IRBNet Account Setup and COI Process Guide
Ensure you have an IRBNet Account -gov.irbnet.org
Ideally a Study Coordinator will do the ‘Submitting’. However, anyone with
Full Access
to the project in
IRBNet can
Create a Package
,
Link
all
applicable forms, and
Submit
There will
always be 2 Packages
for
New Projects
, Continuing Reviews, & Amendments-
adding Investigators
1.
First Package
will contain
ALL
the applicable ‘
Linked’
Disclosures
2.
Second Package
will contain all applicable documents required by the primary review/approval board
Linked Disclosures should be created/updated not-earlier-than 120 days prior to submission in IRBNet
Disclosure Packages should be Submitted
just before
the corresponding New Project, Continuing Review, or
Amendment Package,
(hours to days but
NOT
months please)
Packages containing Linked Disclosures should
NOT
be submitted to any other Review Boards except the
Conflict of Interest Review Board
COI process for New
Projects
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1
2
3
3.1
Select
Step 1
- Create New Project
This creates Package #1 that is to contain a
VA Project Cover
Sheet (PCS)
and
ALL
applicable
Disclosures
for submittal to the
Conflict of Interest Review Board
ONLY!
This should be done
just before
submitting the corresponding
New Project Package, (#2) to its appropriate Review Board
(hours to days before,
NOT
months please)
Step 2
- Create PCS
via the Wizard, listing ALL team
members and their respective Roles
–
The COI Administrator will reference the PCS to validate COIs
Step 3 - Share
this Project
w/team members listed on PCS
–
Investigators
MUST
be shared to the project in order to
create their Disclosure
Strategize and
select
the appropriate
Access Type per each team member’s
role/expectations
Select
Select
TIP:
Indicate your Investigators here. This will
remind you from whom you expect COI Disclosures.
Select
TIP:
Select
Investigators
first,
add Comments to inform that a
COI is required, & Save, then go
back & give access to any others
w/different comments
Please create COI via IRBNet
-Sponsor=None
-Funding= None
-Cooperative Study?
No/Yes
N
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P
r
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4
4.1
5
5.1
Select
Select
Be sure the correct
Purpose
and
Status
are indicated
When Linking a Disclosure, the Status should
always
be “(
Not Submitted
)”.
Select
Select
Step 4
-
Link COI Disclosures
via Designer.
-
Hopefully
, Investigators will reply to the email you
sent when you granted access, to let you know they
have created their Disclosure. You can also check here.
Submit this Package to the
Conflict of Interest Review Board
ONLY!
Select
Step 5
– Submit this Package
However,
DO NOT
submit until
1.
ALL
applicable Disclosures are Linked!
-
see the value in the note?
2.
You are reasonably ready to submit corresponding New Project
Package
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5.2
6
7
Select
Not required but
appreciated
Select
Select
Create a New Package
containing required documents
for submittal to the appropriate review/approval Board.
This package must
NOT
have
COI Disclosures Linked
!
Great! your New Project
COIs are ‘Submitted’
Packages containing ‘Linked’ COI Disclosures are to be
submitted to the
COI Board
Only
!
If a package is submitted
to another board containing COI Disclosures, you will be
instructed to “Un-link” them from that Package.
To continue preparing your project for submission you
MUST
Create a New Package (#2)!
For Example, see remaining slides:
1.
Attach required documents
IAW instructions
related to the type of project you are proposing
2.
Sign this Package
3.
Submit this Package
Sign
then
Submit
N
e
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P
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9
Select
Not required but
appreciated
Select
Project History
shows the status of each
Package throughout the life of a project.
- Pay attention to the view options
This Package to be submitted to the appropriate
Board for project review/approval
ONLY!
Remember, COIs were already submitted to
the COI Board in a previous Package
8
Select
Shows the status of the
most recent
Disclosure
Submission
COI process for
Amendments
(When adding an investigator or co-investigator)
A
m
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t
t
h
a
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1
2
3
4
Select
Step 2
– Update the Project Cover Sheet (PCS)
via Designer
–
Add
the Investigators and their respective Roles
–
The COI Administrator will reference the PCS to validate Linked COIs
Step 3 - Share
this Project
with added Investigators
–
Investigators
MUST
be shared to the project in order to
create their COI Disclosure
Strategize and
select
the appropriate
Access Type per each team member’s
role/expectations
Select
Select
Invs= AR
Select
Step 4
-
Link COI Disclosures
via Designer.
