PREFACE
Institutional Authority and Role of the University of Central Oklahoma
Animal Care and Use Committee (IACUC)
The UCO Institutional Animal Care and Use Committee (IACUC) was established in
2012 under the authority of the Provost to be administered under the auspices of the
Office of Research Compliance (ORC), which is a freestanding division of Academic
Affairs. The Provost has granted to the UCO IACUC the authority and responsibility
to implement, monitor, and regulate a program that encompasses research activities
involving the use of vertebrate animals. The purpose of the IACUC is to ensure
compliance with federal regulations regarding the care and use of vertebrate animals
in research as established by the Health Research Extension Act of 1985 (HREA; Public
Law 99-158), implemented through the Public Health Service Policy on Humane Care
and Use of Laboratory Animals (PHS Policy), and administered under the auspices of
the Office of Laboratory Animal Welfare (OLAW). These policies and regulations are
summarized in the Guide for the Care and Use of Laboratory Animals, 8th Ed.
The Provost has empowered the IACUC with the authority to review all proposals
involving the use of vertebrate animals in research activities conducted at or
sponsored by UCO involving UCO faculty, staff, and students to ensure the
responsible use and humane treatment of the study animals. The IACUC further has
the authority to investigate and report to the Provost incidents of noncompliance with
UCO policies, and state and/or federal law, to suspend or terminate approval of
research activities found to be in noncompliance, and to impose appropriate sanctions.
Although the IACUC operates as a part of the UCO Office of Research Compliance,
and has relationships with other entities within the University, no administrative
official or other individual may intervene in the activities or determinations of the
IACUC.
The following abbreviations will be used throughout this policy manual:
University- the University of Central Oklahoma
IACUC-Institutional Animal Care and Use Committee
Chair-the chair of the UCO IACUC
PI/Co-PI-Principal Investigator/Co-Principal Investigator
ORC-the UCO Office of Research Compliance
Staff-the staff of the UCO Office of Research Compliance
SOP-Standard Operating Procedure
Application-an application submitted to the IACUC for review
OLAW-Office of Laboratory Animal Welfare
AWAR-Animal Welfare Act Regulations
PHS-Public Health Service
AV-Attending Veterinarian
COI-Conflict of Interest
ESA-Endangered Species Act
CITES- Convention on International Trade in Endangered Species
INDEX
OR 100: IACUC Organization
101 Composition of the IACUC
102 Management of the IACUC
GA 200: General Administration (IACUC Responsibilities and Authority)
201 Training
202 Maintenance of SOPs
203 Personnel Management
204 Activities that Require IACUC Review
205 Conflicts of Interest
IO 300: IACUC Operations
301 IACUC Meetings and Communication
302 Submission Requirements
303 Determination and Documentation of Types of Review
304 Guidelines on Pain Categories
RR 400: IACUC Review of Research
401 Initial Review
402 Continuing Review
403 Amendments to Approved Research
404 Unanticipated Problems or Noncompliance
405 Closure of Research
406 Communication between IACUC and Investigators
SC 500: Special Considerations
501 Research at External or Multiple Sites
502 Research at International Sites
503 Research Involving Endangered Species
RI 600: Responsibilities of Investigators
601 Initial Submission of Research Proposal
602 Amendments or Changes
603 Continuing Review
604 Closure of Research
QA 700: Quality Assurance
701 Procedures for Measuring Performance Consistency
SOP 101
Composition of the IACUC
1.0
POLICY
The membership of the UCO IACUC is to be composed such that its members
have the knowledge, expertise and training to review and approve all proposals
submitted. Per Public Health Service Policy, the IACUC shall consist of not less
than five (5) members, and must include at least one practicing scientist, one
Doctor of Veterinary Medicine who must be licensed by the State of Oklahoma
to serve as Attending Veterinarian (AV), one nonscientist, one community
member who is not in any way affiliated with UCO nor is a member of the
immediate family of any person affiliated with UCO, and a Chair of the IACUC.
The Associate Vice President for Academic Affairs and the Director of the Office
of Research and Grants shall serve as ex officio members, with nonvoting status,
in order to provide and ensure administrative support.
The Chair is to be selected and appointed by the Provost for an indefinite term.
The Chair serves at the pleasure of the Provost and can be suspended or
removed by the Provost for violations of UCO policy, local, state, or federal
regulations, or failure to competently discharge the duties of Chair of the
IACUC.
Members of the IACUC shall be appointed by the Provost, on the
recommendation of the Chair, and shall serve for a term of three (3) years with
the possibility of renewal. Efforts shall be made to choose members who can
broadly represent the colleges within the university, while providing the
necessary expertise to exercise the mandate of the IACUC. When necessary or
desirable, the Chair may appoint one or more persons to serve in an ad hoc
capacity whose particular expertise can supplement that of the existing
members and can provide additional insight relevant to IACUC issues or
specific proposals. Such persons shall not have the right to vote with IACUC
membership. The Chair may also invite visitors to attend IACUC meetings to
witness or to discuss with the members the general business of the IACUC. Such
persons, though, may not be present for deliberations on specific IACUC
proposals or issues regarding investigators, nor vote on any matter before the
Committee.
All persons present for a meeting of the IACUC, including any visitors or
outside experts, are bound to keep confidential all matters raised before the
Committee and the outcome of any discussions, deliberations, or votes, which
were undertaken.
2.0
RESPONSIBILITIES
2.1 The Chair is responsible for ensuring that the composition of the IACUC
meets all regulatory requirements.
2.2 The Chair shall solicit the names of interested, qualified individuals for
openings on the IACUC, as necessary.
2.3 The Chair shall recommend to the Provost the names of individuals who are
deemed qualified to serve on the IACUC, as openings become available.
2.4 The Chair or staff of the ORC shall notify all members of the IACUC in
advance of a scheduled meeting of any visitor and the reason for their
presence, and provide assurances of the confidentiality of the proceedings
of the IACUC.
2.5 Any member of the IACUC who intends to step down from membership
must notify the Chair in writing a minimum of thirty (30) days prior to the
date of their intended resignation.
3.0
PROCEDURES
3.1 Upon the authorization of the Provost, the Chair shall notify each member
of his or her appointment to the IACUC.
3.2 The Chair shall report the composition of the IACUC to relevant federal
authorities as required.
3.3 Prior to the beginning of the academic year in which a member’s term is to
end, the Chair shall notify each member of the impending end of their term
of service and shall at that time seek to determine their desire to continue.
3.4 The Chair shall report to the Provost any violation of UCO policy or breach
of professional ethics that might compromise the integrity of the IACUC
process as soon as such violations can be determined.
3.5 The Chair shall investigate any violations by IACUC members. After the
investigation is completed, a report shall be made to the Provost, along with
any recommended action. At the direction of the Provost, the Chair shall
notify the member involved of the results of the investigation and any
remedies to be taken, including suspension or removal.
4.0
REFERENCES
PHS Policy IV.A.3.a-b
9 CFR 2.31(a)-(b)
OLAW
SOP 102
Management of the IACUC
1.0
POLICY
The UCO IACUC is a university standing committee that is tasked with the
responsibility to review, approve, and monitor vertebrate animal research for
the purpose of ensuring best practices for the conduct of animal research, the
humane treatment and disposal of animal subjects, and compliance with local,
state, and federal regulations. The IACUC operates in alignment with FDA,
PHS, and OLAW and is under the authority of the UCO Provost. The daily
operation of the IACUC is managed by the Director of the UCO Office of
Research Compliance and the Chair of the IACUC.
2.0
RESPONSIBILITIES
2.1 The Chair shall inform all members of the IACUC, including ex officio, of all
activities of substance pertaining to the operation of the IACUC on a timely
basis.
