UNIVERSITY OF MASSACHUSETTS, BOSTON CAMPUS
ANIMAL WELFARE ASSURANCE OF COMPLIANCE
I, Matthew Meyer as named Institutional Official for animal care and use at University of
Massachusetts, Boston (UMB) provide assurance that this Institution will comply with
the Public Health Service Policy (PHS Policy) on Humane Care and Use of Laboratory
Animals.
I.
Applicability of Assurance
This Assurance applies whenever this Institution conducts the following activities: all research,
research training, experimentation, biological testing, field studies and related activities involving
live vertebrate animals supported by the PHS, or other extramural funding source. This Assurance
covers only those facilities and components listed below.
A. The following are branches and components over which this Institution has legal authority,
included are those that operate under a different name:
University of Massachusetts, Boston
B. The following are other institution(s), or branches and components of another institution:
None
II.
Institutional Commitment
A. UMB complies with all applicable provisions of the Animal Welfare Act (AWA), other Federal
and Commonwealth of Massachusetts statutes (as they apply) relating to the care and use
of vertebrate animals.
B. UMB is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate
Animals Used in Testing, Research, and Training."
C. UMB acknowledges and accepts responsibility for the care and use of animals involved in
activities covered by this Assurance. As partial fulfillment of this responsibility, UMB
schedules two training sessions per year for investigators, instructors, laboratory staff,
students and animal care personnel to review policies, procedures and responsibilities
associated with this Assurance.
As part of the training program, UMB reviews the basic principles of the AWA, (see graph)
other applicable Federal statutes and regulations, as well as those of the Commonwealth of
Massachusetts. Maintaining compliance with this Assurance is the primary responsibility of
all UMB personnel associated with the administration, care and use of vertebrate animals in
UMB facilities. Refer to training outline page 13.
D. UMB has adopted The Guide for the Care and Use of Laboratory Animals (Guide, 2010
revision) as the standard for all programs and activities involving the care and use of live
vertebrate animals in UMB facilities.
E. UMB ensures that all performance sites engaged in activities involving live vertebrate
animals under consortium (subaward) or subcontract agreements must have an equivalent
Domestic Assurance
12/10/2012
1
Assurance under PHS Policy, follow Federal statutes and regulations, and that any activities
have been reviewed and approved by an Institutional Animal Care and Use Committee
(IACUC). This Performance Policy must be documented in writing as part of any activities
involving live vertebrate animals.
III.
Institutional Program for Animal Care and Use
A. The lines of authority and responsibility for administering the UMB program and ensuring
compliance with the PHS Policy are as follows:
The Chief Executive Officer/ Vice Provost, Dr. Zong-Guo Xia, has appointed Mathew Meyer
as the Institutional Official (IO) for UMB. Mr. Meyer has complete authority and
responsibility to make the necessary appointments to the IACUC, respond to their oversight
directives and administer all provisions of the UMB Assurance. The Chair of the IACUC, Dr.
William Hagar, and the other members of the IACUC are appointed by Mr. Meyer and report
directly to him. The Attending Veterinarian, Dr. Robert Hopkins, has direct reporting
relationships to Mr. Meyer and Dr. Hagar so that he can fulfill all veterinary, IACUC and
delegated responsibilities. The IACUC and Animal Facility Supervisor of the Animal Facilities
also have direct reporting relationships to Dr. Hagar so that he can direct and maintain
oversight of the day to day operation of the program.
The Organization Chart (Attachment 1) shows the overall reporting relationships associated
with the Program for Animal Care and Use.
B. The UMB Attending and Backup Veterinarians are:
1) Attending Veterinarian: Robert E. Hopkins, II
Qualifications
 Degrees: BS, DVM, Certified CDC and AFIP
 Training and experience in laboratory animal medicine or in the use of the species at
the institution: Dr. Hopkins has more than 40 years experience in comparative
medicine as a scientist and veterinarian. He has experience with laboratory rodents,
rabbits, farm animals, dogs, cats, non-human primates and exotic vertebrate species
(including reptiles, amphibians, fish and exotic mammals) used in research, teaching
or testing. Dr. Hopkins has been employed by and/or consulted with
biopharmaceutical companies, medical device companies, private research
institutions, medical centers and academic institutions. He has special expertise in
safety testing, transmissible diseases of animals and regulatory affairs. Dr. Hopkins
was an ad hoc consultant with AAALAC and served on AAALAC Council on
Accreditation for three years.
Authority: Dr. Robert Hopkins has direct program authority and responsibility to
interact with the IO, Chair of the IACUC, Principal Investigators and the staff of the
Animal Facility to assist and ensure that all aspects of the Program (policies,
procedures and method) are being followed. Dr. Hopkins has complete access to all
animals in the facility.
Time contributed to program: Dr. Hopkins is in contact with the Animal Care
Technical Staff and the IACUC on a weekly basis. He performs site visits to evaluate
the condition of animals, advise on facility development plans, assist in siting and
setting up laboratories for animal experiments, evaluate specific health issues with
animals and draft working documents for the program. This effort requires at least
Domestic Assurance
12/10/2012
2
10% allocation of time or a minimum of four hours per week. Dr. Hopkins maintains
online and cell telephone contact with UMB staff at all times.
2) The UMB Backup Veterinarian: Dr. Michael Duggan, Clinical Veterinarian for the
Transplantation Biology Research Center, Massachusetts General Hospital. Resident of
nearby Milton, Massachusetts.
Qualifications
 Degrees: BS and DVM, expert in veterinary surgery
 Training or experience in laboratory animal medicine or in the use of the species at
the institution: Dr. Duggan is a 1995 graduate of Tufts School of Veterinary Medicine
and has been associated with comparative animal research programs and colonies since
that time. He was the clinical veterinarian under Dr. Hopkins at Massachusetts General
Hospital for two years. Dr. Duggan is knowledgeable about disease free rodent and
specific pathogen free large animal research programs. He is a specialist in veterinary
surgery.
Responsibilities: Dr. Hopkins and Dr. Duggan contact each other and arrange backup
veterinary services if Dr. Hopkins is out of town for more than 96 hours or unavailable
by telephone or internet. The lines of authority and responsibility are the same as for
the Attending Veterinarian.
Time contributed to program: Dr. Duggan is on call and available by e-mail or
telephone when Dr. Hopkins is unavailable.
C. The UMB IACUC at this Institution is properly appointed according to PHS Policy IV.A.3.a.
and is qualified through the experience and expertise of its members to oversee the
Institution's animal care and use program and determine the condition of the animal
facilities. The IACUC consists of twelve (12) voting members with three alternate voting
members for the Facilities Animal Facility Supervisor, Non-Affiliated Member and Safety
Officer Committee members. All appointed members are voting members of the IACUC.
This membership exceeds the minimum composition requirements of PHS Policy IV.A.3.b.
Attachment 2 is a list of IACUC Members headed by the Chair of the IACUC and the other
members including their names, highest degrees/credentials, profession, titles or
specialties, and PHS Policy Membership designation.
D. The UMB IACUC:
1) Reviews at least once every 6 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 reviews are as follows:
All voting members of the Institutional Animal Care and Use Committee (IACUC) are notified
and invited to attend regularly scheduled IACUC meetings four times per year to review
protocols, schedule training sessions and conduct such other business as may be necessary to
ensure compliance with institution policies, procedures and standards.
Two of these
meetings (Winter and Summer) are semiannual where the Program Reviews and Animal
Facility/Laboratory Inspections are performed at intervals not to exceed six months to meet
regulatory requirements. The other scheduled meetings are normally during the Spring and
Fall quarters and are more focused on protocol reviews and training. Other meetings may be
schedule if necessary and all members receive all information including the full text of
protocols to be discussed beforehand. The IACUC uses the Semiannual Program Review
Checklist provided by the Office of Laboratory Animal Welfare (OLAW) to perform the
evaluation, document findings and determine program compliance. All voting members in
attendance at an IACUC meeting participate in the Semiannual Program Evaluation. This
evaluation can only be performed by a quorum of the appointed voting IACUC members. The
