The Life Cycle of a Sponsored Project: An Integrated Approach Part 1 I. Introduction Overview of session 4/10/2015 2 II. Roles and Responsibilities of Primary Players Proposals Principal Investigator (PI) Unit administrator Divisional review University approval Provost office Foundation Relations/Development Legal/Chief Financial Officer 4/10/2015 3 II. Roles and Responsibilities of Primary Players Beyond proposals Comptroller’s office Restricted Fund accounting Purchasing 4/10/2015 4 II. Roles and Responsibilities of Primary Players Key agency personnel Programmatic personnel officer Grants and contracts (administrative) officials 4/10/2015 5 III. Identifying Funding Opportunities Resources URA Web site URA electronic distributions IRIS Fed-X BSD communication tools – ORS Web site – Signals – E-signals 4/10/2015 6 III. Identifying Funding Opportunities Resources (con’t) BSD communication tools (con’t) – Biomedical Sciences Report – Faculty Awards Committee Bulletin Professional 4/10/2015 periodicals 7 III. Identifying Funding Opportunities Mentors/colleagues Service on study section/review committees Current and past funding sources Determining appropriateness Read the guidelines Determine appropriateness for: – The institution? – The individual? – The project? 4/10/2015 8 III. Identifying Funding Opportunities Searches Custom searches Funding opportunity notification systems – IRIS-Alerts – Fed-X – NSF Custom Search Ad-hoc searches Agency Web pages URA training program - using search tools 4/10/2015 9 III. Identifying Funding Opportunities Agency contacts Technical contact/scientific liaison – Programmatic discussion – Special approvals/exceptional issues appendices/late proposals – Funding level – Review process 4/10/2015 10 •III. Identifying Funding Opportunities Current Forms and Guidelines Check for most current forms and guidelines – Web-based information – Campus resources – Diskettes – Direct to PI 4/10/2015 11 •III. Identifying Funding Opportunities Deadlines/target dates Target deadline Rolling deadlines Deadline No deadline 4/10/2015 12 III. Identifying Funding Opportunities Deadlines/target dates (con’t) Receipt date Mailing date Internal deadlines 4/10/2015 13 III. Identifying Funding Opportunities Limited opportunities What is a limited opportunity – Coordination of selection process Deputy Provost/Foundation Relations Divisional Departmental – Nomination letters – Assistance in proposal development 4/10/2015 14 III. Identifying Funding Opportunities Coordination with Foundation Relations Limited opportunities Sensitive foundations 4/10/2015 15 III. Identifying Funding Opportunities Funding instruments Procurement vehicles – Contracts Assistance vehicles – Grants – Cooperative agreements 4/10/2015 16 III. Identifying Funding Opportunities Funding instruments (con’t) Grant – federal, state and local government, foundations, voluntary associations, corporations – investigator initiated – financial assistance – oversight, but not direction – federal grants subjects to OMB Circular A-110 and agency implementation 4/10/2015 17 III. Identifying Funding Opportunities Funding instruments (con’t) Grant (con’t) – Federal grants may be awarded under Federal Demonstration Partnership (FDP) – Federal grants may be awarded under expanded authority/SNAP; some SNAP submissions may now be handled electronically (eSNAP) 4/10/2015 18 III. Identifying Funding Opportunities Funding instruments (con’t) Cooperative agreement (federal) – Agency initiated – Financial assistance – Oversight and some direction; partnership – Federal cooperative agreements subject to OMB Circular A-110 – Generally not awarded under Federal Demonstration Partnership 4/10/2015 19 III. Identifying Funding Opportunities Funding instruments (con’t) Federal contract – Federal, state or local government, corporations – Procurement of services (research) – Sponsor initiated - targeted project Oversight Federal contracts subject to Federal Acquisitions Regulations (FARs) Sponsored research agreement Clinical trial agreement 4/10/2015 20 III. Identifying Funding Opportunities Funding instruments (con’t) Material transfer agreement – Purpose – Incoming/outgoing – Incoming - MTA provided by provider – Outgoing University of Chicago types: 4/10/2015 UB MTA UC MTA (new version to be posted soon) 21 III. Identifying Funding Opportunities Solicitation types Broad agency announcements Request for proposals (contracts/cooperative agreements) Request for applications (grants) Program announcements (grants/cooperative agreements) 4/10/2015 22 III. Identifying Funding Opportunities Types of proposals Letters of intent Pre-proposals Unsolicited proposals Solicited proposals 4/10/2015 23 IV. Proposal Preparation Project description Read the guidelines Agency/program specific Sequence/sections specified Use review criteria 4/10/2015 24 IV. Proposal Preparation Project description (con’t) Standard research elements – Hypothesis – Specific aims – Background – Significance – Materials and methods 4/10/2015 25 IV. Proposal Preparation Project description (con’t) Seek advice and input – Identify mentor – Critique specific aims – Critique project description 4/10/2015 26 IV. Proposal Preparation Determination of project requirements Space Personnel Equipment Specialized resources Access to expertise 4/10/2015 27 IV. Proposal Preparation PI eligibility Two parameters: sponsoring agency/university policy Eligible – Faculty tracks – Academic non-faculty (ANF) 4/10/2015 Senior Scientists, Senior Research Associate and RA track (Asst. Professor, Assoc. Professor, Professor) New hires 28 IV. Proposal Preparation PI eligibility (con’t) Ineligible – Research scientist – Lecturer – Adjunct appointees – Staff – Fellows – Students 4/10/2015 29 IV. Proposal Preparation PI eligibility (con’t) Ineligible – Part-Time (PT) – RA – BSD Specific 4/10/2015 Clinical Associate (CA) RA (Instructor) 30 IV. Proposal Preparation PI eligibility (con’t) Requesting special permission – Sectional, departmental support and oversight – Written request with detailed justification – Curriculum Vitae – Approval by Dean or designee – Approval of URA – Final approval by Provost Office 4/10/2015 Faculty Appointments - Mary Harvey Academic Non-Faculty - Aneesah Ali 31 IV. Proposal Preparation PI eligibility (con’t) Appropriate Reasons – Fellowship but agency requires fellow to serve as PI – In advance of final approval of appointment – Exceptional circumstances on a case by case basis 4/10/2015 32 IV. Proposal Preparation Endorsement and support letters Uncompensated collaborators Those supplying essential research resources Mentors Letters of recommendation Mentor/department chair letter for NIH Kseries 4/10/2015 33 IV. Proposal Preparation Acquisition of technical advice/assistance Collaborators Consultants/independent contractors Subawards 4/10/2015 34 IV. Proposal Preparation Agency and university guidelines Read in detail the solicitation/program guidelines Proposal checklist Adhere to requirements for: – Title length – Description length – Margins 4/10/2015 35 IV. Proposal Preparation Agency and university guidelines (con’t) Adhere to requirements for (con’t): – Type size/font – Obtaining prior sponsor approval for exceptions – Biosketch/CV – Current and pending support – Resources and facilities Use 4/10/2015 most current agency forms 36 IV. Proposal Preparation Completing proposal forms University Information – Congressional District – Employee Identification Number (EIN) – DUNS Number Tax exempt materials University annual report List of board of trustees 4/10/2015 37 IV. Proposal Preparation Completing proposal forms (con’t) Representations and certifications Board of Trustees resolution on signatory authority 4/10/2015 38 IV. Proposal Preparation Completing proposal forms (con’t) Boilerplate – University description – Divisional/department capabilities – Resources and facilities – Resources for descriptions 4/10/2015 39 IV. Proposal Preparation Other supporting materials Current and pending support References Appendices information Biosketch – Format – Page limits – Key information – Conflict of interest 4/10/2015 40 IV. Proposal Preparation Just-in-Time applications/modular grants Abbreviated requirements Special instructions: – Just in Time (JIT): 4/10/2015 Minimal budget/detailed justification Special biosketch requirements No checklist required 41 IV. Proposal Preparation Just-in-Time applications/modular grants (con’t) Special instructions (con’t) – Modular grant: 4/10/2015 Special biosketch instructions Minimal budget/minimal justification No other support Checklist page required 42 IV. Proposal Preparation Small business plans Contracts only Best and final Work with central procurement Small business, minority- and womenowned Examples available from URA Routing - local unit/div/URA 4/10/2015 43 IV. Proposal Preparation Freedom of Information Act (FOIA) When to mark proposal Proposal subject to FOIA when awarded Protection of proprietary/confidential information To be protected, each proposal page must be marked Post award – access to data now required by law 4/10/2015 44 V. Budgeting Project Costs Art of budget development 4/10/2015 45 V. Budgeting Project Costs Budgets Reflect the scope of work of the proposal Compliant with sponsor guidelines Necessary to perform the proposed work and are not precluded by specific program guidelines or applicable cost principles Compliant with departmental, divisional, and University policies and guidelines Narrative justification 4/10/2015 46 V. Budgeting Project Costs Budget categories -- direct costs – confidentiality of salary data Graduate students – Type A; Type B Equipment Consultants Lab supplies “Sensitive” categories: office supplies, telephone costs Personnel 4/10/2015 47 V. Budgeting Project Costs Budget categories -- direct costs (con’t) Subcontracts Graduate student tuition Travel – foreign; domestic Publication costs 4/10/2015 48 V. Budgeting Project Costs Verification of current rates research assistant – division dependent Graduate tuition recovery – division dependent Fringe benefits – choice of rate depends on nature of employment Graduate 4/10/2015 49 V. Budgeting Project Costs Verification of current rates (con’t) centers – verify rates, e.g. Biostatistical Lab; SSD Survey Research Center Recharge 4/10/2015 50 V. Budgeting Project Costs Verification of current rates (con’t) service centers – excluded from MTDC overhead Specialized – Animal Facilities Charge – PSD Central Shop 4/10/2015 51 V. Budgeting Project Costs Verification of current rates (con’t) Confirm current rate through Quick Reference Fact Sheet Use resource web sites – URA 4/10/2015 