PLEASE NOTE: On Friday, August 16ththe Office of Animal Welfare will be closed due to the paid Special Administrative Day Off for Penn faculty and staff awarded by Amy Gutmann, Vincent Price and Craig Carnaroli to thank us for our efforts in supporting the Making History campaign. There will be no one in the office to receive and process submission on Friday, August 16h. ARIES will be available for submissions and they will be processed on Monday, August 19th.
September 10, 2012
The ARIES system was recently updated to streamline the review processwith regards to the secondary reviews (Compliance, Diagnostics, and EHRS).In the previous version, each time a submission was revised and re-submitted for review, all the previously assigned secondary reviewers were re-assigned, regardless of their previous review recommendation.In this new version, each time a submission is revised and re-submitted for review, if the secondary reviewers previously approved the submission and the current revision did not make any changes in their relevant sections, then those reviewers are bypassed in the review.The bypassing of secondary reviewers should help reduce the review timeof submissions by not sending back to reviewers who previously approved the submission.
In addition, the system has been updated to detect items in the submission and automatically assign the correct secondary reviewers. This should further reduce the review time of submissions by allowing speedier assignment of reviewers.
ARIES and PennERA Updates:
Several modifications and improvements have recently been made to the ARIES and PennERA systems. Changes which may affect users are detailed below:
A new 120 day reminder email from PennERA for expiring protocols has been added to notify investigators that their protocols are reaching the 3-year expiration date. This should allow enough time to submit a 3-year renewal for review and approval before the protocol expires.
At the bottom of the Procedures tab in ARIES, when multiple survival surgeries has been indicated, the scientific justification for performing these multiple survival surgeries is now a required field.
Several modifications and improvements have recently been made to the ARIES system.Some important changes are detailed below:
The Exemption Form in ARIES is now active.This form should be used if, due to requirements/specifications of the research protocol, an exemption from the standards, federal regulations, and/or university policies are required (e.g., space requirement [including innovative enclosures and metabolic cages], increased tumor size, etc.).This ARIES form should only be used for ARIES protocols; if the protocol is still on paper, the paper Exemption form should be used.Paper Forms can be found here.
A new procedure type called Injection/Dosing has been added to the Procedures tab.This procedure type should be used when dosing research compounds or injecting other research related material (e.g., antibodies or STZ).
The role of Consultant has been renamed Scientific Advisor to better define the role of the person providing scientific oversight for the project.This role is only available for PIs and co-PIs.Training for individuals with a Scientific Advisor role has been modified and the required training includes:
- Regulations and the IACUC
- Occupational Health and Safety Users Risk Assessment (Animal version and/or Non-Human Primate version depending on
species included in the protocol)
- Species-Specific Curriculum (for each species included in the protocol)
vNote:The Species-Specific Curriculum includes both the web-based training and the instructor-led course.
ARIES Training Dates:
ARIES training sessions are available to researchers and research staff who create, review, or submit animal protocols. These sessions will provide an overview of the ARIES application, including navigation and other features.
The session dates are as follows:
Wednesday, January 18, 2012, 1:00-3:00 pm
Thursday, March 22, 2012, 1:00-3:00 pm
You can sign up for these training sessions by visiting the IACUC Website Training page.
IACUC Guidelines and Policies:
The following Guidelines and Policies are either new or have been recently revised:
- Social Housing of Nonhuman Primates
- Humane Intervention and Endpoints for Laboratory Animal Species
Adoption and Implementation of the Guide for the Care and Use of Laboratory Animals: Eighth Edition (NOT-OD-12-020)
A new edition of The Guide for the Care and Use of Laboratory Animals (The Guide) has recently been published and the Office of Laboratory Animal Welfare has adopted this new version.This new version expands the information relating to the care and use of laboratory terrestrial species and has new information concerning the care and use of aquatic species.This OLAW notice provides position statements concerning the expectations associated with using the updated Guide as well as information and resources for implementing the new Guide.
OLAW’s Frequently Asked Questions can be viewed here .
Training for ARIES Users Now Available
Aries training sessions are now available to researches and research staff who create, review, or approve animal protocols. These sessions will provide an overview of the ARIES application, including navigation and other features.
All of the sessions will take place in the ORA Conference Room located at 3624 Market Street, Suite 301S. You can sign up for these training sessions through Knowledge Link by searching for "Aries" in the search field. http://knowledgelink.upenn.edu/ The session dates are as follows:
Tuesday, August 31, 10:00-12:00pm
Wednesday, September 29, 1:30-3:30pm
Monday, October 25, 10:00-12:00pm
Thursday, November 18, 2:00-4:00pm
Thursday, December 16, 10:00-12:00pm
Animal Research Information & Electronic Submissions (ARIES)
Released on February 22, 2010 ARIES has seen two months of high activity. Over 340 people have used ARIES and 55% of all protocol submissions have been via ARIES. While the use of ARIES is still “voluntary”, we would like to encourage every faculty member and their staff to use ARIES for any new submissions. We have received very valuable feedback from users over the last two months and have been able to incorporate many changes as requested by the early users.
