(1) A researcher requesting data files that contains direct patient identifiers for research must comply with the requirements of RCW 43.70.052 and this section. The department will not release data to a researcher requesting data from the department until all the requirements of this section have been completed to the satisfaction of the department.

(2) A researcher submitting a data request under this section must submit all of the following to the department:

(a) A completed records request form associated with the human research review board application that contains all the information required in subsection (3) of this section;

(b) Approval from the human research review board of the research proposal for which the data is being requested;

(c) A signed confidentiality agreement with the department; and

(d) All fees required by WAC 246-455-990.

(3) A researcher submitting a data request under this section must submit all of the following information on the records request forms provided by the human research review board to the department for review and approval:

(a) Project title;

(b) Principal investigator name, title, and contact information (telephone number and email address);

(c) Study abstract that includes:

(i) Description of the proposed research study and objectives;

(ii) Research study design and analysis plan;

(iii) Duration of research study;

(iv) The plan for dissemination of the results and a certification that the researcher will abide by the department's small numbers guidelines in the dissemination of results; and

(v) A plan for the return or destruction of the information at the conclusion of the research study.

(d) Patient discharge data elements needed to complete the research study;

(e) Years of the requested data; and

(f) Geographic area of interest of the research study.

(4) The department may request additional information regarding the research proposal. If additional information is requested, the researcher must submit the information within 30 days of the department's request or the request for data may be denied.

(5) If the researcher submitting a data request under this section receives an exempt determination letter from the human research review board, the researcher may:

(a) If the researcher is a governmental agency, comply with the provisions of WAC 246-455-105; or

(b) Submit a request to receive data pursuant to WAC 246-455-300.

(6) The department may deny a request for data for research purposes if the researcher submitting a data request under this section fails to meet any of the requirements of this chapter or RCW 43.70.052.