Implementation of VHA Directive 1200.13: Financial Conflicts of Interest and Outside Compensation in VA Research

 
 
I
m
p
l
e
m
e
n
t
a
t
i
o
n
 
o
f
 
V
H
A
 
D
i
r
e
c
t
i
v
e
 
1
2
0
0
.
1
3
 
F
i
n
a
n
c
i
a
l
 
C
o
n
f
l
i
c
t
s
 
o
f
 
I
n
t
e
r
e
s
t
 
a
n
d
O
u
t
s
i
d
e
 
C
o
m
p
e
n
s
a
t
i
o
n
 
f
o
r
 
P
e
r
f
o
r
m
a
n
c
e
 
i
n
V
A
 
R
e
s
e
a
r
c
h
Presented By:
C. Karen Jeans, PhD, CCRN, CIP – Director of Regulatory Affairs
Antonio Laracuente, MBA – Director Field Operations
Angela “Angie” Foster, 
MS, FAC-P/PM Senior Level – Program Manager
Christopher Britt, Ethics Attorney Office of General Counsel
June 18, 2024
 
 
 
O
b
j
e
c
t
i
v
e
s
Describe the key responsibilities required by VHA Directive 1200.13 for 
the
VA
 Medical Center Director, 
Chief of Staff, ACOS
/R,
 
R&D Committee,
Financial Conflict of Interest (FCOI) Administrators, and VA Investigators;
Identify key requirements for submission and review of the Research
Financial Conflict of Interest (FCOI) Statement, OGE Form 450 Alternative-VA
(“Alt-450”);
 
Describe how training for Financial Conflict of Interest Administrators’ 
review
of the OGE Alt-450 
forms will
 be conducted; and
Identify training resources provided by
 the VHA Office of Research and
Development (ORD)
 on the VAIRRS Research Conflict of Interest Module.
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
B
a
c
k
g
r
o
u
n
d
On December 28, 2004, VHA Handbook 1200.13 - 
Financial Conflicts of
Interest in Research Handbook 
was published by ORD and rescinded
shortly afterwards on February 1, 2005.
Although no ORD policy existed, VA employees are required to adhere to
federal ethics laws. The 
Research FCOI Statement, OGE Form 450
Alternative-VA
 ("Alt-450"), was developed and approved by the Office of
Government Ethics (OGE) for VA Investigators to disclose financial conflicts
of interest, allowing review by VA OGC Ethics.  
Implementation of the Alt-450 varied across VA Facility programs with a
lack of a systematic approach for review and determination.  
Numerous attempts were made to develop a national research financial
conflict of interest policy, but major challenges existed.
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
B
a
c
k
g
r
o
u
n
d
 
(
c
o
n
t
.
)
On December 29, 2022, the Joseph Maxwell Cleland and Robert Joseph Dole
Memorial Veterans Benefits and Health Care Improvement Act of 2022 § 182
(2022), which is part of the Consolidated Appropriations Act, 2023 (P.L. 117-
328), was signed into law by President Biden. 
The Law included provisions 
for the VA employees to receive outside
compensation from an academic affiliate or VA Nonprofit Corporation (NPC) to
perform the VA-approved research project if certain conditions are met.
VHA Notice 2023-09(1) was published on November 28, 2023, which included
the implementation policies for the applicable provisions of the Law
involving outside compensation.
VHA Notice 2023-09(1) is now rescinded with the publication of VHA Directive
1200.13 on May 2, 2024; its policies are incorporated within the Directive.
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
Bottom Line Up Front
5
The publication of VHA Directive 1200.13 
codifies the process into formal policy that was implemented with the
publication of the OGE 450 Alternative VA (Alt-450 – Research Financial
Conflict of Interest Statement) in November of 2013 and 
incorporates the policy requirements of VHA Notice 2023-9(1) (Outside
Compensation for Performance of VA Research) published November
28, 2023 into one (1) ORD national Directive.
 
