Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: This amendment removes a reference to the
Director of Research and Evaluation and updates a statutory
citation.
(1) The terms
defined in section
630.005, RSMo are
incorporated into this rule. As used in this administrative rule, the following
terms mean:
(A) Professional review committee
(PRC) is the ten- (10-) person committee established under section
630.193,
RSMo and appointed by the department director or designee to review and
recommend approval or disapproval of proposed research projects;
(B) Approved research is any behavioral or
psychological research, biomedical research, pharmacological research or
program evaluation approved by the PRC;
(C) Facility director is the chief
administrator or director of a state facility, vendor facility or vendor agency
which serves clients of the Department of Mental Health; and
(D) PRC coordinator is appointed by the
department director or designee.
(2) Research which has been approved by the
PRC shall be reviewed at one hundred eighty (180)-day intervals or more often
as determined by the PRC from the date of approval until the project is
completed. The principal investigator shall submit information as specified by
the PRC regarding the status of the research project.
(A) The principal investigator shall provide
a report of the results to the department upon completion of the
project.
(B) Based on the
information obtained in a review, the PRC shall investigate the project if any
harm, increased risk of harm or unap-proved deviation from the research
protocol occurs.
(3) Any
written complaint regarding research which produced harm, increased risk of
harm or which failed to conform to approved research protocol shall be
investigated by the PRC.
(A) A complaint may
be filed with a member of the PRC or its coordinator, or with a facility
director where research is being conducted. Those receiving complaints shall
provide a copy of the complaint to the coordinator.
(B) The coordinator shall notify the
principal investigator and all facility directors where the project is being
conducted of any complaints received.
(C) The principal investigator may respond in
writing to any complaint regarding the project.
(D) The facility director shall investigate
the complaint and provide recommendations to the coordinator of the PRC within
ten (10) days of the filing of the complaint. The facility director may chose
to suspend or halt the project after receiving notification of a complaint. The
facility director shall notify the principal investigator and the coordinator
of any decision to suspend or halt a research project.
(4) The PRC may investigate any research
project which it has approved. The PRC shall investigate any approved research
project when it has reason to believe that harm or increased risk of harm to
the subjects or deviation from approved protocol has occurred.
(A) The PRC may halt the research project
while it is under investigation.
(B) The principal investigator shall provide
information requested by the PRC that is necessary for the
investigation.
(C) Employees of the
department shall provide information requested by the PRC that is necessary for
the investigation.
(D) Staff of
vendor agencies serving clients of the department shall provide information
requested by the PRC necessary for the investigation.
(E) The PRC shall rule on projects which have
been investigated.
1. The PRC may take into
account information received from the facility director where the project is
conducted, from the principal investigator, and from other sources having
information pertaining to the project.
2. The PRC may rule to halt the project or
suspend the project until deficiencies are corrected.
3. The principal investigator and the
facility director shall be notified of the decision of the PRC.
(5) At the request of a
facility director, the PRC may investigate research activities which have not
been reviewed including archival studies and program evaluation
projects.
*Original authority: 630.194, RSMo
1980.
