olaw online seminars. training issues. june 20, 2013 · training issues olaw online webinar june...
TRANSCRIPT
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Training Issues
OLAW ONLINE WEBINAR June 20, 2013
Sara Maloney, IACUC Coordinator Boston Children’s Hospital
Susan Silk, MS, Director, Division of Policy and Education,
OLAW
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PHS Policy on the Guide and AWAR
This Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals and that they comply with the applicable regulations issued by the USDA under the Animal Welfare Act.
IV.A.1. Footnote 2
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OLAW Training Guidance
OLAW FAQ G1: What kind of training is necessary to comply with PHS Policy and how frequently should it be provided? The U.S. Government Principles, Health Research Extension Act of 1985 and the PHS Policy repeatedly refer to appropriately trained, qualified, and experienced personnel, and availability of instruction and training. The institution is responsible for the training of its staff. The size and nature of institutional research programs varies significantly and accounts for the corresponding variation in the scope and depth of instructional programs and the frequency at which they are offered.
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FAQ G1 con’t. • Ensure that individuals are trained and qualified in species-specific
housing methods, husbandry procedures, handling techniques • Ensure that research staff members performing experimental
manipulation are qualified through training or experience to accomplish procedures humanely in a scientifically acceptable fashion
• Provide training or instruction in methods that minimize the number of animals required to obtain valid results, minimize animal distress
• Ensure that staff whose work involves hazardous agents have training or experience to assess potential dangers and select and oversee the implementation of appropriate safeguards
• Ensure compliance with any initial and continuing education regarding State requirements for the licensing of veterinary or animal health technicians.
Condensed from http://grants.nih.gov/grants/olaw/faqs.htm#instresp_1
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USDA Training Requirements
Animal Welfare Act and Regulations (AWARs):
“Training of scientists, animal technicians, and other personnel involved with animal care and treatment at research facilities...
Each research facility shall provide for the training of scientists, animal technicians, and other personnel involved with animal care and treatment in such facility…” (Sec. 2143 (d))
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What is a Best Practice?
• Best practice is a method that has been shown to achieve superior results and is used as a benchmark.
• The guidance in this webinar represents current thinking and experience and draws on best practices followed by the biomedical research community.
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Guidance Regarding Best Practices
• Unless specific statutory or regulatory requirements are cited, this information should be viewed as recommendations.
• A recommendation may not be suitable or applicable to every institution.
• An Assured institution may use an alternative approach if the approach satisfies the requirements of the PHS Policy.
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Training Issues
Minimum Requirements and Best Practices
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Training Issues • WHO? - Personnel to include in training
• WHAT? - Training topics
• HOW OFTEN? - Frequency of training
• HOW? - Methods of training • DOCUMENTING - Documentation of training activities
• EVALUATING - Evaluating the effectiveness of training
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Why Training is Important
• “Laboratory animal science and medicine are rapidly changing and evolving disciplines.”
• Helps ensure high quality science is conducted and animal well-being is prioritized
• Facilitates compliance with the Program
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Considerations for Training Programs
(Guide) Qualifications of personnel required to conduct and support an animal program depend on: • Type and size of the institution
• Administrative structure for providing adequate animal care
• Characteristics of the physical plant
• Number and species of animals maintained
• Nature of the research, testing, teaching, and production
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Personnel to Include in the Training Program
PHS Policy: • Those responsible for housing, feeding, and care of
animals • Those conducting procedures on live animals • Institutional Animal Care and Use Committee (IACUC)
members
AWARs: Closely echoes wording in the PHS Policy Guide: Indicates “all personnel involved” with animal care and use
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Personnel Categories in the Guide Chapter 2, Personnel Management, Training and Education: • Veterinary and other professional staff
• Animal care personnel
• The research team
• The IACUC
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Other Personnel to Include in Training
• Institutional Official
• Occupational health and safety
• Administrative
• Animal transportation
• Facilities
• Emergency management
• Human resources management
• Legal professionals 14
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Training Topics: Considerations
PHS Policy: General requirements
AWARs: More specific criteria (but still general)
Guide: “Must” and “Should” statements are used
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Personnel Training Topics
Training Topics AWARs PHS Policy Guide Must Guide Should
Training, education, experience to conduct activities involving animals
All relevant personnel
All relevant personnel
All relevant personnel
Basic principles, ethics and humane/proper practice of animal care, use, maintenance
All relevant personnel
All relevant personnel
All relevant personnel
Three Rs: Replace, Refine, Reduce
All relevant personnel
All relevant personnel
Research team
Specific procedures All relevant personnel
All relevant personnel
Veterinarian, Research team
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Personnel Training Topics
Training Topics AWARs PHS Policy Guide Must Guide Should
Veterinary/ Laboratory animal medicine
Veterinarian Veterinarian Veterinarian
Housing, feeding, non-medical care of animals
Veterinarian or scientist
Veterinarian or scientist
Animal care
Signs of pain/distress All relevant personnel
Humane endpoints All relevant personnel
Veterinarian, Research team
Reporting concerns All relevant personnel
Research team, Other relevant personnel
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Personnel Training Topics Training Topics AWARs PHS Policy Guide Must Guide Should
Contingency/Disaster plans
All relevant personnel
All relevant personnel
Animal facilities and access
Veterinarian, IACUC, Other relevant personnel
