Overview of University of Wisconsin-Madison’s

Human Research Protection Program (HRPP)

 

Founded in 1848, the University of Wisconsin-Madison (UW-Madison) is a public, land-grant institution that provides a complete spectrum of liberal arts studies, professional programs and student activities on a single campus.  UW-Madison includes 20 colleges and schools and numerous research centers (Table 1).  The State Laboratory of Hygiene is considered a component of UW-Madison.  UW-Madison’s research commitment is nearly unmatched in combining quality, size and scope.  In fiscal year 2006, the university spent more than $700 million in research support, reflecting an effort that consistently puts UW-Madison among the top five US institutions in research expenditures.  Currently, UW-Madison receives more than 50% of its federal extramural research support from Department of Health and Human Services (DHHS), with much of this funding dedicated to studies involving human subjects.  To coordinate this large commitment to human research UW-Madison has established a Human Research Protections Program.

 

Table 1.

Colleges and Schools

Select Research Centers and Facilities (conducting human research)

Agricultural and Life Sciences, College of Business, School of Continuing Studies, Division of Education, School of Engineering, College of Environmental Studies, Gaylord Nelson Institute for Graduate School Human Ecology, School of International Studies and Programs Law School Letters and Science, College of Medicine and Public Health, School of Nursing, School of Pharmacy, School of Veterinary Medicine, School of

Biotechnology Center McArdle Laboratory for Cancer Research Cardiovascular Research Center Center for Neuroscience Center for Study of Cultural Diversity in Health Care Center for Urban Population Health UW Comprehensive Cancer Center Center on Education and Work Eye Research Institute Center for Family Studies Center for Health Systems Research and Analysis Health Emotions Research Institute Institute for Research in the Humanities Institute on Aging Institute for Research on Poverty Population Health Institute University of Wisconsin Survey Center Center for Tobacco Research and Intervention Waisman Center Wisconsin Alzheimer's Institute Wisconsin Center for Education Research Wisconsin Comprehensive Memory Program Wisconsin State Laboratory of Hygiene Wisconsin Stem Cell Research Program Center for Women's Health Research

 

Description of the components of the HRPP (See organizational chart)

The UW-Madison Chancellor, Carolyn A. Martin, has delegated responsibility for oversight of human research protection activities to Martin Cadwallader, Ph.D., the Vice Chancellor for Research and Dean of the Graduate School.  The Associate Dean for Research Policy, William Mellon, Ph.D., serves as the Institutional Official for the campus Federalwide Assurance (FWA00005399).  

 

The UW-Madison Graduate School’s Office of Research Policy (ORP) serves as the central administrative office for all the UW-Madison’s non-financial research compliance programs, including the Human Research Protection Program.  This ORP coordinates and facilitates research policy, ethics, and compliance activities in for the University of Wisconsin-Madison. Major activities include staff support and project development for the following committees and activities: Research Policy Advisory Council (RPAC), Human Research Protection Program (HRPP), Conflict of Interest (COI), Outside Activities Reporting (OAR), Responsible Conduct of Research (RCR), Research Misconduct, Export Control, and Stem Cell Research Oversight (SCRO).

 

The UW-Madison’s Human Research Protection Program (HRPP) works with the Institutional Review Board (IRB) Offices to assure that research with human participants conducted under the jurisdiction of UW-Madison complies with applicable ethical principles, state and federal laws, federal guidance, international codes of conduct, and UW-Madison policies and procedures. The HRPP coordinates HRPP policy development, maintains an HRPP document storage and management system and websites for the HRPP and IRBs, supports IRB protocol management software and other electronic document processes, coordinates education programming on human research protections, communicates pertinent and timely information about human research to members of the research community and plans program enhancements.  The HRPP continually looks for ways to improve operational efficiencies and enhance the quality of the program.  Over the past five years, UW-Madison has been engaged in a process of review and revision designed to improve the quality of all aspects of the campus system for protecting human research participants. 

