IRB Basics

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IACUC Updates /

Health and Safety Training

Elaine Major, Director of Institutional Compliance

215 Wannalancit, ext. 3452

Dr. Scott Perkins, VMD, MPH, ACLAM

Cell 617-947-5770 or email scott.perkins@tufts.edu

Amy Finneral, Animal Research Compliance Manager

618 Olsen, ext. 4698

Overview

Updates

Dr. Peter Gaines, IACUC Chair in Jan. 2013!

Updated Policies and Procedures on web

Guide for the Care and Use of Laboratory Animals: Eighth Edition

(Guide), adopted by NIH 1-1-12 http://grants.nih.gov/grants/olaw/Guide-for-the-careand-use-of-Laboratory-animals.pdf

Facility updates

Per diems- estimate 10% increase, possibly billed through CRF

Occupational Health Evaluation REQUIRED

Schedule all activities in facility (esp. procedure room)

Risks from Working with Animals and Zoonoses

Policy and Procedure Updates

 Core Research Facility process for billing

 Updated Information on website

Forms http://www.uml.edu/Research/OIC/animaluse/forms.aspx

Guidelines and Policies

Murine Tail Biopsy

Physical Restraint and Immobilization

Use of Freund’s Adjuvant

Protocol Process!!!

 Protocols approval PRIOR to animal use

 To assure NIH OLAW in compliance with PHS and

USDA requirements

 AV available to assist and provide recommendations

 Include options to provide flexibility

 Procure all supplies before initiating project

 Review approved protocol with all research personnel

 Review protocol often and update with amendments

 If not enough detail, will not go on meeting agenda

Facility Requirements

 Training Required

 CITI training (regulatory information), every 3 years

 Occupational Health Clearance, annually

 EHS Lab Safety Training, annually

 Animal Handling Training Session, as needed

 Research specific activities (PI), as needed

 No eating or drinking in facility

 No cell phone use (photography policy)

 PPE required

 Schedule activities with facility manager

Facility Reminders (cont.)

 Use controlled substance log as necessary

 NO transport of animals outside facility without specific approval ( Refer to Animal Transport Policy)

 Report ANY incident

 Include description of what occurred, reasons why you think it occurred, what was done to alleviate pain/distress for the animal, suggested revisions to address and prevent the problem from recurring

 OIC investigates and files reports with OLAW, as appropriate

 IACUC can stop activities if necessary

Supplies

OIC provides:

 Cages (unless special)

 Regular food and bedding

 PPE

 Euthanasia supplies

 Supplies for facility training

 Basic housekeeping supplies

Researchers provide:

 All needles, syringes, surgical equipment, etc.

 Drugs/materials as noted on protocol

 Other materials specific to research activity

Visitor Policy

Submit visit requests to OIC with justification for approval

Generally not approved to see how animal research is conducted

Visitors must verify that they have not been in any other animal facility on the day of the visit

Visitors must wear appropriate PPE

Disposal of Dead Animals

• For animals found dead, update census information on cage card and review protocol to follow procedures for carcasses

• PI is notified (referencing protocol number and cage number or cage card information) to determine if necropsy desired

• If no handling instructions or PI is unavailable, animal is placed in a plastic bag and put in designated freezer

• For USDA regulated species, record Found Dead (FD) is noted in the animal's medical record

• ORS Manager contacts EH&S for pickup and disposal of carcasses when the freezer is full.

Working Reminders

 Schedule all activities in facility

 Bring all research supplies

 Wear protective clothing (for you and animals!)

 Gloves, shoe covers, lab coat, mask, goggles

 Dispose of used PPE in facility

 Report ANY injury from an animal

 Report ANY incident affecting an animal

 Clean up work area and wash hands before leaving

 Dispose of sharps and materials appropriately

Reporting Concerns

 Document concern or incident asap

 Date, time, and location incident occurred

 Describe what happened

 Include names of personnel involved

 Outline actions to prevent re-occurrence

 Notify OIC and AV immediately!