 
 
M
o
v
i
n
g
 
F
o
r
w
a
r
d
 
t
o
 
I
m
p
l
e
m
e
n
t
 
V
H
A
 
D
i
r
e
c
t
i
v
e
 
1
2
0
0
.
1
3
The new policy requirements of this Directive are required to be
implemented by September 2, 2024 (no later than 4 months following
publication date).  
Key implementation requirements:
 
Appointment of a Financial Conflict of Interest Administrator
Utilization of IRBNet (VAIRRS) for submission of and processing the
   Alt-450 Forms
Approval process for outside compensation
Including documentation of the decision by the Approving Official
Note that this program is different than the affiliate university or VA NPC
Conflict of Interest program and must be managed separately.
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
W
h
o
 
i
s
 
R
e
q
u
i
r
e
d
 
t
o
 
F
i
l
e
 
t
h
e
 
A
l
t
-
4
5
0
 
F
o
r
m
s
All VA investigators (compensated, WOC or IPA), who meet either of the
following criteria are considered to hold a position that requires them to
complete and submit an
 Alt-450 Form
 as required by 
VHA Directive 1200.13: 
(1) Hold the position of VA investigator (i.e., principal investigator, co-principal
investigator, investigator, co-investigator, sub-investigator or VA medical
facility site investigator). 
NOTE: 
A VA medical facility site investigator in a
multiple-site study can be a VA site principal investigator, co-principal
investigator or sub-investigator.
 
(2) All VA employees being
 proposed for the position of VA investigator.
 
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
K
e
y
 
R
e
s
p
o
n
s
i
b
l
e
 
P
a
r
t
i
e
s
 
f
o
r
 
I
m
p
l
e
m
e
n
t
a
t
i
o
n
 
o
f
 
V
H
A
 
D
i
r
e
c
t
i
v
e
 
1
2
0
0
.
1
3
For questions, please use Q&A box and address to “All
Panelists.”
Medical
Center
Director
Chief of Staff
ACOS/R&D
Research &
Development
(R&D)
Committee
Financial
Conflict of
Interest
(FCOI)
Administrator
VA
Investigators
 
For purposes of this presentation, the following individuals or groups will be discussed, but other
individuals are also included in VHA Directive 1200.13
 
 
 
V
A
 
M
e
d
i
c
a
l
 
F
a
c
i
l
i
t
y
 
D
i
r
e
c
t
o
r
 
K
e
y
 
R
e
s
p
o
n
s
i
b
i
l
i
t
i
e
s
 
f
o
r
 
I
m
p
l
e
m
e
n
t
a
t
i
o
n
 
o
f
V
H
A
 
D
i
r
e
c
t
i
v
e
 
1
2
0
0
.
1
3
VA Medical Facility Director
 (MCD) – Approving Official
Ensuring the VA medical facility’s research FCOI program is not a combined program
with that of the VA medical facility’s Affiliate or other entity.
 
Appointing, in writing, a VA medical facility FCOI Administrator who is responsible for
the VA medical facility’s research FCOI program and reviewing and certifying Alt-450s.
 
Making final binding programmatic decisions in consultation with an OGC Deputy
Ethics Official in situations in which an FCOI can be resolved.
 
Terminating research or taking other appropriate actions upon receiving notification
that a VA investigator is participating in VA research despite an FCOI that cannot be
resolved.
Serving
 as the Approving Official for requests for outside compensation from projects
administered by the Affiliate or VA NPC and providing written approval as appropriate
.
 
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
C
h
i
e
f
 
o
f
 
S
t
a
f
f
 
a
n
d
 
A
C
O
S
/
R
&
D
 
R
e
s
p
o
n
s
i
b
i
l
i
t
i
e
s
 
f
o
r
 
I
m
p
l
e
m
e
n
t
a
t
i
o
n
 
o
f
V
H
A
 
D
i
r
e
c
t
i
v
e
 
1
2
0
0
.
1
3
Chief of Staff
 (COS)
Can be delegated by MCD to be approving official.
Associate Chief of Staff for Research and Development 
(ACOS/R&D)
Ensuring that all VA investigators (compensated, without compensation (WOC) or appointed or
detailed to VA under the Intergovernmental Personnel Act (IPA), 5 U.S.C. § 3371 et seq.) are
assigned annual ethics training within VA Talent Management System (TMS) including tracking
and verifying completion.
 
