Module 3: Overview of Regulations and Compliance (Part 2)
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Transcript of Module 3: Overview of Regulations and Compliance (Part 2)
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Module 3: Overview of Regulations and Compliance (Part 2)
Office of Research and Sponsored ProgramsThe University of Mississippi
100 Barr Hall ~ 662-915-7482www.research.olemiss.edu
Updated October 2009 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.
Updated October 2009 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 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 OfficerSee grants.nih.gov/grants/policy/policy.htm#gps
NIH Grant and Cooperative Agreement
Regulations: Standard Terms and Conditions
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NIH Grants Policy Statement: Standard Terms and ConditionsContains –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 Statement:
Special 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 institution’s 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 >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
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What is NIH prior approval? 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
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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_key=aag
NSF Grant General Conditions (GC-1) General terms and conditions for NSF grantswww.nsf.gov/awards/managing/general_conditions.jsp
NSF Cooperative Agreement General Conditions (CA-1) General terms and conditions for NSF cooperative agreementswww.nsf.gov/awards/managing/co-op_conditions.jsp
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NSF Grant and Cooperative Agreement
Regulations: Standard Terms and ConditionsContain –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 >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
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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? 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
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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 division’s web site.
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USDA CSREES Grant and Cooperative Agreement RegulationsREAD 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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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 < 3 years experience managing
CSREES funds
See www.csrees.usda.gov/business/awards/awardterms.html
USDA CSREES Grant and Cooperative Agreement Regulations:
General Terms and Conditions - A
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USDA CSREES Grant and Cooperative Agreement Regulations:
General 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 Regulations:
Other 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?
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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 grantee’s 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 >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
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What is USDA CSREES prior approval?
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
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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 department’s (or school’s) administrative staff
Decide if you’re hiring faculty or staff For faculty:
Work with the Provost’s 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 don’t 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 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.
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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 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
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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 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/
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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 page:www.olemiss.edu/depts/research/forms/index.html
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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 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.
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Federally owned property Some Very Important Information can be
found here:www.olemiss.edu/depts/research/forms/index.html
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 StidhamOffice of Research and Sponsored Programs
100 Barr Hall915-7482
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 sponsor’s travel policies and the university’s 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 you’re just getting together with some colleagues from another nearby institution (for example), don’t 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 Office:www.olemiss.edu/depts/procurement/travel1.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)
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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.
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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 here:www.olemiss.edu/depts/research/forms/index.html
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.
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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
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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.
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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)
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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
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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/misconduct_policy.html
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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 person’s ideas, processes, results, or words without giving appropriate credit)
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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
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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 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
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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/research_objectivity.html
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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 Department’s Office of Foreign Assets Control are the bases for restricting use and access to this information and technology.
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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.
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Export control Anyone with concerns about export control
issues should contact: Tom Lombardo, Ph.D.
Director of Research Integrity and Compliance 915-7482 or [email protected]
or Robin Buchannon, Ph.D.Assistant Vice Chancellor – ORSP
915-7482 or [email protected] or Donna Gurley
Associate University Attorney 915-7014 or [email protected]
Updated October 2009 81
Resources NIH Grants Policy Statement
NSF Grant General Conditions
USDA CSREES Terms and Conditions
Office of Research and Sponsored Programs
(x7482)