52 V. Budgeting Project Costs Cost sharing/matching commitments University policy – Only when required by sponsor – Avoid commitments requiring detailed supporting documentation – Designation of source of cost sharing/matching – $100,000 threshold requires additional approvals 4/10/2015 53 V. Budgeting Project Costs Cost sharing/matching commitments (con’t) Approvals – Department/division – Provost’s Office – Concurrence of Budget Office – Documentation of approval to URA 4/10/2015 54 V. Budgeting Project Costs Typical budget problems Compensation- employee; consultant; subcontractor; independent contractor Fellows versus postdoctoral research associates Salaries or stipends Equipment that should be supplies (<$5,000) 4/10/2015 55 V. Budgeting Project Costs Typical budget problems (con’t) Effort on PTF matching effort in proposal Effort on budget does not match effort in justification Translating effort to calendar/academic months BSD faculty appointments are 12 month (CY) appointments 4/10/2015 56 V. Budgeting Project Costs Typical budget problems (con’t) Non-BSD faculty appointments are 9 month (AY) appointments Calculation of Animal Facilities Charge Justification matches budget 4/10/2015 57 V. Budgeting Project Costs NIH training Grants Special budget restrictions Stipends are set by NIH Limited post-award flexibility Health benefits Tuition: budget full amount/awarded by NIH formula 4/10/2015 58 V. Budgeting Project Costs Consultants Individual expert in the field of the technical project Use Sponsored Research Consultant Agreement Meet IRS test for independent contractor (should person be a casual employee?) Scope of services 4/10/2015 59 V. Budgeting Project Costs Consultants (con’t) of compensation – test for reasonableness Rate may be capped by sponsor (e.g. NSF) Former UC employee is special case Use SRC Invoice PI confirmation of satisfactory performance of service - OK for payment Rate 4/10/2015 60 V. Budgeting Project Costs Subawards Organization to organization agreement Use of personnel and facilities Approval from subrecipient institution at the time of proposal submission Scope of work Budget, including subrecipient’s indirect costs 4/10/2015 61 V. Budgeting Project Costs NIH modular grants budgets Designed to focus efforts of investigators and reviewers on science and away from detailed budget No detailed categorical budgets Direct cost budgets in modules of $25K up to ceiling of $250K/year 4/10/2015 62 V. Budgeting Project Costs NIH modular grants budgets (con’t) Request the same # of modules for each budget period of project (exceptions permitted) 4/10/2015 63 V. Budgeting Project Costs NIH modular grants budgets (con’t) No detailed or summary budget pages in application No annual escalation – PLAN AHEAD when estimating modules Modular budget evaluated on basis of general, expert estimate of total effort and resources required to carry out the proposed research 4/10/2015 64 V. Budgeting Project Costs NIH modular grants budgets (con’t) Additional budget information will be requested only under special circumstances Departmental/divisional guidelines may require supporting budget detail 4/10/2015 65 V. Budgeting Project Costs Modular grant – postaward notations Modular awards are issued without direct cost categorical breakdowns – significant rebudgeting provision does not apply. Allocate and account for costs related to award by category within FAS system 4/10/2015 66 VI. Proposal Preparation-Compliance Issues Regulatory compliance Public trust, public perception and scientific responsibility Emergence of regulations Consequences of non-compliance 4/10/2015 67 VI. Proposal Preparation-Compliance Issues Protection of human subjects Historical perspective – Tuskegee experiments – Nazi human experimentation 4/10/2015 68 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Development of ethical principles – Nuremberg code 4/10/2015 Voluntary consent to participate Capacity to consent Freedom from coercion Appropriate research design Minimization of risks Appropriate risk/benefit ratio Freedom to withdraw at any time 69 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Development of ethical principles (con’t) – Declaration of Helsinki – Policies for the Protection of Human Subjects (NIH) – Belmont Report 4/10/2015 Respect for persons Beneficence Justice Boundaries between practice and research 70 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Federal regulations – DHHS: 45 CFR 46 – Federal Common Rule: 1991 - 16 federal agencies – FDA: 21 CFR 50 and 56 International Harmonization of Good Clinical Practice 4/10/2015 71 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Applies to: – Any research with human subjects or their information, whether linked or not linked by identifiers to individuals, Includes: – Clinical trials – Behavioral research – Epidemiological and survey research – Outcomes research 4/10/2015 72 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Includes (con’t): – Anthropological research – Educational research – Field research – Oral history 4/10/2015 73 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Any research with human subjects must, therefore, be reviewed and approved by a recognized Institutional Review Board or determined to be exempt 4/10/2015 74 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Institutional Official: Associate Vice President for Research Federal-Wide Assurance (FWA): FWA00005565 Three IRBs – Social Science Division (03) – Social Service Administration (02) – Biological Sciences Division/University of Chicago Hospitals (01) 4/10/2015 75 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Types of review – Exempt from committee review – Expedited review – Review by committee 4/10/2015 76 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Points to remember: – Protocols must be approved by the IRB in full prior to the initiation of any research – Cannot initiate clinical trial without BOTH approved protocol and approved clinical trial agreement – The informed consent process must be completed before any subject can be enrolled in a study 4/10/2015 77 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Points to remember (con’t): – Otherwise - study data is illegitimate – Use of patient charts or radiological films or discarded and unidentified tissues, blood etc, is research and must have IRB approval – Student research subject to human subjects requirements – Deception only allowed at discretion of IRB 4/10/2015 78 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Points to remember: – Field work subject to human subjects requirements – Oral history projects subject to human subjects requirements – IRBS are not allowed to circumvent these rules – Protocol approval for one year or less 4/10/2015 79 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Points to remember: – Institutions are subject to review 4/10/2015 Office for the Protection from Research Risks (OPRR): MPA process Query letters On-site reviews Food & Drug Administration (FDA): periodic on-site audits 80 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Human subject challenges – Balancing ethical principles and research needs – Proxy consent/waiver of consent – Changing face of research, particularly genetic analysis – Need to develop local policy ahead of federal policy to keep up 4/10/2015 81 Vi. Proposal preparation-compliance issues Protection of human subjects (con’t) Human subject challenges (con’t) – Constantly changing regulations – Changing institutional boundaries – International/target group field work Sensitivity to cultural differences – Defining research versus case studies, quality assurance, journalism 4/10/2015 82 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Resources – ORS Web-site: http://ors.bsd.uchicago.edu/ – Office of Human Research Protection • US Food & Drug Administration • FDA Information Sheets 4/10/2015 83 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Resources (con’t) – PRIM&R (Public Responsibility in Medicine and Research) – BSD/UCH IRB 4/10/2015 84 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Training – BSD/UCH IRB Videos Annual orientation provided by UC/UCH IRB – BSD Initiatives 4/10/2015 GCRC training Health studies seminar series K30 proposal 85 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Grant-related issues – Who can be PI on a protocol – Verifying protocol numbers and date – FDA requirements – NIH requirements 4/10/2015 398 Research Plan, Section E Inclusion of women and minorities, children 86 VI. Proposal Preparation-Compliance Issues Protection of human subjects (con’t) Grant-related issues (con’t) – Notification of approval to agency – Ban on fetal research – FAS accounts/regulatory compliance 4/10/2015 87 VI. Proposal Preparation-Compliance Issues Use of animals Ethical principles – US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Teaching: 4/10/2015 Transportation, care and use of animals should be in accordance with the Animal Welfare Act Procedures involving animals should be designated and performed with due consideration of the relevance to human or animal health, the advancement of knowledge, or the good of society 88 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Ethical principles (con’t) – US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Teaching (con’t): 4/10/2015 Animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results Alternatives to use of animals models, such as mathematical models, computer simulation, and in vitro biological systems should be considered. 89 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Ethical principles (con’t) – US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Teaching (con’t): 4/10/2015 Proper use of animals, including the avoidance or minimization of discomfort, distress and pain Procedures that cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. 