Forwarding outside compensation requests to the Approving Official once the VA medical
facility R&D Committee completes their review and provides a recommendation to approve or
disapprove.
 
 Includes modifications.
 
Providing the original approval to the VA employee upon receiving approval from the
Approving Official. A copy of the letter must be placed in VA Innovation and Research Review
System (VAIRRS) under the appropriate project.
 
Notifying the VA Investigator if the Approving Official disapproves the outside compensation.
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
R
&
D
 
C
o
m
m
i
t
t
e
e
 
R
e
s
p
o
n
s
i
b
i
l
i
t
i
e
s
 
f
o
r
 
I
m
p
l
e
m
e
n
t
a
t
i
o
n
 
o
f
V
H
A
 
D
i
r
e
c
t
i
v
e
 
1
2
0
0
.
1
3
R&D Committee
Reviewing outside compensation request recommendations by the VA medical facility
FCOI Administrator and approving or disapproving the recommendation during the VA
medical facility R&D Committee’s initial review of the VA project.
 
Ensuring that each review assesses the request with regard to project budget
appropriateness, the effort required to conduct the project and the rationale for
outside compensation (i.e., why the work cannot be completed during the employee’s
VA tour of duty).
 
Reviewing the memorandum submitted by the ACOS/R&D if the ACOS/R&D is the
employee conducting the research.
Suspending or terminating an approved VA project if a VA Investigator is participating in
an approved VA project despite an FCOI that cannot be resolved. Termination of a
project can only be done by the VA medical facility R&D Committee during a convened
meeting.
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
F
C
O
I
 
A
d
m
i
n
i
s
t
r
a
t
o
r
 
R
e
s
p
o
n
s
i
b
i
l
i
t
i
e
s
 
f
o
r
 
I
m
p
l
e
m
e
n
t
a
t
i
o
n
 
o
f
V
H
A
 
D
i
r
e
c
t
i
v
e
 
1
2
0
0
.
1
3
FCOI Administrator 
– Must be a VA paid employee who does not have an affiliate or
NPC appointment or
 appointed as 
the Research Compliance Officer
.
Reviewing and documenting the review of the
 Alt-450 
and accompanying
documents of the project submissions and filing the signed
 Alt-450 within
VAIRRS
.
 
Notifying both the OGC Deputy Ethics Official and the VA medical facility Director
within 3 business days upon becoming aware that a VA investigator is
participating in VA research despite an FCOI that cannot be resolved.
 
Reviewing requests for outside compensation and providing a recommendation
to the VA medical facility R&D Committee as part of the project approval
process.
 
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
V
A
 
I
n
v
e
s
t
i
g
a
t
o
r
 
R
e
s
p
o
n
s
i
b
i
l
i
t
i
e
s
 
f
o
r
 
I
m
p
l
e
m
e
n
t
a
t
i
o
n
 
o
f
V
H
A
 
D
i
r
e
c
t
i
v
e
 
1
2
0
0
.
1
3
VA Investigator
:
Ensuring that he or she discloses any financial conflicts that may impact the study.
Filing initial and annual Alt-450 Forms in VAIRRS
Filing a new Alt-450 in VAIRRS
 if a VA investigator has a change in a financial interest
that requires disclosure, such as when a new financial interest may result in a
potential conflict, within 45 calendar days of the time the change occurred.
Completing annual ethics training.
Submits requests for outside compensation when warranted.
Not participating or initiating research when an FCOI has been determined.
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
R
e
q
u
i
r
e
d
 
V
A
 
I
n
v
e
s
t
i
g
a
t
o
r
 
T
r
a
i
n
i
n
g
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
T
r
a
i
n
i
n
g
 
R
e
q
u
i
r
e
m
e
n
t
s
 
f
o
r
 
V
A
 
I
n
v
e
s
t
i
g
a
t
o
r
s
Unless live training is provided by a qualified OGC instructor prior to
first project submission and annually thereafter, the following TMS
courses are required:
For VA Investigators: Government Ethics – The Essentials (TMS
#3812493)
For health professions trainees:
VHA Mandatory Training for Trainees (TMS #3185966) and VHA
Mandatory Training for Trainees – Refresher (TMS #3192008)
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
R
e
s
e
a
r
c
h
 
