Q: Is it permissible to grant an administrative extension of IACUC approval so as to avoid expiration?
A: No. For PHS purposes, IACUC review following the provisions at IV.C.2. of the PHS Policy must be accomplished at least once every three years. The IACUC may not extend the three-year approval by any means other than IACUC review and approval using the procedures of IV.C.2. When IACUC approval expires, it is no longer valid. Continuation of animal activities beyond the expiration is a serious and reportable violation of PHS Policy. In all issues involving animal care and use, it is wise to first consult the IACUC before proceeding with the activity.
Q: The IACU office has notified me that my animal protocol expires in 90 days. I am very busy and do not have time to submit my protocol. Can I request an extension of approval?
A: NO, Protocol approval is good for one year (365 days). If an investigator does not respond to requests for either continuation after years 1 and 2 or for renewal after year 3 prior to the approval anniversary date, the protocol will be inactivated. If any animal work takes place without IACUC approval, such as during the time a protocol is inactive, the animal research is no longer in compliance with federal regulations. Lapses of approval must be reported to relevant federal agencies in accordance with federal regulations. The protocol will remain inactive until such time as the annual update or renewal is completed and approved. Reference OLAW FAQ#8 http://grants.nih.gov/grants/olaw/references/lab_animal2003v32n9_wolff.htm
Q: Where do I find MSDS sheets, biohazard and toxicity information?
A: There are several websites where Material Safety Data Sheets can be obtained. Most can be acquired from chemical manufacturers and suppliers. The IACUC may require the investigator to provide safety information for certain chemicals or potential biologic, chemical or radiation hazards. This information is easily retrievable from the following sources:
MSDS Sheets – www.ilpi.com/msds is an excellent link to hundreds of MSDS sources, many of are free of charge. This site also provides a link to Federal Chemical and Bloodborne Pathogen Standards as well as their interpretations. If you are interested in finding a supplier of a certain chemical, links to various chemical manufacturers and suppliers is also located on this page.
The National Toxicology Program has website that provides a variety of information on chemicals, drugs and other agents. http://ntp.niehs.nih.gov/.
The SIRI MSDS Index can be found at www.hazard.com/msds/.
Q: May materials that are past their expiration date be used in research involving animals?
A: No - for survival procedures. The use of expired medical materials such as drugs, fluids, or sutures on regulated animals is not considered to be acceptable veterinary practice and does not constitute adequate veterinary care as required by the regulations promulgated under the Animal Welfare Act. Therefore, for survival procedures, these materials are not appropriate.
Maybe - For acute terminal procedures. UDSA/APHIS does not oppose the use of expired medical materials if their use does not adversely affect the animal’s well-being or compromise the validity of the scientific study. It is up each investigator to document the lack of adverse affects and to include description in their animal activities protocols. More detailed descriptions of this and other related issues may be found in the Animal Welfare Act, Section 13, 9 CFR, Part 2, Sections 2.31, 2.32, 2.33, 2.40, 9 CFR, Part 3, Section 3.110.
Q: I have a DEA license that allows me to obtain controlled substances for animal experiments such as Nembutal. May I let other investigators use my Nembutal for their procedures?
A: In most cases, No. Federal regulations provide clear guidance in this matter and are found in Title 21, Chapter 13, Subchapter 1, Part C, Section 828.
In short, you are not allowed to distribute schedule I or II control substances unless you do so by written request from the receiver. That written request must be on official forms (DEA form 222) and the forms can only be obtained if the receiver has a DEA license for schedule I or II substances. These come pre-printed with the receiver's name. It is unlawful to alter the registrant’s name on the form. It is unlawful for other than licensed personnel to use these forms to obtain controlled substances or for another to furnish these forms to anyone so that they may procure controlled substances. Records of distribution must be maintained for a minimum of two years and are subject to inspection upon request.
Q: I have submitted an IACUC protocol that will involve the use of chemicals. I have filled out the noxious challenge and hazard exposure sections. What else do I need to do?
A: The Office of Research Compliance at UTHSC has developed a Standard Operating Procedure (SOP) template that should be submitted as an addendum to the IACUC protocol. The template can be located at http://www.uthsc.edu/research/research_compliance/procedures.php. Information contained in the Material Safety Data Sheet (MSDS) will be instrumental in completing the SOP template.
Q: What causes delays in approval of my animal protocols?
A: Protocols submitted by the last day of a month are reviewed on the second Tuesday of the following month, and reviews are usually available to PIs that Thursday. The majority of protocols require small changes, and are typically reevaluated by the assigned reviewers within a few days of a revised protocol submission. Most serious delays, requiring deferral until the next committee meeting, are caused by the failure to provide critical information requested in the online form, perhaps sometimes by accident in the submission process. The best way to avoid this is to carefully review the protocol as a pdf prior to hitting 'submit'. Another significant source of delay is the absence of required approval by other committees that meet on different schedules (e.g., Radiation Safety, IBC, IRB). If there is any doubt about the information needed, PIs should contact the IACUC office (x3904) well in advance of the deadline (i.e., two weeks or more) to ask for a pre-review prior to submission. Although most protocols can be approved within the calendar month after they are submitted, it is prudent to assume a 2 month interval between the online submission deadline and approval of a complicated protocol. Note: PIs will receive 90, 60, and 30 day notices from the IACU office to remind the PI of deadlines for protocol submission for 3rd annual renewals . It is crucial for PI's not to wait until the last reminder to submit the protocol. If approval is not obtained by the protocol expiration date, protocols are inactivated until re-approval is obtained.
