Articles Tagged With: research
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AMA Prepares for COVID-19 Vaccine with Coding Updates
Laying the administrative groundwork is an important part of ensuring success for administration of an eventual vaccine.
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National Organization Calls on DEA to Remove Cannabis from Schedule I List
American Heart Association says easing restrictions would allow for better scientific research on drug’s risks and benefits.
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White Paper Calls for Overhaul of Federal Nutrition Research
Coalition of experts say extra funding, better coordination needed to improve public health.
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Federal Agencies, Pharma Industry Work to Speed COVID-19 Therapeutics, Vaccine
Public-private partnership aims to streamline, coordinate large-scale efforts.
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OHRP’s standard of care draft guidance elicits praise, criticism
Critics and supporters both have weighed in on recent standard of care guidance published by the Office for Human Research Protections (OHRP). -
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. -
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. -
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. -
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.