Hektoen Institute for Medical Research, L.L.C., Cook County Hospital hereafter referred to as institution, hereby gives assurance that it will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy.
 

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-supported activity by this institution. 

"Institution" includes all components of the Hektoen Institute for Medical Research, L.L.C., Cook County Hospital.

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 Institutional Official is the Executive Director of the Hektoen Institute for Medical Research, L.L.C., George Dunea, MD. The Responsible Institutional Official reports to the Board of Trustees, Hektoen Institute for Medical Research, L.L.C.. The Supervisor and the Division Chair of the central animal facility report to the Responsible Institutional Official. The animal facility Supervisor has been delegated line authority for administration of the programs. The consulting veterinarian reports to Harry M. Richter, III, MD (Division Chair) or Robert J. Walter, PhD (Supervisor). The Institutional Animal Care and Use Committee (IACUC) reports to the Responsible Institutional Official and is charged with those responsibilities as outlined in the PHS Policy.

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

The consulting veterinarian has completed a four-year residency in Laboratory Animal Medicine, is a Diplomate of the American College of Laboratory Animal Medicine, and has a Ph.D. in Pathology. In addition to the residency training, he has 30 years experience in directing a centralized animal research facility. During this 30 years he has also consulted to 5 other research facilities. The consulting veterinarian is at the facility four hours per week and otherwise available as needed. This amounts to approximately ten percent per week.

The Division Chair and the animal facility Supervisor have authorized jurisdiction over all animal use within the institution. Animals can be brought into the institution only by approval of the Division Chair or the animal facility Supervisor. The Division Chair, the animal facility Supervisor, and the consulting veterinarian are responsible for following all recommendations of the Guide to the extent possible within the physical facilities of the animal facility. Following the Guide, the veterinarian recommends policies and procedures that will ensure adequate veterinary care of all animals within the institution. Along with advice of the IACUC, the animal facility Director is delegated the authority to enforce those policies and procedures, with consultation by the consulting veterinarian. Within this authorization, the animal facility Director and consulting veterinarian have final authority over when euthanasia is appropriate and have the authority to suspend animal activities, if warranted, pending IACUC review.

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 Executive Director of the Hektoen Institute for Medical Research, L.L.C. appointed the members of the IACUC and appoints all replacements. Any changes in the membership of the IACUC are reported annually to OPRR. The IACUC consists of at least five members, and its membership meets the compositional requirements set forth in the PHS Policy at IV.A.3.b. Attached is a current list of the names, degrees, position titles, specialties and institutional affiliations of the IACUC Co-Chairmen and members appointed by the Executive Director.

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:

Each member of the committee is presented with a copy of the manual "Essentials for Animal Research, A Primer for Research Personnel", B.T. Bennett, M.J. Brown, and J.C. Schofield and also a copy of the Animal Welfare Act. In addition, policies and procedures specific to this Facility have been reviewed by the IACUC and are available for examination in the Division office. These materials form the guidelines and regulations for faculty, students, and staff. They describe the Policies and Procedures of the Animal Care and Use Program, Policies of the IACUC, Research Guidelines, and Occupational Health and Safety Program. At the time of the semiannual inspection, any comments concerning the program review are addressed. During the semiannual inspection, committee members are advised that during the inspection, they should also be addressing any questions concerning the program that may be observed during the inspection. At the next committee meeting when the semiannual inspection and review are reviewed and approved by the committee, any questions or concerns about the program may be addressed. 

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 will inspect the animal facilities once every six months, including satellite facilities. The IACUC will try to inspect all facilities within same day. In the event that the inspection of all facilities cannot be completed within the same day, they will be inspected within the same week. Each member of the IACUC is provided with a copy of the Guide and guidelines on how to conduct an inspection. Inspections will be scheduled by the animal facility office as all the committee records will be maintained by that office. The inspections will be scheduled at a time most convenient for all of the Committee members. No member will be excluded from having an opportunity to participate in the inspection. The IACUC may make additional inspections as determined by the Committee or as requested by the Responsible Institutional Official.

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

The IACUC Recording Secretary prepares the report describing all deficiencies found during the IACUC review of the facilities and program. The report identifies each deficiency as being major or minor and provides a plan for correction of each. Any minority views are also included in the report. The report is presented to the Committee for review and approval at the IACUC meeting following the inspection. The report is then signed by the IACUC Chairperson and forwarded to the Responsible Institutional Official.

