Assurance A3822-01 :Expires February 28, 2009

I. APPLICABILITY

This Assurance is applicable to all research, research training, experimentation, biological testing, and related activities, hereinafter referred to as activities, involving live, vertebrate animals supported by the Public Health Service (PHS) and conducted at this institution, or at another institution as a
consequence of the subgranting or subcontracting of a PHS-conducted or supported activity by this institution.

“Institution” includes the following branches and major components of Georgia Institute of Technology:

Georgia Tech Research Corporation

Georgia Tech Applied Research Corporation

II. INSTITUTIONAL POLICY

A. This institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.

B. This institution is guided by the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training.”

C. This institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Assurance. As partial fulfillment of this responsibility, this institution will make a reasonable effort to ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance as well as all other applicable laws and regulations pertaining to animal care and use.

D. This institution has established and will maintain a program for activities involving animals in accordance with the Guide for the Care and Use of Laboratory Animals (Guide).

III. INSTITUTIONAL PROGRAM FOR ANIMAL CARE AND USE

A. The lines of authority and responsibility for administering the program and ensuring compliance with this Policy are:

The President (CEO) of the Georgia Institute of Technology delegated authority through the Vice Provost for Research to the Associate Vice Provost for Research to serve as the Institutional Official. The Institutional Official/AVPR regularly attends IACUC meetings and participates actively in policy discussions with the Chair, attending veterinarian, other IACUC members, and compliance office staff. The Chair of the IACUC is directly responsible to the Institutional Official/AVPR for ensuring the proper execution of the responsibilities of the Committee. He is assisted by the Office of Research Compliance, which provides program administration. The Director of Research Compliance reports directly to the Institutional Official/AVPR and is responsible for coordinating activities of the Georgia Institute of Technology Institutional Animal Care and Use Committee (IACUC) and for providing administrative support to the committee. The attending veterinarian reports to the Vice Provost for Research; the facility manager reports through the attending veterinarian to the Vice Provost for Research.

B. The qualifications, authority, and percent of time contributed by the veterinarian(s) who will participate in the program are:

The attending veterinarian position is currently being reclassified and will be 100% time by spring 2004. The current attending veterinarian, Dr. Laura O’Farrell, meets the required professional qualifications for the position of attending veterinarian. She completed her DVM at the University of California, Davis in 1993, her PhD in Neuroscience from the University of California, Los Angeles (UCLA) in 1995, and her Master’s in Laboratory Animal Science from Pennsylvania State University in 1995. The latter was earned as part of residency training in Laboratory Animal Medicine. She became a Diplomate of the American College of Laboratory Animal Medicine (ACLAM) in 1997. She has worked at the Georgia State University since 1996 as that university’s attending veterinarian and came to Georgia Institute of Technology on a 25% time basis in 2000. She is on pager call for Georgia Tech 24 hours daily, seven days a week, and has unlimited access to the animal facility. When she is unavailable, veterinarians from the Emory University Department of Animal Resources provide services in accordance with a formal, contractual agreement.

Dr. O’Farrell is a voting member of the Georgia Institute of Technology Institutional Animal Care and Use Committee. As attending veterinarian, she has been delegated the authority and responsibility to implement the PHS Policy and recommendations of the Guide and the Animal Welfare Act. The attending veterinarian routinely inspects the animal facilities and all animals at Georgia Institute of Technology. The attending veterinarian is available to make recommendations concerning preventive health programs for animals, disease treatment, analgesia, post-operative recovery, euthanasia, general animal welfare and technical training. The attending veterinarian provides routine veterinary care, preventive medical care as well as on-call emergency care and consultation for Georgia Institute of Technology’s animals. The attending veterinarian must review any animal research protocol before it can proceed and has the authority to suspend any protocols that do not follow the Guide or the Animal Welfare Act. Any such suspension will immediately be reported to the IACUC and will be discussed in a convened meeting.

C. This institution has established an Institutional Animal Care and Use Committee (IACUC), which is qualified through the experience and expertise of its members to oversee the institution’s animal program, facilities, and procedures. The IACUC currently consists of six members, and its membership meets the composition requirements set forth in the PHS Policy at IV.A.3.b. Attached at Appendix 1 is a list of the chairperson and members of the IACUC and their degrees, position titles, specialties and institutional affiliations.

D. The IACUC will:

1. Review at least once every six months the institution’s program for humane care and use of animals, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual program evaluations are:

At least semiannually, the IACUC reviews the program for humane care and use of animals. This review follows the Guide for the Care and Use of Laboratory Animals (Guide) checklist and refers to the Guide as a basis for evaluation. Elements that are evaluated include IACUC membership and function, IACUC records and reporting requirements, veterinary care, personnel qualifications and training, and occupational health and safety of personnel.