2.2 At the discretion of the Chair, a member of the Committee who has
expertise in a relevant field may be selected to serve as Primary Reviewer
for one or more applications to be presented before the Committee.
2.3 Each member of the Committee will agree to serve as assistant to the Chair
for at least two (2) semesters during his or her three-year term.
2.4 The Chair shall appoint from among the voting membership a member to
serve as Interim Chair if the Chair will be away from the University for
more than (5) consecutive working days.
2.5 The Interim Chair shall perform all of the IACUC-related duties of the
Chair, and will act with the authority of the Chair under the supervision of
the Provost, until such time as the Chair has returned to the University.
2.6 Each member of the IACUC will sign a Confidentiality Agreement as a
condition of service.
3.0
PROCEDURES
3.1 ORC staff will prepare an agenda for every regularly scheduled IACUC
meeting. This is to include all submissions under any type of review that
require action by the Committee, as well as a report of IACUC review and
approval activity occurring since the pervious meeting.
3.2 The designated assistant to the Chair will review all submissions that
require review and will make recommendations.
3.3 Upon review and disposition of a submission, the Chair will send a letter to
the investigator(s) detailing the recommendations of the IACUC. Copies of
all correspondence relating to a particular submission will be archived with
that submission and kept on file in the ORC office.
4.0
REFERENCES
5.0
APPENDIX
Confidentiality Agreement
IACUC SOPs
SOP 201
Training
1.0
POLICY
All members of the IACUC are required to undergo training in vertebrate
animal research consistent with UCO policy and local, state and federal
guidelines and regulations, in particular the Animal Welfare Act (AWA) 1996
and amended in 2008, and the USDA Pain and Distress Categories. Training will
be managed by the ORC and directed by the Chair. New members will not be
allowed to review or vote on research proposals until they have completed
training.
2.0
RESPONSIBILITIES
2.1 The Chair shall provide training for all new IACUC members.
2.2 The Chair shall provide continuing education for all IACUC members and
shall communicate to the committee any changes in UCO policy or local,
state and federal regulations.
2.3 The Chair shall provide annual training opportunities for the University
community.
2.4 The Chair will obtain external certification in IACUC operations and
management.
3.0
PROCEDURES
3.1 All members of the Committee shall be provided with initial and continuing
training in UCO policies and IACUC procedures.
3.1.1 Introductory training will provided to all new members as they join
the Committee.
3.1.2 At least annually the Chair will provide continuing educational
updates to the Committee.
3.1.3 As specific issues arise, the Chair will provide information from
current regulations and policies, as relevant.
3.1.4 Each member of the Committee shall be provided with a copy of the
Guide for the Care and Use of Laboratory Animals.
3.1.5 Copies federal regulations and materials relating to IACUC activities
will be available in the ORC office, and all members shall have access
to these materials.
3.2 Training in IACUC policies and procedures will be available to the
University community.
3.2.1 Campus-wide training will be scheduled annually for the University
community.
3.2.2 The Chair will be available to provide more specialized training to
individual colleges and departments.
4.0
REFERENCES
5.0
APPENDIX
ORC website
OLAW
SOP 202
Maintenance of SOPs
1.0
POLICY
All IACUC operations and actions shall proceed according to approved policies
that define and regulate all aspects of IACUC operations at UCO. These policies
must clearly describe the composition and scope of the IACUC, requirements
for membership, training, types of research, procedures for conducting review,
and the professional and ethical responsibilities of investigators and those
assisting in research.
Developing and maintaining current SOPs shall be the responsibility of the
Director of the ORC and the Chair of the IACUC, supported by ORC staff, and
such other persons with particular expertise who may be consulted, in order to
ensure that IACUC policies are in compliance with University policies and with
local, state and federal regulations.
2.0
RESPONSIBILITES
2.1
2.2
2.3
2.4
3.0
The Chair and ORC staff will conduct annual review of SOPs.
The Chair shall develop new SOPs as necessary in order to remain current
and in compliance.
All new policies or changes to existing policy must be approved by the
IACUC prior to implementation.
The Director of the ORC shall provide the most current approved iteration
of the IACUC SOPs to the Provost and shall ensure that they are available
to the University community.
PROCEDURES
3.1
3.2
3.3
The Chair will conduct an annual review of SOPs to ensure alignment with
University policies and procedures, and with local, state and federal
regulations.
The Chair will review and update individual policies as necessary.
3.2.1 Proposed revisions will be placed on the agenda for the next
scheduled meeting of the IACUC.
3.2.2 Copies of new or revised SOPs will be sent to all members at least
five (5) days prior to the next scheduled meeting.
All new or revised SOPs must be approved by the IACUC before
implementation.
3.4
3.5
A current version of the SOPs will be available on the ORC website and in
the ORC office.
A current version of the SOPs will be provided to the Provost, and the
Provost will be notified of any changes or addition to the SOPs.
4.0
REFERENCES
5.0
APPENDIX
ORC website
IACUC SOP manual
SOP 203
Personnel Management
1.0
POLICY
The University is required to provide the Office of Research Compliance with
sufficient resources to maintain a functioning IACUC and enable the carrying
out of its responsibilities. The Director of the ORC will be responsible for hiring
and supervising administrative personnel necessary for the regular functioning
of the IACUC.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
3.0
The Director of the ORC shall hire an administrative assistant to assist with
the daily operations of the IACUC.
The Director shall provide proper training and supervision to the ORC
administrative staff consistent with the responsibilities of maintaining an
IACUC.
The administrative assistant shall be responsible for the receiving,
documenting and processing of all materials related to IACUC operations
and review, and for communications and correspondence to relevant
parties.
PROCEDURES
3.1
3.2
3.3
The Director shall follow all University regulations and policies regarding
the employment, supervision and evaluation of ORC staff.
The Director will provide training and supervision of ORC staff.
The administrative assistant will be responsible for intake, data entry and
management of records relating to the IACUC.
4.0
REFERENCES
5.0
APPENDIX
UCO Human Resources
IACUC SOP manual
SOP 204
Activities Requiring IACUC Review
1.0
POLICY
The utilization of animals in teaching and research is valuable and worthwhile
to the educational mission of the University. The UCO IACUC was established
by the Provost of the University and has the responsibility and authority to
oversee and evaluate the University’s program of vertebrate animal research.
This includes the review of proposals to engage in research on vertebrate
animals by UCO faculty, staff, and students, inspection of off-campus facilities,
and monitoring of animal research activities. The purpose of review is to ensure
that all policies and regulations are followed, that best practices are maintained,
that the animals subjects are treated humanely.
The proposed use of vertebrate animals for teaching or research undertaken by
UCO faculty, staff or students, whether on campus or at an off-campus site,
must be approved the IACUC prior to initiation of the proposed activity.
Research that is subject to IACUC review may be defined as “any systematic
investigation designed to develop or contribute to generalizable knowledge.” It is the
responsibility of potential investigators to determine if their research falls under
the purview of the IACUC.
The Animal Welfare Act (AWA) defines an “animal” as being any live or dead
dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warmblooded vertebrate animal to be used for research, testing, experimentation or
exhibition, or kept as a pet. Exemptions in the AWA regulations extend to birds,
rats of the genus Rattus and mice of the genus Mus bred specifically for research
purposes, horses not used for research, and any other farm animals, including
livestock and poultry, which are used or intended for use as food or feed (AWA
7.54.2132(g)). In order to encourage best practices for teaching and research, the
UCO IACUC has extended review to include all vertebrates, including all birds,
rodents, reptiles and amphibians. This is consistent with PHS Policy III.A.
2.0
RESPONSIBILITIES
2.1 The IACUC has been given the institutional authority to establish and
implement a review process for all research activities involving vertebrate
animals, in accordance with federal guidelines for such research.
