Print this pageResearch Protocols
- Animal Use
- Human Subjects
- Biological Safety
- Stem Cells
- Protocol Lookup System
Animal Use
Updates | Guidelines | Submitting Protocols | Training | Resources | Contacts
The College of Agricultural and Life Sciences received AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) accreditation for its animal care program and facilities in March 2010, and will begin the process of reaccreditation in Fall 2012. Our pursuit of this accreditation demonstrates our commitment to humane and ethical treatment of research animals.
For more information on accreditation, see The Benefits of AAALAC International Accreditation
Updates
- AAALAC Reaccreditation Site Visit Oct. 22-25
Posted Oct. 2, 2012
The AAALAC reaccreditation site visit will begin Oct. 22. An exit briefing is scheduled for Oct. 25:
AAALAC Exit Briefing
Thursday, Oct. 25
(Time TBD - will be distributed via email)
Rm 2321 Biochemical Sciences
440 Henry Mall (view on map) - New Contact for Animal Protocol Submission
Posted July 2, 2012
Animal Protocol forms should now be submitted to Nancy Spilker, 890-4403 spilker@rarc.wisc.edu - Recent All Campus Animal Program Policy Changes
Posted July 2, 2012
The policies listed below were added or amended during the past few months. Please review these policies and consider their impact on your work. Contact Cheryl Deering, (608) 262-2536 or cdeering@cals.wisc.edu with any questions about these changes.
Amended Policy
- 2010-037: Policy on the Use of Non-pharmaceutical-Grade Compounds in Research Animals Amended 6/01/2012
New Policies
- 2012-046: Use of Tribromoethanol (Avertin) Published 5/25/2012
- 2012-045: Laboratory Housing of Animals Published 5/25/2012
- 2012-047: Access to UW Animal Use Areas Published 6/01/2012
- 2012-044: Zebrafish Larval Form Published 5/04/2012
- 2012-048: Photography and Videography in UW Animal Use Areas Published 6/20/2012
Guidelines
The Animal Welfare Act mandates humane and ethical treatment of animals used in teaching and research, therefore, requirements for conducting animal research are extensive.
Research Animal Resources Center (RARC)
At UW-Madison, the Research Animal Resources Center (RARC) provides oversight and assistance in assuring compliance with all laws, regulations, and rules governing the care and use of laboratory animals.
Investigator Requirements
In order to ensure that animals are properly housed and cared for, RARC requires that investigator's who wish to use live vertebrate animals in a project:
- Submit an Animal Protocol for review by the CALS Animal Care and Use Committee
- Ensure that lab personnel complete appropriate Training
- Report adverse animal health events to their Program Veterinarian immediately
Submitting Protocols
An Animal Protocol is a concise description of an animal research project. It is also contractual agreement between the Principal Investigator and the Animal Care and Use Committee that ensures that animals receive the highest standard of care.
Protocol Guidance/Forms
- Forms and instructions are available from the RARC website: RARC Protocol Forms
- Submit protocols to Nancy Spilker, 890-4403 spilker@rarc.wisc.edu
- Protocols must be submitted by 4:00 pm on the 1st of the month for consideration during that month.
- Protocols are approved for a maximum of 3 years, and must be reviewed annually. Protocols for longer projects have a de novo review every 3 years.
- For additional information, visit the RARC Animal Protocol FAQ page.
Protocol Amendments
In certain situations, a protocol may need to be changed during the course of a project. There are two types of changes, or amendments, to protocols:
- Administrative Amendments are needed when funding sources or lab personnel change.
- Scientific Amendments are needed when the scope of work changes.
Examples include changing or adding experimental procedures, changing drugs or dosages, increasing the number of animals, adding a new species of animal, etc.
When an amendment is needed, follow the instructions included on the RARC website:
RARC Fact Sheets: How to Change an Existing Protocol.
Training
Animal user training is provided through RARC. Visit the RARC Training Program website for additional information and assistance regarding training.