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

Concerns about the care and use of animals at Hektoen Institute for Medical Research, L.L.C. may be brought to the attention of the Responsible Institutional Official, the Chairperson of the IACUC, or the animal facility Director. The Responsible Institutional Official will be notified if the concern did not originate through that office. The concerns will be referred to the IACUC for review and recommendations. If the concerns are urgent, a special meeting of the IACUC will be called and if not, the concerns will be reviewed at the next regularly scheduled meeting. The IACUC recommendations will be prepared in writing and transmitted to the Responsible Institutional Official. In consultation with the IACUC Chairperson and the Director of the Animal facility, appropriate corrective action will be taken by the Responsible Institutional Official if indicated. 

No employee or IACUC member may be discriminated against or subject to any reprisal for reporting violations or noncompliance with institutional animal care and use policies. All reports of such activities will remain as confidential as possible. 

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

The IACUC may make recommendations regarding any aspect of the animal care and use program at any time to the Responsible Institutional Official. These recommendations will be made after review at a convened meeting of the IACUC and majority approval. These recommendations will be transmitted to the Responsible Institutional Official in writing from the IACUC Chairperson. Any member of the IACUC at any time may make an individual recommendation to the "Responsible Institutional Official."

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:

a. Application or Proposal Receipt and Routing

The IACUC "Application For Animal Use Protocol Review" (IACUC Application) for any proposed animal use shall be submitted to IACUC through the animal facility Office. IACUC meetings are currently scheduled for the last Thursday of each month with the deadline for submission of IACUC Applications the second to last Thursday of each month. The investigator shall submit six (6) copies of the IACUC Application (animal use summary form) and if applicable, one complete copy of a grant application or other request for funding. Proposals with departmental or other private funding may not have a grant or other funding application. The animal facility office will check to ensure that all the material is present and complete. If incomplete, the application will not be reviewed and will be returned to the investigator to complete. 

Copies of the IACUC Application will then be sent to each of the Committee members. One of the Co-Chairs of the Committee will serve as a primary reviewer and will also receive a copy of the grant or other funding application if applicable. The application will then receive Full Committee Review as described below.

Investigator's are encouraged to discuss their proposed studies with the veterinarian or with the Co-Chairs of the IACUC prior to completing their IACUC Applications so most of the Committee's concerns can be adequately addressed before submitting to the Committee and reduce the number of applications requiring Full Committee Review for omissions.

b. Full Committee Review Process

After the IACUC Applications are received, each Committee member is requested to review the applications. At the Committee meeting, the Committee will review each protocol and any additional information that the PI has provided as a result of conversations with the veterinarian or Co-Chairmen. After appropriate deliberation, the Committee may approve the application, approve pending clarifications, require modifications in (to secure approval), or withhold approval. If one of the Co-Chairmen or the veterinarian feel it is necessary, the PI may be requested to appear before the Committee at this meeting or at a later meeting if the Committee concerns cannot be resolved with the PI. The PI may also request to appear before the IACUC. 

At the meeting, the protocol is brought up for review and the concerns expressed are discussed. If all of the concerns are answered to everyone's satisfaction either through availability of other committee member's expertise or from the PI's response to the Co-Chair's inquiry, the protocol may receive approval. Additional information, clarifications or modifications may be requested for approval. A motion is then made to approve, approve pending clarifications, approve with modifications required for approval, or withhold approval. If needed, one of the Co-Chairs will relay any concerns that require addressing to the Principal Investigator (PI). If all of the concerns submitted to the PI are resolved to the satisfaction of the designated Co-Chair, the protocol will receive IACUC approval. These approved protocols will not require further review at an IACUC meeting and will be listed on the next IACUC meeting agenda as having been approved. If all of the concerns are not adequately addressed the protocol will again be referred for further Full Committee Review at the next convened meeting of the IACUC.

If any member of the IACUC has a protocol to be reviewed by the Committee, he/she will be absent from the meeting during the discussion and voting on his/her protocol.