 For reporting any general concerns

 Email (Amy Finneral or Elaine Major)

 Phone (Anonymous Hotline x3100)

 Intercampus mail

For Success with the IACUC

 Provide enough detail in your protocol

 Follow protocol procedures as approved

 All personnel must complete training

 Follow the protocol and submit amendments if necessary

 Understand risks and how to minimize them

 Be respectful- may not agree but need to follow AV and

IACUC’s directives to ensure UML is in compliance

 Use the resources provided by the AV

Risks and Precautions for Work with

Animals

 LOW risk if follow precautions

 EXTREMELY LOW risk of disease using animals from reputable sources

 Immunization awareness

 Tetanus required, Hepatitis B recommended

 Occupational Health Clearance

 Baseline

 Annual review

Occupational Health Program

Essential part of the overall Program of Animal Care and Use at UML

Required for anyone working with animals or entering facility

Goal to identify personnel with animal allergies and determine PPE or equipment available to protect them

Complete Baseline Health History Questionnaire

Email to Jeanne.cotter@allonehealth.com or

Fax with Cover Sheet to All One Health, Attn: Jeanne

Cotter, (781) 938-4686

Reviewed by a health professional and clearance sent to EHS and the Facility Manager before allowed access to the facility

Common Exposure Routes

 Aerosol (inhalation)

 Ex. gases, centrifuging, flaming, shaking, pouring, etc.

 Ingestion (swallowing)

 Ex. Water or food with Salmonella or Giardia

 Absorption (skin, mucus membranes, open wounds)

 Ex. Material splashed on skin or open wound exposed directly to animal or materials used

 Skin penetrated (punctures)

 Ex. Accidental needle sticks, cuts, or bites

Common Hazards

 Injuries

 Bites, scratches, needle sticks

 Repetitive motions

 Working with equipment

 Allergies

 Airborne contaminants

 Zoonoses

 Bloodborne pathogens (biohazards)

 Biological and Chemical agents

If Injured...

 Notify your supervisor

 Thoroughly wash site with soap and water

 Report any bite or scratch

 Flu like symptoms w/in several days after bite

 Seek medical attention as necessary

 Call ext. 2911 if serious or go to an ER

 Prevention: Complete animal handling training and use proper restraint techniques

Allergies

 Allergies affect ~30% of all workers

 Caused by proteins from a variety of fluids/tissues from many animal species

 Worsen after repeated exposure

 Can lead to asthma

 Symptoms: runny nose, itchy or watery eyes, cough, sneezing, hives/skin rashes

 Precautions: PPE, wash hands, respirators, antihistamines, allergy shots

 Severe reactions: Call 2911 or go to an ER

Anaphylaxis

 Airway problem due to severe allergic reaction

 Life threatening and can develop quickly

 Symptoms:

 Hives: red, itchy, raised blotches on the skin

 Itchy watery eyes, runny nose

 Increased heart rate

 Wheezing, stridor, coughing

 Nausea & vomiting

 Swelling of the face

Zoonoses

 Disease transmitted from animals to humans

 viruses, bacteria, fungi, protozoa

 internal and external parasites

 Very rare in commercially bred animals and sporadic

 Prevention: use PPE, get animals from reputable vendors, personal hygiene, avoid bedding and contaminated water, monitor animals for infection

Recognize Zoonoses Risk Factors

 Learn about animals you work with

 Understand mode of transmission for infectious agents

 Assess potential for aerosolization, splash, or contamination and reduce risk of exposure

 Evaluate waste handling

 Identify how emergencies or spills could occur

& implement preventative measures

Testing of Biological Products

• Biological products (cell lines, blood, etc.) are the most common source for introduction of infectious disease to a colony

• ALL biological products must be tested prior to use (PCR, etc.)

• Even products (blood, serum) that have been passaged in rodents may be contaminated

Agents of Disease

Parasites

Fungi

Bacteria

Viruses

Zoonotic Parasitic and Fungal Diseases

Ringworm

Giardia

Mange

Tapeworm

Note: Minimal risk in vendor-acquired animals

Ringworm

(Trichophyton or Microsporum sp.)

Species: all species

Animals: asymptomatic; alopecia (hair loss) & circular areas of flaky skin

Humans: asymptomatic; raised area of itchy, flaky, red skin

Mode of Transmission: direct contact

Diagnosis: culture, Woods Lamp

Treatment/Prevention: oral & topical medications and good sanitation, use PPE’s

Ringworm

(Trichophyton or Microsporum sp.)

Giardia sp.