Occupational health and safety concerns
Research team, Other relevant personnel
Institutional Program Research team, IACUC
Animal care and use legislation, regulations, guidelines, policies
Research team, IACUC
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Frequency of Training PHS Policy: Leaves it up to the individual institution
Guide: Multiple “should” statements are used
AWRs: Review of qualifications with “sufficient frequency”
Other possible requirements: • Formal education requirements • State and local laws
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Frequency of Training Categories of frequency: 1. Initial training 2. Ongoing/continuing education 3. Interim (timely) notifications “Should” undergo continuing education (Guide): • Veterinary and other professional staff • Animal care personnel • Research team • The IACUC
Best practice: • Perform a risk assessment for all personnel • Base on performance standards
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Training Methods: Considerations
PHS Policy and AWARs: Training must be provided, and adequate training and experience ensured Guide: Multiple “should” statements are used Best practice considerations • One size does not necessarily fit all • Defined what is necessary and how it can be
achieved • Collaborative effort
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Methods of Initial and Continuing Training and Education
• Formal education (degree or non-degree) • On-the-job
• Employee orientation • Verified by Memoranda of Understanding
agreement
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Methods of Initial and Continuing Training and Education
• Laboratory animal science meetings and workshops
• Webinars
• Institution-sponsored seminars
• Self-guided study
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Methods of Timely Notification
• Posted signage
• Email notifications • Text message notifications • Institutional website
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Documenting Training: Animal Welfare Assurance and
Animal Use Protocol
PHS Policy: The written assurance must describe “the qualifications” of the veterinarian as well as “a synopsis of training” of personnel. Guide: The animal use protocol should describe the “adequacy of training and experience of personnel in the procedures used, and roles and responsibilities of the personnel involved”.
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Other Documenting Considerations
Guide: “all Program personnel training should be documented” Training that may not be documented in the animal use protocol: • Personnel outside of the research team • Animal care and use legislation, regulations, principles, etc. • Contingency/disaster plans • Occupational health and safety practices • During post-approval monitoring • Continuing education activities 26
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Documenting: Methods and Maintenance
Methods of documenting: • Paper-based systems • Electronic systems (commercially available or home-
grown) Document maintenance: • Know who is responsible • Availability for review • Duration (OLAW, local)
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Evaluating the Effectiveness of Training
PHS Policy: Continuing review of ongoing activity Guide: The IACUC is responsible for “evaluating the effectiveness of the training program.” AWARs: One IACUC function is to make “recommendations to the Institutional Official regarding any aspect of…personnel training.”
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Methods of Evaluating the Effectiveness of Personnel Training
• Semiannual program review
• Inspections and site visits
• Certification status
• Staff meetings
• Employee performance evaluations
• Audits • Morbidity and mortality • Post-approval monitoring
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Methods of Evaluating the Effectiveness of Personnel Training
• Review of non-compliance events
• Quizzes • Evaluation by IACUC
leadership and IO
• Feedback from personnel • Review of responses to
unexpected events and practice drills
• Review of occupational health and safety-related incidents
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Resources • PHS Policy and OLAW FAQs
• Animal Welfare Act and Regulations • Guide for the Care and Use of Laboratory Animals, 8th Edition • Animal Welfare Information Center (AWIC) • Laboratory Animal Welfare and Training Exchange (LAWTE)
• American Association for Laboratory Animal Science (AALAS) • Institute for Laboratory Animal Research (ILAR) • Guidelines from other countries may be useful considerations
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Question 1
Many institutions depend on their PI’s to conduct some procedure specific training since they at times are the experts. Regarding documenting the PI conducted training - is it adequate for the PI to include in a protocol that “personnel” will be trained on a procedure before beginning a procedure, or is there an expectation that the PI will keep a separate training log that specifically identifies (date, and sign-off by the trainer for example) when each technician was adequately trained?
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Question 2
The intensity of trainings can vary significantly from institution to institution. How would you suggest evaluating the effectiveness of a training program? Any suggestions on evaluation standards?
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Question 3
Relating to establishing comprehensive training programs, any suggestions for small institutions with limited resources?
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Question 4
One common sanction for noncompliant events is for the IACUC to require a PI to retake, for example, an online training course. If OLAW sees this sanction time after time from the same institution, would OLAW question the effectiveness of the training?
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Question 5
Must all training be documented?
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Question 6
Is it OK for the PI or a member of his staff to do some of the training?
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Question 7
Should the IACUC look at training records during every semiannual inspection and program review?
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Question 8
What if someone hasn’t completed the specific species training and starts to work with animals? Is this reportable to OLAW?
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Question 9
A collaborating surgeon whose specialty is human cardiology will be conducting an experiment using sheep at our institution. He claims he does not need training as he works on human subjects daily. Should we allow him to proceed without additional training?
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Upcoming OLAW Online Seminars
• September 19, 2013 – Topic: TBD • December 12, 2013 – Topic: TBD
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