65-4974. Research protocols; informed consent of adults and emancipated minors. (a) In accordance with the provisions of 21 C.F.R. § 56.101 et seq., and amendments thereto, and 45 C.F.R. § 46.101 et seq., and amendments thereto, in the case of an adult or emancipated minor who: (1) Is being treated by a person licensed to practice medicine and surgery and who has medical staff membership with a medical care facility, as defined in K.S.A. 65-4921, and amendments thereto, that has its own, or contracts with, an independent institutional review board; and (2) is incapable of giving informed consent for the research protocol, which has been approved by an institutional review board, the research protocol may proceed upon obtaining the informed consent of the adult or emancipated minor's legal guardian or the attorney in fact with the authority to make health care decisions for that person pursuant to K.S.A. 58-625 et seq., and amendments thereto.
(b) If neither of the designations described in subsection (a) has been made or neither of the parties described in subsection (a) can be contacted using reasonably diligent efforts, any member of the adult or emancipated child's family, in the order listed in this subsection, who has the capacity to provide informed consent and can be contacted using reasonably diligent efforts may provide informed consent to a research protocol, as described in subsection (a). The order of priority for family members to provide consent is as follows:
(1) The adult or emancipated minor's spouse, unless they are legally separated;
(2) an adult child;
(3) a parent; or
(4) an adult relative by blood or marriage.
(c) Nothing in this section shall authorize a legal guardian, attorney in fact with the authority to make health care decisions or family member authorized to provide informed consent pursuant to subsection (b) to provide informed consent as to research protocols that are contrary to the incapacitated person's permission, expressed orally or in writing, regarding such research protocols.
History: L. 2004, ch. 109, § 1; July 1.
Structure Kansas Statutes
Article 49 - Health Care Providers
65-4902 Same; notice to parties; designation or selection of health care provider.
65-4905 Rejection by one or more parties; court action.
65-4906 Immunity of screening panel from damages, when.
65-4907 Compensation of panel members; assessment of costs.
65-4908 Filing memorandum request for panels to toll statute of limitations, when.
65-4914 Public policy relating to provision of health care.
65-4923 Reporting requirements.
65-4924 Reports relating to impaired providers; procedures.
65-4926 Immunity from civil liability for report or investigation, limits.
65-4927 Failure to report; remedies; immunity from civil liability.
65-4928 Employer retribution for reporting; prohibition; remedy.
65-4930 Act supplemental to existing law.
65-4941 Do not resuscitate orders or directives; definitions.
65-4943 Same; requirements of form.
65-4944 Same; immunity from liability.
65-4945 Same; existing documents, compliance with act.
65-4946 Same; DNR identifier; duties of emergency medical services board; rules and regulations.
65-4947 Same; validity of DNR order during transport of patient.
65-4948 Same; rules and regulations.
65-4955 Health care provider cooperation act; legislative findings; protection of public.
65-4961 Same; advisory committee of health care providers created.
65-4969 Contact lens advisory council established; membership on council; expenses of members.
65-4974 Research protocols; informed consent of adults and emancipated minors.
65-4975 Pain patient's quality of care act.
65-4976 Legislative findings on pain treatment.
65-4977 Persons suffering from pain; use of controlled substances for pain treatment.
65-4978 Medical retainer agreement; definitions; requirements; notice.