Training Required for All Animal Users
All lab personnel who handle live research animals (including the Investigator, animal care staff, research staff, and visiting guests) must complete the following RARC training courses before working with animals:
- RARC Animal User Orientation Training
Note: Animal User Orientation must be re-taken every five years. - Occupational Health Animal Safety Training
Note: after completing this course, participants must complete an
Animal Contact Risk Questionnaire
These courses are completed online, and are available 24 hours a day, 7 days a week. A valid UW-Madison NetID is needed in order to access the courses.
Additional Training for Certain Personnel
Depending on the scope of the project, additional RARC courses, such as Lab Animal Surgery or species-specific training, may be also be required. Once an Animal Protocol is approved, lab personnel and their PI's are notified via email of training requirements.
Resources
| UW-Madison Campus Resources | ||
|---|---|---|
| CALS Animal Program Policies | List of animal policies that apply only to CALS | |
| RARC All Campus Animal Program Policies | Complete list of animal policies that apply to all UW-Madison Schools/Colleges | |
| RARC Animal Protocol FAQ | Guidelines for completing and submitting an Animal Protocol | |
| RARC Forms | Collection of all RARC forms, including protocol and Wildlife Waiver forms. | |
| RARC Training Program | Course info and registration; access to online courses. | |
| UW-Madison Animal Care and Use Committees | Info on structure/function of UW-Madison's Animal Care and Use Committees | |
| UW-Madison Program Veterinarian Contacts | List of Lab Animal Veterinarians, by program | |
| UW-Madison Researcher's Guide to Animal Care & Use | Complete guide to animal use practices and protocols. | |
| External Resources | ||
| American Association for Laboratory Animal Sciences (AALAS) | Professional organization for researchers and technicians involved in laboratory animal science. | |
| AVMA Guidelines on Euthanasia | American Verterinary Medical Association (AVMA) standards for animal euthanasia. | |
| Animal Welfare Act | Full text of the act, legislative history and quick reference guides | |
| FASS Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, 3rd ed. | Primary reference for meeting the needs of agricultural animals utilized in research and teaching, publishd by the Federation of Animal Science Societies | |
| Institutional Animal Care and Use Committee (IACUC) Resource Site | Information resource for members and staff of institutional animal care and use committees. | |
| ILAR Guide for the Care and Use of Laboratory Animals, 8th ed. | Guide published by the Institute for Laboratory Animal Research (ILAR) and adopted by OLAW and AAALAC | |
| OLAW Public Health Service Policy on Humane Care and Use of Laboratory Animals | ||
| NIH Vertebrate Animal Section (VAS) Fact Sheet | Quick reference guide/checklist for completing an NIH Vertebrate Animal Section (VAS), from OLAW | |
| NIH Vertebrate Animal Section (VAS) Instructions | Complete instructions for completing the Vertebrate Animal Section (VAS) of an NIH grant proposal | |
Contacts
General Compliance Questions
Cheryl Deering
CALS Research Compliance Specialist
(608) 262-2536
cdeering@cals.wisc.edu
Protocol Submission
Nancy Spilker
(608) 890-4403
spilker@rarc.wisc.edu
Lab Animal Veterinarians
Human Subjects
Updates | Guidelines | Submitting Protocols | Training | Resources | Contacts
In order to protect the rights and welfare research subjects, all research involving human subjects must comply with applicable institutional policies, laws, and regulations.
Generally, this involves gaining Institutional Review Board (IRB) approval for your research and completing appropriate training.
Updates
- New ED & SBS IRB Submission System Coming Oct. 1
Posted Aug 14, 2012
The ED & SBS IRB Office will move to a new online submission system – ARROW – on Monday, October 1, 2012. Protocol applications will only be accepted in ARROW starting on October 1st.
Once ARROW is live, all active protocol applications will need to be recreated in ARROW - by the study teams - and resubmitted for review.
For more information, visit http://www.irb.wisc.edu/arrow-faqs.htm. Watch for ARROW training dates coming this fall!