90 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Ethical principles (con’t) – US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Teaching (con’t): 4/10/2015 Animals that would suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure The living conditions of animals should be appropriate for their species and contribute to their health and comfort 91 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Ethical principles (con’t) – US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Teaching (con’t): 4/10/2015 Investigators and other personnel shall be appropriately qualified and experienced for conducting the specified procedures on animals Any exceptions to these principle can be made only by the IACUC 92 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Federal regulations – Public Health Service Policy on Humane Care and Use of Laboratory Animals – Animal Welfare Act of 1966 (1970, 1976, 1985, 1990) - USDA – Endangered Species Act 4/10/2015 93 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Principles – Guide for the Care and Use of Laboratory Animals- National Research Council 4/10/2015 94 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Principles (con’t) – Institutional Animal Care and Use Committee (IACUC) Responsibilities 4/10/2015 Approve all use of animals for research, teaching or testing purposes Review protocols on an on-going basis Provide oversight of the Animal Resources Center Semi-annual program review, includes ARC and inspection of all labs where animals are housed more than 12 hours 95 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) PHS regulations apply to all use of animals in research, teaching, testing USDA regs currently apply to: non-human primates, cats, dogs, pigs, sheep, rabbits, hamsters, chincillas, etc. USDA regs do not currently apply to: rodents, birds, fish or reptiles 4/10/2015 96 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Institutional Official: Dean of the Biological Sciences Assurance: NIH-OPRR Single institutional animal care and use committee Animal Resources Center 4/10/2015 97 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) IACUC Reviews – Use of live animals – Use of tissue, including tissue from slaughterhouse and/or routine tissue harvest – Production of antibodies in live animals, whether on-campus or from vendor – Use of animal parts from dead animals – Breeding of colonies 4/10/2015 98 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) IACUC Reviews (con’t) – Field research – Preserved specimens 4/10/2015 99 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Special considerations – Special mandate to reduce the number of animals used in research, to replace animals with either lower order animals or in vitro/computer methods and to refine methods to reduce pain and distress – Animals cannot give consent, so IACUC charged with their welfare 4/10/2015 100 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Special considerations (con’t) – Special issues 4/10/2015 Production of antibodies using the Ascites Method Sensitivity toward animal rights Need for security Animal must be ordered through ARC IACUC/ARC responsible for all animals, even if housed outside ARC Housing outside ARC is supposed to conform with standards of Guide 101 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Special considerations (con’t) – Special issues (con’t) 4/10/2015 Partnership between Institutional Official (Dean Steele), IACUC, ARC and users Occupational health and safety Coordination with other committees Periodic review Good Laboratory Practice AAALAC Accreditation 102 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Special considerations (con’t) – Special issues (con’t) 4/10/2015 Laboratory protocol No eating Standard requirements 103 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Special considerations (con’t) – Special issues (con’t) 4/10/2015 Physical restraint Training Appropriate anaesthesia/analgesia Multiple survival surgery Food or fluid restrictions Peer review Transferring animals into and out of institution 104 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Resources – ORS Web-site: http://ors.bsd.uchicago.edu/ 4/10/2015 105 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Training – Introduction Monthly Required for all with access to ARC facilities – Monthly seminars – Mandatory training for biohazards, primates Printed 4/10/2015 materials 106 VI. Proposal Preparation-Compliance Issues Use of animals (con’t) Special grant related issues – Who can be PI on a protocol – Verifying protocol numbers and date – Agency notification – Grace period – NIH requirements: research plan, Section F – FAS accounts/regulatory compliance – Peer review 4/10/2015 107 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials Infectious agents – Risk to laboratory personnel – Risk to general public Recombinant DNA – Perceived risk to general public 4/10/2015 108 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Federal oversight and regulations – Centers for Disease Control - Biosafety in Microbiological and Biomedical Laboratories (BMBL) – NIH Guidelines for Research Involving Recombinant DNA – Classification of Etiologic Agents on the Basis of Hazards – OSHA Blood Borne Pathogen Standard 4/10/2015 109 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Institutional official: Dean of the Biological Sciences Division Single institutional biosafety committee 4/10/2015 110 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Principles in biosafety – Biosafety in the laboratory: Prudent practices for the handling and disposal of infectious materials (National Research Council) – Four biosafety levels – Containment 4/10/2015 Laboratory practice and technique Safety equipment (primary barriers) Facility design (secondary barriers) 111 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Principles in biosafety (con’t) – Importation and interstate shipment of certain biomedical materials 4/10/2015 USDA Department of Transportation Public Health Service Foreign Quarantine Regulations 112 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Biosafety Levels I-IV – Biosafety Level 1: well characterized agents not known to cause disease in healthy adults and of minimal potential hazard to lab personnel and the environment 4/10/2015 Recombinant DNA Vectors from viruses 113 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Biosafety Levels I-IV (con’t) – Biosafety Level 2: agents of moderate potential hazard 4/10/2015 E. Coli, anthrax, chlamydia, most mycobactierim, adenoviruses, hepatitis, retrovirus 114 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Biosafety Levels I-IV (con’t) – Biosafety Level 3: applicable to clinical, diagnostic, teaching, research or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal infections Mycobacterium tuberculosus, encephalitis – Biosafety Level 4: dangerous exotic agents 4/10/2015 Hanta virus, hemorrhagic fever, ebola 115 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Determining BL risk group – American Type Culture Collection Catalogues – Department of Labor, Occupational Safety and Health Administration - Exposure to Bloodborne Pathogens – International Committee on Taxonomy of Viruses – Chart: 61 FR 1486 4/10/2015 116 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Noteworthy considerations – Identify biohazard – Determine biosafety level/risk group – Facilities limitations 4/10/2015 117 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Pertains to: – Laboratory work – Work with animals – Work with plants – Greenhouses 4/10/2015 118 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Resources – ORS Website: http://ors.uchicago.edu/l – Institutional Biosafety Committee (IBC) – University Safety and Environmental Affairs – Office NIH Office of Biotechnology Activities – Office of Recombinant DNA Activity – USDA Biotech and Science Services 4/10/2015 119 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Training – PI training – Videos on biosafety or infectious agents available in crerar library 4/10/2015 120 VI. Proposal Preparation-Compliance Issues Use of biohazardous materials (con’t) Occupational Health and Safety – Human Resources – Health Services – IBC – Coordination with other regulatory committees 4/10/2015 121 VI. Proposal Preparation-Compliance Issues Use of radiation Federal/state oversight – FDA – Nuclear Energy Commission – Illinois Department of Nuclear Safety 4/10/2015 122 VI. Proposal Preparation-Compliance Issues Use of radiation (con’t) Oversight – Committee on Radiation Hazards – Human Use of Radioisotopes and Radioactive Drug Research Committee (RDRC) – Office of Radiation Safety 4/10/2015 123 VI. Proposal Preparation-Compliance Issues Use of radiation (con’t) Regulatory requirements – Purchasing restrictions – Emission limits – No eating 4/10/2015 124 VI. Proposal Preparation-Compliance Issues Use of radiation (con’t) IDNS regulatory licenses – University - laboratory research – Hospital - clinical care and clinical research Annual or more frequent inspections Reports - citations 4/10/2015 125 VI. Proposal Preparation-Compliance Issues Use of radiation (con’t) Resources – ORS Website: http://ors.bsd.uchicago.edu – Radiation Safety Website http://facilities.uchicago.edu/organization/radiation/ho me.html Training – Mandatory training with periodic updates Newsletter 4/10/2015 – Office of Radiation Safety 126 VI. Proposal Preparation-Compliance Issues Other Regulatory considerations Chemical and laboratory safety OSHA Occupational 4/10/2015 health and safety 127 VI. Proposal Preparation-Compliance Issues Conflict of interest Federal regulations University policy Assurance Form Disclosure Form Process of review Approval of management plan by Office the Provost 4/10/2015 128 VI. Proposal Preparation-Compliance Issues Compliance with University policies – “Whistleblower” policy [Compliance with University Policies and Procedures] http://hr.uchicago.edu/policy/p103.html PI eligibility U103 4/10/2015 129 VI. Proposal Preparation-Compliance Issues Compliance with University policies (con’t) Development- sensitive foundations Cost sharing/ matching funds 4/10/2015 130 VI. Proposal Preparation-Compliance Issues Compliance with divisional/departmental guidelines – faculty salary recovery Tuition recovery for graduate research assistants BSD 4/10/2015 131 VI. Proposal Preparation-Compliance Issues Proposal review and clearance Forms and agency guidelines Project personnel Evaluation of scope and nature of work to be performed Representations and certifications University audit and financial reports 4/10/2015 132 VI. Proposal Preparation-Compliance Issues Proposal review and clearance (con’t) Taking exception to binding terms and conditions – Approval of publications – Indemnification – Assignment of intellectual property Recipient organization: The University of Chicago (not Medical Center; not Hospital; not department) 4/10/2015 133 VI. Proposal Preparation-Compliance Issues Proposal review and clearance (con’t) management – where does the responsibility lay? Deadline 4/10/2015 134 VI. Proposal Preparation-Compliance Issues Proposal Transmittal Form – internal control document Purpose Instructions 4/10/2015 135 VI. Proposal Preparation-Compliance Issues Proposal Transmittal Form (con’t) Trouble spots – Incomplete data – PTF data does not match proposal data – Salary and effort of PI and senior investigators