Module 3 Overview of Regulations and Compliance Part

Module 3: Overview of Regulations and Compliance (Part 2) Office of Research and Sponsored Programs The University of Mississippi 100 Barr Hall ~ 662 -915 -7482 www. research. olemiss. edu 1

Part 2 of Module 3 will cover federal agency-specific regulations governing research grants and cooperative agreements; university policies regarding common transactions on sponsored projects; and compliance issues in university research. Updated October 2009 2

Federal agency-specific regulations for research grants and cooperative agreements n n n National Institutes of Health (NIH) National Science Foundation (NSF) U. S. Department of Agriculture Cooperative State Research, Education and Extension Service (USDA CSREES) CSREES is used as an example. There are other research divisions within USDA, each with their own terms and conditions. Updated October 2009 3

National Institutes of Health (NIH) Updated October 2009 4

NIH Grant and Cooperative Agreement Regulations READ THE NOTICE OF GRANT AWARD to determine applicable terms and conditions. These include: n Standard Terms and Conditions and n Special Terms and Conditions Updated October 2009 5

NIH Grant and Cooperative Agreement Regulations: Standard Terms and Conditions NIH Grants Policy Statement n Provides guidance on almost every policy issue n Exceptions to Policy Statement are rare and may be done only with approval of the Grants Management Officer See grants. nih. gov/grants/policy. htm#gps Updated October 2009 6

NIH Grants Policy Statement: Standard Terms and Conditions Contains – Information such as: q q q Technical and financial reporting requirements Carryover allowability Inclusion or exclusion from Streamlined Noncompeting Award Process (SNAP) Salary cap Program income information Updated October 2009 7

NIH Grants Policy Statement: Special Terms and Conditions Contains – Information such as: q q q Revised award or Supplemental award or Cooperative agreement Requirement terms (such as cost sharing) Restrictive terms (failure to follow = disallowed costs) Information items Updated October 2009 8

What are examples of actions that the ORSP can approve? Updated October 2009 9

Actions NOT requiring prior approval from NIH n n n One-time no-cost extension of up to 12 months Pre-award costs ≤ 90 days of award start date (at institution’s risk) Foreign travel Updated October 2009 10

Pre-award costs n If you plan to incur pre-award costs, you must request a preliminary account number n Contact the ORSP at x 7482 for a preliminary account form Updated October 2009 11

What are examples of actions that NIH must approve? Updated October 2009 12

Examples of actions requiring prior written approval from NIH n n n Change in scope, principal investigator, or key personnel Change of grantee organization Any deviation from stated special terms or conditions Transfer the performance of “substantive work” on the project to a third party Any change from the approved use of animals or human subjects Substitution of one animal model for another Second no-cost extension or extension >12 months Need for additional funding Pre-award costs >90 days Transfer of funds between construction and non-construction Addition of a foreign component to the project Updated October 2009 13

What is NIH prior approval? n n NIH’s acceptance of the proposal and/or proposal budget and subsequent incorporation into the award, or Written approval of a separate request submitted by the ORSP on behalf of the institution Updated October 2009 14

National Science Foundation (NSF) Updated October 2009 15

NSF Grant and Cooperative Agreement Regulations READ THE NOTICE OF GRANT AWARD to determine applicable terms and conditions. These include: n Standard Terms and Conditions and n Special Terms and Conditions Updated October 2009 16

NSF Grant and Cooperative Agreement Regulations: Standard Terms and Conditions n NSF Award and Administration Guide (AAG) q Basic policies for award and administration of NSF grants and cooperative agreements www. nsf. gov/publications/pub_summ. jsp? ods_awards/managing/ge neral_conditions. jsp n NSF Grant General Conditions (GC-1) q General terms and conditions for NSF grants www. nsf. gov/awards/managing/general_conditions. jsp n NSF Cooperative Agreement General Conditions (CA-1) q General terms and conditions for NSF cooperative agreements www. nsf. gov/awards/managing/co-op_conditions. jsp Updated October 2009 17

