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I am a new investigator at Johns Hopkins. What do I need to do before beginning animal research? To begin working with animals you will need to submit an animal protocol or be added to an existing approved animal protocol. Once you are on an approved protocol you can obtain access to animal facilities. The following steps must be completed (these can be done in any order):
If you will be added to an existing protocol, the P.I. needs to fill out and sign the change in personnel amendment request form (found on our web site at web.jhu.edu/animalcare/forms). Submit the completed personnel amendment form along with the AESP certificate of enrollment document to the ACUC office in Reed Hall room B122 or by fax at 443-287-3787. To obtain access to central animal facilities: All investigators and laboratory personnel must be on an approved JHU animal protocol and complete specific training to be given access to the animal facilities.
For access to Broadway Research Building, Ross Building, Wilmer Building, Blalock 13th Floor and Pathology 8th Floor:
Do I need to submit an ACUC protocol application? A protocol needs to be submitted if you will be conducting research for which you need to obtain live animals (all warm and cold-blooded vertebrates). Who is eligible to submit an animal protocol application? Only persons with a faculty rank can be a P.I. Any qualified member of JHU can be a Co-investigator. Protocols are due the 1st business day of each month to be reviewed in that month. For 3rd yr replacements the due date is the 1st business day of the month prior to the month of expiration (i.e., a protocol that expires 7/1 is due by the first business day of June). The same is true for Procedure, Numbers and Change in P.I. amendments. (Click HERE for the schedule). Changes in personnel can be handled administratively and do not go through a formal review process. What does a person have to do to be added to a protocol? First, all personnel must complete the Animal Care and Use online training. You can access this from our webpage (web.jhu.edu/animalcare) under Quick Links or through My Learning Portal under Animal Care and Use. You must also enroll in the Animal Exposure Surveillance Program (AESP) through Occupational Health.The PI must then complete the Change in Personnel amendment request form and submit the certificates for completion of online training and AESP along with it. How often do I need to renew my animal protocol? A full application must be submitted every 3 years. Do you send out reminders to renew protocols? Yes. Reminders for protocol renewals are sent out by campus mail to the PI ninety days prior to their expiration date. What happens if my protocol expires? If the PI has animals on a protocol but does not renew the protocol by the expiration date then the animals will be transferred to a holding protocol under the direction of Research Animal Resources (RAR). The PI and associated lab staff may have access to the animals restricted and no experimental activities will be allowed until a replacement protocol is submitted and approved. In some cases (e.g., federally funded research), an alternative funding source may need to be utilized for animal care during the period when animals are on the holding protocol. ____________________________________________________________________________________________________________________________________________________________________________ What if I need additional animals? All your animals are placed into the database as the protocol is being entered for the three year period. Additional animals are only added if you have submitted a Change in Procedure requesting additional animals and it has been approved (to obtain this form Click HERE). Can you send correspondence about the protocol to me rather than the P.I.? Because this is a privileged communication, correspondence can only be sent to the P.I. It is the P.I’s responsibility to give copies of protocols, amendments, etc. to staff or persons needing them. Can I get information on my P.I.’s protocol if I’m not listed on it? If a person is not listed on a particular protocol the ACUC office will not give out any information pertaining to that protocol. The P.I. is responsible for giving the person the information they need. How will you let us know if our protocols and/or amendments have been approved? Once a protocol, renewal, or amendment has been approved, a copy of the approval letter for the protocol, and a complete set of the renewals and amendments are emailed to the PI and the original is then sent to the P.I. via campus mail. How long does it take for an amendment or protocol to be approved? If these items are received in the ACUC office on or before the first business day of any given month, they will be reviewed by the Committee by the end of the month, usually on the third Thursday of that month. If it is perfectly written it will be approved at that meeting. If additional information is needed, the PI will be asked to revise the protocol. The reviewer then re-reviews the new submission and if all the issues have been adequately addressed the protocol will be approved at that time. Where can I find the forms I need? All current forms used by the ACUC can be found on our web site www.jhu.edu/animalcare. These forms are frequently updated so always check to make sure you have the latest version of each form. How do I add a different strain of animals? If you are going to begin breeding, need additional animals or pain/distress level may change then an amendment of procedure must be submitted (to obtain this form Click HERE) because these changes are considered significant. The addition of a different strain of animals is considered a minor change and, an e-mail stating the strain you will be adding will be sufficient. A change in species requires a new protocol submission. Is it possible to get blood or tissue from another investigator’s animals without