Module 3: Overview of Regulations and Compliance (Part 2)

1
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

2

• 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.

3
Federal agency-specific regulations for research
grants and cooperative agreements

• 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.

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National Institutes of Health (NIH)
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NIH Grant and Cooperative Agreement Regulations

• READ THE NOTICE OF GRANT AWARD to determine
  applicable terms and conditions. These include
• Standard Terms and Conditions and
• Special Terms and Conditions

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NIH Grant and Cooperative Agreement Regulations
Standard Terms and Conditions

• NIH Grants Policy Statement
• Provides guidance on almost every policy issue
• Exceptions to Policy Statement are rare and may
  be done only with approval of the Grants
  Management Officer
• See grants.nih.gov/grants/policy/policy.htmgps

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NIH Grants Policy Statement Standard Terms and
Conditions

• Contains
• Information such as
• Technical and financial reporting requirements
• Carryover allowability
• Inclusion or exclusion from Streamlined
  Noncompeting Award Process (SNAP)
• Salary cap
• Program income information

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NIH Grants Policy StatementSpecial Terms and
Conditions

• Contains
• Information such as
• Revised award or
• Supplemental award or
• Cooperative agreement
• Requirement terms (such as cost sharing)
• Restrictive terms (failure to follow disallowed
  costs)
• Information items

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What are examples of actions that the ORSP can
approve?
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Actions NOT requiring prior approval from NIH

• One-time no-cost extension of up to 12 months
• Pre-award costs 90 days of award start date (at
  institutions risk)
• Foreign travel

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Pre-award costs

• If you plan to incur pre-award costs, you must
  request a preliminary account number
• Contact the ORSP at x7482 for a preliminary
  account form

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What are examples of actions that NIH must
approve?
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Examples of actions requiring prior written
approval from NIH

• 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 gt12 months
• Need for additional funding
• Pre-award costs gt90 days
• Transfer of funds between construction and
  non-construction
• Addition of a foreign component to the project

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What is NIH prior approval?

• NIHs 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

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National Science Foundation (NSF)
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NSF Grant and Cooperative Agreement Regulations

• READ THE NOTICE OF GRANT AWARD to determine
  applicable terms and conditions. These include
• Standard Terms and Conditions and
• Special Terms and Conditions

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NSF Grant and Cooperative Agreement Regulations
Standard Terms and Conditions

• NSF Award and Administration Guide (AAG)
• Basic policies for award and administration of
  NSF grants and cooperative agreements
• www.nsf.gov/publications/pub_summ.jsp?ods_keyaag
• NSF Grant General Conditions (GC-1)
• General terms and conditions for NSF grants
• www.nsf.gov/awards/managing/general_conditions.jsp
  
• NSF Cooperative Agreement General Conditions
  (CA-1)
• General terms and conditions for NSF cooperative
  agreements
• www.nsf.gov/awards/managing/co-op_conditions.jsp

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NSF Grant and Cooperative Agreement Regulations
Standard Terms and Conditions

• Contain
• Information such as
• Technical and financial reporting requirements
• Budget considerations
• Prior approval requirements

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NSF Grant and Cooperative Agreement Regulations
Special Terms and Conditions

• Contain
• Information such as
• Conference or group travel award
• Facilities modernization grant conditions
• Foreign grant conditions
• Small Business Innovation Research (SBIR) grant
  conditions

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What are examples of actions that the ORSP can
approve?
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Actions NOT requiring prior approval from NSF
(NSF FastLane notifications)

• 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)

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What are examples of actions that NSF must
approve?
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Actions requiring NSF prior approval (requests in
NSF FastLane)

• Addition of subaward
• Withdrawal of PI/Co-PI
• Long-term absence of PI/PD (over three months)
• Second no-cost extension or extension of gt12
  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

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Pre-award costs

• If you plan to incur pre-award costs, you must
  request a preliminary account number
• Contact the ORSP at x7482 for a preliminary
  account form

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What is NSF prior approval?