NSF Grant and Cooperative Agreement Regulations: Standard Terms and Conditions Contain – Information such as: q q q Technical and financial reporting requirements Budget considerations Prior approval requirements Updated October 2009 18

NSF Grant and Cooperative Agreement Regulations: Special Terms and Conditions Contain – Information such as: q q Conference or group travel award Facilities modernization grant conditions Foreign grant conditions Small Business Innovation Research (SBIR) grant conditions Updated October 2009 19

What are examples of actions that the ORSP can approve? Updated October 2009 20

Actions NOT requiring prior approval from NSF (NSF Fast. Lane notifications) n n n Grantee-approved one-time no-cost extension of up to 12 months Anticipated residual funds in excess of $5, 000 or 5% Significant changes/delays or events of unusual interest Significant changes in methods/procedures Short-term absence of the PI/PD (up to three months) Updated October 2009 21

What are examples of actions that NSF must approve? Updated October 2009 22

Actions requiring NSF prior approval (requests in NSF Fast. Lane) n n n Addition of subaward Withdrawal of PI/Co-PI Long-term absence of PI/PD (over three months) Second no-cost extension or extension of >12 months PI transfer Pre-award costs in excess of 90 days Rearrangement/alteration of $25, 000 or over Change PI and add/change Co-PI Significant change in person-months devoted to project Changes in objective or scope Reallocation of funds budgeted for participant or trainee support costs Updated October 2009 23

Pre-award costs n If you plan to incur pre-award costs, you must request a preliminary account number n Contact the ORSP at x 7482 for a preliminary account form Updated October 2009 24

What is NSF prior approval? n n NSF’s acceptance of the proposal and/or proposal budget and subsequent incorporation into the award, or Written approval of a separate request submitted by the ORSP on behalf of the institution Updated October 2009 25

USDA CSREES Note: There are many different divisions within USDA. CSREES is only one example. ORSP will help you find your specific USDA division’s web site. Updated October 2009 26

USDA CSREES Grant and Cooperative Agreement Regulations READ THE NOTICE OF GRANT AWARD to determine applicable terms and conditions. These include: n General Terms and Conditions – A n General Terms and Conditions – B n Small Business Innovation Research Grants Program n Special Terms and Conditions – C n Special Terms and Conditions – D n Federal Demonstration Partnership Updated October 2009 27

USDA CSREES Grant and Cooperative Agreement Regulations: General Terms and Conditions - A n Apply to all awards except n n n Formula-funded awards Awards under the Facilities Program Awards under the SBIR Program Awards to institutions that are part of the Federal Demonstration Partnership (UM is not a part) Awards to individuals Awards to recipients with < 3 years experience managing CSREES funds See www. csrees. usda. gov/business/awardterms. html Updated October 2009 28

USDA CSREES Grant and Cooperative Agreement Regulations: General Terms and Conditions - B n n Apply to the same awards as General Terms and Conditions – A with the same exceptions However, B applies to those recipients (institutions) who have not had at least three years managing CSREES funds Updated October 2009 29

USDA CSREES Grant and Cooperative Agreement Regulations: Other Terms and Conditions n SBIR Grants Program q n Special Terms and Conditions – C q n Apply to awards under the Facilities Program Special Terms and Conditions – D q n Apply to awards under the Small Business Innovation Research Grants Program Apply to awards to individuals Federal Demonstration Partnership q Apply to all grants to institutions that are part of FDP Updated October 2009 30

What are examples of actions that the ORSP can approve? Updated October 2009 31

Actions NOT requiring prior approval from USDA CSREES n n One-time no-cost extension of up to 12 months Pre-award costs ≤ 90 days of award start date (at grantee’s risk) Re-budgeting among budget categories Foreign travel Updated October 2009 32

What are examples of actions that USDA CSREES must approve? Updated October 2009 33

