1. (a) The department shall use the Institutional Review Board for the purposes of:

   1. (1) evaluating applications for various measures or variables that are found in the department's hospital discharge data "research" file or outpatient surgical and radiological procedures at hospitals and ambulatory surgical centers "research" file or hospital outpatient emergency department data "research" file; and
   2. (2) deciding whether the data requests should be granted.
2. (b) The Institutional Review Board functions relating to §421.45 of this title (relating to Data Requests and Release) and this section are abolished at such time as the department ceases to maintain a hospital discharge data "research" file or outpatient surgical and radiological procedures at hospitals and ambulatory surgical centers "research" file or hospital outpatient emergency department data "research" file.
3. (c) Meetings. Meetings of the Institutional Review Board shall be posted and conducted in accordance with the Texas Open Meetings Act, Government Code, Chapter 551.

4. (d) Decision-Making Guidelines.

   1. (1) Requests should reasonably identify and justify the requested data elements. Requesters who have detailed information that would assist in justifying the records request are urged to provide such information in order to expedite the handling of the request. Envelopes in which written requests are submitted should be clearly identified as Open Records requests. Requests should include the fee or request determination of the fee.
   2. (2) Fee structures for the public use data file and the research file shall be set by the executive commissioner.
   3. (3) Waiver or reduction of the fees charged for the public use data file or the research file may be made upon a determination by the department in consultation with the executive commissioner when such waiver or reduction is in the department's interest.
   4. (4) All requests for data must be submitted in writing, either on the form provided by the department or on a similar form containing all of the same information. Denials of written requests will be in writing and will contain the reasons for the denial including, as appropriate, a statement that a document or data element requested is nonexistent or is not reasonably described, or is subject to one or more clearly described exemption(s).
   5. (5) Only data elements requested by the requestor and approved for release by the Institutional Review Board, shall be included in the research file for release to the requestor in accordance with this chapter.
5. (e) Reports to the department. The Chair of the Institutional Review Board shall file with the Program Director a written report of all action taken relating to requests under this section at any meeting of the Institutional Review Board or of a Subcommittee within three working days of such meeting, including a detailed list of how each participating member voted.

Source Note:The provisions of this §421.46 adopted to be effective July 5, 2017, 42 TexReg 3373.