 

The Human Research Protection Program Advisory Committee (HRPP Advisory Committee) is responsible for oversight of the UW-Madison’s HRPP, including the UW-Madison IRBs. The UW-Madison Institutional Official, Dr. Mellon, Associate Dean for Research Policy, Graduate School, serves as chair of the Advisory Committee, and the Office of Research Policy provides staff support for the Advisory Committee.  The Advisory Committee advises the UW-Madison Institutional Official and IRBs on issues relating to human research protection, including the suspension of research privileges and reporting to federal authorities of noncompliance, unanticipated problems and suspension and termination of research. Campus policies for research involving human participants are approved by the HRPP Advisory Committee. Major HRPP policy changes are brought to the Research Policy Advisory Council by Dr. Mellon, as needed.  The HRPP Advisory Committee oversees campus-wide communications and training regarding human research protections. It also hears investigator appeals from decisions of the UW-Madison IRBs on issues of noncompliance, unanticipated problems and suspensions and terminations of research and reviews matters referred to it by the IRBs.

 

UW-Madison has four Institutional Review Boards (IRBs) that review more than 5,500 research protocols annually.

 

These IRBs are distinguished by the type of research they review:

 

1)       The Health Sciences IRB reviews all research protocols involving medical interventions or procedures where medical expertise is required for evaluation.  The HS IRB Office staff consists of a director and 6-8 staff members.  The HS IRB Office director reports to the Medical School’s Associate Dean for Clinical and Translational Research, who is responsible for budget and personnel issues for the office. 

 

2)       The Health Sciences Minimal Risk IRB reviews primarily research protocols that present minimal risk to subjects and that involve medical interventions, involve procedures requiring medical expertise, or require knowledge of the health care setting (e.g., medical record reviews and exemption applications).  The MR IRB manager reports to the HS IRB Office director.

 

3)       The Social and Behavioral Sciences IRB reviews social, behavioral, and non-medical health research. It does not have appropriate expertise for review of medical research, but may review research protocols involving minimal risk health-related studies, such as those involving exercise, tape sensors, and single venipuncture, where medical training is not necessary for the evaluation of risk to research subjects.  The SBS IRB reviews all non-medical prisoner protocols. 

 

4)       Education Research IRB specializes in education research. It does not have appropriate expertise for review of medical research, but may review research protocols involving minimal risk health-related studies, such as those involving exercise, tape sensors, and finger sensors, where medical training is not necessary for the evaluation of risk to research subjects. 

 

The SBS IRB and ED IRB have consolidated their administrative functions in one office, the Office of Education Research and Social and Behavioral Science Research Institutional Review Boards.  Staff consists of a director and two assistant directors and two part-time administrative assistants -- one for the SBS IRB and one for the ED IRB.  The ED IRB and SBS IRB staff members report to the assistant directors who, in turn, report to the director.  The director reports to the Associate Dean for Research of the College of Letters and Science and the Dean of the College of Letters and Science, who is responsible for budget and personnel issues for the office.  The School of Education’s Dean and Associate Dean for Research remain responsible for budget issues for the ED IRB assistant director and administrative assistance staff and for participating in recruiting and appointing ED IRB members and appointing the ED IRB chair.

 

An attorney from the University's Office of Administrative Legal Services office is available to provide legal counsel to UW-Madison's IRBs and IRB staff in applying federal and state law to the review of research involving human subjects.  Legal counsel is sought in two ways: (1) IRB chairs, IRB directors or other IRB staff call or email the attorney when questions come up regarding human subjects research, and (2) the attorney attends IRB meetings to answer legal questions from the IRBs when requested. 

 

The Associate Deans for Research involved in the HRPP all serve on the Research Policy Advisory Council (RPAC).  RPAC meets monthly, and HRPP policy issues are discussed by this group as needed. 

 

Key Representatives

Carolyn A. Martin, Chancellor

Martin Cadwallader, Vice Chancellor for Research and Dean of the Graduate School

Julie Underwood, Dean, School of Education

Gary Sandefur, Dean, College of Letters and Science

Robert Golden, Dean, School of Medicine and Public Health

Adam Gamoran, Associate Dean for Research, School of Education

Susan Ellis Weismer, Associate Dean for Research, College of Letters and Science

Paul DeLuca, Associate Dean for Research, School of Medicine and Public Health

Marc Drezner, Associate Dean for Clinical and Translational Research, School of Medicine and Public Health

William Mellon, Associate Dean for Research Policy, Graduate School

James Wells, Director, Office of Research Policy, Graduate School

Lois Kallunki, HRPP Manager, Graduate School

James Turk, Quality Assurance Program Manager, Graduate School

Kelly Ullrick, Conflict of Interest Program Manager, Graduate School

Bradford Brown, Chair, Education Research IRB

Lyn Turkstra, Chair, Social and Behavioral Science IRB

Yoram Shenker, Chair, Health Science IRB

Peter Rahko, Chair, Health Science Minimal Risk IRB

(To be hired), Director, Education Research and Social and Behavioral Science IRBs Office