Actions requiring prior written approval from USDA CSREES n n n n Change in scope, principal investigator, or key personnel Change of grantee organization Transfer the performance of “substantive work” on the project to a third party Second no-cost extension or extension >12 months Need for additional funding Pre-award costs >90 days Transfer of funds between construction and nonconstruction Addition of a foreign component to the project Updated October 2009 34

What is USDA CSREES prior approval? n n USDA CSREES’s acceptance of the proposal and/or proposal budget and subsequent incorporation into the award, or Written approval of a separate request submitted by the ORSP on behalf of the institution Updated October 2009 35

University policies and procedures n n n Personnel Consultants Equipment Good and services Travel Subawards Updated October 2009 36

Personnel n n The hiring of personnel to be associated with a sponsored program is guided by UM policies and procedures as well as any sponsor regulations For a given sponsored program, the PI can recruit for positions listed in the award Updated October 2009 37

Personnel – how to hire n n Start by consulting your department’s (or school’s) administrative staff Decide if you’re hiring faculty or staff q For faculty: n q Work with the Provost’s Office to settle tenure questions and rank, among other things For staff: n Work with Human Resources Updated October 2009 38

Hiring staff n Does your department already have an unfilled position on the books that is suitable for what you need? q YES? n n Then just do an HR Personnel Requisition Form – this will open the position for you Then conduct interviews, and hire www. olemiss. edu/depts/HR/ Updated October 2009 39

Hiring staff q NO? n n Then you must fill out a Job Analysis Questionnaire (JAQ) and submit it to your department chair. After it has been through the chain of approvals, someone from Human Resources will call you to set up a desk audit and talk to you about what you need a person in this proposed position to do. Then HR will establish a job classification, approve the title, compose the job description, and assign a hiring rate Then you can submit an HR Personnel Requisition Form to open the position Then you establish a search committee, conduct interviews, and hire www. olemiss. edu/depts/HR/ Updated October 2009 40

Temporary employees n n Sometimes you don’t need a permanent employee UM identifies two types of temporary employees: q q Temp I: Someone who works for a department on a regular basis for a short period of time, not to exceed 4. 5 months (no benefits) Temp II: Someone who works for a department on a regular basis for more than 4. 5 months, but less than 12 months (with benefits), EXCEPT for post-docs, who may be hired on a temporary basis for 2 -3 years Updated October 2009 41

Consultants n Do you really need a permanent (or even temporary) employee, or can you hire a consultant? q q q To decide, use the “Checklist to Determine Status as Employee, Consultant, or Independent Contractor” on the ORSP Forms and Information page under Awards: www. olemiss. edu/depts/research/forms/index. html If you decide to hire a consultant, use the HR Form 13. How much can you pay a consultant? Payments should be comparable or customary fees charged and received by the consultant for comparable services, and must pass the test of reasonableness. Updated October 2009 42

Personnel – some additional things you should know n n For federal awards, recruitment costs of personnel required for the performance of obligations arising under the agreement are allowed Advertising costs for such positions are allowed EXCEPT for: q q q The use of color in publications Excessive size Including material in the ad for other than recruitment purposes Updated October 2009 43

Personnel – Federal Policy (OMB Circular A-21) n Costs of help wanted advertising, special emoluments, fringe benefits, and salary allowances incurred to attract professional personnel from other institutions that do not meet the test of reasonableness are unallowable Updated October 2009 44

Personnel – Federal Policy (OMB Circular A-21) n n Regarding relocation costs: you must have budgeted for such costs in your proposal. Then it’s a good idea to put in place a contract or at least some guidelines (perhaps a spending limit) for the new employee. These expenses have to meet the test for reasonableness. If the newly hired employee resigns for reasons within his control within 12 months after hire, the institution will be required to refund or credit such relocation costs to the federal government. Relocation expenses are paid one time only. UM cannot reimburse temporary living expenses while the employee seeks permanent housing. Procurement Services can advise you: www. olemiss. edu/depts/procurement/relexp. htm Updated October 2009 45