C
o
n
f
l
i
c
t
 
o
f
 
I
n
t
e
r
e
s
t
 
M
o
d
u
l
e
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
U
t
i
l
i
z
a
t
i
o
n
 
o
f
 
I
R
B
N
e
t
All Alt-450 Forms must be submitted via IRBNet utilizing the Conflict of
Interest wizard.
A project shell must be created to begin entering Alt-450 Forms
Training is available in the Training Archives at:
Conflict of Interest (COI) Module for Investigators and Committee
Members (va.gov)
VAIRRS Support is also available to host training webinars for the
researcher community
Outside Compensation memorandums may be entered into IRBNet in the
R&DC workspace.
Implementation of VHA Notice 2023-09, Outside Compensation for
Performance of VA Research
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
F
C
O
I
 
A
d
m
i
n
i
s
t
r
a
t
o
r
 
(
F
C
O
I
A
)
 
R
o
l
e
 
a
n
d
 
F
C
O
I
 
A
d
m
i
n
i
s
t
r
a
t
o
r
T
r
a
i
n
i
n
g
Training for FCOI Administrators will be provided by OGC EST prior to
the full implementation of the Directive and will be announced.
Goal
 of the training is to ensure that FCOI Administrators understand
their role in reviewing the Alt-450 Forms, including circumstances
when the FCOIA should certify the Alt-450 Forms instead of assigning
it to OGC Ethics. 
IRBNet will provide Conflict of Interest module training to FCOI
Administrators upon notification the research office is ready to begin
using the module.
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
S
u
m
m
a
r
y
Standardizing submission and review of research financial conflict of
interest disclosures is critical to ensuring VA complies with the
applicable federal ethics laws.
The date for compliance with VHA Directive 1200.13's policies is
September 2, 2024.
For questions, please use Q&A box and address to “All
Panelists.”
 
 
 
R
e
f
e
r
e
n
c
e
s
The Joseph Maxwell Cleland and Robert Joseph Dole Memorial Veterans Benefits and Health
Care Improvement Act of 2022 § 182 (2022)
,
VHA Directive 1200.13 
Financial Conflicts of Interest and Outside Compensation for
Performance in VA Research (May 2, 2024)
 located at 
VHA Publications
Research Financial Conflict of Interest Statement – OGE Form 450 Alternative-VA
located at 
conflict_of_interest.pdf (va.gov)
ORD Webpage: Outside Compensation Guidelines located at 
Outside Compensation
Guidelines: Guidance under development (va.gov)
Delegation of Authority from Secretary to the Under Secretary - Outside Compensation
Delegation of Authority from Under Secretary to Facility Directors
Matrix: Scenarios and Considerations for Outside Pay to VA Compensated Investigators and
Staff Engaged in VA Research
Sample Memo - 
https://www.research.va.gov/resources/policies/sample-memo-outside-
comp.docx
For questions, please use Q&A box and address to “All
Panelists.”
 
 
Q
u
e
s
t
i
o
n
s
 
?
?
?
?
?
For questions, please use Q&A box and address to “All
Panelists.”
Slide Note
Embed
Share

The presentation discusses the implementation of VHA Directive 1200.13 concerning financial conflicts of interest and outside compensation for performance in VA research. It outlines key responsibilities for various roles, submission requirements for conflict of interest statements, training programs, and the background leading up to the directive's publication. The content also covers recent legislative changes impacting VA employees' ability to receive outside compensation for research projects.


