Departures from the Guide for IACUC Members
Target Audience: IACUC Members
Target Level: Intermediate
Developed by:
Ron Banks, Beth Ford, Neera Gopee,
Marley Thrasher, Jim Weed
Departures from the
Guide
Goals
Our goals for this session:
U
n
d
e
r
s
t
a
n
d
d
e
p
a
r
t
u
r
e
s
f
r
o
m
t
h
e
p
r
o
v
i
s
i
o
n
s
o
f
t
h
e
G
u
i
d
e
M
a
n
a
g
e
d
e
p
a
r
t
u
r
e
s
t
o
e
n
s
u
r
e
c
o
m
p
l
i
a
n
c
e
D
e
t
e
r
m
i
n
e
r
e
p
o
r
t
i
n
g
r
e
q
u
i
r
e
m
e
n
t
s
4
A
p
p
l
y
t
o
o
l
(
s
)
t
o
m
a
n
a
g
e
d
e
p
a
r
t
u
r
e
s
3
I
d
e
n
t
i
f
y
e
x
a
m
p
l
e
s
o
f
d
e
p
a
r
t
u
r
e
s
2
D
e
f
i
n
e
“
d
e
p
a
r
t
u
r
e
”
f
r
o
m
t
h
e
p
r
o
v
i
s
i
o
n
o
f
t
h
e
G
u
i
d
e
1
After attending this module, you will be able to:
Learning Objectives
Define
“departure” from the provision of the
Guide
Identify
examples of departure
Understand departures from
the provisions of the
Guide
D
e
p
a
r
t
u
r
e
s
h
a
v
e
c
o
n
s
e
q
u
e
n
c
e
s
w
h
i
c
h
m
a
y
i
m
p
a
c
t
t
h
e
a
n
i
m
a
l
p
o
s
i
t
i
v
e
l
y
o
r
n
e
g
a
t
i
v
e
l
y
.
Talk to your group:
1. When you think of the word “departure,” what does
that look like? Discuss as a group what a pictorial
representation would look like. Use your flip chart to
create a picture. (2 minutes)
2. Share your art with the rest of us. (2 minutes)
Group Work: Pictogram
Deviating from a “must”
statement
Deviating from a
“should” statement
…under certain circumstances
So…what’s a Departure?
From the Guide…
Provision of 10 to
15 fresh air changes per hour in
animal housing rooms is an
acceptable guideline to maintain
macroenvironmental air quality (p. 46)
GEU has a rabbit room with six air
changes per hour
Is this a departure from the
Guide
?
What do you think?
This flag indicates a page in reference
materials.
D
i
r
e
c
t
i
o
n
s
:
u
s
i
n
g
y
o
u
r
c
o
l
o
r
e
d
c
a
r
d
s
,
v
o
t
e
o
n
t
h
e
f
o
l
l
o
w
i
n
g
s
t
a
t
e
m
e
n
t
s
w
h
e
n
a
s
k
e
d
:
M
u
s
t
=
B
l
u
e
S
h
o
u
l
d
=
O
r
a
n
g
e
M
a
y
=
G
r
e
e
n
What do you think?
From the Guide, page 14
Must = Blue
Should = Orange
May = Green
Institutional mission, programmatic goals,
including the nature of animal use at the
institution, and Program size will determine
whether fulltime, part-time, or consultative
veterinary services are needed. If a full-time
veterinarian is not available on site, a
consulting or part-time veterinarian
__________ be available in visits at
intervals appropriate to
programmatic needs.
What do you think?
From the Guide, page 14
Must = Blue
Should = Orange
May = Green
If a full-time veterinarian is not available on
site, a consulting or part-time veterinarian
should be available in visits at intervals
appropriate to programmatic needs. In
such instances, there _________ be an
individual with assigned responsibility for
daily animal care and use and facility
management.
What do you think?
From the Guide, page 51
Must = Blue
Should = Orange
May = Green
Wooden items ______ be replaced
periodically because of damage or
difficulties with sanitation. Painting or
sealing wood surfaces with nontoxic
materials may improve durability in many
instances.
What do you think?
Don’t Forget!
Performance Standard
•
Describes a desired outcome while providing
flexibility to achieve the desired outcome
•
Usually deals with programs
Exception
•
Three exceptions in the
Guide
: experimental
reasons for individual housing (e.g. urine collection),
social incompatibility (e.g. male hamsters and
fighting) and veterinary clinical concerns
Other Terms
Apply
tool(s) to manage departures
Determine
reporting requirements
Manage departures to ensure
compliance
https://grants.nih.gov/grants/olaw/Departures_flow_chart.pdf
Our Tool Today
https://grants.nih.gov/grants/olaw/Departures_flow_chart.pdf
Determine the
standard
Determine if it’s a
departure
Is it a requirement,
strong
recommendation or
suggestion?
Is it a specifically
described exception
or IACUC
approved?
Determine reporting
requirements.
How do you use it?
