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  • These are characteristics that can help you tell.
  • Re-arranged all of the cost-principle circulars together and the uniform administrative requirement circulars together and that A-133 affects all of these groups
  • ---Notes---
  • Often with private foundations, the letter proposal will be what determines the funding decision; the “second stage” may only be a request for a revised budget and some further additional information Often letter proposals and/or preliminary proposals are the result of conversations between the principal investigator and the sponsor’s program staff.
  • Abstract – usually “plain English”; should also specify relevance of project Statement of Work – the “science” Appendices – cannot be used to circumvent page limitations
  • Generally, as research administrators, we’re not reviewing the science, but we should be making sure all the required parts are there and in the right order, etc. For private foundations, you might want to spend more time reading the programmatic description, especially if your faculty/project directors who are applying are new to grant writing or if the foundation is a a more-community based agency than a research foundation. It’s always a judgment call, if your sponsored projects office should be reading and commenting on the proposal. But depending on the department and the sponsor, I have found that project directors/PIs are generally grateful to know about grammatical and editing errors during a review. Of course there’s always the case where they just don’t understand the mistake… we were reviewing a proposal cover letter which stated that the project would begin on July 1, 2000 and would commence on June 30, 2001. When brought to the attention of the submitting department (which was either the English or Education dept. – I don’t quite remember), they argued that the word “commence” meant “end.” It was quite a battle to have them change the letter.
  • Purpose: Establishes uniform administrative requirements; establishes maximum and consistent requirement – it’s the ceiling.
  • Purpose: Establishes instructions and forms used in applying for federal assistance. Substantial Involvement is generally of a programmatic nature.
  • The research funding agencies (NIH, NSF, Defense Agencies, DOE, etc) have used their own forms for years. With grants.gov, they have created the 424R&R (research and research related) to more closely align with the other agencies.
  • “ Exceptional Institutions”
  • NIH Salary cap – applies to grants, cooperative agreements and contracts for all personnel, except consultants; part of NIH’s annual appropriation from Congress; changes annually with Federal pay raises in January. COLA – if your institution uses them
  • I’m going to skip around here and talk about “other” costs. I’ll cover sub-agreements and consultants together as “third party” agreements.
  • NSF no longer specifies a maximum daily rate for consultants; however, this policy change is not retroactive. Any earlier awards are still subject to the maximum daily rate.
  • Construction/Renovation/Remodeling is only allowable under certain circumstances; check agency regulations.
  • Mandatory – required; stated in the program announcement or funding guidelines. Voluntary – listed on the budget, but not required as part of the program announcement – generally to be discouraged! Voluntary Uncommitted – not part of proposal budget, generally faculty academic year effort, should not be counted as cost-sharing by auditors Most federal agencies only want to see cost-sharing if it is mandatory – It does not help the fundability of a project!
  • Representations & Certifications – May also be called Assurances – provided by the Authorized Official at the time the proposal is signed – insures that the institution has appropriate policies in place and is compliant with the Federal Law regarding equal employment, protection of rights (race, age, gender, religion, sexual preference) Institution is not delinquent on Federal Debt (loans) – Ask your financial officer about any issues – contact with post-award – Sanctions for delinquent debt can include awards not being made and agencies collecting delinquent debt of offsetting payments due under other federal programs Neither the institutions nor any of its principals are presently debarred or suspended, not been convicted or had a civil judgment for fraud within the previous three year period. from participation in government programs Regulations implemented by common rule (Grants) Federal Acquisition Regulations (Contracts) BACKGROUND: Development of a government-wide system for transactions with federal agencies to detect fraudulent or improper use of government funds APPLICABILITY: Agreements in excess of $25,000. Flow down required CERTIFICATION: Applicants, their principals and researchers are not: Presently debarred or suspended Have not been convicted or had civil judgment for fraud rendered within a three year period Are not presently charged by a Government entity Have not had a public transaction terminated for cause or default within a three year period Drug-Free Workplace Regulation: Federal Register, May 25, 1990 Applicability: All grants to institutions & individuals All federal contracts to individuals All other contracts over $25k- with exceptions Compliance: Generally handled by combination of institution personnel office and student affairs; certification made by research administration office Applies to Controlled Substances, but not Alcohol Drug-free Work Force Regulation: DFAR, Subpart 223.570 Contract clause: DFAR, 252.223-7004 Applicability: All contracts involving access to classified information Any other contract upon determination that clause is necessary for national security or protecting health and safety No flow-down requirements Expands upon drug-free workplace by adding: Random drug testing requirements Supervisory training Applies to Controlled Substances, but not Alcohol Drug-Free Schools and Campuses Act - Statute and Regulation: Public Law 101-226 Federal Register, August 16,1990 Applicability: all programs receiving federal financial assistance; No flow-down requirement; Applies to Controlled Substances AND Alcohol Requirements: Adoption and implementation of a drug prevention program to prevent the unlawful possession, use or distribution of illicit drugs and alcohol to all students and employees on institutional premises or as part of any of its activities
  • Sponsor Requirements – page limitations, font size and type, elements of proposal, method of transmittal, limitation on number of proposals from institution, signatures Institutional Policies – cost sharing Statutory Requirements – requirement for state review, research subjects, recombinant DNA, HESC… Appropriateness of the budget – research subjects in budget, cost sharing, correct rates used, correct base used
  • Typical Peer Review Criteria Conformity to goals of sponsor Quality of proposal Soundness of proposal budget program space, resources, personnel Probability of accomplishment
  • Rights To Inventions Made By Nonprofit Organizations & Small Business Firms Under Gov’t Grants, Contracts and Cooperative Agreements - Bayh-Dole Act - 37 CFR Part 401 Requirements (contd): Preference for U.S. industry in licensing Reasonable efforts to license to small businesses No assignment of title except to invention management organizations Royalty sharing with inventor Balance of royalties to be used for scientific research or education Written agreements with all technical employees Invention awareness programs
  • Phase IV Participants in the Federal Demonstration Partnership Federal Agencies 1. National Science Foundation 2. National Institutes of Health 3. Office of Naval Research 4. Department of Energy 5. Department of Agriculture 6. Air Force Office of Scientific Research 7. Army Research Office 8. Army Medical Research & Materials Command 9. National Aeronautics & Space Administration 10. Environmental Protection Agency 90 Institutional Members 2 Emerging Research Institutions Affiliate Organizations (including NCURA) Expanded Authorities - No Cost Extension Pre-Award Costs Equipment Foreign Travel These provisions may be superseded by particular award terms and conditions. Prior approval of the sponsor is required for change in the scope or objectives of the project; for the absence of more than 3 months of the PI; or for more than 25% reduction of the PI’s time devoted to the project. Subawards normally require prior sponsor approval, unless included in the approved budget. The mission of FDP is to explore methods that streamline and simplify grants administration Expanded authorities is an example of a successful FDP initiative that has significantly simplified the administration of grants
  • A-110: Reports and Records When required, performance reports (technical reports) shall generally contain: Comparison of actual accomplishments with goals established for the period, the finding or both; Reasons why established goals were not met; and Other information including, when appropriate, analysis and explanation of cost overruns or high unit costs. Recipient shall notify the federal awarding agency when: Events occur that have a significant impact on the project or program; and/or Problems, delays or adverse conditions occur that materially impair the ability to attain program objectives. Site visits A-110: Reports and Records (continued) Financial Reporting Standard forms are specified for obtaining financial information. Financial Status Report (SF-269) Federal Agency has option to use Request for Advance or Reimbursement or Cash Transactions Report if they provide adequate information. FSR is required at completion of project. May require cash or accrual basis. Timing: 30 days after the conclusion of each specified reporting period for quarterly and semi-annual reports and within 90 days of annual or final reports. A-110: Reports and Records (continued) Report of Federal Cash Transactions (SF-272) For advances through letter of credit and reporting within 15 days after each quarter. May require explanation of cash in excess of 3 days needs, legislative requirements, or accounting standards questions. Machine readable formats allowed . Request for advance or reimbursement (SF-270) Used only where letter of credit or predetermined advance method is not used.
  • web.mit.edu

    1. 1. Pre-Award Fundamentals of Research Administration NCURA Region I Annual Spring Meeting May 7 th , 2006 Portland, Maine
    2. 2. FACULTY <ul><li>Sara Clabby </li></ul><ul><ul><li>Contract Administrator, Office of Sponsored Programs, Brown University </li></ul></ul><ul><li>Bethanne Giehl </li></ul><ul><ul><li>Assistant Director, Research Funding Services </li></ul></ul><ul><ul><li>University of Massachusetts Medical School </li></ul></ul><ul><li>Celia Gravely </li></ul><ul><ul><li>Project Manager </li></ul></ul><ul><ul><li>Huron Consulting Services </li></ul></ul>
    3. 3. Frequently Asked Questions that will NOT be Answered… <ul><li>Why do faculty always wait until the last minute? </li></ul><ul><li>Why does the government only add regulations, but never takes any away? </li></ul><ul><li>Is it too late to find another line of work? </li></ul><ul><li>Is there a profession with more acronyms than Research Administration? </li></ul><ul><li>Why is this meeting room so hot? </li></ul><ul><li>And….. </li></ul><ul><li>Why is this room so cold? </li></ul>
    4. 4. PreAward Fundamentals <ul><li>Rules & Requirements </li></ul><ul><li>Federal Guidelines </li></ul><ul><li>Sponsor Guidelines </li></ul><ul><li>Institution Policies </li></ul><ul><li>Sponsored Projects Administration </li></ul><ul><li>What we do </li></ul><ul><li>Who we are </li></ul><ul><li>Central and De-central </li></ul><ul><li>Why? </li></ul>
    5. 5. Lifecycle of a Proposal/Award Pre-Award Post-Award Development Agency Review (6-9 mos) Project Period 1st Budget Period 2nd Budget Period 3rd Budget Period No Cost Extension Revised Budget Submit Renewal / Competing-Continuation Closeout Final Reports Submit Proposal Pre-Award Costs Award Award Apply Find/Explore Administer/Monitor (Post-Award Office) Perform (Principal Investigator) Technical Close (Principal Investigator) Financial Close (Post-Award Office)
    6. 6. “ Research and development! My goodness!”
