Many SMPH faculty, staff and students conduct research with human subjects. Human subjects research studies run the gamut from those posing minimal risk to those that can cause significant harm to participants. Click this link for more information about the Human Research Protection Program. The information and links below can help with navigating required trainings; submitting protocols for Institutional Review Board (IRB) approval; and policies and procedures governing human subjects research. The links provided below are a place to start accessing information and are not an exhaustive list. More information is available on the SMPH Research Compliance page for Human Subjects.
Training
All personnel involved in human subjects research must participate in training in order to ensure their research is safe, compliant, and brings no harm to the human subjects or researcher involved. Some trainings are required for everyone and other trainings are determined by the type of research conducted, methods used, etc. Some trainings are not required, but may be useful to faculty, staff, or personnel conducting, advising, or involved in human subjects research. There are different entities and web spaces on campus to navigate for human subjects research training. Other trainings may be required for faculty and staff conducting interdisciplinary research. Please review this list of compliance, protocol, and safety related training requirements. We have tried to include the most important links and information below but this is not an exhaustive list.
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Human Research Protection Program
Human Research Protection Program
This link provides access to required trainings such as CITI Human Research Protections, Good Clinical Practice and HIPAA Privacy and Security. Optional trainings include Basics of Conducting Clinical Research at UW, Office of Research Integrity: The Research Clinic and PREP: Professional Research Education Program.
Other useful links for human subjects research training include:
- The PI Portal (https://my.research.wisc.edu/) provides a place to check trainings completed or needed as well as a host of other research related tasks and tracking.
- The VCRGE Lookup Utilities (https://my.gradsch.wisc.edu/lookups/citi/trainingStatus.html) allows you to look up current training status for yourself, faculty, staff and students (requires netID).
UW-Madison Collaborative Institutional Training Initiative (CITI) Portal
UW-Madison Collaborative Institutional Training Initiative (CITI) Portal
UW-Madison, UW Health, and Madison VA personnel that are involved in research studies on human subjects must complete this training via CITI using their net ID. Training requires renewal every three years.
Research Compliance, Protocol, And Safety Related Training Requirements Matrix
Research Compliance, Protocol, And Safety Related Training Requirements Matrix
This matrix includes compliance, protocol, and safety related training requirements for many types of research and research related activities. Additionally, the list indicates the population of individuals or researchers who would need to complete the training and training renewal times if required. Reviewing this list could be particularly useful for faculty and staff who conduct interdisciplinary research.
Linking Previous CITI Training to Your NetID
Linking Previous CITI Training to Your NetID
New faculty and staff that have previously completed CITI human subjects training at another institution should complete this section.
Effort Certification Training
Effort certification is a federal requirement to ensure sponsors are reasonably charged for projects and the commitments of their project will be met. Refer to Effort Reporting and Certification and the SMPH Effort Policy for more information.
(See pages 33-36 for SMPH module not included in RSP office original publication)
Safety Training
Chemical Safety: Please refer to the EH&S Office of Chemical Safety if your research will involve chemicals. This UW-Madison Laboratory Safety Manual and this chemical safety resource guide may also be useful.
Radiation Safety: Please refer to the EH&S Office of Radiation Safety if your research will involve radiation or lasers. You may need to complete the Radionuclides in Vertebrate Animals form, or the Handling and Storing Radioactive Materials form. This UW-Madison Radiation Safety Manual may also be useful.
Biological Safety: Please refer to the EH&S Office of Biological Safety if your research includes the use of biological materials. This guide may be useful in determining if you need to declare a Biosafety Protocol. Also review this information about select agents, and dual use research of concern (DURC) to ensure compliance.
Building Safety: See General & Building Safety Training for onsite courses in general health and safety topics. Role, function, and workplace-specific content is also available through division and academic unit courses.
Please complete this fire safety training if your research has the potential risk of fires.
Policies, Procedures, and Compliance
At a large research institution such as UW-Madison many layers of required rules, regulations, procedures and policies are applied to protect our researchers and human subjects; ensure we are compliant with the rules our funding sources; and conduct the highest quality research. Below is a collection of links campus committees and systems faculty and staff may need to access to conduct human subjects research at UW-Madison.
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ARROW: Application Review for Research Oversight at Wisconsin
Application for Review of Research Oversight at Wisconsin (ARROW) is an online system used at the University of Wisconsin–Madison to review and track applications for institutional research oversight. You will need your NetID to login to ARROW.
For help accessing, navigating, or applying to ARROW use Health Sciences ARROW or ED Sci ARROW for each department.
Collaborative Research and Single IRB Review Basics
Collaborative Research and Single IRB Review Basics
Consult this link if your project or study involves collaboration with any sites and/or personnel outside the UW-Madison/UW Health/Madison VA then it is considered to be multisite research and IRB reliance issues will need to be addressed. More information is available if UW-Madison Acting as IRB of Record for the Education and Social/Behavioral Sciences IRB or IRB of Record for the Health Sciences and Minimal Risk IRBs
Conducting Human Subjects Research—Initiation to Closure
Conducting Human Subjects Research—Initiation to Closure
Select the guidance and resources for conducting research, from study initiation to study closure based on whether you need to submit your protocol to
Institutional Review Boards (IRBs)
Institutional Review Boards (IRBs)
UW-Madison has 3 institutional review boards where faculty, staff and students must submit human subject research project protocols. This link explains the authority and independence of the UW-Madison IRBs. The IRBs have recently launched a new combined website with information for all UW-Madison IRBs. Please visit the new website (above) for information on upcoming IRB changes, the new Investigator Manual, and the Toolkit Library.