2. Inspect at least once every six months all of the institution’s animal facilities, including satellite facilities, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual facility inspections are:

The IACUC at least semiannually makes a physical inspection of the central animal facility, all other areas where animals are housed, the laboratories where animal work takes place, and the vehicles that transport animals. This inspection follows the Guide as a basis for evaluation. At least two members of the committee make the inspection.

3. Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to the Institutional Official/AVPR. The IACUC process for developing reports and submitting them to the Institutional Official/AVPR is:

The Director of the Office of Research Compliance accompanies the IACUC on the semiannual inspections and writes the report in accordance with the sample formal for the semiannual report. The report is reviewed by the inspection team, then by the entire committee. Once approved and signed by the IACUC, the report is forwarded by the Director of Research Compliance to the Institutional Official/AVPR. Should there be a minority views, that would also be provided in writing to the Institutional Official/AVPR, along with the semiannual report. If there are any deficiencies in the program or facilities, these are tracked by the Office of Research Compliance and reported on at subsequent IACUC meetings.

4. Review concerns involving the care and use of animals at the institution. The IACUC procedures for reviewing concerns are:

Anyone with a concern about any aspect of animal care and use at Georgia Institute of Technology or who wants to express a complaint about how animals are being treated, or cared for, is encouraged to contact the Institutional Official/AVPR, the IACUC Chair, any IACUC member, the Compliance Administrator, or the Director of Research Compliance. This information, along with contact information, can be found on the Office of Research Compliance website. It is also provided in seminars and other training presented to Georgia Tech faculty, staff, and students.

Reports of concern about animal care and use will be delivered to the IACUC Chair for further action and to the Institutional Official/AVPR, if warranted. Strict confidentiality will be maintained to the extent possible. The Chair will investigate the allegation, naming a subset of IACUC members and/or the Director of Research Compliance to an investigatory committee, if warranted. The person(s) against whom a complaint or concern is lodged will be asked to address the complaint or concern in a discussion with the Chair and the Director of Research Compliance, and possibly with the subset of IACUC members.

No adverse action will be taken against anyone making a good-faith report. No Institute employee, committee member, laboratory technician, or other employee shall be discriminated against or be subject to any reprisal for reporting concerns or violations of regulations or standards under the Animal Welfare Act. Persons with no formal relationship with the Georgia Institute of Technology are also encouraged to register their concerns, also without fear of reprisal or future discrimination.

Concerns, if warranted, are reported by the Institutional Official/AVPR to the Office of Laboratory Animal Welfare.

5. Make written recommendations to the Institutional Official/AVPR, regarding any aspect of the institution’s animal program, facilities, or personnel training. The procedures for making recommendations to the Institutional Official/AVPR are:

The Institutional Official/AVPR attends most Institutional Animal Care and Use Committee meetings and stays fully informed about the animal program. If recommendations regarding any aspect of the institution’s animal program, facilities, or personnel training are made, they may initially be made during a regular committee meeting but are always provided in writing to the Institutional Official/AVPR. Written recommendations to the Institutional Official/AVPR may be presented by the IACUC Chair or by the Office of Research Compliance. Recommendations may cover any aspect of the institution’s animal program, facilities, or personnel training.

6. Review and approve, require modifications in (to secure approval), or withhold approval of those activities related to the care and use of animals as set forth in the PHS Policy at IV.C. The IACUC procedures for protocol review are:

All research, teaching and biological testing involving animals and conducted by anyone at Georgia Institute of Technology, regardless of the source of funding, must be reviewed in advance by the Institutional Animal Care and Use Committee. All research, teaching and biological testing projects conducted at another institution or elsewhere by faculty, students, staff or other representatives of Georgia Institute of Technology in connection with the investigator’s institutional responsibilities, regardless of the source of funding, must be reviewed in advance by the Institutional Animal Care and Use Committee.

Protocols are submitted to the Office of Research Compliance, where they are logged into a database and screened for completeness and required signatures, training on file for principal investigator and others on protocol, current credentials for principal investigator, and a copy of the grant/contract statement of work, if any. A veterinary consult is required at the time of application, and the application must be modified to conform with the vet consult. The protocol is placed on the agenda for the next meeting and distributed for designated review or distributed for full committee discussion at the upcoming meeting.

