Executive Director Training March 15 2017 Specialty Team Advising Research STAR Presented by April W Robinson Attorney STAR Staff Locations Attorneys Maryam Azarion VACO Rebecca Baird Maryland ID: 805251
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Slide1
Nonprofit Program OfficeExecutive Director TrainingMarch 15, 2017
Specialty Team Advising Research (STAR)
Presented by April W. Robinson
Attorney, STAR
Slide2Staff LocationsAttorneys:Maryam Azarion (VACO)Rebecca Baird (Maryland)Josyl Barchue (Connecticut)Maryann Fede (New Jersey)
Nisha Hall (Maryland)Derwood Haskell (New Hampshire)
Sarah Hestad (Nebraska)
April Robinson (Alabama)
Lisa Shamirian (Rhode Island)Legal Assistant:Daniel Knoll (VACO)
OGC STAR NPPO ED Mar. 2017
Slide3OGC STAR NPPO ED Mar. 2017April Robinson(202)615-6762
Lisa
Shamirian
(401)
457-3350
Josyl Barchue
(202)
258-1925
Maryann
Fede
(202)
701-5632
Rebecca Ahern Baird
(202) 341-1446
Derwood (Woody)
Haskell
(603) 222-5852
Sarah
Hestad
(202)
461-7722
Nisha
Hall
(202)
309-3283
Maryam
Azarion
(202)
461-7616
Alabama
Idaho
Alaska
Delaware
Loma Linda, CA
Connecticut
Colorado
California (Northern)
VACO
Arkansas
Michigan
Arizona
Florida
Long
Beach, CA
Maine
Nebraska
Illinois
Georgia
Montana
Fresno, CA
New Jersey
Maryland
Massachusetts
Ohio
Indiana
Kansas
Nevada
Hawaii
New York City/Long Island
Minnesota
New Hampshire
Oklahoma
Iowa
Missouri
Oregon
Los Angeles, CA
North Dakota
North Carolina
New York (Upstate)
Pennsylvania
Kentucky
Mississippi
Virginia
Louisiana
San Diego, CA
Wyoming
Rhode Island
Puerto
Rico
Washington
S. Carolina
New Mexico
Vermont
South Dakota
Washington, DC
Tennessee
Sepulveda,
CA
Wisconsin
Utah
Texas
West Virginia
Slide4STAR’s Areas of LawResearch Agreements – Cooperative Research and Development Agreements, Material Transfer Agreements, Confidentiality Disclosure Agreements, Cooperative Technology Administration Agreements, Invention Management Agreement, Subawards, Memorandum of Understanding/AgreementResearch Issues
– Institutional Review Boards (including informed consent and HIPAA authorization), research misconduct, research oversight, treatment of
subject injury, adverse events
Intellectual Property
– Licenses, Determination of rights including representing the agency before the Commerce Department for any appeals,
Actions
at the USPTO limited to patent assignments, recordation at USPTO, power of attorney, establishing right of assignee to take action, recordation of Government use licenses
OGC STAR NPPO ED Mar. 2017
Slide5STAR’s Areas of Law – (cont’d)VA Nonprofit Corporations – Creation/dissolution/merger; Drafting and revising bylaws and policies; Advising
Boards of Directors, Officers, and Employees; Attendance at NPC
meetings
Exclusions
–
Non-research matters,
e.g.,
personnel, contracts, real property, etc
.
OGC STAR NPPO ED Mar. 2017
Slide6STAR LingoCRADA – Cooperative Research and Development Agreement (CRADA), 15 USC 3710a
et seq.
Model CRADA
– Available a la carte templates for various types of studies (Data Collection through Phase IV). Includes all required VA policy and legal provisions. Located on VA Technology Transfer Program’s (TTP) intranet website at http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm or internet website
at
http://www.research.va.gov/programs/tech_transfer/model_agreements/default.cfm
.
Master CRADA
–
Previously negotiated CRADAs with industry sponsors for Phase I-IV clinical studies. No negotiation is permitted at the local site. Only site-specific changes are permitted,
e.g., parties, PI’s name, contact persons, SOW, protocol, and budget
. Located
on
TTP’s intranet website at http://vaww.research.va.gov/programs/tech_transfer/crada/master-crada.cfm.