Domestic Assurance
12/10/2012
3
evaluation includes reviewing the membership of the IACUC, verifying records and regulatory
reports, review of the program of veterinary care, reviewing personnel qualifications,
evaluating the training program and reviewing the occupational health program. If any minor
or significant deficiencies are identified, the committee requires a discussion to determine
alternatives for resolving each deficiency, prescribes a final definitive course of action,
prescribes a timeline for resolution of the deficiency and determines the responsible UMB
personnel to resolve the issue. These deliberations and actions will occur during the regularly
scheduled meeting or specially scheduled meeting where the deficiency is identified. The
determination of final resolution of a deficiency may be delegated by the Full IACUC (FCR) to
a Designated Review Committee (DRC) which is a subcommittee of voting members of the
IACUC, or may be required to come back to the Full IACUC during a regularly scheduled or
special meeting of the Full IACUC if the deficiency is significant. The DRC consists minimally
of the Chair, Attending Veterinarian, one scientist, a safety officer and the Supervisor of the
Animal Care Facilities. Significant deficiencies are those which are considered to jeopardize
the health and/or well being of animals if not resolved promptly. Significant program
deficiencies must be resolved within 30 days. Minor deficiencies, which may be considered
procedural and not directly affecting the health and/or well being of animals, must be
corrected by the next quarterly meeting of the IACUC. Deficiencies must be documented in
writing as having been completed by the responsible individual(s) and reviewed and approved
as being completed by the DRC or the Full IACUC. All actions associated with minor or
significant deficiencies are reported to the IO on at least a semiannual basis using the NIH
template for reporting the status of the program to the IO.
2) Inspect at least once every 6 months all of the Institution's animal facilities, including
satellite facilities and animal surgical sites, using the Guide as a basis for evaluation. The
IACUC procedures for conducting semiannual facility inspections are as follows:
All voting members of the IACUC are notified and invited to attend the four regularly
scheduled meetings per year. Two of these meetings (Winter and Summer) are semiannual
where the Program Reviews and Animal Facility/Laboratory Inspections are performed at
intervals not to exceed six months to meet regulatory requirements. The Facilities
Inspections are minimally performed by a designated Subcommittee of voting members of
the IACUC consisting of the Chair, Attending Veterinarian, at least one scientist, the Animal
Facility Supervisor, a safety officer and the IACUC Coordinator. Any other voting members of
the Full IACUC in attendance at the meeting where Facilities Inspections are scheduled are
invited participate in the inspection. These inspections are usually performed at the
conclusion of the meetings in which the Program Evaluations are performed. Depending
upon the projected workload (new, rewrites, or annual review of protocols, or other tasks)
the Full IACUC may move-up the Facilities Inspections to the quarter preceding the Program
Evaluation. If this rescheduling occurs, it is a decision of the Chair and IACUC Coordinator
based upon materials submitted to the Coordinator. The Animal Facility Inspection is
documented on a UMB customized NIH template of the Semiannual Facility Inspection of
Animal Housing & Support Areas Health Checklist (Checklist). Animal Facilities inspections
include inspection of each animal room, procedure area, storage areas, cage washing
facilities, and laboratories where animal procedures are performed.
When the Facility Inspection Checklist is completed, the Subcommittee and any Full IACUC
members in attendance, discusses the findings and determine if there are any minor or
significant deficiencies.
A significant deficiency is one that is viewed as potentially
detrimental to the health and/or well being of animals. Minor deficiencies may represent
lapses in cleaning, record keeping, etc. which do not directly affect the health and/or well
being of animals. At the conclusion of the Facilities Inspection, the Subcommittee meets to
finalize the findings on the Checklist and determines whether any finding(s) constitute a
deficiency. All deliberations of the Subcommittee are documented on the Checklist. If a
significant deficiency is noted, the IACUC Subcommittee and any attending voting members
Domestic Assurance
12/10/2012
4
of the Full IACUC reserve the right to notify the Principal Investigator (PI) and/or the PI
designee to join the Facility Inspection and explain and resolve any animal issue
immediately. If the PI/PI designee is summoned, the condition must be remedied based
upon a determination by the Subcommittee and participating Full IACUC members. If the
findings are determined to be minor, the Subcommittee and participating Full IACUC
members can decide on a course of action to resolve the condition and prescribe a time
frame for the PI to resolve the issue. All findings, prescribed corrective actions and time
frame for completing corrective actions are at the deliberation and discretion of the IACUC
Subcommittee and participating Full IACUC members during the Facilities Inspections. If a
significant deficiency is noted and the PI/PI designee is not available, the AV can
prescriptively resolve the situation with assistance from the Animal Facility Supervisor. If
this action occurs, the PI/PI designee must accept the action by the action by the AV. The
Facility Inspection Checklist is signed by all members present during the inspection and then
submitted to the Institutional Official. All actions taken by the Animal Facility Inspection
Subcommittee and participating Full IACUC members are communicated electronically to the
Full IACUC. If a significant deficiency is observed and is not corrected by the PI/PI designee
or by a prescription of the AV, the activity can be suspended by the Facility Inspection
Subcommittee and participating Full IACUC members. The motion to suspend an activity
must be electronically communicated to the Full IACUC at the conclusion of the Facilities
Inspection to facilitate timely reporting to the IO and OLAW. Remedial actions taken by the
AV and Facilities Animal Facility Supervisor are communicated to both the IACUC and the
PI/PI designee, if they occur. If, upon reviewing the Facility Inspection Checklist any
member of the Full IACUC may call for a meeting of the Full IACUC
3) Prepare reports of the IACUC evaluations according to PHS Policy IV.B.3. and submit the
reports to the Institutional Official. The IACUC procedures for developing reports and
submitting them to the Institutional Official are as follows:
Upon completion of the Facilities Inspection Checklist and the Program Evaluation are
electronically transmitted to the voting members of the Full IACUC and if no voting member
calls for a meeting of the Full IACUC both documents are submitted to the IO as attachments
to the OLAW Semiannual Report to the IO. The report specifically describes any dates and
findings considered to be deficiencies in the Semi-Annual Program Evaluation or Facilities
Inspection Checklist. The Report to the IO distinguishes minor from significant deficiencies
and describes the corrective actions necessary and dates for completion. The draft Report is
forwarded electronically to the members of the Full IACUC and is subject to comment and
editing. An edited Final Report is then redistributed to the Full IACUC and if no member calls
for a meeting of the Full IACUC the Report is forwarded to the IO. The Final Report to the IO
includes must be approved by a majority of the IACUC members and shall include any
minority reports from IACUC members and a description of any IACUC reviews of any
concerns into the care or use of animals. If any Significant Deficiency is reported (one which
directly affects the health or well being of an animal), and the condition was not corrected by
the PI during the courses of the Facilities Inspection, the voting members of the Full IACUC
must consider a recommendation of Suspending any animal activity and complete the
submission of the Report to the IO in 5 working days and the IO must be informed that the
issue must be reported to OLAW immediately.
The IACUC procedure for follow-up to any minor or major deficiency is to have a designated
subcommittee of the voting members of the IACUC (minimally the DRC) review the corrective
action by the responsible individual and issue an electronic report back to the voting members
of the Full IACUC that the deficiency has been corrected according to the IACUC prescription.
If the deficiency is a Minor Deficiency (not involving the health or well being of animals
directly) and not been corrected, the subcommittee may recommend that the correction date
be extended if significant progress has been made towards implementing the corrective
action. If a Significant Deficiency is involved and the deficiency appears not to have received
appropriate corrective action, the subcommittee must report this finding immediately to the
Domestic Assurance