2.2 The Provost will provide resources sufficient to fulfill this function.
2.3 The IACUC shall review all submissions to determine which are exempt
and which will require IACUC approval.
2.4 If an outside expert is involved in review, the Chair will clarify for the
Committee the scope and limits of the outside expert’s role.
3.0
PROCEDURES
3.1
3.2
3.3
3.4
4.0
The Provost will provide assurance to federal agencies of the intention of
the university to establish an IACUC in accordance with federal guidelines.
The Provost shall communicate to the University community the necessity
for IACUC review and oversight.
The ORC will publish on the IACUC link on the ORC website a current
version of IACUC policies and Standard Operating Procedures in order to
assist investigators with the process of submitting a proposal for IACUC
review.
The Chair will provide information to the University community regarding
the process of IACUC.
REFERENCES
AWA 7.54.2132(g)
PHS Policy III,A
5.0
APPENDIX
SOP 501
OLAW
SOP 205
Conflicts of Interest
1.0
POLICY
A conflict of interest (COI) may occur when an investigator, research assistant,
or IACUC member may have a financial, fiduciary, or other interest that has the
possibility of yielding a tangible professional and/or personal benefit having the
potential to exert an improper influence on that individual’s professional
judgment, introducing an unethical bias into the performance of their particular
roles as reviewers or investigator(s).
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
2.5
3.0
It is the responsibility of IACUC members to report any real or potential
conflicts of interest as soon as such conflicts may become known.
IACUC members serving as assistants to the Chair must report any real or
potential conflicts of interest regarding any proposal they have been asked
to review.
Any invited guest or outside expert has the responsibility to report to the
Chair any real or potential conflicts of interest regarding their presence
before the IACUC or any matter about which they have been invited to
discuss.
The Chair will not act on any business brought before the IACUC where
there exists a real or potential conflict of interest.
It is the responsibility of investigators to report to the Chair any real or
potential conflicts of interest related to their proposal.
PROCEDURES
3.1
IACUC members shall not be present for deliberation on any matter
brought before the IACUC about which they have a conflict of interest. If a
matter is raised during a meeting of the IACUC about which a member
has a conflict of interest they are to declare this fact immediately and
recuse themselves from any further participation on that matter. For
example:
1) Presentation of an application on which the member is named as an
investigator or research team member
2) Discussion of an application from a student to whom the member
may be related, serves as a mentor, chair, or thesis committee member
3)
3.2
3.3
3.4
4.0
Discussion and voting on violations or non-compliance involving
colleagues with whom the IACUC member has a relationship that
would make it difficult to provide objective judgment
The Chair will not review or participate in any discussion of a proposal,
nor vote or make any decision on the disposition of a proposal on which
they are named as an investigator, or on any matter where the Chair has
revealed a conflict of interest
3.2.1 In such cases the assistant to the Chair will act as reviewer of the
proposal, and the Chair must be absent from such deliberations
unless invited to participate by the Acting Chair.
3.2.2 The assistant to the Chair will serve as Acting Chair for purpose
deliberation and disposition of a proposal on which the Chair is
named as an investigator, or on any matter where the Chair has
revealed a conflict of interest.
The assistant to the Chair must notify the Chair of any conflict of interest
the assistant may have regarding a proposal under review or on any
matter brought before the Committee, and recuse themselves from
participation on the IACUC during the disposition of that issue.
Investigators are responsible for declaring any real or potential conflicts of
interest at the time of the submission of the application. If the investigator
fails to do this, and a conflict is subsequently revealed, the investigator
shall be regarded as being in violation of IACUC policy, and their research
suspended pending an investigation.
REFERENCES
AWAR 2.31,d,2
PHS Policy IV,C,2
5.0
APPENDIX
SOP 301
IACUC Meetings and Communication
1.0
POLICY
The IACUC has the authority to review research activities at UCO involving the
use of vertebrate animals conducted by UCO faculty, staff or students, whether
on UCO’s campus or on off-campus sites. On the basis of that review, the
IACUC may approve, approve with modifications, require modifications prior
to approval, defer, or disapprove a submitted proposal.
The IACUC will convene at regularly scheduled times during the academic
semesters and, if necessary, during the summer. The convened IACUC will
review all submissions requiring full board consideration, any amendments or
continuing review requests, and any other business brought before it requiring
full board consideration.
IACUC members will be provided with all relevant materials prior to each
meeting which are necessary to conduct informed discussions and votes.
IACUC deliberations will be recorded and distributed prior to the next
scheduled meeting to members for review and correction, if necessary. All
minutes of IACUC meetings will be confidential.
The IACUC and the university are jointly responsible for maintaining effective
communication. It is necessary that the IACUC, the ORC staff, and investigators
have the means to communicate and solicit information that is necessary to the
activities of the IACUC, and the University accepts the responsibility to provide
adequate resources and technologies for the review of research activities. It is
necessary that the ORC and IACUC members have access to the Provost and
other such persons designated by the Provost to support the IACUC. Any
reports of violations of University policy or instances of noncompliance with
federal regulations will be immediately communicated to the Provost. [See SOP
404]
2.0
RESPONSIBILITIES
2.1
2.2
2.3
The Chair is responsible for scheduling and setting meeting dates and
times, and for calling special meetings, if necessary.
The ORC staff will distribute to all IACUC members an agenda at least 48
hours prior to the next scheduled meeting.
The Chair will determine which submissions require a full board review
and the ORC staff will forward to the members all materials necessary for
consideration.
2.4
2.5
2.6
3.0
The Chair (or other designated reviewer) will provide a summary of each
proposal to be discussed at the meeting.
ORC staff will attend all meetings and record minutes of the meetings to
distribute to IACUC members.
Any corrections, additions, or emendations to the minutes of the previous
meeting will be discussed, and the minutes approved at the outset of the
next meeting.
PROCEDURES
3.1
3.2
3.3
3.4
3.5
3.6
3.7
A schedule of IACUC meeting dates and times will be determined prior to
the beginning of each academic semester, and the schedule distributed to
all members prior to the beginning of the semester.
The ORC staff will distribute to the members all documents and related
materials necessary for IACUC review no later than 48 hours prior to the
scheduled meeting.
The ORC staff will distribute an agenda no later than 48 hours prior to the
scheduled meeting.
A minimum of five (5) voting members, one of which must be a licensed
Doctor of Veterinary Medicine and one of which must be a community
member, are required for a quorum. If there is no quorum, no matter
concerning a submitted or approved IACUC proposal may be voted on.
Each submission to the IACUC will be reviewed by the Chair or by a
designated primary reviewer, and a summary of the proposal will be
presented to the committee for discussion and disposition.
Members shall discuss each proposal, and shall then vote in one of the
following ways:
1) Approve as presented with no modifications
2) Conditionally approve where some modifications are necessary
and the Chair is authorized to approve once modifications are
completed
3) Defer where more extensive modifications are necessary and the
modified proposal must then be reviewed by the full board at the
next meeting
4) Disapprove in cases where the application is not acceptable even
with modifications
For a vote to be valid, a quorum must be present and a majority opinion
from among voting members must be reached. A majority is defined as an
“Aye” or “No” vote by a simple majority of the voting members present.
3.8
3.9
4.0
A member may vote “Abstain”, which constitutes neither an “Aye” nor a
“No” vote. Such a vote will count against a majority, though not against a
quorum. Failure to obtain a simple majority shall automatically table a
proposal until the next meeting of the committee
The results of all votes will be recorded in the minutes. The Chair will
communicate the results of the vote and any further directions to the
relevant parties in writing within five (5) working days of the meeting.