-
Hopefully
, Investigators will reply to the email you sent
when you granted access to let you know they have
created their Disclosure. You can also check here.
TIP:
Indicate your added Investigators here. This will
remind you from whom you expect COI Disclosures.
Step 1
- Create a New Package
This creates a Package that you will Link ALL applicable
Disclosures
to for submittal to the
Conflict of Interest Review
Board
ONLY!
This should be done
just before
submitting the corresponding
Amendment Package to its appropriate Review Board
(hours to days before,
NOT
months please)
TIP:
The user will receive an
email when granted access…
Select
Investigators,
add
Comments to inform that a
COI is required, & Save
.
Please create COI via IRBNet
-Sponsor= None
-Funding= None
-Cooperative Study?
No/Yes
A
m
e
n
d
m
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t
h
a
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a
t
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r
4.1
5
5.1
5.2
Select
Select
Be sure the correct
Purpose
and
Status
are indicated
When Linking a Disclosure, the Status should
always
be “(
Not Submitted
)”.
Select
Select
Submit this Package to the
Conflict of Interest Review Board
ONLY!
Select
Select
Not required but
appreciated
Step 5
– Submit this Package
However,
DO NOT
submit until
1.
ALL
applicable Disclosures are Linked!
-
see the value in the note?
2.
You are ready to create & submit corresponding Amendment Package
A
m
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n
d
m
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t
h
a
t
A
d
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a
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i
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6
7
Select
Create a New Package
containing required documents
for submittal to the appropriate review/approval Board
1.
Attach required documents
IAW instructions
from your committee of primary oversight
2.
Sign this Package
3.
Submit this Package
This package must
NOT
have
COI Disclosures Linked
!
Great! your Amendment
COIs are ‘Submitted’
Packages containing ‘Linked’ COI Disclosures are to be
submitted to the
COI Board Only!
If a package is submitted
to another board containing COI Disclosures, you will be
instructed to “Un-link” them from that Package.
To continue preparing your Amendment for submission,
review & approval you
MUST
Create a New Package!
For Example, see remaining slides:
Sign
then
Submit
A
m
e
n
d
m
e
n
t
t
h
a
t
A
d
d
s
a
n
I
n
v
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s
t
i
g
a
t
o
r
9
Select
Not required but
appreciated
Select
Project History shows the
status of each
Package
throughout the life of a project.
- Pay attention to the view options
Remember, COIs were already submitted
to the COI Board in a previous Package
8
Select
This Package to be submitted to the appropriate
Board for review/approval
ONLY!
Not required but
appreciated
Shows the status of
the
most recent
Disclosure
Submission
COI process for
Continuing Review
C
o
n
t
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u
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n
g
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1
2
3
3.1
Select
Select
Select
Select
Select
Select
Invs= CR, KC, AR
Step 3
-
Link
COI Disclosures
via Designer.
-
Hopefully
, Investigators will reply to the email you
sent to let you know they have created their
Annual Disclosure. You can also check here.
TIP:
Indicate your Investigators here. This will
remind you from whom you expect COI Disclosures.
Step 2
– Notify Investigators
to create their Annual COI
Disclosure for Continuing Review.
Send Project Mail
is
suggested
, provided Investigators check the email they used
when creating their IRBNet accounts -
adjust accordingly.
Select
Step 1
- Create New Package
This creates a package that you will Link
ALL
applicable
Disclosures to, for submittal to the
Conflict of Interest Review
Board
ONLY!
This should be done
just before
submitting the Continuing
Review Package
(hours to days before,
NOT
months please)
Please login to IRBNet and Create your Annual Disclosure for Continuing Review
Be sure the correct
Purpose
and
Status
are indicated
When Linking a Disclosure, the Status should
always
be “(
Not Submitted
)”.