Protocols distributed for designated review: If no committee member calls for full committee review, a designated reviewer performs the review. No member may disapprove the protocol, but any member may request review by the full committee. In the event that an IACUC member recommends withholding approval of a protocol, then he or she calls for full committee review. The compliance office notifies the Principal Investigator of the reason(s) for the recommendation and the date on which the protocol will be reviewed by the convened IACUC. The PI has the option to have the unaltered protocol reviewed by the convened committee, to submit modifications to the protocol prior to the committee’s review, and/or to meet with the IACUC to discuss the protocol.

“Designated reviewers may approve or require modifications to a protocol in order to secure approval.”

Upon approval by a designated reviewer the PI is notified. The matter is reported to the IACUC as an agenda item at the next convened IACUC meeting.

Regular full committee review: If at least one IACUC member calls for full committee review, the protocol is reviewed at the next convened meeting where a quorum of the IACUC votes to approve, withhold approval or require modifications in order to secure approval of the protocol.

The IACUC generally meets monthly on the fourth Tuesday of the month. The IACUC may meet more than once a month as necessary to fulfill its responsibilities. A quorum is required at any meeting at which formal action is taken by the IACUC. Members must physically be present at a meeting to be counted toward a quorum. A quorum requires a majority of the current members of the IACUC. A majority vote is required for any formal action taken by the IACUC (i.e. approval, suspension). Any member who has a conflict of interest (i.e. personally involved in the activity under review) in a matter under consideration by the IACUC shall not be counted for purposes of determining the existence of a quorum for that portion of the meeting. That member may answer other committee members’ questions but must leave the room during deliberations and when a vote is taken. If a quorum is lost at any time during the meeting, no further formal action will be taken unless a quorum is restored.

Off-campus work: In cases where the Georgia Institute of Technology faculty member or student is involved in work located at an off-campus site with a PHS-approved IACUC, the Georgia Tech IACUC may accept an approval statement from that other IACUC, in lieu of performing a duplicate review. However, the Georgia Institute of Technology IACUC requires investigators to submit a copy of the application to the other reviewing institution, a copy of that institution’s approval letter, and, if externally funded, a copy of the funding proposal statement of work. The Georgia Institute of Technology IACUC must be allowed to assess whether or not an application should be submitted to the Georgia Tech IACUC under these circumstances.

In cases where all animal work is performed off-campus by non-Georgia Tech personnel and under a PHS-approved IACUC protocol approval, and where there is a relationship due to funding or other involvement, the Georgia Tech faculty member shall provide for the Georgia Tech IACUC’s consideration a copy of that institution’s IACUC application and letter of approval and the signed/dated cover page from the Georgia Tech IACUC application. The committee reserves the right to request additional information. The committee reserves the right to require modifications. Non-substantive issues will not be raised. If the Georgia Tech member does have direct involvement with the off-campus work, the current GT IACUC application process must be followed.

There is a cooperative agreement between Emory University and Georgia Institute of Technology governing protocols where investigators from either school perform the work on the other campus and the animals are housed there. Georgia Tech will accept Emory’s IACUC for the review and oversight of certain protocols where a Georgia Tech investigator is performing a research project at an Emory site. Likewise, Emory will accept Georgia Tech’s IACUC for the review and oversight of protocols where an Emory investigator is performing a research project at a Georgia Tech site. In this case, each reviewing IACUC agrees to use the investigator’s home IACUC forms. Additional information may be requested if deemed necessary by the reviewing IACUC. Each institution will comply with its own policies and procedures when reviewing and monitoring designated protocols.

Each institution agrees to abide by the decision of the other institution’s IACUC with regard to protocols reviewed by that IACUC. Disapprovals by Emory’s IACUC may not be administratively overruled by Georgia Tech. Likewise, disapprovals of protocols by Georgia Tech’s IACUC may not be administratively overruled by Emory. However, the investigator’s home institution has the right to review and deny any protocol, prior to submission or subsequently approved by the other IACUC, upon written notice to the reviewing IACUC.

The foregoing procedures apply to all new and continuing protocols, amendments, and other activities involving the use of vertebrate animals.

7. Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy at IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are:

Any revisions to an existing protocol that result in a significant change must be reviewed and approved by the IACUC before the changes are implemented. Letters of approval advise that all changes must be reviewed prior to their initiation. Revisions to an existing protocol should be submitted to the Office of Research Compliance on an amendment form. The amendment may be distributed either for designated review or full committee review. Revisions to an existing protocol do not extend the current approval period. Amendments undergo the same scrutiny and review as do new protocols. Substantive revisions may necessitate a new protocol application.