OGC STAR NPPO ED Mar. 2017
Slide7STAR Lingo – (cont’d)Multi-Site CRADA - A CRADA that has been negotiated for one specific protocol expected to be conducted at more than one VAMC. The primary
or lead VAMC/NPC and STAR attorney are responsible
for
the negotiations. The final
template is then used at all other
participating VAMC
sites without the need to renegotiate the
terms.
MTA
–
Material Transfer Agreement
(Can be found on TTP’s intranet and internet sites.)
CDA/NDA
–
Confidential Disclosure Agreement/Nondisclosure Agreement Can be found on TTP’s intranet and internet sites.)
OGC STAR NPPO ED Mar. 2017
Slide8STAR Lingo – (cont’d)Subawards – Research agreements used when a federal agency (NIH/DOD) or nonprofit organization has awarded funds to a university or other entity, and the university or other entity wants to sub out a portion of the work to VA. The parties to the agreement are university or other entity, NPC, and VA.
MOUs/MOAs
-
Memorandum of Agreement (MOA) and Memorandum of Understanding (MOU) are statements of cooperation or understanding about a specific or general topic between two (or more) parties. Often used to clarify the roles and responsibilities of parties in a shared situation of interest. More
formal
than a
gentlemen's agreement and less formal
than a
contract
.
OGC STAR NPPO ED Mar. 2017
Slide9STAR’s StatisticsOGC STAR NPPO ED Mar. 2017
FY’ 13
FY’ 14
FY’ 15
FY’
16
FY’ 17
1
st
Qtr
CRADA
882
839
944
987
162
CDA
386
588
688
688
127
Subawards
45
48
78
89
18
MTA
117
110
140
156
26
Ethics
132
101
111
87
15
MOU
99
83
39
67
19
Slide10CRADA Billing StatsAuthority:38 U.S.C. §7364(a)(1)(D)(2010)Started billing January 2013 Cost Break-down per SOP:Simple
= $215
Moderate =
$650
Complex = $1225Non
CRADA/
Subaward
= $72/hour
OGC STAR NPPO ED Mar. 2017
Slide11CRADA Billing StatsOGC STAR NPPO ED Mar. 2017NOTE: Stats are by calendar year
2013
2014
2015
2016
As of 3/1/17
2017
Total CRADAs billed
338
576
568
496
70
Total amount billed
$106,899
$
177,624
$
215,140
$197,254
$24,994
Total collected
$106,899
$
173,696
$184,028
$133,382
$1,505
Total amount outstanding
$0.00
$3,928
$31,112
$63,872
$23,489
Total outstanding bills
0
8
96
167
63
Slide12What are CRADA Funds used for?1) OGC Staff2) Staff Training 3
) Travel related to such training
Expenses
covered by the “staff” category include:
1) Costs of dedicated attorneys or paralegals
2) Awards or bonuses to staff for
achievements
in this
area
3
) Educational materials related to VA
non-
profits/research
and education. OGC STAR NPPO ED Mar. 2017
Slide13STAR TimelineCRADA/Subaward10 business days for initial review7 business days for any subsequent review
CDA 6 business days for initial review3 business days for any subsequent review
OGC STAR NPPO ED Mar. 2017
Slide14How Can You Facilitate Working with STAR? Work with your STAR attorney closely.Review documents before you forward them.Complete the CRADA cover page and contact sections before forwarding the CRADA.Ensure you have been given an unprotected
draft.Ask if there is a Contract Research Organization (CRO) involved.
Ask if the study is taking place at other VAMC sites.
OGC STAR NPPO ED Mar. 2017
Slide15How Can You Facilitate Working with STAR? Update your contact info (email, address, phone number).Forward a complete CRADA review package
:Redlined/tracked-changes copy of CRADA/agreement, &
Conflict of Interest Form
(PDF fillable form on TTP’s site)
, &Copy of Full Protocol (No abstracts or synopsis)
.
OGC STAR NPPO ED Mar. 2017
Slide16How Can You Facilitate Working with STAR?
Reference STAR GCLaws # in emails.
Keep organized files.
OGC STAR NPPO ED Mar. 2017
Slide17Questions?OGC STAR NPPO ED Mar. 2017
Slide18Questions after Today?Please contact your STAR attorney.OGC STAR NPPO ED Mar. 2017