    7. 7. The Rules and Who Makes Them <ul><li>A Structure Based on: </li></ul><ul><li>Overarching Federal Regulations </li></ul><ul><li>Parties to the relationship </li></ul><ul><ul><li>Sponsors and Performers </li></ul></ul><ul><ul><li>Sponsors announce opportunities </li></ul></ul><ul><li>The formal Agreement between the parties </li></ul><ul><ul><li>Grant; Contract; Cooperative Agreement </li></ul></ul><ul><li>Agreements contain a set of rules, terms, and conditions </li></ul><ul><ul><li>Statutes; regulations; standard terms; specific conditions </li></ul></ul>
    8. 9. Who are our Sponsors? <ul><li>Federal Government </li></ul><ul><ul><li>Departments </li></ul></ul><ul><ul><ul><li>Agencies </li></ul></ul></ul><ul><ul><li>Independent Agencies </li></ul></ul><ul><li>State Government </li></ul><ul><li>Foundations and Non-Profit Organizations </li></ul><ul><li>Industry </li></ul><ul><ul><li>Large Entities (over 500 Employees) </li></ul></ul><ul><ul><li>Small Entities (under 500 Employees) </li></ul></ul>
    9. 10. Examples of our Sponsors <ul><li>Agencies or Sponsors </li></ul><ul><li> DHHS Department of Health and Human Services </li></ul><ul><ul><ul><li>PHS Public Health Service </li></ul></ul></ul><ul><ul><ul><li>NIH National Institutes of Health </li></ul></ul></ul><ul><ul><ul><li>NSF National Science Foundation </li></ul></ul></ul><ul><ul><ul><li>DOD Department of Defense </li></ul></ul></ul><ul><ul><ul><li>AFOSR Air Force Office of Scientific Research </li></ul></ul></ul><ul><ul><ul><li>ARPA Advanced Research Projects Office </li></ul></ul></ul><ul><ul><ul><li>ARO Army Research Office </li></ul></ul></ul><ul><ul><ul><li>ONR Office of Naval Research </li></ul></ul></ul><ul><ul><ul><li>DOC Department of Commerce </li></ul></ul></ul><ul><ul><ul><li>NIST Nat. Inst. of Standards and Technology </li></ul></ul></ul><ul><ul><ul><li>AHA American Heart Association </li></ul></ul></ul><ul><ul><ul><li>JDRF Juvenile Diabetes Research Foundation </li></ul></ul></ul><ul><ul><ul><li>Whitaker Whitaker Foundation </li></ul></ul></ul><ul><ul><ul><li>Monsanto Monsanto Industries </li></ul></ul></ul><ul><ul><ul><li>HP Hewlett-Packard </li></ul></ul></ul><ul><ul><ul><li>MASS-Ed Massachusetts Department of Education </li></ul></ul></ul><ul><ul><ul><li>FL-F&W Florida Department of Fish and Wildlife </li></ul></ul></ul>Federal Non-Profit Industry State
    10. 11. How Sponsors Announce Opportunities <ul><ul><li>PA Program Announcement (sponsor publication, Federal </li></ul></ul><ul><ul><li>Register, FedBizzOpps) (grants, cooperative agreements) </li></ul></ul><ul><ul><li>RFA Request for Applications (grants, cooperative agreements) </li></ul></ul><ul><ul><li>RFP Request for Proposals (contracts) </li></ul></ul><ul><ul><li>RFQ Request for Quotation (contracts) </li></ul></ul><ul><ul><li>RFB Request for Bid (contracts) </li></ul></ul><ul><ul><li>BAA Broad Agency Announcement (grant, cooperative agreement, contract) </li></ul></ul><ul><li>Response to Announcement in Form of Proposal </li></ul><ul><ul><li>Also called application; quotation; bid </li></ul></ul><ul><ul><li>Lays out general plan of work, personnel, budget to meet stated objectives </li></ul></ul>unsolicited solicited
    11. 12. Types of Agreements: <ul><li>Most Common Types of Formal Agreements With the Federal Government </li></ul><ul><li>Types of Award Actions </li></ul>
    12. 13. Formal Agreements <ul><li>Most Common Types Of Formal Agreements </li></ul><ul><ul><li>Grant </li></ul></ul><ul><ul><li>Cooperative Agreement </li></ul></ul><ul><ul><li>Contract </li></ul></ul>Assistance Mechanisms Procurement
    13. 14. Formal Agreements: Assistance Mechanisms <ul><li>Grant </li></ul><ul><ul><li>Purpose is to transfer money, property, services, or anything of value to recipient in order to accomplish a public purpose </li></ul></ul><ul><ul><li>Idea originates with “performer” </li></ul></ul><ul><ul><li>No substantial involvement is anticipated between sponsor and recipient during performance of activity </li></ul></ul><ul><li>Cooperative Agreement </li></ul><ul><ul><li>Principal purpose is to transfer funds to recipient to accomplish a public purpose </li></ul></ul><ul><ul><li>Idea may originate with “performer” </li></ul></ul><ul><ul><li>Substantial involvement is anticipated between sponsor and recipient during performance of activity </li></ul></ul>
    14. 15. Formal Agreements: Procurement Mechanisms <ul><li>Contract </li></ul><ul><ul><li>Often called a “procurement mechanism” </li></ul></ul><ul><ul><li>Sponsor determines that procurement contract is appropriate </li></ul></ul><ul><ul><li>Principal purpose is to acquire property or services for direct benefit or use of the sponsor </li></ul></ul><ul><ul><li>Idea originates with “sponsor” </li></ul></ul>
    15. 16. Contract Types <ul><li>Fixed Price Contract </li></ul><ul><li>Cost-reimbursement Contract </li></ul><ul><li>Time-and-Materials Contract </li></ul><ul><li>Labor-hour Contract </li></ul><ul><li>Plus variations and combinations of each of the above </li></ul>
    16. 17. Fixed Price Contracts <ul><li>Procurement of supplies or services on the basis of reasonably definite functional or detailed specifications. </li></ul><ul><li>When costs can be estimated reasonably accurately. </li></ul><ul><li>Imposes on contractor maximum incentive to control costs, but with minimum administrative burden. </li></ul>
    17. 18. Cost-Reimbursement Contracts <ul><li>Procurement of non-commercial items which cannot be based on reasonably definite functional or detailed specifications (i.e., R&D). </li></ul><ul><li>There is no incentive for contractor to control costs, thus government imposes tighter controls. </li></ul>
    18. 19. CR/FP - How Do I Tell? <ul><li>Cost-Reimbursement </li></ul><ul><ul><li>“ Total estimated cost” or “not to exceed amount” </li></ul></ul><ul><ul><li>Invoicing based on expenditures </li></ul></ul><ul><ul><li>Listed FAR clauses. </li></ul></ul><ul><li>Fixed Price </li></ul><ul><ul><li>“ Total Price” </li></ul></ul><ul><ul><li>Invoicing based on milestones </li></ul></ul><ul><ul><li>Generally, POs are fixed-price </li></ul></ul><ul><ul><li>Listed FAR clauses </li></ul></ul>
    19. 20. Time-and-Materials and Labor Hour Contracts <ul><li>Reimbursement of hours worked, not costs incurred. </li></ul><ul><li>Fixed hourly rate that incorporates salary, fringe benefits, F&A, and fee. </li></ul><ul><li>Rates invoiced must match proposed rates, regardless of actual cost incurred. </li></ul><ul><li>Audit? </li></ul><ul><li>What to do about them… </li></ul><ul><ul><li>Don’t accept unless your financial system can support it. </li></ul></ul><ul><ul><li>Argue on the basis of cost accounting standards; or </li></ul></ul><ul><ul><li>Negotiate a range to the allowable invoicing rates </li></ul></ul>
    20. 21. Grant vs. Contract <ul><li>Grant </li></ul><ul><li>project conceived by </li></ul><ul><li>investigator </li></ul><ul><li>agency supports or assists </li></ul><ul><li>performer defines details and </li></ul><ul><li>retains scientific freedom </li></ul><ul><li>agency maintains cognizance </li></ul><ul><li>unilateral </li></ul><ul><li>Contract </li></ul><ul><li>project conceived by agency </li></ul><ul><li>agency procures service </li></ul><ul><li>agency exercises direction or </li></ul><ul><li>control </li></ul><ul><li>agency closely monitors </li></ul><ul><li>bilateral </li></ul>
    21. 22. Comparing the Basic Types Of Agreements <ul><li>COOPERATIVE GRANT AGREEMENT CONTRACT </li></ul><ul><li>BASIC PURPOSE Provide assistance Provide assistance with substantial Procure tangible with few restrictions involvement between parties goods and services </li></ul><ul><li>SOLICITATION METHOD Application kit or Request for Application Request for Proposal or guidelines Quote </li></ul><ul><li>AWARD INSTRUMENT Short, may refer to Describes involvement, party Long, detailed specs, general conditions relationships clauses, regulations, and expected result </li></ul><ul><li>INVOLVEMENT Generally none Substantial involvement May be extensive </li></ul><ul><li>BY SPONSOR </li></ul><ul><li>REBUDGETING Flexible Usually flexible More restrictive </li></ul><ul><li>EQUIPMENT TITLE Grantee Varies Varies </li></ul><ul><li>PERFORMANCE PERIOD Specified in Grant Specified in Coop. Agreement Specified in Contract </li></ul><ul><li>PATENT RIGHTS Usually favor recipient May be involved Provision in contract </li></ul><ul><li>PUBLICATIONS May ask to be informed May ask to be informed May be prior review/approval </li></ul><ul><li>TECHNICAL Annual summary report No more than quarterly Detailed, maybe monthly </li></ul>
    22. 23. Hierarchy of Federal Regulations <ul><li>Sources: </li></ul><ul><li>Statutory requirements (i.e., an Act of Congress, becoming Public Law) </li></ul><ul><li>Presidential Executive Order </li></ul><ul><li>Federal regulations </li></ul><ul><li>Sponsor’s terms/conditions </li></ul>NIH Salary cap appears as statutory language in the HHS appropriations act Affirmative Action NSF regulations on Uniform Administrative Requirements appear in 45 CFR 602 NSF grant terms and conditions appear in the NSF Grant Policy Manual & NSF Grant General Conditions (CG-1) Examples:
    24. 25. Types of Award Actions <ul><li>New Award/Competing Award </li></ul><ul><li>Continuation Award/Non-competing Award </li></ul><ul><li>Supplemental Award </li></ul><ul><li>Modification (e.g., budgetary revision, change of key personnel, administrative change, termination notice) </li></ul><ul><li>No-Cost Extension </li></ul><ul><li>Amendments (usually associated with contracts) </li></ul><ul><li>Subaward </li></ul>
    25. 26. Typical Elements of an Award Notice <ul><li>Awarding entity and authority </li></ul><ul><li>Award number </li></ul><ul><li>Recipient (institution) </li></ul><ul><li>Name of PI or project director </li></ul><ul><li>Reference to proposal or project title </li></ul><ul><li>Funding (total, incremental?) </li></ul><ul><li>Cost basis (reimbursement, fixed?) </li></ul><ul><li>Dates (start, end) </li></ul><ul><li>Reports, deliverables </li></ul><ul><li>Terms and conditions </li></ul><ul><ul><li>Stated in text, attached, or incorporated by reference </li></ul></ul>
    26. 27. Excerpt from Award Letter Federal <ul><li>The National Science Foundation hereby awards a grant of $70,411 to NAME OF UNIVERSITY for support of the project described in the proposal referenced above as modified by revised budget dated June 2, 2005. This project, entitled &quot;Cyclic Processes Within Surface-exposed Fractures Affecting Evaporation and Salinization Mechanisms,&quot; is under the direction of PI “Smith”. </li></ul><ul><li>This award is effective August 1 , 2005 and expires July 31, 2006. This is a continuing grant which has been approved on scientific / technical merit for approximately 4 years. Contingent on the availability of funds and the scientific progress of the project, NSF expects to continue support at approximately the following level: FY 2006 $123,118 FY 2007 $121,019 FY 2008 $35,192. </li></ul><ul><li>This grant is awarded pursuant to the authority of the National Science Foundation Act of 1950, as amended (42 U.S.C. 1861-75) and is subject to NSF Grant General Conditions (GC-1), dated 6/15/05 available at http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gc1605. </li></ul>
    27. 28. Office of Management and Budget Circulars <ul><li>OMB Circulars for Cost Principles Applicable To All Awards </li></ul><ul><li>A-21 Cost Principles for Educational Institutions </li></ul><ul><li>A-87 Cost Principles for State, Local and Indian Tribal Governments </li></ul><ul><li>A-122 Cost Principles for Non-Profit Organizations </li></ul><ul><li>Uniform Administrative Requirements </li></ul><ul><li>A-110 Grants and other Agreements with Institutions of Higher </li></ul><ul><li>Education, Hospitals, and other Non-Profit Organizations: </li></ul><ul><li>Uniform Administrative Requirements </li></ul>
    28. 29. Office of Management and Budget Circulars <ul><li>OMB Circulars for Uniform Administrative Requirements (contd.) </li></ul><ul><li>A-102 Uniform Administrative Requirements for Grants and </li></ul><ul><li>Cooperative Agreements With State and Local Governments </li></ul><ul><li>Regulations Applicable to Audits </li></ul><ul><li>A-133 Audits of States, Local Governments and Non-Profit </li></ul><ul><li>Organizations </li></ul><ul><li>Regulations Applicable To Procurement Actions </li></ul><ul><li>FAR Federal Acquisition Regulations (first published, Federal Register, 9/19/83; on-going revisions) </li></ul>
    29. 30. The Front Page of the Newspaper Test “ Contemplating any business act, an employee should ask himself whether he would be willing to see it immediately described by an informed and critical reporter on the front page of his local paper, there to be read by his spouse, children, and friends.” --- Warren E.Buffet
    30. 31. Responsible Conduct of Research Compliance Topics <ul><li>Responsible Conduct of Research </li></ul><ul><li>Research Misconduct </li></ul><ul><li>Financial Conflict of Interest </li></ul><ul><li>Human Subjects </li></ul><ul><li>Animal Care </li></ul><ul><li>Recombinant DNA </li></ul><ul><li>Hazardous Materials </li></ul><ul><li>Data Rights, Access, & Protection </li></ul>
    31. 33. Responsible Conduct of Research <ul><li>PHS requirement for trainees on K-30, T-32 and T-34 awards to complete instruction in the following: </li></ul><ul><ul><li>Data acquisition, management, sharing, and ownership </li></ul></ul><ul><ul><li>Mentor/trainee responsibilities </li></ul></ul><ul><ul><li>Publication practices and responsible authorship </li></ul></ul><ul><ul><li>Peer review </li></ul></ul><ul><ul><li>Collaborative science </li></ul></ul><ul><ul><li>Human subjects </li></ul></ul><ul><ul><li>Research involving animals </li></ul></ul><ul><ul><li>Research misconduct </li></ul></ul><ul><ul><li>Conflict of interest and commitment </li></ul></ul>Institution determines content, length, format, and who covered
    32. 34. “ About these experiments you’ve conducted for 12 years — no one remembers hiring you.”
