Post-Approval Monitoring - Animal Research
Post-Approval Monitoring for Animal Research ensures animal care and well being, identifies strengths and areas of improvement in research practices; ascertains compliance with institutional, state and federal guidelines and regulations; and encourages good science by identifying support and educational needs.
Adverse Event Report
- Log into: https://secure.research.vt.edu/iacuc_mgt/
- Once in the system click on the protocol the adverse event is associated with (may have to scroll down the page).
- At the top of the page there will be 8 options: click on Report an Unanticipated Problem/Adverse Event (AE)
- Answer the questions in relation to the event and submit.
Animal Welfare Concerns
Resources
Animal Use Records
Individual records needed for:
- dogs
- cats
- horses
- cows
Group records (i.e. cage cards) needed for:
- pigs
- sheep
- goats
- rabbits
- guinea pigs
- animals housed and treated as a group (i.e. mice and rats)
Acceptable formats include:
- bound laboratory notebook
- electronic (i.e. database such as excel)
- three ring binder
Facilities/laboratories/researchers may develop their animal use records to suite their specific research needs/species. All animal health records should be maintained in close proximity to the animals.
For further requirements, please visit either Research Procedures or Animal Health Records.
Remember, if you do not write it down, it did not happen.
Research Protocol Procedure Form Specifics
- Identity of the animal
- Descriptions of activities (cut-n-paste from the approved protocol)
- Dates, including the name, dose, route, frequency, and duration of treatment with drugs, feed additives, or any other protocol manipulation.
- Dates, including the number and type of samples collected, (e.g. blood, feces, urine, muscle, tail snips, etc.), the amount sampled (mls or grams), and observations post procedurally if required.
- Daily observations even if it is just to say "checked for signs in Experiment 1; no signs yet." For laboratory animals this is often recorded on the cage card, but keeping the same documentation in a notebook is always advisable (cage cards can fall off, and be damaged).
- If surgery is involved very specific documentation of pre and post surgical care is required by the Animal Welfare Act (USDA).
The following forms are examples that may be used or you may create your own with the above specifics
- Sample of a Completed Research Procedures Form
- Research Procedures Form
- Small Animal Inventory
- Template of Procedure Form
- Template of Body Report Form - the form is currently set up for tracking bleeding. However, the form can easily be adapted for other specific purposes (i.e. weighing etc)
Animal Health Form Specifics
- Identity of the animal
- Descriptions of any illness, injury, distress and/or behavioral abnormalities and the resolution of any noted problem.
- Dates, details and results of all medically related observations, examinations, tests and other such procedures.
- Dates, details of all treatments, including the name, dose, route, frequency, and duration of treatment with drugs or other medications (worming, vaccinations, etc).
- Treatment plans should include a diagnosis and prognosis, detailing the type, frequency, and duration of any treatment and the criteria and/or schedule for re-evaluation(s) by the attending veterinarian.
- Surgical records should include detailed pre- and post-, as well as intra-operation, notes.
The following forms are examples that may be used or you may create your own with the above specifics
Post-Approval Monitoring is an examination of the research facility and study documents to assure that animal subjects are protected, and the investigator is in compliance with applicable University and Federal regulations. Conducting post-approval monitoring will help to ensure that appropriate applications and supporting documents are executed as approved, and any changes or adverse events are reported.
Some possible benefits that may be gained from a review include but are not limited to:
- increased understanding of the regulations that guide all our research projects
- increased communication concerning updates to federal and university regulations
- access to resources and individuals to clarify the federal and university regulations
The majority of protocols are selected randomly. Projects whose subjects are at a greater risk have a higher chance of being selected. If a protocol has been selected, it does not necessarily mean the investigator is doing something wrong.
Protocols can be selected for-cause from a complainant (study personnel, anonymous, etc.).
If your documents are complete and organized, the review will take about one hour. If an investigator is not prepared, the review may take several hours.
The following assessment tool will be used: IACUC. You will be asked to pull records / lab notebook's that demonstrate the protocol was followed as approved. You will be asked questions about how the research project is going in relation to problems or adverse events. The scope of review varies greatly depending on the research, but may include:
- a tour of the animal facility
- viewing a procedure at a future date (by appointment)
There are several actions that could result from a Post-Approval Monitor review. They include:
- Compliant, no follow up needed.
- Minor deficiencies, the investigator completes the assessment's resolution comment column with their plans to address the issues within one month and emails the document back to the Post-Approval Monitor.
- Significant deficiencies, the investigator completes the assessment's resolution comment column with their plans to address the issues within the specified time and emails the document back to the Post-Approval Monitor. Furthermore, the investigator will be reviewed again within six months to assure compliance. The IACUC will be notified of significant violations.
About a week from the review date.
It is preferred; however, you may designate a representative if you cannot attend.