Guidelines
Human Research Protection Program (HRPP)
At UW-Madison, the Graduate School's Human Research Protection Program (HRPP) provides oversight and assistance in assuring compliance with policies, laws, and regulations governing Human Subject Research.
Human Subjects are defined as living individuals about whom and investigator obtains data through intervention or private information.
Research involving Human Subjects, as defined above, is subject to HRPP policy and requires approval of a Human Subjects Protocol by an Institutional Review Board.
This includes Human Subject research that meets ANY of the following criteria:
- Sponsored by the UW
- Conducted by or under the direction of any UW employee
- Uses UW property/facilities
- Uses UW non-public information to identify or contact subjects
- Student research (including Senior/Master's theses, Doctoral dissertations, and UW sponsored student awards) submitted for publication
- Any sponsored survey
Investigator Requirements
- Ensure that personnel complete appropriate Training (training must be completed before protocol is submitted)
- If the PI is not a tenure-track faculty member, complete a PI Request Form, and ensure that it is signed by the Department Chair/Dean and submitted to the IRB office for approval before submitting a protocol application. (Note: this is separate from PI status approval needed in order to submit proposals)
- Submit a Human Subjects Protocol for review by the appropriate IRB
- Obtain legally effective informed consent from subjects, as stipulated by your Protocol
- Report adverse events to the IRB
Submitting Protocols
Human Subject Protocols are reviewed and approved by subject-specific Institutional Review Boards (IRBs). Each IRB determines its own protocol submission procedures - visit the website of the appropriate IRB for information on protocol submission.
UW Madison IRBs
Social and Behavioral Sciences/Education Research IRBs
- Social and Behavioral Sciences (SBS): Social, behavioral, and non-medical health research
SBS IRB Meeting Dates and Deadlines - Education (ED): Education research, including minimal risk health-related studies, such as those involving exercise, tape sensors, and finger sensors
ED IRB Meeting Dates and Deadlines
- Health Sciences: Research involving medical interventions or procedures where medical expertise is required for evaluation
Health Sciences IRB 2012 Meeting Dates - Health Sciences Minimal Risk: Research that presents minimal risk to subjects and that involves medical interventions or procedures requiring medical expertise or that requires knowledge of the health care setting (e.g., medical records research, research database and tissue banking projects, survey and interview research, and exemption applications
Health Sciences Minimal Risk IRB 2012 Meeting Dates
Training
All personnel listed on a Human Subjects Protocol must complete Human Subjects Protection Training.
Training must be completed before the protocol is submitted for review.
This training is completed online through the Graduate School's Collborative Institutional Training Initiative (CITI):
- Instructions for completing Human Subjects Protection Training via CITI
- CITI training site log in (requires valid NetID)
Resources
| UW-Madison Campus Resources | |
|---|---|
| Graduate School Human Research Protection Program | Graduate School Human Research Protection Program (HRPP) main site |
| Graduate School Instructions for Obtaining IRB Approval | Step-by-step guide to completing the IRB approval process, from the HRPP site |
| Human Subjects Protection Training Instructions | Step-by-step instructions for accessing and completing online Human Subjects training via CITI |
| CITI Training Website | Log-in page for the Graduates School's CITI online training website (requires valid NetID) |
| Social & Behavioral Sciences and Education Research IRB | |
| Webkit Login | Login page for Social & Behavioral Sciences/Education Research IRB protocol submission tool |
| Health Sciences and Health Sciences Minimal Risk IRB | |
| ARROW Login | Login page for Health Sciences IRB protocol submission tool |
| Human Subjects PI Request Form | Form needed when an academic staff member serves as PI on a human subjects research protocol. Must be submitted prior to protocol application. |
Contacts
General Compliance Questions
Cheryl Deering
CALS Research Compliance Specialist
(608) 262-2536
cdeering@cals.wisc.edu
Social & Behavioral Sciences/Education Research IRBs
(608) 263-2320
In person consultations available - see http://www.irb.wisc.edu/contactus-help.htm for more information.
