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FDA Gene Therapy Draft Calls for Long-term Follow of Subjects
The FDA recently issued multiple draft guideline documents on the fast-emerging field of gene therapy, including guidance on specific diseases like hemophilia and the need to follow some research subjects long-term to assess delayed adverse events.
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Consistency Is a Challenge, but Necessary With Multiple Institutional IRBs
Research institutions that undergo accreditation preparation quickly learn that having separate policies and procedures for each IRB is a problem.
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Newly Accredited Program Has Made Policies and Procedures Easier to Follow
When the human research protection program at the University of Florida decided to undergo accreditation with the Association for the Accreditation of Human Research Protection Programs, officials revised policies and procedures, making them consistent across IRBs and easy to follow.
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Tackling AAHRPP Accreditation Requires Time, Focus, Documentation
Research institutions seeking first-time accreditation or reaccreditation can always expect challenges. These hurdles are a little higher now as rules and regulations will change in 2019 under the new Common Rule.
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Does Use of Biospecimens From Children Require Reconsent When They Are Adults?
There is considerable ethical debate about the issue of reconsent at age 18 from research subjects who provided biospecimens as infants, children, or adolescents. Practices currently vary widely among institutions.
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Empowering Patients to Prompt Hand Hygiene
If the highest calling in the profession is to protect patients, what if they are the ones asking the providers to wash their hands? It has been tried before with mixed results, but researchers in an ongoing study are adding a new feature.
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Key Pieces of a Hospital Water Management Plan
Infection preventionists should familiarize themselves with their facility water systems and work with colleagues in engineering to ensure an outbreak of Legionella is not percolating in pipes.
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Legionella: Be Proactive to Avoid ‘Pain’ of Inspections
Infection preventionists who have put water management programs on the back burner could be in a world of pain if they encounter a case of Legionnaires’ disease — let alone an outbreak. -
Does Your Boss Know All That You Do?
As part of defining your role and knowing when to “stay in your lane,” make sure you are getting credit for all that you do. Doing so will bolster your case if you must say “no” to additional duties. -
Stay in Your Lane Framework
Infection preventionists at BJC HealthCare in St. Louis created a framework to help IPs better determine whether a given issue falls within their role and responsibilities or should be referred to another department.