S.D. Admin. R. 44:22:04:03

Current through Register Vol. 51, page 57, November 12, 2024

Section 44:22:04:03 - Data for research

The department may approve any applicant who submits written application to obtain access to case-specific data or case-specific and patient-identifying data to assist in the applicant's research for cancer prevention, control, and treatment in order to reduce morbidity and mortality as described in SDCL 34-14-1. The applicant shall certify that:

(1) The applicant is a qualified researcher sponsored by a public or private college or university, governmental entity, non-profit medical, sociological or psychological association, or pharmaceutical industry;

(2) The data requested will be used for scientific or medical research for the prevention, cure, or control of cancer only;

(3) Disclosure of the information is necessary to accomplish the purposes of the research;

(4) The research project has been reviewed and approved by an institutional review board on the lists of registered Institutional Review Boards or Independent Ethics Committees and approved Assurances of the Office for Human Research Protections, U.S. Department of Health and Human Services;

(5) No patient, or patient's relatives or friends, will be contacted without prior approval of the patient's physician in accordance with SDCL 34-14-5;

(6) The applicant will maintain the confidentiality and security of the data obtained by establishing adequate safeguards;

(7) The applicant will comply with all federal and state laws, and department guidelines regarding release of data with identifying information and with de-identified information;

(8) The applicant agrees to pay the department reasonable costs of data retrieval and data processing as determined and billed by the department; and

(9) The applicant will provide the results of the research to the department at no cost and not publish the results until two months after submission to the department and that any publication will acknowledge the department and its central cancer registry.

S.D. Admin. R. 44:22:04:03

32 SDR 69, effective 11/7/2005.

General Authority: SDCL 1-43-13.

Law Implemented: SDCL 1-43-11, 1-43-13, 34-14-1.