Print this pageResearch Protocols
- Animal Use
- Human Subjects
- Biological Safety
- Stem Cells
- Protocol Lookup System
Animal Use
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 the February of 2007. Click here for the CALS AAALAC Accreditation Letter. Our pursuit of this accreditation demonstrates our commitment to the humane and ethical treatment of research animals. The following statement is from the AAALAC website.
For some, animal research is a controversial topic. But like others in the animal welfare arena, AAALAC endorses the use of animals to advance medicine and science when there are no non-animal alternatives, and when it is done in an ethical and humane way.
When animals are used, AAALAC works with institutions and researchers to serve as a bridge between progress and animal well-being. This is done through AAALAC's voluntary accreditation process in which research programs demonstrate that they meet the minimum standards required by law, and are also going the extra step to achieve excellence in animal care and use.
In this way, AAALAC International is where science and responsible animal care connect.
Updates
Policy #2003-015 titled Policy on Collaborative Research Projects Subgrants and Subcontracts taking Place at Non UW-Madison Facilities. Please note the changes to this policy are also outlined at RSP's web site (http://www.rsp.wisc.edu/policies/animal.html)
Policy #1999-006 titled Animal User Orientation and Mandatory Training. Please note the Animal Users Training/Certification must be updated every 5 years instead of every 3 years. This policy change extends to the Occupational Health and Safety Training for Animal Users also.
All of the All Campus ACUC Policies can be viewed at the RARC web site (http://www.rarc.wisc.edu/policy/index.html).
Thanks to all of the CALS PIs, Laboratory/Animal Care Managers and Staff for your help! Our college's Animal Program received many accolades and a few suggestions for improvements. We await the AAALAC Council's review of our site visitors report and our responses to the visitors suggestions for improvement. We will be notified in March 2010 of our AAALAC standing.
Guidelines
The use of animals in research is covered by the federal Animal Welfare Act. This act mandates humane and ethical treatment of animals used in teaching and research. The purpose of associating grants with animal protocols is to assure funding agencies that all funded experimental procedures involving animals comply with the Animal Welfare Act. The requirements for conducting animal research are extensive, including proper housing, training of animal care workers and approval of protocols. It is the investigator's responsibility to understand and comply with these requirements. Animal Protocols in CALS should be submitted to the CALS Animal Care and Use Committee (ACUC) by 4:00 pm on the 1st of the month.
Links
- Altweb, the Alternatives to Animal Testing Web Site, was created to serve as a gateway to alternatives news, information, and resources on the Internet and beyond.
- The UW Research Animal Resources Center (RARC)provides extensive information on using research animals including:
- IACUC.org provides information for IACUC members and staff.
- USDA Animal and Plant Health Inspection Service (APHIS) provides leadership for determining standards of humane care and treatment of animals. APHIS is responsible for implementing and enforcing the Animal Welfare Act.
- American Association for Laboratory Animal Science (AALAS) is a forum for the exchange of information and expertise in the care and use of laboratory animals.
- NIH’s Office of Laboratory Animal Welfare (OLAW) provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals.
- Federation of Animal Science Societies (FASS) is an association of several animal science societies. It publishes the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching
Regulatory and Standards Information
- Animal Welfare Act
- American Veterinary Medical Association (AVMA) Guidelines on Euthanasia
- Guide for the Care and Use of Laboratory Animals
- Public Health Service Policy on Humane Care and Use of Laboratory Animals
- Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching
Human Subjects
In 2008 the University of Wisconsin revised its human subjects training program. For more detailed information on those changes, read the memo from the Office of Research Policy. All investigators should have completed the training by the end of 2008. If any investigators have not completed this training, their protocols will not be reviewed. New personnel must take the new training when they arrive on campus.This training helps investigators determine when a human subjects protocol is necessary. CALS Research Division recommends that all staff involved in managing research awards take the training.