An investigator may appeal any decision of the IACUC in writing or may appear before the Committee in person. Appeals will be made to one of the Co-Chairmen of the IACUC. Appeals can also be made to the Responsible Institutional Official. Animal use activities for which approval was withheld or suspended by the IACUC cannot be approved by other authorities.

c. Description of protocol receiving "Full Committee Review" process

Six copies of an IACUC application and 1 copy of a grant application are submitted to the animal facility Office. The application is reviewed for completeness and copies are distributed to each member of the committee for review. Each member has 7 days to review the protocol before the IACUC meeting. The protocol is put on the agenda for the next regularly scheduled IACUC meeting. A protocol receiving "Full Committee" review can be reviewed only at a convened meeting consisting of a majority of the members. A majority is 50 percent of more of the IACUC members. One of the Co-Chairs may contact the investigator prior to the meeting to obtain clarifications to concerns regarding the protocol. At the meeting, the protocol is brought up for review and the concerns expressed are discussed. If all of the concerns are answered to everyone's satisfaction either through availability of other committee member's expertise or from the PI's response to the Co-Chair's inquiry, the protocol may receive approval. Additional information, clarifications or modifications may be requested for approval. A motion is then made to approve, approve pending clarifications, approve with modifications required for approval, or withhold approval. After the meeting, one of the Co-Chairs will draft a letter indicating approval, approval pending clarifications, approval with modifications required for approval or that approval is being withheld pending clarification or modifications. When a protocol receives an approval pending, the PI's response to the clarifications or modifications will go to a designated reviewer, usually one of the Co-Chairs, for review and approval. If the response is satisfactory, meeting with the committee's current standards and review guidelines, it is approved. When a protocol receives a "Withheld Approval" the concerns are usually more significant and the PI's responses must complete the "Full Committee" review process again until it is approved or withdrawn from further Committee consideration. If the investigator cannot satisfy the Committee's requirements and does not withdraw the protocol from further consideration the Committee notifies the investigator that it considers the protocol withdrawn from further consideration.

d. Meeting Attendance and Voting on Research Projects

As indicated above the Committee conducts official business at convened meetings only when there is a quorum present constituting more than 50 percent of the Committee members. A Committee motion for any item before the committee, including protocol approvals, requires a majority affirmative vote of the members present to approve the motion. At any time, a minority view may be expressed and noted in the minutes. 

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:

All requests for changes must be submitted in writing to the IACUC Co-Chair in care of the animal facility Director prior to the change. If the change is minor, the animal facility Director may approve the change. If the change is not minor, i.e. is significant, the request for amendment must be submitted to the Committee for review and follow the process described for protocol review.

8. Notify investigators and the institution in writing of its decisions 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 IACUC shall notify the investigator in writing of its decision to approve or withhold approval of those sections of applications or proposals related to the care and use of animals, or of modifications required to secure IACUC approval. If the IACUC decides to withhold approval of an application or proposal, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. One of the Co-Chairs drafts most IACUC correspondence. In very rare instances and in the absence of the Co-Chairs, a member of the IACUC may sign in place of the Chairperson. Although it has never occurred, the Responsible Institutional Official may also sign in the absence of the Co-Chair. In these instances, the Co-Chairs are copied on the correspondence.

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 procedure for conducting continuing review are:

The IACUC shall conduct annual reviews of applications or proposals. The IACUC shall send the investigator the title(s) and approval number(s) of the document(s) currently on file and a request for updating. Investigators shall be required annually to certify that there have been no changes in the animal related sections of the protocol. Significant changes in the protocol shall require submission of a new request for review, which will be subject to the same review as new proposals. Investigators are required to notify the IACUC of any significant changes in protocols and request approval prior to the modification.

In accordance with PHS Policy, all projects are approved for only three years. Prior to the end of the three years on each approval, all projects must be resubmitted to the Committee by submitting six copies of the current IACUC "Application For Animal Use Protocol Review." The IACUC will send a notice to the investigator indicating that his/her project will have to be resubmitted for review and approval by the IACUC. These protocols are then reviewed according to the same procedures as those use for new protocols (see above).

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 an activity that it has previously approved if it determines that the activity is not being conducted in accordance with the Animal Welfare Act, the Guide, the institution's assurance, IV.C.1.a.-g. of the PHS Policy, or institutional policy. The suspension of such activity by the IACUC may occur only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present.

The animal facility Supervisor or Division Chairman may also suspend any activity using animals at any time. If such activity is suspended by the animal facility Supervisor or Division Chair, it shall be reported to the Responsible Institutional Official immediately and will be reviewed at the next regularly scheduled IACUC meeting or at a specially convened meeting.

