Guidelines for approval of an IACUC submission
Appalachian’s Occupational Health and Safety Requirements for individuals working with live, vertebrate animals in research, teaching or demonstration (effective July 1, 2014):
- Complete the required CITI training module. For information on how to take this online course, see the training instructions on the Research Protections web page.
- Complete the species-specific training module for each species you plan to work with. Some of these species (Mice, Frogs, Toads, Rats, Hamsters, Gerbils, Guinea Pigs, Rabbits, Zebrafish) are on the CITI site and you can add the modules to your training list. Others are in the IACUC Community AsULearn site, under the Species Specific Training block.
- Fill out the appropriate Health Risk Assessment form and send to email@example.com.
- Students who have paid their student health fees should use the Student form.
- Everyone else should use the Faculty/Staff form (includes students who have not paid the health fee).
- The Health Risk Assessment is screened and if any follow up is needed, you will be contacted by the Environmental Health, Safety & Emergency Management office.
- It is your responsibility to complete any follow up requests.
- You will not be cleared for working with animals until you have completed your required training and your completed Health Risk Assessment form has been reviewed and cleared.
Because this is a new requirement, we have some Q & A below.
Things to consider when drafting your protocol review request:
Understanding what the IACUC considers when reviewing a protocol request can be beneficial for PIs to make the review process easier, but also to encourage careful considerations by the PI when designing the research. The following are some of the main focus areas considered by the IACUC during a review:
- No duplicative activities to previous experiments (requires a thorough search).
- Careful consideration of species and numbers requested; only using the minimal # of animals while maintaining the integrtity of the research. Justifiable rationale for using live animals.
- Qualifications of personnel.
- Procedures are designed to minimize pain and distress. All procedures are clearly understood and thoroughly documented.
- Housing and care, including veterinary care, of animals are clearly identified and addressed.
- Research and humane endpoints are identified and planned.
The IACUC follows the guidelines for review and animal use approval using regulations from the USDA (Animal Welfare Act), the PHS Policy on Humane Care and Use of Laboratory Animals, The Guide to the Care and Use of Laboratory Animals, the FASS Guide for the Care and Use of Agricultural Animals in Research and Teaching, the AVMA Guidelines on Euthanasia.
FAQs for Post-Approval Monitoring
- Post-approval Monitoring (PAM) is an observation of the research and verification of study documents. Conducting post approval monitoring is common in animal care and use programs and will help to ensure the safety of the research animals, appropriate applications and supporting documents are executed as approved, and any changes or adverse events are reported.
- PAM is not meant to be a “gotcha” moment nor are you being punished. You may actually see a benefit.
Sure! Benefits that may be gained from a review include:
- Increased awareness of the policies and regulations that guide research at Appalachian State University;
- Increased communication between the IACUC and researchers;
- Being potentially identified as having a “best practice”;
- Having an opportunity to ask the IACUC any questions you have.
- The majority of protocols are selected randomly. Studies may be randomly selected from all approved and active protocols, without cause, no more than once per year. A study may be selected more than once in a given year if a “for cause” review is deemed necessary (i.e. At the IACUC’s request from a review, part of an investigation for non-compliance, upon PI’s request).
- Protocols that are pain class E, have USDA covered species, are funded, or considered higher risk to the animals, are more likely to be selected. Should a PI have multiple protocols, it is possible that each protocol may be selected once per year individually or all protocols may be reviewed at once.
Our goal is to make this as unobtrusive as possible. You will be asked to pull records/lab notebooks 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 it will include:
- Reviewing all records with the PI associated with animal care logs, animal health logs and drugs given to the animals;
- Reviewing all animal housing, protocol facilities and animals on the protocol;
- Reviewing the names of all personnel working with the animals;
- Completion of the PAM Review Checklist.
- Viewing a procedure at a future date (by appointment)
Results from a PAM review include:
- A highlighted best practice: The practice will be shared with the IACUC and may be incorporated into guidelines;
- Compliant with the protocol: No further information or follow up is needed;
- Minor deficiencies are noted: The investigator provides a written plan in the resolution column to address the issues found within 30 calendar days, and e-mails the document back to the Post-Approval Monitor;
- Significant deficiencies are noted: The IACUC chair and the committee are notified of significant deficiencies. The investigator provides a written plan to address the issues found within 15 calendar days, and e-mails the document back to the Post-Approval Monitor; the protocol may be subject to a more in-depth review and monitoring to ensure all issues regarding compliance are met.
If there are no findings or once the investigator satisfactorily responds to requests for clarification or revisions, a written report will be provided to the investigator within approximately a week from the review date. The IACUC will review a summary of PAM visits at each convened meeting.
Q&A about the new OHS requirements
The main reason is to be compliant with the regulations, which require basic elements of an Occupational Health and Safety program for individuals who work with live, vertebrate animals (here is a summary of the requirements). Our process is very similar to others in the UNC system.
The second reason is this is the right thing to do. We did not have a consistent way to ensure our researchers—especially our student researchers—were aware of potential health and safety risks related to working with animals, or that they considered their own health status and how it could be affected.
Effective July 1, 2014, the requirement will be verified during IACUC reviews as follows:
- New protocols: All new protocol applications sent to the IACUC on or after July 1 will have the training requirement for everyone listed on the protocol. Also, students who have paid their student fees must complete the Health Risk Assessment form and send to firstname.lastname@example.org.
- Personnel changes: All students who are added to existing protocols on or after July 1, and who have paid their student fees, must complete the training and Health Risk Assessment form and send to email@example.com. All new faculty/staff added to existing protocols will need to complete the required training.
- Existing protocols: When you send in your annual review and/or protocol amendment for an existing protocol on or after July 1, you will have the same requirements for all personnel as a new protocol.
Note: Faculty, staff and students who have not paid their fees will also be required to complete a health assessment.
No, the Health Risk Assessment does not ask for your health history or personal medical information. It is assessing potential risks based on the species, environment, and possible exposures with which you will be working, and compares them to any self-identified conditions you may have. This does not serve as/replace a physical exam or other medical evaluation. It is designed to flag possible health concerns.
Yes, you can use your primary care physician so long as you 1. Incur the costs yourself, and 2. Provide the completed and signed last page of the form to the Environmental Health, Safety & Emergency Management office.
You will not be cleared to work with animals on an IACUC protocol until your training is complete and your Health Risk Assessment is cleared and on file at EHS & EM.
No, as long as you cover all species you work with in your training and Health Risk Assessment, the process only needs to be completed once. If you change species or your health condition changes, you will be required to complete the appropriate species specific training, and update your Health Risk Assessment as appropriate.
Your students are responsible for meeting the requirements. The IACUC administration will notify you whether a student is cleared at the time of protocol approval. You are also free to inquire about the status of a student's clearance by emailing firstname.lastname@example.org.
There is no cost for health assessments. If a follow up requires a vaccination or other recommendation that could incur a cost, the decision about how to cover the cost will be determined on a case by case basis between the individual, the department, and EHS & EM.