checks. But how many have thought about performing such a quality check on the IRB's work?