If an activity involving animals is suspended, the Responsible Institutional Official in consultation with the IACUC shall review the reasons for suspension and take appropriate corrective action. If the activity involves Public Health Service funding, the action with a full explanation shall be reported to the Office for Protection from Research Risks. If the activity involves animals covered under the AWA it will be reported to the USDA. 

E. The individuals authorized by this institution to verify IACUC approval of those sections of applications and proposals related to the care and use of animals are Harry Richter, III, MD (Chair, Division of Theoretical Surgery; IACUC Co-Chairman) and Robert J. Walter, PhD (animal facility Supervisor; IACUC Co-Chairman), and George Dunea, MD (Executive Director of Hektoen Institute for Medical Research, L.L.C; Responsible Institutional Official).

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

1. Personnel Training

a. Special Qualifications and Training 

All individuals working with radioisotopes must attend training provided by Radiation Safety. Radiation Safety maintains these records. All departments are required to provide training to all staff in accordance with the institution's Chemical Hygiene Plan. Individual departments maintain Chemical Hygiene training records. All of the veterinary staff, surgical staff, and animal care staff also receive annual institutional Bloodborne Pathogen training. The hospital and individual departments maintain these training records.

b. Educational Program(s)

In every protocol submitted to the IACUC the Principal Investigator indicates for review by the IACUC the name and qualifications of every person that may be working on a research project, as well as provide assurance that all individuals will be adequately trained in the use of animals. The institution has a manual for all investigators that they can make available to their technicians. Technicians may also access the manual in the animal facility Office. The manual describes the Occupational Health and Safety Program for the animal care and use program, and includes a section on Zoonoses.

c. Personal Hygiene and Protection 

Regular attire for all animal care technicians includes uniform shirts and pants or scrub suits provided by the animal facility. While working in animal rooms or the cagewash area, all animal care staff are required to wear latex gloves and face masks. Steel-toed work boots are required for all animal care technicians for daily wear. Face shields or goggles are also required in the cage washing area when anyone is using hazardous cleaning agents.

Shower facilities exist in the men's locker room. Work clothes should be covered with a gown or lab coat when leaving the floor. Work clothes should not be worn outside the institution.

There is no eating or drinking allowed in the vivarium except for the designated office or lunch areas. The Hektoen Institute for Medical Research, L.L.C. is a non-smoking institution. 

2. Medical Evaluation and Preventive Medicine for Personnel

a. Occupational health and safety program

All employees are covered by the institution's occupational health and safety program. The occupational health program of the animal facility at the Hektoen Institute for Medical Research, L.L.C. is designed to reduce the risk of adverse health effects in individuals working with animals and infectious agents. This program is administered through the Employee Health Service (EHS) of the Cook County Hospital. A pre-employment physical and medical history is required by the institution and is conducted by the EHS where the records are also maintained. A pre-employment TB test is mandatory. Occupational health records are maintained on each animal facility employee by the animal facility and the employee health service at the Cook County Hospital. The occupational health records on all other employees are maintained by the employee health service. 

b. Aspects of the program that apply to personnel potentially exposed to hazardous agents 

All hospital employees are eligible to receive Hepatitis B vaccination and the animal facility employees are also given the opportunity to receive rabies vaccination. If other employees were determined to have an increased risk for rabies exposure and the EHS physician recommended it they would also be provided with the opportunity to receive rabies vaccination. All employees are required to attend annual training for chemicals and blood borne pathogens.

All personnel are to report any animal related injuries to the animal facility office and the EHS. If any animal care personnel experience any potential exposure to hazardous agents they are to report to their supervisor and EHS. Research technicians would report exposures to their supervisors and EHS. For any injury or exposure, an institutional "Record of Employee Injury/Exposure" is completed prior to the employee going to the EHS. Copies of these reports are in the EHS and the department. Injuries or exposure requiring emergency treatment would be handled through the hospital's Emergency Room.