12/10/2012
5
voting members of the Full IACUC by electronic communication. In this instance the
subcommittee may recommend the Full IACUC immediately suspend the animal activity.
Non-corrective action of a Significant Deficiency and suspension of that activity by the Full
IACUC must be reported to the IO to be forwarded to OLAW within 5 days.
If in the course of routine facilities inspections the AV notices a condition (new or repeated)
that directly affects the health or well being of animals (Significant Deficiency) and the PI/PI
Designee are unavailable to take corrective action, the AV may order the activity
“discontinued,” document the findings in writing and immediately notify the Chair of the
IACUC to electronically notify the Full IACUC of any need to consider a suspension of an
activity.
4) Review concerns involving the care and use of animals at the Institution. The IACUC
procedures for reviewing concerns are as follows:
New animal users are informed of procedures for reporting concerns involving animal care
and use delineated in the “Whistle Blower” Policy that is available on the UMB Website, per:
http://www.umb.edu/research/policies_procedures/research_compliance/institutional_animal
_care_and_use_committee_iacuc. The procedure allows any member of the UMB staff,
student(s) or faculty to describe any concern to a voting IACUC member. This concern may
be submitted verbally or in writing and may be anonymous. Once a concern is submitted, the
IACUC member must notify the IACUC Chair, who in consultation with the AV, the Animal
Facility Supervisor and other members of the IACUC, may make a preliminary determination
about the concern. Initial action by the Chair of the IACUC may be to have the AV and the
Animal Facility Supervisor perform an examination of any animal(s) involved and contact the
PI/PI designee to inquire and document the facts associated with the concern. This inquiry
must take place within 48 hours of the notification to the IACUC Chair. If the AV and the
Animal Facility Supervisor find the conditions do not constitute a Significant Deficiency, they
may interact with the PI/PI designee to correct the situation directly. This result is
communicated back to the Chair of the IACUC. If the concern represents a Significant
Deficiency in which the health and/or well being of animals is a concern according to the
opinion of the AV and the Animal Facility Supervisor and the PI/PI designee are not available
or do not correct the condition while the AV is onsite, the AV can order the activity
discontinued and initiate a recommendation to the IACUC Chair for action by the voting
members of the Full IACUC, including temporarily stopping of the activity.
Any suspension or discontinuance of an activity by the voting members of the Full IACUC
associated with this UMB Policy must be reported to the IO, the Sponsored Research Office,
OLAW and any outside funding agency within 5 days in accordance with the procedure
described in Section D, paragraph 3, above.
If a corrective action that does not involve Suspension is prescribed by the Full IACUC and is
completed within a timeline prescribed by the Full IACUC, the matter is considered resolved is
reported to the IO with no further action required.
5) Make written recommendations to the 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 as follows:
The voting members of the Full IACUC, in conjunction with any quarterly, special or
emergency meeting of the full committee, and inconsideration of the criteria for Program
Reviews and Facilities Inspections, may make any recommendations to the IO that are
appropriate to ensure compliance with the letter and intent of the UMB Assurance, Federal or
Commonwealth statutes and regulations and UMB policies, procedures and practices.
Recommendations to the IO may include requests to change portions of the UMB Assurance,
provide funding to ensure proper care of animals, revise methods of documenting activities
Domestic Assurance
12/10/2012
6
and other issues that may be important to routine program compliance. Such request for a
recommendation to the IO can be initiated by any voting member of the IACUC for any
reason. Requests for recommendations to the IO must be submitted in writing to the Chair of
the IACUC and must be scheduled for either an emergency, special or quarterly meeting of
the voting members of the IACUC. Any recommendation to the IO must be discussed and
approved by a majority of the voting members of the Full IACUC. This type of
recommendation cannot be handled by the DRC.
6) Review and approve, require modifications in (to secure approval), clarify or withhold
approval of PHS-supported activities related to the care and use of animals according to
PHS Policy IV.C.1-3. The IACUC procedures for protocol review are as follows:
All voting members of the IACUC receive the full text of the most current version of a
protocol through electronic communication for purposes of protocol reviews. Most protocols
are reviewed prior to one of the four regularly scheduled meetings. All voting members of
the IACUC receive information to be discussed and reviewed. The following section
discusses the review process and how it relates to Public Health Service (PBS) Policy. (The
next section is the underlined “New Protocol Submission and Three Year Rewrites:”
New Protocols, Significantly Revised and Three Year Rewrite Protocols: New, significantly
revised and three year rewrite protocols must be submitted to the IACUC Coordinator in the
Research Administration Office at least 14 days prior to a quarterly meeting of the voting
members of the Full IACUC, or at any interim date with a request for review by the DRC.
Each of these categories of protocols requires a submission of a complete new protocol
form. The IACUC Coordinator will review these protocols for completeness and return any
incomplete protocols to the PI for completion. New and Significantly Revised protocols must
be reviewed by the voting members of the Full IACUC at a regularly scheduled meeting with
a quorum of IACUC members present. Under extenuating circumstances, a protocol can be
submitted within 10 days of a regularly scheduled IACUC meeting, but must be complete
and such protocols are subject to pre-review by the Chair IACUC, Coordinator, Attending
Veterinarian and Facilities Animal Facility Supervisor. If there are any omissions or
modifications that are required for a late submission, the PI must make the stipulated
changes in the protocol and highlight such changes prior to review by the Full IACUC for
review post pre-review but prior to the meeting). A tracking number is assigned by the
Coordinator for each protocol submitted to a quarterly meeting. All protocols are distributed
electronically approximately 5 days prior to the voting members of the IACUC meeting to
facilitate complete IACUC review at the meeting. If requested by the PI and recommended
by the IACUC Chair, a Three Year Rewrite protocol may be recommended using the DRC for
review, if there have been no changes in species, procedures or any of the other criteria
listed in Section D, paragraph 7 below and no voting members of the Full IACUC request the
protocol be reviewed by the Full IACUC.
Annual Protocol Reviews: Each PI is required to submit and Annual Protocol Review Form
(abbreviated form) to describe the activity level, use of animals, changes in personnel,
training of personnel, etc. on the anniversary date of the original protocol submission. This
form does not require re-writing of any objectives or scientific sections of a protocol that
have not changed. This protocol submission is aimed and updating the Full IACUC on
activity level according to a previously approved protocol. For review of the annual
protocol, the DMR process may be utilized after all members have been notified. DMR
members are appointed by the IACUC Chair. Annual Protocol reviews are electronically
distributed to the Full IACUC (all members), and may be delegated by the Full IACUC to
DRC review if no voting member of the Full IACUC requests the review be conducted by the
Full IACUC.
Protocol Review Procedure: New, Significantly Revised or Three Year Rewrite Protocols
involving pain or stress (USDA Category D) associated with procedures performed on
animals can only be reviewed at a meeting of the voting members of the Full IACUC. Final
action on this category of protocol can only be approved by the voting members of the Full
Domestic Assurance
12/10/2012
7
IACUC procedures. Review discussions are recorded in detail in the written minutes and
maintained in accordance with the PHS Policy, IV.E.1.b.
As noted in the PHS Policy IV.2., any voting members of the Full IACUC who are involved in
the research, teaching or testing project or have any other potential conflict of interest, can
be questioned by voting members of the Full IACUC, may stay during preliminary
discussions to answer questions from any IACUC member, but must leave the room (recuse
themselves) prior to final discussions about any action to be taken on the protocol. Recused
individuals are not part of the quorum voting on the submission. The recusal is noted in the
minutes of the meeting.
Full IACUC reviews by the voting members, after deliberations and discussions, can result in
three outcomes on a protocol:

