Specialty Team Advising Research STAR Presented by April

Specialty Team Advising Research (STAR) Presented by April W. Robinson Attorney, STAR Nonprofit Program Office Executive Director Training March 15, 2017

Staff Locations Attorneys: 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

April Robinson (202) 615 -6762 Alabama Arkansas Georgia Kansas Missouri Mississippi Lisa Shamirian (401) 457 -3350 Idaho Michigan Montana Nevada Oregon Virginia Josyl Barchue (202) 258 -1925 Alaska Maryann Fede (202) 701 -5632 Rebecca Derwood (Woody) Ahern Baird Haskell (202) 341(603) 222 -5852 1446 Sarah Hestad (202) 461 -7722 Nisha Hall (202) 309 -3283 Delaware Loma Linda, CA Colorado California (Northern) Connecticut Arizona Florida Long Beach, CA Maine Nebraska Illinois Fresno, CA New Jersey Maryland Massachusetts Ohio Indiana Hawaii New York City/Long Island Minnesota New Hampshire Oklahoma Iowa North Carolina New York (Upstate) Pennsylvania Kentucky Wyoming Rhode Island Puerto Rico Washington, DC Los North Dakota Angeles, CA Louisiana San Diego, CA S. Carolina New Mexico Vermont South Dakota Tennessee Sepulveda, CA Wisconsin Utah Texas Maryam Azarion (202) 461 -7616 VACO West Virginia OGC STAR NPPO ED Mar. 2017

STAR’s Areas of Law Research Agreements – Cooperative Research and Development Agreements, Material Transfer Agreements, Confidentiality Disclosure Agreements, Cooperative Technology Administration Agreements, Invention Management Agreement, Subawards, Memorandum of Understanding/Agreement Research 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

STAR’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

STAR Lingo CRADA – Cooperative Research and Development Agreement (CRADA), 15 USC 3710 a 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/d efault. cfm or internet website at http: //www. research. va. gov/programs/tech_transfer/model_agreements/de fault. 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/mastercrada. cfm. OGC STAR NPPO ED Mar. 2017

STAR 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

STAR 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

STAR’s Statistics FY’ 13 FY’ 15 FY’ 16 FY’ 17 1 st Qtr CRADA 882 839 944 987 162 CDA 386 588 688 127 45 78 89 18 MTA 117 110 140 156 26 Ethics 132 101 111 87 15 99 67 19 Subawards MOU FY’ 14 48 83 39 OGC STAR NPPO ED Mar. 2017

CRADA Billing Stats Authority: 38 U. S. C. § 7364(a)(1)(D)(2010) Started billing January 2013 Cost Break-down per SOP: �Simple = $215 �Moderate = $650 �Complex = $1225 �Non CRADA/Subaward = $72/hour OGC STAR NPPO ED Mar. 2017

CRADA Billing Stats As of 3/1/17 2013 2014 2015 2016 Total CRADAs billed 338 576 568 496 Total amount billed $106, 899 $177, 624 $215, 140 $197, 254 Total collected $106, 899 $173, 696 $184, 028 $133, 382 Total amount outstanding $0. 00 $3, 928 $31, 112 $63, 872 Total outstanding bills 167 0 8 96 2017 70 $24, 994 $1, 505 $23, 489 63 NOTE: Stats are by calendar year OGC STAR NPPO ED Mar. 2017

What are CRADA Funds used for? 1) OGC Staff 2) 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

STAR Timeline CRADA/Subaward 10 business days for initial review 7 business days for any subsequent review CDA 6 business days for initial review 3 business days for any subsequent review OGC STAR NPPO ED Mar. 2017

How 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

How 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

How Can You Facilitate Working with STAR? Reference STAR GCLaws # in emails. Keep organized files. OGC STAR NPPO ED Mar. 2017

Questions? OGC STAR NPPO ED Mar. 2017

Questions after Today? Please contact your STAR attorney. OGC STAR NPPO ED Mar. 2017