    33. 35. Research Misconduct <ul><li>Research misconduct defined </li></ul><ul><li>does not include honest error or honest differences in interpretations or judgments of data. </li></ul><ul><li>Government-wide policy issued by OSTP, December 2000 </li></ul><ul><li>Designed to replace existing PHS and NSF rules and to be adopted by all federal funding agencies </li></ul><ul><li>Changes adopted by NASA, NSF, VA, USDA, DOE, EPA, DHHS and DOL </li></ul>“ fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.”  
    34. 36. Research Misconduct <ul><li>Institutions must develop policies and procedures to deal with allegations of misconduct to include: </li></ul><ul><ul><li>Definitions </li></ul></ul><ul><ul><li>Written policy </li></ul></ul><ul><ul><li>Description of inquiry and investigational phases </li></ul></ul><ul><ul><li>Process for protection of whistleblowers </li></ul></ul><ul><ul><li>Reporting to agency (process, timing) </li></ul></ul><ul><ul><li>Retention of records </li></ul></ul><ul><ul><li>Certification requirements </li></ul></ul><ul><li>DHHS requires Assurance Annual Report on Possible Misconduct </li></ul>
    35. 37. Financial Conflict of Interest <ul><li>PHS Regulation and final NSF policy effective on October 1, 1995 </li></ul><ul><li>Regulation / policy similar in content </li></ul><ul><li>Major components of the regulations: </li></ul><ul><ul><li>Contractors / grantees must have adequate policies </li></ul></ul><ul><ul><li>Disclosures of financial interests of faculty and family must be made by PIs and others having decision- making authority over conduct of work </li></ul></ul><ul><ul><li>Financial interest defined as $10,000 annual income or 5% equity whichever is less </li></ul></ul><ul><ul><li>Contractors/grantees have discretion over who reviews disclosures </li></ul></ul>
    36. 38. Financial Conflict of Interest <ul><li>Specific criteria for review will be at institution’s discretion </li></ul><ul><li>Management of conflicting financial interests must be undertaken </li></ul><ul><li>Applications must contain certifications </li></ul><ul><li>Institutional records are subject to federal review </li></ul>Bottom line is that at a minimum, institutions must have written policies in compliance with federal regulation/policy.
    37. 40. Financial Conflict of Interest <ul><li>Investigator Conflict of Interest versus </li></ul><ul><li> Institutional Conflict of Interest </li></ul><ul><li>Institutional Conflict of Interest </li></ul><ul><ul><li>Equity Interest in Company </li></ul></ul><ul><ul><li>Licensing Interest </li></ul></ul><ul><ul><li>Interest Held by Institutional Officers </li></ul></ul><ul><li>Human Subject Consideration </li></ul><ul><ul><li>Informed Consent </li></ul></ul><ul><ul><li>May 2004 DHHS Guidance </li></ul></ul>
    38. 41. Confidentiality of Patient Records ( meant to protect patients seeking drug and alcohol treatment) <ul><li>Applicability: </li></ul><ul><li>All programs funded in whole or in part by federal funds </li></ul><ul><li>Flow-down requirement to subrecipients </li></ul><ul><li>Records cannot be used to initiate or substantiate criminal charges </li></ul><ul><li>Records can only be released with consent of patient except: </li></ul><ul><ul><li>when identity withheld </li></ul></ul><ul><ul><li>when authorized by court </li></ul></ul>
    39. 42. Confidentiality of Patient Records: HIPAA <ul><li>Health Insurance Portability and Accountability Act of 1996 (HIPAA) </li></ul><ul><ul><li>Congress failed to pass legislation before 8/21/99, which resulted in authorization of DHHS to issue regulation </li></ul></ul><ul><ul><li>Final Rule issued on August 14, 2002; Implementation by April 14, 2003 </li></ul></ul><ul><li>http://aspe.hhs.gov/admnsimp/pvcfact1.htm </li></ul><ul><li>45 CFR Part 160 </li></ul><ul><li>Provisions: </li></ul><ul><ul><li>Patient Education on Privacy </li></ul></ul><ul><ul><li>Patient Guaranteed Access to Medical Records </li></ul></ul><ul><ul><li>Patient Must Give Prior Approval Before Release of Records </li></ul></ul><ul><ul><li>Release of Minimum Necessary for Health Care Purposes Only </li></ul></ul><ul><ul><li>Provide Recourse if Violated – Civil and Criminal Penalties Through the DHHS Office for Civil Rights </li></ul></ul><ul><ul><li>Records for Research Purposes; Oversight by IRB or Privacy Board </li></ul></ul>
    40. 43. Functions and Organization of Sponsored Projects Administration <ul><li>Functions </li></ul><ul><li>Organizational Participants </li></ul><ul><li>Organizational Models </li></ul>
    41. 44. Functions of Research Administration: Examples <ul><li>Policy and procedure development, implementation </li></ul><ul><li>Funding opportunity development, promotion, advancement </li></ul><ul><li>Interpretation of guidelines, preparation and review of proposals </li></ul><ul><li>Stewardship and accountability </li></ul><ul><li>Financial and programmatic oversight </li></ul><ul><li>Project performance and delivery </li></ul><ul><li>Subcontracts, purchase of goods and services </li></ul>May be handled by different offices
    42. 45. More Examples <ul><li>Training </li></ul><ul><li>Negotiation, dispute resolution </li></ul><ul><li>Reports </li></ul><ul><ul><li>Progress </li></ul></ul><ul><ul><li>Fiscal </li></ul></ul><ul><ul><li>Final </li></ul></ul><ul><li>Certification, compliance </li></ul><ul><li>Risk management </li></ul><ul><li>Transfer to public benefit, economic development, communication of outcomes </li></ul>
    43. 46. Organizational Participants <ul><li>Executive Administration </li></ul><ul><li>Academic and Research Divisions </li></ul><ul><li>Business Divisions </li></ul><ul><li>Legal Office </li></ul><ul><li>Other </li></ul>
    44. 47. “ Friend of the administration or friend of research?”