Health Sciences IRBs
(608) 263-2362
asktheirb@medicine.wisc.edu
In person consultations available - see https://kb.wisc.edu/hsirbs/20861 for more information.
Biological Safety
Updates | Guidelines | Submitting Protocols | Training | Resources | Contacts
As a major research institution, the UW-Madison must provide assurances that its biomedical laboratory practices are in compliance with state and federal regulations and guidelines.
Updates
- NIH Revises its Guidelines for Research Involving Recombinant DNA MoleculesPosted Oct. 2, 2012
An amendment to the NIH Guidelines for Research Involving Recombinant DNA Molecules was posted on Sept. 13, 2012 and will become effective March 5, 2013.
View or download the amended guidelines:
Amended NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
Guidelines
Office of Biological Safety
At UW-Madison, the Office of Biological Safety (OBS) provides oversight and assistance in assuring compliance with all laws, regulations, and rules governing biomedical laboratory practices and facilities.
The OBS is the administrative office of the Institutional Biosafety Committee (IBC), which reviews research activities involving biologically hazardous materials and/or recombinant DNA molecules/organisms.
Biosafety Protocols
OBS requires submission of a Biosafety Protocol for research activities involving:
- Microbiological agents infectious to humans and/or animals.
- Exotic plants, animals, and microbes (e.g., nonindigenous plants or insect pathogens, or biological control agents)
- Potentially infectious materials derived from humans (e.g., established cell lines) and from animals, including their blood, tissues, and cell lines, for which a reasonable potential for transmission of zoonotic agents exists, e.g., wild-trapped animals, sheep, and rhesus macaques.
- Select agents. CDC regulates these microbes and toxins due to their threat to public health and safety.
- Recombinant DNA molecules and recombinant DNA-containing organisms or cell cultures which are subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules. Please contact OBS about requirements for protocols involving human gene therapy trials. (Many rDNA experiments are considered to be low-risk yet still are subject to the Guidelines for Research Involving Recombinant DNA Molecules.)
- Prions: proteins that reproduce independently and cause spongiform diseases (chronic wasting disease in deer, elk; mad cow disease in cattle; Creutzfeld-Jakob disease in humans)
Investigator Requirements
Investigators planning to work with materials/organisms listed above must:
- Submit a Biosafety Protocol for review by OBS and/or the Institutional Biosafety Committee
- Ensure that lab personnel complete appropriate Training
- Report potential exposures to or releases of organisms/biological toxins within 24 hours of the event using the online First Report of Exposure/Release form
Submitting Protocols
Protocol Guidance/Forms
- Forms and instructions are available from the OBS website: Biosafety Protocol Instructions and Forms
- Submit protocols to biosafety@fpm.wisc.edu
- Some protocols do not require review by the IBC; these are reviewd by OBS staff on a rolling basis
- For protocols that require IBC review, protocols must be submitted at least 1 month prior to an IBC meeting (typically held on the first Wednesday of each month)
- Protocols are approved for a maximum of 3 years. Protocols for longer projects must be renewed every 3 years.
- For additional information, visit the OBS Biosafety Protocol Page.
Protocol Amendments
In certain situations, a protocol may need to be changed during the course of a project. There are three types of changes, or amendments, to protocols:
- Administrative Amendments are needed when funding sources are added or changed.
- Personnel Amendments are needed when lab personnel are added or removed.
- Protocol Amendments are needed when the scope of work changes.
Examples include changes in research elements, microbes utilized, and/or laboratory location or room updates.
Amendments can be submitted via email - follow the instructions included on the OBS Biosafety Protocol. page
Training
Required Training
All lab personnel (including PIs and graduate students) involved in biological research must complete the training courses below within 30 days of beginning work on campus.
- Biosafety 101: Building Biosafety into Your Research- Risk Assessment
- Biosafety 104: Building Biosafety into Your Research - Safe Use of Sharps
- Biosafety 201: NIH Guidelines
These courses are completed online via Learn@UW, and are available 24 hours a day, 7 days a week. A valid UW-Madison NetID is needed in order to access the courses.
