Section 15: Research Uses and Disclosures of PHI
Callier Center PHI can be accessed for research purposes with satisfactory evidence that UT Dallas Internal Review Board (IRB) has approved the research proposal and granted a HIPAA authorization waiver. To access Callier patient information, the Director of Audiology Clinical Services, Director of Speech-Language Pathology Clinical Services, or Cochlear Implant Program Manager will serve as the liaison with the Primary Investigator (PI) or approved IRB member associated with the study and is responsible to report the study to the Executive Director.
UT Dallas Workforce must follow these procedures to access or use any Callier Center PHI for research of any kind.
1. Determine That the Requested Use or Disclosure Is for Research Purposes
This policy only applies when the purpose of the requested use or disclosure is research, defined as a systematic investigation including research development, testing, and evaluation that is designed to develop or contribute to generalizable knowledge. This policy does not apply if the purpose of the requested use or disclosure is health care operations, defined to include quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities. This includes population-based activities relating to improving health or reducing health care costs, protocol development, case management and care coordination.
2. Determine that the Information to be Used or Disclosed Is PHI
This policy only applies if the information being used for research is PHI. If the information being used or disclosed has been completely de-identified in accordance with Section 16 of this Manual, this policy does not apply.
3. Initiate Contact with Callier Patients for Purposes of Research Registry Recruitment
The Director of Clinical Services or Program Manager will be responsible for oversight of all recruitment activities for Callier patients. The PI or approved IRB member associated with the IRB approved study may contact patients who are listed in the clinical research registry. Individual clinic patients may opt out of participation in the research registry by:
- Email: firstname.lastname@example.org
- Telephone: Callier Clinical Research Center, (972) 883-3600
- Mail: Callier Clinical Research Center, Participant Registry, 811 Synergy Park Boulevard, Richardson, Texas 75080
4. Obtain Patient Authorization for Participation in a Study
To use or disclose PHI for research purposes, the PI or approved IRB member associated with the study must do one of the following:
a. Obtain Written Authorization. The PI or approved IRB member associated with the study shall obtain written authorization (Callier Center Release of Records form) from each patient to participate in the research study who is the subject of the PHI being used or disclosed for research purposes.
b. Obtain Representations From the Researcher That the Review Is Preparatory to Research. In order to use PHI, the Director of Clinical Services or Program Manager may rely on the following written representations from the researcher:
- i) the use or disclosure is sought solely to review PHI as necessary to prepare a research protocol or for similar purposes preparatory to research;
- ii) no PHI will be removed from the Callier Center’s premises by the researcher in the course of the review; and
- iii) the PHI for which the use or access is sought is necessary for research purposes.
The use or disclosure of PHI may enable a researcher to do the following:
- i) review, but not remove, PHI to determine whether the Callier Center has PHI relating to prospective research participants who may meet the eligibility criteria for enrollment in the researcher’s study; or
- ii) make a determination regarding whether there are a sufficient number of patients with a particular health condition within the community that would make the researcher’s study feasible.
A researcher who is not part of UT Dallas’s Workforce is not able to obtain PHI to contact prospective research subjects.
c. Obtain Representations and Documentation from the Researcher That the Research Relates to a Decedents’ Information.
In order to use PHI, the Callier Center may rely on the following from the researcher:
- i) a representation that the use or disclosure is sought solely for research on the PHI of decedents;
- ii) documentation, at the request of the Callier Center, of the death of such individuals; and
- iii) a representation that the PHI for which use or disclosure is sought is necessary for the research purposes.
d. Disclose a Limited Data Set Pursuant to a Data Use Agreement. The Callier Center is permitted to use or disclose a limited data set of information for research purposes pursuant to a data use agreement without the prior written authorization of the individual(s) who is/are the subject of the information.
5. Make Minimum Necessary Uses and Disclosures
a. The Medical Records Administrator is permitted to rely on the requesting researcher’s representation that the purpose of the request is to review PHI as necessary to prepare a research protocol; the Callier Center may only disclose to the requesting researcher the PHI specifically requested by the researcher.
b. The Medical Records Administrator is permitted to rely on the requesting researcher’s representation that the purpose of the request is for research on the PHI of decedents and that the request meets the minimum necessary requirements; the Callier Center may only disclose to the requesting researcher that PHI specifically requested by the researcher.
6. Include Required Disclosures in the Accounting of Disclosures (i.e., Patient’s Disclosure Log)
To the extent that Callier’s Medical Records Department discloses PHI for research purposes pursuant to an authorization, or discloses a limited data set pursuant to a data use agreement, the disclosure(s) need not be included in the accounting.
7. Notice of Privacy Practices
The Callier Center HIPAA Privacy Officer will ensure that its Notice of Privacy Practices informs individuals of the possible disclosures for research purposes contained in this section.
HIPAA Regulatory Citations: 45 CFR § 164.501, § 164.502(d),
§ 164.508, § 164.512
Donise W. Pearson, HIPAA Privacy Officer
UT Dallas Callier Center