REFERENCES
AWAR 1.1; 2.31,c,1-2
PHS Policy III,1, IV,B,1-3; IV,E,1,b
5.0
APPENDIX
SOP 302
IACUC Submission Requirements
1.0
POLICY
The IACUC has the authority to review research activities at UCO involving the
use of vertebrate animals conducted by UCO faculty, staff or students, whether
on UCO’s campus or on off-campus sites. The responsibilities and procedures
described below shall apply to all submissions to the IACUC, sponsored or
unsponsored.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
3.0
It is the responsibility of investigators to access and fill out the required
documents for submission to the IACUC. Further, investigators should be
aware that, once submitted, a proposal would need to be processed by the
ORC staff prior to distribution to the IACUC for review. It is, therefore,
important that submissions are as complete as possible and are submitted
in a timely manner.
The ORC staff and the Chair of the IACUC are available for any assistance
in completion of the necessary forms.
Electronic and hard copy versions of each proposal must be submitted to
the ORC office prior to IACUC consideration.
Upon receipt of a proposal the ORC will log in the submission, assign it an
IACUC submission number and open a file for that proposal.
PROCEDURES
3.1
All faculty, staff or students wishing to engage in animal research must
contact the Chair regarding their intention to do so by filling out the
IACUC application (available on the website of the Office of Research
Compliance under “IACUC”). An electronic copy must be filled out and
sent to iacuc@uco.edu, and a hard copy with all signatures and supporting
documentation (such as copies of collector permits) must be delivered to
the Office of Research Compliance (ADM 216). Instruction for completing
an IACUC application are available on the ORC website.
3.2
3.3
3.4
4.0
If an investigator believes their proposal to be eligible for “Exempt” status,
that form is available on the IACUC site, but final determination of
exempt research lies with the Chair. Investigators are encouraged to
contact the ORC or the IACUC Chair to assist in the determination of
exempt research.
The ORC staff will review the contents of the application to determine if
all signatures and supporting documentation are present. The application
will be assigned a number by which it will be thenceforth referred. A hard
copy will be placed on file and the electronic copy entered into the IACUC
database. All documents and materials relating to the application will be
archived under its IACUC submission number.
It is the responsibility of the researcher to ensure that all relevant
documents are submitted. No proposal will be reviewed until completed
hard copies and electronic copies are submitted to the ORC office.
REFERENCES
PHS Policy IV,A,1; IV,C,1,a-g; IV,C,2
AWAR 2.31,d,2
5.0
APPENDIX
SOP 303
Determination and Documentation of Types of Review
1.0
POLICY
Research proposals involving vertebrate animals must be submitted to the
IACUC for review. Ordinarily this review requires the IACUC Application and
will be reviewed by the full board, or can be given an expedited review by the
Chair. Some research proposals, however, may be considered exempt from the
necessity of full board consideration, and may instead be considered “Exempt
Category” research. Examples of “Exempt Category” research may include
passive observation of animals in their natural habitat, examination and analysis
of fluids, excreta, or tissues that were already procured from prior IACUCapproved studies, which were gathered without any manipulation of the
animals themselves, which were harvested from already-deceased animals, or
studies involving retrospective data analysis. Exempt research does not imply
that the proposal is not subject to IACUC review nor absolve the investigator(s)
from following best practices.
The “Request for Exempt Category Research” is a separate form found on the
ORC website under “IACUC”. There is also an IACUC Checklist to be filled out
and submitted with an exempt category application.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
2.5
Investigators should determine the appropriate type of research and then
complete the appropriate form.
The Chair will examine the submission and determine the category for
review.
If an investigator fills out the “Exempt Category” form but the Chair
determines that a full IACUC application is required, the Chair will
notify the investigator of this finding and explain the rationale for the
decision. The investigator may then resubmit the proposal using the
IACUC application.
If the proposal meets the criteria for exempt status, the Chair will notify
the investigator.
The ORC will notify investigators of impending anniversary dates and
instruct the investigator to complete the “Annual Renewal or Protocol
Modification” form. It is the responsibility of the investigator to complete
the form and indicate any personnel changes or other modifications to
the current study on the form.
2.6
3.0
According to PHS Policy, an IACUC-approved study may only be
renewed annually two times; after three years, investigators wishing to
continue a study must resubmit a full IACUC Application or Exempt
Category form, as appropriate.
PROCEDURES
3.1
3.2
3.3
3.4
3.5
The investigator will complete the appropriate application form.
The investigator will submit an electronic copy and a hard copy with
signatures and all supporting documentation to the ORC.
The Chair will review the submission and determine if the appropriate
type of application has been completed, and the ORC staff will determine
if the application is complete.
The ORC staff will notify investigators of impending anniversary dates.
If requested, the investigator may attend an IACUC meeting to explain
their proposal. The Chair may also request that an investigator attend an
IACUC meeting to provide clarification of the proposal. In neither case
will the investigator be present during deliberation or voting.
4.0
REFERENCES
5.0
APPENDIX
PHS Policy IV,A,1; IV,C,1,a-g; IV,C,2
AWAR 2.31,d,2
SOP 304
Guidelines on USDA Pain and Distress Categories
1.0
POLICY
UCO is committed to the humane and responsible treatment of animals used in
research. The IACUC is given the responsibility of insuring that research
animals are treated humanely, that pain and distress is minimized as much as
possible without compromising the integrity of the research, and that, where
necessary, humane endpoints are observed. It is recognized that the
manipulation of vertebrate animals that result in pain and/or distress can be an
important component of an investigation; the purpose of this policy is to
provide to investigators guidelines for determining the level, extent and
potential duration of any pain and/or distress study animals may experience.
Investigators must provide a rationale that sufficiently justifies that no lesser
category is sufficient to meet experimental objectives. If pain and/or distress are
unavoidable for experimental purposes the burden lies solely with the
investigator to justify its necessity, particularly if no analgesia is used.
The IACUC review will be guided not only by the USDA Guidelines, but also
the search for more humane alternatives, including the replacement of animals
with non-animal methods such as computer simulations, reduction of the
number of animals necessary to satisfy experimental goals, and the refinement
of experimental methods to minimize pain and distress.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
Investigators should refer to the UCO “Guidelines for Assigning Animals
into USDA Pain and Distress Categories”, available on the ORC website.
In crafting a proposal that may entail the manipulation of animals
resulting in pain and/or distress, it is the responsibility of investigators to
justify such procedures and to explain why no lesser procedure can be
considered to yield satisfactory experimental results.
Consultation with the IACUC attending veterinarian may be required.
Investigators must be able to justify the number of animals used, the
duration and intensity of pain and distress the animals will experience,
and humane endpoints.
3.0
PROCEDURES
3.1
3.2
3.3
3.4
3.0
Investigators will consult the UCO pain category policy, available on the
ORC website.
When completing the IACUC application, investigators will provide a
detailed description of all manipulations that have the potential to cause
pain and/or distress, and a justification for each.
Whenever possible, the use of analgesics or anesthetics is recommended if
it will not compromise experimental results.
When necessary, investigators will define humane endpoints and
methods of euthanasia.
REFERENCES
AWA regulations (9 CFR 2.C.2.36.b.5)
PHS Policy on Humane Care and Use of Animals
ILAR Guide to the Care and Use of Laboratory Animals
UCO Guidelines for Assigning Animals into USDA Pain and Distress Categories
SOP 401
Initial Review
1.0
POLICY
The IACUC will initially review all submissions to determine if they are in
compliance with UCO policies and with all local, state and federal regulations
regarding animal research, including conflicts of interest and pain categories,
and to determine if all required documentation has been included in the
submission.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
2.5
2.6
3.0
The Primary Investigator (PI) shall deliver to the ORC a signed copy of the
appropriate application prior to the initiation of any research activity
related to that application.