Uploaded on Aug 19, 2024 | 0 Views


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


  1. Implementation of VHA Directive 1200.13 Financial Conflicts of Interest and Outside Compensation for Performance in VA Research Presented By: C. Karen Jeans, PhD, CCRN, CIP Director of Regulatory Affairs Antonio Laracuente, MBA Director Field Operations Angela Angie Foster, MS, FAC-P/PM Senior Level Program Manager Christopher Britt, Ethics Attorney Office of General Counsel June 18, 2024

  2. Objectives Objectives Describe the key responsibilities required by VHA Directive 1200.13 for the VA Medical Center Director, Chief of Staff, ACOS/R, R&D Committee, Financial Conflict of Interest (FCOI) Administrators, and VA Investigators; Identify key requirements for submission and review of the Research Financial Conflict of Interest (FCOI) Statement, OGE Form 450 Alternative-VA ( Alt-450 ); Describe how training for Financial Conflict of Interest Administrators review of the OGE Alt-450 forms will be conducted; and Identify training resources provided by the VHA Office of Research and Development (ORD) on the VAIRRS Research Conflict of Interest Module. For questions, please use Q&A box and address to All Panelists.

  3. Background Background On December 28, 2004, VHA Handbook 1200.13 - Financial Conflicts of Interest in Research Handbook was published by ORD and rescinded shortly afterwards on February 1, 2005. Although no ORD policy existed, VA employees are required to adhere to federal ethics laws. The Research FCOI Statement, OGE Form 450 Alternative-VA ("Alt-450"), was developed and approved by the Office of Government Ethics (OGE) for VA Investigators to disclose financial conflicts of interest, allowing review by VA OGC Ethics. Implementation of the Alt-450 varied across VA Facility programs with a lack of a systematic approach for review and determination. Numerous attempts were made to develop a national research financial conflict of interest policy, but major challenges existed. For questions, please use Q&A box and address to All Panelists.

  4. Background (cont.) Background (cont.) On December 29, 2022, the Joseph Maxwell Cleland and Robert Joseph Dole Memorial Veterans Benefits and Health Care Improvement Act of 2022 182 (2022), which is part of the Consolidated Appropriations Act, 2023 (P.L. 117- 328), was signed into law by President Biden. The Law included provisions for the VA employees to receive outside compensation from an academic affiliate or VA Nonprofit Corporation (NPC) to perform the VA-approved research project if certain conditions are met. VHA Notice 2023-09(1) was published on November 28, 2023, which included the implementation policies for the applicable provisions of the Law involving outside compensation. VHA Notice 2023-09(1) is now rescinded with the publication of VHA Directive 1200.13 on May 2, 2024; its policies are incorporated within the Directive. For questions, please use Q&A box and address to All Panelists.

  5. Bottom Line Up Front The publication of VHA Directive 1200.13 codifies the process into formal policy that was implemented with the publication of the OGE 450 Alternative VA (Alt-450 Research Financial Conflict of Interest Statement) in November of 2013 and incorporates the policy requirements of VHA Notice 2023-9(1) (Outside Compensation for Performance of VA Research) published November 28, 2023 into one (1) ORD national Directive. 5

  6. Moving Forward to Implement VHA Directive 1200.13 Moving Forward to Implement VHA Directive 1200.13 The new policy requirements of this Directive are required to be implemented by September 2, 2024 (no later than 4 months following publication date). Key implementation requirements: Appointment of a Financial Conflict of Interest Administrator Utilization of IRBNet (VAIRRS) for submission of and processing the Alt-450 Forms Approval process for outside compensation Including documentation of the decision by the Approving Official Note that this program is different than the affiliate university or VA NPC Conflict of Interest program and must be managed separately. For questions, please use Q&A box and address to All Panelists.

  7. Who is Required to File the Alt Who is Required to File the Alt- -450 Forms 450 Forms All VA investigators (compensated, WOC or IPA), who meet either of the following criteria are considered to hold a position that requires them to complete and submit an Alt-450 Form as required by VHA Directive 1200.13: (1) Hold the position of VA investigator (i.e., principal investigator, co-principal investigator, investigator, co-investigator, sub-investigator or VA medical facility site investigator). NOTE: A VA medical facility site investigator in a multiple-site study can be a VA site principal investigator, co-principal investigator or sub-investigator. (2) All VA employees being proposed for the position of VA investigator. For questions, please use Q&A box and address to All Panelists.