    45. 48. Organizational Models <ul><li>Unified </li></ul><ul><ul><li>Under one division at the institution </li></ul></ul><ul><ul><li>May have other offices distributed (e.g., compliance) </li></ul></ul><ul><li>Separate </li></ul><ul><ul><li>Parallel </li></ul></ul><ul><ul><li>Under academic and business divisions </li></ul></ul>
    46. 49. Organizational Models <ul><li>Organizational Models Depend on: </li></ul><ul><ul><li>Tradition </li></ul></ul><ul><ul><li>Philosophy </li></ul></ul><ul><ul><li>Size and mission of institution </li></ul></ul><ul><ul><li>Experience </li></ul></ul><ul><li>Key to success with any model: </li></ul><ul><li>COMMUNICATION </li></ul>
    47. 50. Why Sponsored Projects? (The Institution’s Perspective) <ul><li>Increase Status/Prestige </li></ul><ul><li>Attract New Faculty and Students </li></ul><ul><li>Train Future Scientists/Teachers </li></ul><ul><li>Upgrade Programs and Build Infrastructure </li></ul><ul><li>Enhance Connections </li></ul><ul><li>With Other Segments of Society </li></ul><ul><li>Service to State/County </li></ul>Often centered around institution’s standing and mission Research Administration Faculty Institution Sponsored Projects
    48. 51. Expectations Made of Our Faculty <ul><li>Take a few minutes and consider the range of expectations and demands placed on our faculty. </li></ul><ul><li>What expectations can you identify? </li></ul>
    49. 52. Faculty How DO Faculty Learn to Write Proposals? Quality of Idea Match to Sponsor Infrastructure Support Conducting Research and Scholarship Department/college committee service University committee service Teaching/preparing lectures/grading Maintain currency with literature Personal/family life Write proposals Prepare/present professional papers Promotion and tenure Student advising Professional service
    50. 54. Common Goals: Research Administrator and Investigator <ul><li>Increase Sponsored Program Activity and Publication of Results to Advance Knowledge </li></ul><ul><li>Enhance Educational Opportunities for Students </li></ul><ul><li>Expand Research and Public Service Activities </li></ul><ul><li>Streamline and Improve the Research Environment </li></ul><ul><li>Protect and Minimize Risk to Individuals and Institution </li></ul>Research Administration Faculty Institution Sponsored Projects
    51. 55. The Research Administration Balancing Act <ul><li>Research administrators seek a balance of interests that respects the shared responsibilities throughout the institution . </li></ul><ul><li>Research administrators balance facilitating the research, teaching, and public service activities of faculty, students and other investigators while accommodating the priorities and stewardship expectations of the institution, governmental entities, sponsors and the public. </li></ul>Internal Stakeholders External Stakeholders
    52. 56. Proposal Development
    53. 57. Proposal Development <ul><li>Gather Funding Information </li></ul><ul><li>Disseminate Funding Information </li></ul><ul><li>Help Develop Sponsor Contacts </li></ul><ul><li>Provide Proposal Assistance </li></ul><ul><li>Produce Workshops and Manuals </li></ul><ul><ul><li>Proposal Preparation for Faculty </li></ul></ul><ul><ul><li>Departmental Administrators </li></ul></ul><ul><ul><li>Specific Sponsors </li></ul></ul><ul><ul><li>Electronic Proposal Submission </li></ul></ul><ul><ul><li>Budgets </li></ul></ul><ul><li>Administer In-House Grants Programs </li></ul>
    54. 58. Types of Proposals <ul><li>Letter of Inquiry </li></ul><ul><li>Letters of Intent </li></ul><ul><li>Preliminary Proposals </li></ul><ul><li>Concept Papers </li></ul><ul><li>White Papers </li></ul><ul><li>Formal Proposals </li></ul>
    55. 59. Letter of Inquiry or Preliminary Proposal <ul><li>Letter Proposal </li></ul><ul><li>Used by private foundations for screening to second stage </li></ul><ul><li>Preliminary Proposal </li></ul><ul><li>Used by both federal and non-federal sponsors </li></ul><ul><li>Length: </li></ul><ul><li>3 – 5 pages </li></ul><ul><li>Format </li></ul><ul><li>cover letter and 3 – 4 page proposal, or </li></ul><ul><li>All information in 3 – 5 page letter </li></ul>
    56. 60. Letter of Inquiry or Preliminary Proposal <ul><li>Elements to be covered: </li></ul><ul><li>Areas of research/content of project (be rather specific) </li></ul><ul><li>Needs and purpose statement </li></ul><ul><li>Unique qualifications, abilities, and facilities </li></ul><ul><li>Benefits/anticipated results of the project </li></ul><ul><li>Estimate of cost (no detailed budget) </li></ul><ul><li>Offer to meet </li></ul><ul><li>Request for response </li></ul>
    57. 61. Concept Paper/White Paper <ul><li>Concept Paper: </li></ul><ul><li>Generally internal working document or used for informal feedback </li></ul><ul><li>White Paper: </li></ul><ul><li>Concept paper sent unsolicited to a sponsor </li></ul>
    58. 62. Formal Proposal <ul><li>Put together according to guidelines established by sponsor </li></ul><ul><li>Always use forms and format required by sponsor </li></ul>
    59. 63. Formal Proposal (continued) <ul><li>The Usual Sections: </li></ul><ul><li>Title/Cover Page with appropriate signatures </li></ul><ul><li>Abstract (less than one page) </li></ul><ul><li>Statement of Work </li></ul><ul><li>Key Personnel CVs/Bio Sketch </li></ul><ul><li>Detailed budget with Justification </li></ul><ul><li>Facilities/Resources Statement </li></ul><ul><li>Appendices (as needed and </li></ul><ul><li> allowable by sponsor) </li></ul>
    60. 64. Formal Proposals (continued) <ul><li>Parts: </li></ul><ul><li>Scientific/Program Description </li></ul><ul><li>Representations and Certifications </li></ul><ul><li>Budget </li></ul>
    61. 65. Formal Proposals (continued) <ul><li>The Science </li></ul><ul><li>A concise explanation of the project </li></ul><ul><li>the what </li></ul><ul><li>why </li></ul><ul><li>how </li></ul><ul><li>Usually must conform to a specified structure and page limitations </li></ul>
    62. 66. Formal Proposal (continued) <ul><li>Administrative Sections – </li></ul><ul><li>The Reps. & Certs. </li></ul><ul><li>Certifications may be incorporated into the proposal, i.e., the Checklist Page for NIH, the Cover Page for NSF </li></ul><ul><li>Or the certifications can be separate, i.e., “Certifications and Assurances for Assistance Agreements” for the Defense Agencies and Standard Form 424B for DED, EPA, etc. </li></ul><ul><li>May also need “Certification Regarding Lobbying” and “Disclosure of Lobbying Activities” </li></ul>
    63. 67. Formal Proposal (continued) <ul><li>OMB Circular A-110 </li></ul><ul><li>Uniform Administrative Requirements </li></ul><ul><li>for Grants and Agreements with </li></ul><ul><li>Institutions of Higher Education and </li></ul><ul><li>Other Non-profit Organizations </li></ul><ul><li>Subpart A – General </li></ul><ul><li>Subpart B – Pre-Award Requirements </li></ul><ul><li>Subpart C – Post-Award Requirements </li></ul><ul><li>Subpart D – After the Award Requirements </li></ul><ul><li>Appendix A – Contract Provisions </li></ul>
    64. 68. Formal Proposal (continued) <ul><li>A-110 Subpart A – General </li></ul><ul><li>Effect of A-110 on Other Issuances </li></ul><ul><li>Awards subject to A-110, all other </li></ul><ul><li> administrative requirements codified </li></ul><ul><li> in program regulations, manuals, </li></ul><ul><li> handbooks inconsistent with this </li></ul><ul><li> circular are superseded, unless </li></ul><ul><li> required by statute or authorized by </li></ul><ul><li> the deviations provisions of this </li></ul><ul><li> circular </li></ul><ul><li>Deviations </li></ul><ul><li>Exceptions to A-110 are permitted in </li></ul><ul><li> unusual circumstances by OMB </li></ul>
    65. 69. Formal Proposal (continued) <ul><li>A-110 Subpart A (cont.) </li></ul><ul><li>Subawards </li></ul><ul><li>A-110 should be flowed down to </li></ul><ul><li> sub-recipients which fall under </li></ul><ul><li> this circular </li></ul><ul><li>A-110 Subpart B – Pre-Award </li></ul><ul><li>Agency Decides on Appropriate Award Instrument </li></ul><ul><li>Grant: Principal Purpose is to Provide Support to </li></ul><ul><li> Accomplish a Public Purpose </li></ul><ul><li>Cooperative Agreement: Same as a Grant, Except </li></ul><ul><li> Substantial Involvement is Expected by the </li></ul><ul><li> Awarding Agency </li></ul>
    66. 70. Formal Proposal (continued) <ul><li>A-110 Subpart B (cont.) </li></ul><ul><li>Contract: Principal Purpose is </li></ul><ul><li> Acquisition of Property or Services </li></ul><ul><li> for Direct Benefit of Government </li></ul><ul><li>Forms Used When Applying for Assistance: </li></ul><ul><li>Agencies must comply with 5CFR part </li></ul><ul><li> 1320 – “Controlling Paperwork </li></ul><ul><li> Burdens on the Public” </li></ul><ul><li>Applicants shall use SF-424 series, or </li></ul><ul><li> forms and instructions prescribed by </li></ul><ul><li> agency </li></ul><ul><li>Programs covered by E.O. 12372 </li></ul><ul><li> “ Intergovernmental Review of Federal </li></ul><ul><li> Programs” – applicants must complete </li></ul>
    67. 71. Formal Proposal (continued) <ul><li>A-110 Subpart B (cont.) </li></ul><ul><li> appropriate sections of SF 424 and </li></ul><ul><li> send a copy of proposal to the state </li></ul><ul><li> coordinating office. </li></ul><ul><li>Debarment and Suspension </li></ul><ul><li>Agencies and recipients must comply with </li></ul><ul><li> the non-procurement common rule </li></ul><ul><li>Special Award Conditions </li></ul><ul><li>Additional requirements may be imposed by </li></ul><ul><li> agencies if: </li></ul><ul><li>Recipient has history of poor </li></ul><ul><li> performance </li></ul>
    68. 72. Formal Proposal (continued) <ul><li>A-110 Subpart B (cont.) </li></ul><ul><li>Recipient is not financially stable </li></ul><ul><li>Recipient has management system </li></ul><ul><li> that does not meet standards </li></ul><ul><li>Recipient has not conformed with </li></ul><ul><li> terms and conditions of previous </li></ul><ul><li> award </li></ul><ul><li>Recipient is not responsible </li></ul><ul><li>Recipient must be notified in writing </li></ul><ul><li>Special conditions removed once </li></ul><ul><li> corrections are made </li></ul>
    69. 73. Formal Proposal (continued) <ul><li>Basically, the Agency is looking for us to certify compliance with all of their statutory requirements </li></ul>
    70. 74. Budget Development <ul><li>Include both direct and F&A costs </li></ul><ul><li>Should be detailed </li></ul><ul><li>Include only allowable costs </li></ul><ul><li>If required, include matching or cost-sharing (if cost-sharing is proposed it should be proportional between direct and F&A) </li></ul>
    71. 75. Budget Development (cont.) <ul><li>Direct Costs: </li></ul><ul><li>Costs that can be identified specifically </li></ul><ul><li> with a particular sponsored project, </li></ul><ul><li> an instructional activity, or any other </li></ul><ul><li> institutional activity; or that can be </li></ul><ul><li> directly assigned to such activities </li></ul><ul><li> relatively easily with a high degree of </li></ul><ul><li> accuracy </li></ul><ul><li>Examples of Direct Costs: </li></ul><ul><li>Salary of Researcher (including FB) </li></ul><ul><li>Laboratory Supplies </li></ul>