The ORC staff will process the application, assign a submission number,
and deliver it to the Chair (or a reviewer designated by the Chair) for
initial review.
The Chair will determine the type of review and whether the proposal
requires full board review.
The Chair may select additional reviewers, either IACUC members or
outside experts, to assist in review of an application.
The Chair will summarize the results of the review, and the ORC staff will
communicate the outcome of the review to the investigator(s), including a
list of any modifications deemed necessary.
It is the responsibility of the investigator(s) to complete such modifications
as may be required and to resubmit the modified application to the ORC
office.
PROCEDURES
3.1
3.2
3.3
The PI will complete and submit one electronic copy to iacuc@uco.edu and
one signed hard copy to the ORC office (ADM 216).
The ORC staff will log the submitted application into the ORC database
by assigning to it a sequential submission number, and distributing copies
to the Chair and any other designated reviewer.
The Chair will make a determination regarding the type of review that the
application requires.
3.4
3.5
3.6
3.7
4.0
The Chair will verify that the submission is complete, including required
signatures, current copies of collector permits, and permissions to collect
on public or private property.
Reviewers will review the submission and submit comments, including
modifications, to the Chair.
Through the ORC staff, the Chair will communicate by email the outcome
of the review, along with any modifications necessary.
If the proposal requires full board review, the PI and any Co-PIs will be
notified and are invited to attend the IACUC meeting when the proposal
is being discussed.
REFERENCES
AWAR 2.31,d-e
PHS Policy IV,C,1,a-g; IV,D,1,a-e
SOP 402
Continuing Review
1.0
POLICY
IACUC proposals will be approved for three years from the date of approval.
According to PHS Policy, a research study may only be approved for a
maximum of three years from the date of initial approval, and must be renewed
on an annual basis. If an investigator wishes to continue the study, a new
IACUC Application will be required, even if there are no changes to the original
study. After the initial three-year approval, if the investigator wishes to continue
the study, s/he must complete the “Annual Renewal or Protocol Modification
Form,” found on the IACUC link on the ORC website, and must submit this
form, along with any relevant supporting documentation, to the ORC office.
If the anniversary of the approval date passes without a request to renew the
study, all research activities must cease until a renewal is granted. The ORC
office will notify researchers well in advance of the anniversary date that
approval is set to expire, along with an inquiry as to the researchers’ intentions
regarding renewal, but it is the responsibility of the researcher(s) to complete the
appropriate form in a timely manner.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
2.5
The ORC office will send inquiries on an annual basis to determine if the
study is still active and if there have been any changes over the past year
to the study design or personnel.
At 60 days and 30 days prior to the expiration of the study the ORC office
will send a notice of the impeding expiration of the study, indicating that
if the investigator wishes to renew the study, an “Annual Renewal or
Protocol Modification” must be completed and submitted to the ORC
before the expiration date.
A study may only be renewed for one year; however, annual renewals
may be granted indefinitely provided that the appropriate form is filled
every year.
Studies not renewed prior to the expiration date must suspend all datagathering activities.
If the study expires and no “Annual Renewal” form is submitted, the
study may administratively closed after 30 days. At this time a notice will
be sent to the investigator(s) of the administrative closure.
2.6
2.7
2.8
2.9
3.0
PROCEDURES
3.1
3.2
4.0
A closed study may not be revived; the investigator must fill out a new
IACUC Application, even if there are no changes to the study itself.
The ORC will notify investigators regarding the request for renewal.
Substantive changes to the study design or adverse events may require a
full board review. In this case the investigator(s) will be notified and
invited to attend the next scheduled IACUC meeting to clarify the new
circumstances of their study.
Continuing to gather data or samples after notification of the expiration
of a study constitutes noncompliance and will result in the initiation of
the procedures to investigate the noncompliance. [See SOP 404]
When a study is completed, investigator(s) will submit the “IACUC
Closure Form” found on the IACUC link on the ORC website. [See SOP
405]
Investigator(s) will complete either the renewal form or the closure form,
sending a hard copy or an electronic version in an email attachment to
the ORC office.
The Chair will review the submitted form and determine how to proceed.
3.2.1 If the proposal was initially exempt, and the renewal request
involves no substantive changes in the study, the Chair will send
by an email a notification of renewal.
3.2.2 If the renewal request of an initially exempt proposal contains a
request for modifications, disposition of the request will be done
in writing.
3.2.3 If the proposal was initially approved by a full board review,
renewal requests may require a vote of the full board. In this case
the Chair will notify the investigator and invite the investigator to
the next IACUC meeting.
REFERENCES
AWAR 2.31,d.5
PHS Policy IV,C,5
SOP 403
Amendments to Approved Research
1.0
POLICY
It is recognized that circumstances may arise during the conduct of a study that
may affect the progress, design, or success of the study. Any changes to an
IACUC-approved study require approval prior to their implementation. The
only exception is in cases where immediate action is needed in order to preserve
the integrity of the study or the safety of the investigators. In such cases a
written report of the action taken and the justification for it in the absence of
IACUC approval will be required.
If an investigator determines that an emendation to an IACUC-approved study
is necessary, the investigator shall submit the “Annual Renewal or Protocol
Modification Form” found on the IACUC website.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
3.0
Investigators are responsible for determining when an amendment to an
IACUC-approved protocol is necessary. If so, the investigator must fill
out the proper form and submit it to the ORC office (AMD 216) either in
hard copy with signature or in an email attachment from the investigator
to iacuc@uco.edu.
The Chair will review all requests for modification and determine if the
modification is sufficient to warrant full board approval.
The Chair will notify the investigator of the approval of the proposed
modification or of the need for additional documentation.
The ORC staff will update the file of the study in order to reflect the
modification(s).
PROCEDURES
3.1
3.2
3.3
The investigator will prepare and submit the “Annual Renewal or
Protocol Modification Form.”
A signed hard copy must be delivered to the ORC office or an electronic
version sent from the investigator’s UCO email account.
The Chair will review the request and determine if the modification
requires full board approval or if it only needs the approval of the Chair.
3.4
3.5
3.6
3.7
3.8
4.0
If full board approval is required, the Chair shall notify the investigator
of the decision and invite the investigator to the next scheduled meeting
of the IACUC to discuss the modification.
If the modification is relatively minor, such as a change in personnel due
to graduation, the Chair has the authority to approve the modification
without the approval of the committee.
The Chair will notify the investigator of the decision on the requested
modification by email.
The Chair will direct the ORC staff to update the file of the study to
reflect the modification.
A modification to an IACUC-approved study will not affect the date of
expiration of the study.
REFERENCES
AWAR 2.31,c,7
PHS Policy IV,B,7
SOP 404
Unanticipated Problems or Noncompliance
1.0
POLICY
The UCO IACUC has oversight responsibility to ensure approved protocols
follow university policy and that they are in compliance with all relevant local,
state, and federal regulations. If the IACUC receives a report that an instance of
noncompliance has occurred, it is the duty of the IACUC to investigate the
allegation. The Chair will initiate and conduct an investigation and report the
findings to the IACUC at the next full board meeting, and to the Provost. The
IACUC, in consultation with the Provost, will determine if noncompliance has
occurred and, if so, the degree of seriousness, and will decide and vote on any
sanctions. The full policy on noncompliance is detailed in the “IACUC Policy
and Procedures for Responding to Allegations of Misconduct,” which is found
on the IACUC website. This policy is summarized briefly below.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
2.5
2.6
2.7
Upon receiving notification that a potential violation has occurred, the
Chair, serving as the university’s Research Integrity Officer (RIO), shall
initiate an investigation into the allegation.
If there is a potential for a conflict of interest having the Chair conduct the
investigation, then with the assent of the Provost another member of the
IACUC may be appointed to conduct the investigation. This person shall
have the full authority of the Chair for the purposes and duration of the
investigation, and shall have access to all records and persons deemed
necessary to make an informed determination regarding the allegation.