Hiring staff/other considerations n n Affirmative Action: All of your forms/requests will be sent to the EEO office. They may contact you with specific questions. Immigration and naturalization procedures, if you’re hiring a foreign national, will require a Form I-9. If you’re hiring students, you’ll need an HR Form 7 (salaried position) or HR Form 18 (hourly wages). Again, work with your departmental administrative staff. www. olemiss. edu/depts/HR/ Updated October 2009 46

Equipment n As of July 1, 2008, UM defines equipment as: q Visible tangible personal property q Non-consumable in nature q Must have an anticipated life of at least one year q Must cost $1, 000 or more n At UM, the following items will be reported as equipment regardless of their purchase price: weapons, two-way radio equipment, lawn maintenance equipment, cellular telephones, chain saws, air compressors, welding machines, generators, motorized vehicles n Reported as equipment if purchase value is ≥ $250: cameras/camera equipment, televisions, computers/computer equipment (computer systems, printers, external hard drives) Updated October 2009 47

Equipment n General UM requirements for purchasing equipment: q q If / then: n $5, 000 or less – one price quote required, either verbal or written n $5, 000. 01 to $50, 000 – two written price quotes required n $50, 000. 01 or more – sealed bids required A purchase order is the preferred method for purchasing equipment. You must buy from the “State Contract List” if available, unless you can find the item cheaper elsewhere (justification required) Create your Purchase Requisition via SAP; Procurement Services will issue the Purchase Order Contact Procurement Services for Assistance Updated October 2009 48

Special circumstances approval n Procurement Services recognizes special circumstances that may require: q q n Emergency purchases Sole-source purchases Special purchases for research purposes Special exemption from state contract Use the Special Circumstances Approval Form available from the Procurement Services website: www. olemiss. edu/depts/procurement/formbank 1. html Updated October 2009 49

Federal equipment n Federal definitions for equipment are more comprehensive: q q Special Purpose Equipment: Equipment which is used only for research, medical, scientific, or other technical activities. General Purpose Equipment: Equipment which is NOT limited to research, medical, scientific or other technical activities. Capital expenditures for Special Purpose Equipment are usually allowable; but if cost is $5, 000 or more, must have prior approval and must conduct a pre-acquisition screening within your department. If the cost is $50, 000 or more, the screening must be university-wide. Capital expenditures for General Purpose Equipment are unallowable, except where approved in advance. Updated October 2009 50

Federal equipment n n n Some agencies retain ownership of equipment (i. e. , property) purchased with their funding The PI is responsible for knowing whether UM owns the property, or if the federal government owns it Special policies and procedures are in place for determining if there is a need for the purchase Special policies and procedures are in place for tracking Use the Non-Availability of Equipment form found on the ORSP Forms and Information page: www. olemiss. edu/depts/research/forms/index. html Updated October 2009 51

Federally owned property n n n Title to government property vests with the government. This may be UM-purchased (or built) property, or it may be something we’ve borrowed from the government. All property is held on the UM inventory list. We also track federally-owned property separately and report it at least annually. Updated October 2009 52

Federally owned property n Some Very Important Information can be found here: www. olemiss. edu/depts/research/forms/index. html n Look for: q q q Federal Property Manual Non-Availability of Equipment Form Grant/Contract Equipment Inventory Form Subcontract Equipment Inventory Form Transfer of Equipment Form Updated October 2009 53

Federally owned property Our Federal Property Administrator is: Beth Stidham Office of Research and Sponsored Programs 100 Barr Hall 915 -7482 estidham@olemiss. edu Get to know her! Updated October 2009 54

Federally owned property n Duties of the Federal Property Administrator: q q Checks to see if you have completed a Non. Availability of Equipment form Checks to see if you budgeted for it, or if you need special permission to purchase Gives Procurement Services permission to make the purchase on your behalf Insures that the item is tagged as federal property Updated October 2009 55

Commodities and contractual services n n Either create a Purchase Requisition in SAP (Procurement Services will then issue the Purchase Order) OR – Purchase with Visa Procurement Card Consult your departmental administrative staff for assistance – there are far too many “issues” to mention here Updated October 2009 56

