UTMB RECORD OF PROTECTED HEALTH INFORMATION REVIEW FORM For Material Transfer Agreements For Human Tissue Samples Name of UTMB Faculty Member: ___________________________________ Department: _______________________________________________ Title: _______________________________________________ Date: _______________________________________________ Technical Review (To be completed By UTMB Faculty) Are you the Provider or the Recipient of the materials? ____________________________________________ Please provide complete information of the Recipient: (include full names of the parties) Name(s) of person: ____________________________ Recipient:_________________ Name(s) of person: ____________________________ Recipient Address:______________________________________________________ Describe the materials that will be transferred to the Recipient (e.g. adipose tissue) and the purpose of the transfer. (attach page if necessary). _____________________________________________________________________________________________ _____________________________________________________________________________________________ Please check the appropriate box: 1. Are the materials being sent are samples that have been collected from humans participating in a clinical trial? Yes No. If No, please explain why the samples are being released: _____________________________________________________________________________________________ _____________________________________________________________________________________________ 2. Have all Protected Health Information*(PHI)(see definition) identifiers been removed from materials being provided *? Yes No. If No, please explain: _____________________________________________________________________________________________ _____________________________________________________________________________________________ 3. If a Limited Data Set* is going to be provided, is a Data Use Agreement executed? 4. No PHI will be provided after the materials have been sent. Yes Yes No No By signing below, I certify that I have read this document and completed the appropriate sections to the best of my knowledge and belief: ______________________________ Faculty signature _________________________ Date Please return completed form by email to: magrove@utmb.edu *This document must accompany the MTA in UTMB OTT files* Page 1 of 3 Definitions Protected Health Information (PHI): Individually identifiable health information transmitted or maintained in any form or medium, including oral, written, and electronic. Individually identifiable health information relates to an individual’s health status or condition, furnishing health services to an individual or paying or administering health care benefits to an individual. Information is considered PHI where there is a reasonable basis to believe the information can be used to identify an individual. Demographic information on patients is also considered PHI. PHI identifiers include: 1. Names 2. Address information smaller than a state, including street address, city, county, zip code 3. All elements of dates (except year), including DOB, 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. Fax numbers 6. Email addresses 7. Social Security Number (SSN) 8. UH number (medical record number) 9. Health beneficiary plan number 10. Account numbers 11. Certificate/License Number 12. Vehicle identifiers, including license plate numbers 13. Device ID and serial number 14. Universal Resource Locator (URL) 15. Identifier Protocol (IP) addresses 16. Biometric identifiers, including finger and voice prints 17. Full face photographic images and comparable images 18. Any other unique identifying number characteristic, or code Use: The sharing, employment, application, utilization, examination, or analysis of such information within the UTMB system. Disclosure: The release, transfer, provision of access to, or divulging in any other manner of information outside of the UTMB system. De-identification: Health information that does not identify an individual in any manner with no reasonable basis to believe that the information can be used to identify the individual. See IHOP Policy 6.2.29, De-identification of PHI. Limited Data Set: A limited amount of Protected Health Information (PHI) that may be used and disclosed for research, public health or health care operations. This limited amount of PHI may be shared with another entity only after both parties have executed a data use agreement. See IHOP Policy 6.2.13, Use and Disclosure of PHI for Limited Data Set. Use and Disclosure of PHI for Limited Data Set: A subset of protected health information (PHI) that excludes the direct identifiers listed below. All the direct identifiers listed below must be removed for the individual and relatives, employers, or household members of the individual. 1. Names; Page 2 of 3 2. Postal address information, other than town or 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 numbers, including license plate numbers; 12. Device identifiers and serial numbers; 13. Web Universal Resource Locators (URLs); 14. Internet Protocol (IP) address numbers; 15. Biometric identifiers, including finger and voice prints; and 16. Full face photographic images and any comparable images. Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. Page 3 of 3