Policies,Administrative,UWHC,UWHC-wide,Legal Affairs

Clinical Research Guidelines (4.24)

Clinical Research Guidelines (4.24) - Policies, Administrative, UWHC, UWHC-wide, Legal Affairs


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Administrative (Non-Clinical) Policy
As of August 23, 2017, this administrative policy applies to the operations and staff of legacy UWHC.
Effective July 1, 2015, the legacy operations and staff of UWHC and UWMF were integrated into the
University of Wisconsin Hospitals and Clinics Authority (UWHCA). All administrative policies are being
transitioned to apply UWHCA-wide, but until future revision to this policy # 4.24, it applies only to the
operations and staff of legacy UWHC.

Policy Title: Clinical Research Guidelines
Policy Number: 4.24
Effective Date: August 23, 2017
Chapter: Legal Services
Version: Revision


To provide for the protection of human subjects at the facilities and clinics of the University of Wisconsin
Hospitals and Clinics Authority (“UW Health”) through a review and approval or exemption process for
research involving human subjects.


UW Health’s statutory mission states in part that UW Health will sponsor and support “research in the
delivery of health care to further the welfare of the patients treated and applying the advances in health
knowledge to alleviate human suffering, promote health and prevent disease.” As a result, UW Health
provides an environment for research in the health services and sciences, and members of the UW Health
staff to conduct, coordinate, support and/or promote scientific research. All decisions concerning the use
of UW Health employees and material resources are made by UW Health administrators and professional
staff members. All research conducted in UW Health facilities and clinics is subject to applicable UW
Health policies and procedures.

Individuals interested in conducting research involving human subjects at UW Health facilities and clinics
must comply with applicable law, and obtain the approval of or an exemption from the appropriate
Institutional Review Board (IRB) approved by the University of Wisconsin-Madison prior to the initiation
of such research, consistent with applicable law. Usually this will be the UW-Madison Health Sciences
IRB (HS-IRB) or the UW-Madison Minimal Risk IRB (MR-IRB). The investigator has the responsibility
for safeguarding the rights of individuals who volunteer for or consent to be subjects in research.


There are no UW Health forms. The applicable IRBs have forms.

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A. The prospective investigator shall:
1. When research subjects are also UW Health patients, coordinate with the appropriate
clinical staff responsible for the care of the patient as necessary to manage any impact on
clinical care.

2. When required by UW-Madison Departmental policy, obtain appropriate departmental
committee approvals and the approval of the Department Chair.

3. Obtain approval from other committees and stakeholders as required by applicable
UW-Madison and UW Health policies and operational procedures.

4. Unless determined to be exempt from IRB review, obtain approval from an IRB approved
by the UW Health Sciences IRBs Office. The following IRBs are authorized to approve
research at UW Health:
a. HS-IRB, registered as UW-Madison (Health Science) IRB #1 [IRB00000366]
b. MS-IRB, registered as UW-Madison (Minimal Risk) IRB #5 [IRB00003739]
c. ED/SBS, registered as UW-Madison (Educ./Social & Behavioral Sci) IRB #3
d. Or other IRB with which the UW-Madison enters into an IRB authorization
agreement for IRB oversight.

The UW-Madison Office of Research Policy can be contacted to determine whether
any other IRB has been approved as an alternative.

5. Perform research consistent with a protocol reviewed and approved by the applicable IRB.

6. Obtain approval from the UW Health Research Safety Committee before beginning
research that involves drugs, agents, devices and/or procedures and possessing potential
health hazards for which no standard environmental or personal safety procedures exists
(see UW Health Administrative Policy 12.10-Research Safety Committee Authority &

7. Be responsible for making arrangements for appropriate billing services to UW Health
patients participating in research studies (see UW Health Administrative Policy 2.13-UW
Health Charges for Patients in Research Studies).

8. Be responsible for assuring compliance with other UW Health and UW-Madison policies
and procedures applicable to the activities involved in the research.

B. Record keeping
When a UW Health patient participates in a research project in UW Health facilities and written
consent is required by the IRB, a copy of the written consent shall be placed in the electronic
medical record, unless otherwise directed by the IRB or policy, or maintained in research files
(as directed by the research protocol).

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A. University of Wisconsin-Madison Health Sciences IRBs Guidelines at https://kb.wisc.edu/hsirbs/
B. University of Wisconsin-Madison Human Research Protection Program Policies and Guidelines
at https://kb.wisc.edu/gsadminkb/page.php?id=34101
C. U.S. Department of Health and Human Services (DHHS) regulations for the
Protection of Human Subjects (45 CFR Part 46).
D. US Food and Drug Administration regulations for the Protection of Human Subjects
(21 CFR Part 56)


Sr. Management Sponsor: SVP/ Chief Academic Officer
Author: Director, Clinical Research
Reviewer: UW Madison Health Sciences IRBs Director, UW Health Corporate Counsel,
UW-Madison Office of Legal Affairs

Approval Committee: UW Health Administrative Policy & Procedure Committee


Elizabeth Bolt
UW Health Chief Administrative Officer