• NSFs 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

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USDA CSREES Note There are many different
divisions within USDA. CSREES is only one
example. ORSP will help you find your specific
USDA divisions web site.
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USDA CSREES Grant and Cooperative Agreement
Regulations

• READ THE NOTICE OF GRANT AWARD to determine
  applicable terms and conditions. These include
• General Terms and Conditions A
• General Terms and Conditions B
• Small Business Innovation Research Grants Program
• Special Terms and Conditions C
• Special Terms and Conditions D
• Federal Demonstration Partnership

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USDA CSREES Grant and Cooperative Agreement
RegulationsGeneral Terms and Conditions - A

• Apply to all awards except
• 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 lt 3 years experience
  managing CSREES funds
• See www.csrees.usda.gov/business/awards/awardterms
  .html

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USDA CSREES Grant and Cooperative Agreement
RegulationsGeneral Terms and Conditions - B

• 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

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USDA CSREES Grant and Cooperative Agreement
RegulationsOther Terms and Conditions

• SBIR Grants Program
• Apply to awards under the Small Business
  Innovation Research Grants Program
• Special Terms and Conditions C
• Apply to awards under the Facilities Program
• Special Terms and Conditions D
• Apply to awards to individuals
• Federal Demonstration Partnership
• Apply to all grants to institutions that are part
  of FDP

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What are examples of actions that the ORSP can
approve?
32
Actions NOT requiring prior approval from USDA
CSREES

• One-time no-cost extension of up to 12 months
• Pre-award costs 90 days of award start date (at
  grantees risk)
• Re-budgeting among budget categories
• Foreign travel

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What are examples of actions that USDA CSREES
must approve?
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Actions requiring prior written approval from
USDA CSREES

• 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 gt12 months
• Need for additional funding
• Pre-award costs gt90 days
• Transfer of funds between construction and
  non-construction
• Addition of a foreign component to the project

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What is USDA CSREES prior approval?

• USDA CSREESs 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

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University policies and procedures

• Personnel
• Consultants
• Equipment
• Good and services
• Travel
• Subawards

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Personnel

• 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

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Personnel how to hire

• Start by consulting your departments (or
  schools) administrative staff
• Decide if youre hiring faculty or staff
• For faculty
• Work with the Provosts Office to settle tenure
  questions and rank, among other things
• For staff
• Work with Human Resources

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Hiring staff

• Does your department already have an unfilled
  position on the books that is suitable for what
  you need?
• YES?
• 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/

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Hiring staff

• NO?
• 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/

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Temporary employees

• Sometimes you dont need a permanent employee
• UM identifies two types of temporary employees
• 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

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Consultants

• Do you really need a permanent (or even
  temporary) employee, or can you hire a
  consultant?
• To decide, use the Checklist to Determine Status
  as Employee, Consultant, or Independent
  Contractor on the ORSP Forms and Information
  page under Awardswww.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.

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Personnel some additional things you should know

• 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
• The use of color in publications
• Excessive size
• Including material in the ad for other than
  recruitment purposes

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Personnel Federal Policy (OMB Circular A-21)

• 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

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Personnel Federal Policy (OMB Circular A-21)

• Regarding relocation costs you must have
  budgeted for such costs in your proposal. Then
  its 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

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Hiring staff/other considerations

• 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
  youre hiring a foreign national, will require a
  Form I-9.
• If youre hiring students, youll 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/

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Equipment

• As of July 1, 2008, UM defines equipment as
• Visible tangible personal property
• Non-consumable in nature
• Must have an anticipated life of at least one
  year
• Must cost 1,000 or more 
• 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
• Reported as equipment if purchase value is
  250 cameras/camera equipment, televisions,
  computers/computer equipment (computer systems,
  printers, external hard drives)

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Equipment

• General UM requirements for purchasing equipment
• If / then
• 5,000 or less one price quote required, either
  verbal or written
• 5,000.01 to 50,000 two written price quotes
  required
• 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

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Special circumstances approval

• Procurement Services recognizes special
  circumstances that may require
• 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/formbank1.html

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Federal equipment

• Federal definitions for equipment are more
  comprehensive
• 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.

