Human Tissue/Biological Samples MTA FORM

advertisement
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
Download