ACTG Leadership PI and Chair –Daniel Kuritzkes, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA Vice Chair –Judith Currier, U. California Los Angeles, Los Angeles, CA, USA International Vice Chair –Ian Sanne, U. Witwatersrand, Johannesburg, S.A. SDMC PI –Michael Hughes, Center for Biostatistics and AIDS Research Harvard School of Public Health, Boston, MA, USA Network Laboratory PI –Robert Coombs, U. Washington, Seattle, WA, USA
Develop & Manage ACTG Network CORE budget Develop & Manage all budgets for consortium partners Develop & Manage all Network protocol budgets Manage Financial interactions with government agencies & other sponsors Report on financial status and management to ACTG Leadership Manage annual progress report, grant applications, and other federal and non-federal reports Maintain financial disclosure program Meeting planning & coordination Manage Social media & press releases Leadership and Operations Center Functions
Compliance Requirements Code of Federal Regulations (CFR) 42 CFR Part 52 – Grants for Research Projects 45 CFR Parts 74 and 92 – Public Welfare, Administrative Requirements (74) (92) 45 CFR Part 46 – Public Welfare, Protection of Human Subjects 9
Cost Principles by Institution OMB Circular A-21 (relocated to 2 CFR part 220) — Educational Institutions.OMB Circular A-21 (relocated to 2 CFR part 220) OMB Circular A-87 (relocated to 2 CFR part 225) — State and Local Governments and Indian Tribal Governments.OMB Circular A-87 (relocated to 2 CFR part 225) OMB Circular A-122 (relocated to 2 CFR part 230) — Non-Profit Institutions. Larger non-profit organizations that are specifically listed in Attachment C to OMB Circular A-122 are subject to the Federal cost principles applicable to commercial organizations (48 CFR part 31.2) rather than to the cost principles for non-profit organizations.OMB Circular A-122 (relocated to 2 CFR part 230) 45 CFR part 74, Appendix E —Hospitals45 CFR part 74, Appendix E 48 CFR part 31.2 (Federal Acquisition Regulation) — Contracts with Commercial Organizations.48 CFR part 31.2 (Federal Acquisition Regulation)
Compliance Requirements NIH Grants Policy Statement (GPS) Notice of Award (NoA) NIH Guide to Grants and Contracts 11
ACTG Protocol Budgets
Protocol Budget Process Who creates the protocol budgets? Where did the costs come from that are applied to protocol budgets? How are the protocol budgets used?
How are Protocol Budgets Created? Protocol Team requests a pre- budget review from Budget Analyst Budget Analyst works closely with the Clinical Trials Specialist (SSS/Network Coordinating Center), the Protocol Chairs and Specialty Labs to accurately capture all protocol related expenses. Finalized budget is reviewed by TSG and SASC. Several reviews and budget revisions may be necessary until protocol is approved for implementation
Where did the costs come from? Routine Site Costs: Personnel and lab costs collected from site surveys in January 2013 Protocol costing working group of a representative group of PIs to review and assign appropriate prices to protocol items. Procedure Costs: Costs collected from site surveys in January Protocol chair, budget analyst and clinical trial specialist review of protocol-specific procedures to determine and apply all costs associated with the procedure
Each study visit is assigned a per patient total by adding all visit assessment costs. How are Protocol Budgets Used? The per patient per visit totals are used to in conjunction with the FSTRF enrollment reports to calculate the total protocol funds (PF)
How are Protocol Funds (PF) Allocated? Using the protocol budgets, FSTRF prepares reports to reflect: - Total cost per site per protocol for continuing patient visits -Total cost per protocol for new patient enrollment Historical patient enrollment data is analyzed to determine future enrollment projections for each site PF is reviewed by the ACTG Executive committee and recommendations are submitted to DAIDS
ACTG Subcontract Process
Statements of Intent (SOI’s) SOI’s need to be completed by cooperating institution before a contract can be issued Contain information necessary to craft a contract such as: –Clear Budget –Clear Statement of Work –Institution business contact information FFATA - Federal Funding Accountability and Transparency Act
Statements of Work (SoW’s) Every transactional contract needs a statement of work in one way or another The purpose of a contract is to create a clear record of agreement for a relationship The clearer and more accurate the SoW is, the stronger and more useful the contract In research agreements, SoW’s must be drafted by those doing the work – in the majority of ACTG cases, that means the subcontractor PI
Per-Patient SoW Example The University of Awesome CRS (site #45481) has met and exceeded their anticipated enrollment into the below high priority ACTG protocols for Year 6 patient enrollment figures and are set to receive an additional monetary supplement. The below listed protocols are incorporated into this Statement of Work by reference.
New International Collaborations BWH requires certain documentation before entering into agreements for research with international sites with whom they have not worked before. Why? Subrecipient Monitoring NIH Grants Policy Statement (10/12) Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities, Consortium Agreements : “The grantee, as the direct and primary recipient of NIH grant funds, is accountable to NIH for the performance of the project, the appropriate expenditure of grant funds by all parties, and all other obligations of the grantee, as specified in the NIHGPS.” “The grantee must require consortium participants to comply with the requirements of OMB Circular A-133 or 45 CFR 74.26(d), as applicable, for audit of NIH grant funds expended by consortium participants.”
International Subrecipient Monitoring Information Needed: –Completed BWH Questionnaire –Most-Recent External Audit (or, if necessary, completed A-133 Audit) Reviewed by BWH Research Controller –Verifies compliance with Federal Regulations Institutional audit –Should be provided by the applicable institutions on an annual basis
New Financial Conflict of Interest Regulations
New Financial Conflict of Interest Requirements Financial Conflict of Interest Regulations from U.S. DHHS apply What does this mean for ACTG sites? –All institutions must have a compliant policy for reporting financial conflicts of interest in research –Additional requirements for reporting conflicts of interest to prime institutions (BWH) and sponsor –Institutions must develop and implement training for research investigators –More information:
Contract Set-Up & Site Payments Angela Rhodes – Amanda Sturchio – Protocol Budgets Melanie King – Contract Negotiations Ben Raynak – No Cost Extensions Angela Rhodes – Steve Fetters – Not sure whom to contact or need additional assistance: Lauren Robertson – I need help, whom do I contact?
Case Study Dr. Award, the PI, is asked to provide Other Support in response to a “Just-In-Time” request (application is being considered for funding). Dr. Award has several NIH grants, funding from a pharmaceutical company, and institutional gift funds. What should Dr. Award include as Other Support?
Case Study A University employee transfers expenses from one account to another and annotates the cost transfer “to correct an accounting error.” Internal Audit takes exception. Why?
Case Study You were recently informed that a foreign sub- recipient had not completed it’s annual audit to be in compliance with U.S. Federal Regulations. You contact the foreign university and are assured that they are in compliance with their country’s regulations and they do not have to comply with U.S. requirements. Is this correct? 31
You just received the great news that your abstract was accepted and will be presented at the 2013 International AIDS Conference, held in Malaysia. You began searching for the most economical flight reservation and found two that would meet your itinerary requirements. Option 1 – American Airlines flight with 3 stopovers, costing $2,500. Option 2 – Singapore Airlines flight with 2 stopovers, costing $1,600. Because the abstract is from your ACTG project you know you are allowed to charge the flight to your CRS award, however, you recall there are restrictions when charging airfare to federal funds. Which flight do you choose? Why? Case Study