Approval means a protocol is considered adequate in detail, complete and contains
correct information reflecting the policies, procedures and practices approved by the
UMB IACUC. The final action of Approval can only be given to protocols in which
approval by the voting members of the Full IACUC.

Require Modification to Secure Approval means there is missing information
and/or assurances of compliance with UMB policies, procedures or practices.
Modifications must be re-written into the protocol and the document resubmitted to
the voting members of the Full IACUC.


If all members of the IACUC are present at a meeting, the committee may
vote to require modifications to secure approval and have the revised
research protocol reviewed and approved by designated member review, or
returned for FCR at a convened meeting. If all members of the IACUC are not
present at a meeting, the committee may use DMR subsequent to FCR
according to the following stipulations:

All IACUC members agree in advance in writing that the quorum of members
present at a convened meeting may decide by unanimous vote to use DMR
subsequent to FCR when modification is needed to secure approval. However,
any member of the IACUC may, at any time, request to see the revised
protocol and/or request FCR of the protocol. ---AND-----

In order to conduct reviews by DMR subsequent to FCR, the institution should
specify its intention to conduct reviews in this manner in its Assurance with
OLAW. (IACUCs that newly elect to utilize a standard operating procedure for
DMR subsequent to FCR should provide information about this program
change to OLAW in the next Annual Report.)

If all members are not present and the IACUC lacks written standard
procedures as described above, the committee has the option to vote to
return the protocol for FCR at a convened meeting or to employ DMR. If
electing to use DMR, all members, including the members not present at the
meeting, must have the revised research protocol available to them and must
have the opportunity to call for FCR. A DMR may be conducted only if all
members of the committee have had the opportunity to request FCR and
none have done so.
Withhold Approval is usually only considered if an applicant describes the use of a
species that cannot be housed at UMB or for which the care and use could not be
adequately provided through simple modification(s) within the Animal Care and Use
Program, or to the Animal Facilities.
Domestic Assurance
12/10/2012
8
Designated Member Procedures (DMR): DMR is conducted by Designated Review
Committee (DRC). DMR may be utilized only after all members have been provided the
opportunity to call for full-committee review. If any member requests full committee review
then that method must be used. If not, the IACUC Chairperson may appoint one or more
appropriately qualified IACUC members to serve as the designated reviewer(s). Designated
review may result in approval, a requirement for modifications (to secure approval), or
referral to the full committee for review. Designated review may not result in withholding of
approval.
If a protocol is assigned more than one designated reviewer, the reviewers must be
unanimous in any decision. They must all review identical versions of the protocol and if
modifications are requested by any one of the reviewers then the other reviewers must be
aware of and agree to the modifications.
The voting members of the IACUC may use the DRC to review Three Year Rewrite protocols
that have USDA Category B or C procedures, Modified Protocols from a previous DMR or Full
IACUC review (FCR), Modified Protocols or Annual Review protocols. These protocols must
be electronically distributed to the voting members of the Full IACUC and if no voting
member calls for a meeting of the Full IACUC. Designated review may result in approval, a
requirement for modifications or clarifications (to secure approval), or referral to the full
committee for final review and action.
Individual voting members of the Full IACUC have 4 days following the receipt of any
electronic communication in which to call for a meeting of the Full IACUC for any protocol,
any concerns involving animal activities (i.e., “whistle blowing” report), or other animal care
and use issue that pertains to the responsibilities of the FCR. After 4 days, the protocol can
be reviewed using the DMR procedures.
To conduct the DMR procedure, we have a standard group called the DRC which consists of
a least four voting members to include the IACUC Chair, Attending Veterinarian, the IACUC
Coordinator, at least one scientist the Animal Facility Supervisor. Scientists participating in
the DRC review are generally appointed on a rotation basis from all IACUC Scientists. The
IACUC Chair may also assign additional voting IACUC members to the DRC, such as a
Safety Officer if a safety issue might be part of the review. All decisions by the DMR must be
unanimous. All DMR must review identical versions of the protocol. If modifications are
requested by any one of the reviewers all of the other reviewers must be made aware of
and agree to the modifications.
Designated review procedure cannot result in disapproval of the protocol. Protocols
reviewed and approved by the DRC are electronically re-distributed to the voting members
of the Full IACUC and chronologically documented as the approved protocol in electronic and
paper files.
Expedited Reviews: Whenever expedited reviews occur it is performed as follows, there will
be a pre-review of the submission and any corrections or additions will forwarded to the
Principal Investigator. The corrected protocol will be reviewed by the DMR procedures.
The electronic protocol management system maintains the history of the protocol including
records of amendment and annual reviews. The most recent version of an approved protocol
is always the active version. No animal activities can be initiated, or animals ordered to be
received at UMB without a protocol number and approval by either FCR or DMR review.
7) Review and approve, require modifications in (to secure approval), clarify or withhold
approval of proposed significant changes regarding the use of animals in ongoing activities
according to PHS Policy IV.C. The IACUC procedures for reviewing proposed significant
changes in ongoing research projects are as follows:
Domestic Assurance
12/10/2012
9
A revision to an approved protocol must be submitted for IACUC review when a significant
change is planned for some aspect of the protocol that potentially affects the care and use
of animals directly. Significant changes that must be approved by the IACUC before being
involved with the care and use of any animals include, but are not limited to:

Changes in objectives.

Changing to survival surgery from a non-survival procedure or changes in surgerical
procedures in general.

Changes in anesthesia (including methods of administration), analgesia, or
tranquilization drugs or doses.

Changes in methods of euthanasia.

Changes in the species used.

Changes in procedures and/or the duration of a procedure and/or the frequency of a
procedure for USDA Category C and D procedures.

Changes in the approved number of animals used if it is expected to exceed the
approved total by more than 10%.

The introduction of the use of any hazardous substance (toxic agent, mutagen,
carcinogen, radioactive substance, etc.) which will be administered to animals.

A change in the PI of an approved protocol.

Other changes as may be determined by the IACUC in their deliberations.
For the significant changes described above, the PI must edit or rewrite the approved
protocol and re-submit the complete version of the revised protocol for FCR and action
(same as in III.D.6). The most recent version of an approved protocol is always the active
version. No animal activities can be initiated, or animals ordered to be received at UMB
without a protocol number and approval by either FCR or DMR review.
Changes in personnel other than the PI, the addition of personnel, contact information,
training and/or role of personnel already associated with a protocol are reviewed and
approved by the Chair administratively. These types of changes are not considered
significant changes, or having an affect the care and use of animals directly. Personnel
training have to be assured by the IACUC. Minor changes approved by the IACUC, such as
described in this paragraph, must be chronologically documented in the electronic protocol
system and the most recently revised constitutes the active protocol.
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 according to PHS Policy IV.C.4. The IACUC procedures
to notify investigators and the Institution of its decisions regarding protocol review are as
follows:
Notice of Approval: The IACUC Coordinator prepares notifications to PIs when a protocol,
amendment to a protocol, or annual review has been approved by the IACUC. A hard copy of
the approval letter is printed, signed by the Chair IACUC and forwarded to the PI.
The letter includes the PI’s full name, title of the protocol, the date of approval, the period of
approval (three years maximum for any protocol). The expiration date is always shown as
Domestic Assurance
12/10/2012
10
one year from the date of initial approval because of the requirement for annual review and
re-approval by the IACUC.
Notice of Continued Review: When the IACUC cannot conclude the review of a protocol based
upon the original submission, they may vote to continue the review and request and
extensive rewrite of the protocol. In this instance the IACUC Coordinator will summarize the
deficiencies of the protocol in detail, have the document reviewed by the DRC and have the
Chair of the IACUC send a written letter detailing the reasons for the requirement for more
information. In this instance, the decision for Continued Review carries a requirement for a
mandatory response from the PI to allow the review to go forward.
Notice Non-approval of a Protocol: When the IACUC votes Non-approval for a protocol, the PI
is notified in detail and in writing of the reasons for non-approval. Under these conditions,
the PI has the right, according to PHS Policy, to submit a revised protocol that might meet
the conditions cited for non-approval.
Notification of the IO of protocol review decisions: Every three months the IACUC office
forwards IACUC minutes, IACUC office’s documents, monthly reports and other information
to the IO that documentation 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
at least once every 3 years according to PHS Policy IV.C.1.-5. The IACUC procedures for
conducting continuing reviews are as follows:
All researchers submit an Annual Report approximately up to 14 days before the first and
second anniversaries of the protocol’s original approval date. These reports must document
the status of the protocol (continuing, suspended, discontinued), indicate the number of
animals used, update participating personnel and describe any minor changes in activities.
Late Annual Reports are not accepted and it is the policy of the UMB IACUC that all animal
activities must be discontinued until the Annual Report is submitted, reviewed and approved
by electronic submission to the FCR. Annual Reports submitted on time to the FCR for
electronic protocol review can be delegated to the DRC for review and approval if no member
of the FCR calls for a meeting. Annual reviews are not adequate for protocols in which
significant changes are intended, per Section 7 above.
On the third anniversary of a protocol’s original approval the protocol approval expires. If the
PI wishes to continue a project described in the expiring protocol he/she must submit a new,
rewritten protocol. The IACUC review process for a ‘renewal protocol’ is the same as for a
new protocol. If the third anniversary of the approval passes without the IACUC having
approved a new protocol no further use of the animals as described in the expired protocol is
allowed. Animals covered by an expired protocol are transferred to the Director of Animal
Care’s holding protocol pending approval of a new protocol.
No USDA covered species are used at UMB.
10)
Be authorized to suspend an activity involving animals according to PHS Policy IV.C.6.
The IACUC procedures for suspending an ongoing activity are as follows:
A decision to suspend an approved activity using animals requires a quorum vote at a
convened IACUC meeting of the voting members of the FCR. If necessary, an emergency
meeting of the IACUC is convened. The IACUC suspends an activity by a convened meeting
of a quorum of the IACUC and with the suspension vote of a majority of the quorum present.
If the IACUC votes to suspend a protocol, the IO, in consultation with the IACUC, will review
the reasons for the suspension, and take appropriate corrective action. Criteria for
remediation and timelines for resolution of the matter are recorded in the minutes along with
the outcome of the vote to suspend and any minority views. A written statement of the
Domestic Assurance
12/10/2012
11
IACUC’s decision is sent to the PI by the IACUC Chair and the IO is copied. Only corrective
action by the PI that is reviewed and accepted by a quorum of the FCR allows the suspension
to be lifted. A written report to OLAW is submitted whenever a suspension is authorized by
the FCR. A suspension can be lifted only when the PI provides a written plan to the IACUC
for preventing the deficiency from recurring. This plan may require revision of the protocol
by the PI. Once the suspension has been lifted the IO sends a final report to OLAW
describing the reason(s) for the suspension and measures that were taken to address the
problem.
The IACUC is authorized to deny investigators the privilege of using animals for research or
teaching if they demonstrate a history or pattern of repeated non-compliance, or who are
recalcitrant in following the Guide, the Animal Welfare Act and/or direction from of the IACUC
and/or the AV. Implementing this step is executed by the IO after consultation with the
IACUC Chair, the appropriate University Dean, and the PI’s Department Head.
E. The risk-based occupational health and safety program for personnel working in laboratory
animal facilities and personnel who have frequent contact with animals is as follows:
The occupational health and safety program for animal users at this institution is a collaborative
program involving:
1. The Office of the Vice Chancellor for Research and Sponsored Programs. This office
manages IACUC review, training new personnel regarding the occupational health program
(OHP), collecting OHP forms from new animal users, and interfacing with University of
Massachusetts, Boston personnel at University Health Services (UHS) to ensure their
recommended precautions are followed.
2. Laboratory Safety personnel in Environmental Health & Safety. EH&S staff provide training
in safe laboratory practices, waste management, and safe use of hazardous materials, and
inspect equipment, laboratories and facilities to ensure the work environment is safe and
use and disposal of hazardous agents is appropriate. They provide respirator fit testing.
3. Covered personnel are all full-time, part-time, and temporary employees and students of
the University of Massachusetts Boston have contact, in terms of physical proximity or
handling animals in the course of their employment for research, teaching or testing
purposes.
Hazard identification and risk assessment. The PI lists hazardous agents to be used in the study
in the animal use protocol. The Biosafety Officer and EH&S (IACUC members) reviews each
protocol for the Risk Level to personnel. The IACUC may refuse approval to work with animals
for individuals whose risk of injury or disease related to the proposed animal use is
unacceptably high, or individuals who refuse to take precautions recommended by UHS
(vaccinations, use of PPE etc.).
Personnel training regarding zoonoses, chemical safety, physical hazards, allergies, handling of
waste materials, precautions taken during pregnancy, illness or immune suppression.
1)
The basic training provided by Animal Care Facility Supervisor. This training is required for
all new animal users and includes discussion of occupational health issues including risks
from zoonotic diseases, allergies, physical hazards, and how pregnancy and other health
conditions may increase risk.
When necessary Safety personnel in the Department of Environmental Health and Safety
(EH&S) provide training on Chemical Safety, Waste Handling, and other topics through:
Domestic Assurance
12/10/2012
12
2)
Laboratory Health and Safety Seminar. The two-hour seminar is given by EH&S safety staff
and covers Laboratory Safety and Laboratory Waste Management. Laboratory Safety
Training covers:

The UMass Boston Integrated Chemical Hygiene and Environmental Management Plan.

How to read MSDS forms.

Basic toxicology including routes of entry and occupational exposure limits (PELs, TLVs).

Physical and health hazards of hazardous chemicals.

Information on safety equipment and personal protective equipment.

Proper use of fume hoods.

Laboratory inspections.

Emergency awareness.
3) Laboratory Waste Training includes:

Federal and state Requirements for point of generation collection.

Management and disposal of laboratory waste.
4) Radiation Safety Training. This is provided by Radiation Safety staff and is required for all
personnel using radiologicals. It includes:

There is no one on campus using radiation.
A description of the Laboratory Safety policies, procedures and guidelines are contained in the
UMass Boston Integrated Chemical Hygiene and Environmental Management Plan (The CH/EM
Plan) Laboratory Health and Safety Manual at:
http://www.umb.edu/administration_finance/contracts_compliance/ehs/lab_safety/ch_em_plan/2
This document includes policies, procedures and guidelines for personal hygiene, handling
hazardous agents, and personnel protection.
Personal hygiene
All employees and students working in animal facilities are instructed to:

Keep hands away from mouth, nose and eyes.

Not eat, smoke, drink, prepare food, change contact lenses or apply cosmetics in the
facility.

Use appropriate PPE (including protective gloves, and surgical mask and lab coat).

Those associated with Professor Park will use disposable gowns, mask, and polymer
gloves.

Wash hands after animal contact and before leaving the facility.
Domestic Assurance
12/10/2012
13

Remove gloves and wash hands after handling animals, carcasses, or tissues derived
from them before leaving the facility.

Decontaminate work surfaces after spills and when procedures are completed.
Facilities, procedures, and monitoring.
Ensuring the safety of personnel in animal facilities is shared between the Departments of
Psychology, University Health Services, and Environmental Health & Safety (EH&S). Washing
facilities appropriate to the animal use are provided in animal facilities. A variety of animal housing
and equipment is available in animal facilities as appropriate for the needs of the study and
protecting personnel, including compost bins for cage changes, ventilated racks, and micro isolator
cages.
Safety personnel in EH&S complement the IACUC’s new users’ training with training in
recommended procedures. For safe use of biohazardous agents they refer to the different biosafety
th
levels as described in Biosafety in Microbiological and Biomedical Laboratories 5 Edition to
determine the equipment and precautions need to protect personnel. Personnel working with, or
potentially exposed to, biological hazards in the context of their animal use, including zoonotic
agents, take classroom training with the Biosafety Program Animal Facility Supervisor in addition to
the laboratory safety trainings listed above. The biohazards class is followed by project-specific
hands-on training in the laboratory/facility provided by EH&S biosafety personnel. IACUC approval
for the person to start the project is withheld until the Safety Officer in EH&S is satisfied the person
is competent in the safe procedures, including, as needed:

Safe practices at the appropriate biosafety level (BL2, BL2+, and BL3 as defined in
Biosafety in Microbiological and Biomedical Laboratories 5th Edition).

Working in a Biosafety cabinet.

Use of the PPE appropriate for the project and the person’s health status, and how to
wear it (including respirator fitting and test as necessary).

Project-specific procedures for disinfecting and cleaning up spills, and reporting spills
and exposures.