  8. Key Responsible Parties for Implementation of VHA Directive 1200.13 Key Responsible Parties for Implementation of VHA Directive 1200.13 Research & Development (R&D) Committee Financial Conflict of Interest (FCOI) Administrator Medical Center Director VA ACOS/R&D Chief of Staff Investigators For purposes of this presentation, the following individuals or groups will be discussed, but other individuals are also included in VHA Directive 1200.13 For questions, please use Q&A box and address to All Panelists.

  9. VA Medical Facility Director Key Responsibilities for Implementation of VA Medical Facility Director Key Responsibilities for Implementation of VHA Directive 1200.13 VHA Directive 1200.13 VA Medical Facility Director (MCD) Approving Official Ensuring the VA medical facility s research FCOI program is not a combined program with that of the VA medical facility s Affiliate or other entity. Appointing, in writing, a VA medical facility FCOI Administrator who is responsible for the VA medical facility s research FCOI program and reviewing and certifying Alt-450s. Making final binding programmatic decisions in consultation with an OGC Deputy Ethics Official in situations in which an FCOI can be resolved. Terminating research or taking other appropriate actions upon receiving notification that a VA investigator is participating in VA research despite an FCOI that cannot be resolved. Serving as the Approving Official for requests for outside compensation from projects administered by the Affiliate or VA NPC and providing written approval as appropriate. For questions, please use Q&A box and address to All Panelists.

  10. Chief of Staff and ACOS/R&D Responsibilities for Implementation of Chief of Staff and ACOS/R&D Responsibilities for Implementation of VHA Directive 1200.13 VHA Directive 1200.13 Chief of Staff (COS) Can be delegated by MCD to be approving official. Associate Chief of Staff for Research and Development (ACOS/R&D) Ensuring that all VA investigators (compensated, without compensation (WOC) or appointed or detailed to VA under the Intergovernmental Personnel Act (IPA), 5 U.S.C. 3371 et seq.) are assigned annual ethics training within VA Talent Management System (TMS) including tracking and verifying completion. Forwarding outside compensation requests to the Approving Official once the VA medical facility R&D Committee completes their review and provides a recommendation to approve or disapprove. Includes modifications. Providing the original approval to the VA employee upon receiving approval from the Approving Official. A copy of the letter must be placed in VA Innovation and Research Review System (VAIRRS) under the appropriate project. Notifying the VA Investigator if the Approving Official disapproves the outside compensation. For questions, please use Q&A box and address to All Panelists.

  11. R&D Committee Responsibilities for Implementation of R&D Committee Responsibilities for Implementation of VHA Directive 1200.13 VHA Directive 1200.13 R&D Committee Reviewing outside compensation request recommendations by the VA medical facility FCOI Administrator and approving or disapproving the recommendation during the VA medical facility R&D Committee s initial review of the VA project. Ensuring that each review assesses the request with regard to project budget appropriateness, the effort required to conduct the project and the rationale for outside compensation (i.e., why the work cannot be completed during the employee s VA tour of duty). Reviewing the memorandum submitted by the ACOS/R&D if the ACOS/R&D is the employee conducting the research. Suspending or terminating an approved VA project if a VA Investigator is participating in an approved VA project despite an FCOI that cannot be resolved. Termination of a project can only be done by the VA medical facility R&D Committee during a convened meeting. For questions, please use Q&A box and address to All Panelists.

  12. FCOI Administrator Responsibilities for FCOI Administrator Responsibilities for Implementation of VHA Directive 1200.13 VHA Directive 1200.13 FCOI Administrator Must be a VA paid employee who does not have an affiliate or NPC appointment or appointed as the Research Compliance Officer. Reviewing and documenting the review of the Alt-450 and accompanying documents of the project submissions and filing the signed Alt-450 within VAIRRS. Notifying both the OGC Deputy Ethics Official and the VA medical facility Director within 3 business days upon becoming aware that a VA investigator is participating in VA research despite an FCOI that cannot be resolved. Reviewing requests for outside compensation and providing a recommendation to the VA medical facility R&D Committee as part of the project approval process. Implementation of For questions, please use Q&A box and address to All Panelists.