    72. 76. Budget Development (cont.) <ul><li>Facilities and Administrative </li></ul><ul><li>(F&A) Costs </li></ul><ul><li>Costs that are incurred for common or </li></ul><ul><li> joint objectives, and, therefore, cannot </li></ul><ul><li> be identified readily and specifically </li></ul><ul><li> with a particular sponsored project, </li></ul><ul><li> an instructional activity, or any other </li></ul><ul><li> institutional activity </li></ul><ul><li>Examples of F&A Costs: </li></ul><ul><li>Salary of Department Administrator </li></ul><ul><li>Building utility and maintenance costs </li></ul><ul><li>Purchasing, Controllers’ offices </li></ul>
    73. 77. Budget Development (cont.) <ul><li>Composition of Total Costs </li></ul><ul><li>A-21, section C.1. </li></ul><ul><li>The cost of a sponsored agreement is </li></ul><ul><li> comprised of the allocable direct </li></ul><ul><li> costs incident to its performance, plus </li></ul><ul><li> the allocable portion of the allowable </li></ul><ul><li> F&A costs of the institution… </li></ul><ul><li>Therefore, Federal sponsors reimburse </li></ul><ul><li> the institution for the allowable costs </li></ul><ul><li> of a project, including direct costs and </li></ul><ul><li> F&A costs…. </li></ul>
    74. 78. Budget Development (cont.) <ul><li>Elements of Direct Costs </li></ul><ul><li>Salaries and Wages </li></ul><ul><li>Fringe Benefits (FB) </li></ul><ul><li>Equipment </li></ul><ul><li>Expendable Supplies and Materials </li></ul><ul><li>Travel </li></ul><ul><li>Subcontracts </li></ul><ul><li>Consultants </li></ul><ul><li>External </li></ul><ul><li>Interdepartmental </li></ul><ul><li>Other </li></ul>
    75. 79. Budget Development (cont.) <ul><li>Salaries and Wages </li></ul><ul><li>Institutional Policy on Academic Year </li></ul><ul><li> Salary Recovery </li></ul><ul><li>Summer Salary </li></ul><ul><li>Postdoctoral Research Associates </li></ul><ul><li>Undergraduate & Graduate Students </li></ul><ul><li> (salaries or stipends?) </li></ul><ul><li>Technical and Clerical Support* </li></ul><ul><li>Use Percent of Effort, Not Hourly Wage </li></ul><ul><li>Include Increases for COLA and Merit- </li></ul><ul><li> based Adjustments </li></ul><ul><li>Follow institutional policies on FB </li></ul>
    76. 80. Budget Development (cont.) <ul><li>Equipment </li></ul><ul><li>Note the differences between the sponsor’s equipment definitions/ thresholds and your institution’s </li></ul><ul><li>General purpose equipment is not allowable as a direct cost unless programmatically necessary and used exclusively/primarily for research </li></ul><ul><li>Expendable Materials/Supplies </li></ul><ul><li>Must be programmatically necessary; general office supplies should be treated as an F&A cost – unless a major program. </li></ul>
    77. 81. Budget Development (cont.) <ul><li>Travel </li></ul><ul><li>Adhere to Institutional Policy and Agency </li></ul><ul><li> Guidelines </li></ul><ul><li>Distinguish between Domestic and </li></ul><ul><li> Foreign Travel </li></ul><ul><li>Foreign Travel may require prior approval </li></ul><ul><li> from sponsor prior to trip (even if in </li></ul><ul><li> original budget/proposal </li></ul><ul><li>Subcontracts </li></ul><ul><li>Proposed costs should be Reasonable and Allowable (however, keep in the mind the sub-contractor may be under different cost principals) </li></ul>
    78. 82. Budget Development (cont.) <ul><li>Consultants </li></ul><ul><li>External: required expertise needed for the project which cannot be provided by faculty or staff at the institution; rate must be reasonable; in most instances, consultants’ level of effort and participation should not rise to the level of “key personnel” – that would imply substantive programmatic work </li></ul><ul><li>Interdepartmental: in some instances, a faculty or staff member may serve on a project as a consultant, but only if the expertise required is not part of this person appointment or job function </li></ul>
    79. 83. Budget Development (cont.) <ul><li>Other Direct Costs </li></ul><ul><li>Communications </li></ul><ul><li>Publications </li></ul><ul><li>Animal Care Costs </li></ul><ul><li>Human Subject Costs </li></ul><ul><li>Shop Charges </li></ul><ul><li>Maintenance/Service Contracts </li></ul><ul><li>Computer Costs </li></ul><ul><li>Graphic Arts/Photographic Services </li></ul><ul><li>Rental/Lease of Facilities </li></ul><ul><li>Construction/Renovation/Remodeling Costs </li></ul><ul><li>All of the above must be programmatically necessary! </li></ul>
    80. 84. Budget Development (cont.) <ul><li>What Does “Allowable” Mean? </li></ul><ul><li>An allowable cost must be: </li></ul><ul><li>REASONABLE: A prudent business </li></ul><ul><li> person would have purchased this item </li></ul><ul><li> and paid this price. </li></ul><ul><li>ALLOCABLE: It can be assigned to the </li></ul><ul><li> activity on some reasonable basis. </li></ul><ul><li>CONSISTENTLY TREATED: Like costs must </li></ul><ul><li> be treated the same in like circumstances, </li></ul><ul><li> as either direct or F&A costs. </li></ul><ul><li>If a cost cannot meet the above criteria, it is </li></ul><ul><li> unallowable, no matter what it is for. </li></ul>
    81. 85. Budget Development (cont.) <ul><li>What Does “Allowable” Mean? (cont.) </li></ul><ul><li>An “allowable” cost is one that is eligible for </li></ul><ul><li> reimbursement by the federal government. </li></ul><ul><li>Contrast with: </li></ul><ul><li>PERMISSIBLE BY INSTITUTION: A cost is </li></ul><ul><li> permitted by institution, as outlined in its </li></ul><ul><li> various administrative policies or procedures. </li></ul><ul><li>ALLOWABLE BY AGENCY: A cost is permitted </li></ul><ul><li> by the policies of the sponsoring agency or </li></ul><ul><li> the terms of an award. </li></ul>
    82. 86. Budget Development (cont.) <ul><li>Assessing Whether a Cost Is </li></ul><ul><li>Allowable or Unallowable </li></ul><ul><li>A cost may be “expressly” unallowable, </li></ul><ul><li> i.e., it is always unallowable as either </li></ul><ul><li> a direct or indirect. </li></ul><ul><li>Unallowable activities: fund raising, </li></ul><ul><li> alumni relations, lobbying, etc. </li></ul><ul><li>Unallowable transactions: alcohol, </li></ul><ul><li> entertainment, fines, etc. </li></ul><ul><li>A cost may be allowable but only as an </li></ul><ul><li> indirect/F&A cost, not a direct charge, </li></ul><ul><li> e.g., proposal preparation </li></ul>
    83. 87. Budget Development (cont.) <ul><li>Assessing Whether a Cost Is </li></ul><ul><li>Allowable or Unallowable (cont.) </li></ul><ul><li>Generally, it is not the type of cost that </li></ul><ul><li> determines allowability, it is the purpose </li></ul><ul><li> and circumstance of the expenditure. Many </li></ul><ul><li> categories of costs are allowable as a </li></ul><ul><li> direct or indirect, e.g. salaries, travel, </li></ul><ul><li> materials, etc. </li></ul>
    84. 88. Budget Development (cont.) <ul><li>Third Party Agreements </li></ul><ul><li>Types of third party agreements: </li></ul><ul><li>Purchase Order </li></ul><ul><li>Subcontract/Subgrant/Subagreement </li></ul><ul><li>Consulting Agreement </li></ul>
    85. 89. Budget Development (cont.) <ul><li>Purchase Order </li></ul><ul><li>A particular kind of agreement issued to </li></ul><ul><li> enter into a legally-binding commitment </li></ul><ul><li> with an outside vendor for the </li></ul><ul><li> acquisition of goods and services. </li></ul><ul><li> Normally the purchasing department is </li></ul><ul><li> responsible for purchase orders, and </li></ul><ul><li> for their negotiation or revision where </li></ul><ul><li> necessary. </li></ul><ul><li>Vendor Subcontracts: used for the </li></ul><ul><li> procurement of goods or services from </li></ul>
    86. 90. Budget Development (cont.) <ul><li>Purchase Order (cont.) </li></ul><ul><li> an organization which provides the </li></ul><ul><li> goods or services to many different </li></ul><ul><li> purchasers as part of its normal </li></ul><ul><li> business operations within a competitive </li></ul><ul><li> environment. These subcontracts (or </li></ul><ul><li> purchase orders) are not subject to </li></ul><ul><li> compliance requirements of the Federal </li></ul><ul><li> award (per A-133). </li></ul>
    87. 91. Budget Development (cont.) <ul><li>Subawards/Subcontracts/ </li></ul><ul><li>Subgrants/Subagreements </li></ul><ul><li>Whatever you call them… </li></ul><ul><li>A written agreement with a third party for </li></ul><ul><li> the acquisition of services or goods or </li></ul><ul><li> for the conduct of prescribed activities </li></ul><ul><li> or functions under an award. </li></ul><ul><li>Subrecipient Subawards: used to procure </li></ul><ul><li> substantive programmatic work under </li></ul><ul><li> a grant or contract. The sub-recipient </li></ul><ul><li> has responsibility for programmatic </li></ul>
    88. 92. Budget Development (cont.) <ul><li>Subawards (cont.) </li></ul><ul><li> decision making and measurable </li></ul><ul><li> performance requirements related </li></ul><ul><li> directly to the award. Sub-recipients </li></ul><ul><li> must adhere to federal compliance </li></ul><ul><li> requirements. </li></ul><ul><li>Subaward Process Requirements </li></ul><ul><li>Letter of Intent </li></ul><ul><li>Statement of Work </li></ul><ul><li>Period of Performance </li></ul><ul><li>Budget </li></ul>
    89. 93. Budget Development (cont.) <ul><li>Process Requirements (cont.) </li></ul><ul><li>Other Documentation </li></ul><ul><li>F&A Cost Agreement </li></ul><ul><li>Cost Justification </li></ul><ul><li>Statement of Work Approval </li></ul><ul><li>Certifications/Assurances (these </li></ul><ul><li> are usually part of the subaward </li></ul><ul><li> agreement) </li></ul>
    90. 94. Budget Development (cont.) <ul><li>Consulting Agreement </li></ul><ul><li>A form of subcontract </li></ul><ul><li>An agreement issued for services too </li></ul><ul><li> urgent, temporary, specialized, or highly </li></ul><ul><li> technical to be provided by existing </li></ul><ul><li> university personnel. Consulting </li></ul><ul><li> agreements are not issued to procure </li></ul><ul><li> “ substantive programmatic work.” </li></ul><ul><li>Consultants operate as independent </li></ul><ul><li> contractors without detailed supervision, </li></ul><ul><li> like subcontractors. Unlike subcontractors, </li></ul><ul><li> they most often participate on a “work-for- </li></ul><ul><li> hire” basis. </li></ul>
    91. 95. Budget Development (cont.) <ul><li>Consulting Agreements (cont.) </li></ul><ul><li>Remember – a “consultant” is not an </li></ul><ul><li> “ employee.” </li></ul><ul><li>If am employee is misclassified as an </li></ul><ul><li> “ consultant,” the institution is subject to </li></ul><ul><li> fines and penalties. </li></ul><ul><li>Employer/employee relationships imply: </li></ul><ul><li>More discretion to direct or control the </li></ul><ul><li> contents of work and results to be </li></ul><ul><li> accomplished and means by which </li></ul><ul><li> accomplished </li></ul><ul><li>Continuing relationship whether full- </li></ul>
    92. 96. Budget Development (cont.) <ul><li>Consulting Agreements (cont.) </li></ul><ul><li> time, part-time, seasonal, or short </li></ul><ul><li> duration. </li></ul><ul><li>Set Hours </li></ul><ul><li>Guaranteed minimum pay and pay intervals </li></ul><ul><li>Mutual right to terminate without liability </li></ul><ul><li>Furnishing of facilities, supplies, and </li></ul><ul><li> equipment needed to accomplish work </li></ul><ul><li>Training supplied </li></ul><ul><li>Some Possible Considerations For Consulting </li></ul><ul><li> Agreements: </li></ul><ul><li>Prior Approval to Publish, Etc. </li></ul><ul><li>Work-For-Hire </li></ul>
