/policies/,/policies/administrative/,/policies/administrative/uwhc/,/policies/administrative/uwhc/uwhc-wide/,/policies/administrative/uwhc/uwhc-wide/environmental-safety/,

/policies/administrative/uwhc/uwhc-wide/environmental-safety/1210.policy

201611322

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UWHC,UWMF,

Policies,Administrative,UWHC,UWHC-wide,Environmental Safety

Research Safety Committee Authority and Function (12.10)

Research Safety Committee Authority and Function (12.10) - Policies, Administrative, UWHC, UWHC-wide, Environmental Safety

12.10

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Administrative (Non-Clinical) Policy
Category:
 UWHC only (Hospital Administrative-entity wide)  UWMF only (entity wide)
 UWHC Departmental (indicate name)  UWMF Departmental (indicate name)
 UWHC and UWMF (shared)
Policy Title: Research Safety Committee Authority & Function
Policy Number: 12.10
Effective Date: August 1, 2015
Chapter: Environmental Safety
Version: Revision
I. PURPOSE

To establish a process by which clinical (human) research protocols possessing potential health hazards
are identified, reviewed and approved before entrance into the University of Wisconsin's Hospital and
Clinics (UWHC) health system network.

II. POLICY

Research protocols involving drugs and/or agents possessing potential health hazards must be reviewed
and approved by the Research Safety Committee (RSC) before said research could begin at UWHC. This
committee will focus on research protocols possessing safety concerns that are not adequately covered by
existing biohazardous or cytotoxic policies and/or where safety policies do exist but the research novelty,
location, route of administration or employees involved render the standard operating procedures not
applicable or inadequate. Research protocols affected by this policy are:
• Protocols requiring Institutional Biosafety Committee (IBC) approval (eg., gene transfer
protocols)
• Research protocols intentionally exposing subjects to infectious agents
• Other research protocols that meet novelty or hazardous criteria for review by the Research
Safety Committee
III. FORMS USED

RSC Application form (Appendix A)

IV. PROCEDURE
A. Identification of research protocols that require RSC review and approval
1. Affected protocols will be identified as they are processed through the UW Health
Sciences Institutional Review Board (IRB) IRB
2. Affected protocols may also be identified in advance of IRB submission by:
a. The Pharmaceutical Research Center (PRC) program
b. Principal investigators (PI) and/or study coordinators
B. Submission process for RSC review

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1. Once identified, PI will be informed that their protocol requires RSC review and approval
and will be instructed to submit to the RSC Chair, the following information a minimum
of 2 weeks prior to the scheduled RSC meeting:
a. An electronic copy of the most up to date protocol
b. An electronic copy of the investigational drug brochure (if available)
c. An electronic copy of the pharmacy manual/preparation instructions (if available)
d. A completed RSC Application form depicting all involved areas as well as the
movement of the research subject from the point of UWHC arrival to discharge
and subsequent study visits.
2. The RSC meets the third Wednesday of the month from 1300-1400. If no protocols are
received by the submission deadline, the meeting will be cancelled.
3. RSC review and approval is protocol specific, not agent specific. Therefore if an
investigator is conducting two protocols with the same agent, and that agent meets
novelty and hazardous criteria for RSC review and approval, then each protocol must be
submitted.
4. Submission to the RSC does not obviate the need for IRB approval or other committee
approvals mandated by federal regulations or institutional policy.

NOTE: RSC approval process takes considerable time (may be in excess of two months)
and PI/study groups should plan accordingly.
C. Review requirements
1. Core RSC members will include representatives from the UW Pharmaceutical Research
Center, Infection Control, Environmental Services, UW Health Sciences IRB, Oncology
Nursing, Biosafety and Hospital Safety.
2. Representatives from UWHC areas exposed to the research protocol and/or subject will
be invited to be present for the discussion
3. Study coordinator(s) and/or PI are required to take part in the review process
4. The RSC, PI, study group and involved area representatives will collaboratively:
a. review of the proposed flow of the research subject through the institution
b. determine if subjects must be handled under any isolation categories
c. determine appropriate protective procedures for all involved areas
d. determine disinfectant and biohazard destruction procedures
e. determine if a professional informational document is required
i. If professional document is required, study coordinator will work with an
RSC member on drafting such document. This document will require
full committee and PI review/approval.
f. determine if subject informational document is required
i. If subject informational document is required, study coordinator will
work with an RSC member on drafting such document. This document
will require full committee, PI and IRB review and approval
g. determine Employee health instructions
h. determine if other safety considerations and precautions other than those noted
above are required
i. determine the involved areas that will require educational forum(s)
5. The RSC will summarize all of the recommendations and instructions for the safe
handling of the research protocol into a final protocol-specific RSC instruction document.
6. Note: If RSC considers an agent within a protocol to be unsuitable to administer within
UWHC due to safety concerns; it will be disapproved and not permitted within the
hospital. This will be reported to the PI, the IRB and the IBC.
D. Approval requirements
1. Educational forums (when mandated by RSC)

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a. Once the final protocol-specific RSC instruction document has been developed,
the PI/study group must conduct educational forums (content, number and
location to be determined by RSC) to review the protocol and RSC safety
procedures with affected staff areas.
b. One member of the RSC must be present at each educational forum. Contact the
RSC Chair for appropriate RSC member identification
c. Any questions and/or concerns raised at the educational forum(s) must be
appropriately addressed by the PI
2. Upon approval the RSC will provide the PI with a protocol approval notice and subject
recruitment may begin (once additional regulatory requirements are fulfilled)
3. RSC protocol approval notices will be copied to
a. IRB
b. Employee Health
c. IBC ( if applicable)
d. Others as needed
E. Changes of protocol/adverse event procedures/protocol review/ withdrawal of approval.

RSC approval of a protocol shall continue as long as IRB approval contuse, unless withdrawn.
Annual re-approval by the RSC is not required. Changes of protocol must be submitted to the
RSC chair, and approval granted before protocol modifications (as governed by RSC) can be
implemented.
V. COORDINATION

Sr. Management Sponsors: VP, Facilities and Support Services
Author: Director, Life Safety

Approval Committee: Administrative Policy and Procedure Committee

SIGNED BY

Ronald Sliwinski
President, University of Wisconsin Hospitals and Chief of Clinical Operations


Revision Detail:

Previous revision: August 2012
Next revision: August 2018