does not match up – Cost sharing/.matching information incomplete – Illegible handwriting Sign 4/10/2015 offs 136 VI. Proposal Preparation-Compliance Issues Proposal Transmittal Form (con’t) required for revised budgets – but major project budgets, especially with cost sharing, are rerouted for approval when proposed award has significant budget reduction Not 4/10/2015 137 VII. Routing and Review Process Electronic research administration Science Foundation – FASTLANE NIH Commons See URA page on electronic submissions National 4/10/2015 138 VII. Routing and Review Process Traditional proposal and award procedures Review through channels of draft cover page + budget +abstract + current and pending support + senior investigator CVs + draft project description URA completes and authorizes “Reps and Certs” 4/10/2015 139 VII. Routing and Review Process Traditional proposal and award procedures (con’t) URA provides financial reports; insurance/liability certifications Comment and sign off by URA Changes required by URA: “*” requirements versus suggestions 4/10/2015 140 VII. Routing and Review Process Traditional proposal and award procedures (con’t) Submission to agency Final proposal to URA, division, LBC, department or local unit for files 4/10/2015 141 VIII. Updating Submissions and Award Negotiations Special considerations Changes in Scope or budget Regulatory Approvals Updating Current and Pending Support Just in Time Updates Best and Final Offers Preaward audits 4/10/2015 142 VIII. Updating Submissions and Award Negotiations Special considerations (con’t) Site visits – Inform departmental/divisional/URA offices – Office of Special Projects expertise – Critical importance of run-through – Involve senior academic administrators – Assure administrative and financial systems support 4/10/2015 143 VIII. Updating Submissions and Award Negotiations Negotiation of award terms and conditions PI key point of contact for technical negotiations URA point of contact for business and budget negotiations Review and approval of negotiated technical and budget changes 4/10/2015 144 VIII. Updating Submissions and Award Negotiations Preaward costs and advance accounts Account create Limitations on advance accounts State and local government agreements are increasingly problematic Clinical Studies – subjects may not be enrolled until agreement is negotiated and signed (IRB approval is not sufficient) 4/10/2015 145 VIII. Updating Submissions and Award Negotiations Postaward considerations Authorities – Preaward – Rebudgeting – Project period – No-cost extension – Carry-forward authority 4/10/2015 146 VIII. Updating Submissions and Award Negotiations Postaward considerations (con’t) Equipment issues – Ownership – Reporting Financial reporting requirements Invoicing requirements 4/10/2015 147 VIII. Updating Submissions and Award Negotiations Receipt of award notifications – NSF, NIH Award letters – unilateral or bilateral Distribution of award information Acceptance by “institutional or authorized” official – this means URA! Exceptional agreements – PI leaving or left University Email 4/10/2015 148 VIII. Updating Submissions and Award Negotiations Special cases studies – routing of protocols and proposed agreements Visiting scientists – corporate scientific visitors Corporate-sponsored research Subsequent to ARCH license agreement Gifts and grants and contracts and which is which is which Clinical 4/10/2015 149 The Life Cycle of a Sponsored Project: An Integrated Approach Part 2 The Life Cycle of a Sponsored Project: An Integrated Approach Part 2 Outline IX X XI XII XIII XIV XV XVI XVII XVII XIX XX XXI 4/10/2015 Award evaluation & acceptance Referenced conditions & documents Administrative information Award review with PI Award accounts Managing programmatic aspects Managing award funding Audits Financial reports Billing & collecting funds Intellectual Property Project Termination Relinquishing/transferring programs or awards 151 IX. Award Evaluation & Acceptance Notification of award For most Federal grants: Expenditure of funds constitutes acceptance of award, e.g. NIH, NSF Formal acceptance by “Authorized Institutional Official” - NOT the PI 4/10/2015 152 IX. Award Evaluation & Acceptance Administrator’s role: Review of terms & conditions of award Notation of special restrictions/conditions Limitation on spending, prior approvals 4/10/2015 153 IX. Award Evaluation & Acceptance Trouble spots to look for Cost Sharing requirements Unanticipated budget reductions that could impact scope of work Never assume year-to-year boilerplate is same – changes do appear 4/10/2015 154 IX. Award Evaluation & Acceptance Legal Office Review--URA point of contact Indemnification requirements Unusual certifications and compliance clauses National Laboratory User Agreements 4/10/2015 155 IX. Award Evaluation & Acceptance UCTech participation in sponsored research & MTA agreements Unusual intellectual property rights & requirements Pre-agreed upon licensing royalty rates for research outcomes 4/10/2015 156 IX. Award Evaluation & Acceptance Risk Management--URA point of contact Unusual insurance requirements Off campus site conditions 4/10/2015 157 IX. Award Evaluation & Acceptance Notification to URA of PI/departmental/divisional approval to accept: File Documentation – PI Approval (not administrator signing for PI) Acceptance of unusual terms and conditions by department/division Distribution of signed agreement 4/10/2015 158 X. Referenced Conditions & Documents Federal Grants OMB Circulars General terms and conditions Specific terms and conditions Agency publications Administrative regulations Program regulations 4/10/2015 159 X. Referenced Conditions & Documents Federal Grants OMB Circulars A-21: Cost Principles for Educational Institutions A-110: Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations 4/10/2015 160 X. Referenced Conditions & Documents Federal Grants OMB circulars (con’t) A-133: Audits of States, Local Governments, and Non-Profit Organizations 4/10/2015 161 X. Referenced Conditions & Documents Federal Grants OMB Circulars (con’t) Referenced through: – General T&Cs – Referenced agency publications – Referenced administrative regulations 4/10/2015 162 X. Referenced Conditions & Documents Federal Grants General terms and conditions Federal Demonstration Partnership (FDP) terms and conditions & agency specific terms and conditions – Research awards from: NSF, NIH, NASA, Energy, Air Force, Army, EPA, ONR & USDA 4/10/2015 163 X. Referenced Conditions & Documents Federal Grants General terms and conditions (con’t) NSF – Grant General Conditions (GC-1) – Cooperative Agreement General Conditions (CA-1) – Facilities Modernization Grant Conditions (FAA GC-1) – Fixed Amount Award General Conditions (FAA GC-1) 4/10/2015 164 X. Referenced Conditions & Documents Federal Grants Award specific T&Cs 4/10/2015 165 X. Referenced Conditions & Documents Federal Grants Agency publications NSF Grant Proposal Guide NIH Grants Policy Statement NASA Grant and Cooperative Agreement Handbook 4/10/2015 166 X. Referenced Conditions & Documents Federal Grants Agency administrative regulations agency’s implementation of A-110 Examples Includes – Agriculture: 7 CFR 3019 – DHHS: 45 CFR 74 – Education: 34 CFR 74 – Energy: 10 CFR 600 – NASA : 14 CFR 1260` 4/10/2015 167 X. Referenced Conditions & Documents Federal Grants Program regulations May be published in – Code of Federal Regulations – Agency publications 4/10/2015 168 X. Referenced Conditions & Documents Federal Grants Program regulations (con’t) When are they important? – Research awards? 4/10/2015 No, information tends to apply to whole class of awards 169 X. Referenced Conditions & Documents Federal Grants Program regulations (con’t) When are they important? – Non-research awards? 4/10/2015 Yes, information tends to be award specific Usually available through other agency publications Examples: 34 FR 648: Graduate Assistance in Areas of National need 34 CFR 675: Federal Work-Study Program 170 X. Referenced Conditions & Documents Federal Contracts Consists of 4 parts Part I: The “Schedule” Part II: Contract clauses Part III: List of documents, exhibits and other attachments Part IV: Representations and instructions 4/10/2015 171 X. Referenced Conditions & Documents Federal Contracts The “Schedule” Section A: Solicitation information – May contain administrative information, instructions Section B: Description of the supplies or services Section C: Specifications and statement of work 4/10/2015 172 X. Referenced Conditions & Documents Federal Contracts The “Schedule” (con’t) Section D: Packaging and marking requirements Section E: Inspection and acceptance requirements Section F: Requirements for delivery and performance 4/10/2015 173 X. Referenced Conditions & Documents Federal Contracts The “Schedule” (con’t) Section G: Contract administration Section H: Special contract requirements – See 35.015 requirements that would be placed here 4/10/2015 174 X. Referenced Conditions & Documents Federal Contracts Part II: Contract Clauses Many clauses are sited Clauses that warrant particular attention include – 52.216-7 Allowable cost & payment Reference OMB Circular A-21 – 52.232-20 Limitation of cost 4/10/2015 Applies to “fully funded” contracts Requires notification when cost thresholds are approached 175 X. Referenced Conditions & Documents Federal Contracts Part II: Contract Clauses (Con’t) Clauses that warrant particular attention include (con’t) – 52.232-22 Limitation of funds 4/10/2015 Applies to incrementally funded contracts Requires notification as cost thresholds on allotted funds are approached 176 X. Referenced Conditions & Documents Federal Contracts Part II: Contract Clauses (Con’t) Clauses that warrant particular attention include (con’t) – 52.244-2 Requires contracting officer approval – 52.245-5 4/10/2015 Subcontracts Government property Maintenance and management requirements Unless specifically stated in the “Schedule”, title vests with the government 35.014 Addresses equipment title subject 177 X. Referenced Conditions & Documents Non-Federal Grants & Contracts Conditions & documents are referenced in a manner similar to what is done for federal grants and contracts 4/10/2015 178 XI. Administrative Information Administrator needs to learn from the award instrument information on: Program and budget revisions Cost Principles Period of availability of funds Program (technical) reporting requirements Financial reporting requirements Record retention requirements 4/10/2015 179 XI. Administrative Information Administrator needs to learn from the award instrument information on (con’t): Cost sharing Program