PROTOCOL APPLICATION FORM INSTRUCTIONS
I.
General IACUC Information
The IACUC is the Institutional Animal Care and Use Committee. The Public Health
Service Policy on Humane Care and Use of Laboratory Animals, the Animal Welfare Act
(and amendments) and the Animal Welfare Regulations require every research institution
in the United States to establish an IACUC. The IACUC, in part, is charged with the
responsibility for reviewing and approving research and teaching protocols involving
animals. No activity involving animals for teaching or research can begin without
prior approval by the IACUC. This includes protocol driven animal activities as well as
non-protocol driven animal activities.
It is the policy of the Lincoln Memorial University IACUC that use of any vertebrate animal,
regardless of coverage by federal regulations, that are used in teaching courses or
research project must receive IACUC review and approval. Further clarification on
activities requiring IACUC approval can be found in the IACUC Policy: Guidelines on
Conduct of Activities Requiring Protocols.
The IACUC, by Federal law, includes a combination of veterinarians, scientists,
nonscientists and nonaffiliated members. The nonaffiliated member is chosen to reflect
community interest in animal research.
II.
Procedure for Submitting a Protocol Review Form to the IACUC
A.
Obtain a current electronic version of the protocol review form from the IACUC
coordinator or the IACUC website.
Two versions are available, one designed for use of animals in Teaching courses, the
other for use of animals in Research Projects. Complete the form accurately and with
as much detail as possible. All members of the committee do not have extensive
scientific backgrounds. Attach any reference material that may help the IACUC review
the form.
B.
Submit the signed protocol review form (electronic or hard copy signatures are
acceptable) to the IACUC coordinator (IACUC@LMUnet.edu) who will enter into the
IACUC records and forward it to the attending veterinarian.
C.
The attending veterinarian reviews the form to assure regulatory compliance, screens
animal-related activities for appropriateness and verifies that the animal care
personnel are trained to perform the proposed procedures.
D.
The attending veterinarian signs the review form and returns it (within 48 hours) to
the IACUC coordinator who distributes copies to all of the IACUC members.
All members have the option to call for a full committee review (FCR) at any
point during the review process. If no member calls for a FCR, the protocol will be
reviewed at the next convened IACUC meeting or one member may be named the
designated member reviewer (DMR) by the chairperson.
Rev. 4/2016
PROTOCOL APPLICATION FORM INSTRUCTIONS
All protocols will have reviews completed within 30 calendar days from the date
of receipt. During the review process the Principal Investigator or his/her designee
must be available to answer questions.
If approval is needed in a shorter period than described above, the IACUC coordinator
should be notified immediately.
E.
Following the review by DMR, the reviewer returns it to the IACUC coordinator.
Responses by the DMR may be
1. Approve
2. Request modifications in the protocol (to secure approval)
3. Request full committee review (FCR)
F.
If a protocol receives FCR, the committee returns it to the IACUC coordinator
following the convened meeting.
Responses by the FCR may be
1. Approve
2. Require modifications in the protocol (to secure approval)
3. Withhold Approval
G.
If Approval has been granted, the coordinator forwards the review form to the IACUC
chairperson for their signature.
Obtain Protocol No. From IACUC
Coordinator
Complete Protocol & Review Form
IACUC Coordinator
Attending Veterinarian Review
IACUC Coordinator
IACUC Committee
(Review method chosen: DMR or FCR)
IACUC Coordinator
IACUC Chair Signature
IACUC Coordinator
Copies to Principal Investigator
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PROTOCOL APPLICATION FORM INSTRUCTIONS
H.
Once signed, a copy of the review form is returned to the originator. The original is
filed in the IACUC files for a minimum of 3 years.
I.
Amendments
Any change in a protocol that affects the animals must be approved by the IACUC.
