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Stephen F. Austin State University
Grants and Contracts Procedures Manual (GCPM)

Adopted by SFA policy 8.3 - Revised: March 7, 2017

PART 5 - Policies and Compliance

 

I. Regulations, Policies, and Procedures

A. Responsibilities of the Principal Investigator (PI) or Project Director (PD)
B. SFA Policies Governing External and Internal Funding
C. Federal and State Regulations

II. Compliance and Safety in Research - Requirements, Training, and Forms

A. Introduction: Ethics in the conduct of sponsored projects
B. RCR - Responsible Conduct of Research
C. FCOI - Conflict of Interest Disclosure Form
D. IRB - Protection of Human Research Subjects
E. IACUC - Animal Care and Use
F. Export Control Regulations
G. Biosafety and Select Agents
H. Environmental Safety and Health/Radiation
I. CITI Research Ethics Training Programs (including IRB, IACUC, RCR, FCOI)

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I. Regulations, Policies, and Procedures

A. Responsibilities of the Principal Investigator (PI) / Project Director (PD)

Awards from external sources (grants, contracts, cooperative agreements, and other instruments) are made to SFA, not the PI or PD who prepared the proposal.

The president of SFA, or his/her designated signature authority, is the only individual who can commit the university to the terms of a sponsored agreement, as indicated by the approved signature on a proposal or a contract.

Pre-award: A PI or PD should notify ORSP as early as possible in the application/proposal phase so that ORSP staff can assist with the proposal. Specifically, the PI/PD should complete the following prior to project submission:

Post-award: The PI/PD has overall responsibility for the successful conduct of the project, including the responsibility to:

Close-out: The PI/PD has the responsibility to:

The language that follows is found on the Request to Establish a Banner Fund for Grants and Contracts (REF), which is signed by the PI/PD:

Principal Investigator (PI)/Project Director (PD) Acceptance of Responsibility

The Principal Investigator/Project Director is responsible for the programmatic management of the grant or contract and conducts the project activities as approved by the funding agency to meet project goals and objectives while adhering to sponsor guidelines and policies and procedures of the University.

My signature below acknowledges that I understand I am responsible for ensuring:

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B. SFA Policies Governing External and Internal Funding

Research and sponsored project funds awarded to and administered by SFA must conform to university policies and guidelines, as well as those of the sponsor. When SFA is a subawardee, projects are subject to applicable policies of the prime sponsor, as well as whatever other terms and conditions are specified by the entity that provides the funds to SFA.

Relevant University Policies (see the University Policy Manual for a complete listing of policies)

8.1
8.3
8.2
8.7
7.19
8.11
8.5
8.12
8.4
8.8
8.10
8.6

Effort Reporting and Certification for Sponsored Activities
Grants and Contracts Administration (incorporates this manual by reference)
Financial Conflicts of Interest in Sponsored Activities
Misconduct in Federally Funded Research
Misconduct in Scholarly or Creative Activities (non-federal/non-research)
Research Enhancement Program
Facilities and Administrative (Indirect) Cost Recovery, Distribution and Use
Fixed Award Amounts
Human Research Subjects Protection
Payments to Human Research Subjects
Texas Comprehensive Research Fund
Institutional Animal Care and Use Committee (IACUC)

1.3
3.26
17.6
3.16
3.17
17.8
17.22
3.12
17.12
2.7
3.18

Contracting Authority
Receipts and Deposits
Food Purchases
Gift Reporting
Gifts, Loans, Endowments, and Bequests
Interagency and Interlocal Contracts
Purchasing Ethics and Confidentiality
Establishing a New Departmental Account: Fund - Organization - Program (FOP)
Professional and Consulting Services
Fraud
Gifts, Prizes and Awards

9.4
2.9

Intellectual Property
Records Management

12.16
11.16
11.19
2.6
12.1

Salary Supplements, Stipends and Additional Compensation
Nepotism
Outside Employment
Ethics
Compensation from Grants, Contracts and Other Sponsored Agreements

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C. Federal and State Regulations

Prevent grant fraud, waste, and abuse

When a sponsor provides federal funding for a project, either directly or indirectly as pass-through funds, there are specific compliance requirements.

