Human Research Protection Program: Other
The University of Wisconsin-Madison (UW-Madison) bears full responsibility for all research involving human subjects covered under its Federalwide Assurance.
The Chancellor, as chief executive officer of the UW-Madison, has the authority to establish and empower UW-Madison’s Institutional Review Boards (IRBs). The Chancellor delegates oversight of the IRBs to the Vice Chancellor for Research/Dean of the UW-Madison Graduate School.
The Vice Chancellor for Research/Dean of the Graduate School exercises oversight authority over the IRBs and the Human Research Protection Program. The Vice Chancellor, in turn, appoints the Associate Dean for Research Policy of the Graduate School as the Institutional Official (IO) for the protection of human research subjects at UW-Madison.
The IO is appointed by the Vice Chancellor for Research/Dean of the Graduate School, to whom the Chancellor has delegated the responsibility for oversight of the research review process.
The Associate Dean for Research Policy of the Graduate School is the Institutional Official (IO) for the protection of human research subjects at UW-Madison. In this federally-mandated role, the IO assumes operational authority for UW-Madison’s Human Research Protection Program (HRPP) and is directly responsible for assuring that the program is functional, adequately staffed and funded, and respected in the research community.
The IO assures that the IRBs function independently and free from coercion and undue influence and that the IRBs have access to: (1) independent legal counsel and (2) more senior UW-Madison officials when an IRB deems such access to be warranted.
In addition, the IO is responsible for ensuring that UW-Madison officials and federal regulatory agencies are aware of the activities of the IRBs.
The IO is also the resident expert on federal and institutional regulations involving the use of human research subjects, acting as a consultant in service to the UW-Madison research community when needed.
The IO approves institutional agreements for cooperative research activities involving human subjects.
The IO also serves as Chair of the Human Research Protection Program Advisory Committee (Advisory Committee).
Human Research Protection Program
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, 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.
IRBs have one paramount responsibility: To protect the rights and welfare of human research subjects. IRBs take into account national and, when appropriate, international ethical standards of research on a protocol-by-protocol basis.
All human subjects research projects at the UW-Madison must be reviewed and approved by one of the UW-Madison IRB before the project begins.
At UW-Madison, IRBs are peer review bodies. IRB chairs and most members are UW-Madison faculty or staff. IRBs have both scientist and nonscientist members. Each IRB also has at least one community member, someone not affiliated with the UW-Madison.
The IRBs, with the assistance of their staffs, review:
· Research protocols before any work is started
· Ongoing research at least annually
· All changes to research protocols before implementation (except when implementation is necessary to eliminate immediate hazards to subjects)
· Reports of unanticipated events
· Protocol violations
The objective of IRB review is to ensure that the rights and welfare of the subjects are adequately protected and that all activities involving human subjects are in compliance with applicable UW-Madison policies and external regulations. The IRBs are also charged with assessing suspected or alleged protocol violations, subject complaints, or violations of external regulations or UW-Madison policies. Each IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's decisions, conditions, and requirements or that has been associated with unexpected serious harm to subjects.
The IRBs may suspend activities in which serious or continuing violations occur and must report such violations to applicable organizations.
Four IRBs have been established at UW-Madison for review of research protocols:
The Health Sciences IRB (HS IRB) and the Health Sciences Minimal Risk IRB (MR IRB) share staff. Each IRB meets twice a month on alternating weeks. Although most health sciences protocols that present minimal risk to subjects and that involve medical interventions or procedures requiring medical expertise or that require knowledge of the health care setting (e.g., medical record reviews and exemption applications) are directed to the MR IRB, the HS IRB also reviews minimal risk protocols if workload and timing require. The HS IRB and the MR IRB review all health sciences VA protocols.
The HS IRB reviews research protocols involving medical interventions or procedures where medical expertise is required for evaluation.