  13. VA Investigator Responsibilities for VA Investigator Responsibilities for Implementation VHA Directive 1200.13 VHA Directive 1200.13 Implementation of of VA Investigator: Ensuring that he or she discloses any financial conflicts that may impact the study. Filing initial and annual Alt-450 Forms in VAIRRS. Filing a new Alt-450 in VAIRRS if a VA investigator has a change in a financial interest that requires disclosure, such as when a new financial interest may result in a potential conflict, within 45 calendar days of the time the change occurred. Completing annual ethics training. Submits requests for outside compensation when warranted. Not participating or initiating research when an FCOI has been determined. For questions, please use Q&A box and address to All Panelists.

  14. Required VA Investigator Training Required VA Investigator Training For questions, please use Q&A box and address to All Panelists.

  15. Training Requirements for VA Investigators Training Requirements for VA Investigators Unless live training is provided by a qualified OGC instructor prior to first project submission and annually thereafter, the following TMS courses are required: For VA Investigators: Government Ethics The Essentials (TMS #3812493) For health professions trainees: VHA Mandatory Training for Trainees (TMS #3185966) and VHA Mandatory Training for Trainees Refresher (TMS #3192008) For questions, please use Q&A box and address to All Panelists.

  16. Research Conflict of Interest Module Research Conflict of Interest Module For questions, please use Q&A box and address to All Panelists.

  17. Utilization of IRBNet Utilization of IRBNet All Alt-450 Forms must be submitted via IRBNet utilizing the Conflict of Interest wizard. A project shell must be created to begin entering Alt-450 Forms Training is available in the Training Archives at: Conflict of Interest (COI) Module for Investigators and Committee Members (va.gov) VAIRRS Support is also available to host training webinars for the researcher community Outside Compensation memorandums may be entered into IRBNet in the R&DC workspace. Implementation of VHA Notice 2023-09, Outside Compensation for Performance of VA Research For questions, please use Q&A box and address to All Panelists.

  18. FCOI Administrator (FCOIA) Role and FCOI Administrator FCOI Administrator (FCOIA) Role and FCOI Administrator Training Training Training for FCOI Administrators will be provided by OGC EST prior to the full implementation of the Directive and will be announced. Goal of the training is to ensure that FCOI Administrators understand their role in reviewing the Alt-450 Forms, including circumstances when the FCOIA should certify the Alt-450 Forms instead of assigning it to OGC Ethics. IRBNet will provide Conflict of Interest module training to FCOI Administrators upon notification the research office is ready to begin using the module. For questions, please use Q&A box and address to All Panelists.

  19. Summary Summary Standardizing submission and review of research financial conflict of interest disclosures is critical to ensuring VA complies with the applicable federal ethics laws. The date for compliance with VHA Directive 1200.13's policies is September 2, 2024. For questions, please use Q&A box and address to All Panelists.

  20. References References The Joseph Maxwell Cleland and Robert Joseph Dole Memorial Veterans Benefits and Health Care Improvement Act of 2022 182 (2022), VHA Directive 1200.13 Financial Conflicts of Interest and Outside Compensation for Performance in VA Research (May 2, 2024) located at VHA Publications Research Financial Conflict of Interest Statement OGE Form 450 Alternative-VA located at conflict_of_interest.pdf (va.gov) ORD Webpage: Outside Compensation Guidelines located at Outside Compensation Guidelines: Guidance under development (va.gov) Delegation of Authority from Secretary to the Under Secretary - Outside Compensation Delegation of Authority from Under Secretary to Facility Directors Matrix: Scenarios and Considerations for Outside Pay to VA Compensated Investigators and Staff Engaged in VA Research Sample Memo - https://www.research.va.gov/resources/policies/sample-memo-outside- comp.docx For questions, please use Q&A box and address to All Panelists.

  21. Questions ????? Questions ????? For questions, please use Q&A box and address to All Panelists.

More Related Content

giItT1WQy@!-/#giItT1WQy@!-/#giItT1WQy@!-/#giItT1WQy@!-/#giItT1WQy@!-/#giItT1WQy@!-/#giItT1WQy@!-/#