Instructions for completing courses: OBS Biosafety Training Courses
Optional Training
Additional biosafety courses are available via Learn@UW to all UW faculty, staff, and students. See OBS Biosafety Training Courses for more information.
Resources
| UW-Madison Campus Resources | |
|---|---|
| Biosafety Protocol Instructions and Forms | OBS biosafety protocol instructions and forms |
| First Report of Exposure/Release Form | Online form for reporting potential exposures to or releases of organisms/biological toxins |
| OBS General Biosafety Information | Overview of biosafety guidelines and resources by topic |
| UW Madison Office of Biological Safety (OBS) | Office of Biological Safety main site |
| UW Madison Select Agent Program | Forms, links, and training information for researchers using Select Agents |
| Biosafety Guidebooks | |
| Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition | CDC biosafety guidebook |
| Guidelines for Handling Pathogenic Microorganisms and Disposing Biohazardous Waste | OBS waste disposal guidebook |
| NIH Guidelines for Research Involving Recombinant DNA Molecules | |
| External Resources | |
| CDC Regulation of Select Agents and Toxins | Information on the regulation of Select Agents, from the Centers for Disease Control website |
| USDA Animal and Plant Health Inspection Service (APHIS) | Information on regulations and permits for import/export and transport of exotic plants, animals, and microbes (e.g., nonindigenous plants or insect pathogens, or biological control agents). |
Contacts
General Compliance Questions
Cheryl Deering
CALS Research Compliance Specialist
(608) 262-2536
cdeering@cals.wisc.edu
Office of Biological Safety
(608) 265-6400
biosafety@fpm.wisc.edu
For individual OBS staff contacts, see Office of Biological Safety Staff page
Stem Cells
Guidelines | Submitting Protocols | Training | Resources | Contacts
Following guidelines established by the National Academies and the National Institutes of Health, UW Madison has adopted policies and procedures governing research involving human pluripotent stem cells that ensure adherence to ethical and legal principles, as well as state and federal regulations.
Guidelines
Stem Cell Research Oversight Committee (SCRO)
The Stem Cell Research Oversight (SCRO) Committee provides oversight for all research on campus or involving campus faculty or staff that involves either:
- the use of human embryonic stem cells (hESCs) or their derivatives; or
- the introduction of human pluripotent stem cells (hPSCs, or their derivatives, obtained from a non-embryonic source, into non-human animals at any embryonic, fetal, or postnatal stage, if an expected effect is that human cells will be integrated into the central nervous system, testes, or ovaries of the animal.
This oversight is in addition to the oversight provided by campus committees, such as the Institutional Review Boards, the Biosafety Review Board, and the Animal Care and Use Committees.
SCRO Committee oversight applies regardless of the source of funding and the applicability of federal regulations.
UW-Madison Policy for Human Pluripotent Stem Cell Research
The UW-Madison Policy for Human Pluripotent Stem Cell Research establishes requirements for research involving hPSCs. Among other requirements, this policy mandates that:
- hESCs may only be used after documentation of the their provenance has been approved by the SCRO committee.
- Approved hESC lines are added to the UW-Madison hESC Registry. Researchers do not need to provide further documentation regarding the provenance of those lines.
- Research falling within the purview of the SCRO can only be initiated after a protocol application has been approved.
- Certain ethical requirements involving donation of pre-implantation embryos must be met
- Any facility engaed in banking hESC lines must be certified by the SCRO committee
Investigator Requirements
- Submit a Stem Cell protocol for review by the Stem Cell Research Oversight (SCRO) Committee
- Ensure that lab personnel complete Stem Cell Ethics and Policy Training
Submitting Protocols
Stem Cell Protocols are submitted electronically via WebKit, the same system used for submitting Human Subjects Protocols to the Social & Behavioral Sciences and Education Research IRBs.
The Stem Cell Research Oversight (SCRO) Committee does not provide specific intructions for submitting a Stem Cell Protocol via WebKit, however, WebKit instructions for Human Subjects Protocols from the Social & Behavioral Sciences/Education Research IRBs may be useful.
