The Clinical Research Compliance Manual: An Administrative Guide1 is a substantial update from previous editions.
First published in 2006, the manual outlines the exhaustive recordkeeping required for federally funded clinical research.
Most chapters are written by lawyers—a perspective that may be less useful for scientists, clinicians and principal investigators. However, it is a well-written, well-referenced text on the administrative requirements of clinical research. Hopefully, the following brief outline will prove useful.
The first chapter provides an overview of the subject at hand, followed by chapters on protecting subjects and informed consent. Chapter four discusses Institutional Review Boards (IRBs), and five deals with Federal Grant Administration. Chapter six focuses on the unique requirements for grants from NIH; accounting practices, including allocation of a professor’s time to teaching, research and clinical practice, are covered in chapter seven.
Chapter eight centers on conflicts of interest. The Gelsinger clinical trial conducted in 1999 at the University of Pennsylvania and the Vioxx incident of 2004 are presented as cases in which financial incentives appear to have compromised scientific objectivity. The ramifications of the Bayh-Dole Act, which governs revenue-sharing arising from developed intellectual property, are explored. Intellectual property is also covered in chapter 13A, “Protecting research materials, results and inventions: a university perspective.”
“Misconduct in clinical research” (chapter nine) precedes “Good clinical practices” (chapter 10). Both give an overview of requirements but lack specifics: it would be preferable if the required forms and model declarations were provided.
Reference
- Brent, P.; Vernaglia, L.W. Clinical Research Compliance Manual: An Administrative Guide, Wolters Kluwer Law & Business, 2015; ISBN 978-0-7355-6966-9.
Robert L. Stevenson, Ph.D., is Editor Emeritus, American Laboratory/Labcompare; e-mail: [email protected].
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