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  • Innovative program effectively educates nurses on clinical ethics

    A Clinical Ethics Residency for Nurses has been developed at two large northeastern academic medical centers. One goal is to teach nurses how to be effective advocates for patients whose circumstances, problems, and treatments are ethically complex.

  • Ensure patients’ wishes are respected through surrogate decisionmakers

    A recent ethics consult at The Ottawa Hospital in Ontario, Canada involved a victim of domestic violence. “The challenge was that the husband, who had severely beaten the patient, was the patient’s substitute decisionmaker,” recalls Thomas Foreman, DHCE, MA, MPIA, director of the Department of Clinical and Organizational Ethics.
  • IOM: End-of-Life Care is Inadequate in the US

    The American healthcare system is poorly equipped to care for patients at the end of life, according an Institute of Medicine report.

  • Guest column: Is “Right to Try” the right fit for better access to investigational drugs?

    There is a constant struggle between giving people, particularly the terminally ill, access to new treatments quickly, while also ensuring that those treatments are as safe and effective as possible. The debate continues with the proposal and passage of state “Right to Try” laws, which would give terminally ill people access to investigational drugs that have completed Phase I studies.

  • When creating a resource guide, hyperlinks can be useful

    The main goal of creating an IRB resource guide is for it to be used and useful. If it’s too large and difficult to search, such as a 50-page paper document, or if it’s too cumbersome, such as a spreadsheet, staff might avoid it.

  • New SACHRP member brings legal and bioethical perspective to board

    IRB Advisor asked Holly Fernandez Lynch, JD, MBioethics, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, MA, to discuss her role in joining the Secretary’s Advisory Committee on Human Research Protections (SACHRP). Before joining the Petrie-Flom Center, Lynch was a senior policy and research analyst for the Presidential Commission for the Study of Bioethical Issues’ report on the Guatemala STD inoculation study.

  • NIH issues guidance promoting central IRB use

    The National Institutes of Health (NIH) is officially promoting the use of a single IRB for large, multisite clinical trials.

  • SUPPORT study that started controversy was complicated

    A study called SUPPORT, short for Surfactant, Positive Pressure, and Oxygenation Randomized Trial, was a major reason behind recent draft guidance published by the Office for Human Research Protections (OHRP).

  • Standard of Care Draft Guidance Praised, Criticized

    Weighing in on a recent standard of care guidance published by the Office for Human Research Protections.

  • Internal Medicine [ALERT]

    The United States Preventive Services Task Force (USPSTF) gave a level B recommendation in support of annual low-dose computed tomography (LDCT) to screen for lung cancer in appropriate risk groups. The USPSTF decision was largely based on the National Lung Screening Trial (NLST), a mega-trial (n = 53,454) in the United States that randomized subjects to annual LDCT or chest X-ray. The primary endpoint of the study was lung cancer mortality, and all-cause mortality was a secondary endpoint. Inclusion criteria included at least a 30-pack/year history of smoking (if stopped within 15 years), ability and willingness to complete follow-up for abnormal findings, and absence of problematic comorbidities that might otherwise compromise long-term survival.