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1. Disclosure of Risks and Uncertainties Are Especially Vital in Light of Regenerative Medicine.

Author

Niemansburg, S. L., Habets, M. G. J. L., van Delden, J. J. M., and Bredenoord, A. L.

Subjects
CLINICAL trials & ethics, INFORMED consent & ethics, DISCLOSURE, UNCERTAINTY, HUMAN research subjects, ETHICS
Abstract

The article focuses on a framework and criteria developed to make obligatory the inclusion of a controversial risk in the model informed consent document while avoiding the need to list every possible harm that could inflict a person. It discusses research integrity that relies on government regulations and foundational documents, an overview of a study on the Action to Control Cardiovascular Risk in Diabetes (ACCORD) and a proposed example of the items to be included in a consent document.

Published
2014
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