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Authorization is the written confirmation that a Research subject has voluntarily agreed, pursuant to an Authorization in substantially the form required by this Policy, to permit the use, sharing, copying and release of his or her current and future health information related to a particular Research study, after having been apprised of the types of persons permitted to make such uses and releases of health information, their rights in connection with that information and the potential risks relevant to the subjectÕs decision to permit use and release of health information.
Disclosure means the release, transfer, provision of access to, or divulgence in any other manner, of information to any organization external to the entity holding the information.
Healthcare Professional means a physician, nurse, nutritionist, therapist or other individual who is both trained in a particular area of health care delivery and directly involved in the delivery of clinical care to patients.
HIPAA means the Health Insurance Portability and Accountability Act of 1996 and the privacy regulations promulgated under the Act.
Information ("Information") means individual health information (whether identifiable or not) transmitted or maintained in any form or medium.
Northwestern University shall include all operations of Northwestern University, including, without limitation, all Northwestern University controlled research centers and institutes.
Northwestern University Personnel shall include all faculty, staff (including student employees), students, residents, post-doctoral fellows, and non-employees (including visiting faculty, courtesy, affiliate and adjunct faculty, industrial personnel, fellows, etc.).
Provider or Provider Entity means any health care provider that is a "Covered Entity" within the meaning of HIPAA, including, without limitation, the following: (1) any provider Covered Entity Components of Northwestern University, (2) Northwestern Memorial Hospital ("NMH"); (3) The Rehabilitation Institute of Chicago ("RIC"); (4) Northwestern Memorial Faculty Foundation ("NMFF"); (5) other McGaw affiliated hospitals and health care facilities; and (6) physicians acting as health care providers not as a researcher.
Recruitment of subjects for a research study includes (1) review of Information for the purpose of identifying specific individuals to enroll as study participants, and (2) actually contacting such individuals to enroll them in the study. Recruitment does not include review of Information for purposes of ascertaining whether or not a sufficient and appropriate pool of subjects exists to support the Research Study.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Use means, with respect to individually identifiable health information, the sharing, employment, application, utilization, examination, or analysis of such information within an entity that holds such information.
Workforce means employees, volunteers, trainees, and other persons whose conduct, in the performance of work for a Provider Entity, is under the direct control of such Entity, whether or not they are paid by the Provider Entity.
Mailing address: Office for the Protection of Research Subjects : Rubloff Hall, 7th Floor, 750 N. Lake Shore Drive, Chicago, IL 60611-3078
Chicago: (312) 503-9338 .:. Evanston: (847) 467-1723 .:. Comments: irb@northwestern.edu
Last modified 10/2/08 .:. World Wide Web Disclaimer and University Policy Statements | © 2007 Northwestern University