News

IRB News 

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

https://medley.isc-seo.upenn.edu/hsProtocol/jsp/fast.do  Date: June 2, 2008

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.

Access
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To access the application:

Note: If you do not have a PennKey, or if you have a PennKey but forgot your password, go to the PennKey web site for more information at http://www.upenn.edu/computing/pennkey/.  If you have any trouble with the PennKey process, contact your Local Support Provider.  For a contact list, go to http://www.upenn.edu/computing/view/support/.

Desktop requirements
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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/.

End-user support
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A support system is in place for HS-ERA users; information is on the PennERA web site at http://project.pennera.upenn.edu/help.asp. 

Reference materials available
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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
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If you have any questions, comments, or suggestions, please send an e-mail to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .  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...

IACUC News

10/1/09

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.

08/31/09

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.

IACUC Guideline on Mouse Breeding and Cage Density and ULAR SOP Correction of Overcrowded Mouse Cages

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             
• 1 unweaned litter = 1 adult mouse, when considering overcrowded cages (previously 1 litter = 2 adults)
• 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.
• Other "conditionally acceptable" methods of euthanasia are described in the AVMA Guidelines for Euthanasia.
• 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.

03/17/09

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 27^th, review during June-July, Council approval in August with the first disbursement of funds no later than September 30^th.  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 ( This e-mail address is being protected from spam bots, you need JavaScript enabled to view it ) 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.

7/01/08 
New Animal Care and Use Guidelines:
There has recently been several new or updated animal care and use guidelines created to better assist the research community in being compliant with regulatory guidelines, policies, and recommendations.

If your research involves any of the following topics, please review the new guidelines.

•  3. Use Of Complete Freund's Adjuvant In Laboratory Animals.  This guideline closely follows the NIH Guidelines for the Research Use of Adjuvants with regards to administration and now also strongly encourages the use of alternative methods of immune activation.
• 10. Egg and Oocyte Harvesting From Xenopus Laevis.  This guideline will help investigators design frog oocyte and egg harvesting protocols and now provides additional information regarding best veterinary practices
• 11. Rodent Surgery and Post-Anesthetic Monitoring. This guideline will help investigators design rodent surgery protocols and is now better aligned with best veterinary practices.
• 14. Vaporizer Calibration.  Anesthesia vaporizers must be certified at least every two years by either the Department of Anesthesia Critical Care (SoM) or an outside vendor.
• 15. Rodent Anesthesia and Analgesia Formulary.  This document provides investigators guidance in choosing an appropriate anesthesia or analgesia regimen for laboratory rodents.

The entire list of all IACUC Guidelines may be found here.  If you have any questions, please contact the IACUC Office at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or 215-573-2540.

7/01/08
Updated Animal Research Submission Forms
There has recently been several updated animal care and use submission forms updated to better assist the research community in submitting applications to conduct animal research and to allow the Institution to remain fully compliant with federal regulations, guidelines, and policies.

If your research involves any of the following topics, please review the new guidelines.

• Privately Owned Animal Protocol (POAP) – Investigators at the Veterinary School conducting clinical research on privately owned animals should find the new format more user-friendly.
• Exemption – To be completed and reviewed under the unique circumstances when an exemption to the standards, federal regulations, and/or Penn policies is required for scientific purposes.
• Amendment – Significant – Required for changes in IACUC protocols involving strain/species changes, request for addition animal numbers, animal use and procedures, use of hazardous substances, and changes in principal investigators.
• Amendment – Administrative – Required for changes in IACUC protocol involving personnel, finding source, protocol title and locations of procedures.

All forms necessary for conducting animal research may be found on the “Forms” page of the IACUC website.

6/26/08
Notice to investigators regarding IACUC protocols and grants/awards
In order to improve the Penn’s compliance with OLAW’s Public Health Service Policy, the IACUC will require more information regarding specific animal use sections of the grant/award with every submission—new protocols, animal use amendments, and amendments to change funding sources.

             1.      Face page
             2.      Specific Aims
             3.      Research Methods
             4.      Vertebrate Animals

The requirement is consistent with the following federal guidance from the PHS Policy (IV.D.2.):
…Applications or proposals (competing and non-competing) covered by this Policy from institutions which have an approved Assurance on file with OLAW shall include verification of approval (including the date of the most recent approval) by the IACUC of those components related to the care and use of animals…

Penn has an approved assurance with PHS, “assuring” that we will follow the guidelines set forth by the PHS.  The renewal letter can be viewed on the IACUC website here.  Investigators will be responsible for updating both the IACUC and any Institutes under DHHS regarding any significant changes in the grants/award and/or animal use protocols, respectively.  It will improve the efficiency and speed of the review process  if these documents are include with the initial protocol submissions, rather than being requested further along in the review process.

If you have any questions, please contact the IACUC Office at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or 215-573-2540.

5/26/08
Penn Profiler/Knowledge Link Rollout
Penn Profiler has been released University-wide to specific groups starting May 26, 2008 and the rollout is still ongoing.

Penn Profiler was designed to help determine what training each employee is required to complete as based upon their job description and duties.  For personnel working on animal research protocols, this will include at least IACUC Training and Species-Specific Training.  Please see the Penn Profiler/Knowledge Link homepage and the ULAR and IACUC Training webpages for more information.

1/22/08
New Office Location
The Office of Regulatory Affairs, including both the Institutional Animal Care and Use Committee and the Institutional Review Boards, relocated to a new office suite. 

We are now located at:

                                3624 Market Street, Suite 301
                                South Science Center
                                Philadelphia, PA, 19104-6006

The ORA main desk telephone numbers remain 215-898-2540 and 215-573-2541 and all other phone numbers may still be found in the “Contact”  list on the ORA Homepage.  General IACUC requests or questions may also be sent to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .

7/1/05
New IACUC Protocol Form Released
The IACUC has published the 2005 version of the IACUC Protocol Submission form. The 2004 version will be accepted until July 2005, after that date only the 2005 Protocol Form will be accepted.

2/27/03
IACUC Policies updated
The IACUC has published their official policies concerning Cage Cards. The Protocol Amendment Forms have also been updated.