At the discretion of the Chair, other members of the IACUC may be
appointed to assist in the investigation.
The findings of the investigation shall be reported to the IACUC at the
next scheduled meeting. The IACUC will review the findings and the full
board will decide on any sanctions.
The Chair will submit all documents related to the investigation to the
Provost, serving as the Deciding Official (DO), including a summary
finding of the investigation, and any actions taken by the IACUC.
All documents relating to the investigation, including final disposition,
become the property of the University.
All documents and deliberations relating to the investigation are to be
strictly confidential.
3.0
PROCEDURES
3.1
The Chair will direct the ORC staff to collect all documents relating to the
investigation, and will contact all parties involved in or potentially
affected by the alleged noncompliance.
3.2 Interviews of affected parties will be conducted by the Chair in person,
unless circumstances prevent it; in the event that in-person interviews are
not possible, phone interviews are permitted, but it must be made clear to
those who are being interviewed that an investigation into potential
noncompliance is being conducted, and that a record of what is said in the
interview will be made and become a part of the official record of the
investigation.
3.3 The Chair is responsible for providing assurances of the confidentiality of
any information given and privacy of the identity of any person being
interviewed.
3.4 The Chair will write a summary of the investigation and present the
findings to the IACUC at the next scheduled meeting, and to the Provost.
3.5 The full IACUC will determine if an instance of noncompliance has taken
place and, if so, what remedies and/or penalties are to be imposed. Any
action taken by the IACUC must be consistent with UCO policy as well as
with federal regulations.
3.6 Members of the IACUC who may have a conflict of interest (COI)
regarding anyone involved in the allegation shall inform the Chair and
shall recuse themselves from any further participation in the investigation.
3.7 Any remedies and/or sanctions handed down by the IACUC shall be
reported to the Provost, who will have the ultimate authority to accept the
findings of the investigation and any remedies and/or penalties imposed
by the IACUC.
3.8 The Provost will notify all persons receiving sanctions of the decision of
the IACUC, and of any further action deemed appropriate.
3.9 If it is determined that no instance of noncompliance has occurred, this,
too, will be reported to the Provost and to all parties involved.
3.10 Per federal regulations, all documents pertaining to the investigation,
even if no finding of noncompliance was found, are to be retained for 7
years from the date of the initiation of the inquiry. [42 CFR 93.317(b)]
4.0
REFERENCES
42 CFR 93
SOP 205
SOP 405
Closure of Research
1.0
POLICY
An active study may be closed at any time by the study investigator(s), or by
administrative action following an investigation. A study also will close on the
date of its expiration if no further action is taken to renew. The “IACUC Closure
Form” is to be used by investigators to complete the process of closure. This
form is located on the IACUC link on the ORC website.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
2.5
3.0
If an investigator wishes to close down an IACUC-approved study, s/he
must fill out the “IACUC Closure Form” and submit a signed copy to the
ORC office (ADM 216). This may be done at any time by the investigator.
The ORC office will notify investigators of impending expiration dates,
but it is the responsibility of the investigator to complete the appropriate
form regarding the disposition of the study.
If an investigator wishes to revive an expired study, a renewal of the
expired study is not allowed; the investigator must fill out a new IACUC
application, even if there are no changes to the study design. [See SOP
402]
If a closure form is completed, the investigator will receive an email
notification by the ORC staff that the study is officially closed.
If an investigator receives notification of an impending anniversary, but
does not renew the study formally, the ORC staff will notify the
investigator that the study approval has expired. If this occurs, the
investigator may not continue to gather any data, collect specimens,
manipulate or observe specimens, or do any other active research related
to the study other than analysis of already-acquired data.
PROCEDURES
3.1
3.2
The ORC staff will notify investigators 60 days and 30 days prior to the
expiration of a study. It will then be the responsibility of the investigator
to determine if the study is to be renewed or closed.
To close a study, the investigator must fill out the “IACUC Closure
Form” and submit a written and signed copy to the ORC office. This
3.3
3.4
4.0
form will be placed in the IACUC file for that study and the file label
color-coded to indicate that the study is closed.
If an investigator does not fill out the closure form and the expiration
date passes, the ORC staff will notify the investigator that the date has
passed. If the investigator wishes to renew the study, they will have 7
days to do so.
If the renewal is not requested after this 7-day period, the ORC will
administratively close the study and a notification to that effect will be
sent to the investigator. At this point the study is permanently closed. An
investigator who continues to conduct the study beyond data analysis
will be regarded as being in violation of IACUC policy on noncompliance
and an investigation will be initiated. [See SOP 404]
REFERENCES
AWAR 2.31,d.5
PHS Policy IV,C,5
SOP 406
Communication between IACUC and Investigators
1.0
POLICY
The effectiveness of the IACUC process requires that investigators and the ORC
staff maintain regular and open communication. The ORC will be responsible
for keeping investigators informed in a timely manner about the application
process, including the results of initial IACUC review, any modifications to the
application which may be necessary, the status of requests for amendments,
modifications, final approval, annual renewal, closure notices, and any reports
of protocol violations. All communications will be by email unless the
investigator or the ORC office requests a hard copy, or if the communication
requires a signature.
Investigators are responsible for submitting all required documents and forms
to the ORC and for maintaining effective contact with the ORC throughout the
application process, and for responding to requests for information regarding
renewals, amendments, and closures. Should the occasion arise where there is
an investigation into a report of a protocol violation, investigators are required
to be forthcoming with all requested documentation and to be available for
interviews, as necessary. [See SOP 404]
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
2.5
3.0
The Chair will notify the investigator(s) of the results of reviews and any
changes or emendations that may be required.
The Chair shall notify the PI of a full board review of a proposal, or if the
IACUC wishes that the PI be present at a meeting of the IACUC to
provide information about a submission.
The ORC staff will notify the PI of the final approval of a proposal.
The ORC staff will notify the PI of impending anniversary dates in order
to facilitate annual renewal or closure of a study.
The ORC staff will maintain records of all documents related to a study
and all communications between the IACUC and investigator(s).
PROCEDURES
3.1
The ORC will notify the PI that all documentation regarding a proposal
has been received and that the proposal is under review.
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
The Chair will notify the PI about an exempt proposal as soon as a
decision on its status has been reached.
The Chair will notify the PI in writing and by email as soon as all requests
for modifications have been satisfied and the proposal has been reviewed
and approved.
If the proposal requires full board review, the Chair will notify the PI of
the date and time of the IACUC meeting, and extend an invitation to
attend to answer any questions the board may have about the proposal. It
is not required that the PI attend unless requested to do so by the Chair.
The Chair will communicate the results of any discussion and the outcome
of voting on a proposal to the PI.
The Chair will notify the PI in writing of the final approval of a proposal.
The ORC staff will notify the PI of impending anniversary dates and the
need to either renew or close a study.
The ORC staff will maintain a current file in hard copy and electronically
of all actions, communications, and documents relevant to a particular
study.
Paper documents will be kept on file for three (3) years from the date of
the closure of a study; after this point all records will scanned into the
IACUC database and kept indefinitely.
4.0
REFERENCES
5.0
Guide Ch.2
APPENDIX
SOP 301
SOP 320
SOP 303
SOP 404
SOP 501
Research at External or Multiple Sites
1.0
POLICY
The UCO IACUC has the responsibility of reviewing all research involving
vertebrate animals conducted by UCO faculty, staff, and students to ensure that
such research follows UCO policies and is in compliance with local, state, and
federal regulations. This authority extends to studies conducted off-site and/or
at multiple sites, whether field studies or laboratories. Though UCO currently
does not have on-campus facilities for housing research animals, the mandate of
the UCO IACUC extends to UCO personnel doing research at other sites.