    93. 97. Budget Development (cont.) <ul><li>Consulting Agreements (cont.) </li></ul><ul><li>Conflict of Interest </li></ul><ul><li>Indemnification </li></ul><ul><li>Flow-through Provisions from Prime </li></ul><ul><li>Rate Limitation </li></ul><ul><li>Sponsors May Set Allowable Rates </li></ul><ul><li> Consultants </li></ul><ul><li>Travel Is In Addition to Daily Rate </li></ul>
    94. 98. Budget Development (cont.) <ul><li>Cost-Sharing/Matching Costs </li></ul><ul><li>is the portion of the cost of a project not borne by the sponsoring agency </li></ul><ul><li>Types of cost sharing: </li></ul><ul><li>Mandatory </li></ul><ul><li>Voluntary </li></ul><ul><li>Voluntary Uncommitted </li></ul>
    95. 99. Budget Development (cont.) <ul><li>What Can be Used to Meet </li></ul><ul><li>Cost Sharing? </li></ul><ul><li>Cash </li></ul><ul><li>Third Party Contributions (however, </li></ul><ul><li> federal funds cannot be used as cost </li></ul><ul><li> sharing on federal funds) </li></ul><ul><li>Unrecovered F&A costs (can be used if </li></ul><ul><li> agency has approved) </li></ul><ul><li>Establishing values for contributions of </li></ul><ul><li> services and property (in accordance </li></ul><ul><li> with applicable cost principles) </li></ul><ul><li>Volunteer Services: if necessary and </li></ul><ul><li> integral part of project </li></ul>
    96. 100. Budget Development (cont.) <ul><li>Cost Sharing (continue) </li></ul><ul><li>Other employee services (valued at </li></ul><ul><li> regular rate of pay + fringe benefits) </li></ul><ul><li>Donated supplies (must be reasonable </li></ul><ul><li> and at fair market value) </li></ul><ul><li>Cost Sharing Considerations </li></ul><ul><li>Cash and third party in-kind </li></ul><ul><li> contributions must meet all of the </li></ul><ul><li> following criteria: </li></ul><ul><li>Are verifiable from the recipient’s records </li></ul>
    97. 101. Budget Development (cont.) <ul><li>Cost Sharing Considerations </li></ul><ul><li> (continued) </li></ul><ul><li>Cannot be used as cost sharing on other </li></ul><ul><li> federal projects </li></ul><ul><li>Are necessary and reasonable for </li></ul><ul><li> accomplishment of project objectives </li></ul><ul><li>Are allowable under the cost principles </li></ul><ul><li>Are not paid by the Federal government </li></ul><ul><li> under another award </li></ul><ul><li>Are provided for in the approved budget </li></ul><ul><li> when required by Federal agency </li></ul><ul><li>Conform to other provisions of A-110, </li></ul><ul><li> as applicable </li></ul>
    98. 102. Budget Development (cont.) <ul><li>Potential Problems Associated with Cost Sharing </li></ul><ul><li>Can we demonstrate to the funding </li></ul><ul><li> agency that the cost sharing </li></ul><ul><li> commitment has been fulfilled? Do </li></ul><ul><li> track cost sharing on a project-by- </li></ul><ul><li> project basis? </li></ul><ul><li>Are we treating cost sharing consistently </li></ul><ul><li> with other project costs, i.e., classify </li></ul><ul><li> it as organized research? </li></ul>
    99. 103. Budget Development (cont.) <ul><li>Potential Problems (cont.) </li></ul><ul><li>Are we overstating our F&A rate by not </li></ul><ul><li> capturing cost sharing? </li></ul><ul><li>Do effort reports capture cost shared </li></ul><ul><li> effort (both mandatory and </li></ul><ul><li> voluntarily committed)? </li></ul><ul><li>Are the same cost sharing funds used to </li></ul><ul><li> meet the matching requirements on </li></ul><ul><li> more than one project? </li></ul><ul><li>Do we recover cost sharing expenditures </li></ul><ul><li> through our F&A rate? </li></ul>
    100. 104. Budget Development (cont.) <ul><li>Facilities and Administrative Costs </li></ul><ul><li>Points to Consider: </li></ul><ul><li>F&A cost recovery is the reimbursement for actual </li></ul><ul><li> costs incurred by the institution in support of </li></ul><ul><li> sponsored projects </li></ul><ul><li>F&A costs are incurred on all institutional </li></ul><ul><li> activities, not just sponsored research </li></ul><ul><li>F&A costs are REAL COSTS! </li></ul><ul><li>A significant portion of F&A cost not recovered </li></ul><ul><li>When an external sponsor pays less than the full </li></ul><ul><li> F&A rate, the unrecovered F&A costs must be </li></ul><ul><li> absorbed by the institution (it’s an institutional </li></ul><ul><li> decision) </li></ul>
    101. 105. Budget Development (cont.) <ul><li>Types of F&A Rate Bases </li></ul><ul><li>Total Direct Costs (TDC) </li></ul><ul><li>All direct costs of research </li></ul><ul><li>Modified Total Direct Costs (MTDC) </li></ul><ul><li>All direct cost of research less: </li></ul><ul><li>Equipment </li></ul><ul><li>Subcontracts in excess of $25,000 </li></ul><ul><li>Tuition Remission </li></ul><ul><li>Patient Care </li></ul><ul><li>Capital Expenditures </li></ul><ul><li>Rental Costs </li></ul><ul><li>Scholarships & Fellowships </li></ul><ul><li>Other items may be excluded where necessary to avoid a serious inequity in the distribution of F&A </li></ul>
    102. 106. Budget Development (cont.) <ul><li>F&A Rate Bases (cont.) </li></ul><ul><li>Salaries and Wages (S&W) </li></ul><ul><li>Can only be used with the Simplified </li></ul><ul><li> Method </li></ul><ul><li>Types of F&A Cost Rates </li></ul><ul><li>Provisional – Estimated rate used when </li></ul><ul><li> parties cannot agree on an equitable </li></ul><ul><li> rate. May be replaced by fixed or </li></ul><ul><li> predetermined rate before the end of </li></ul><ul><li> the fiscal year. </li></ul><ul><li>Predetermined – Rate established for </li></ul>
    103. 107. Budget Development (cont.) <ul><li>F&A Cost Rates (cont.) </li></ul><ul><li> for period, normally 2 to 4 years. No </li></ul><ul><li> carry forward provision. </li></ul><ul><li>Fixed with Carryforward – Rate established </li></ul><ul><li> for period. Over/under recovery is </li></ul><ul><li> determined and an adjustment is applied </li></ul><ul><li> to a subsequent rate negotiation. </li></ul><ul><li>F&A Rate Versus F&A Recovery </li></ul><ul><li>F&A is often waived or reduced for cost </li></ul><ul><li> sharing </li></ul><ul><li>F&A rate calculation based on recoverable </li></ul>
    104. 108. Budget Development (cont.) <ul><li>Rate Versus Recovery (cont.) </li></ul><ul><li> costs, i.e., all awards receive a full </li></ul><ul><li> allocation of F&A, not recovery </li></ul><ul><li>In reality, institutions subsidize a </li></ul><ul><li> significant portion of F&A costs </li></ul><ul><li>On-Campus Research Rate </li></ul><ul><li>Applied to on-campus organized </li></ul><ul><li> research activities </li></ul><ul><li>Most frequently used rate; may be the </li></ul><ul><li> only rate negotiated </li></ul>
    105. 109. Budget Development (cont.) <ul><li>Off-Campus Research Rate </li></ul><ul><li>Applied to sponsored agreements at off- </li></ul><ul><li> campus facilities </li></ul><ul><li>Off-Campus is usually not a university- </li></ul><ul><li> owned facility </li></ul><ul><li>Recovers administrative costs associated </li></ul><ul><li> with sponsored agreements </li></ul><ul><li>Typically is the “A” portion of the On- </li></ul><ul><li> Campus Research Rate; “F” costs are </li></ul><ul><li> direct charged </li></ul><ul><li>The “A” portion is generally 26% because of federal cap </li></ul>
    106. 110. Budget Development (cont.) <ul><li>Other Sponsored Programs </li></ul><ul><li>Institutions with large amount of non- </li></ul><ul><li> research sponsored projects may </li></ul><ul><li> negotiate a separate rate for these </li></ul><ul><li> projects </li></ul><ul><li>Rates for Specific Facilities </li></ul><ul><li>The costs of certain programs/facilities </li></ul><ul><li> may be unique enough to warrant a </li></ul><ul><li> separate F&A rate </li></ul><ul><li>Examples: Agricultural Experiment Station; </li></ul><ul><li> Federally Funded Research and </li></ul><ul><li> Development Center (FFRDC); University </li></ul><ul><li> Medical Center </li></ul>
    107. 111. Proposal Review <ul><li>Typical Institutional Checklist </li></ul><ul><li>for Proposal Review </li></ul><ul><li>Correct Forms </li></ul><ul><li>Internal Review Checklist/Approval Form </li></ul><ul><li>Compatibility with Internal Review Checklist </li></ul><ul><li>Intellectual Property </li></ul><ul><li>Space Needs </li></ul><ul><li>Renovation Requirements </li></ul><ul><li>Cost Sharing/Matching </li></ul><ul><li>Human Subject Use </li></ul><ul><li>review and approval </li></ul><ul><li>Animal Use </li></ul><ul><li>review and approval </li></ul>
    108. 112. Proposal Review (cont.) <ul><li>Checklist for Proposal Review (cont.) </li></ul><ul><li>Recombinant DNA </li></ul><ul><li>review and approval </li></ul><ul><li>Conflict of Interest Policy </li></ul><ul><li>Publications/Proprietary Information </li></ul><ul><li> Restrictions </li></ul><ul><li>Hazardous Materials </li></ul><ul><li>Undergraduate & Graduate Students </li></ul><ul><li>Page Limitations </li></ul><ul><li>Type Size Limitations </li></ul><ul><li>All Elements of Proposal Included </li></ul>
    109. 113. Proposal Review (cont.) <ul><li>Checklist (cont.) </li></ul><ul><li>Correct Rates Used </li></ul><ul><li>Budget Correct </li></ul><ul><li>Signatures </li></ul><ul><li>Subcontractor Commitment Letter </li></ul><ul><li>All Certifications Included </li></ul><ul><li>If RFP, is Exception Letter Needed </li></ul><ul><li>If Foundation/Corporation, on </li></ul><ul><li> “ restricted” list </li></ul><ul><li>Requirement for State Review Ascertained </li></ul><ul><li>Correct Number of Copies, Deadline Date </li></ul><ul><li> Mailing/Delivery Address </li></ul>
    110. 114. Proposal Review (cont.) <ul><li>Checklist (cont.) </li></ul><ul><li>Method of Transmittal, Packaging </li></ul><ul><li> Instructions </li></ul><ul><li>Limitation on Number of Proposals </li></ul><ul><li> from Institution </li></ul><ul><li>And You’re Done!!! </li></ul>
    111. 115. Pre-Award: Part II Proposal Submission & Review <ul><li>Certifications & Representations </li></ul><ul><li>Routing & Internal Approval Signatures </li></ul><ul><li>Special Consideration </li></ul><ul><li>Peer Review, Site Visits, </li></ul><ul><li>Pre-Award & Audits </li></ul>
    112. 116. Representations and Certifications for Proposals <ul><li>Civil rights, Non-discrimination </li></ul><ul><li>Delinquent Federal Debt </li></ul><ul><li>Drug-free Workplace </li></ul><ul><li>Drug-free Workforce </li></ul><ul><li>Debarment and Suspension </li></ul><ul><li>Drug- and Alcohol-free Schools </li></ul><ul><li>Procurement Integrity </li></ul><ul><li>Small Business Utilization & Subcontracting </li></ul><ul><li>Lobbying </li></ul>
    113. 117. Debarment and Suspension (Final Rule May 1989) <ul><li>Regulations implemented by common rule (Grants) </li></ul><ul><li>Federal Acquisition Regulations (Contracts) </li></ul><ul><ul><li>BACKGROUND: Development of a government-wide system for transactions with federal agencies to detect fraudulent or improper use of government funds </li></ul></ul><ul><ul><li>APPLICABILITY: Agreements in excess of $25,000. Flow down required </li></ul></ul><ul><ul><li>CERTIFICATION: Applicants, their principals and researchers are not: </li></ul></ul><ul><ul><ul><li>Presently debarred or suspended </li></ul></ul></ul><ul><ul><ul><li>Have not been convicted or had civil judgment for fraud rendered within a three year period </li></ul></ul></ul><ul><ul><ul><li>Are not presently charged by a Government entity </li></ul></ul></ul><ul><ul><ul><li>Have not had a public transaction terminated for cause or default within a three year period </li></ul></ul></ul>Sanctions: Termination, debarment or suspension of awardee.
