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There is nobody who walks the path to the NIST Malcolm Baldrige Quality Excellence award and calls it a sprint. It is something deliberately undertaken with some knowledge that it will be a matter of years before you have any real chance of being one of the organizations named a winner.
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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?
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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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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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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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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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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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A patient came for a consult for a prophylactic bilateral salpingoopherectomy the removal of fallopian tubes and ovaries because of a strong maternal family history of breast cancer.
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The ethical justification for the Affordable Care Act (ACA) is distributive justice, with the goal of making health insurance available to more Americans, notes Dennis M. Sullivan, MD, director of the Center for Bioethics at Cedarville (OH) University
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At the University of Missouri School of Medicine in Columbia, MO, about 80% of ethics consults are called for patients who are either dying or near death in the critical care setting, estimates David A. Fleming, MD, MA, FACP, professor of medicine, chairman of the Department of Medicine and director of the Center for Health Ethics.