income Equipment 4/10/2015 180 XI. Administrative Information: Program and Budget Revisions Federal agency grant prior approval requirements Located in – For grants: General terms & conditions Agency publications Agency administrative regulations that implement Section 25 of A-110 – For contracts 4/10/2015 The “Schedule” 181 XI. Administrative Information: Program and Budget Revisions Federal agency prior approval is mandatory for: Change in scope Change in key personnel Program director/principal investigator’s: – absence for more than 3 months – 25% reduction in effort Need 4/10/2015 for additional funding 182 XI. Administrative Information: Program and Budget Revisions Federal agency prior approval is mandatory for (con’t) Transfer of training allowance funds to other categories Subcontracting project scope Award specific restrictions 4/10/2015 183 XI. Administrative Information: Program and Budget Revisions Federal agency prior approvals required unless waived: Transfers between direct and indirect cost categories – FDP awards: All agencies have waived – Other awards 4/10/2015 NIH has waived NSF has waived 184 XI. Administrative Information: Program and Budget Revisions Federal agency prior approvals required unless waived (con’t): Transfers between direct and indirect cost categories (con’t) – Other awards (con’t) 4/10/2015 NASA reserves the right not to waive DOE has waived unless prohibited by program regulations Others: Check agency publications & regulations that implement A-110 §__.25(c)(5) 185 XI. Administrative Information: Program and Budget Revisions Federal agency prior approvals required unless waived (con’t): Costs that require prior approval because of A-21 – Include: 4/10/2015 Intra-University consulting compensation Insurance on federal owned equipment Equipment Pre-agreement (pre-award) costs Special arrangement and alteration costs 186 XI. Administrative Information: Program and Budget Revisions Federal agency prior approvals required unless waived (con’t): Costs that require prior approval because of A-21 (con’t) – Intra-University consulting compensation Assume no waivers – Insurance on federal owned equipment 4/10/2015 Assume no waivers 187 XI. Administrative Information: Program and Budget Revisions Federal agency prior approvals required unless waived (con’t): Costs that require prior approval because of A-21 (con’t) – Equipment 4/10/2015 FDP awards All agencies have waived Other awards NIH has waived for < $25k NSF has waived Other agencies: Assume no waivers 188 XI. Administrative Information: Program and Budget Revisions Federal agency prior approvals required unless waived (con’t): Costs that require prior approval because of A-21 (con’t) – Pre-agreement (pre-award) costs 4/10/2015 FDP awards All agencies have waived prior approval for costs incurred within 90 days of the award Other awards Assume no waivers 189 XI. Administrative Information: Program and Budget Revisions Federal agency prior approvals required unless waived (con’t): Costs that require prior approval because of A-21 (con’t) – Special arrangement and alteration costs 4/10/2015 FDP awards NSF has waived only for arrangement and alteration cost < $10k Other agencies have waived Other awards Assume no waivers 190 XI. Administrative Information: Program and Budget Revisions Federal agency prior approvals required unless waived (con’t): One-time no cost extensions – FDP awards All agencies have waived Agency notifications required – Other awards 4/10/2015 Research awards Waiver is likely Non-research awards Assume no waivers 191 XI. Administrative Information: Program and Budget Revisions Federal agency prior approvals required unless waived (con’t): Carry forward unobligated balances to subsequent funding periods – FDP awards 4/10/2015 All agencies have waived Agency notifications required 192 XI. Administrative Information: Program and Budget Revisions Federal agency prior approvals required unless waived (con’t): Carry forward unobligated balances to subsequent funding periods (con’t) – Other awards 4/10/2015 Research awards Waiver is likely Non-research awards Assume no waivers 193 XI. Administrative Information: Cost Principles Allowability of costs is determined in accordance with the provisions of A-21, Cost Principles for Educational Institutions A-21 states that specific provisions of the award take precedence – Effectively allows awarding agencies to write additional cost principles – NIH Grants Policy Statement and NSF Grant Policy Manual address some costs in more detail than A-21 4/10/2015 194 XI. Administrative Information: Cost Principles A-21 reference – For grants: General terms & conditions Agency publications Agency administrative regulations that implement Section 27 of A-110 – For contracts 4/10/2015 The “Schedule” Contract Clause 52.216-7 195 XI. Administrative Information: Period of Availability of Funds Grants Period of availability is governed by by Section 28 of A-110. Section 28 states that where funding period is specified, only allowable costs resulting from obligations incurred during the funding period are allowable. 4/10/2015 196 XI. Administrative Information: Period of Availability of Funds Grants (con’t) Most multi-year awards are incrementally funded. Each incrementally funded period then has its funds restricted to obligations that arise during that period Section 25 of A-110, however, allows awarding agency to give grantee authority to carry-forward unobligated balances to subsequent periods. 4/10/2015 197 XI. Administrative Information: Period of Availability of Funds Grants (con’t) A-110 reference – General terms & conditions – Agency publications – Agency administrative regulations that implement Section 28 & 25 of A-110 4/10/2015 198 XI. Administrative Information: Period of Availability of Funds Contracts There is no FAR clause analogous to Section 28 of A-110 4/10/2015 199 XI. Administrative Information: Period of Availability of Funds Contracts Unlike grants, contracts that are incrementally funded do not have those funds restricted to that incremental period. However, – The “Schedule” may specifically restrict funds to a period – Funds may be used only for costs incurred within the contract’s period of performance 4/10/2015 200 XI. Administrative Information: Technical Reporting Requirements Grants Awarding agencies technical reporting requirements must comply with Section 51 of A-110 – Award references 4/10/2015 General terms & conditions Agency publications Agency administrative regulations that implement Section 51 of A-110 201 XI. Administrative Information: Technical Reporting Requirements Contracts There is no FAR clause analogous to Section 51 of A-110 Reporting requirements will be detailed in the “Schedule” 4/10/2015 202 XI. Administrative Information: Financial Reporting Requirements Grants Awarding agencies financial reporting requirements must comply with Section 52 of A-110 – Section 52 provides: 4/10/2015 Use of standard forms SF269, 269A, 270 or 272 Reports shall not be more frequently than quarterly, or less frequently than annually Annual reports shall be due no later than 90 days after the grant year 203 XI. Administrative Information: Financial Reporting Requirements Grants (con’t) Awarding agencies financial reporting requirements must comply with Section 52 of A-110 (con’t) – Award references 4/10/2015 General terms & conditions Agency publications Agency administrative regulations that implement Section 52 of A-110 204 XI. Administrative Information: Financial Reporting Requirements Contracts There is no FAR clause analogous to Section 52 of A-110 Reporting requirements will be detailed in the “Schedule” 4/10/2015 205 XI. Administrative Information: Record Retention Requirements Grants Awarding agencies financial reporting requirements must comply with Section 53 of A-110 – Award references to Section 53 4/10/2015 General terms & conditions Agency publications Agency administrative regulations that implement Section 53 of A-110 206 XI. Administrative Information: Record Retention Requirements Grants (con’t) Requirement – Awards that are renewed quarterly or annually Retain records for a period of 3 years from the date of submission of the quarterly or annual financial report – Awards that are renewed annually 4/10/2015 Retain records for a period of 3 years from the date of submission of the quarterly or annual financial report 207 XI. Administrative Information: Record Retention Requirements Contracts FAR clause 52.215-2 is analogous to Section 53 of A-110 Requirement – “The contractor shall make available . . . records until 3 years after final payment. . . .” 4/10/2015 208 XI. Administrative Information: Cost Sharing Cost sharing expenses are award expenses funded by the University Cost sharing not required as a condition of the award is referred to as voluntary Cost sharing required as a condition of the award is referred to as mandatory 4/10/2015 209 XI. Administrative Information: Mandatory Cost Sharing Grants Awarding agencies cost sharing requirements must comply with Section 23 of A-110 – Award references to Section 23 4/10/2015 General terms & conditions Agency publications Agency administrative regulations that implement Section 23 of A-110 210 XI. Administrative Information: Mandatory Cost Sharing Grants (con’t) Requirements – Allowable cost – Documentation – Cost sharing indirect costs requires agency prior approval Contracts Cost sharing almost never applies to a contract 4/10/2015 211 XI. Administrative Information: Program Income Program income is income that is earned as a result of an award funded activity Possible examples Fees charged for award sponsored conferences Equipment user charges 4/10/2015 212 XI. Administrative Information: Program Income Grants Awarding agencies must comply with Section 24 of A-110 – Award references to Section 24 4/10/2015 General terms & conditions Agency publications Agency administrative regulations that implement Section 24 of A-110 213 XI. Administrative Information: Program Income Grants Requirement – Agencies may exclude royalty and copyright income – For included income, agencies may 4/10/2015 Allow the income to be added to the award Allow the income to be used to fund required cost sharing Reduce the award by the amount of income 214 XI. Administrative Information: Program Income Contracts There is no FAR clause analogous to Section 24 of A-110 Reporting requirements will be detailed in the “Schedule” 4/10/2015 215 XI. Administrative Information: Equipment Grants Awarding agencies equipment requirements must comply with Section 33 of A-110 – Award references to Section 33 4/10/2015 General terms & conditions Agency publications Agency administrative regulations that implement Section 33 of A-110 216 XI. Administrative Information: Equipment Grants Requirement – Title For research awards, title may be vested with the University Most, if not all, agencies have done this For other awards, title remains with the government – Equipment Management 4/10/2015 Prudent maintenance and safekeeping Inventory records Annual reporting of government owned equipment 217 XI. Administrative Information: Equipment Contracts FAR clause 52.245-1 is analogous to Section 53 of A-110 Requirement – Title belongs to the government 4/10/2015 218 XII. Award Review with the PI Terms & Conditions Article 1 of NSF T&Cs require that, “the Principal Investigator or Project Director receives a copy of the award conditions, including the award letter, the budget, the general terms and conditions, any special terms and conditions, and any subsequent changes in the award conditions.” 