IRB Advisor – September 1, 2011
September 1, 2011
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Proposed Common Rule changes have pros and cons for institutions
When human subjects research directors finish sifting through the proposed Common Rule changes, they likely will find some things they can live with and plenty of others they'd like to modify. -
Reporting incidental findings: ethical & vital
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. -
Common Rule makeover denotes research reform
In its proposed revision of the Common Rule, the U.S. Department of Health and Human Services is considering the most extensive changes to human subjects protection regulations in decades. -
Exempt, expedited studies face ANPRM changes
The Advance Notice of Proposed Rulemaking (ANPRM) proposes extensive changes to the way that exempt and expedited studies are currently handled, with an emphasis on streamlining the process for researchers who conduct minimal risk activities, particularly in the social sciences. -
OHRP cites lack of safety reporting in hip study
Researchers studying whether specially padded underwear protected elderly wearers from hip fractures came up with a one-sided garment design that allowed them to compare the results of a padded hip and an unprotected hip on the same person. -
New AAHRPP metrics show less IRB funding
The most recent statistics gathered from the Association for the Accreditation of Human Research Protection Programs' (AAHRPP) client institutions don't look all that different from the baseline metrics released last year. -
Compliance Corner: QA assessments render positive review changes
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?