    114. 118. Procurement Integrity <ul><li>Applicability: </li></ul><ul><ul><li>All federal contracts </li></ul></ul><ul><ul><li>Certification required when contract exceeds $100,000/year </li></ul></ul><ul><ul><li>No flow-down requirement </li></ul></ul><ul><li>Requirements: </li></ul><ul><ul><li>No competing contractor or any officer, employee or consultant of such contractor shall: </li></ul></ul><ul><ul><ul><li>make any offer or promise of future employment </li></ul></ul></ul><ul><ul><ul><li>offer any money, gratuity, or other thing of value to any procurement officer of such agency </li></ul></ul></ul><ul><ul><ul><li>solicit any proprietary data or source selection information concerning such procurement </li></ul></ul></ul><ul><ul><li>Key to Compliance: inform PI, and others, of requirements </li></ul></ul>
    115. 119. Utilization of Small and Small Disadvantaged Business Concerns <ul><li>Applicability: </li></ul><ul><ul><li>Most contracts in excess of $100,000 </li></ul></ul><ul><ul><li>Flow-down to subcontractors </li></ul></ul><ul><li>Special requirements: </li></ul><ul><ul><li>When contract is in excess of $500,000, subcontracting plan required and special reporting requirements apply </li></ul></ul><ul><ul><li>Subcontracting” means procurement of goods and services </li></ul></ul><ul><li>Subcontracting plan compliance and reporting can be handled by either purchasing office, research administration, or by project administrator </li></ul>
    116. 120. Lobbying Terms Defined <ul><li>Lobbying activities include: </li></ul><ul><ul><li>Lobbying contacts </li></ul></ul><ul><ul><li>Preparation and planning for lobbying </li></ul></ul><ul><ul><li>Collaboration with others, such as associations </li></ul></ul><ul><ul><li>Most public activities exempted </li></ul></ul><ul><li>Lobbying contact means: </li></ul><ul><ul><li>Any oral, written or electronic communication </li></ul></ul><ul><ul><li>Certain contact with executive officials </li></ul></ul><ul><ul><li>Certain contacts with legislative officials </li></ul></ul><ul><ul><li>With regard to </li></ul></ul><ul><ul><ul><li>Legislation </li></ul></ul></ul><ul><ul><ul><li>Federal rule, regulation, policy </li></ul></ul></ul><ul><ul><ul><li>Federal program (contracts, grants, loans, etc.) </li></ul></ul></ul>Use of appropriated funds to pay a person to influence or attempt to influence a federal official or employee in connection with a specific award is prohibited by law; disclosure required if use of non-appropriated funds to pay for lobbying activities
    117. 121. Lobbying <ul><li>Applicability: </li></ul><ul><ul><li>All federal agreements </li></ul></ul><ul><ul><li>Flow-down to subcontractors is required </li></ul></ul><ul><li>Aspects Of Compliance: </li></ul><ul><ul><li>Lobbying costs may not be paid from federal funds </li></ul></ul><ul><ul><li>“ Federal funds” interpreted to mean direct costs only </li></ul></ul><ul><ul><li>Certification required for awards over $100,000 </li></ul></ul><ul><ul><li>Disclosure of lobbying expenses required in certain instances </li></ul></ul>
    118. 122. Certification Signatures <ul><li>Authorizing Official </li></ul><ul><ul><li>Chief Executive or those delegated authority </li></ul></ul><ul><li>Supported by internal approvals and signatures </li></ul><ul><ul><li>PI, department, dean, business officers </li></ul></ul><ul><li>Signature is indication of assurances, representations and certifications </li></ul><ul><li>See agency program guides and forms for summary of assurances that are made by signature of authorizing official and principal investigators </li></ul>
    119. 123. Typical Institutional Checklist for Proposal Review <ul><li>Compliance with Sponsor Requirement </li></ul><ul><li>Compliance with Institutional Policies </li></ul><ul><li>Compliance with Statutory Requirements </li></ul><ul><li>Application Completeness </li></ul><ul><li>Appropriateness of Budget </li></ul><ul><li>If applicable, review Guidelines of Solicitation </li></ul>
    120. 124. Solicitations – Special Consideration at Time of Institutional Review <ul><ul><li>RFP Request for Proposals </li></ul></ul><ul><ul><li>RFQ Request for Quotation </li></ul></ul><ul><ul><li>RFB Request for Bid </li></ul></ul><ul><ul><li>RFA Request for Applications </li></ul></ul><ul><li>Proposers must register objections to proposed terms and conditions, scope of work, etc., at the time of response. It may be the only opportunity to take exception. </li></ul><ul><li>For example: </li></ul><ul><ul><li>resist using hours for faculty and professional staff </li></ul></ul>contracts grants and cooperative agreements
    121. 125. Peer Review <ul><li>Primary basis for most funding decisions </li></ul><ul><li>Variations: some contract procurements may be based on a combination of qualifications and proposed cost (administrative and scientific review) </li></ul><ul><li>Role of program official is a variable </li></ul><ul><li>Evaluations are anonymous, and given in summary form to applicant on request </li></ul><ul><li>Reviews usually assign scores, rankings, or categories </li></ul><ul><li>Funding decisions are based on available funds </li></ul><ul><li>Amount of award may be unilateral, or may be negotiated </li></ul>If the proposal is rejected by the sponsor, the PI should obtain the reviews from the sponsor, address the issues, and resubmit the proposal See program guides or solicitation for details about review criteria
    122. 127. Negotiation of Awards, Dispute Resolution <ul><li>Negotiation Framework: </li></ul><ul><li>Clear channels of communication; documentation </li></ul><ul><li>Know institutional policies; be familiar with scope of work and your history with the sponsor, project, PI, … </li></ul><ul><li>Terms and Conditions: programmatic and business </li></ul><ul><li>Negotiations with federal sponsors often include: </li></ul><ul><li>Budget level; Project Goals; Business Standards </li></ul><ul><li>Negotiations with non-federal sponsors often include: </li></ul><ul><li>Academic principles (freedom, publications, ownership of data and reports) </li></ul><ul><li>Intellectual property </li></ul><ul><li>Business standards (salary basis, academic calendar) </li></ul><ul><li>Financial reporting (level of detail) </li></ul>
    123. 128. Intellectual Property Bayh-Dole Act - 37 CFR Part 401 <ul><li>Allows retention of entire right, title, and interest throughout the world to each invention made with federal funding </li></ul><ul><li>Government Retains nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention for or on behalf of the government </li></ul><ul><li>Requirements: </li></ul><ul><ul><li>Disclosure within two months after inventor discloses to institution </li></ul></ul><ul><ul><li>Election of title within two years of disclosure to agency </li></ul></ul><ul><ul><li>Filing of initial patent application within one year of electing title </li></ul></ul>
    124. 129. Material Transfer Agreement Considerations <ul><ul><ul><ul><ul><li>See Uniform Biological Material Transfer Agreement for standard model ( http:// www.autm.net/ubmta/UBMTAWord.doc ) </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Ensure it is an institutional rather than a personal agreement </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Clearly and specifically define material involved </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Define use to which material is (and is not) to be put, and how to return or dispose of unused quantities. </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Define limitations on use and what is to be considered confidential </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>May address use of names of organizations involved </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Ownership of derivatives </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Commercial/Non-commercial use </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Publications (usually requires acknowledgement, perhaps co-authorship) </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Indemnification </li></ul></ul></ul></ul></ul>
    125. 130. Clinical Trials <ul><li>The institution is usually reimbursed on a per patient basis often with a fixed F & A rate of 20 - 30% TDC </li></ul><ul><li>Negotiation concerns: </li></ul><ul><ul><li>Ownership of Data </li></ul></ul><ul><ul><li>Ownership and Confidentiality of Patient Records </li></ul></ul><ul><ul><li>Publication of Results </li></ul></ul><ul><ul><li>Patent Rights </li></ul></ul><ul><ul><li>Indemnification </li></ul></ul><ul><ul><li>Billing of Third-party Carriers for Costs </li></ul></ul><ul><ul><li>Liability for Subject Injury </li></ul></ul><ul><ul><li>Informed Consent Requirements </li></ul></ul><ul><ul><li>F&A Costs </li></ul></ul>
    126. 131. Electronic Research Administration <ul><li>A Definition of ERA </li></ul><ul><li>What It Means for Sponsored Projects Offices </li></ul><ul><li>The Future of ERA </li></ul>
    127. 132. NIH Mail Room at Proposal Deadline Each day NSF receives a stack of proposals the equivalent of 2-3 stories high
    128. 133. ERA: A Definition <ul><li>Electronic Research Administration simply means using electronic tools to perform the activities related to research administration. Keeping step with technology and the business world. </li></ul><ul><li>Goal to work more efficiently – time is money </li></ul>
    129. 134. ERA: What It Means for Sponsored Projects <ul><li>Less Paper </li></ul><ul><li>Training in multiple sponsor systems </li></ul><ul><li>ERA Initiatives from Sponsors </li></ul><ul><li>NEED FOR LOTS & LOTS OF PATIENCE!!! </li></ul>
    130. 135. ERA: Federal Transactions <ul><li>NSF FastLane </li></ul><ul><ul><li>Proposal Review </li></ul></ul><ul><ul><li>Proposal Preparation & Submission </li></ul></ul><ul><ul><li>Checking Proposal Status </li></ul></ul><ul><ul><li>Project Report Submission – Progress and Fiscal </li></ul></ul><ul><li>NIH Commons </li></ul><ul><ul><li>Edison Invention Reporting – now interagency </li></ul></ul><ul><ul><li>CRISP – searchable database of federally funded biomedical research </li></ul></ul><ul><ul><li>Electronic Streamlined Noncompeting Award Process (e-SNAP) </li></ul></ul>
    131. 136. ERA Today <ul><li>Improvements in Technology </li></ul><ul><li>More Customized Programs </li></ul><ul><li>Not Yet a Paperless Environment </li></ul><ul><li>Expanded Federal Participation – Grants.Gov </li></ul><ul><ul><li>http://www.grants.gov </li></ul></ul><ul><ul><ul><li>“ a common face of the government, offering all grantees (state and local governments, universities, small businesses, etc.) full service grants processing across all functions in the grant life cycle.” </li></ul></ul></ul>
