Utah Administrative Code

The Utah Administrative Code is the body of all effective administrative rules as compiled and organized by the Division of Administrative Rules (see Subsection 63G-3-102(5); see also Sections 63G-3-701 and 702).

NOTE: For a list of rules that have been made effective since April 1, 2019, please see the codification segue page.

NOTE TO RULEFILING AGENCIES: Use the RTF version for submitting rule changes.


R436. Health, Center for Health Data, Vital Records and Statistics.

Rule R436-17. Review and Approval of Research Requests.

As in effect on April 1, 2019

Table of Contents

R436-17-1. Purpose and Authority.

(1) This rule sets forth procedures for the review and approval of research requests received by the Bureau of Vital Records and Health Statistics.

(2) Authority for this rule is found in Sections 26-2-3 and 26-2-22.

R436-17-2. Definitions.

In addition to the definitions in Section 26-2-2, "Institutional Review Board" or "IRB" means a multi-disciplinary committee which reviews proposed research involving human subjects.

R436-17-3. Requests for Access to Records for Research.

(1) If the research does not involve the use of any personal identifying information from the vital records, the State Registrar shall provide the researcher with the requested statistical information upon receipt of the written request and payment of the associated costs.

(2) If the research involves the use of personal identifying information, the request must be in writing and must be signed by the researcher. In addition:

(a) The request must outline the research protocol to be used.

(b) If the research involves a follow-back or follow-up study, the request must describe who is to be contacted, how, by whom, and what questions will be asked. If a survey is planned, a copy of the survey must be submitted. Approval by an Institutional Review Board must be included with the request.

(c) If the research involves linking data files, the variables to be used to determine the match must be identified.

(d) The researcher and all persons who may have access to the identifying information in the vital records shall sign a Researcher's Confidentiality Agreement, which is available from the Bureau of Vital Records and Health Statistics.

(e) The researcher may not use or allow other persons to use the vital records information for any purpose other than the approved research.

(f) The State Registrar shall review all research requests upon receipt at which time one of the following outcomes may occur:

(i) The request is approved and the researcher is notified in writing of the approval and of the associated costs.

(ii) The request is given tentative approval and the researcher:

(A) is notified in writing of the approval and associated costs;

(B) discusses and resolves technical concerns identified by the State Registrar. (iii) The request is not approved and the researcher is:

(A) notified in writing the reasons for the disapproval;

(B) notified of the areas of concern with the request;

(C) allowed to address the areas of concern and resubmit the request.

(D) notified that the decision to deny may be appealed to the Executive Director of the Department of Health.

R436-17-4. Approval by Institutional Review Board.

(1) The State Registrar may require approval by an Institutional Review Board before authorizing a researcher access to the vital records.

(2) The IRB shall deny a research proposal if:

(a) it violates any federal or state law;

(b) the risks to the subjects outweighs the benefits to them or society;

(c) unnecessary risks are created;

(d) selection of subjects is inequitable;

(e) procedures for obtaining and documenting informed consent are inadequate;

(f) payment or other offered inducements are likely to influence subjects' judgment;

(g) the study is poorly or improperly designed such that meaningful conclusions cannot be derived.

R436-17-5. Confidentiality Requirements.

Researchers shall abide by the confidentiality requirements specified in the Researcher's Confidentiality Agreement. Failure to observe the confidentiality requirements shall result in the loss of privilege to access vital records for research purposes and may also result in civil court action pursuant to Section 26-23-5. Vital records information may only be used for the designated research and must be destroyed at the conclusion of the study, or returned to the State Registrar. If the researcher destroys the vital records the State Registrar shall be informed in writing. The information may not be used for other research unless authorized by the State Registrar.

KEY

vital statistics, research

Date of Enactment or Last Substantive Amendment

1993

Notice of Continuation

March 21, 2018

Authorizing, Implemented, or Interpreted Law

26-2-3; 26-2-22


Additional Information

Contact

For questions regarding the content or application of rules under Title R436, please contact the promulgating agency (Health, Center for Health Data, Vital Records and Statistics). A list of agencies with links to their homepages is available at http://www.utah.gov/government/agencylist.html or from http://www.rules.utah.gov/contact/agencycontacts.htm.