IRB Advisor – December 1, 2014
December 1, 2014
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OHRP issues draft guidance on standard of care research
A year after its public meeting on the Support study, the Office of Human Research Protections (OHRP) issued a draft guidance to clarify its thinking on the disclosure of reasonably foreseeable risks in standard of care research. -
Ethics in age of ‘big data’ go beyond privacy issue
summer when debates raged over Facebooks social media study. Public rebukes of studies involving big data and social media are fairly rare, but these studies can raise all kinds of ethical challenges. -
HRPP is ready for growth, including compliance changes
Human research protection programs (HRPPs) are poised for the next level of evolution as todays controversies push research ethics in new directions. -
Having IC templates can backfire
For years now, IRB managers have been developing and using tools, including checklists and templates. The goal is to improve IRB review consistency and to expedite the approval turnaround process. While checklists and tools are useful, they can also be a problem. -
Sample questions from the IRB self-evaluation survey
Enid Virago, PhD, CIP, CCRP, and Joanna Lyons, RN, DEd, developed the Evaluation of Research Protections Programs and Committee Membership Self-Evaluation to measure IRB member service satisfaction and performance of the HRPP. -
IRB self-evaluation form also evaluates HRPP performance
IRB board member self-evaluations are crucial for determining how members view their IRB service and measuring the performance of the HRPP itself. But IRB administrators who are looking for self-evaluation tools may have a hard time deciding where to start, or which issues should be the focus.