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									HIPAA Identifiers

Data stripped of these identifiers is considered de-identified data

   1. Names
   2. All geographic subdivisions smaller than a state, including street
      address, city, county, precinct, zip codes, and their equivalent
      geocodes, except for the initial 3 digits of zip code
   3. All elements of date for dates directly related to an individual
   4. Telephone numbers
   5. Fax numbers
   6. Electronic mail addresses
   7. Social Security numbers
   8. Medical record numbers
   9. Health plan beneficiary numbers
   10.Account numbers
   11.Certificate/license numbers
   12.Vehicle identifiers and serial/license plate numbers
   13.Device identifiers, serial numbers
   14.URLs
   15.Internet Protocol (IP) address numbers
   16.Biometric identifiers
   17.Full-face photographs/other comparable images
   18.Any other unique identifying number, characteristic or code
Limited Data Set

Partially De-identified Patient Information (Limited Data Set)

To be considered a limited data set all of the following identifiers must be
removed from the protected patient information. This includes data elements
related to the individual or relatives, employers, or household members of the
individual. (Vanderbilt policy OP 10-40.19)

   1. Names
   2. Postal information, other than town/city, state, and zip code
   3. Telephone numbers
   4. Fax numbers
   5. Electronic mail addresses
   6. Social Security numbers
   7. Medical record numbers
   8. Health plan beneficiary numbers
   9. Account numbers
   10. Certificate/license numbers
   11.Vehicle identifiers and serial/license plate numbers
   12. Device identifiers, serial/license plate numbers
   13.URLs
   14. Internet Protocol (IP) address numbers
   15.Biometric identifiers
   16.Full face photographs/other comparable images




May retain town/city and/or 5-digit zip codes and dates (month/year or year)
SAMPLE HUMAN SUBJECTS SECTION OF RO1 GRANT APPLICATION

                           Protection of Human Subjects


No Human Subject Research is proposed in this application.

The proposed study does not involve human subjects for the following reasons:

       1. No data will be specifically obtained for the proposed research through any
          interaction or intervention with a living individual.

       2. The investigator cannot readily identify any individual involved in the three
          studies from which the datasets were obtained because:

              a. The analysis dataset from the XXX Program (See Section B.1.1) will
                 not contain individually identifiable private information. The
                 investigator does not have access to a coding system by which an
                 individual can be directly or indirectly identified. Data will be supplied
                 by John Doe, MD. Dr. Doe has agreed to serve as a consultant on
                 the scientific context of the data. The investigator will sign a Data Use
                 Agreement with the XXX Coordinating Center at Johns Hopkins
                 University, stipulating the use of the data for research purposes only
                 and the responsibilities of the investigator to safeguard the privacy of
                 the data.

              b. The analysis dataset from the YYY Study (see Section B.2.1) will not
                 contain individually identifiable private information. The investigator
                 does not have access to a coding system by which an individual can
                 be directly or indirectly identified. The dataset will be supplied by
                 Jane Smith, PhD. Dr. Smith has agreed to serve as a consultant on
                 the scientific context of the data. The investigator will sign a Data Use
                 Agreement with University of Chicago, stipulating the use of the data
                 for research purposes only and the responsibilities of the investigator
                 to safeguard the privacy of the data.

              c. The analysis dataset from the ZZZ Study (see Section B.3.1) will not
                 contain individually identifiable private information. The investigator
                 does not have access to a coding system by which an individual can
                 be directly or indirectly identified. The dataset will be supplied by Paul
                 Jones, PhD. Dr. Jones has agreed to serve as a consultant on the
                 scientific context of the data. The investigator will sign a Data Use
                 Agreement with National Institute of Child Health and Human
                 Development, stipulating the use of the data for research purposes
                 only and the responsibilities of the investigator to safeguard the
                 privacy of the data.

              d. Analysis datasets will only be used to develop outcome dependent
                 sampling designs and analysis procedures for longitudinal data. No
                 direct clinical applications are planned for the results of this study.
Protection against risk: The only risk to study subjects involves the confidentiality of
the data. No individual study subject will be contacted or identified. The risk that
someone other than the investigator of this study will gain access to information through
which a study subject could be identified is negligible.

     Data will be stored on a Linux workstation in the Department of Biostatistics at
Vanderbilt University. The confidentiality of this data is protected through the secrecy of
the computer password required to gain access to the data and the manner in which the
data are encoded. Paper records will be kept under lock and key.

								
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