Lillian Larson, Assistant Director, Social and Behavioral Science IRB

Michael Bingham, Assistant Director, Education Research IRB

Nichelle Cobb, Director, Health Sciences IRB Office and Health Science IRB

Carol Pech, Assistant Director, Health Sciences IRB Office

Gretchen Anding, Manager, Health Sciences Minimal Risk IRB

Lisa Wilson, Legal Counsel, UW-Madison Office of Administrative Legal Services

Kim L. Moreland, Associate Vice Chancellor for Research Administration and Director, Research and Sponsored Programs

Daniel A. Kolk, Director, Office of Clinical Trials

Rebecca Marnocha, Director, Pharmaceutical Research Center

Types of Human Research Conducted at UW-Madison

UW-Madison IRBs review a broad spectrum of human research including clinical trials, social and behavioral studies and education research.  Research at the UW-Madison is sponsored by the federal and state governments, private industry and non-profit organizations and foundations.  Last year, UW-Madison IRBs reviewed 5645 research studies (1622 initial review applications) submitted by 2959 investigators.  Numbers of protocols reviewed by each IRB and review categories are shown in Table 2.

 

Table 2 (Data from July 1, 2006 to June 30, 2007)

	Health Sciences	Minimal Risk	Social & Behavioral Sciences	Education Research	Total (Percent)
Initial Review by Full IRB	395	205	174	23	797 (14%)
Initial Review by Expedited Process	0	0	96	145	241 (4%)
Reviewed to determine if Exempt	0	251	190	133	584 (10%)
Continuing Reviews	1338	206	270	133	1974 (35%)
Change of Protocol Reviews	1642	175	152	80	2049 (36%)
Total	3393	737	882	514	5645 (100%)

 

The UW-Madison Office of Research and Sponsored Programs (RSP) is responsible for the final review, negotiation and submission of all grant and contract applications and for the negotiation of agreements.  RSP staff provides financial and other administrative assistance by preparing financial reports, submitting invoices, processing payments, and addressing other primary functions including the following:

 

Ÿ         Transmitting extramural support applications

Ÿ         Negotiating and accepting awards on behalf of The Board of Regents 

Ÿ         Administering accounts on a daily basis

Ÿ         Providing training on UW-Madison and sponsor policies/procedures

Ÿ         Maintaining the extramural support database

Ÿ         Collecting receipts and preparing financial reports/invoices

Ÿ         Managing the Effort Reporting system

Ÿ         Performing facilities and administrative cost studies

 

A summary of federal funding is provided in Table 3.  Non-federal funding is provided in Table 4.

 

Table 3.  UW-Madison Federal Awards by Agency for Fiscal Year 2006

Agency $ in Millions % of Total Dept. Health & Human Services 270.7 50.3% National Science Foundation 141.6 26.3% Dept. of Energy 43.3 8.1% Dept. of Defense 25.9 4.8% Other 15.1 2.8% Dept. of Agriculture 13.2 2.5% NASA 12.6 2.4% Dept. of Education* 9.4 1.7% AID 3.4 0.6% Dept. of Commerce 2.7 0.5% TOTAL 537.3 100%

 

Table 4.  UW-Madison Non-Federal Awards by Donor for Fiscal Year 2006

Donor $ in Millions % of Total UW Foundation 93.3 27.5% Other Foundations (non-UW) 91.6 27.5% Wisconsin Alumni Research Foundation 47.5 14.0% Business & Industry 45.6 13.4% Individual & Multiple Donors 25.5 7.5% WI State & Local Government 11.6 3.4% Other Government & Institutions 10.6 3.1% Alumni 8.6 2.5% Various 5.4 1.6% TOTAL 339.7 100%

 

Other Research Support Units

The UW-Madison School of Medicine and Public Health's Office of Clinical Trials (OCT) serves as a single contact point for private industry seeking to conduct clinical trials at the University of Wisconsin and associated hospitals and clinics.  The OCT, in conjunction with the Pharmaceutical Research Center (see, below), the IRBs and the Clinical Translational Research Core (see, below), support industry-sponsored Phase I, II, III and IV clinical trials; government-funded clinical research (National Institutes of Health and other agencies), privately funded research, and investigator-initiated research.