Federal Regulations - The University and the PI/PD, in accepting an award from a sponsoring agency, assume the responsibility for the financial, technical, and administrative aspects of the award. There are five principal sets of federal regulations that provide guidance in the financial and programmatic management of awards to universities:

2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards - Effective 12/26/2014

2 CFR Part, 220 (OMB Circular A-21), Cost Principles for Educational Institutions - Principles for Determining Costs Applicable to Grants, Contracts, and Other Agreements with Educational Institutions - (Note that A-21 applies to contracts and to subrecipients performing work under federal awards.)

2 CFR Part, 215 (OMB Circular A-110), Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations - (Note that federal contracts are subject to Federal Acquisition Regulations rather than A-110).

OMB Circular A-133, Audits of States, Local Governments, and Non-Profit Organizations

EDGAR - Administrative regulations for the U.S. Department of Education grants.

FAR - Federal Acquisition Regulations are the primary regulations used by federal sponsors to govern contracts for supplies and services, including research services. FAR incorporates OMB Circular A-21 for the purpose of defining allowable costs. FAR is not applied to grants and cooperative agreements that are governed by OMB Circular A-110, agency grant regulations, or Federal Demonstration Project (FDP) terms and conditions (FDP is not applicable to SFA). Federal contracts typically incorporate all of the FAR clauses applicable to a given project.

Allowable, Allocable, and Reasonable - Quick decision guide to allowability of federal expenditures

State Regulations and Guidelines - Each state agency provides regulatory guidance in requests for proposals, in award documents, and/or in contract terms. In addition, the Governor's Office has adopted standards that apply to most grants and contracts awarded by state of Texas agencies. In practice, they apply OMB Circular A-21 to universities.

UGMS - State of Texas Uniform Grant Management Standards (UGMS)

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II. Compliance and Safety in Research - Requirements, Training, and Forms

A. Introduction: Ethics in the conduct of sponsored projects

As stated in policies A-31.5 and A-80, SFA strives to create a climate that promotes faithful adherence to high ethical standards in the conduct of scientific research, scholarship, and creative activities without inhibiting the productivity and creativity of the academic community.

Faculty scholars and other personnel at SFA are expected to adhere to the highest ethical standards for all research and scholarly work. It is the responsibility of every research investigator to maintain the integrity of research projects, including maintaining an auditable record of experimental protocols, data, and findings.

Misconduct in research or scholarly/creative activity is a major breach of the relationship between a faculty or staff member and the university. Coauthors on research reports or scholarly/creative works of any type must have a bona fide role in the research or scholarly work and must accept responsibility for the quality of the work reported.

Misconduct in science and allegations of such behavior will be handled promptly and confidentially. The university's policies regarding research integrity include: SFA Policy 7.19, Misconduct in Scholarly or Creative Activities and SFA Policy 8.7, Misconduct in Federally Funded Research

A Principal Investigator (PI) or Project Director (PD) should have no conflict of interest that would affect the conduct of a project.

SFA's policy requires that an employee of the university who applies for grants or cooperative agreements from any sponsor for research or other sponsored activities, or otherwise submits a proposal for sponsored activities to any entity, ensures that there is no reasonable expectation that the design, conduct, and reporting of research will be biased by any significant financial interest of a PI/PD responsible for the research or other sponsored activity. Based upon federal regulations and the university's objectives to maintain an environment that promotes faithful attention to high ethical standards, this policy relating to conflicts of interest is to be administered in conjunction with Texas laws setting forth standards of conduct.

Texas Government Code, Chapter 572, and SFA Policy 8.2, Financial Conflicts of Interest in Sponsored Activities

SFA has subscribed to the Collaborative Institutional Training Initiative (CITI) program. Training modules (CITI) for Responsible Conduct in Research (RCR) and Financial Conflict of Interest (FCOI) are available, as well as training modules for IRB and IACUC members, faculty, and students. For more information, see section I, below.

Compliance and safety in research also applies to research activities funded by gifts.

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B. Responsible Conduct of Research (RCR)

In compliance with the National Science Foundation’s (NSF) policy, as well as other federal agencies, in response to provisions of the America COMPETES Act, SFA developed a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in federally funded research.