When a revision accompanies a continuation application, the extent of the revision dictates whether a new application is required. PIs may submit renewals and amendments at the same time. Generally, the continuation is reviewed and approved first, and then the amendment is treated. In any case, all amendments undergo committee review, whether by the full committee or by designated review.

8. Notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in the PHS Policy at IV.C.4. The IACUC procedures to notify investigators and the institution of its decisions regarding protocol review are:

The PI will be given written notice, either by email or letter, of the IACUC’s decision concerning the application. Reviewed applications will be assigned to one of the five following categories:

Approved. The application is approved as presented with no modifications required. The Compliance Office will provide the PI with an IACUC approval letter. Copies are provided to the Office of Sponsored Programs and to Purchasing. For activities funded by an external agency, the Office of Sponsored Programs bears the responsibility of forwarding the IACUC approval information.

Approved Pending Clarification. The PI will be notified in writing, either by email or letter, as to the nature of any required clarifications.

Tabled. The IACUC requires additional information and/or has a concern. The Compliance Office shall notify the PI in writing, either by email or letter, of the decision and arrange to discuss the protocol with the investigator. Before IACUC review can continue, the PI must submit a revised application clearly identifying changes from the tabled application.

Disapproved. The Compliance Office will notify the PI in writing when an application is disapproved and will provide the basis for the IACUC’s decision. If a protocol is disapproved, the PI has the right of appeal to the IACUC. The IACUC may, at its discretion, obtain external review of the application by a PHS approved IACUC of an equivalent institution and/or by expert consultants in the field of that research. The Georgia Institute of Technology IACUC, however, shall be the final authority in determining the acceptability of the protocol.

Decline to Review. Where the application has significant deficiencies in information, or where the PI has failed to properly complete the application, or other similar situations, the IACUC will return the application to the PI with an explanation of why the application was not be reviewed. In those situations, the PI is encouraged to discuss the application with the IACUC Chair or Attending veterinarian to receive assistance in correcting the situation. The revised application should be resubmitted on or before the 1st day of the month for IACUC review.

The Office of Sponsored Programs, animal care facility, purchasing department, and other appropriate persons/offices are advised in writing by the Office of Research Compliance of protocol approvals.

9. Conduct continuing review of each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS Policy at IV.C. 1-4. at least once every three years. The IACUC procedures for conducting continuing review are:

Protocols are reviewed by the IACUC at least annually, either during convened meetings or by designated review. The purpose of this continuing review is to provide the IACUC with current information concerning the status of the protocol and to ensure that the committee concurs with its continuation. The Office of Research Compliance sends the investigator an expiration notice and instructions on submitting the Annual/Final Progress Report & Continuation Application form prior to the protocol anniversary date. The PI must complete and return the form to the Office of Research Compliance in sufficient time for review prior to the anniversary (expiration) date. The investigator is required to report the number of animals utilized in the closing year, project the number of animals to be utilized in the coming year, summarize experiments, and provide plans for the coming year. If the PI fails to timely complete and return the Annual/Final Progress Report & Continuation Application form, IACUC approval expires on the anniversary date, and no further activities can be conducted with animals until the IACUC reinstates the protocol.

Three Year Renewal. If a protocol is expected to continue beyond three years, the PI must submit a complete new application, including a veterinary consult, to the Office of Research Compliance for IACUC review prior to the 3-year anniversary date. Upon receipt of the application the IACUC will conduct a review as for any new application.

10. Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6. The IACUC procedures for suspending an ongoing activity are:

The IACUC may suspend any protocol at any time if it determines that the activity is not being conducted in accordance with the protocol approved by the IACUC, or with guidance from the AWA, PHS Policy, the Guide, or Georgia Institute of Technology’s Assurance or policies. Suspension of a protocol requires a review by the IACUC at a convened meeting of a quorum with a majority vote of the quorum. The only exception is in cases where the Attending Veterinarian suspends a protocol on an emergency basis. The Attending Veterinarian has the authority to suspend any protocols that do not follow the Guide, Animal Welfare Act, PHS Policy, the Guide, or Georgia Institute of Technology’s Assurance or policies.. Any such suspension will immediately be reported to the IACUC and will be discussed in a convened meeting. If an activity involving animals is suspended, the Institutional Official/AVPR, in consultation with the IACUC, shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to APHIS and any Federal agency funding that activity and, depending on the seriousness of the non-compliance, the IACUC may additionally impose a period of suspension for some or all of an individual’s ability to use animals until it is clear that the personnel and procedures have been brought into compliance with federal and institute policies and guidance.

