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(Editor's note: In this special issue of Same-Day Surgery, we explore the impact of the current economy on outpatient surgery. We've included a status report, an economic outlook, an examination of the impact of the Obama administration, and cost-cutting tips.)
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The final report on the three-year recovery audit contractor (RAC) demonstration project for hospitals shows that the Centers for Medicare & Medicaid Services (CMS) has made "a lot of important changes," says Don May, vice president of policy for the American Hospital Association (AHA).
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When a local public health department in California opened packages of FluVirin pre-filled syringes to start the flu immunization campaign, the vaccine administrators were stunned. Contrary to federal law and regulation, the syringes had a fixed needle with no safety device.
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Military veterans who recently served in Afghanistan, Iraq, and other countries often return home with “invisible” healthcare needs that might be overlooked in community healthcare settings.
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Community-based participatory research (CBPR) brings members of the community into a study as partners who are involved with subject recruitment, study design, informed consent, and other aspects of research. Community partners can include tribal councils, religious organizations, neighborhood groups, and other social organizations.
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The agencys Notice of Proposed Rulemaking (NPRM), released in November, expands clinical trial registration and reporting guidelines for clinical trials that are required to register with ClinicalTrials.gov under the U.S. Food and Drug Administration Amendments Act (FDAAA).
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Blogs, message boards, and patient communities are being used not only by patients, but also by research participants. In some cases, this reveals whether or not a participant is taking actual medication or placebos, compromising the studys validity.
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IRB Advisor asked Diana T. Chingos, MS, MFA, executive director of the Noreen Fraser Foundation in Los Angeles, to tell readers a little more about herself and her hopes and goals for the Secretarys Advisory Committee on Human Research Protections (SACHRP), to which she was appointed in October 2014.
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Its a long-standing issue with IRBs: Studies are approved, participants are enrolled, study interventions and visits occur and someone complains. But then what?
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Federal regulations require researchers to maintain an equitable selection of participants, and IRBs take this into consideration when reviewing study protocols. But what are the ethical implications when a study has difficulty recruiting or retaining subjects? From an IRB perspective, recruitment must not be coercive, but how can researchers ensure participants are truly willing volunteers in small studies that require a major physical commitment?