Guidelines
Social, Behavioral, and Educational guidelines regarding research involving human subjects, including ethical issues, legal requirements, and campus-wide policies, are provided at the Graduate School's pages specifically intended to guide faculty who are conducting non-medical research involving human subjects.
Health Sciences guidelines regarding research involving medical interventions or procedures where medical expertise is required for protocol evaluation are provided at the Health Sciences Institutional Review Boards website (see link above).
Links
Human Research Protection ProgramThe University of Wisconsin-Madison HRPP is an integrated institution-wide program coordinated by the Graduate School Office of Research Policy in concert with the Associate Deans for Research of the College of Letters and Science, School of Education and School of Medicine and Public Health, which house the four campus Institutional Review Boards (IRBs), and in consultation with the Office of Administrative Legal Services. The website contains a vast amount of information regarding human subjects research and policies.
Obtaining IRB Approval for Human Subjects Research–Step by Step. This overview of the IRB process covers...
- Determining if your research is covered under the Federal Common Rule, with links to definitions and examples of human subjects research
- Explanation of UW-Madison IRBs to help determine where you need to submit your protocol
- Explanation of IRB review categories: full, expedited, or exempt
- Issues to consider when planning your research
- Plan for informed consent and HIPAA authorization
- Continuing review of approved research, or changes to approved protocls
- Incident reporting
Online Research Training Requirements. Note that...
- All current investigators and students should have completed the new training by the end of 2008. Any investigators that have not completed this training will not have their protocols reviewed.
- All new personnel must complete the training when they arrive on campus or initiate plans for human subjects research
- You should review the frequently asked questions regarding the new CITI training
- You can directly access the Login to the CITI training site here
UW-Madison IRB Websites QuickLinks
IRB contacts, protocol submission, guidelines and deadlines for new and continuing IRB protocol review by UW-Madison's Institutional Review Boards (IRBs) and Human Research Protection Program Advisory Committee.
Biological Safety
As a major research institution, the UW-Madison provides assurances that its sponsored research activities are in compliance with state and federal regulations and guidelines. In this context, the Institutional Biosafety Committee reviews research activities involving biologically hazardous materials and/or recombinant DNA molecules/organisms.
Updates
This Mandatory Biosafety Training is for all personnel working in labs with biohazard materials. All current investigators and students listed on biosafety protocols must complete this training by October 1, 2009. All new personnel must complete this training before working in research that needs Institutional Biosafety Committee review.
To Complete the Mandatory Training:
- Open the Mandatory Biosafety Training web page
- When the web page opens, click on any of the Biosafety Training Title links or the Learn@UW links
- Login with your NetID
- Use these instructions to register for the Mandatory Biosafety Training
Beginning on July 1, 2009, all amendments and renewals must now be submitted using this form.
- Biological Materials and Recombinant DNA Protocol Form
- Biological Materials and Recombinant DNA Protocol Instructions
Please review the current issue of the Safety & Compliance Alert. Published in April 2009, this issue covers antibiotic drug resistance.
Guidelines
A biosafety protocol should be submitted 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.
- Potentially hazardous chemicals administered in vivo or in vitro to induce a biological outcome (e.g., carcinogens, mutagens, teratogens, drugs, and toxins).
- 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)
Links
- Office of Biological Safety. This office is the administrative home of the IBC. It provides guidance, information, review, monitoring and training for topics including:
- Biohazard Recognition and Control (BRC)
- Biological Safety Cabinets (BSCs)
- Biosafety in Microbiological and Biomedical Laboratories (BMBL)
- Exposure Procedures
- Haz Mat shipping
- Large Scale Biosafety Guidelines (ASM Policy)
- Opportunistic and Borderline Pathogens
- Precautions for Work with Poxviruses that Infect Humans
- Provides administrative support for researchers needing USDA Animal and Plant Health Inspection Service (APHIS) permits for regulated plant or animal use.
- Advises on the appropriate disposition of post-research animals.