S
C
E
N
A
R
I
O
:
O
p
e
n
-
t
o
p
s
t
a
t
i
c
c
a
g
e
s
w
h
i
c
h
h
o
u
s
e
d
a
m
s
a
n
d
p
u
p
s
c
a
n
’
t
b
e
d
i
s
t
u
r
b
e
d
f
o
r
t
h
e
f
i
r
s
t
1
0
-
1
4
d
a
y
s
i
n
a
c
c
o
r
d
a
n
c
e
w
i
t
h
w
e
l
l
-
e
s
t
a
b
l
i
s
h
e
d
p
e
r
f
o
r
m
a
n
c
e
s
t
a
n
d
a
r
d
s
.
T
h
e
I
A
C
U
C
h
a
s
a
p
p
r
o
v
e
d
.
Group Work: Scenario
D
e
t
e
r
m
i
n
e
r
e
p
o
r
t
i
n
g
r
e
q
u
i
r
e
m
e
n
t
s
4
A
p
p
l
y
t
o
o
l
(
s
)
t
o
m
a
n
a
g
e
d
e
p
a
r
t
u
r
e
s
3
I
d
e
n
t
i
f
y
e
x
a
m
p
l
e
s
o
f
d
e
p
a
r
t
u
r
e
s
2
D
e
f
i
n
e
“
d
e
p
a
r
t
u
r
e
”
f
r
o
m
t
h
e
p
r
o
v
i
s
i
o
n
o
f
t
h
e
G
u
i
d
e
1
After attending this module, you will be able to:
Learning Objectives
•
Departures Flowchart:
https://grants.nih.gov/grants/olaw/Departures_flow_chart
•
The
Guide
:
https://grants.nih.gov/grants/olaw/Guide-for-the-Care-
and-use-of-laboratory-animals.pdf
•
OLAW:
https://grants.nih.gov/grants/olaw/olaw.htm
•
Policy NOT-OD-12-148:
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-
12-148.html
Resources and Additional Info
1.
T/F – Departures stem from the “must,” “should,” and “may”
in the
Guide.
2.
Match the term with the statement:
3. Describe a situation where a departure is identified but no
report to the IO is required.
T
e
r
m
S
t
a
t
e
m
e
n
t
_
_
_
_
_
“
M
u
s
t
”
s
t
a
t
e
m
e
n
t
A
.
P
e
r
f
o
r
m
a
n
c
e
S
t
a
n
d
a
r
d
a
n
d
a
s
t
r
o
n
g
r
e
c
o
m
m
e
n
d
a
t
i
o
n
_
_
_
_
_
“
S
h
o
u
l
d
”
s
t
a
t
e
m
e
n
t
B
.
S
u
g
g
e
s
t
i
o
n
_
_
_
_
_
“
M
a
y
”
s
t
a
t
e
m
e
n
t
C
.
M
i
n
i
m
u
m
s
t
a
n
d
a
r
d
r
e
q
u
i
r
e
d
Summative Assessment
S
C
E
N
A
R
I
O
:
A
m
o
u
s
e
r
o
o
m
c
a
n
’
t
b
e
a
c
c
e
s
s
e
d
o
r
a
n
i
m
a
l
s
o
b
s
e
r
v
e
d
f
o
r
2
4
h
o
u
r
s
b
e
c
a
u
s
e
t
o
t
a
l
d
a
r
k
n
e
s
s
i
s
r
e
q
u
i
r
e
d
d
u
r
i
n
g
t
h
i
s
p
e
r
i
o
d
.
T
h
e
P
I
p
r
o
v
i
d
e
d
s
c
i
e
n
t
i
f
i
c
j
u
s
t
i
f
i
c
a
t
i
o
n
a
n
d
t
h
e
p
r
o
t
o
c
o
l
w
a
s
a
p
p
r
o
v
e
d
b
y
t
h
e
I
A
C
U
C
.
Q
U
E
S
T
I
O
N
S
:
I
s
t
h
i
s
a
d
e
p
a
r
t
u
r
e
?
I
f
y
e
s
,
w
h
y
?
I
s
i
t
r
e
p
o
r
t
a
b
l
e
a
n
d
i
f
y
e
s
,
t
o
w
h
o
m
?
Summative Assessment - Scenario
Thank You!
NOTE TO FACILITATOR: This module is designed to teach IACUC members how to understand and manage departures from the Guide. It can be used with small groups or large group; ideally, learners have already completed basic modules (AALAS or CITI) regarding IACUC function. Split learners into group using tables or by counting off numbers. Tools needed include: flip chart paper, markers, colored cards for pollinging (three colors), the Guide, the Notice NOT-OD-12-148 and the departures flowchart. Links to each of the handout materials are located on the “Resources” slide. This presentation is designed to be modified to meet your needs – please feel free to make changes relevant to YOUR team.