C
o
n
t
i
n
u
i
n
g
R
e
v
i
e
w
4
4.1
4.2
Select
Select
Select
Submit this Package to the
Conflict of Interest Review Board
ONLY!
Invs= CR, KC, AR
Select
Not required but
appreciated
The Project Overview shows that ‘
Package 5’
in this Project has been submitted to the
Conflict of Interest Board
Step 4
– Submit this Package
However,
DO NOT
submit until
1.
ALL
applicable Disclosures are Linked!
-
see the value in the note?
2.
You reasonably ready to create & submit corresponding CR Package
Also shows the status
of the
most recent
Disclosure
Submission
C
o
n
t
i
n
u
i
n
g
R
e
v
i
e
w
5
6
Select
Create a New Package
containing required documents
for submittal to the appropriate Review Board.
This package must
NOT
have
COI Disclosures Linked
!
Packages containing ‘Linked’ COI Disclosures are to be
submitted to the
COI Board Only!
If a package is submitted to
another board containing COI Disclosures, you will be
instructed to “Un-link” them from that Package.
To continue preparing your Continuing Review for submission,
review & approval you
MUST
Create a New Package!
For Example, see remaining slides:
Great! your Continuing Review
COIs are ‘Submitted’
1.
Attach required documents
IAW instructions
from your committee of primary oversight
2.
Sign this Package
3.
Submit this Package
Sign
then
Submit
C
o
n
t
i
n
u
i
n
g
R
e
v
i
e
w
8
Select
Not required but
appreciated
Select
Project History shows the
status of each
Package
throughout the life of a project.
- Pay attention to the view options
Remember, COIs were already submitted
to the COI Board in a previous Package
7
Select
This Package to be submitted to the appropriate
Board for review/approval
ONLY!
Not required but
appreciated
COI process for Change
in Financial Status
When an investigator’s financial situation changes
I
n
t
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r
i
m
,
I
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v
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t
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a
t
o
r
s
i
t
u
a
t
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o
n
c
h
a
n
g
e
1
2
3
Select
Step 1 – Create a New Package
This creates a package that you will Link the
applicable COI Disclosure for submittal to the
Conflict of Interest Review Board ONLY!
Select
Select
Step 2
-
Link COI Disclosure
via Designer.
-
In this situation the Investigator would have notified a
team member w/Full Access to the project, that he/she
updated their Disclosure, and it needs to be Submitted.
2.1
Select
Step 3
– Submit this Package
However,
DO NOT
submit until
the
applicable Disclosure is Linked.
Select
Be sure the correct
Purpose
and
Status
are indicated
When Linking a Disclosure, the Status should
always
be “(
Not Submitted
)”.
I
n
t
e
r
i
m
,
I
n
v
e
s
t
i
g
a
t
o
r
s
i
t
u
a
t
i
o
n
c
h
a
n
g
e
3.2
Select
Not required but
appreciated
Select
The Project Overview shows that ‘
Package 7’
in this Project
has been submitted to the
Conflict of Interest Board
Also shows the status
of the
most recent
Disclosure
Submission
3.1
Select
Submit this Package to the
Conflict of Interest Review Board
ONLY!
Not required but
appreciated
The COI Administrator ‘Forwarded’ this
submission to OGC for determination
FAST FORWARD
Status remains Pending until
Ethics Review is complete
Comprehensive instructions on setting up an IRBNet account, creating packages for new projects, continuing reviews, and amendments, as well as submitting linked disclosures to the Conflict of Interest Review Board. The guide also outlines the COI process for new projects, including creating a VA Project Cover Sheet (PCS) and sharing the project with team members.