Research involving any UCO personnel being conducted at other sites must be
reviewed and approved by the UCO IACUC, regardless of its being approved
by other universities and/or agencies. In the event of disagreement between
UCO policies and those followed at off-campus sites, it is the duty of UCO
personnel to abide by UCO policy. Any deviation from UCO policy must be
approved in writing by the full board review of the UCO IACUC prior to UCO
personnel engaging in any research. Failure to abide by UCO policies in this
event shall constitute noncompliance, and shall be dealt with according to UCO
policy. [See SOP 404]
UCO personnel are permitted to work with other IACUCs but remain subject to
UCO policies and procedures.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
UCO investigative personnel doing research off the UCO campus must
provide documentation granting permission to do research on that site
from the individual, institution, or agency responsible for that site.
If the research being conducted is under the authority of another IACUC,
the UCO IACUC shall require signed documentation of the approved
research, including a detailed description of the duties of UCO-affiliated
personnel. UCO personnel must nevertheless abide by all UCO policies
and procedures.
If the research is being conducted on state or federal land, the PI must
provide documentation of permission to conduct that research, and must
specify the location and duration of the permission to do research. The PI
is responsible for abiding by all local, state, and federal laws related to
doing research on the site(s).
2.4
2.5
3.0
PROCEDURES
3.1
3.2
3.3
3.4
3.5
3.6
4.0
If the research is being conducted on private land, the PI must provide
written permission from the owner(s), including contact information, and
must specify the location and duration of the permission to do the
research.
For off-campus sites under the authority or control of UCO, AWAR and
PHS Policy require biannual inspections, to be conducted by the Chair or
a designated representative of the IACUC.
The PI must submit a completed UCO IACUC application, and provide
supporting documentation, including permissions and current collector
permits (if applicable).
If UCO personnel are doing research under the authority of another
IACUC, the PI will submit a signed copy of the approved proposal, and
include contact information for the other IACUC.
UCO personnel may not engage in any research under the authority of
another IACUC until the study has been reviewed by the UCO IACUC,
and includes a detailed description of the duties of the UCO personnel
involved.
The PI will provide written permission and contact information from the
owners/managers of any private land upon which UCO personnel are
engaged in research.
The PI will submit written authorization from the proper authorities to
conduct research on any state or federal land. This includes land in other
states.
An inspection procedure checklist, consistent with AWAR, can be found
at http://grants.nih.gov/grants/olaw/sampledoc/cheklist.pdf
REFERENCES
AWAR 2.31, c, 1-3
PHS Policy IV, A, 1
SOP 502
Research at International Sites
1.0
POLICY
All vertebrate animal research involving UCO-affiliated personnel conducted at
international sites must follow all UCO regulatory and ethical policies and
procedures, and proposals to conduct such research must be submitted to the
UCO IACUC for review and approval. This applies regardless of the location of
the site(s) where the research is conducted, the source of the funding for the
study, or the existence of a local analogue to an IACUC. Researchers are
expected to abide by all UCO policies, as well as state and federal regulations,
but special care must be taken to be cognizant and respectful of local laws and
customs. The same burdens of providing documentation of permission to
conduct research apply to international sites.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
2.5
2.6
2.7
Any proposal to do research involving UCO-affiliated personnel that will
be conducted at any international site must be approved by the full
board.
At the discretion of the Chair, full board review may be waived, but it is
the duty of the PI to make the case for doing so.
The PI is responsible for providing documentation of compliance with
UCO policies and applicable state and federal laws.
All UCO personnel doing research at international sites remain agents
and representatives of UCO, and are expected to act according to the
highest principles of professionalism and ethical behavior.
The PI is responsible for insuring that the study is in compliance with
local laws (if any) and with local customs. This applies to the acquisition
of tissue, animal waste, carcasses, humane endpoints, and export
regulations regarding live specimens, tissue, and carcasses. [See
http://www.aphis.usda.gov/import_export/animals/animal_import/anim
al_imports.shtml]
If there is a local analogue to an IACUC, UCO researchers must abide by
that body’s regulations regarding research, but are expected to hold
themselves to the highest standards of professionalism and ethical
behavior, regardless of local ordinances.
Regular communication between the IACUC and UCO personnel must be
maintained.
3.0
PROCEDURES
3.1
3.2
3.3
3.4
3.5
3.6
4.0
UCO PIs will submit a completed UCO IACUC application, along with all
supporting documentation, for full board review.
The PI will submit documentation of permission to do the research at the
site(s) specified in the application.
If there is a local version of an IACUC, the PI will submit documentation
of the approval by the local body to do the research.
Whatever the local regulatory environment, UCO personnel will abide by
all applicable UCO policies and by all state and federal regulations.
Failure to do so will constitute noncompliance and will be dealt with
according to existing UCO policies. [See SOP 404]
Any modifications to an approved study must be dealt with according to
UCO policy.
UCO personnel will abide by local customs and laws as much as possible.
REFERENCES
USDA Animal and Plant Health Inspection Service
CITES
ESA
SOP 302
SOP 304
SOP 401
SOP 402
SOP 403
SOP 404
SOP 406
SOP 501
SOP 503
Research Involving Endangered Species
1.0
POLICY
In the event that an investigator wishes to study an endangered species, greater
protections exist in order to ensure the ongoing efforts to enable such species to
recover. Given that such species are, by definition, a vulnerable population,
investigators will be required to demonstrate a higher level of responsibility in
the design and conduct of a proposal aimed at endangered species. The UCO
IACUC desires to encourage studies on endangered species, and will take great
care in the review of proposals involving endangered species to ensure
compliance with applicable state and federal regulations. All proposals
involving endangered species will be subject to full board review.
Research involving endangered species must conform not only to the general
rules and regulations governing animal research, but also the specific laws and
ordinances designed to protect and help the recovery of endangered species.
The Endangered Species Act (ESA) of 1973, jointly administered by the U.S.
Fisheries and Wildlife Service and the National Marine Fisheries Service,
provide the foundation for policies regulating research on endangered species.
In addition, the United States is a signatory to the Convention on International
Trade in Endangered Species (CITES). In all cases, research involving
endangered species generally requires specific permits, and it is the
responsibility of researchers to have secured the appropriate permits prior to the
initiation of their study. [See http://www.fws.gov/endangered/]
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
3.0
Investigators who wish to study an endangered species are required to fill
out the full IACUC application; such studies do not qualify as exempt.
All proposals involving endangered species will require review by the
full board for approval even if such proposals involve observation only.
Any special permits that are required for the study of endangered species
must be secured prior to the approval of the proposal by the IACUC, and
must be submitted with the IACUC application for full board review.
If a study proposes any manipulation of an endangered species, the Chair
may require the researcher to attend the meeting of the IACUC to explain
the proposal.
PROCEDURES
3.1
3.2
3.3
3.4
3.5
4.0
Investigators will complete the IACUC application, and provide adequate
justification for a study involving endangered species.
The PI will submit with the application all special permits that may be
required under state or federal law regarding endangered species.
The Chair will review the application and the ORC staff will distribute it
to all members of the IACUC for the purpose of full board review.
All IACUC policies regarding annual renewal or protocol modification
will apply to studies involving endangered species. [See SOP 403]
Investigators will observe all state and federal regulations involving the
collecting and disposition of endangered species.
