Browse Compliance Articles by Topic

Military IRBs May Err on the Side of Bureaucracy

Military IRBs may “err on the side of bureaucracy,” but the delays can place unnecessary burdens and risks on human research subjects.

Clinical Trials: More is Not Necessarily Better

While one may reasonably assume that more clinical research could increase the likelihood of medical breakthroughs, a contrarian’s view is that the effect could be quite the opposite — and it falls to IRBs to intervene and reduce the risks of the current glut of trials.

Inexact Science: The Complicated Quest To Replicate Research

A deeper look into the actual mechanics necessary to reproduce a trial reveals a process that is beset by variables that make clear conclusions difficult.

Strategies to Better Manage Noncompliance

The IRB at the Biomedical Research Alliance of New York in Lake Success, NY, noticed a problematic trend of researchers amending their studies in the continuing review reports.

Final Common Rule Is An Improvement, But Leaves Some Questions Unanswered

There were many changes between the Notice of Proposed Rulemaking and the final rule, and even more changes since the Advanced Notice of Proposed Rulemaking, which is a good thing, IRB experts say.

Common Rule Change Took Six Years to Complete — And Could Be Upended in 30 Seconds

After six years of debate, criticism, and waiting, the 543-page Common Rule looks a lot better than the original proposal in 2011, but the biggest question now is whether the work will be upended with the stroke of a pen.

Here are Some Sample Items From New HFAP Requirements

HFAP has released new environmental rules in its accreditation requirements for ASCs.

HFAP Changes Standards After Updated Life Safety Code Rules

ASCs must meet environmental safety standards, but they do not always put the most knowledgeable people in charge of this task, which could result in a big mistake.

Ready for That Survey? Here are Some Helpful Tips

Here’s what everyone about to be surveyed has in common: Fear.

Employee Health Must Navigate Conflict Between State And Federal Marijuana Laws

Evolving state laws regarding the legal use of marijuana mean that healthcare providers’ existing policies on drug use should be reviewed to ensure they do not violate labor laws or provide an opportunity for civil litigation, while still ensuring patient safety, experts say.