PLEASE NOTE: On Friday, August 16ththe IRB 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 submission on Friday, August 16h. HS-ERA will be available for submissions and they will be processed in the order received on Monday, August 19th. Please see the guides page for contact information for any emergent situations.
March 6, 2013
Please be advised that the IRB’s requirements related to Unanticipated Problem and Adverse Event reporting has been updated:
In alignment with 21 CFR 312, investigators are required to promptly report to the IRB:
(1) Unanticipated problems including suspected adverse reactions and adverse reactions.
An event is considered a “suspected adverse reaction” when there is reasonable possibility that the drug/investigational product caused the adverse event. For these reporting purposes, reasonable possibility means there is evidence to suggest a causal relationship between the drug/investigational product and the event.
For University of Pennsylvania IRB reporting, this means an event should be considered probably or definitely related to the research procedures.
(2) Unanticipated adverse device reaction. Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
(3) In addition to unanticipated problems, the IRB also requires prompt reporting of the following events:
-Complaint of a participant when the complaint indicates unexpected risks or the complaint cannot be resolved by the research team.
-Violation or deviation (meaning an accidental or unintentional change to the IRB approved protocol) only when: one or more participants were placed at increased risk of harm, or, the event has the potential to occur again, the event represents serious or continuing noncompliance.
-Breach of confidentiality.
-Incarceration of a participant when the research was not previously approved under Subpart C and the investigator believes it is in the best interest of the subject to remain on the study.
Please note that the IRB was closed on 10/29/2012 and 10/30/2012 due to the University closure for the storm. Incoming items received through the electronic submission system or received via paper will be processed in the order they were received starting on 10/31/2012. The review timeline for items submitted will be delayed by the two day period of the office closure. If you have an item that requires rush review, please contact the Administrator for the Board assigned to the review to request this and the Administrator will provide an updated review timeline for that submission. Please limit rush requests to only those items that warrant a rush review.
Penn releases new guidance document and revised informed consent templates. Please visit the Forms page of the IRB website for the most recent version of the informed consent form template. The informed consent form templates have been revised to include standard language to describe the reporting requirements for certain infectious diseases and have been updated to include new language describing the inclusion of research results in the electronic medical record (EMR). The language related to research results and the EMR will be required for most studies as of February 1, 2012. For more information please visit the Guides page for a new guidance document on the required language. Please visit the training page for information on upcoming training sessions that discuss the new required language.
Penn IRB's Comply with FDA's New IRB Registration Requirements All IRBs reviewing FDA-regulated research are required to provide FDA-specific information to the federal Office of Human Research Protections (OHRP). Penn's IRBs are fully compliant with the FDA registration requirements. To view the Penn IRB registrations, go to the OHRP website.
American Recovery and Reinvestment Act Funding Opportunities
With the passage of the American Recovery and Reinvestment Act, we anticipate an increase in the number of IRB submissions. This may impact the workflow through the IRB over the next few months. To ensure prompt review despite the expected increase in volume and at the same time maintain rigorous compliance with federal regulations and institutional policies, the iRB asks for investigator's assistance in ensuring that IRB submission and review processes run smoothly.
For previously reviewed but unfunded grants: Contact your program officer to determine if your prevously reviewed grant now falls within the funding line. If so, confirm that you have IRB approval and that your submission to the IRB included your grant proposal. You may access Ben Reports http://www.finance.upenn.edu/ben/benrep/ to check the status of your IRB submission or contact the IRB at 215.573.2540. If you have not prevously submitted an application to the IRB, we recommend that you prepare and submit an application for IRB review. If you are unsure whether your proposal requires IRB review, please contact our office.