The HS IRB consists of more than five members, and membership includes scientists and non-scientists, as well as non-affiliated members. HS IRB members do not participate in the discussion or vote on research protocols in which they may have a conflict of interest. The HS IRB is composed of individuals, both female and male, with the following expertise and perspectives:
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Administration/Research Administration |
Medicine/Women’s Health |
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Biostatistics |
Neurology |
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Clergy |
Nursing |
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Human Oncology |
Pediatrics/Genetics |
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Law |
Pharmacology/Investigational Drugs |
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Medical Ethics |
Psychiatry |
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Medicine/Asthma-Allergy |
Public Defender/Prisoner Representative |
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Medicine/Cardiology |
Radiology |
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Medicine/ Family Practice |
Surgery/Transplant |
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Medicine/Gastroenterology |
Veteran’s Administration (VA) Representative |
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Medicine/Oncology |
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The HS IRB considers the scientific or medical review of other UW-Madison committees and involves consultants with particular expertise as needed.
The MR IRB primarily reviews research protocols that present minimal risk to subjects and that involve medical interventions or procedures requiring medical expertise or that require knowledge of the health care setting (e.g., medical records research, research database and tissue banking projects, survey and interview research, and exemption applications). The MR IRB can review more than minimal risk research, when the committee consists of members with the appropriate expertise or ad hoc consultant(s) are appointed, should additional expertise be necessary.
The MR IRB consists of more than five members, and membership includes scientists and non-scientists, as well as a non-affiliated member. MR IRB members do not participate in the discussion or vote on research protocols in which they may have a conflict of interest.
The MR IRB is composed of individuals, both female and male, with the following expertise and perspectives:
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Administration/Privacy |
Nursing |
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Community Member |
Obstetrics/Gynecology |
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Family Medicine |
Population Health Sciences |
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Law |
Surgery |
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Medicine |
VA |
The MR IRB considers the scientific or medical review of other UW-Madison committees and involves consultants with particular expertise, as needed.
The Education Research IRB (ED IRB) and Social and Behavioral Sciences IRB (SBS IRB) share staff. The SBS IRB reviews all non-medical prisoner protocols. Each IRB meets once a month.
The ED 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 ED IRB is composed of individuals, both female and male, representing each research areas within the UW-Madison School of Education, a representative from the Madison Public School District, and a UW-Madison academic staff member.
The SBS 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 is composed of individuals, both female and male, with a board range of expertise and perspectives, always including a representative from the community and a prisoner advocate.
The Chair is the spokesperson for the IRB. He or she acts as a voting member and assures that the panel decisions are represented accurately and responsibly in letters and actions.
The IRB members are a diverse group with diverse opinions and backgrounds. Their role is to bring to the review of each research proposal a broad view of what is needed to maximize the protection of human research subjects.
Each IRB Office has an office
staff, including a director and assistant
director, administrator or coordinator..
Daily operations of an IRB are the responsibility of anthe
IRB director, IRB assistant director or
IRB manageradministrator
or coordinator. An IRB office
director, aassistant director or
IRB managerdministrator or coordinator may be
voting members of the IRB and are involved in protocol review. The
IRB staff reviews protocol
applications for accuracy and completeness and acts as liaison
between the investigators and the IRB members.
This office 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 Embryonic Stem
Cell Research Oversight (ESCRO)
An attorney from the UW-Madison's Office of Administrative Legal Services is available to provide legal counsel to UW-Madison's HRPP and to 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.
All personnel engaged in human subjects research are on the front lines in human subjects protection. Personnel engaged in research, with respect to a human subjects research protocol, include all individuals who:
· design research,
· direct research or serve as the principal investigator,
· enroll research subjects (including obtaining subjects’ informed consent or screening potential subjects) or make decisions related to eligibility to participate in research,
· conduct study procedures,
· analyze or report research data,
· analyze or report adverse events, or
· author manuscripts concerning the research for publication.
Students, subcontractors, and consultants who act in any of the roles listed above are personnel engaged in research.
Many studies, particularly in medical research, appoint a study director who assists with preparation and implementation of the protocol. These individuals are listed as points of contact on UW-Madison protocols.
The IRBs are at times required to interact with other departments or research compliance committees. In some cases, the approval of another UW-Madison body may be required prior to, or in addition to, IRB review.