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Presentation Transcript
Ensure you have an IRBNet Account - gov.irbnet.org If you do not already have an account - Self register here Ideally a Study Coordinator will do the Submitting . However, anyone with Full Access to the project in IRBNet can Create a Package, Link all applicable forms, and Submit There will always be 2 Packages for New Projects, Continuing Reviews, & Amendments- adding Investigators 1. First Package will contain ALLthe applicable Linked Disclosures 2. Second Package will contain all applicable documents required by the primary review/approval board Linked Disclosures should be created/updated not-earlier-than 120 days prior to submission in IRBNet Disclosure Packages should be Submitted just before the corresponding New Project, Continuing Review, or Amendment Package, (hours to days but NOT months please) Packages containing Linked Disclosures should NOT be submitted to any other Review Boards except the Conflict of Interest Review Board
COI process for New Projects
New Project New Project Select Step 2 - Create PCS via the Wizard, listing ALL team members and their respective Roles The COI Administrator will reference the PCS to validate COIs Step 1 - Create New Project This creates Package #1 that is to contain a VA Project Cover Sheet (PCS) and ALL applicableDisclosuresfor submittal to the Conflict of Interest Review Board ONLY! This should be done just before submitting the corresponding New Project Package, (#2) to its appropriate Review Board (hours to days before, NOT months please) 2 1 Select Strategize and select the appropriate Access Type per each team member s role/expectations Select Step 3 - Share this Project w/team members listed on PCS Investigators MUST be shared to the project in order to create their Disclosure 3 3.1 Please create COI via IRBNet -Sponsor=None -Funding= None -Cooperative Study? No/Yes Suggested Select
New Project New Project Be sure the correct Purpose and Status are indicated When Linking a Disclosure, the Status should always be (Not Submitted) . Step 4 - Link COI Disclosures via Designer. - Hopefully, Investigators will reply to the email you sent when you granted access, to let you know they have created their Disclosure. You can also check here. Select 4 4.1 Select Select Step 5 Submit this Package However, DO NOT submit until 1.ALL applicable Disclosures are Linked! - see the value in the note? 2.You are reasonably ready to submit corresponding New Project Package Submit this Package to the Conflict of Interest Review Board ONLY! Select Check your work 5 5.1 Select
New Project New Project Great! your New Project COIs are Submitted Packages containing Linked COI Disclosures are to be submitted to the COI Board Only! If a package is submitted to another board containing COI Disclosures, you will be instructed to Un-link them from that Package. Select To continue preparing your project for submission you MUSTCreate a New Package (#2)! 5.2 Select For Example, see remaining slides: 1. Attach required documents IAW instructions related to the type of project you are proposing Sign this Package Submit this Package Create a New Package containing required documents for submittal to the appropriate review/approval Board. 2. 3. Sign then Submit Select Example 6 7
New Project New Project This Package to be submitted to the appropriate Board for project review/approval ONLY! Select Example 8 9 Select Select FYI Project History shows the status of each Package throughout the life of a project. - Pay attention to the view options Shows the status of the most recent Disclosure Submission
COI process for Amendments (When adding an investigator or co-investigator)
Amendment Amendment that Adds an Investigator that Adds an Investigator Step 1 - Create a New Package This creates a Package that you will Link ALL applicable Disclosuresto for submittal to the Conflict of Interest Review Board ONLY! Invs= AR Select Select This should be done just before submitting the corresponding Amendment Package to its appropriate Review Board Step 2 Update the Project Cover Sheet (PCS) via Designer Add the Investigators and their respective Roles The COI Administrator will reference the PCS to validate Linked COIs (hours to days before, NOT months please) 1 2 Step 3 - Share this Project with added Investigators Investigators MUST be shared to the project in order to create their COI Disclosure Strategize and select the appropriate Access Type per each team member s role/expectations Step 4 - Link COI Disclosures via Designer. - Hopefully, Investigators will reply to the email you sent when you granted access to let you know they have created their Disclosure. You can also check here. Select 3 4 Please create COI via IRBNet -Sponsor= None -Funding= None -Cooperative Study? No/Yes Suggested Select
Amendment Amendment that Adds an Investigator that Adds an Investigator Step 5 Submit this Package However, DO NOT submit until 1.ALL applicable Disclosures are Linked! - see the value in the note? 2.You are ready to create & submit corresponding Amendment Package Be sure the correct Purpose and Status are indicated When Linking a Disclosure, the Status should always be (Not Submitted) . Select Select 5 4.1 Check your work Select Submit this Package to the Conflict of Interest Review Board ONLY! Select 5.2 5.1 Select Select