4/10/2015 219 XII. Award Review with the PI Terms & Conditions General FDP T & Cs T & Cs Artl. 1 Recipient responsibilities and federal requirements Artl. 2 Allowable costs and prior approvals – Artl. 3 Programs of related projects – Artl. 4 Payment Artl. 5 Significant project changes Artl. 6 Non-competitive or continuation award requirements 4/10/2015 220 XII. Award Review with the PI Terms & Conditions General T & Cs FDP T & Cs (con’t) – Artl. 7 Artl. 8 Artl. 9 Artl. 10 Artl. 11 – Artl. 12 Artl. 13 4/10/2015 Financial reports Final report requirements Dissemination of project results Acknowledgement of support and disclaimer Data collection Site visits Pre-award costs 221 XII. Award Review with the PI Terms & Conditions General FDP T & Cs T & Cs (con’t) Artl. 14 Extensions without additional funds – Artl. 15 Equipment and real property – Artl. 16 Alteration and renovation – Artl. 17 Use of U.S.-Flag air carriers – Artl. 18 Financial management system – Artl. 19 Procurement system Artl. 20 Program income 4/10/2015 222 XII. Award Review with the PI Terms & Conditions General T & Cs FDP T & Cs (con’t) Artl. 21 Unobligated balances and limit of federal liability Artl. 22 Patents and inventions Artl. 23 Audits and records – Artl. 24 Termination and enforcement – Artl. 25 National security – Artl. 26 Nondiscrimination Artl. 27 Animal Welfare 4/10/2015 223 XII. Award Review with the PI Terms & Conditions General FDP T & Cs T & Cs (con’t) Artl. 28 Research involving recombinant DNA Molecules Artl. 29 Clean air and water Artl. 30 Human subjects – Artl. 31 Activities abroad 4/10/2015 224 XII. Award Review with the PI Terms & Conditions General FDP T & Cs T & Cs (con’t) – Artl. 32 – Artl. 33 – Artl. 34 – Artl. 35 4/10/2015 Debarred or suspended parties Closeout Rights in data Changes 225 XII. Award Review with the PI Terms & Conditions Special terms & conditions What controls are needed to ensure compliance? 4/10/2015 226 XII. Award Review with the PI Administrative information Administrative information learned from the award instrument Program and budget revisions Cost principles Period of availability of funds Program income requirements 4/10/2015 227 XII. Award Review with the PI Administrative information (con’t) Administrative information learned from the award instrument Cost sharing requirements Equipment management requirements Program (technical) reporting requirements Financial reporting requirements 4/10/2015 228 XII.Award Review with the PI Budget Compare award budget to proposal budget What is the impact of the changes – Are additional funds needed? – Can work be revised without changing scope? – Is there an impact on other awards? 4/10/2015 229 XII.Award Review with the PI Budget Develop a budget management strategy Taylor to the specific award Develop reporting mechanism – Reconcile reports back to FAS’ AM090, 91 Reports – Establish reporting formats & schedule 4/10/2015 230 XII.Award Review with the PI Budget Payroll appointments Verify compensation budget – Individuals to be charged – Charge % <= Effort % – Other account distributions that are affected Procurements Are agency prior approvals required? – Equipment – Subcontracts 4/10/2015 231 XII.Award Review with the PI Budget Procurements (con’t) One-time – When: Now or future – How & when should procurement be initiated? Recurring – Recharge center procurements – Other misc’l supplies & expenses 4/10/2015 232 XII.Award Review with the PI Budget Establish communications protocol Identify roles and responsibilities of: – P.I. – Research staff – Administrative staff Review Financial Policy No. 2101, PI Responsibilities for Financial Oversight of Grants and Contracts 4/10/2015 233 XIII. Award Accounts Considerations How many accounts are needed? Every award needs at least one master account Are new accounts needed for each budget year? – Only if carry forward needs agency approval Are additional accounts need to show compliance with T&Cs – Are funds restricted by multiple purposes? 4/10/2015 234 XIII. Award Accounts Considerations How many accounts are needed? (con’t) Additional accounts are needed if both onand off-campus indirect cost rates are used Additional accounts are needed if cost sharing is required 4/10/2015 235 XIII. Award Accounts Considerations How many accounts are needed? (con’t) Are additional accounts needed for University management purposes – Research may be subdivided into multiple subprojects with their own budgets – University requires multiple accounts when award is for student aid that crosses divisional/school lines 4/10/2015 236 XIII. Award Accounts Considerations Regulatory compliance Approvals required before account can be created/opened – Human subjects – Animals – Recombinant DNA – Biosafety 4/10/2015 237 XIII. Award Accounts How are Regular Accounts Created LBC-Account Create Process Non-LBC Account Create Process Awards other than NIH and NSF – Department completes Form 70, “Request for Restricted Funds Account - Ledgers 5 and 6” – Divisional office reviews and approves – URA reviews and approves – Restricted Funds creates the account 4/10/2015 238 XIII. Award Accounts How are Regular Accounts Created Non-LBC Account Create Process (con’t) NIH and NSF awards – URA e-mails the awards to P.I. Department Divisional office Restricted funds – Restricted funds creates the account 4/10/2015 Based upon Form 70 template completed by department 239 XIII. Award Accounts How are Regular Accounts Created Advance accounts Restricted Funds receives the award from URA – Changes the status from “Advance” to “Regular” – Enters the budget based upon the award agreement 4/10/2015 240 XIV. Managing Programmatic Aspects Interim technical reporting to funding agency Critical stewardship Requirement = part of terms and conditions On-going, incremental funding may be dependent upon programmatic reporting Timing: annual or more frequent Differing formats 4/10/2015 241 XIV. Managing Programmatic Aspects NSF requirements Annual progress report Submitted to cognizant program officer with copy to URA Expected three months before end of current funding period NSF annual reports now submitted electronically by PI 4/10/2015 242 XIV. Managing Programmatic Aspects NSF requirements (con’t) Report format requests information on: – Summary of progress – Summary of proposed work in next year of support – Proposed budget for coming year 4/10/2015 243 XIV. Managing Programmatic Aspects NSF requirements (con’t) Report format requests information on (con’t): – Current and pending support – Contribution to education and human resource development – Updated info on animal, human, biosafety, etc. – PI certification 4/10/2015 244 XIV. Managing Programmatic Aspects NIH non-competing continuations under SNAP Administrative, financial, and programmatic review Four core questions-gauge key issues – Personnel/effort – Spending patterns – Budget required ? Human subjects/animals 4/10/2015 245 XIV. Managing Programmatic Aspects NIH non-competing continuations eSNAP submissions Annual progress report NIH prepares pre-printed 2590 face page; see NIH Commons Requires administrative, financial and programmatic review 4/10/2015 246 XIV. Managing Programmatic Aspects NIH non-competing continuations (con’t) NIH Awards under SNAP ( R and K series) – Budget not required – Requires four questions: 4/10/2015 Significant rebudgeting Carry forward of 25% or $250,000 Change in the effort of key personnel Change in other support of key personnel 247 XIV. Managing Programmatic Aspects NIH non-competing continuations (con’t) NIH Awards under SNAP ( R and K series) – Requires four questions con’t): 4/10/2015 Answers of yes trigger Justification Additional, updated materials, like Current and Pending Support Budget 248 XIV. Managing Programmatic Aspects NIH non-competing continuations (con’t) NIH Awards under SNAP ( R and K series) – Narrative Report on Programmatic Progress – Update on Human and Animal use – Update on project effort for key personnel – Updated checklist with indirect cost rate (not calculation) 4/10/2015 249 XIV. Managing Programmatic Aspects NIH non-competing continuations (con’t) If not awarded under SNAP – Budgets required Review by program officer Review triggers non-competing NGA 4/10/2015 250 XIV. Managing Programmatic Aspects Annual Regulatory Review Continuing review requirements Regulatory requirement No less than annual Period determined at initial review or previous continuing review 4/10/2015 251 XIV. Managing Programmatic Aspects Annual Regulatory Review Human subjects Is study/protocol still active Have any changes crept in Have there been adverse events Do benefits outweigh risks 4/10/2015 252 XIV. Managing Programmatic Aspects Annual Regulatory Review Human subjects (con’t) Is consent form still current and appropriate Must be reviewed at convened meeting Approval must occur before the anniversary date If not renewed in time, terminated 4/10/2015 253 XIV. Managing Programmatic Aspects Annual Regulatory Review Animal care and use Is study still active Reassess animal numbers Morbidity/mortality in animals Annual renewals maybe approved by subcommittee Every three years, complete resubmission 4/10/2015 254 XIV. Managing Programmatic Aspects Compliance with terms and conditions of award Publication review Publication citations Sharing research resources 4/10/2015 255 XIV. Managing Programmatic Aspects Compliance with terms and conditions of award (con’t) Confidential materials--marking, storage, agreement with research team Intellectual property--disclosure, informing sponsor Record retention and storage 4/10/2015 256 XIV. Managing Programmatic Aspects Approval of changes to award terms Expanded authority/FDP – OMB A-110, plus