UW-Madison Internal Audit
Internal Audit provides the University of Wisconsin-Madison with independent assurance activities including operational audits to test systems and procedures, assistance in the design and implementation of accounting and compliance systems, assistance in the development of campus-wide policies and procedures for business related activities, and investigative audits.
The Office of Biological Safety (OBS) assists faculty, students, and staff in observing safe practices in research in the biological sciences as prescribed by the Centers for Disease Control and Prevention (CDC) and the National Institute of Health (NIH), and endeavors to assure that research is done in secure facilities in compliance with all local, state, and federal regulations. UW-Madison is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules (rDNA). OBS provides the administrative mechanism by which research involving rDNA can be reviewed, thereby assuring compliance with the NIH guidelines.
The Chemical & Environmental Safety Program offers many services to support research and teaching at the UW-Madison. Areas of expertise include chemical safety, hazardous waste disposal, environmental engineering, EPA and OSHA lab compliance, and chemical hygiene.
The Radiation Safety Office, a service and training branch of the UW-Madison Safety Department, manages the Radiation Safety Program and implements the policies of the UW-Madison's Radiation Safety Committee. This program does not review protocols but instead certifies individuals as authorized to use radioactive materials and approves applications for the use of radionuclides on vertebrate animals.
The Biosecurity Task Force was established to implement the new federal regulations governing bioterrorism prevention.
The Research Animal Resource Center (RARC) trains investigators and supports them in providing the highest quality care for the UW-Madison's research animals. Training and protocol approval are required before initiating research projects involving animals.
UW-Madison Bioethics Advisory Committee
The Bioethics Advisory Committee reviews ethical, legal and social issues regarding specific research at the University of Wisconsin-Madison and advises the Dean of the Graduate School on the development of University policy.
All faculty and academic staff are required by state and federal law to file an annual disclosure of outside activities and financial interests. The Conflict of Interest Committee reviews disclosures and provides guidance for managing, reducing, or eliminating actual or apparent conflicts of interest.
This committee was established by
the University of Wisconsin-Madison to provide oversight to research using human
human embryonic stem cells. All
researchers at the UW-Madison working with human embryonic human
stem cells work under these guidelines, which are based on the National Academies of Sciences
Guidelines.
UW-Madison Research Misconduct
The University has a policy for dealing with allegations of research misconduct in scholarly research. It provides for a three phase process consisting of an inquiry phase, a Chancellor’s review, and a hearing phase. If the College/School Dean authorizes an inquiry, the Associate Dean for Research Policy appoints a committee to undertake it.
The 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:
· Transmitting extramural support applications
· Negotiating and accepting awards on behalf of The Board of Regents of the UW System.
· Administering accounts on a daily basis
· Providing training on UW-Madison and sponsor policies/procedures for administrators and investigators
· Maintaining the extramural support database
· Collecting receipts and preparing financial reports/invoices
· Managing the personnel activity reporting system (PAR)
· Performing facilities and administrative cost studies
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 and 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 UW Paul P. Carbone Comprehensive Cancer Center Clinical Affairs 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.
UW-Madison IRBs are at times required to interact with outside entities in overseeing research involving humans.
University of Wisconsin Hospital 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.
The UWHC Research Safety Committee reviews protocols possessing health hazards, such as gene transfer studies, and protocols intentionally exposing subjects to infectious agents.
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
Reviews all research protocols involving: 1) UW-Madison health sciences researchers with paid appointments at the VA; 2) enrollment of subjects (including use of residual tissue and access to medical records) associated with the VA; or 3) use of VA facilities. UW-Madison’s IRBs review all human research conducted at the VA through a Memorandum of Understanding.
Meriter Hospital’s IRB reviews all research protocols, primarily neonatal research, conducted at their facilities by UW-Madison investigators. UW-Madison researchers must seek review and approval of research protocols by both UW-Madison’s and Meriter’s IRBs. UW-Madison approval is contingent on Meriter approval.
National Cancer Institute Central Institutional Review Board
UW-Madison may rely on NCI CIRB reviews of human research protocols through an IRB Authorization Agreement.