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Federal equipment

• 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
  pagewww.olemiss.edu/depts/research/forms/index.h
  tml

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Federally owned property

• Title to government property vests with the
  government.
• This may be UM-purchased (or built) property, or
  it may be something weve 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.

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Federally owned property

• Some Very Important Information can be found
  herewww.olemiss.edu/depts/research/forms/index.h
  tml
• Look for
• Federal Property Manual
• Non-Availability of Equipment Form
• Grant/Contract Equipment Inventory Form
• Subcontract Equipment Inventory Form
• Transfer of Equipment Form

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Federally owned property

• Our Federal Property Administrator is
• Beth Stidham
• Office of Research and Sponsored Programs
• 100 Barr Hall
• 915-7482
• estidham_at_olemiss.edu
• Get to know her!

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Federally owned property

• Duties of the Federal Property Administrator
• 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

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Commodities and contractual services

• 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

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Goods and services

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

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Travel

• Travel activities must be in compliance with the
  sponsors travel policies and the universitys
  travel policy.
• Most sponsors allow domestic travel. Most also
  allow foreign travel, with permission.

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Travel

• UM Travel Authorizations
• Are required for all out-of-state travel
• Are required for in-state travel for conventions,
  associations, or meetings
• 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 youre just getting together
  with some colleagues from another nearby
  institution (for example), dont call it a
  meeting.
• Are required for 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.

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Travel

• Travel advances
• 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 Officewww.olemiss.edu/depts/procurement/t
  ravel1.html

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Travel

• Expenses that require receipts
• 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

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Travel

• Expenses that do not require receipts
• 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)

63
Special travel

• 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.

64
Travel

• The Travel website is extremely helpful
• www.olemiss.edu/depts/procurement/travel1.html
• Look for things like
• 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., etc.

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Subawards

• 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.

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Subawards

• Some Very Important Information can be found
  herewww.olemiss.edu/depts/research/forms/index.h
  tml
• Look for
• 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 (eSRS)

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Subawards

• Some of the important highlights are
• 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.

68
Responsible Conduct of Research (RCR)

• This concept is the umbrella for all regulatory
  research compliance as well as unregulated
  ethical and practical research habits

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Responsible Conduct of Research (RCR) The 11
RCR Areas

• 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

70
Regulations and policies on research using human
or animal subjects

• Under the University of Mississippis 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.

71
Relevant compliance boards

• Human subject research is reviewed by the
  Institutional Review Board (IRB)
• Animal research is reviewed by the Institutional
  Animal Care and Use Committee (IACUC)

72
Just-in-Time (JIT) policy for IRB and IACUC
applications

• If the funding agency or other source permits,
  the IACUC and IRB follow the NIH guidelines that
  permit JIT submissions of applications
• 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

73
Research Misconduct Policy

• 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/mis
  conduct_policy.html

74
Primary research misconduct actions

• 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 persons
  ideas, processes, results, or words without
  giving appropriate credit)

75
Additional research misconduct actions

• 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

76
Additional research misconduct actions

• 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 persons
  consent and/or with the intent to deceive
• Making a demand to be listed as an author on a
  researchers 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

77
Conflict of Interest Policy

• 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/res
  earch_objectivity.html

78
Export control

• 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 Departments Office of Foreign Assets
  Control are the bases for restricting use and
  access to this information and technology.

79
Export control

• 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.

80
Export control

• Anyone with concerns about export control issues
  should contact
• Tom Lombardo, Ph.D.Director of Research
  Integrity and Compliance 915-7482 or
  pytwl_at_olemiss.edu
• or Robin Buchannon, Ph.D.Assistant Vice
  Chancellor ORSP
• 915-7482 or rcb_at_olemiss.edu
• or Donna GurleyAssociate University Attorney
  915-7014 or dgurley_at_olemiss.edu

81
Resources

• NIH Grants Policy Statement
• NSF Grant General Conditions
• USDA CSREES Terms and Conditions
• Office of Research and Sponsored Programs
• (x7482)