Human Subjects Electronic Research Application Now Available at
The PennERA (Electronic Research Administration) Team would like to announce that the Human Subjects Electronic Research Application (HS-ERA) is now available to researchers at Penn. HS-ERA is a new secure, web-based protocol application. Release 1.0 allows the creation, submission, electronic routing, and approval of Human Subject Protocols to the Institutional Review Boards (IRB), including the ability to submit Continuing Reviews, Unanticipated Problems, and Modifications to an existing Human Subjects Protocol created within the HS-ERA system. Also included is the ability to report Unanticipated Problems for protocols that were submitted on paper. Release 1.0 includes electronic notifications to internal review entities and the ability for the IRB member to review protocols.
HS-ERA also replaces the former system for reporting adverse events, PennAEs, which has been retired.
Desktop requirements -------------------------- It is recommended that you access HS-ERA via Internet Explorer or Firefox with browser caching disabled. Disabling caching ensures that you will see the most recent data. For information on how to disable caching and for other desktop requirements, see the Desktop Requirements page at http://project.pennera.upenn.edu/desktop_req.asp. If you have any questions about the desktop requirements, contact your Local Support Provider. For a contact list, go to http://www.upenn.edu/computing/view/support/.
Reference materials available ------------------------------------- HS-ERA reference materials, including Frequently Asked Questions (FAQ) and a Quick Reference Guide, are available on the PennERA web site. To access the documents, go to the PennERA Reference Materials page at https://rosetta.upenn.edu/cgi-bin/websec/websec_authform?app=RMDocs, authenticate with your PennKey and PennKey password, and see the "Human Subjects Electronic Research Application (HS-ERA)" section.
Questions ------------- If you have any questions, comments, or suggestions, please send an e-mail to
. For more information on PennERA, please visit the PennERA web site at https://www.pennera.upenn.edu/.
5/30/08 REVISED Cooperative Agreement with CHOP: The CHOP/Penn Cooperative agreement has been recently been revised to include additional scenarios. The revised agreement is intended to streamline the IRB review process by defining criteria for a single IRB review by either an IRB at Penn or CHOP.
6/28/07 University of Pennsylvania Earns Accreditation for Human Research Protection Program from AAHRPP: The University of Pennsylvania has received full accreditation for its human research protection program from the Association for the Accreditation of Human Research Protection Programs, Inc., a nonprofit that works with organizations that conduct research to raise the level of protection for participants. Continued...
2/23/07 Electronic Request for Exemption (RFE) now Universally Available: The Human Subjects Research Protocol Request for Exemption (RFE) module is a secure web-based application that allows Human Subjects investigators to electronically submit information for research they feel is eligible for IRB exemption status. It streamlines the submission, review, tracking, and approval process for Human Subjects Requests for Exemptions and will eventually replace the paper Claim of Exemption Form currently in use. The Human Subjects Protocol Request for Exemption (RFE) module is accessible to anyone at Penn with a valid PennKey and PennKey password, provided that the person's school/center has been set up for access. Follow the instructions below, and if you cannot access the application, check with your school/center's business administrator to see if access for your organization was set up. Continued...
1/18/07 School District of Philadelphia approval required to conduct research within the school district: The School District of Philadelphia frequently receives requests from outside individuals and agencies to conduct research studies. While it is District policy to cooperate with researchers whose projects might benefit education, it is incumbent on the District to ensure that such activities do not interfere with the instruction, or require excessive pupil or staff time. For this reason, all requests to conduct studies research studies in schools, utilizing questionnaires, surveys, interviews, focus groups, and/or requests for student data, are screened by the Office of Research and Evaluation's Research Review Committee . Ultimate responsibility for authorization rests with the Director of the Office of Research and Evaluation and the Chief Accountability Officer.
10/3/06 New Information about the CISCRP on the Participants Page: The University of Pennsylvania has joined the Circle of Supporters for Center for Information and Study on Clinical Research Participation (CISCRP). The mission of the CISCRP is to: Educate, inform and empower patients, the public, medical and research professionals, the media and policymakers about clinical research participation and what it means to be an active participant in the process. MORE...
August 14, 2013
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.