Goods and services n n Some notes: q See OMB Circular A-21, Section J Unless specifically addressed in your award document: q Alcoholic beverages are not allowed q Only long distance telephone charges (not local services) are allowable q Donations and contributions are not allowed q Entertainment costs are not allowed q Institution memberships in business, technical, and professional organizations are allowed q Institution memberships in civic or community organizations, or country clubs and social or dining clubs are not allowed Updated October 2009 57

Travel n Travel activities must be in compliance with the sponsor’s travel policies and the university’s travel policy. n Most sponsors allow domestic travel. Most also allow foreign travel, with permission. Updated October 2009 58

Travel n UM – Travel Authorizations: q q Are required for all out-of-state travel Are required for in-state travel for conventions, associations, or meetings n q q Be careful with this word “meetings. ” If it is an organized event with many participants, such as an annual meeting, where information is shared, research results are presented, and professional development occurs, you must request a Travel Authorization. If you’re just getting together with some colleagues from another nearby institution (for example), don’t call it a meeting. Are required foreign travel We recommend you submit a Travel Authorization for all travel that is related to your position at UM, regardless of who pays your expenses. Updated October 2009 59

Travel n Travel advances: q q q Are available for any travel outside Mississippi Maximum is 80% of Travel Authorization; available one week prior to travel Credit card charges incurred prior to travel may be reimbursed before the trip by sending a memo and copy of your credit card charges to the Travel Office: www. olemiss. edu/depts/procurement/travel 1. html Updated October 2009 60

Travel n Expenses that require receipts: q q q q Lodging Air, train, or bus tickets Registration fees Car rentals Taxis or limos, if over $10 Parking, tolls, gasoline charges Banquet meals that cause you to spend more than your daily meal allowance Updated October 2009 61

Travel n Expenses that do not require receipts: q q Meal and meal tips Personal vehicle mileage Baggage handling Business calls if itemized on your hotel receipt (you must justify that they were for business purposes) Updated October 2009 62

Special travel n For UM-hosted events held on campus that require registration fees, you must submit a Travel Authorization in order to be reimbursed for those fees. Updated October 2009 63

Travel n The Travel website is extremely helpful: www. olemiss. edu/depts/procurement/travel 1. html n Look for things like: q q q Maximum per diem for meals Rental car rules, etc. Group travel rules Rules like: no meals reimbursed for day trips, and no alcoholic beverages reimbursed Etc. , etc. Updated October 2009 64

Subawards n A subaward is an agreement between UM and any other organization in which a PI at the other organization will assist UM in accomplishing an externally-funded project by performing substantive work on the project. Updated October 2009 65

Subawards n Some Very Important Information can be found here: www. olemiss. edu/depts/research/forms/index. html n Look for: q q q q Subaward Policies and Procedures Subaward Checklist Federal Contract Provisions – Definitions and Descriptions Checklist for Determination of Vendor/Subrecipient on Sponsored Programs Request to Issue Subcontract/Subcontract Modification Certification for Payments under Subcontract Electronic Subcontract Report System (e. SRS) Updated October 2009 66

Subawards n Some of the important highlights are: q q q The ORSP negotiates and issues all subawards on behalf of UM. The only authorized signatory is the Vice Chancellor for Research and Sponsored Programs. The issue of vendor vs. subrecipient is a very important one. Seek guidance from the ORSP. All invoices from subawardees come first to the ORSP. Our Sponsored Programs Accountant will approve these for payment from a fiscal perspective. The PI must approve from a technical perspective. All subawards must be monitored by the PI. Updated October 2009 67

Responsible Conduct of Research (RCR) n This concept is the umbrella for all regulatory research compliance as well as unregulated ethical and practical research habits Updated October 2009 68

Responsible Conduct of Research (RCR): The 11 RCR Areas n n n Data acquisition, management, sharing, and ownership Mentor/trainee responsibilities Publication practices and responsible authorship Peer review Collaborative science Research misconduct Conflict of interest and commitment Fiscal responsibility and grants management Environmental health and safety Human subjects Research involving animals Updated October 2009 69

