In our February 2014
newsletter, we provided information regarding the Institutional Animal Care and Use Committee (IACUC) protocol review process (“Where’s my Protocol? Understanding the Review Process”). The article described the different routes a new or renewal protocol or amendment can take for review (Full Committee Review, or FCR, and Designated Member Review, or DMR). As a protocol works its way through either review process, it goes through different states that determine who is able to edit or review the document. The table below provides data regarding the average amount of time (days) that protocols are in each of these states. The data analyzed were collected from time stamps when protocols changed state within the e-Protocol system and covered the period January 1 to September 30, 2014.
Mean Time (in Days) in Various Review States
To understand how to read this table, let’s follow an amendment through the review process. A PI (or study team member) creates an amendment and submits it for veterinary review. The average time in the PI queue for pre-submission is 14 days. This includes the time while the PI and staff are creating the amendment and also the time spent reviewing and responding to any comments from the veterinarian. The average amount of time that a veterinarian may be reviewing an amendment before sending it back with comments or forwarding it for IACUC review is two days.
Submission to the IACUC includes the time the amendment is available for IACUC members to review. We are required by the regulations to allow all committee members an opportunity to request that a document in the DMR process be moved to FCR at a convened meeting. Approximately 97% of all amendments are reviewed by the DMR process. The average time between submission to the IACUC and when the amendment is scheduled for review is six days for DMR and 11 days for FCR.
The average time the amendment spends in the PI queue after IACUC review before being sent back with responses for final review is 11 days. Final approval is not obtained until a PI has completed any requests for ancillary information, which takes an average of 18 days. Ancillary information requests include the need to update a chemical hygiene plan or obtain Institutional Biosafety Committee (IBC) approval for agents being used, and is not needed for every amendment. The best way to reduce the time for review for any document is to quickly respond to the requests for further information from either the veterinarian or the IACUC.
Fall semiannual inspections
Teams of IACUC members inspected nearly 600 animal use and housing locations for the fall semiannual inspections that ran from August 1 to October 15, 2014. Results from all the inspections have been categorized and counted, and the top three most frequent deficiencies were in documentation, expired materials and sanitation.
Among deficiencies in documentation, common findings included absence of a date of sterilization, chemical indicators, or initials on an autoclaved package of surgical instruments (as required by the policy Autoclave Verification and Validation for Survival Surgical Equipment
); absence of reporting action or corrective action taken when temperatures in housing locations were outside the Guide recommended range (as required in the policy Reporting of Temperature Excursions in Animal Housing Locations
); and absence of correct labeling information on secondary containers of drugs or compounds, which must include the name of the compound, the final concentration, the diluent (if applicable) and the date of expiration (as required in the policy Use of Pharmaceutical and Non-Pharmaceutical Grade Compounds in Animals
Deficiencies in expired materials included the presence of unused expired analgesics, sedatives, anesthetics or euthanasia solutions in laboratory drug boxes and the presence of unlabeled expired medical materials near a location where survival procedures are performed. All labs are reminded to check expiration dates for all therapeutic agents and diluents before semiannual inspections and either appropriately discard expired agents or label vials as expired and not in use until proper disposal can be arranged, especially for controlled substances. In addition, labs are reminded to either discard expired medical materials, or segregate them from non-expired materials and label them as “Expired for Acute Terminal Studies Only.” These requirements are described in the policy Expired Medical Materials
Although the sanitation category ranked third in the number of deficiencies, there was a 30% decrease in the number of sanitation deficiencies compared to the spring inspections. Deficiencies in sanitation vary from cluttered rooms and labs to broken glass on the floor to custom equipment constructed out of unfinished wood. Unsealed wood cannot be properly sanitized and should be sealed with paint to facilitate proper cleaning.
Other categories that saw an overall decline in the number of deficiencies included administrative (i.e., animal protocol) deficiencies, environmental health and safety concerns, physical facilities issues and descriptions of activities such as survival surgery or euthanasia that are not in accordance with policy.
The IACUC thanks all members of the animal care and use program at Ohio State for making progress toward improvements as reflected in the decrease in the number of deficiencies overall. Keep up the good work!
Representatives from Ohio State attended the National Meeting of the American Association for Laboratory Animal Science in October in San Antonio, Texas. In sessions that included nearly 250 posters, Ohio State presented nine posters and won two out of nine awards presented. Congratulations to Candace Hedrick, Michael Rowley and Stephanie Lewis for their poster “Repurposing and Recycling an Institutionally Retired Enrichment Device,” and to Brie Smith, Diane Harrison, Christian Hofer, Joann Petty, Mackenzie Nicolaus, Valerie Bergdall and Judy Hickman-Davis for their poster “Verification of Sanitation Standards for Micro Isolator Filtered Cage Lids.”
All of the policies developed by the Ohio State Institutional Animal Care and Use Committee to assist investigators and staff with their research are available on the IACUC Policies
webpage of the Office of Responsible Research Practices (ORRP) website. These polices are reviewed on a regular basis to ensure that they still meet the regulatory requirements.
– Blood Collection
: This policy revision reflects the requirements for various blood collection methods. It is important to note that any deviation from this policy requires scientific justification and IACUC approval.
– Genotyping Rodents
: This policy was revised to describe common DNA collection sites and emphasize that hemostasis must be achieved by the use of topical coagulants, manual compression or cautery
before the animal is returned to the home cage.
– Rodent Survival Surgery
: This policy revision clarifies the procedures for maintaining aseptic technique during a survival surgery and reflects the post-operative care process. Aseptic technique is used to reduce microbial contamination to the lowest possible practical level during survival surgery. By performing the requirements outlined below, aseptic technique can be achieved or maintained.