Significant changes to an IACUC-approved protocol should be reviewed and approved by
the IACUC before they occur. Any questions on the significance of a change may be
directed to the IACUC Chair or any IACUC member. The following are considered by the
IACUC to be significant changes:
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Changes in the objectives of the study
Proposals to change from non-survival to survival surgery
Changes in the degree of invasiveness of a procedure and/or potential discomfort to
an animal, especially if it changes the Pain/Distress Category to increased severity
Change in the species or approximate number (>10% excluding approved
replacements) of animals used
Change in the Study Director
Change in anesthetic agent(s) or in the use of or withholding of analgesics
Change in method of euthanasia
Change in the duration, frequency, or number of procedures performed on an animal
Protocol changes may be handled by submitting the Protocol Amendment Form to the
IACUC coordinator. The coordinator will forward to the IACUC chair. The chair will
determine if the requested changes are minor, [if yes he will sign and return to
coordinator], or major, [if yes he will request distribution to the committee with
approval to be issued by FCR or DMR].
J.
The IACUC must approve the use of animals for blood or tissue collection that is not
part of a specific approved research protocol.
K.
Summary of requirements and timetable:
Animal Care and Use Proposal Initial Review and Approval
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A completed IACUC Protocol Form must be submitted prior to conducting any
animal related procedures indicated in the protocol.
Protocols should be approved prior to animal arrival on campus, however, animals
may be received prior to approval but no activities other than husbandry may be
conducted with them.
No animal activities involving teaching or research may occur without IACUC
approval.
A copy of each approved protocol is returned to the originator.
Animal Care and Use Amendment Review and Approval
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Rev. 4/2016
Amendments must be reviewed and approved by the IACUC if they contain
animal-related changes.
No new proposed animal activities may occur without IACUC approval.
A copy of each approved amendment is returned to the originator.
PROTOCOL APPLICATION FORM INSTRUCTIONS
III.
Instructions for Completing the IACUC Protocol Review Form
A.
B.
C.
Title Page
1.
If you have questions concerning the proper way to complete the review form, feel
free to contact an IACUC member.
2.
Obtain a protocol number, to identify the project, from the IACUC Coordinator prior to
submission.
3.
Complete the form accurately and completely. Do not leave blanks in the form unless
a question does not apply to your protocol. If key questions are not completed, the
form will be returned, resulting in a delay of the review.
4.
Provide the dates that the protocol is to cover. Any protocols exceeding 1 year (12
months) in length must have annual Review and Approval filed with the IACUC prior to
the 1 and 2 year anniversaries based on original date of approval (not based on dates
of subsequent amendments).
5.
For Teaching Protocols, provide the course number(s) to be supported by the
protocol. For Research Protocols, provide the funding source and grant numbers. if
applicable.
6.
Provide the anticipated date of first animal-based activities for the protocol. The
expected date of first animal activities cannot precede the requested dates of protocol
coverage.
Section 1):
1.
List all species to be used within the protocol, numbers of animals to include any
extras (you may indicate maximum numbers of animals to be used if exact numbers
cannot be predicted), age or size/weight, and sex.
2.
Provide the source of the animals including clarification of numbers from each source
if more than one source is to be used (e.g. shelter animals and client-owned pets).
Section 2):
1.
D.
Section 3):
1.
E.
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You must provide justification for the numbers of animals requested. The basis for the
numbers must be clearly described and may include text description or mathematical
calculations.
Indicate the physical facility and type of social housing that will be used for the
protocol.
Section 4):
1.
Indicate the expected category of Pain or Distress that the animals in this protocol will
be experiencing. If uncertain, please consult the attending veterinarian or the IACUC
Policy on USDA Categorization for guidance.
2.
If Pain or Distress (Category D or E) is anticipated, indicate if the source will be
PROTOCOL APPLICATION FORM INSTRUCTIONS
surgical or non-surgical.
F.
Section 5):
1.
G.
Section 6):
1.
H.
L.
Use of prolonged restraint, as defined by IACUC Policy on the Restraint of Animals,
must be described and justified including the reasons for use and any acclimation to
be conducted to minimize Pain or Distress associated with the restraint.
Section 11):
1.
Euthanasia of animals on the protocol must be conducted in accordance the the
guidelines of the AVMA Guidelines for the Euthanasia of Animals: 2013 Edition.
2.
Use of procedures not within this guidance must be clearly described and approved by
the IACUC.
Section 12):
1.
Rev. 4/2016
Per the regulations of the Animal Welfare Act and other guidance, the principal
investigator must provide review of the literature or other sources to determine if there
are means to Refine, Reduce, or Replace the use of animals. If there are no
alternatives, this must be clearly described in this section and supported by a literature
review. Consult the attending veterinarian if further guidance is needed.