Amendment Amendment that Adds an Investigator Great! your Amendment COIs are Submitted that Adds an Investigator Packages containing Linked COI Disclosures are to be submitted to the COI Board Only! If a package is submitted to another board containing COI Disclosures, you will be instructed to Un-link them from that Package. To continue preparing your Amendment for submission, review & approval you MUSTCreate a New Package! For Example, see remaining slides: 1. Attach required documents IAW instructions from your committee of primary oversight Sign this Package Submit this Package Create a New Package containing required documents for submittal to the appropriate review/approval Board 2. 3. Sign then Submit Select Example 6 7
Amendment Amendment that Adds an Investigator that Adds an Investigator This Package to be submitted to the appropriate Board for review/approval ONLY! Select Example 8 9 Select Select FYI Project History shows the status of each Package throughout the life of a project. - Pay attention to the view options Shows the status of the most recent Disclosure Submission
COI process for Continuing Review
Continuing Review Continuing Review Step 1 - Create New Package This creates a package that you will Link ALL applicable Disclosures to, for submittal to the Conflict of Interest Review Board ONLY! Select Select This should be done just before submitting the Continuing Review Package (hours to days before, NOT months please) Step 2 Notify Investigators to create their Annual COI Disclosure for Continuing Review. Send Project Mail is suggested, provided Investigators check the email they used when creating their IRBNet accounts - adjust accordingly. Please login to IRBNet and Create your Annual Disclosure for Continuing Review 1 2 Suggested Select Be sure the correct Purpose and Status are indicated When Linking a Disclosure, the Status should always be (Not Submitted) . Invs= CR, KC, AR Select Step 3 - LinkCOI Disclosures via Designer. - Hopefully, Investigators will reply to the email you sent to let you know they have created their Annual Disclosure. You can also check here. Select Select 3.1 3 Select
Continuing Review Continuing Review Step 4 Submit this Package However, DO NOT submit until 1.ALL applicable Disclosures are Linked! - see the value in the note? 2.You reasonably ready to create & submit corresponding CR Package Invs= CR, KC, AR Select Submit this Package to the Conflict of Interest Review Board ONLY! 4.1 4 Check your work Select FYI Select The Project Overview shows that Package 5 in this Project has been submitted to the Conflict of Interest Board 4.2 Select Also shows the status of the most recent Disclosure Submission
Continuing Review Continuing Review Great! your Continuing Review COIs are Submitted Packages containing Linked COI Disclosures are to be submitted to the COI Board Only! If a package is submitted to another board containing COI Disclosures, you will be instructed to Un-link them from that Package. To continue preparing your Continuing Review for submission, review & approval you MUSTCreate a New Package! For Example, see remaining slides: 1. Attach required documents IAW instructions from your committee of primary oversight Sign this Package Submit this Package Create a New Package containing required documents for submittal to the appropriate Review Board. 2. 3. Sign then Submit Select Example 5 6
Continuing Review Continuing Review This Package to be submitted to the appropriate Board for review/approval ONLY! Select Example 7 8 Select Select - Pay attention to the view optionsFYI Project History shows the status of each Package throughout the life of a project.
COI process for Change in Financial Status When an investigator s financial situation changes
Interim, Interim, Investigator situation change Investigator situation change Step 1 Create a New Package This creates a package that you will Link the applicable COI Disclosure for submittal to the Conflict of Interest Review Board ONLY! Step 2 - Link COI Disclosure via Designer. - In this situation the Investigator would have notified a team member w/Full Access to the project, that he/she updated their Disclosure, and it needs to be Submitted. Select Select 1 2 Be sure the correct Purpose and Status are indicated When Linking a Disclosure, the Status should always be (Not Submitted) . Step 3 Submit this Package However, DO NOT submit until the applicable Disclosure is Linked. Select Select 3 2.1 Select Check your work
Interim, Interim, Investigator situation change Investigator situation change Submit this Package to the Conflict of Interest Review Board ONLY! Select 3.1 3.2 Select Select FYI The COI Administrator Forwarded this submission to OGC for determination The Project Overview shows that Package 7 in this Project has been submitted to the Conflict of Interest Board Also shows the status of the most recent Disclosure Submission Status remains Pending until Ethics Review is complete