agency implementation – No cost extensions – Carry-forward Requiring agency approvals--grants – Significant change in PI effort – Change in PI – Change in institution 4/10/2015 257 XIV. Managing Programmatic Aspects Approval of changes to award terms (con’t) Requiring agency approvals--grants (con’t) – Significant changes of effort – Significant change in scope of work – Subcontacting – Requests for additional funding – Foreign travel – Use of non-USA airline 4/10/2015 258 XIV. Managing Programmatic Aspects Approval of changes to award terms (con’t) Requiring agency approvals--contracts – Change in budget – Carry forward – Change in personnel/effort – Etc. 4/10/2015 259 XV. Managing Award Funding Allowable Cost Determinates A-21 Cost Principles Requirements Reasonable – Reflects action of a prudent person Generally recognized as necessary Arm’s-length bargaining Circumstances at the transaction time Institutional policies and practices Allocable – Cost can be assigned to a sponsored agreement on the basis of the relative benefits received or some other equitable basis 4/10/2015 260 XV. Managing Award Funding Allowable Cost Determinates A-21 Cost Principles Requirements (Con’t) Treated consistently – Costs incurred for 4/10/2015 Same purpose In like circumstances Are either direct costs only or indirect costs only 261 XV. Managing Award Funding Allowable Cost Determinates A-21 Cost Principles Requirements (Con’t) Conform to limitations in A-21 or the sponsored agreement – Examples 4/10/2015 A-21 prohibits student aid charges to research agreements DHHS awards prohibit salary charges at a rate that exceeds $125,900/yr.. 262 XV. Managing Award Funding Allowable Cost Determinates A-21 Cost Principles Requirements (Con’t) Practical guidelines Cost must – Benefit the project – Be charged consistently as direct cost – Be included in the award budget or list of allowable costs in Section J of A-21 or an agency publication 4/10/2015 263 XV. Managing Award Funding Allowable Cost Determinates Costs normally treated as indirect costs Administrative, secretary, & clerical compensation Telecommunications, memberships, postage, office supplies University guidelines for charging appear in Section 307B of URA’s Guidelines for Grant and Contract Management 4/10/2015 264 XV. Managing Award Funding Allowable Cost Determinates Other costs that warrant attention Alterations & renovations – May require prior approval Alcoholic beverages – Generally unallowable Animals – Excluded from indirect cost MTDC base 4/10/2015 265 XV. Managing Award Funding Allowable Cost Determinates Other costs that warrant attention (con’t) Books and periodicals – Normally treated as indirect cost Dependency allowances – Generally unallowable 4/10/2015 266 XV. Managing Award Funding Allowable Cost Determinates Other costs that warrant attention (con’t) Consultants – May require prior approval if substantive work is involved – Compensation caps may exist – Sponsored Consulting Agreement required Drugs Entertainment costs – Unallowable 4/10/2015 267 XV. Managing Award Funding Allowable Cost Determinates Other costs that warrant attention (con’t) Property insurance – Prior approval needed for government owned property – University provided insurance generally allowable Medical insurance for sponsored fellows and trainees – Allowable because University requires proof of coverage 4/10/2015 268 XV. Managing Award Funding Allowable Cost Determinates Other costs that warrant attention (con’t) Participant support costs--NSF awards – Rebudgeting prior approval required 4/10/2015 269 XV. Managing Award Funding Allowable Cost Determinates Other costs that warrant attention (con’t) Patient care costs – Routine and ancillary medical services – Require prior approval Publications – Costs exceeding certain amount may require prior approval – Acknowledgements, disclaimers required 4/10/2015 270 XV. Managing Award Funding Allowable Cost Determinates Other costs that warrant attention (con’t) Salaries and wages – % salaries charged must be <= % of effort – Must conform with effort reporting procedures – Unallowable if Annual Certification Statement is not completed 4/10/2015 271 XV. Managing Award Funding Allowable Cost Determinates Other costs that warrant attention (con’t) Salaries and wages (con’t) – Salary funds may become restricted if Research Career Development Award is received – College Work Study Program may be used to pay non-federal share of research project expenses 4/10/2015 272 XV. Managing Award Funding Allowable Cost Determinates Other costs that warrant attention (con’t) Student aid (tuition, fees and stipends) – Unallowable charge to federal research awards – Special terms and conditions usually apply 4/10/2015 e.g.. NRSA awards 273 XV. Managing Award Funding Allowable Cost Determinates Other costs that warrant attention (con’t) Travel – Must comply with University travel policies – Use of foreign flag-carriers generally prohibited – Foreign travel may require prior approval 4/10/2015 274 XV. Managing Award Funding Allocating Costs Guidelines A-21, Section C.4.d University Financial Policy No. 2109 4/10/2015 275 XV. Managing Award Funding Allocating Costs (con’t) If a cost benefits one project or activity, the cost should be charged to that project or activity. 4/10/2015 276 XV. Managing Award Funding Allocating Costs (con’t) If a cost benefits two or more projects or activities in proportions that can be determined without undue effort or cost, the cost should be allocated to the projects based on the proportional benefit. 4/10/2015 277 XV. Managing Award Funding Allocating Costs (con’t) If a cost benefits two or more projects or activities in proportions that cannot be determined because of the interrelationship of the work involved, then the cost may be allocated to benefited projects on any reasonable basis. 4/10/2015 278 XV. Managing Award Funding Official Accounting Reports FAS reports Monthly Reports AM090: Account Statement in Whole Dollars AM091: Report of Transactions 4/10/2015 279 XV. Managing Award Funding Official Accounting Reports Payroll reports Reports generated for each monthly and biweekly payroll Expense Summary Report Expense Detail Report 4/10/2015 280 XV. Managing Award Funding Official Accounting Reports Reconcile to “shadow” reports Act to correct errors Update cost projections Consider commitments not shown on FAS Reports cease when Acct Admin names are removed 4/10/2015 281 XV. Managing Award Funding Cost Sharing Procedures Accounting documents cost sharing compliance Recorded in separate associate account “Funding” account is designated FAS cost sharing entry moves expense to funding account See Financial Policy No. 2110 4/10/2015 282 XV. Managing Award Funding Cost Transfers A-21 Costs allocable to an award may not be transferred to another award: – To meet deficiencies caused by overruns – To avoid restrictions imposed by the terms of an agreement – Or for other reasons of convenience Must comply with any agency specific policies 4/10/2015 283 XV. Managing Award Funding Cost Transfers NIH and PHS Grants Policy Statement Requires – Timeliness Within 90 days of original transaction – Full explanation 4/10/2015 “To correct error” is insufficient explanation 284 XV. Managing Award Funding Cost Transfers University policy & procedures Ensure conformance with regulations Policy – Financial Policy No. 2111 Procedures 4/10/2015 285 XV. Managing Award Funding Effort System Required by A-21 Non-compliance results in disallowance of salaries, wages and benefit expense System characteristics Work plan Monitoring & reporting Significant changes Certification 4/10/2015 286 XV. Managing Award Funding Effort System Work plan Payroll distributions reflect work plan Distributions to sponsored agreements – % of salary charge <= % of effort 4/10/2015 287 XV. Managing Award Funding Effort System Monitoring & reporting Payroll reports issued with pay periods Monthly monitoring report – Individuals charge to sponsored agreements – Shows all payroll % distributions – Distributed to departmental payroll contact person Attachment to “closing memo” – Shows % distribution and end date 4/10/2015 288 XV. Managing Award Funding Effort System Significant changes Future – Enter payroll distribution changes Retroactive – Submit cost transfers 4/10/2015 289 XV. Managing Award Funding Effort System Certification Monthly employees – Annual Biweekly employees – Biweekly 4/10/2015 290 XVI. Audits Test for compliance Federal regulations – Award specific – Non-award specific Not to be feared if UC policies and procedures are followed Award specific restrictions are met 4/10/2015 291 XVI. Audits Audit requests Comptroller Office coordinates response Department assists in response where necessary 4/10/2015 292 XVI. Audits Types A-133 Award closeout Special subjects Proposal 4/10/2015 293 XVI. Audits Types A-133 – Performed by KPMG – Federal programs divided into 3 categories 4/10/2015 Research Student financial assistance Other 294 XVI. Audits Types A-133 (con’t) – Emphasis on UC systems 4/10/2015 Allowable costs: Salary caps, student aid, etc. Effort reporting Cost transfers Period of funding availability Financial reporting 295 XVI. Audits Types A-133 (con’t) – Emphasis on UC systems (con’t) 4/10/2015 Procurement Recharge center pricing Billing Equipment inventory Subrecipient monitoring 296 XVI. Audits Types A-133 (con’t) – Tests compliance with award specific restrictions 4/10/2015 Prior approval requirement Cost sharing Student assistance awards unique regulations Training program eligibility Etc. 297 XVI. Audits Types (con’t) Award interim and closeouts – Performed by – – – – 4/10/2015 DHHS Prime contractor Non-federal awarding agency Usually federal direct contracts or subcontract Desk audit vs.. on-site audit Tests for allowable costs Tests for compliance with award specific restrictions 298 XVI. Audits Types (con’t) Special subjects – Examples 4/10/2015 NSF Graduate Research Training Program NSF travel expenses HHS Recharge centers 299 XVI. Audits Types (con’t) Proposal – Seldom done – Usually involves contracts – Emphasis is on 4/10/2015 Reviewing estimating techniques Compliance with FAR solicitation provisions 300 XVII. Financial Reports Deadlines A-110 requires agencies to impose filing date deadlines Most are due 90 days after end of reporting period Non-compliance is reported as an audit finding 4/10/2015 301 XVII. Financial Reports Types Request for Advance or Reimbursement (SF 270) Report of Federal Cash Transactions (SF 272) Financial Status Report (SF 269, 269A) 4/10/2015 302 XVII. Financial Reports Closing Memo The Closing Memo is a workpaper used to complete FSR (i.e., Financial Status Report SF 269 or 269A) Closing Memo is issued to Account Administrator #1 one month prior to budget or award end date Closing Memo is returned to Comptroller’s Office no later than 15 days prior to the FSR due date 4/10/2015 303 XVII. Financial Reports Closing Memo (Con’t) Steps to complete: 1.Post the Budget Balance from AM090 2.Add encumbrance balance from AM090 3.Add trailing credit transactions 4.Subtract trailing charge transactions 5.Equal unobligated balance to report 6.Certify the charges are appropriate (allowable) to the award. 