 

The OCT coordinates administrative aspects of clinical investigations including:

 

·         Preparing and negotiating budgets

·         Facilitating negotiation of clinical trial agreements

·         Preparing IRB applications and consent forms

·         Preparing CTRC and VA research applications

·         Preparing IDE and IND applications

·         Developing subject recruitment procedures

·         Supporting investigator-initiated research

·         Training clinical research staff

·         Providing experienced research coordinator support

·         Maintaining regulatory compliance

 

The Clinical and Translational Research Core (CTRC) is a UW-Madison School of Medicine and Public Health unit, which is funded as a part of the NIH/NCRR Clinical and Translational Science Award given to UW-Madison on Sept. 28, 2007. Formerly called the General Clinical Research Center, this new CTRC is an 18-bed research unit within UW Hospital and Clinics, with satellite services currently at other units in the hospital and in clinics throughout Madison.  For investigators, the CTRC provides inpatient and outpatient rooms, a sample processing facility, research nurses and administrative support, supplies and equipment to perform high-quality research on healthy subjects and patients with disease.

 

The Pharmaceutical Research Center (PRC) is a dedicated research service within the University of Wisconsin Hospital and Clinic (UWHC) Department of Pharmacy. This program's mission is to ensure the safe and ethical provision of investigational/study drugs to research subjects enrolled in clinical drug trials within the UWHC; to provide education and training to pharmacists, pharmacy students, technicians, residents, physicians, nurses and other health care providers relating to the use of investigational drugs, clinical drug study design integrity and human research regulation; to ensure that drug research protocols proceed optimally through the UWHC medication use system and in accordance with all federal, state, institutional and sponsor regulations and to continually refine and expand its services to meet the needs of the research community.

 

Services offered by the PRC include:

 

·         Detailed protocol review and feasibility assessments within the confines of an academic medical center.

·         Activation and maintenance of protocols to ensure full compliance with federal, state, sponsor and institutional requirements

·         Facilitation of 24 hours per day, 7 days per week study drug preparation

·         Provision of a 24 hour per day, 7 days per week research pharmacy on-call service

·         Access to satellite pharmacy locations throughout the UWHC health care system thereby optimizing accrual goals  

·         Provision of a comprehensive quality improvement program

·         Randomization and blinding assistance

·         Development of investigational drug information sheet for health care providers

 

The UW Comprehensive Cancer Center Protocol Review and Monitoring Committee reviews all cancer-related research protocols prior to IRB approval.

 

The UW Cardiology Clinical Research Committee reviews all Cardiology Section research protocols prior to IRB approval and provides consultation to the IRBs if needed on cardiac issues for protocols originating elsewhere.

 

The UWHC Research Safety Committee reviews protocols possessing health hazards, such as gene transfer studies, and protocols intentionally exposing subjects to infectious agents.

 

Other Organizations

University of Wisconsin Hospitals and Clinics Authority and University of Wisconsin Medical Foundation.  The UW-Madison School of Medicine and Public Health (UWSMPH) has strong partnerships with University of Wisconsin Hospital and Clinics Authority (UWHCA) and the University of Wisconsin Medical Foundation (UWMF).  Together with UWSMPH, these entities comprise an academic health center that uses a common logo "UW Health."

 

UWHC is a 471-bed academic medical center.  UWSMPH faculty members in the clinical sciences serve on the medical staff of UWHC. 

 

UWMF is the clinical practice organization for the faculty physicians of the UWSMPH, the largest academic, multi-specialty physician group in Wisconsin.

 

UWHC and UWMF provide clinical sites, technical and professional staff and administrative services to UW-Madison faculty physicians and, together with the UWSMPH, are dedicated in pursuing their common missions of quality patient care, medical education and research.  The UW-Madison IRBs act as IRBs of record for both UWHCA and UWMF pursuant to IRB Authorization Agreements.

 

Meriter Hospital.  Meriter Hospital’s IRB reviews all research protocols, primarily neonatal research, conducted at their facilities by UW-Madison investigators.  UW-Madison researchers must submit research proposals to both UW-Madison’s and Meriter’s IRBs.  UW-Madison IRB approval is contingent on Meriter IRB approval.

 

Middleton Memorial Veterans Hospital (VA).  UW-Madison’s IRBs review all human research conducted at the VA through a Memorandum of Understanding.

 

The National Cancer Institute Central Institutional Review Board (CIRB). UW-Madison may rely on CIRB reviews of human research protocols through an IRB Authorization Agreement.