All personnel are instructed to report changes in their health status (e.g. pregnancy,
illness or immune suppression) to the Biosafety Program Officer who will review, with
OHP personnel in UHS, whether the person needs to take additional precautions against
exposure to hazards or stop working with the animal system.
Personal protective equipment (PPE).
Basic PPE (gloves, lab coats, masks) must be worn in all animal facilities. Disposable PPE is
required for those working in the Park colony in the gowning area of the animal facility. A
container is provided in the gowning area for discarded PPE.
Medical evaluation and preventive medicine for personnel.
Compliance with the institution’s Occupational Health Policy (OHP) is required for all animal
users and animal care staff. A new animal user completes a form documenting the species
he/she will be working with and completes an Occupational Health Acknowledgement Form. The
form verifies that the person working with animals is aware of risks associated with laboratory
animal contact.
Reporting and treating injuries
Domestic Assurance
12/10/2012
14
A notice posted in all animal facilities instructs personnel, if injured by a laboratory animal, to
wash the injured area thoroughly with soap and water, wear gloves to assist an injured person,
and if possible to note or label the cage of the animal that inflicted the injury. All injuries are
seen promptly by a health care professional at University Health Services (UHS). After being
seen at UHS the injured employee completes and returns an accident report form to the Animal
Care Office.
The training or instruction available to scientists, animal technicians, and other personnel
involved in animal care, treatment, or use is as follows:
Laboratory Safety and CH/EM Plan training for students and researchers is described in section
E. Animal technicians receive the same training and, in addition, hands-on and facility-specific
training for new animal care staff provided by the Supervisor of the Animal Care Facility.
Before starting to work with live animals, staff, students and investigators at the institution are
all required to attend a classroom training provided by the Veterinarian and take an online
training component via CITI website “Working with the IACUC”.
Training certification must be renewed every three years. New animal user training includes
discussion of the 3Rs, the need to justify animal numbers to be used, and how to conduct a
statistical analysis to justify group sizes. The IACUC reviewers work with the PI if it is evident
that he/she has not understood how to estimate and justify numbers needed. The new users’
training also includes “searching for alternatives” to minimize pain and distress and USDA’s
brochure “Alternatives and the Animal Welfare Act” is included in the package of materials
provided to new PIs through the IACUC Office.
TOPIC
Regulations and IACUC
IACUC Coordinator
Consulting Veterinarian
Alternatives/Justifying
Use of
Animals/Searches
Unnecessary Duplication
USDA Pain/Distress
Endpoints
Surgery
Collecting Blood or
Tissue
Prolonged Restraint
Housing
Reporting Problems
With Animals
Domestic Assurance
SUBJECTS
Assurance, AWA, Guide, Field Studies, Com Mass
Wildlife, responsibilities of IACUC, Whistle Blowing
Submissions, types of protocols, submission periods,
communications from Chair and IACUC
Attending Veterinarian responsibilities, contact
information, consulting, training
Russell Principles – Refine, Reduce and Replace the use
of animals in research and teaching; justifying the use
of animals; and how to conduct a proper search.
Scientific or animal model literature searches
Categories B, C and D are allowed. Category E is not
allowed.
Anticipated and unanticipated endpoints. Death as
endpoint not allowed.
Major v. Minor. Survival v. Non-survival. Multiple
Survival Surgeries.
Simple protocol requirements unless ascites produced
monoclonal antibody preparation in mice is
contemplated. No rabbits onsite currently – contracted
off site.
This practice is for use of restraining devices for periods
longer than 30 minutes.
Health status, caging options, space allocation, back-up
training of euthanasia.
Misuse, Mistreatment or Non-compliance usually first
observed by Animal Facility Supervisor or Staff through
daily observations. Avoiding a whistle blowing incident.
12/10/2012
PRESENTER
Dr. Hagar
Ms. Kenny
Dr. Hopkins
Dr. Hopkins
Dr. Hopkins
Dr. Hopkins
Dr. Hopkins
Dr. Hopkins
Dr. Hopkins
Dr. Hopkins
Ms. Boates
Ms. Boates
15
In addition animal users receive project-specific training from a member of the laboratory staff with
appropriate experience and, as needed, the Attending Veterinarian for projects involving
anesthesia, surgery and/or the need for pain relief. How project-specific training will be provided is
described in the protocol and approved by the IACUC. Project-specific training includes all
procedures including surgery, post-surgery care, and record-keeping for surgery and post-op
monitoring, and maintaining medical records for the animal(s). The attending veterinarian monitors
the performance of surgery and other invasive procedures and provides ongoing training as
needed.
All voting IACUC Members are trained online, in UMB sponsored seminars, or have personal copies
of the PHS Policy, AW Regulations, the Assurance and the Guide. Investigators and staff receive
online training and must participate in at least one inhouse training seminar covering the following
topics:
Responsibilities of the IACUC and IACUC Members
The Members of the IACUC
The IACUC, the CEO, and the IO
Authority of the IACUC
The Types of Protocol Reviews and Review Procedures
Documenting IACUC Actions
Semi-Annual Evaluations - Facility Inspections and Program Review
Correcting Deficiencies
Investigating Allegations of Improper Animal Care or Use.
IV.
Institutional Program Evaluation and Accreditation
All of this Institution's programs and facilities (including satellite facilities) for activities involving
animals have been evaluated by the IACUC within the past 6 months and will be reevaluated by the
IACUC at least once every 6 months according to PHS Policy IV.B.1.-2. Reports have been and will
continue to be prepared according to PHS Policy IV.B.3. All IACUC semiannual reports will include a
description of the nature and extent of this Institution's adherence to the PHS Policy and 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’s evaluations will be submitted to the
Institutional Official. Semiannual reports of IACUC evaluations will be maintained by this Institution
and made available to the OLAW upon request.
[From the following two paragraphs, retain the one that is applicable and delete the one that is
not applicable.]
(1) This Institution is Category 2 — not accredited by the Association for Assessment and
Accreditation of Laboratory Animal Care International (AAALAC) . As noted above, reports
of the IACUC’s semiannual evaluations (program reviews and facility inspections) will be
made available upon request. The report of the most recent evaluations (program review
and facility inspection) is attached.
[For Category 2 only, attach the most recent semiannual program review and facility
inspection report.]
V.
Recordkeeping Requirements
A. This Institution will maintain paper, and electronic records for at least 3 years:
1. A copy of this Assurance and any modifications made to it, as approved by the PHS
2. Minutes of IACUC meetings, including records of attendance, activities of the committee,
and committee deliberations
Domestic Assurance
12/10/2012
16
3. Records of applications, proposals, and proposed significant changes in the care and use
of animals and whether IACUC approval was granted or withheld
4. Records of semiannual IACUC reports and recommendations (including minority views)
as forwarded to the Institutional Official, Mathew Meyer
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 3 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. The Institutional reporting period is the calendar year (January 1 – December 31). The
IACUC, through the Institutional Official, will submit an annual report to OLAW by January
31 of each year. The annual report will include:
1. Any change in the accreditation status of the Institution (e.g., if the Institution obtains
accreditation by AAALAC or AAALAC accreditation is revoked)
2. Any change in the description of the Institution's program for animal care and use as
described in this Assurance
3. Any change in the IACUC membership
4. 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 Institutional Official, Director of Research and Sponsored Program,
Matthew Meyer.
5. Any minority views filed by members of the IACUC
[Note: if there are no changes to report, provide written notification that there are no
changes.]
B. The IACUC, through the Institutional Official, Matthew Meyer, will promptly provide OLAW
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 VI.B. above should include any minority views filed by
members of the IACUC.
Domestic Assurance
12/10/2012
17
VII.
Institutional Endorsement and PHS Approval
A. Authorized Institutional Official
Name:
Title:
Matthew Meyer
Director of the Office of Research and Sponsored Programs
Name of Institution: University of Massachusetts, Boston
Address: (street, city, state, country, postal code)
Quinn Building
100 Morrissey Boulevard
Boston, MA 02125
Phone:
617-287-5372
E-mail:
Matthew.Meyer@umb.edu
Fax:
617-287-5396
Acting officially in an authorized capacity on behalf of this Institution and with an understanding
of the Institution’s responsibilities under this Assurance, I assure the humane care and use of
animals as specified above.
Signature:
Date:
B. PHS Approving Official (to be completed by OLAW)
Name/Title:
Office of Laboratory Animal Welfare (OLAW)
National Institutes of Health
6705 Rockledge Drive
RKL1, Suite 360, MSC 7982
Bethesda, MD USA 20892-7982 (FedEx Zip Code 20817)
Phone: +1 (301) 496-7163
Fax: +1 (301) 915-9465
Signature:
Date:
Assurance Number:
Effective Date:
Domestic Assurance
Expiration Date:
12/10/2012
18
VIII. Membership of the IACUC
Date: December 10, 2012
Name of Institution:
University of Massachusetts, Boston
Assurance Number:
A3383-01
IACUC Chairperson
Name*: William Hagar
Title*: Associate Dean College of Science &
Mathematics
Address*: (street, city, state, zip code)
Degree/Credentials*: PhD
100 Morrissey Boulevard
Boston, MA 02125
E-mail*: William.Hagar@umb.edu
Phone*: 617-287-5776
Fax*:617-287-6511
IACUC Roster Codes: AV = Attending Veterinarian; VC = Vice Chair.
Name of Member/
Code**
Highest
Degree/
Credentials
William Hagar, Chair
PhD
Robert Hopkins, AV
DVM
Kristen Kenny
BFA
Eric Berry, Alternate
For Elizabeth Boates
BS
Kenneth Kleene, VC
PhD
Elizabeth Boates
BA
Alexia Pollack
PhD
Susan Zup
PhD
Nathan Notis
McConarty
JD
Steven Ackerman
PhD
S. Tiffany Donaldson
PhD
Eugene Gallagher
PhD
Domestic Assurance
Position Title***
Associate Dean CSM
Associate Professor
Biology
Attending
Veterinarian
Administrator and
IACUC Coordinator
Director of
Laboratories
Professor Biology
Animal Facility
Supervisor
Associate Professor
Biology
Assistant Professor
Psychology
Non-affiliated, Private
Sector Attorney,
Alternate
Associate Professor
Biology
Associate Professor
Psychology
Associate Professor
Environmental,
Coastal, and Ocean
12/10/2012
PHS Policy Membership
Requirements****
Scientist
Veterinarian and Scientist
Non-Scientist
Non-Scientist
Scientist
Non-Scientist
Scientist
Scientist
Non-Affiliated Non-Scientist
Scientist
Scientist
Scientist
19
Sciences
Nobel Troung
MS
Formulation Scientist,
non-affiliated
Non-Affiliated Scientist
Debra Gursha,
Alternate
MS
Fire Safety Officer
Non-Scientist
Zehra SchneiderGraham
MS
Deputy Director,
Environmental Health
and Safety
Non-Scientist
*
This information is mandatory.
Names of members, other than the chairperson and veterinarian, may be represented by a
number or symbol in this submission to OLAW. Sufficient information to determine that all
appointees are appropriately qualified must be provided and the identity of each member must
be readily ascertainable by the institution and available to authorized OLAW or other PHS
representatives upon request.
**
List specific position titles for all members, including nonaffiliated (e.g., banker, teacher,
volunteer fireman; not “community member” or “retired”).
***
****
PHS Policy Membership Requirements:
Veterinarian
Veterinarian with training or experience in laboratory animal science and
medicine or in the use of the species at the institution, who has direct or
delegated program authority and responsibility for activities involving
animals at the institution.
Scientist
Practicing scientist experienced in research involving animals.
Nonscientist
Member whose primary concerns are in a nonscientific area (e.g., ethicist,
lawyer, member of the clergy).
Nonaffiliated
Individual who is not affiliated with the institution in any way other than as
a member of the IACUC, and is not a member of the immediate family of a
person who is affiliated with the institution. This member is expected to
represent general community interests in the proper care and use of
animals and should not be a laboratory animal user. A consulting
veterinarian may not be considered nonaffiliated.
[Note: all members must be appointed by the CEO (or individual with specific written
delegation to appoint members) and must be voting members. Non-voting members and
alternate members must be so identified.]
Domestic Assurance
12/10/2012
20
IX.
Other Key Contacts (optional)
If there are other individuals within the Institution who may be contacted regarding this Assurance,
please provide information below.
Contact #1
Name:
Shemetra Owens, BS
Title:
Research Compliance Manager
Phone:
617-287-5478
E-mail:
Shemetra.Owens@umb.edu
E-mail:
Kristen.Kenny@umb.edu
Contact #2
Name:
Title:
Phone:
Kristen Kenny
IACUC Administrator and Coordinator
617-287-5374
Domestic Assurance
12/10/2012
21
X.
Facility and Species Inventory
Date: October 1, 2012
Name of Institution:
University of Massachusetts, Boston
Assurance Number:
A3383-01
Laboratory, Unit, or
Building*
Science, Animal
Facility
Gross Square
Feet [include
service areas]
2334
Species Housed [use
common names, e.g.,
mouse, rat, rhesus, baboon,
zebrafish, African clawed
frog]
Rat
Mice
Science, Green House
100
Approximate
Average Daily
Inventory
384
518
Lizards
68
Turtles
21
Institutions may identify animal areas (buildings/rooms) by a number or symbol in this
submission to OLAW. However, the name and location must be provided to OLAW upon request.
*
Domestic Assurance
12/10/2012
22