Q: What restrictions are there to doing animal work at sites other than UTHSC?
A: UTHSC, through its PHS Assurance and AAALAC accreditation, guarantees that all work performed will be in accordance with federal, state and local regulations and laws. Because this assurance and accreditation cannot be extended to sites outside of the university, and because the IACUC does not oversee these sites, it is university policy not to approve protocols that involve work performed at sites outside of the university. For those studies in which investigators collaborate with others outside the University, the portion of the study performed at university facilities can be reviewed and approved.
Q: What kind of training is necessary to comply with PHS Policy, and how frequently should it be provided?
A.: The following guidance has been provided by the Office of Laboratory Animal Welfare and the NIH:
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. At a minimum, the PHS Policy and Guide require institutions to:
- ensure that individuals who use or provide care for animals are trained and qualified in the appropriate species-specific housing methods, husbandry procedures, and handling techniques.
- ensure that research staff members performing experimental manipulation, including anesthesia and surgery, are qualified through training or experience to accomplish such procedures humanely and in a scientifically acceptable fashion.
- provide training or instruction in research and testing methods that minimize the number of animals required to obtain valid results and minimize animal distress.
- ensure that professional staff whose work involves hazardous biological, chemical, or physical 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. Of specific interest is the third point. UTHSC provides training through traditional courses and instruction offered by members of the LACU. With the advent of mandatory on-line training, additional avenues will be available to provided and document project-specific training. (Excerpted from frequently asked questions that are found at: http://grants1.nih.gov/grants/olaw/faqs.htm)
Q: If I wish to transfer animals listed on one of my protocols to another, do I need to do so formally?
A: Yes. When protocols are approved, the number of animals to be used in the studies covered by that protocol is also approved. The Department of Comparative Medicine (DCM) tracks the number of animals used and assesses charges for their care based on the protocol to which they are assigned. Neglecting to transfer animals from one protocol to another may risk exceeding quota for on going studies. Moreover, DCM needs to know in which studies the animals are involved to be able to provide appropriate veterinary care if needed. Animals can be readily transferred from one of your protocols to another by contacting DCM. Remember that the animals transferred must be of the same species and strain as those described in the protocol receiving the animals. Modification of the species and/or strain
of animals in any protocol require submission of a protocol revision.
Q: How do I go about receiving animals from or transferring animals to another institution or facility?
A: Permission to receive animals from or transfer animals to another institution or facility primarily is dependent on the health status of the animals being transferred. The standards for receipt and quarantine of animals must be rigorous in order to protect on the integrity of other animal colonies at UTHSC. Animals, especially rodents, cannot be received without thorough and recent health screening which may involve quarantine and testing. DCM veterinarians are the primary contacts for any investigators wishing to receive animals from or transfer animals to another institution or facility (448-5656). The appropriate procedure to follow is:
- The PI must submit an animal request and an outside vendor health information form to DCM.
- The sending institution must submit a health status report and health certification to the DCM veterinarian.
- The DCM veterinary staff may require additional information if the health report is not current, or is incomplete, or contains suspect testing results. If the originating colony, facility or program is not free of murine pathogens, arrangements must be made for rederivation by an outside vendor.
- Following an evaluation of pertinent animal health information, a decision will be made whether to allow the animal transfer. If animals are to be received by UTHSC, appropriate quarantine and testing procedures will be determined, if needed.
- The standard quarantine period is 8 weeks. Thorough testing of contact sentinels will be conducted at the end of the quarantine period.
- Currently, quarantine housing is limited. Access to the quarantine area is limited to the DCM quarantine technician.
- Due to limited quarantine space, requests for shipments from outside sources and quarantine are on a first come, first serve basis. Actual waiting time (after receipt to release for use) is dependent on the number of requests submitted. Currently, the typical wait time is about 12 weeks.
For more information, please see the LACU policy and procedure on rodent import/export.
Q: Who do I contact about animal-related concerns?
A: UTHSC is firmly committed to the humane care and treatment of all animals used for research and teaching. Our animal care and use program is governed by federal guidelines for the care and use of animals. If you observe or have knowledge of activities that you believe constitute inappropriate animal care or use, you are encouraged to report these activities so that they can be investigated. UTHSC has policies and procedures in place regarding investigation and remediation of any concerns about animal care or use, as mandated by the Animal Welfare Act and PHS guidelines. The Animal Welfare Act states that
“no facility employee, committee member, or laboratory personnel shall be subject to any reprisal for reporting violations of any regulation or standards under the Act”
The best way to address animal care and use concerns is directly. Sometimes unfamiliar research activities may be misinterpreted as painful or distressful. Frank discussion may clear up misunderstandings. If you do not wish to speak to those involved directly (e.g., investigator, technicians, and/or students), please call any of the following numbers to discuss your concerns. Your confidentiality will be respected to the best of the IACUC’s abilities.
Institutional Animal Care and Use Office – 448-3904 or
Chairman, Department of Comparative Medicine – 448-5656
Q: Where do I find NIOSH and OSHA standards?
A: The National Institute of Occupational Safety and Health publishes work- related health and safety information. The information deals with diseases, injuries and recommendations for safe work practices. Specific information about zoonotic diseases, occupational asthma can be found using the search engine at www.cdc.gov/niosh/homepage.html. The Centers for Disease Control (www.cdc.gov) has an easy to use health index search engine with up to date information on just about every health related topic.
Randall J. Nelson, Ph.D.
Professor and Associate Vice Chancellor for Research
Memphis, TN 38163
Phone: (901) 448-3533
Fax: (901) 448-5222