Section 10):
1.
K.
Protocol methods will be entered into the form in Appendix A. The methods that will
involve animal use must provide clear information as to the procedures and
techniques to be used. Any SOPs supporting animal care or use can be cited. If
there are elements of animal care or use that are not covered by an SOP, then those
should be clearly described in the methods. In vitro methods, or sample processing
methods after collection from animals do not need to be provided in detail unless a
Sponsor is requesting that information to be included.
Section 8 and 9):
1.
J.
The use of any vertebrate animals in a research or teaching protocol results in
potential risk to the animal’s health or well-being. This section must provide an
evaluation of the benefits of the information or outcome of the study relative to the
risks to the animals (risk/benefit analysis) and provide clear justification for IACUC
approval of the protocol activities.
Section 7):
1.
I.
The Lay Description is a critical part of the application as this will provide an overall
description of the goals of the protocol in terms that a non-scientist will be able to
understand and evaluate. This is to be a summary of the intended project and should
not use unnecessary scientific jargon or acronyms.
List all personnel to be associated with the protocol whether they will have direct
animal contact or not. The PI must ensure all training is complete prior to the first date
of animal use.
PROTOCOL APPLICATION FORM INSTRUCTIONS
M.
Appendix A
Provide a complete description of the proposed teaching or research activities in this
section. If complete description of activities in this section can be used to fulfill
subsequent Appendices (e.g. surgical description, selected drugs, etc) then those
Appendices can refer back to the methods description
N.
Appendix B
Provide complete description of proposed surgical activities including pre-operative,
operative, and post-operative plans. Provide description of proposed responses to
unexpected but possible negative events.
O.
Appendix C
Provide complete description of any pain and distress anticipated for the protocol and
the proposed plan to alleviate pain and distress by pharmacological or nonpharmacological methods. Include any criteria to be monitored for indications of pain
and distress. Contact the attending veterinarian for consultation to ensure the plan is
complete and appropriate prior to submitting the protocol.
P.
Appendix D
This section provides the option to select proposed analgesic, sedative, and
anesthetic agents based on drugs available at LMU. Provide the primary selections to
be used on the protocol. Be sure to verify these are available prior to submission.
In the case of an unexpected unavailability of a selected drug or in an emergency, the
other drugs on this list can be used.
However, any change in an analgesic, sedative, or anesthetic plan is considered a
major protocol change and will require a subsequent amendment to be filed for IACUC
approval.
The amendment for an UNPLANNED change in drugs must be filed within 24 hrs
of the use of the alternative drug(s), and no further use of the alternate drug
selection may occur until IACUC approval is received.
Any PLANNED change to the drug(s) to be used on a protocol must have an
IACUC approved amendment prior to the use of any new drugs.
Use of any drug(s) not on the approved list must receive IACUC approval prior
to use.
Q.
Appendix E
Provide complete description of any bodily fluid(s) to be collected on the protocol. Be
sure to include site(s) of collection, volume(s), and frequency of collection. Describe
the proposed limitations to total volume(s) collected per time period, total number of
collections per site per time period, and proposed resting interval once limitations have
been met.
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PROTOCOL APPLICATION FORM INSTRUCTIONS
R.
Appendix F
Provide a complete description of the material(s) to be administered to animals as part
of a research protocol (other than drugs for analgesia, sedation, or anesthesia). Any
compounds that are biohazards, radioactive, or known toxins should be reviewed by
the Institutional Biosafety Committee.
S.
Appendix G
Provide a complete description of any modified housing, feeding activity, or fluid intake
used for animals as part of a research protocol including those modifications to
promote behavioral influences as part of the study.
IV.
Current IACUC Contacts
IACUC Email:
IACUC@lmunet.edu
(e-mail recipients include coordinator, chair, and attending
veterinarian)
Rev. 4/2016
IACUC Coordinator:
Teresa Creech
IACUC Coordinator
304 Duke Hall
IACUC@lmunet.edu
Attending Veterinarian:
Michael Stonerook, PhD DVM DABT
114 MANS
Michael.Stonerook@lmunet.edu
Mobile: 614.354.2939 (primary contact number)
Office: 423.869.6523.