REFERENCES
16 USC 35
50 CFR 222
64 FR
ESA
CITES
SOP 601
Initial Submission of a Research Proposal
1.0
POLICY
An investigator wishing to do research on vertebrate animals must submit a
proposal to do so to the UCO IACUC for review and approval prior to the
initiation of the research. This applies to UCO faculty, staff, and students, and
applies regardless of where the actual study will take place. If the IACUC
determines that a proposal does not qualify as research under the authority of
the IACUC, then a notification to that effect will be sent to the investigator. If
there are questions regarding whether a proposal qualifies as research, contact
the Chair of the IACUC for clarification.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
The investigator must determine if a proposed study qualifies as research
and, if so, whether it may qualify as exempt. The investigator will submit
the appropriate form to the ORC, along with signatures, and any
supporting documentation, such as collector permits or permissions to be
on private, state, or federal land.
If the proposal involves endangered species, the PI will notify the ORC to
determine what extra precautions may be necessary. [See SOP 503]
The Chair will determine the disposition of the submission, and inform
the PI accordingly.
After a review of the proposal, the PI must complete any modifications or
corrections deemed necessary as a result of initial review.
Data gathering, even if this involves passive observation of animals in
their natural habitat, cannot begin until the PI receives an official letter of
approval of the proposal from the IACUC, signed by the Chair.
Any proposed changes to an IACUC-approved study must be approved
by the IACUC following the submission of the appropriate form.
When notified of an impending anniversary date, the PI is responsible for
determining whether the study needs to continue or may close. In either
case, the PI must complete the proper form and submit it to the ORC for
disposition.
It is the responsibility of the PI to report any adverse event or instance of
potential noncompliance immediately to the ORC.
The PI must report any occasion of conflict of interest.
3.0
PROCEDURES
3.1
3.2
3.3
3.4
3.5
3.6
4.0
Investigators will fill out and submit the appropriate application and all
supporting documentation to the ORC for processing and review.
If the proposal involves endangered species, the PI will be available to the
Chair and to the IACUC for clarification of the study. [See SOP 503]
The PI will make any corrections or modifications recommended by the
IACUC and submit the corrected application to the ORC.
The study may only commence when the submission has been approved
by the IACUC and notification of approval sent to the PI.
The PI will make the appropriate response to notification of the date for
renewal.
The PI will report to the ORC any adverse event or instance of potential
noncompliance, along with all relevant supporting documentation.
REFERENCES
AWAR 2.31,d-e
PHS Policy IV,C,1,a-g; IV,D,1,a-e
5.0
APPENDIX
SOP 401
SOP 602
Amendments and Changes
1.0
POLICY
In the event that changes or modifications to an IACUC-approved study become
necessary, the investigators must complete and submit the “Annual Renewal or
Protocol Modification Form” to the IACUC for review and approval. In most
cases, the Chair can expedite proposed modifications; however, at the discretion
of the Chair a proposed modification may be submitted to the full board for
review prior to approval.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
3.0
PROCEDURES
3.1
3.2
3.3
4.0
The PI is responsible for identifying any changes that need to be made to
an approved study, and for completing and submitting a signed copy of
the appropriate form.
No changes to an approved study may be implemented until the PI has
received written notification from the ORC that the modification has been
approved.
Approving a modification to an approved study does not change the date
of the anniversary of the study’s initial approval.
Investigators will request modifications to an IACUC-approved study by
completing and submitting the modification form to the ORC. [See SOP
403]
The investigator will provide a justification for the proposed changes.
Implementation of the proposed changes must await IACUC approval.
REFERENCES
AWAR 2.31,c,7
PHS Policy IV,B,7
5.0
APPENDIX
SOP 403
SOP 603
Continuing Review
1.0
POLICY
The authority of the IACUC does not end with the approval of a proposal; the
IACUC has the further duty to monitor the continuing progress of all approved
studies. All IACUC-approved studies have terminal dates, usually three years,
with the additional requirement of annual renewal. Investigators shall
determine the future course of their studies and, if desired, submit the “Annual
Renewal” form to the ORC for review. After three years, federal regulations
require that a new application be completed and submitted, even if there are no
changes to the study. After this point, a study can be renewed indefinitely, but
an annual renewal form must be completed each year.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
3.0
PROCEDURES
3.1
3.2
3.3
4.0
Upon receiving notification of an impending anniversary date, the
investigator must notify the IACUC of the desire to continue a study by
completing and submitting to the ORC the “Annual Renewal or Protocol
Modification Form.”
In most cases, the Chair may give approval to a request for continuing
review, but if the renewal is accompanied by changes to the design of the
study, the renewal request may be submitted to the full board for
approval.
The investigator must not implement any changes made during the
renewal without prior written approval of the changes by the IACUC.
The PI will respond to a notification by the ORC of an anniversary date
by completing either the Annual Renewal form or the Closure form.
Either form must be submitted in hard copy, with signatures, and
electronically to the ORC.
Any changes to the existing study must be detailed on the Annual
Renewal form.
REFERENCES
SOP 402
SOP 604
Closure of Research
1.0
POLICY
The investigator is responsible for notifying the ORC office that their study is
complete and that they intend to close the study. This may occur at anytime
during the IACUC-approved duration of the study, and is a matter of the PI’s
discretion. In this case the investigator must complete the “IACUC Closure
Form” found on the IACUC website. If the anniversary date for the study has
passed, and the investigator has taken no further action, the study will be
administratively closed by the ORC 30 days after the anniversary date. If the
investigator wishes to renew a closed study, a new IACUC application will be
required.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
3.0
PROCEDURES
3.1
3.2
3.3
4.0
The investigator will notify the ORC of their desire to close a study.
The investigator must complete the Closure form and submit it to the
ORC prior to the anniversary date.
Upon notification of closure by the ORC, the investigator must undertake
no new data gathering or collecting, though data analysis may continue.
Prior to the anniversary date, if a study has been completed, the
investigator will submit the Closure form to the ORC, together with a
letter or email stating that the project has been completed.
Upon receipt of a notification by the ORC of the anniversary date of a
study, the investigator will submit the Closure form to the ORC, together
with a letter or email stating that the project has been completed.
Upon receipt of the Closure form the ORC will process the form and
place it the file for the study, which will then be color-coded as being
closed. Once a study has been closed, either by PI request or
administratively by the ORC, and email will be sent to the PI confirming
that the study is now closed.
REFERENCES
SOP 405
SOP 701
Procedures for Measuring Performance Consistency
1.0
POLICY
Though the UCO IACUC is an independent standing committee, according to
PHS Policy (IV, B, 3; IV, B, 5) and the AWAR (2.31, c, 3), the UCO IACUC must
submit periodic reports of its activities and decisions to the Provost, who
functions in this case as the Institutional Official (IO). Such reports include an
accounting of protocols submitted and approved, membership changes to the
IACUC, reports of conflicts of interest, investigations into reports of adverse
events or noncompliance, and recommendations regarding the operations of the
IACUC. Acting as the Institutional Official, the Provost will conduct a review of
the IACUC and its operations to ensure that the IACUC is operating according
to UCO policy and in compliance with local, state, and federal regulations.
At the discretion of the Provost, an institutional official who is unconnected to
the IACUC whom the Provost appoints, or the UCO Research Advisory Council
(RAC), may carry out this review.
2.0
RESPONSIBILITIES
2.1
2.2
2.3
3.0
PROCEDURES
3.1
3.2
3.3
4.0
The Chair shall initiate a review of IACUC activities by examining files
that were approved during the previous calendar year, and by a review
of the minutes of IACUC meetings.
The Chair will deliver to the RAC 5 randomly selected files for review
The Chair will provide a summary of the review and provide a written
report to the IACUC and the IO.
The Chair will meet with the RAC and provide all documents necessary
to conduct a review.
The RAC will report back to the Chair within 10 working days and return
all submitted documents, along with a review report.
The Chair will write a summary of the RAC review and report the results
to the IACUC membership and the IO.
REFERENCES
UCO IRB SOP 901