Regulations and policies on research using human or animal subjects Under the University of Mississippi’s Animal Welfare Assurance and the University's Federalwide Assurance: All human and animal research conducted at, by, or under the auspices of this institution, whether funded or not and whether conducted by administrators, faculty, staff, or students, must be reviewed and approved before the research begins. Updated October 2009 70

Relevant compliance boards n Human subject research is reviewed by the Institutional Review Board (IRB) n Animal research is reviewed by the Institutional Animal Care and Use Committee (IACUC) Updated October 2009 71

Just-in-Time (JIT) policy for IRB and IACUC applications n If the funding agency or other source permits, the IACUC and IRB follow the NIH guidelines that permit JIT submissions of applications q q To save time, PIs should not submit IRB/IACUC applications when they submit proposals When a fundable score (or other evidence that the project is very likely to be funded) is received, the PI should submit an IRB/IACUC application Updated October 2009 72

Research Misconduct Policy n To protect the integrity of the research enterprise and to sustain the public trust in researchers and the products of research, and in compliance with the DHHS Office of Research Integrity, UM has a policy that defines research misconduct and includes procedures for reporting and handling allegations of misconduct. www. olemiss. edu/depts/research/office/policies/misconduct_policy. html Updated October 2009 73

Primary research misconduct actions n n n Fabrication (making up data or results and recording or reporting them) Falsification (manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record) Plagiarism (the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit) Updated October 2009 74

Additional research misconduct actions n n n Failure to report known or suspected acts of misconduct on the part of others Violation of any criminal or civil law in obtaining, analyzing or reporting data Applying for federal funding while under federal suspension or debarment, or knowingly utilizing as a Co-Principal Investigator, technician, consultant, or subcontractor a person who is suspended or debarred Updated October 2009 75

Additional research misconduct actions n n Failure to maintain a record of primary data, with the intent to deceive Abuse of confidentiality when gathering or reporting data Use of honorary authorships without the person’s consent and/or with the intent to deceive Making a demand to be listed as an author on a researcher’s publication, without being involved with the research in question, solely because the person making the demand is in a position of authority over the author Updated October 2009 76

Conflict of Interest Policy n n The university has a responsibility to manage any actual or potential conflict of interest that may be presented by a financial interest of an investigator. Thus, the university requires that investigators disclose significant financial interests that may present an actual or potential conflict of interest in relationship with a sponsored project. The policy applies to ALL sponsored projects — research, educational, and service. www. olemiss. edu/depts/research/office/policies/research_objectivity. html Updated October 2009 77

Export control n n Since the events of September 11, 2001, the federal government has become increasingly concerned with protecting information and technology from disclosure by universities, the release of which could hamper U. S. economic vitality or contribute to the military potential of U. S. international adversaries. Export laws and regulations that have been in effect for the past 20 years and which are promulgated by the U. S. Department of Commerce, the U. S. Department of State, and the U. S. Treasury Department’s Office of Foreign Assets Control are the bases for restricting use and access to this information and technology. Updated October 2009 78

Export control n Because these laws may conflict with our tradition of academic freedom and openness in research, and may impose severe criminal and civil fines upon individuals and the university for noncompliance, it is important that all persons involved in sponsored research understand the regulations and implementation requirements. Updated October 2009 79

Export control n Anyone with concerns about export control issues should contact: Tom Lombardo, Ph. D. Director of Research Integrity and Compliance 915 -7482 or pytwl@olemiss. edu q or Robin Buchannon, Ph. D. Assistant Vice Chancellor – ORSP 915 -7482 or rcb@olemiss. edu q or Donna Gurley Associate University Attorney 915 -7014 or dgurley@olemiss. edu q Updated October 2009 80

Resources n NIH Grants Policy Statement n NSF Grant General Conditions n USDA CSREES Terms and Conditions n Office of Research and Sponsored Programs (x 7482) Updated October 2009 81