Data Transfer Agreement guidance for the transfer or use of human subject data

The transfer and use of human subject data is a complicated issue that cannot be adequately addressed on this website.  Duke researchers wishing to transfer or use human subject data must contact ORC to initiate a discussion on the proposed data transfer or use.

As a summary only and not intended to be complete guidance on the transfer or use of data, generally the transfer and use of data is governed by various important considerations including those related to Duke IRB rules, the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), ethical considerations, whether or not the transfer and/or use of the data is subject to contractual constraints, and issues related to intellectual property.  A researcher wanting to transfer or use data should be prepared to discuss with ORC, among other things: the purpose of the transfer; the identities of the transferor and transferee; the nature of the data to be transferred (human subject data? contains identifiers?); whether the data was collected under a research study or standard of care, and, if a research study, whether any third party constraints may exist; whether an applicable informed consent form allows the proposed use or transfer of the data; how the data is to be transferred; whether any patents are related to data; and whether any samples will be sent with, or in conjunction with, the data.       

To help reduce confusion over what constitutes Protected Health Information (“PHI”)(health information that includes additional information that can be used to identify the subject of the data) under HIPAA, a researcher should understand that HIPAA defines identifiers as any of the following:

1. Names
2. Any geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census:
   • The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people.
   • The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000.
3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older.
4. Telephone numbers.
5. Facsimile 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 numbers, including license plate numbers.
13. Device identifiers and serial numbers.
14. Web universal resource locators (URLs).
15. Internet protocol (IP) address numbers.
16. Biometric identifiers, including fingerprints and voiceprints. 
17. Full-face photographic images and any comparable images.
18. Any other unique identifying number, characteristic, or code, unless otherwise permitted  by the Privacy Rule for re-identification.

HIPAA defines a Limited Data Set of indirect identifiers (which are still PHI) which may be disclosed under a Data Use Agreement for research, public health or health care operations purposes without authorization, as the following:

• Dates and ages greater than 89.
• Some geographic information (City, county, state and more than 3-digit ZIP codes, including ZIP+4,  are allowed in a Limited Data Set, but street address is not).
• A Limited Data Set may include a link field to allow the provider to re-identify the individual.

Please note that Duke researchers are not authorized to sign DTAs on behalf of Duke  - the DTA must be submitted to ORC to obtain the proper signature.