- Coordinates Select Agent Program requirements
- Reviews “Dual-Use Life Sciences Research” - data and/or materials that may have both military and civilian use.
- UW Select Agent Program. Identifies select agents, regulations, and resources
- Centers for Disease Control (CDC) final rules regarding Select Agents and bioterrorism.
Stem Cells
As we await news from the federal government on possible regulatory changes in stem cell research, the UW-Madison oversight of stem cell research will continue according to the guidelines adopted in May 2007 by the UW-Madison. For detailed information on the UW-Madison policy for human pluripotent stem cell use go to this link: http://www.grad.wisc.edu/admin/committees/scro/documents/UWPolicyforhPSCResearchRevised9June2008.pdf.
Researchers currently engaged in either category of stem cell research listed in the guidelines below but currently do not have an approved protocol registered with the Stem Cell Research Oversight (SCRO) Committee must complete the training and begin the electronic protocol application process. The deadline to meet these compliance requirements for those individuals is June 1, 2009.
Guidelines
The Stem Cell Research Oversight (SCRO) Committee is responsible for the development and maintenance of UW-Madison Human Pluripotent Stem Cell Research policies and procedures, as well as the review of the SCRO Committee Initial Application Form that must be submitted to be enrolled in the UW-Madison human embryonic stem cells (hESC) registry and to ensure approval of covered research activities.
The 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 or their derivatives; or
- the introduction of human pluripotent stem cells, 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 that might be provided by other committees on campus, 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.
Links
- UW-Madison hESC Registry
- http://www.grad.wisc.edu/admin/committees/scro/registry.html
- To view hESC lines previously approved by the SCRO Committeee go to the UW-Madison registry. hESC lines listed on the UW-Madison registry do not need any further documentation regarding the provenance of those lines (although protocols using those lines still require SCRO Committee approval). Once the SCRO Committee has reviewed the provenance for an hESC line and found it to be in accordance with UW-Madison policy, that line will be added to the UW-Madison registry.
- Required Training
- CITI Training Portal: https://my.gradsch.wisc.edu/citi/index.php
- Online stem cell ethics and policy training must be completed before the protocol application will be reviewed by the SCRO Committee.
- Obtaining SCRO Committee Protocol Approval
- WebKit Login: https://rcr.gradsch.wisc.edu/irbwebkit/Login.asp
- SCRO Committee approval can be obtained through the electronic submission of a protocol through WebKit.
- UW-Madison Stem Cell Resources
- http://www.wicell.org/
- WiCell Research Institute is responsible for distributing the UW's hPSC lines as well as reviewing and negotiating agreements for obtaining hPSC lines from WiCell and the National Stem Cell Bank.
- Other stem cell research resources
- Understanding Stem Cells: An Overview of the Science and Issues
- The National Academy of Sciences' Guidelines for Human Embryonic Stem Cell Research
- The 2007 Amendments to the NAS Guidelines
- The National Academies: Human Embryonic Stem Cell Research Advisory Committee
- Stem Cell Information: The Official National Institutes of Health resource for stem cell research
- The National Stem Cell Bank: responsible for banking, characterizing, and distributing hPSC lines listed on the NIH registry.
If you have any additional questions/comments regarding stem cell compliance, please contact Cheryl Deering at (608) 262-2536 or cdeering@cals.wisc.edu.
Graduate School's
"Protocol Lookup System" (PLuS)
The Graduate School has developed the PLuS (Protocol Lookup System) database. The PLuS database lists:
- UW human subject protocol numbers,
- UW biological materials protocol numbers,
- UW animal protocol numbers, and
- approval dates for your PIs.
If you are a Department Administrator or Research Administrator who requires access to the Protocol Lookup System to assist in performing your responsibilities regarding research administration and compliance, you can submit your request to Carol Hillmer in CALS Research Division (chillmer@cals.wisc.edu).
Please use the following format for your access request:
CLAP PLuS Access Request Name: Department: Email Address: Campus Phone Number:
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