    132. 137. Electronic Data Retention <ul><li>Conversion of Paper Records to Electronic Form </li></ul><ul><li>Department of Health and Human Services (HHS) </li></ul><ul><li>Office of Grants and Acquisition Management (OGAM) Action Transmittal 99-1 (8/9/99) </li></ul><ul><li>(http://www.hhs.gov/grantsnet/gps/ogamat.htm) </li></ul><ul><ul><li>Applicability: HHS Grantees receiving the majority of Federal funding from HHS awarding agencies </li></ul></ul><ul><ul><li>Subject: Use of Electronically Imaged Record Storage </li></ul></ul><ul><ul><li>Purpose: Permits the substitution of electronically imaged records for original records and encourages grants recipients to do so </li></ul></ul><ul><ul><li>Action: Organizations that would like to implement the use of electronic records may do so provided the institution establishes the appropriate procedures and notifies DHHS in writing </li></ul></ul>
    133. 138. Federal Demonstration Partnership <ul><li>Intent: To reduce administrative burdens in order to increase research productivity by standardizing and simplifying federal regulations. </li></ul><ul><li>Background: Began as a two year pilot program with Florida universities and five federal agencies. Originally called the Florida demonstration project. </li></ul><ul><li>Goal: To demonstrate that accountability may be maintained while simplifying research administration. </li></ul><ul><li>The Federal Demonstration Partnership currently governs grant awards only; contracts and cooperative agreements are not included. </li></ul>
    134. 139. Monitoring Requirements <ul><li>Recipients are responsible for: </li></ul><ul><ul><li>Monitoring each project, program, subaward, function or activity supported by award </li></ul></ul><ul><ul><li>Ensuring subrecipients have met audit requirements </li></ul></ul>
    135. 140. Research Involving Humans Research Human Subjects AND AND AND AND AND a living individual; investigator obtains (1) data through intervention or (2) identifiable private information a systematic investigation designed to contribute to generalizable knowledge indirect activities (survey, observation) direct activities or intervention (interview, blood draw)
    136. 141. Elements of Compliance with Human Subjects Regulations <ul><li>FWA </li></ul><ul><li>Approval from Institutional Review Board (institutional or local) </li></ul><ul><li>Compliance with requirements - </li></ul><ul><ul><li>Institutional </li></ul></ul><ul><ul><li>OHRP </li></ul></ul><ul><ul><li>Sponsor </li></ul></ul>
    137. 142. Use of Animals in Research, Teaching, and Testing Research Teaching Testing AND AND To provide for the humane care and use of live vertebrate animals in biomedical and behavioral research, teaching or testing.
    138. 143. Elements of Compliance with Animal Care Regulations <ul><li>Assurance Number </li></ul><ul><li>Approval from Institutional Animal Care & Use Committee </li></ul><ul><li>Compliance with requirements - </li></ul><ul><ul><li>Institutional </li></ul></ul><ul><ul><li>AAALAC, OLAW </li></ul></ul><ul><ul><li>Sponsor </li></ul></ul>
    139. 145. Research Involving Recombinant DNA Molecules <ul><li>Applicability </li></ul><ul><li>Applies to research funded by public or private agencies external to the NIH if the Institution receives NIH funds for related research. Recombinant DNA molecules are either: (i) molecules constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or (ii) molecules that result from the replication of those cells. Revised guidelines issued by the National Institutes of Health in October 2000 - http://www4.od.nih.gov/oba </li></ul><ul><li>Institutional Requirements </li></ul><ul><ul><li>1. Establish and implement policies that comply with NIH guidelines </li></ul></ul><ul><ul><li>2. Establish an Institutional Biosafety Committee (IBC) that </li></ul></ul><ul><ul><ul><li>a) has at least 5 members selected because of their expertise - </li></ul></ul></ul><ul><ul><ul><li>2 unaffiliated, 1 plant expert, 1 animal containment expert, and a Biological Safety Officer if BL 3 or BL 4 or large scale research is conducted </li></ul></ul></ul><ul><ul><ul><li>b) reviews and approves all non-exempt rDNA research </li></ul></ul></ul><ul><ul><ul><li>c) keeps minutes and makes them available to the public on request </li></ul></ul></ul>
    140. 146. Research Involving Recombinant DNA Molecules (continued) <ul><li>Institutional Requirement (continued) </li></ul><ul><li>3. Report as required to NIH </li></ul><ul><li> a) the source(s) of the DNA and nature of the inserted DNA sequence </li></ul><ul><ul><li> b) the hosts and vectors to be used </li></ul></ul><ul><ul><li>c) whether a deliberate attempt will be made to express a foreign gene </li></ul></ul><ul><ul><li> d) containment conditions specified in the Guidelines </li></ul></ul><ul><li>Exempt categories </li></ul><ul><li>1. Those that are not in organisms or viruses </li></ul><ul><li>2. Those consisting entirely of DNA segments from a single </li></ul><ul><li>nonchromosomal or viral DNA source </li></ul><ul><li>3. Those consisting entirely of DNA from a prokaryotic host including its </li></ul><ul><li>indigenous plasmids or viruses when propagated only in that host or </li></ul><ul><li> when transferred to another host by established physiological means </li></ul><ul><li>4. Certain recombinant DNA molecules consisting entirely of DNA segment </li></ul><ul><li>from different species that exchange DNA by known processes </li></ul>
    141. 147. Research Involving Human Gene Transfer <ul><li>Investigators must: </li></ul><ul><ul><li>Obtain prior RAC review, IRB approval and all applicable regulatory authorizations for experiments involving deliberate transfer of rDNA or DNA or RNA derived from rDNA into human research participants. </li></ul></ul><ul><ul><li>Obtain IND from the Food and Drug Administration if required. </li></ul></ul><ul><ul><li>Submit to NIH, no later than 20 working days after enrollment, a copy of the approved informed consent document, the protocol approved by the IBC and the IRB, the IBC approval and the IRB approval, a brief written report on recommendations of the RAC and any modifications required by the FDA, any NIH grant number, the IND number and the date of initiation. </li></ul></ul><ul><ul><li>Submit Annual Data Report Forms to NIH Office of Biotechnology Activities. </li></ul></ul><ul><ul><li>Clinical trial sites added after RAC review, must submit materials to NIH/OBA prior to any enrollment. </li></ul></ul><ul><ul><li>Submit Serious Adverse Events immediately to IRB, IBC, Office for Human Research Protections (if applicable) and NIH OBA, followed by full written report to each. </li></ul></ul>
    142. 148. Hazardous Materials <ul><li>Statutory Basis </li></ul><ul><ul><li>Sections 103 and 107 of the Contract Work Hours and Safety Standards Act (40 USC 327-330), supplemented by DOL regulations at 29 CFR, Part 5 </li></ul></ul><ul><ul><li>FAR, Subpart 23.3 </li></ul></ul><ul><ul><li>OMB Circular A-110, Subpart D, Appendix A </li></ul></ul><ul><li>Applicability </li></ul><ul><ul><li>All awards over $2000 for construction </li></ul></ul><ul><ul><li>All awards over $2500 for other activities </li></ul></ul><ul><li>Requires </li></ul><ul><ul><li>Notification to employees </li></ul></ul><ul><ul><li>Preparation and submission of a material safety data sheet </li></ul></ul>
    143. 149. USA PATRIOT Act <ul><li>“ Uniting and Strengthening America Act by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001” was signed by President Bush on October 26, 2001. </li></ul><ul><ul><li>Mission: To deter and punish terrorist acts in the U.S. and around the world and to enhance law enforcement investigatory tools. Criminalized possession and use of a type or quantity of Select Agents not reasonably justified by bona fide research or other peaceful purpose. Criminalized possession, use, or transfer by a restricted person. </li></ul></ul>
    144. 150. Data Access and Retention <ul><li>Basis For Requirement: </li></ul><ul><li>... &quot;Financial records, supporting documents, statistical records, and all other records pertinent to an award shall be retained for a period of three years from the date of the submission of the final expenditure report”… </li></ul><ul><li>OMB APRIL 11, 1994 LETTER TO NSF GENERAL COUNSEL </li></ul><ul><li>....&quot;The term 'all other records pertinent to an award' was meant to encompass all records that were produced in connection with a grant. Therefore, laboratory records and primary data should be retained for three years and the recipient should provide access to the records.” </li></ul><ul><li>OMB CIRCULAR A-110 SECTION.53(b) </li></ul>
    145. 151. Project Close-out <ul><li>Responsibility: </li></ul><ul><li>Institution’s Sponsored Projects Office is usually responsible for overseeing the close-out of awards. </li></ul><ul><li>Report Responsible Person/office </li></ul><ul><li>Technical Principal Investigator </li></ul><ul><li>Equipment Central Property Control Office </li></ul><ul><li>Patent/Invention Sponsored Project Office </li></ul><ul><li>Collaboration with PI and Technology Transfer </li></ul><ul><li> Office </li></ul><ul><li>Fiscal Accounting Office </li></ul><ul><li>Subrecipients Sponsored Projects Office with PI and </li></ul><ul><li>Accounting Office </li></ul><ul><li>Reports from Subrecipients Needed in Advance in Order to Incorporate into Reports to Sponsor </li></ul>
    146. 152. “ I already wrote the paper. That’s why it’s so hard to get the right data.”
    147. 153. Hot Topics and Continuing Developments: <ul><li>Research funding </li></ul><ul><li>Federal policy </li></ul><ul><li>Regulatory news </li></ul><ul><li>Electronic Submission </li></ul><ul><li>Other </li></ul>
    148. 154. THE END This has been brought to you by NCURA! Your friendly research administration folks who strive to make your jobs fun, exciting and rewarding!
    149. 155. Fundamentals of Sponsored Projects Web Site <ul><li>Bookmark Today: </li></ul><ul><li>http://www.ncura.edu/members/fundamentals/ </li></ul><ul><li>Broken into Sections: </li></ul><ul><ul><li>Legal Framework </li></ul></ul><ul><ul><li>Pre-Award: Research Administration Services </li></ul></ul><ul><ul><li>Pre-Award: Proposal/Budget Development, Costing </li></ul></ul><ul><ul><li>Compliance </li></ul></ul><ul><ul><li>Negotiation and Award </li></ul></ul><ul><ul><li>Post-Award Administration </li></ul></ul>Searchable!