having to submit a protocol? The ACUC office (acuc@jhmi.edu) can assist you in locating an appropriate source without having to submit a protocol. However, this request must go through the office to assure that the procedures required to obtain the blood or tissues do not represent a deviation from an approved protocol. If you have already identified a source, it is imperative that any procedure done to the animal is not being performed specifically for your needs but is part of an already approved protocol. For example, tissues could be obtained from animals that were being euthanized by an investigator in accordance with their existing protocol. What is the best way to submit a protocol or an amendment? The protocol can be faxed, hand delivered, or e-mailed with an electronic signature. Only one submission is necessary and e-mail with electronic signature is preferred. Can you send me a copy of the protocol approval letter for a grant? All grant related issues must go through Office of Research Administration (ORA). What is Just in Time (JIT) and what do I need to do to comply with a JIT request? NIH will email just-in-time notifications to the PI and business office as a single notice. Just-in-time notifications for R01 applications will be sent ~15 days after the priority score is released. The Office of Research Administration (ORA) contact for your department will ask you to send the grant and protocol numbers that apply to the grant to the ORA office. This information is then sent to the ACUC office where it is reviewed by a Training and Compliance Specialist or other qualified personnel who compares the procedures in the grant to those in the protocol. If the procedures listed in the grant are significantly different from those in the protocol, the PI will be contacted to submit an amendment. Once the amendment is received and approved, the ACUC office signs off on the grant for the ORA. The ORA then sends the information to the NIH. What is the difference between RAR and ACUC? RAR (Research Animal Resources) oversees daily care of the animals and houses the veterinary care program. The ACUC (Animal Care and Use Committee) is responsible for protocol/amendment review and approval, inspections, and compliance with federal regulations. What kind of training is required for new personnel? All personnel must enroll in the Animal Exposure Surveillance Program through the Occupational Health Office, complete the on-line Animal Care and Use Training course and be on an approved animal protocol before ACUC approval to work with animals. How do I get access to the animal facilities? To obtain access to central animal facilities:
For access to Broadway Research Building, Ross Building, Wilmer Building, Blalock 13th Floor and Pathology 8th Floor:
Is practical training in animal handling and/or surgery available? Rodent Handling and Small Animal Surgery seminars w/wet lab are given throughout the year (Click HERE for a schedule of classes). If specialized procedural training is needed this can be arranged through the ACUC office by calling 443-287-3743. Can I keep animals in my laboratory overnight? Non-USDA species (rats and mice) can be kept in a laboratory for up to 24 h (12 h for USDA species) without specific ACUC approval. If animals are kept for longer periods of time, scientific justification needs to be provided and approved by the ACUC. The laboratory will then be inspected by RAR and the IACUC to determine if it meets JHU requirements as a satellite housing facility. Can rodents be brought into JHU from another research institution? Yes. Arrangements for bringing rodents in from another institution need to be made through Research Animal Resources (RAR). Animals from other institutions will be required to have approved health status and may have to undergo a period of quarantine. Detailed information for the proper procedures for import and export of animals can be obtained at www.hopkinsmedicine.org/animalresources. What do I need to do to obtain a license from the Drug Enforcement Agency (DEA)? First, you must register in the state of MD. The registration form can be found at: https://health.maryland.gov/ocsa/Documents/3%20Year%20Practitioner%20Fill-Able%20Application.pdf If applying as a researcher, a Reseacher Form must also be submitted: https://health.maryland.gov/ocsa/Documents/OCSA%20Researcher%20Questionnaire%20Form%20rev%2009.14.2016.pdf
MD State Department of Health and Mental Hygiene
Second, you must register with the Federal Drug Enforcement Agency. The registration form can be found at: https://www.deadiversion.usdoj.gov/drugreg/reg_apps/225/225_form.pdf#search=dea%20form%20225 United States Drug Enforcement
_________________________________________________________________________________________________________________________________________ How do I transport animals from one animal facility to another? Submit a transfer request form to Ross 459 fax 2-5068. For more information contact the transfer coordinator. Collect the transfer cage cards from Ross 459 and place them on the cages to be moved. Animal Resources office will schedule transfer with the supervisor and loading dock as applicable Animal Resources office notifies you of moving date and final location. These are our goals for transfers: Up to 10 cages: 48 hours after form is logged in Animal Movement Restrictions: Helicobacter positive may not move to Helicobacter negative space High Risk Return animals may not move back to regular animal rooms Animals housed in laboratories overnight may not move back to core facilities, including HRR All animals entering BRB must be transferred by RAR personnel through the airlock.(There is a special exception for overnight mating for the transgenic core). How do I transport animals from the animal facility to my lab? Animals must be transported using designated animal transport routes. If you need more information, please call Ms. Kinta Diven at 7-3743. |
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