E. The individual(s) authorized by this institution to verify IACUC approval of those sections of applications and proposals related to the care and use of animals is/are:

o Barbara S. Henry

o Melanie Clark

o Anna Marie Lee

o Mary Beran

o Nadia Zitman

F. The occupational health and safety program for personnel who work in laboratory animal facilities or have frequent contact with animals is set forth in Appendix 2.

G. The total gross number of square feet in each animal facility (including each satellite facility), the species of animals housed therein, and the average daily inventory of animals, by species, are shown in the attached Appendix 3.

H. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is:

Georgia Institute of Technology provides training for all personnel caring for or using laboratory animals in research, testing and teaching. Training is provided in the following areas:.

· Humane methods of animal maintenance and experimentation, including the basic needs of each species of animal; proper handling and care for the various species of animals used by the facility; proper pre-procedural and post-procedural care of animals; and aseptic surgical methods and procedures;

· The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress;

· Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility;

· Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility;

· Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information on appropriate methods of animal care and use; on alternatives to the use of live animals in research; that could prevent unintended and unnecessary duplication of research involving animals; and regarding the intent and requirements of 9 CFR 2.

Training requirements are met by completion of the appropriate training modules provided by the Laboratory Animal Training Association (LATA) on the care and use of animals at http://www.latanet.com/client/gatech/introduction.htm. All personnel are required to complete the Laboratory Animal module and the Health & Safety Module, plus any others that are appropriate to the specific protocol. Names of those who complete each training module are recorded by the Office of Research Compliance. Training is verified for all personnel proposing to work with animals, at the time of protocol application, continuing review, and when new personnel, including students, are added to the protocol. Those who have completed training at another institution must provide proof of training.

A graduate level special topics course, entitled “Living System Modeling and Analysis”, is offered. This course covers selection of animal models, alternatives, experimental design, laws and regulations, safety, anesthesia and analgesia, euthanasia, aseptic surgical methodology and pre- and post-procedural care. It includes five hands-on laboratory sessions. A course synopsis is attached at Appendix 4.

Principal investigators are responsible for providing supplemental, adequate, and appropriate training to team members (students, co-PIs) who work with animals on their protocols. Training is also provided in basic animal handling, manipulation, and techniques by the animal facility manager and, in some cases, by the attending veterinarian. In all cases, it is the responsibility of the principal investigator to ensure that all personnel are appropriately trained, and that their continuing education is up-to-date.

The IACUC application requires the principal investigator to sign a certification that all personnel involved with the project are qualified and adequately trained.

IV. INSTITUTIONAL STATUS

As specified in the PHS Policy at IV.A.2, as Category 2, all of this institution’s programs and facilities, including satellite facilities, for activities involving animals have been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months in accord with IV.B.1. and 2. of the PHS Policy, and reports prepared in accord with IV.B.3. of the PHS Policy.

All IACUC semiannual reports will include a description of the nature and extent of this institution’s adherence to the Guide. Any departures from the Guide will be identified specifically, and reasons for each departure will be stated. Reports will distinguish significant deficiencies from minor deficiencies. Where program or facility deficiencies are noted, reports will contain a reasonable and specific plan and schedule for correcting each deficiency. Semiannual reports of the IACUC evaluations will be submitted to the Associate Vice Provost for Research. Semiannual reports of IACUC evaluations will be maintained by this institution and made available to the Office of Laboratory Animal Welfare (OLAW) upon request. The most recent semiannual report of the IACUC is attached at Appendix 5.

V. RECORD KEEPING REQUIREMENTS

A. This institution will maintain for at least three years:

1. A copy of this Assurance and any modifications thereto, as approved by PHS.

2. Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations.

3. Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.

4. Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official/AVPR.

5. Records of accrediting body determinations.

B. This institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional three years after completion of the activity.

C. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

VI. REPORTING REQUIREMENTS

A. At least once every 12 months, the IACUC, through the Institutional Official/AVPR, will report in writing to OLAW:

1. Any change in the status of the institution (e.g., if the institution becomes accredited by AAALAC or AAALAC accreditation is revoked), any change in the description of the institution’s program for animal care and use as described in this Assurance, or any changes in IACUC membership. If there are no changes to report, this institution will provide OLAW with written notification that there are no changes.

2. Notification of the dates that the IACUC conducted its semiannual evaluations of the institution’s program and facilities (including satellite facilities) and submitted the evaluations to the Associate Vice Provost for Research.

B. The IACUC, through the Institutional Official/AVPR, will provide the OLAW promptly with a full explanation of the circumstances and actions taken with respect to:

1. Any serious or continuing noncompliance with the PHS Policy.

2. Any serious deviations from the provisions of the Guide.

3. Any suspension of an activity by the IACUC.