- All surgical equipment, instruments and supplies that will come in contact with the surgical site are sterilized before use.
- Surgeons must wear a surgical face mask and clean surgical gown, scrub top or lab coat. Also, sterile or properly disinfected exam gloves must be used.
- The patient’s hair/fur must be removed at the surgical site and this preparation should take place in a location separate from where the surgery will be performed. The surgical site must be scrubbed three times with a recommended skin disinfectant (e.g., chlorhexidine or iodophors) and alternating each disinfectant scrub with a scrub of sterile water or 70% isopropyl alcohol.
- If hands contact a non-sterile object, gloves must be changed or properly disinfected.
- If whole instruments contact a non-sterile object or surface,then it must be replaced with an individually sterilized instrument or an instrument from a new sterilized surgery pack.
- If instrument tips contact a non-sterile object, a new sterile pack of instruments must be opened or alternatively, instrument tips can be wiped with 70% isopropyl alcohol, sterile water or saline and placed in a hot bead sterilizer.
For additional details regarding aseptic technique, refer to the Best Practices for Rodent Survival Surgery
and Disinfectant and Sterilization Recommendations
Also, this policy revision provided clarification for post-operative care. It is important to note that non-absorbable skin sutures or wound clips must be removed between 10-14 days after surgery.
– Biological, Chemical and Radiological Safety in Research, Testing and Teaching Involving Animals
: This policy was reformatted and updated with the new name for the safety sheet form. The safety form is now called the Animal Health Safety Protocol (AHSP), and replaces the old form, OSU Animal Safety Information Sheet (OASIS).
Manual reporting of animals
Why is manual reporting of animal numbers important?
The IACUC is required to document and monitor the number of animals acquired and used. Also, periodically the IACUC must submit reports to regulatory and accrediting agencies regarding the procurement of animals. The e-Protocol system automatically counts for animals housed in University Laboratory Animal Resources (ULAR) facilities at the time of order or weaning. Conversely, manual reporting of animal numbers is required if animals are not housed, ordered or weaned by ULAR.
Examples of scenarios in which animals are required to be manually reported include:
How to manually report the animal numbers
- Animals used prior to weaning
- Animals not housed in a ULAR facility (e.g., OARDC, Ag locations, VMC, etc.)
- Animals involved in field studies
- Animals privately owned
- Animals donated
The PI or designated study team member is responsible for providing the number of animals used on a protocol. This information can be entered into e-IACUC by clicking on “Reporting Animal Number” activity under “My Activities” in the protocol workspace.
For additional details regarding manual reporting of animal numbers, refer to the policy Documenting Number of Animals Used for Research/Teaching
and the instructions
for reporting animal numbers which can be found on the Investigator Guidance
Use of expired materials
Remember that expired analgesics, sedatives, anesthetics and euthanasia solutions must not be used, even in acute terminal procedures. Expired medical materials may be resterilized and used for survival surgery provided a new expiration date is clearly labeled on the package. Expired medical materials may be used for acute terminal procedures but must be segregated from non-expired materials and clearly labeled as “Expired for Acute Terminal Studies Only.”
Investigator guidance resource
Remember that the IACUC provides additional information for researchers at Ohio State on the Investigator Guidance
website. This resource includes information about best practices for housing of animals
and templates for standard operating procedures and emergency plans that accompany a request for housing in non-ULAR investigator spaces; instructions and additional information on policies (such as Guidance for IACUC Policy on Movement of Animals
, How to Prepare an Animal Use Protocol
or How to Report Animal Numbers Manually
); and information about alternatives to animal testing and research (such as information about assistance available for Searching for Alternatives
and a Fact Sheet
about the differences among various databases).
Internet browser compatibility
One known issue with the e-Protocol system is that there are compatibility issues with Internet Explorer 11. Researchers may experience problems when attempting to edit text boxes within the e-Protocol form. If you expect to be able to edit text but can only view a read only webpage in your browser, try logging in to e-Protocol in an alternate browser such as Mozilla Firefox, Google Chrome or Safari.
Responding to changes requested
When responding to and making changes requested by a veterinarian or reviewer, remember that the change must be made in the body of the protocol document and not just in the reply box. The comments entered into the green reply boxes will disappear after the protocol is approved, so these responses will not be included in the final document.
Satellite housing SOP templates now available
Standard operating procedure (SOP) templates are now available for investigators requesting housing of mice or rats in non-ULAR investigator spaces. Templates are available for investigators requesting to house mice in static cages or in ventilated cages/racks or rats in ventilated cages/racks in satellite housing locations. Contact protocol consultant Angela Phillips (email@example.com
) or the IACUC staff (IACUCinfo@osu.edu
) to request the templates, or look for them on the Investigator Guidance
New IBC lentiviral safety training requirement
Over the past year, the Institutional Biosafety Committee (IBC) has seen an increase in the number of protocols submitted requesting to use lentiviral vectors as part of the research. Many researchers are proposing to use these vectors for the first time. To fulfill our responsibilities of verifying that ourresearch staff is aware of and understands the potential hazards of the material they are working with, the IBC is now offering a new Lentiviral Safety
Training, available from the Environmental Health & Safety
training webpage. The training was developed by the University of Cincinnati and has beenreviewed and approved by the Ohio State IBC for use. Beginning January 1, 2015 all investigators, co-investigators and study team members listed on IBC protocols using lentivirus will need to complete this one-time training program prior to protocol approval. It is recommended that individuals on currently approved protocols take the training; however, it will not be a retroactive requirement for previous approvals.