Articles Tagged With: guidance
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OHRP Looks Back at its First 20 Years
IRB Advisor asked OHRP to look back since its launch in June 2000 to see how human research protections has evolved.
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FDA Answers Audit Questions from Researchers, Industry
The Food and Drug Administration issued new guidance on inspections during the COVID-19 pandemic, as the agency began to resume domestic inspections in July.
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FDA Releases Q&A for COVID-19 and Clinical Trials
The Food and Drug Administration recently released updated guidance on conducting clinical trials of medical products during the COVID-19 pandemic. The new version of the guidelines includes a question-and-answer section that clarifies some emergency changes affecting human research protection policies and procedures.
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Group Issues Guidance on PPE Pressure Injuries
The bruised faces of healthcare workers have become a badge of courage, the price they are willing to pay for wearing respirators, masks, and other personal protective equipment (PPE) over long work shifts caring for COVID-19 patients. The National Pressure Injury Advisory Panel has issued some general guidance to help healthcare workers — with the caveat that PPE effectiveness must not be compromised.
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Q&A Part 1: IRBs Face Their Toughest Challenges with COVID-19
IRB leaders describe the challenges staff faced during the transition to remote working.
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Group Issues Guidance on PPE Pressure Injuries
The bruised faces of healthcare workers have become a badge of courage, the price they are willing to pay for wearing respirators, masks, and other personal protective equipment over long work shifts caring for COVID-19 patients.
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FDA Guidance Offers Foundation for IRB, Researcher Flexibility
The Food and Drug Administration’s guidance on conducting clinical trials during the pandemic provides reassurance that IRBs and research organizations can employ flexibility as they make changes to accommodate a world in which many patient visits are conducted remotely. The guidance does not change or modify existing regulations, but synthesizes existing regulations and emphasizes the built-in flexibility.
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New Working Group to Produce Guidance for Pediatric Gene Therapy
The NYU Grossman School of Medicine’s working group on Pediatric Gene Therapy and Medical Ethics formed in the fall of 2019 to address and propose recommendations to issues involving gene-based therapies in pediatric populations, including research activities.
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Work With Public Health Partners on Treatment, Care of Patients Diagnosed With COVID-19
The recommended care of a patient with COVID-19 is similar to what is required for other viral pneumonias, such as those associated with influenza or respiratory syncytial virus. Further, mild disease does not necessarily require hospitalization.
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CDC Guidelines for Home Isolation for Coronavirus
The Centers for Disease Control and Prevention has issued new guidelines for home care and isolation of patients with emerging 2019-nCoV.