65-4974. Research protocols; informed consent of adults and emancipated minors.
65-4974
65-4974. Research protocols; informed consent ofadults and emancipated minors.(a) In accordance with the provisions of 21 C.F.R. 56.101, et seq., andamendments thereto, and 45 C.F.R. 46.101, et seq., and amendments thereto, inthe case of an adult or emancipated minor who: (1) Is being treated by a personlicensed to practice medicine and surgery and who has medical staff membershipwith a medical care facility, as defined in K.S.A. 65-4921, and amendmentsthereto, that has its own, or contracts with, an independent institutionalreview board; and (2) is incapable of giving informed consent for the researchprotocol, which has been approved by an institutional review board, theresearch protocol may proceed upon obtaining the informed consent of the adultor emancipated minor's legal guardian or the attorney in fact with theauthority 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 madeor neither ofthe parties described in subsection (a) can be contacted using reasonablydiligent efforts, anymember of the adult or emancipated child's family, in the order listed in thissubsection, who hasthe capacity to provide informed consent and can be contacted using reasonablydiligent effortsmay provide informed consent to a research protocol, as described in subsection(a). The order ofpriority for family members to provide consent is as follows:
(1) The adult or emancipated minor's spouse, unless they are legallyseparated;
(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 infact with theauthority to make health care decisions or family member authorized to provideinformedconsent pursuant to subsection (b) to provide informed consent as to researchprotocols that arecontrary to the incapacitated person's permission, expressed orally or inwriting, regarding suchresearch protocols.
History: L. 2004, ch. 109, § 1; July 1.