Training
All personnel listed on a protocol submitted to the Stem Cell Research Oversight (SCRO) Committee must complete online Stem Cell Ethics and Policy Training.
Training must be completed before the application will be reviewed.
This training is completed online through the Graduate School's Collborative Institutional Training Initiative (CITI):
- Instructions for completing Stem Cell Ethics and Policy Training via CITI
- CITI training site log in (requires valid NetID)
Resources
| UW-Madison Campus Resources | ||
|---|---|---|
| Stem Cell Research Oversight (SCRO) Committee | Stem Cell Research Oversight (SCRO) Committee section of the Graduate School website | |
| UW-Madison Policy for Human Pluripotent Stem Cell Research | ||
| UW-Madison hESC Registry | UW-Madison hESC lines currently approved by the SCRO committee | |
| CITI Training Instructions | Step-by-step instructions for accessing and completing online Stem Cell Ethics and Policy Training via CITI | |
| CITI Training Website | Log-in page for the Graduates School's CITI online training website (requires valid NetID) | |
| WebKit Login | Log-in page for online protocol submission | |
| UW–Madison Stem Cell and Regenerative Medicine Center (SCRMC) | SCRMC provides a central point of contact, information and facilitation for all stem cell research activities on campus | |
| WiCell | WiCell distributes UW's hPSC lines and negotiates agreements for obtaining hPSC lines from WiCell and the National Stem Cell Bank | |
| External Resources | ||
| National Academies Guidelines for Human Embryonic Stem Cell Research | Ethical standards guide for stem cell research (with 2010 amendements) | |
| Stem Cells at the National Academies | Information and reports about activities related to stem cell research at the National Academies. | |
| NIH Stem Cell Information | NIH resource for stem cell research information and policy. | |
| NIH Stem Cell Registry | List of stem cell lines eligible for use in NIH-funded research. | |
Contacts
General Compliance Questions
Cheryl Deering
CALS Research Compliance Specialist
(608) 262-2536
cdeering@cals.wisc.edu
Stem Cell Research Oversight (SCRO) Committee
Heather Mc Fadden
SCRO Manager, Office of Research Policy
(608) 890-2468
hnmcfadden@grad.wisc.edu
The SCRO Manager is available weekdays to answer questions concerning stem cell training, consult on SCRO application preparation, and help researchers respond to SCRO requests and questions.
Protocol Lookup System (PLuS)
The Graduate School's PLuS (Protocol Lookup System) database contains information concerning UW-Madison Animal, Human Subject, Biological Materials and Stem Cell protocol status, including:
- Protocol numbers
- Protocol approval dates
PLuS is intended for administrators who have wide-ranging needs for protocol status information.
This request process is for CALS personnel only. Individuals from other schools/colleges should contact their department administrator.
If you are a CALS Department Administrator or Research Administrator who requires access to PLuS in order to perform position duties related to research administration and compliance, follow the instructions below to submit an access request via email:
- Use "CALS PLuS Access Request" as your email subject line
- Copy and paste the text below into the body of your email
- Add your contact information and question responses to the pasted text
- Send your request to Carol Hillmer in the CALS Research Division chillmer@cals.wisc.edu
CALS PLuS Access Request
Name:
Department:
Position:
Campus Email Address:
NetID:
Campus Phone Number:
- Briefly describe your current position as it relates to PLuS access.
- Briefly describe your role in research with regards to IRB/ACUC/SCRO submissions. Please indicate if you work primariy with the IRB or ACUC.
- For how many PIs are you responsible for monitoring IRB/ACUC/SCRO submissions?
- For how many protocols are you responsible for monitoring IRB/ACUC/SCRO submission?
- How will PLuS will benefit you in your current position?
- Does anyone else in your department have access to PLuS? If so, please provide the names of the individuals.
Note: By accepting access to PLuS, you agree that: all material you view will be treated as confidential; you will not share PLuS information with anyone without access to PLuS; and you will not let others use your credentials to access to PLus.