Regulation text
CODE OF STATE REGULATIONS 1JOHN R. ASHCROFT (1/29/17)
Secretary of State
Rules of
Department of Mental Health
Division 60—Research
Chapter 1—Rules for Conducting Research
and Program Evaluation
Title Page
9 CSR 60-1.010 Application for Client Research..............................................................3
9 CSR 60-1.015 Review of Research in Progress..............................................................3
9 CSR 60-1.020 Archival and Program Evaluation Activities (Rescinded March 30, 1996) ...........4
9 CSR 60-1.030 Research Review Committee (Rescinded March 30, 1996) .............................4
Title 9—DEP ARTMENT OF
MENTAL HEALTH
Division 60—Research
Chapter 1—Rules for Conducting
Research and Program Evaluation
9 CSR 60-1.010 Application for Client
Research
PURPOSE: This rule prescribes procedures
by which applications for research involving
any client or patient or any individual identi-
fied by virtue of being a former client or
patient of the department are submitted and
reviewed for approval.
(1) The terms defined in section 630.005,
RSMo are incorporated into this regulation.
As used in this administrative rule the fol-
lowing terms mean:
(A) Archival research is the review or anal-
ysis of historical data generated by the depart-
ment and kept as part of the permanent man-
agement information record;
(B) Behavioral or psychological research is
the experimentation with patients, clients, or
residents to determine the effects of manipu-
lation or application of environmental vari-
ables including, but not limited to, experi-
mental use of behavior modification;
(C) Biomedical research is experimenta-
tion by intruding into a patient’s, client’s, or
resident’s body to monitor the biological
reaction to controlled stimuli or biological
study involving experimental medical or sur-
gical procedures, withdrawal or removal of
body tissues or fluids, or input of energy or
manipulation of bodily processes;
(D) 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 disap-
proval of proposed research projects;
(E) Pharmacological research is experi-
mentation with patients, clients, or residents
to determine responses to drugs or other sub-
stances;
(F) Program evaluation is an activity
designed to assess or evaluate policies, proce-
dures, or programs currently in operation to
determine their effectiveness or usefulness or
to identify needed changes, including survey
research and specifically limited to instances
where no manipulation of variables or
condi-
tions is involved; and
(G) Research is experimentation or inter-
vention with or on departmental patients,
clients, or residents, including behavioral or
psychological research, biomedical research,
pharmacological research, and program evalu-
ation. Excluded are those instances where the
manipulation or application is intended solely
and explicitly for individual treatment of a con-
dition, falls within the prerogative of accepted
practice, and is subject to appropriate quality
assurance review. Also excluded are activities
limited to program evaluation conducted by
staff members as a regular part of their jobs,
the collection or analysis of management infor-
mation system data, archival research, or the
use of departmental statistics.
(2) Any person may request to do research on
departmental clients by requesting the appli-
cation for research with clients from the
department director or designee. It is incum-
bent on the individual wishing to conduct
research to seek and gain approval for
research before initiating the project.
(3) The person requesting to do research shall
send an application to the department direc-
tor or designee as indicated on the applica-
tion. Based on the completed application, the
department director or designee may exempt
from PRC review those projects which do not
meet the criteria of research as defined in
section (1). In the case of projects approved
by the facility director which are exempted
from review, the facility director accepts the
responsibility of insuring client confidentiali-
ty, informed consent, and the right to refuse
to participate.
(4) For approved projects, it is incumbent on
the principal investigator to ensure that exe-
cution of the project does not violate statutes.
(5) Statements provided in this regulation
shall not be construed to limit client rights
established by statutes, including the right to
informed consent and the right to refuse to
participate.
AUTHORITY: sections 630.192, 630.193 to
630.198, RSMo 2016.* Original rule filed
March 18, 1987, effective Aug. 15, 1987.
Amended: Filed July 17, 1995, effective
March 30, 1996. Amended: Filed July 26,
2016, effective Feb. 28, 2017.
*Original authority: 630.192, RSMo 1980, amended
1996, 201 1 and 630.193 to 630.198, RSMo 1980. See
Missouri Revised Statutes, 2016.
9 CSR 60-1.015 Review of Research in Pro-
gress
PURPOSE: This rule prescribes the proce-
dures by which the Professional Review
Committee may review and investigate
research.
(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 disap-
proval of proposed research projects;
(B) Approved research is any behavioral or
psychological research, biomedical research,
pharmacological research, or program evalu-
ation approved by the PRC;
(C) Facility director is the chief administra-
tor or director of a state facility, vendor facil-
ity, 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 deter-
mined by the PRC from the date of approval
until the project is completed. The principal
investigator shall submit information as spec-
ified 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 mem-
ber of the PRC or its coordinator, or with a
facility director where research is being con-
ducted. Those receiving complaints shall pro-
vide a copy of the complaint to the coordina-
tor.
(B) The coordinator shall notify the princi-
pal 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 pro-
ject.
(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 direc-
tor may chose to suspend or halt the project
after receiving notification of a com
plaint. The
CODE OF STATE REGULATIONS 3JOHN R. ASHCROFT (1/29/17)
Secretary of State
Chapter 1—Rules for Conducting Research and Program Evaluation 9 CSR 60-1
facility director shall notify the principal
investigator and the coordinator of any deci-
sion 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 devi-
ation 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 nec-
essary for the investigation.
(C) Employees of the department shall pro-
vide 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 inves-
tigation.
(E) The PRC shall rule on projects which
have been investigated.
1. The PRC may take into account infor-
mation 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 deci-
sion 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.
AUTHORITY: section 630.194, RSMo 2016.*
Original rule filed Nov. 30, 1987, effective
May 12, 1988. Rescinded: Filed Sept. 1,
1995, effective March 30, 1996. Readopted:
Filed May 20, 1996, effective Dec. 30, 1996.
Amended: Filed July 26, 2016, effective Feb.
28, 2017.
*Original authority: 630.194, RSMo 1980.
9 CSR 60-1.020 Archival and Program
Evaluation Activities
(Rescinded March 30, 1996)
AUTHORITY: sections 630.192 to 630.198,
RSMo 1986. Original rule filed March 18,
1987, effective Aug. 15, 1987. Rescinded:
Filed July 17, 1995, effective March 30,
1996.
9 CSR 60-1.030 Research Review Commit-
tee
(Rescinded March 30, 1996)
AUTHORITY: sections 630.196 and 630.198,
RSMo 1986. Original rule filed March 18,
1987, effective Aug. 15, 1987. Rescinded:
Filed July 17, 1995, effective March 30,
1996.4 CODE OF STATE REGULATIONS (1/29/17) J OHN R. ASHCROFT
Secretary of State
9 CSR 60-1—DEPARTMENT OF MENTAL HEALTH Division 60—Research