Download HRP-Policy-111 Research Involving Adults Under Court

IRB: Research Involving Adults under Court Jurisdiction
Policy number:
HRP-111
References:
Minnesota Statute 253B.095, Subd.; Minnesota Statute 524.5313(c)(4)(i)
Date: 8/15/16
Policy Owner:
Executive Director, HRPP
Cross Reference:
HRP-023; HRP-322
Definitions:
None
1.0 Reason for Policy
The University of Minnesota is committed to the ethical and responsible conduct of research and to ensuring
that the rights and welfare of participants are protected. Research involving adults under court jurisdiction may
not be enrolled in human research.
2.0 Scope of Policy
This policy establishes conditions under which potential subjects may not be enrolled
3.0 Policy Statement
Adults Under a Hold
Due to the potential for coercion or undue influence and concerns about potential lack of decisional capacity or
diminished capacity to consent, researchers may not recruit or enroll the following persons in any clinical drug
trial under Minnesota law (effective August 1, 2016) and/or existing IRB Policy: 1) individuals subject to a
commitment petition; and/or 2) individuals temporarily confined involuntarily under: a) 72-hour emergency
admission holds; b) “intent to leave” periods; or c) peace officer/health officer authority (formerly “transport
hold”) or a court apprehend and hold order.
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This restriction applies during the period of the emergency admission or hold. It does not prohibit a person
already enrolled in a clinical drug trial at the time of the emergency admission or peace officer/court hold from
continuing their participation.
Under IRB Policy, the above restrictions on recruitment and enrollment also apply to any clinical trial involving
psychiatric devices or biologics (as well as all clinical drug trials).
Additionally, under Minnesota law, an individual who has had a commitment hearing, and is released by the
court before a commitment order is issued, is prohibited from participating in a psychiatric clinical drug trial
during the period of a stay of commitment, unless the court specifically authorizes the participation.1
Investigators wishing to recruit such individuals must provide justification for doing do and a process compliant
with the terms of the statute.
In addition, no member of a study team may participate in a decision to rescind or discontinue a patient’s
involuntary status (as described above) before its expiration, provisionally discharge a committed patient, or
rescind a provisional discharge, when the patient is a prospective research subject for a study conducted by the
study team.
Adults Under Court Appointed Guardianship
Under Minnesota law, adults with court appointed guardians may not participate in “experimental treatment of
any kind” unless: 1) the court first approves the treatment through a court order; 2 or 2) the court’s guardianship
order specifically authorizes the guardian to consent for research participation in addition to medical treatment
generally. The University interprets “experimental treatment” in this context to align with the National Institutes
of Health (NIH) definition of a clinical trial as a “research study in which one or more human subjects are
prospectively assigned to one or more interventions to evaluate the effects of those interventions on healthrelated or behavioral outcomes.” As such, any investigator who seeks to enroll or include participants who are
under a legal guardianship must propose specific processes to ensure and to document that necessary judicial
orders are secured for each such participant, as well as comply with the tenets of this policy as applicable.
Adults Classified as "Incompetent"
Competence is a legal state, not a medical state. Distinct from capacity, competence may only be determined
by a court of law. Under this policy, adults who are individually adjudicated or classified by law as
"incompetent" may be considered for participation in research but are automatically deemed to lack capacity to
consent to participation. Investigators intending to include or recruit such individuals must include in the
protocol a strong rationale for doing so and plans for use of an LAR to consent to the research.
These requirements are not intended to prevent access by individuals to potentially life-saving experimental
treatment. See HRP-023 - SOP - Emergency Use Review and HRP-322 - WORKSHEET - Emergency Use.
4.0 Required approvals for this document
Title
Executive Director, HRPP
1
2
Minnesota Statute 253B.095, Subd. 1(e). https://www.revisor.mn.gov/statutes/?id=253B.095
Minnesota Statute 524.5-313(c)(4)(i). https://www.revisor.mn.gov/statutes/?id=524.5-313
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5.0 Revision History
Revision
8/2/16
5/25/16
Reason for change
Minor clarifications
Original
Date of release
8/15/16
To obtain a copy of a historical policy, e-mail at [email protected] or call 612-626-5654
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