We will make ARIES “mandatory” for all new submissions and 3-year renewals as soon as the ARIES development team and the Vice Provost for Research is confident that our submission count is high enough to assure that ARIES works exactly how we want it to work. I suspect that the use of ARIES will become mandatory in the next few months.
Here are a few important reminders regarding ARIES submissions:
<!-- Protocols on “paper” will stay on paper until the 3-year resubmission date, i.e. all amendments and continuing reviews must be submitted on paper until the 3-year resubmission date. At that point, ARIES must be used for the submission.
<!-- All available supporting document associated to an ARIES protocol must be submitted via ARIES. This includes amendments, exemptions, salary support, etc. All associated documents will be available in a few days.
<!-- Paper 3-year resubmissions will be considered “Initial Submissions” for the 1st time the protocol is entered in ARIES, thus a PI should select “Initial submission” in ARIES when drafting the 3-year resubmission. The 3-year resubmission link will only be used when “ARIES protocols” reach the 3-year anniversary (March 2013).
<!-- Paper protocols submitted in ARIES for the first time as part of their 3-year resubmission will be assigned new protocol numbers. Thus, a ULAR “Request for Animal Transfer Form” must be completed in order to transfer the animals to the new protocol and new cage cards will be required to be printed. We realize that this may be an inconvenience, but it will give laboratories an opportunity evaluate the size of their colonies which may make additional space available and to improve compliance by eliminating reused cage cards which make it impossible for the institution to accurately track animal use. Additionally, this is a one-time event for existing protocols—it is only relevant for protocols making the transition from paper-to-ARIES, a 3-year resubmission in ARIES (in 2013) will maintain the same protocol number just as our “paper” system has previously worked.
Guidance on Confirming Appropriate Charges to NIH Awards during Period of Noncompliance for Activities Involving Animals (NOT-OD-10-081)
The Office of Laboratory Animal Welfare (the compliance office within the NIH/PHS/DHHS) point forth a new notice clarifying a previous notice on “…Allowable Costs for Grant Activities…” (Notice NOT-OD-07-044). The clarification states:
The conduct of animal activities in the absence of a valid Institutional Animal Care and Use Committee (IACUC) approval of the activity. Absence of IACUC approval includes failure to obtain IACUC approval, expiration, or suspension of IACUC approval.
Institutions are required to report such situations to the Institute/Center (IC) supporting the award and to OLAW. In cases where charges have been made for unauthorized animal activities, appropriate adjustments must be made to the grant to remove those charges.
This notice makes it very clear that any “animal use” performed without IACUC approval is violation of NIH policy and must be reported to both OLAW and the specific agency or institute sponsor. In 2008, the University of Pennsylvania IACUC defined "use of animals" as “ANY physical or experimental manipulation by research staff on a laboratory animal-- including (but not exclusive of) breeding, measurement of biologic variables, tissue harvest, or sample collection”.
As many of you know, expired protocols had been a serious issue, one that everyone involved in the animal program (e.g. IACUC, ULAR, and the research community) has been able to minimize and almost eliminate over the past 2 years. This new NIH notice emphasizes the importance of this issue. Penn is obligated to report any use of animals on an expired protocol to NIH/OLAW and the specific sponsor.
Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals (NOT-OD-10-049)
The NIH put forth a new notice clarifying their requirement for completion of the Vertebrate Animal Sections in the NIH proposals. While this is certainly not a new requirement, there is more detail presented that should help PIs complete this section to the level that NIH/OLAW now expects.
Form-E now INACTIVE
Form-E has been replaced with the Knowledge Link training modules: Occupational Health - Animal Users Risk Assessment (all animal users) and Occupational Health - NHP Users Risk Assessment (nonhuman primate users). Please log-on to Knowledge Link and complete the appropriate course based on the species used. These modules will be found in your "Optional Training" section under Course Master ID: UNIV_ALL_IACUC_OCCHEALTHALL (all animal users) and UNIV_ALL_IACUC_OCCHEALTHNHP (nonhuman primate users).
Please Note: The Occupational Health - NHP Users Risk Assessment (nonhuman primate users) must be re-taken annually and The Occupational Health - Animal Users Risk Assessment (all animal users) must be re-taken every three years.
Challenge Grant Just-In-Time and IACUC Protocols
The Challenge Grant program and other federal awards related to the "Stimulus Package" will make their Just-In-Time notifications in the next few weeks. The IACUC Office requests that investigators please submit any IACUC protocols related to ARRA funding as soon as possible after JIT notification. The NIH requires IACUC approval by November 30th, the end of the "restricted award" period. Please click here for further information regarding the PHS requirements on the Policy on Humane Care and Use of Laboratory Animals.
