ATTACHMENT C. Agreement to Keep Participant Data Private FINAL

ATTACHMENT C:

MULTI-SITE IMPLEMENTATION EVALUATION OF TRIBAL HOME VISITING (MUSE)

STUDY TEAM AGREEMENT TO KEEP PARTICIPANT DATA PRIVATE

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.

STUDY TEAM AGREEMENT TO KEEP PARTICIPANT DATA PRIVATE

It is the policy and practice of James Bell Associates, Inc. (JBA) and the Centers for American Indian and Alaska Native Health (CAIANH), Colorado School of Public Health (CSPH), that all research data and personal health information is held in strict privacy. Any personnel involved in data collection at the 17 partnering Tribal Home Visiting sites will be fully trained and certified in the protection of human subjects and in the study-specific protocols for protecting the privacy of individuals and their data. JBA and CAIANH maintain responsibility for providing and documenting this training and certification process. By signing below, all personnel within JBA, CAIANH, and partnering study sites working on this evaluation research study agree to abide by the IRB-approved researcher-participant agreements for the collection and protection of research data and to adhere to all study protocols for data handling and management.

In addition, studies though the University of Colorado Denver, the CSPH and its Centers are required to adhere to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), which protects personal health information. Personal health information is defined as health information that contains any of the following identifiers, and can be in any form – oral, electronic, print or video.

• Name

• Postal address (geographic subdivisions smaller than state)

• All elements of dates except year (birthdate, if over 89, must be aggregated)

• Phone number

• Fax number

• Email address

• Social Security number

• Medical Record number

• Health plan number

• Account numbers

• Certificate/License number

• URL

• IP address

• Vehicle identifiers (VIN/license plate number)

• Device ID

• Biometric ID

• Full face/identifying photo

• Any other unique identifying number, characteristic, or code

HIPAA mandates that personal health information may not be used or disclosed except: 1) to the individual; 2) for Treatment, Payment, or Healthcare Operations (TPO); 3) for mandatory reporting; or 4) with an authorization (e.g., signed consent/release form) and then only to those specifically authorized in the consent form to receive that information.

All data and other records containing personal health information are to be carefully safeguarded. Breach of privacy is defined as any use or disclosure of personal health information for any purpose other than noted above. If such breach of privacy occurs, inadvertent or purposeful, it will be regarded as willful misconduct and may result in disciplinary action in the case of JBA and CAIANH staff or in no longer being able to participate in the MUSE study in the case of staff at partnering study sites.

I have read and understand this policy.

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