 | Nancy M. P. King, Gail Henderson, Jane Stein - Medical - 1999 - 279 pages
...agency has specific responsibility for regulating as a research activity (for example, Investigational New Drug requirements administered by the Food and...that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been... | |
 | Thomas E. Ogden, Israel A. Goldberg - Medical - 2002 - 368 pages
...REGULATIONS, TITLE 45, PART 46, PROTECTION OF HUMAN SUBJECTS (45: CFR-461 defines human subjects as follows: Human subject means a living individual about whom...that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been... | |
 | Administrative law - 2003
...gathered (for behavior when the investigator(s) do not participate In the activities being observed. example, venipuncture) and manipulations of the subject...that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been... | |
 | Administrative law - 2004
...agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and...that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been... | |
 | Daniel Farb, Bruce Gordon - Medical - 2005 - 332 pages
...Agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and...that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been... | |
 | Dorothea Magnus - Law - 2006 - 321 pages
...research activities which are incidentally regulatcd by a federal department or agency solely äs pari of the department's or agency's broader responsibility...that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has becn... | |
 | Elizabeth A. Bankert, Robert J. Amdur - Medical - 2006 - 530 pages
...agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and...that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been... | |
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Labor). (f) Human subject means a living Individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or Interaction with the individual, or (2) Identifiable private information. Intervention... 