The individual knowledgebases remain as an archive:
The ED/SBS IRB reviews all human research protocols for education and social or behavioral related research in accordance with federal regulations, state laws, local and university policies. Follow the link for more information and news.
The Health Sciences is home to two IRBs. The HS‐IRB and MR‐IRB review all human subject research protocols for health science and minimal risk related research in accordance with applicable federal regulations, state laws, and local and university policies. Follow the links for more information and news.
Human Research Protection Program (HRPP) Policy Index
Human Research Protection Program (HRPP) Policy Index
The HRPP maintains the human subjects research protections policies utilized by all UW-Madison Institutional Review Boards (IRBs) and campus officials. Click the link for more information.
SMPH Policies, Guidelines and Procedures
SMPH Policies, Guidelines and Procedures
This link provides a collection of policies, guidelines and procedures that are both school-specific and campus or UW system-wide.
UW-Madison Research Policies
This page provides quick access to UW-Madison research compliance, protocol training, and data stewardship policies, including information needed to safely and efficiently close out laboratory activities.
Resources
Below is a selection of the numerous resources available to assist faculty and staff conduct Human Subjects Research.
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CITI Human Subjects Protections (HSP) Training Instructions
CITI Human Subjects Protections (HSP) Training
UW-Madison, UW Health, and Madison VA personnel that are involved in research studies on human subjects must complete this training via CITI using their net ID—Log into CITI here. Both trainings require renewal every three years.
Fundamentals of Protocol Writing (video)
Fundamentals of Protocol Writing Workshop
This workshop provided a review of the core components of a clinical trial protocol, strategies to engage biostatistical collaboration in creating protocols, and an opportunity to learn about processes in protocol writing in industry. Please also see the slides and virtual handbook.
Presenter(s): Dr. Nasia Safdar & Dr. Bernadette Gillick, ICTR
Materials:
Grant Writing Webinar Series (link)
The WiSys Grant Writing Webinar Series encourages UW System grantseekers to cultivate grant writing skills, connect with WiSys grant writing experts and create new funding opportunities for their work
Health Innovation Program: Integrating Healthcare and Research Practice (link)
HIP provides researchers the resources they need to conduct health services research and work with our partners—from developing study ideas to disseminating results. Their goal is to strengthen your project and make it more likely to receive funding, be accepted for publication, and to improve clinical practice.
ICTR Qualitative & Mixed Methods Research Resources (link)
ICTR Qualitative & Mixed Methods Research Resources
The Intro to Qualitative Research for the Applied Health Sciences: A Self-Study Course is a no cost course developed by qualitative research expert, Nora Jacobson. Great for the busy clinician, as it’s self-paced and can do every module or view single modules.
Introduction to Statistics for Everyday Use in Research (video)
Introduction to Statistics for Everyday Use in Research
This course provides general information on “statistics” for everyday use either in the planning of a study or for a manuscript, such as common statistical tests, analysis software, and statistical plans. Topics also include non-statistical factors such as study design, feasibility of recruitment, and sample sizes.
NIH Online Course: Introduction to the Principles and Practice of Clinical Research (IPPCR) (link)
NIH Online Course: Introduction to the Principles and Practice of Clinical Research (IPPCR)
This course will be of interest to physicians, scientists, medical and dental students, nurses, public health professionals, and others conducting or planning a career in clinical research. Free, online. Includes info on health disparities research, D&I research, community-based participatory research, etc. if you do not wish to enroll in the course, you can still view the individual course lectures. This is a good option for individuals who want to focus on part but not all of the course material.
Materials:
PI Portal
The PI Portal is a tool for principal investigators to access a host of information and systems across the spectrum of research administration and compliance. Access quick-reference guides for research administration and compliance, by subject area; your proposals, protocols, outside activity reports, etc; centralized tools to update a protocol, certify effort, and much more.
Research at SMPH
Discover the SMPH Research Strategic Plan and guidance to finding funding.
Translational Science Biocore (TSB)
Translational Science Biocore (TSB)
The UW Carbone Cancer Center (UWCCC) Translational Science BioCore (TSB) supports world class biomedical research by facilitating cancer-related basic science and translational research through the integration of human biospecimen collection and storage with associated histological and molecular services. These services are provided through the partnership of the TSB BioBank and the TSB Translational Research Initiatives in Pathology (TRIP) laboratory.
VA Research Overview
A central KnowledgeBase linking to VA Research Policy, guidance documents, and contact information.
VCRGE Lookup Utilities
Look up your current training status or the training status of other faculty, staff and students (requires netID).