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Research Compliance: Hospital Approval—Non-Delegable Obligations of a Covered Entity

Non-academic hospitals knowingly and unknowingly engage in clinical research every day, and these hospitals have nontransferable obligations, particularly when the research has been reviewed and approved by an external institutional review board (IRB). These studies utilize a wide gamut of hospital services, from outpatient diagnostics to surgical services for implantable investigational devices, and the non-delegable […]

Michael Causey, ACRP Editor-In-Chief

New Opportunities and Threats in the Realm of Informed Consent

Informed consent errors have fallen to sixth from first place as cited in most common clinical investigator findings by the U.S. Food and Drug Administration (FDA) over the past five years. While that suggests clinical researchers and sites have gotten better at handling this critically important set of tasks, it may not tell the whole […]

Informed Consent: Improving the Process

Ensuring individuals are able to make an informed decision when deciding whether or not to enroll in a research study is a cornerstone of conducting ethical research. How do we ensure that the consent is valid, and that the signature on the document represents a truly informed study participant? This article addresses the rational for […]

Therapeutic Innovations in Oncology: What Ethical Challenges Does Gene Therapy Bring?

While clinical research is often ethically challenging, clinical trials in oncology can bring uniquely difficult ethical considerations. Researchers and study teams have long struggled with the difficulties of conducting research and obtaining truly informed consent in patients who may be driven by understandable, but irrational, desperation for an intervention that has promise to be a […]

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Big buzz surrounds Research Hive

Let’s face it: clinical research coordinators (CRCs) can make or break any trial. Beginning with the site selection visit, the coordinator is carrying a large load. Tasked to learn new trial procedures, vendors, and schedules, they must also explain these details to patients and their team. Tight timelines and pressure from all sides wreak havoc […]