Wash. Admin. Code § 246-492-100 - Requests for birth or fetal death record data that contains direct identifiers for research purposes

(1) A researcher requesting birth or fetal death record data that contains direct identifiers for research purposes must comply with the requirements of chapter 70.58A RCW 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 state registrar.

(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 246-492-990.

(3) A researcher submitting a data request under this section must submit all of the following information on the records request form provided by the human research review board to the state registrar 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) Vital records 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 state registrar may request additional information regarding the research proposal. If additional information is requested, the researcher must submit the information within thirty days of the state registrar'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 and will use the data for a public health purpose, comply with the provisions of WAC 246-492-200; or

(b) Submit a request to receive data pursuant to WAC 246-492-300.

(6) The state registrar may deny a request for data for research purposes if the researcher submitting a data request under this section fails to meet the requirements of this section or chapter 70.58A RCW, or for the reasons permitted by chapter 70.58A RCW. If the state registrar denies a request under this section, the researcher may appeal the decision by requesting a brief adjudicative proceeding pursuant to WAC 246-10-501 through 246-10-505, and RCW 70.58A.550.

Notes

Wash. Admin. Code § 246-492-100

Adopted by WSR 21-06-041, Filed 2/24/2021, effective 4/1/2021