3. Animal Experimentation Involving Hazards

a. Institutional policies

The animal facility requires that the animal husbandry of certain protocols also become the responsibility of the principal investigator and his research staff. This is a measure of occupational safety appropriate to reduce the cumulative effects of repeated exposure by the animal facility personnel to hazardous materials. All procedures required for the maintenance and husbandry of the particular animal species to be used will be demonstrated by the animal facility staff to the appropriate person(s) from the investigator's laboratory. The animal facility will provide any additional assistance to ensure that all projects proceed without complication.

b. Oversight process and husbandry practices

All procedures required for the maintenance and husbandry of the particular animal species to be used will be demonstrated by the animal facility staff to the appropriate person(s) from the investigator's laboratory. The animal facility will provide any additional assistance to ensure that all projects proceed without complication and monitor the study to ensure that the research technician and animal facility personnel are not endangered. Appropriate hazard signage is used for all hazardous studies.

c. How hazardous agents are contained

The handling of hazardous agents is described in each protocol application for which they will be used. Each agent, depending upon its chemical composition, penetrating ability in the case of radioisotopes, or potential for transmission, i.e, aerosol, fomite or direct contact is handled according to guidelines suggested in the CDC/NIH Biosafety in Microbioloical and Biomedical Laboratories handbook, the NIH Guidelines for Research Involving Recombinant DNA Molecules, or the Institutional Radiation Safety Office.

d. How anesthetic gases are scavenged

Anesthetic gases are scavenged utilizing one of 3 primary methods: 1) direct vaporizer scavenge line to central exhaust (room exhaust is 100% exhaust); 2) manual line connected to room exhaust outlet; 3) use of fume hood while conducting open drop anesthesia.

4. Facilities, Procedures, and Monitoring

a. Requirements for showers and change 

All animal care personnel are required to wear specified uniforms while working in the facility. Two lockers are provided for each employee to keep street clothes separate from work clothes. There are no special barrier facilities requiring shower in/out protocol. Shower facilities are available in the locker rooms.

b. Procedures that reduce potential for physical injury.

All employees are given instruction on lifting technique to avoid back injury. Back braces are available for those who wish to wear them. Carts, dollies, and trucks are available for moving heavy objects. Transport carts are used to move large animals long distances. All employees are strongly discouraged from lifting heavy objects alone when alternative methods have been demonstrated to them.

c. Special facilities provided for use with hazardous agents 

No special facilities exist for hazardous agent containment. Studies with hazardous agents are usually isolated in an individual room. 

G. The total gross number of square feet in each animal facility, the species of animals housed therein and the average daily inventory of animals, by species, in each facility is provided in the attached table.

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

Training is provided to investigators and research technicians by staff of the facility as needed or upon request. Fellows, Residents, and Graduate students are encouraged to take the "Care and Use of Animals in Research" course at the University of Illinois at Chicago. Animal technicians, with the sponsorship of the Institution, are required to enroll in and attend this course periodically.

In every protocol submitted to the IACUC for review, the Principal Investigator indicates the name and qualifications of every person that may be working on a research project, as well as provides assurance that all individuals will be adequately trained in the use of animals. 

The IACUC specifically addresses the use of the minimum number of animals to obtain valid results and instructs investigators to seek the assistance of a biostatistician in determining the number of animals if not aware of how to conduct a power analysis.
 

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. The report of the IACUC evaluation has been submitted to the Responsible Institutional Official and a copy of the report is appended C). The report contains a description of the nature and extent of this institution's adherence to the Guide. Any departures from the Guide are identified specifically and reasons for each departure are stated. Where program or facility deficiencies are noted, the report contains a reasonable and specific plan and schedule for correcting each deficiency. The report distinguishes significant deficiencies from minor deficiencies. Semiannual reports of the IACUC evaluation submitted to the Institutional Official, will also contain a reasonable and specific plan and schedule for correcting each deficiency and distinguish significant deficiencies from minor deficiencies. Semiannual reports of IACUC evaluations will be maintained by this institution and made available to OPRR upon request.

V. Recordkeeping

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 as forwarded to the Responsible Institutional Official.

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 the completion of the activity.

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

A. At least once every 12 months, the IACUC, through the Institutional Official will report in writing OPRR:

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 OPRR with written notification that there are no changes.

2. Notification of the date that the IACUC conducted its semiannual evaluations of the institution's program and facilities (including satellite facilities) and submitted the evaluations to the Responsible Institutional Official.
 

B. The IACUC, through the Institutional Official, will provide the OPRR 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.

 
C. Reports filed under VI.A. and IV.B. above shall include any minority views filed by members of the IACUC.