Species: all

Animals: asymptomatic; diarrhea

Humans: asymptomatic; diarrhea, vomiting

Mode of Transmission: fecal-oral route

Diagnosis: fecal examination

Treatment/Prevention: Oral medication, through sanitation/removal of wastes and routine fecal analysis of colony

Mange (Sarcoptes scabei)

Species: all

Animals: asymptomatic; itching, dermatitis

Humans: itching, dermatitis

Mode of Transmission: direct contact

Diagnosis: skin scrape

Treatment/Prevention: topical medication, good sanitation and use of PPE’s

Tapeworm (Rodentolepis nana)

Species: mice & rats (from pet stores)

Animals: asymptomatic; wasting/weight loss

Humans: asymptomatic; vomiting, diarrhea

Mode of Transmission: fecal-oral route

Diagnosis: fecal floatation

Treatment/Prevention: oral medication, good sanitation and use of PPE’s

Zoonotic Bacterial Diseases

 Staphylococcus

 Streptococcus

 Tetanus

 Campylobacter

 Salmonella

 Pasturellosis

 Rat-bite fever

Staphylococcus and Streptococcus

Species: all

Animals: asymptomatic; small skin blisters, ulcers and wounds

Humans: asymptomatic; small skin blisters, ulcers and wounds, septicemia

Mode of Transmission: exposure through non-intact skin/wounds

Diagnosis: culture

Treatment/Prevention: oral medication, good sanitation and use of PPE’s

Tetanus (Clostridium tetani)

Species: all

Animals: rigid limbs

Humans: rigid limbs

Mode of Transmission: inoculation through skin

Diagnosis: culture

Treatment/Prevention: oral medication, good sanitation and use of PPE’s, vaccination

Before vaccinations!

Campylobacter

Species: all

Animals: asymptomatic; diarrhea

Humans: asymptomatic; diarrhea, vomiting

Mode of Transmission: fecal-oral route

Diagnosis: culture

Treatment/Prevention: oral medication, good sanitation and use of PPE’s

Salmonella

Species: all

Animals: asymptomatic; diarrhea

Humans: asymptomatic; diarrhea, vomiting

Mode of Transmission: fecal-oral route

Diagnosis: culture

Treatment/Prevention: oral medication, good sanitation and use of PPE’s

Pasturellosis (Pasturella multocida)

Species: all

Animals: asymptomatic; abscesses, septicemia

Humans: asymptomatic; localized infection in the skin

Mode of Transmission: skin puncture

Diagnosis: culture

Treatment/Prevention: oral medication, good sanitation and use of PPE’s

Rat-bite Fever

(Streptobacillus monilformis)

Species: rats

Animals: asymptomatic

Humans: flu-like symptoms, rash, arthritis

Mode of Transmission: scratch or bite

Diagnosis: culture

Treatment/Prevention: oral medication, good sanitation and use of PPE’s

Zoonotic Viral Diseases

Lymphocytic choriomeningitis

(LCMV)

Hantaan virus (never reported in US commerically bred rodents)

LCMV (Lymphocytic choriomeningitis virus)

Species: mice & rats

Animals: asymptomatic; general poor condition

Humans: flu-like symptoms, joint/muscle pain

Mode of Transmission: exposure to saliva/urine

Diagnosis: ELISA & antibody test

Treatment/Prevention: supportive care of symptoms, sentinel program, us of PPE’s

Note: risk is primarily for wild-caught animals

Hantaviruses

Species: rats & mice

Animals: asymptomatic

Humans: flu-like symptoms, kidney damage, hemorrhaging & respiratory failure

Mode of Transmission: exposure to urine, saliva or feces

Diagnosis: Antibody detection

Treatment/Prevention: anti-viral therapy, supportive care of symptoms, good sanitation and use of PPE’s

Note: risk is primarily for wild-caught animals

Wild-caught Rodents

Risk higher!!!

Rabies

Listeriosis

Leptospirosis

Typhus

Typhoid fever

Yersinia pestis (plague)

Other ecto- and endoparasites

 Scrub typhus

 Other rickettsial diseases

Summary

 Complete all training

 Follow facility policies

 Use PPE

 Understand risks

 Follow protocols and safety precautions

 Ask questions

 Report ANY incidents, problems, or injuries

 Contact us for help

 Questions???

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