Ethics, Ethics Everywhere

By: Katie Schaefer, Cosmetics & Toiletries magazine

Posted: July 2, 2008, from the July 2008 issue of Cosmetics & Toiletries.

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Quality assurance is one of the highest responsibilities of the sponsor, according to Callaghan, who elaborates, “A sponsor may transfer any or all of the sponsor’s trial related duties and functions to a CRO but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor, irrespective of whether [it was transferred] or not.” Callaghan highly emphasizes the importance of considering the safety of the human volunteers. She references the Declaration of Helsinki, where it is stated that concerns for the humans involved must always supersede science or society. One way to ensure the safety of the volunteers is to supply a study protocol to an independent ethics committee.

To ensure the accuracy and safety of a study, Callaghan recommends closely monitoring the volunteers, those carrying out the tests and the tests themselves. She adds, “Only by rigorously inspecting your study with trained resources can you be reasonably sure the study follows/followed the agreed, signed protocol.”