The IACUC guideline on Mouse Breeding and Cage Density was approved by the IACUC in October 2008 and sent to the faculty in a previous "IACUC Announcement" in November 2008. ULAR subsequently reviewed, modified, and recently finalized their SOP describing the "Correction of Overcrowded Rodent Cages". Highilghts of the IACUC guideline and ULAR SOP include:
More generous housing density limits than is described in the Guide for Care and Use of Laboratory Animals
Allowance of 28-day weaning (with a single dam) without the need for an IACUC exemption
Clarification of overcrowded cage responsibilities
PI's must take responsibility for colony management and providing valid contact information to be used by ULAR
ULAR will separate overcrowded cages after "one full day" (i.e. after contacting the lab regarding an overcrowded cage on Thursday, ULAR will separate that overcrowded cage on Saturday, Friday being the "one full day" for the lab to address the situation).
Various breeding strategies for 21-and 28-day weaning are approved to maintain a high level of animal welfare and animal production.
Changes in the Training Program
The IACUC recently approved changes to the training program.
Occupational Health and Safety Program-Risk Assessment will soon be released as a Knowledge Link module. It describes how to enroll in the occupation health and safety program, including relevant information on allergies, personal protective equipment, and contagious diseases.
This Knowledge Link module will *REPLACE* Form-E, eliminating the need to submit a signed Form-E for every person on a protocol, with every protocol.
The general module is suitable for all species except nonhuman primates, which has a specialized occupational health module.
On or after October 1st, 2009, this training must be completed by all personnel listed on an IACUC protocol prior to approval.
This training must be updated every three years. The nonhuman primate-specific module must be updated every year with annual continuing review (i.e. Form-B) and annual tuberculosis testing.
"Conditionally Acceptable" Euthanasia training is required of all individuals who will perform euthanasia most commonly by cervical dislocation or decapitation without anesthesia.
This is an instructor-led hands-on course that must be scheduled with the ULAR Training Division.
This training is required only once.
"Aseptic Technique" Training is a Knowledge Link Module that will be required for all personnel listed on surgical protocols beginning October 1st 2009.
This improvement of the University animal research surgical program comes as a follow-up to citations in both the 2008 and 2009 USDA inspection reports regarding large animal surgery and suggestion for improvement from the School of Medicine's recent AAALAC site visit (March 2009) regarding rodent surgery.
This training is required only once.
The Stimulus Package and IACUC Submissions
As many of you know, with the recent passage of the American Recovery and Reinvestment Act (ARRA), the National Institutes of Health has issued a strategy to best invest the additional funds made available by the ARRA. There are two new funding opportunities that may impact on the administrative flow of the protocol—funding of previously reviewed but unfunded NIH proposals and new Challenge Grants.
Considering these new funding opportunities, we anticipate an increase in IACUC protocol applications over the next few months. In order to remain compliant with the federal-mandated protocol review requirements AND do so in a timely manner despite an increased volume of protocol submissions, the IACUC asks for the faculty’s assistance in assuring that this process runs smoothly.
ACTION ITEM FOR THE IACUC OFFICE:
The IACUC Office will suspend the expectation regarding protocol submissions and Just in Time (JIT) notification. The IACUC Office encourages the faculty to submit protocols to be linked to grants in these two categories—highly scoring, but previously unfunded NIH awards and new Challenge Grants. PIs should NOT hesitate to submit an IACUC protocol application PRIOR TO just-in-time notification of a potential award.
As stated above, the two specific changes in the NIH proposal application process that we believe will have the most impact on the IACUC process are:
<!--[Previously reviewed, but unfunded NIH awards. Although many institutes have not yet posted their guidelines, it is likely that JIT notices for these awards may have a short turnaround time. This may potentially have implications for the protocol and grant concerning the IACUC review process.
ACTION ITEMS FOR PRINCIPAL INVESTIGATORS:
Confirm that you have an approved IACUC protocol that is congruent with your unfunded proposals. You may access Ben Reports to check your protocol status or contact the Office of Regulatory Affairs at 215-573-2540.
Submit a new protocol application as soon as possible if you have a previously unfunded grant that could potentially be funded under the ARRA.
<!--[NIH Challenge Grant program. The application-to-award time period will be completed in only a few months—the submission deadline is April 27th, review during June-July, Council approval in August with the first disbursement of funds no later than September 30th. Thus, the JIT notice given to awardees of Challenge Grants will likely be on a much shorter timeframe than typical awards. This may potentially have implications for the protocol and grant concerning the IACUC review process.
ACTION ITEMS FOR PRINCIPAL INVESTIGATORS:
If you submit an application for a Challenge Grant, please do NOT hesitate to submit an IACUC protocol application PRIOR TO just-in-time notification of a potential award (April to June). We recommend doing so as early as possible, at the time you submit the grant application.
If you receive word that your application for a Challenge Grant will not be funded, please email the IACUC Office (
) and simply request an administrative termination of the protocol. The temporary suspension of the submission-JIT process will create many unfunded but approved IACUC protocols—protocols that we would like to remove from PennERA if they are not going to be active.
Please keep in mind that this change in the IACUC protocol submission process is temporary. In the fall of 2009, after the Challenge Grant disbursement date, we will return to normal submission procedure, i.e. our expectation will again be that a protocol application is only submitted when the Principal Investigator receives just-in-time notification.