The State of Missouri has enacted legislation that outlines how research participants unable to consent for themselves may be enrolled in research studies. The state recognizes the spouse as the highest priority for providing consent on behalf of another and specifically lists the circumstances under which the spouse may be bypassed. The guidelines below are to be used when consent of a legally authorized representative is used to enroll research participants.
For all studies of Greater than Minimal Risk:
The Missouri statute lists the people who may give consent on behalf of a potential participant who is incapacitated. The order is as follows: Legal guardian, attorney-in-fact, or family member in the following order of priority:
- Spouse, unless the patient has no spouse, or is separated, or the spouse is physically or mentally incapable of giving consent, or the spouse’s whereabouts is unknown or the spouse is overseas;
- Adult child;
- Brother or sister;
- Relative by blood or marriage.
This priority order is to be followed without deviation; that is, if the potential participant has a spouse, the spouse must give consent (unless the spouse is unavailable as described above). Consent may only be sought from the adult child if there is (1) no spouse; or (2) the spouse is unavailable as described above.
The standard language in the informed consent document has been revised to help make this clear.
For Minimal Risk Studies:
Because the statute describes the situations of “experimental treatment, test or drug”, studies that are minimal risk in nature may use the LAR process in a more flexible way. If the spouse in not generally available, after documented attempts to contact the spouse, you may proceed down the list to obtain consent from one of the others on the list.
This scenario ONLY applies to minimal risk studies.
Download the LAR Consent Note to File [DOC]. (Sample record of attempts to contact spouse)
Missouri Revised Statutes
General Provisions as to Contracts
August 28, 2010
Experimental treatment, tests, and drugs, consent to administer by third party–life-threatening emergencies, consent by whom.
431.064. 1. When an adult person, because of a medical condition, is treated by a teaching hospital for a medical school accredited by the Americal Osteopathic Association or the Americal Medical Association and such person is incapable of giving informed consent for an experimental treatment, test or drug, then such treatment, test or drug may proceed upon obtaining consent of a legal guardian, attorney-in-fact, or a family member in the following order or priority:
(1) Spouse unless the patient has no spouse, or is separated, or the spouse is physically or mentally incapable of giving consent, or the spouse’s whereabouts is unknown or the spouse is overseas;
(2) Adult Child;
(4) Brother or sister;
(5) Relative by blood or marriage.
2. Nothing in this section shall authorize such legal guardian, attorney-in-fact, or family member to consent to treatment in contravention to such incapacitated person’s expressed permission regarding such treatment.
3. In a life-threatening emergency, consent of such an incapacitated person to any research program or experimental procedure shall not be required when the institutional review board responsible for the review, approval, and continuing review of the research activity has approved both the research activity and a waiver of informed consent and has both found and documented that the requirements for an exception from informed consent requirements for emergency research, as provided under Part 50 of Title 21 or Part 46 of Title 45 of the Code of Federal Regulations, as amended, have been satisfied.