Utah Administrative Code
Topic - Human Services
Title R495 - Administration (Human Services)
Rule R495-820 - Institutional Review Board
Section R495-820-6 - Research Involving Placebos
Universal Citation: UT Admin Code R 495-820-6
Current through Bulletin 2024-06, March 15, 2024
(1) When the use of placebos is proposed, the Department imposes the following restrictions to protect participants from studies that would withhold active treatment:
(a) The DHS IRB shall not approve
placebo studies that target individuals having:
(i) Any pending criminal case;
(ii) Who are incarcerated or in detention;
or
(iii) Who have a pending
competency evaluation or commitment procedure.
(iv) No minor or vulnerable adult under the
guardianship or custody of any division of the Department may be recruited,
enrolled, or participate in any research study that involves the use of a
placebo.
(v) A serious medical or
mental illness.
(b) If an
individual has entered a study prior to involvement with civil or criminal
legal proceedings, and subsequently becomes involved in any such action, the
researcher shall report the event to:
(i) The
DHS IRB;
(ii) The agency or entity
that has assumed guardianship or responsibility for that person, if
any.
(ii) If a minor or vulnerable
adult has entered a study involving placebos prior to entrance into state
guardianship or legal custody, then a referral will be made to the division
gatekeeper or entity that has guardianship or custody, to determine whether the
minor's or vulnerable adult's continued participation in the study is
appropriate. That determination shall consider:
(A) The opinions of medical or psychological
experts who have provided care for the minor or vulnerable adult prior to and
during the study;
(B) If the
placebo research involves a minor in the custody of the Division of Child and
Family Services, the minor's Guardian ad Litem, if one has been appointed,
shall be notified and that notification shall be documented in Department
records and sent to the DHS IRB.
(C) If the minor's parent(s), prior to the
minor's entrance into state custody or guardianship, had agreed to and signed
an informed consent form prior to the minor's participation in the
study.
(D) If the placebo research
involves a vulnerable adult who is a ward of the Office of Public Guardian, the
Office of Public Guardian shall be notified and that notification shall be
documented in Department records and sent to the DHS
IRB.
(c)
Placebos may only be used in studies where no proven or known effective
standard of care, prophylactic, diagnostic, or therapeutic method exists. If a
proven or known effective standard of care or treatment exists, whether or not
the standard of care has been subjected to empirical testing, that treatment
shall not be withheld unless the participant is also receiving another known
effective standard of care or treatment during the duration of his/her study
participation. The IRB may consider for review placebo studies as long as
participants continue to receive a known pharmaceutical and/or
psychotherapeutic standard of care.
(d) Recruitment for the placebo study shall
not be limited exclusively to subjects who are receiving services that are
either partially or fully funded by monies allocated through the
Department.
(e) If the minor or
adult has a current diagnosis of serious mental illness at the beginning of a
proposed study, the individual will be excluded from participation in placebo
studies, unless the participant is also receiving, and continues to receive
during the study participation, another active known effective standard of
pharmaceutical or non-pharmaceutical care or treatment intervention.
(f) Frequent and close clinical monitoring,
as dictated by the medical need of each client, is required in order to assure
the ongoing safety and well-being of each human subject. Monitoring shall be
documented by the researchers and medical personnel in each client's clinical
record.
(g) Any individual with
active homicidal or suicidal ideations, or who poses a foreseeable threat to
themselves or others, is prohibited from participation in any study that
involves the use of a placebo.
Disclaimer: These regulations may not be the most recent version. Utah may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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