4/10/2015 304 XVII. Financial Reports Financial Status Report (SF 269, 269A) When are Closing Memos required Required for all final FSRs Interim FSRs – Required only if prior approval required for carry forward of unobligated balance 4/10/2015 305 XVII. Financial Reports Financial Status Report (SF 269, 269A) Steps to complete Step 1: Closing Memo issued to Account Administrator Step 2: Closing Memo returned to Comptroller’s Office Step 3: Closing Memo audited by Comptroller’s Office Step 4: FSR completed and submitted by Comptroller’s Office 4/10/2015 306 XVII. Financial Reports Other Financial Reports Request for Advance or Reimbursement (SF 270) Completed for awards not funded by a letter of credit agreement May require Closing Memo Completed by Comptroller’s Office 4/10/2015 307 XVII. Financial Reports Other Financial Reports Report of Federal Cash Transactions (SF 272) Shows both expenditures and cash receipts Completed by Comptroller’s Office 4/10/2015 308 XVII. Financial Reports Other Financial Reports Non-federal reports Similar to federal reports 4/10/2015 309 XVIII. Billing & Collecting Funds Billing Federal – 95% are letter-of-credit funded (“billed”) – 5% are invoiced Non-federal – 5% are invoiced – 95% are on a payment schedule or paid up front 4/10/2015 310 XIX. Intellectual Property University policies Patent Policy – Board of Trustees Statute 18 New Information Technologies – Rights to Intellectual Property Determination of who has rights to discoveries in the course of sponsored research/projects? 4/10/2015 311 XIX. Intellectual Property Data Rights Who has access rights? What are PI responsibilities for retention of data? Do employees who have worked in a sponsored project have the right to remove data, materials from The University when they leave? 4/10/2015 312 XIX. Intellectual Property FOIA public right to federally-sponsored research data OMB in process of defining implementing regulation Each agency will do agency-specific implementation 4/10/2015 313 XIX. Intellectual Property PI responsibility to disclose discoveries Office of Special Projects Guidance on Disclosure Process and forms – Review of Disclosure to confirm sponsored research and relevant MTAs – University turns over disclosure to UCTech 4/10/2015 314 XIX. Intellectual Property PI responsibility to disclose discoveries (con’t) UCTech assesses commercial potential of discovery UCTech has brief period to elect title to disclosure If elected, UCTech must seek appropriate protection for intellectual property (IP) 4/10/2015 315 XIX. Intellectual Property Governing regulations for IP derived from sponsored projects Bayh-Dole Act for all Federally-funded IP Bayh-Dole spells out extensive compliance and reporting requirements for IP elected by UCTech Terms and Conditions of awards for other sponsored projects MTA Terms & Conditions 4/10/2015 316 XIX. Intellectual Property Governing regulations for IP derived from sponsored projects (con’t) Compliance obligations – Royalty sharing – Release of IP if unelected or UCTech abandons commercialization effort – Rights of Sponsors take precedence over rights of PI – March-in 4/10/2015 317 XX. Project Termination Final technical report FASTLANE for NSF projects Confirmation of receipt of FASTLANE submission sent to URA Other Technical Reporting – – Confirm submission of report to URA 4/10/2015 URA follows up on late technical reports – Administrator, PI, Department Chair, Dean, Provost 318 XX. Project Termination Final technical report (con’t) Sponsor may withhold funding for University if ANY Final Report is overdue – Agencies that do this include NEH, Air Force 4/10/2015 319 XX. Project Termination NIH Invention Report Requires URA signature 4/10/2015 320 XX. Project Termination Integration of close out of records with restricted funds Confirmation of Compliance with Technical Reporting requirements Confirmation that Restricted Funds has closed financial report All URA Terminated Project Files archived for at least 3 years after closing of project 4/10/2015 321 XX. Project Termination Integration of close out of records with restricted funds (con’t) A-110 records retention requirement Obligations to keep local records 4/10/2015 322 XX. Project Termination Delete project accounts from FAS Before accounts can be delete – Budget balance must be reduced to zero – Voucher payable balance and other balance sheet account controls must be zero AM090 and 91 reports stop only after accounts have been deleted Accounting is not completed until accounts are deleted 4/10/2015 323 XXI. Relinquishing/Transferring Programs or Awards Managing Faculty Arrivals/Departures Faculty appointment/termination Space commissioning/decommissioning Equipment - transfer in and purchase/ transfer out and sell Other personnel Protocols - initiating/terminating Subcontracting to or from current/new institutions 4/10/2015 324 XXI. Relinquishing/Transferring Programs or Awards Managing Faculty Arrivals/Departures (con’t) On-going responsibilities - IP, record retention and access, sharing research resources Transferring awards into or out of University of Chicago 4/10/2015 325 XXI. Relinquishing/Transferring Programs or Awards Transferring property to/from U of C Title generally resides with University University must approve transfers of equipment to which it holds title If University does not hold title, entity with title must provide permission 4/10/2015 326 XXI. Relinquishing/Transferring Programs or Awards Transferring property to/from UC (con’t) Property inventory and tagging, as well as local inventories = key – Transferring property with Departing Faculty – Agency expectations for equipment in support of active awards – Equipment purchased from institutional funds – University policy and form 4/10/2015 327 XXI. Relinquishing/Transferring Programs or Awards Transferring property to/from UC (con’t) Transferring property for Newly-recruited faculty – Decision made at prior institution – Effect official transfer of title – U of C property to tag and inventory 4/10/2015 328 XXI. Relinquishing/Transferring Programs or Awards Transfer of awards Agency prerogative Agency requirements vary 4/10/2015 329 XXI. Relinquishing/Transferring Programs or Awards Transfer of awards Transfer of awards from U of C – Should U of retain award 4/10/2015 Change of PI On-going support of personnel/students Is award individual or institutions (e.g. RO1 versus training grants, SCOR, etc.) Issues: Estimating final balances Carry forward 330 XXI. Relinquishing/Transferring Programs or Awards Transfer of awards Transfer of awards from U of C (con’t) – Possibilities 4/10/2015 Leave award at U of C and name substitute PI Leave at U of C, name substitute PI and request permission to subcontract Relinquish award Relinquish award with expectation of subcontract to U of C 331 XXI. Relinquishing/Transferring Programs or Awards Transfer of awards Transferring a NIH award from UC – Contact program officer and request institute specific instructions – Prepare and submit through normal sign-off channels: 4/10/2015 Relinquishment statement Invention and Patent statement List of equipment purchased from that award and proposed to be moved A copy of the instructions received from NIH 332 XXI. Relinquishing/Transferring Programs or Awards Transfer of awards Transferring a NIH award to the UC – Contact program officer and request institute specific instructions – Prepare and submit through normal sign-off channels: 4/10/2015 Face page (with IRB/IACUC info) Proposed budget (transfer year and future years) and justification Workscope 333 XXI. Relinquishing/Transferring Programs or Awards Transfer of awards Transferring a NIH award to the UC (con’t) – Prepare and submit through normal sign-off channels: 4/10/2015 Description of effects of transfer on project Description of Facilities and Resources at U of C Biosketch and other support, if changing Checklist page Copy of original NGA Specific instructions from NIH 334 XXI. Relinquishing/Transferring Programs or Awards Transfer of awards Transferring NSF award from U of C – Contact program officer to determine course of action – If NSF endorses transfer, complete 4/10/2015 NSF Form 1263 - NSF Grant Transfer Request Cover memo explaining impending move and requesting grant be transferred List of equipment purchased with grant funds for transfer 335 XXI. Relinquishing/Transferring Programs or Awards Transfer of awards Transferring NSF award to U of C – Contact program officer to determine course of action – If NSF endorses transfer, complete 4/10/2015 NSF Form 1263 - NSF Grant Transfer Request Brief summary of progress to date Description of work to be completed Budget and justification List of equipment Ideally, copy of original grant and award letter 336 XXI. Relinquishing/Transferring Programs or Awards Transfer of awards Transferring NSF award to U of C (con’t) – Contact program officer to determine course of action – Contact program officer and request institute specific instructions – Prepare and submit through normal sign-off channels 4/10/2015 337 Related Web Sites FDP general and agency specific terms & conditions NSF Grant Proposal Guide NIH Grants Policy Statement 4/10/2015 338 Related Web Sites NIH terms and conditions for individual and institutional National Research Service Awards OMB Circulars A-21, A-110, A-133 4/10/2015 339 Related Web Sites NASA Grant and Cooperative Agreement Handbook Code of Federal Regulations (CFR) Agency administrative regulations that implement A-110 (Accessible through the CFR Web site) Agriculture Defense 4/10/2015 7 CFR 3019 32 CFR 32 340 Related Web Sites Agency administrative regulations that implement A-110 (Accessible through the CFR Web site) Con’t: Education Energy NIH/DHHS HUD Interior Justice Labor State 4/10/2015 34 CFR 74 10 CFR 600 45 CFR 74 24 CFR 84 43 CFR 12 28 CFR 70 29 CFR 95 22 CFR 145 341 Related Web Sites Agency administrative regulations that implement A-110 (Accessible through the CFR Web site) Con’t: DOT AID EPA NASA 49 CFR 19 22 CFR 226 40 CFR 30 14 CFR 1260 Federal Acquisition Regulations 4/10/2015 342