This module delves into departures from the provisions of the Guide for IACUC members at an intermediate level. It covers defining departures, identifying examples, managing departures, and determining reporting requirements. Through various activities and discussions, participants gain insight into handling departures effectively to ensure compliance.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
Departures from the Guide Target Audience: IACUC Members Target Level: Intermediate Developed by: Ron Banks, Beth Ford, Neera Gopee, Marley Thrasher, Jim Weed
Goals Our goals for this session: Understand departures from the provisions of the Guide Manage departures to ensure compliance
Learning Objectives After attending this module, you will be able to: Define departure from the provision of the Guide 1 Identify examples of departures 2 3 Apply tool(s) to manage departures 4 Determine reporting requirements
Understand departures from the provisions of the Guide Define departure from the provision of the Guide Identify examples of departure
Group Work: Pictogram Talk to your group: 1. When you think of the word departure, what does that look like? Discuss as a group what a pictorial representation would look like. Use your flip chart to create a picture. (2 minutes) 2. Share your art with the rest of us. (2 minutes) Departures have consequences which may impact the animal positively or negatively.
Sowhats a Departure? Deviating from a must statement Deviating from a should statement under certain circumstances
What do you think? From the Guide Provision of 10 to 15 fresh air changes per hour in animal housing rooms is an acceptable guideline to maintain macroenvironmental air quality (p. 46) GEU has a rabbit room with six air changes per hour Is this a departure from the Guide?
What do you think? Directions: using your colored cards, vote on the following statements when asked: Must = Blue Should = Orange May = Green This flag indicates a page in reference materials.
What do you think? Institutional mission, programmatic goals, including the nature of animal use at the institution, and Program size will determine whether fulltime, part-time, or consultative veterinary services are needed. If a full-time veterinarian is not available on site, a consulting or part-time veterinarian __________ be available in visits at intervals appropriate to programmatic needs. Must = Blue Should = Orange May = Green From the Guide, page 14
What do you think? If a full-time veterinarian is not available on site, a consulting or part-time veterinarian should be available in visits at intervals appropriate to programmatic needs. In such instances, there _________ be an individual with assigned responsibility for daily animal care and use and facility management. Must = Blue Should = Orange May = Green From the Guide, page 14
What do you think? Wooden items ______ be replaced periodically because of damage or difficulties with sanitation. Painting or sealing wood surfaces with nontoxic materials may improve durability in many instances. Must = Blue Should = Orange May = Green From the Guide, page 51
Dont Forget! MUST A statement as a minimum standard required of all assured institutions. In other words Don t whine about it, just do it! SHOULD Often involves performance standards In other words Strongly recommended unless the IACUC says not to MAY Suggestions In other words Just think about it
Other Terms Performance Standard Describes a desired outcome while providing flexibility to achieve the desired outcome Usually deals with programs Exception Three exceptions in the Guide: experimental reasons for individual housing (e.g. urine collection), social incompatibility (e.g. male hamsters and fighting) and veterinary clinical concerns
Manage departures to ensure compliance Apply tool(s) to manage departures Determine reporting requirements
Our Tool Today https://grants.nih.gov/grants/olaw/Departures_flow_chart.pdf https://grants.nih.gov/grants/olaw/Departures_flow_chart.pdf
How do you use it? Determine the standard Determine if it s a departure Is it a requirement, strong recommendation or suggestion? Is it a specifically described exception or IACUC approved? Determine reporting requirements. https://grants.nih.gov/grants/olaw/Departures_flow_chart.pdf https://grants.nih.gov/grants/olaw/Departures_flow_chart.pdf
Group Work: Scenario SCENARIO: Open-top static cages which house dams and pups can t be disturbed for the first 10-14 days in accordance with well- established performance standards. The IACUC has approved.
Learning Objectives After attending this module, you will be able to: Define departure from the provision of the Guide 1 Identify examples of departures 2 3 Apply tool(s) to manage departures 4 Determine reporting requirements
Resources and Additional Info https://grants.nih.gov/grants/olaw/Departures_flow_chart.pdf Departures Flowchart: https://grants.nih.gov/grants/olaw/Departures_flow_chart .pdf The Guide: https://grants.nih.gov/grants/olaw/Guide-for-the-Care- and-use-of-laboratory-animals.pdf OLAW: https://grants.nih.gov/grants/olaw/olaw.htm Policy NOT-OD-12-148: https://grants.nih.gov/grants/guide/notice-files/NOT-OD- 12-148.html https://grants.nih.gov/grants/olaw/Departures_flow_chart.pdf https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-use-of-laboratory-animals.pdf https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-use-of-laboratory-animals.pdf https://grants.nih.gov/grants/olaw/olaw.htm https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-148.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-148.html
Summative Assessment 1. T/F Departures stem from the must, should, and may in the Guide. 2. Match the term with the statement: Term Statement A. Performance Standard and a strong recommendation _____ Must statement _____ Should statement B. Suggestion _____ May statement C. Minimum standard required 3. Describe a situation where a departure is identified but no report to the IO is required.
Summative Assessment - Scenario SCENARIO: A mouse room can t be accessed or animals observed for 24 hours because total darkness is required during this period. The PI provided scientific justification and the protocol was approved by the IACUC. QUESTIONS: Is this a departure? If yes, why? Is it reportable and if yes, to whom?
Thank You! Questions?
