Guidance on Research Involving Coded Private Information or Biological Specimens (Office for Human Research Protections). [Excerpt] This document applies to research involving coded private information or human biological specimens (hereafter referred to as "specimens") that is conducted or supported by HHS. This document does the following: (1) Provides guidance as to when research involving coded private information or specimens is or is not research involving human subjects, as defined under HHS regulations for the protection of human research subjects (45 CFR part 46). (2) Reaffirms OHRP policy (see OHRP guidance on repository activities and research on human embryonic stem cells) that, under certain limited conditions, research involving only coded private information or specimens is not human subjects research. (3) Clarifies the distinction between (a) research involving coded private information or specimens that does not involve human subjects and (b) human subjects research that is exempt from the requirements of the HHS regulations. (4) References pertinent requirements of the HIPAA Privacy Rule that may be applicable to research involving coded private information or specimens. Category: Interesting websites, Category: Privacy in research. This website was last verified on June 06, 2007. URL: www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm