34-14-1
Information obtained in medical studies confidential--Inadmissibility in
evidence.
34-14-2
Omitted.
34-14-3
Disclosure of information from medical study as misdemeanor.
34-14-4
Immunity from liability for furnishing information to research agencies.
34-14-5
Physician's consent required for research interviews.
34-14-6
Legislative findings as to use of animals in research.
34-14-7 to 34-14-9. Repealed.
34-14-10, 34-14-11. Repealed.
34-14-12 to 34-14-15. Repealed.
34-14-16
Research that destroys human embryo prohibited--Violation as misdemeanor.
34-14-17
Research subjecting human embryo to substantial risk prohibited--Sale or
transfer of embryos for research prohibited--Violation as misdemeanor.
34-14-18
Use of cells or tissues obtained in violation of § 34-14-16 or 34-14-17
prohibited.
34-14-19
"Nontherapeutic research" defined.
34-14-20
"Human embryo" defined.
34-14-21
Definition of terms used in §§ 34-14-21 to 34-14-24.
34-14-22
Informed consent required prior to predictive genetic testing--Minimum
requirements of written, informed consent.
34-14-23
Person to be tested to receive copy of signed consent form--Original signed
form to be filed in medical records.
34-14-24
Tests performed in pursuance of criminal investigation or court order not
affected.
34-14-25
Genetic testing to be performed by accredited laboratory enrolled in proficiency
testing program--State health laboratory not affected.
34-14-26
Definition of terms.
34-14-27
Human cloning as felony--Civil penalty.
34-14-28
Scientific research not restricted if not prohibited.
34-14-1. Information obtained in medical studies confidential--Inadmissibility in evidence.
All information, interviews, reports, statements, memoranda, or other data procured by the Department of Health, South Dakota State Medical Association, allied medical societies, or in-hospital staff committees of accredited hospitals in the course of a medical study for the purpose of reducing morbidity or mortality shall be strictly confidential and shall only be used for medical research.
Such information, records, reports, statements, notes, memoranda, or other data, shall not be admissible as evidence in any action of any kind in any court or before any tribunal, board, agency, or person.
Source: SL 1959, ch 134, §§ 1, 2; SDC Supp 1960, § 27.0117.
34-14-3. Disclosure of information from medical study as misdemeanor.
It is a Class 1 misdemeanor to disclose any information, records, reports, statements, notes, memoranda, or other data obtained for or contained in any medical study for the purpose of reducing morbidity or mortality, except that necessary for the purpose of the specific study.
Source: SL 1959, ch 134, §§ 5, 6; SDC Supp 1960, §§ 27.9960, 27.9961; SDCL, § 34-14-2; SL 1977, ch 190, § 22.
34-14-4. Immunity from liability for furnishing information to research agencies.
The furnishing of information described in § 34-14-1 in the course of a research project to the Department of Health, South Dakota State Medical Association, or allied medical societies or their authorized representatives, shall not subject any person, hospital, sanitarium, nursing, or rest home or any such agency to any action for damages or other relief.
Source: SL 1959, ch 134, § 3; SDC Supp 1960, § 27.0117.
34-14-5. Physician's consent required for research interviews.
No patient, or patient's relatives, or patient's friends named in any medical study, shall be interviewed for the purpose of such study unless consent of the attending physician and surgeon is first obtained.
Source: SL 1959, ch 134, § 4; SDC Supp 1960, § 27.0117.
34-14-6. Legislative findings as to use of animals in research.
The public health and welfare depend on the humane use of animals for the diagnosis and treatment of human and animal diseases, the advancement of veterinary, dental, medical, and biological sciences, and the testing and diagnosis, improvement, and standardization of laboratory specimens, biologic products, pharmaceuticals, and drugs.
Source: SL 1951, ch 136, § 1; SDC Supp 1960, § 27.2601.
34-14-7 to 34-14-9. Repealed by SL 2012, ch 177, §§ 9 to 11.
34-14-12 to 34-14-15. Repealed by SL 2012, ch 177, §§ 12 to 15.
34-14-16. Research that destroys human embryo prohibited--Violation as misdemeanor.
No person may knowingly conduct nontherapeutic research that destroys a human embryo. A violation of this section is a Class 1 misdemeanor.
Source: SL 2000, ch 169, § 1.
34-14-17. Research subjecting human embryo to substantial risk prohibited--Sale or transfer of embryos for research prohibited--Violation as misdemeanor.
No person may knowingly conduct nontherapeutic research that subjects a human embryo to substantial risk of injury or death. No person may sell or transfer a human embryo with the knowledge that the embryo will be subjected to nontherapeutic research. A violation of this section is a Class 1 misdemeanor.
Source: SL 2000, ch 169, § 2.
34-14-18. Use of cells or tissues obtained in violation of § 34-14-16 or 34-14-17 prohibited.
No person may use for research purposes cells or tissues that the person knows were obtained by performing the activities described in §§ 34-14-16 and 34-14-17. A violation of this section is a Class 1 misdemeanor.
Source: SL 2000, ch 169, § 3.
34-14-19. "Nontherapeutic research" defined.
For purposes of §§ 34-14-16 to 34-14-20, inclusive, the term, nontherapeutic research, means research that is not intended to help preserve the life and health of the particular embryo subjected to risk. It does not include in vitro fertilization and accompanying embryo transfer to a woman's body or any diagnostic test which may assist in the future care of a child subjected to such tests.
Source: SL 2000, ch 169, § 4.
34-14-20. "Human embryo" defined.
For purposes of §§ 34-14-16 to 34-14-20, inclusive, the term, human embryo, means a living organism of the species Homo sapiens at the earliest stages of development (including the single-celled stage) that is not located in a woman's body.
Source: SL 2000, ch 169, § 5.
34-14-21. Definition of terms used in §§ 34-14-21 to 34-14-24.
Terms used in §§ 34-14-21 to 34-14-24, inclusive, mean:
(1) "Genetic information," information derived from a genetic test about a gene, gene product, or inherited characteristic;
(2) "Genetic test," a test of human DNA, RNA, chromosomes, or genes performed in order to identify the presence or absence of an inherited variation, alteration, or mutation which is associated with predisposition to disease, illness, impairment, or other disorder. Genetic test does not mean a routine physical measurement; a chemical, blood, or urine analysis; a test for drugs or HIV infection; any test commonly accepted in clinical practice; or any test performed due to the presence of signs, symptoms, or other manifestations of a disease, illness, impairment, or other disorder;
(3) "Predictive genetic test," a genetic test performed for the purpose of predicting the future probability that the person tested will develop a genetically related disease or disability.
Source: SL 2001, ch 184, § 1.
34-14-22. Informed consent required prior to predictive genetic testing--Minimum requirements of written, informed consent.
No person may order or perform a predictive genetic test without first obtaining the written, informed consent of the person to be tested. For purposes of this section, written, informed consent consists of a signed writing executed by the person to be tested or the legally authorized representative of the person to be tested that includes, at a minimum, all of the following:
(1) The nature and purpose of the predictive genetic test;
(2) The effectiveness and limitations of the predictive genetic test;
(3) The implications of taking the predictive genetic test, including, the medical risks and benefits;
(4) The future uses of the sample taken from the person tested in order to conduct the predictive genetic test and the information obtained from the predictive genetic test;
(5) The meaning of the predictive genetic test results and the procedure for providing notice of the results to the person tested; and
(6) A listing of who will have access to the sample taken from the person tested in order to conduct the predictive genetic test and the information obtained from the predictive genetic test, and the person's right to confidential treatment of the sample and the information.
Source: SL 2001, ch 184, § 2.
34-14-23. Person to be tested to receive copy of signed consent form--Original signed form to be filed in medical records.
If a person to be tested or the person's legally authorized representative signs a copy of the informed consent form developed pursuant to § 34-14-22, the person obtaining the informed consent shall give the person to be tested a copy of the signed informed consent form and shall include the original signed informed consent form in the medical record of the person tested.
Source: SL 2001, ch 184, § 3.
34-14-24. Tests performed in pursuance of criminal investigation or court order not affected.
Nothing in §§ 34-14-21 to 34-14-24, inclusive, or § 34-14-25, alters the ability to perform genetic tests done in pursuance of a lawful criminal investigation or court order.
Source: SL 2001, ch 184, § 4; SL 2002, ch 166, § 2.
34-14-25. Genetic testing to be performed by accredited laboratory enrolled in proficiency testing program--State health laboratory not affected.
If a genetic test, as defined in § 34-14-21, is required or authorized by state law, or performed in the state, the test shall be performed in a laboratory accredited by the College of American Pathologists, the Joint Commission on Accreditation of Healthcare Organizations, or any accreditation body approved by the United States Secretary of Health and Human Services and which has requirements that are substantially equivalent to, or more comprehensive than, those of the College of American Pathologists. In addition, the laboratory shall be enrolled in a proficiency testing program sponsored by an organization approved by the Centers for Medicare and Medicaid Services. Nothing in this section alters the ability of the state health laboratory to perform genetic tests.
Source: SL 2002, ch 166, § 1.
34-14-26. Definition of terms.
Terms used in §§ 34-14-26 to 34-14-28, inclusive, mean:
(1) "Human cloning," human asexual reproduction accomplished by introducing the nuclear material of a human somatic cell into a fertilized or unfertilized oocyte whose nucleus has been removed or inactivated to produce a living organism, at any stage of development, with a human or predominantly human genetic constitution;
(2) "Human somatic cell," a diploid cell, having a complete set of chromosomes, obtained or derived from a living or deceased human body at any stage of development;
(3) "Nuclear transplantation," transferring the nucleus of a human somatic cell into an oocyte from which the nucleus or all chromosomes have been or will be removed or rendered inert;
(4) "Nucleus," the cell structure that houses the chromosomes, and thus the genes;
(5) "Oocyte," the female germ cell, the egg.
Source: SL 2004, ch 227, § 1.
34-14-27. Human cloning as felony--Civil penalty.
No person or entity, public or private, may:
(1) Perform or attempt to perform human cloning;
(2) Participate in an attempt to perform human cloning;
(3) Transfer or receive the product of human cloning; or
(4) Transfer or receive, in whole or in part, any oocyte, embryo, fetus, or human somatic cell, for the purpose of human cloning.
Any person that knowingly or recklessly violates this section is guilty of a Class 6 felony. Any person or entity that violates this section and derives a pecuniary gain from such violation is subject to a civil penalty of two thousand dollars or twice the amount of gross gain, or any intermediate amount at the discretion of the court.
Source: SL 2004, ch 227, § 2.
34-14-28. Scientific research not restricted if not prohibited.
Nothing in §§ 34-14-26 to 34-14-28, inclusive, restricts areas of scientific research not specifically prohibited by §§ 34-14-26 to 34-14-28, inclusive, including research in the use of nuclear transfer or other cloning techniques to produce molecules, deoxyribonucleic acid, cells other than human embryos, tissues, organs, plants, or animals other than humans.
Source: SL 2004, ch 227, § 3.
