Human and Animal Studies

Manuscripts reporting results of prospective or retrospective studies involving human subjects must document that appropriate institutional review board approval and informed consent were obtained after the nature of the procedure(s) had been fully explained. (It should also be stated if informed consent was waived by the institutional review board.) More information can be found at the ICMJE Web site (http://www.icmje.org). Manuscripts on prospective studies for which institutional review board approval and informed consent were not obtained will not be considered for publication. For U.S. studies, a statement regarding compliance with HIPAA (Health Insurance Portability and Accountability Act) guidelines is needed for both prospective and retrospective studies. Refer to the Special Series articles published in the August–December 2005 issues of Radiology for a discussion of ethical research with human subjects.

The maintenance and care of experimental animals to ensure humane treatment and reliable results are described in the National Institutes of Health guidelines for use of laboratory animals. Authors must affirm their compliance with these guidelines or approval by the appropriate institutional review board or animal care committee for studies involving animals.