CHAPTER 44:22:04
CONFIDENTIALITY OF REPORTS AND DATA
Section
44:22:04:01 Duty to maintain confidentiality.
44:22:04:02 Publication of data.
44:22:04:03 Data for research.
44:22:04:01. Duty to maintain confidentiality.
Information contained in the central cancer registry constitutes medical
research. Confidentiality of identifying data shall be maintained in accordance
with SDCL 34-14-1.
Source:
18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32
SDR 69, effective November 7, 2005.
General
Authority: SDCL 1-43-13.
Law
Implemented: SDCL 1-43-11, 1-43-13, 34-14-1.
44:22:04:02. Publication of data. Published information
may not contain the name of an individual who is or was the subject of a report
of cancer submitted to the department and may not contain an identifying
number, mark, or description which can be readily associated with an individual
who is or was the subject of a report of cancer submitted to the department.
All published data must be presented in such a statistical manner that no
person can be identified. Data existing in cells with zero counts shall be
published as "0" and cells with data counts of "1" or
"2" shall be published as less than three individuals except on a
statewide basis. Except as provided in § 44:22:05:01, published
information may not identify reporting entities in relation to cancer data or
statistics.
Source:
18 SDR 142, effective March 9, 1992; 32 SDR 69, effective November 7, 2005.
General
Authority: SDCL 1-43-13.
Law
Implemented: SDCL 1-43-11, 1-43-13.
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.
Source:
32 SDR 69, effective November 7, 2005.
General
Authority: SDCL 1-43-13.
Law
Implemented: SDCL 1-43-11, 1-43-13, 34-14-1.