Training is applicable to all new NSF awards applied for and/or received after January 1, 2010, and all other federal awards as detailed in award documents and specific agency guidelines.

Each individual subject to this requirement will be required to complete the free, online RCR course offered by the Collaborative Institutional Training Initiative (CITI). For more information, see section I, below.

CITI web site
RCR Training Verification Form
RCR Training Plan Procedures

The Principal Investigator (PI) or Project Director (PD) is responsible for ensuring that the appropriate topic(s) for the on-line training program are completed in a timely manner and that the appropriate documentation is forwarded to the Office of Research and Sponsored Programs for record retention.

RCR training covers: research misconduct; data management; conflict of interest; and responsible authorship (all four REQUIRED); and collaborative science; mentoring; peer review; lab animals; and human subjects (Optional, to be added based on their applicability to the specific research). Discipline-specific topics to choose from include: biomedical; social & behavioral research; physical sciences; humanities; engineers; and administrators.

The PI/PD is encouraged to provide mentoring to students in the following areas as applicable to the specific research or program design in addition to the online program and to refer the student to applicable resources (SFA policies, procedures, committees, etc.):

ORSP Compliance Contact:Amanda Romig, Federal Compliance Coordinator
Phone: 936.468.1067, romigad@sfasu.edu

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C. Conflicts of Interest (FCOI)

To protect the credibility and integrity of SFA and ensure the public trust and confidence in the university's research and sponsored activities, actual or potential conflicts of interest must be identified, and then managed, reduced, or eliminated prior to the university's expenditure of any funds under an award, and if required by a sponsor, certify to the funding agency what actions have been taken or report conflicts that cannot be satisfactorily managed, reduced, or eliminated.

All investigators are required to disclose any significant financial interest that could directly or indirectly affect the design, conduct, and/or reporting of research and/or affect professional judgment in the conduct of sponsored activities.

Conflicts of interest include: (1) a significant, related financial interest for a project as defined below; and (2) family relationships related to a project.

Additional requirements pertain specifically to Public Health Service (PHS) sponsored research and to research sponsored by other federal agencies with similar financial conflict of interest regulations. For PHS supported research, resolution of any potential or actual conflicts of interest shall not be required until after funding has been approved and prior to any expenditure under the PHS award. Prior to the expenditure of any funds under a PHS-funded research project, the Institutional Official at SFA shall develop and implement a management plan that shall specify the actions that have been and shall be taken to manage the financial conflict of interest.

For pending or active research or other sponsored activities, a significant financial interest that must be disclosed by an investigator consists of one or more of the following: interests of the investigator, and/or the investigator's spouse and dependent children, or any other financially interdependent individual in the household; which reasonably appears to be related to the investigator's institutional responsibilities; and was received, obtained, or held during the twelve (12) months preceding the disclosure:

Training in FCOI is required for all NIH awards applied for and/or received after August 24, 2012. For more information, see section I, below.

CITI web site

Additional requirements are outlined in SFA policy A-11.5.

Financial Conflicts of Interest in Sponsored Activities (policy 8.2)
Nepotism (policy 11.16)
Disclosure of Substantial Interest Form (SFA, general) - Submitted in SSB; due annually and when circumstances change
FCOI Disclosure Form/PCF (ORSP, grant specific) - Due at the time of application with the PCF
FCOI Disclosure Form (ORSP, grant specific) - Due when circumstances change

See also 2 CFR 200.112.

ORSP Compliance Contact:Amanda Romig, Federal Compliance Coordinator
Phone: 936.468.1067, romigad@sfasu.edu

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D. Protection of Human Research Subjects (IRB)

The Institutional Review Board (IRB) is responsible for reviewing and approving research involving the use of human subjects, including surveys. Principal Investigators (PIs) proposing research using human subjects at any level should review related policies and are encouraged to communicate with and submit the appropriate application to the chair of the IRB early in the process. This includes research conducted by students.

Many agencies require documentation of IRB approval, or that the IRB process has been initiated, in the funding application.

Copies of IRB approval letters and/or e-mails for all externally funded projects must be provided to ORSP.

Stephen F. Austin State University's IRB IORG number is: IORG0000733.
IRB Committee
IRB-H Application Form - Application for Approval of Research Involving Human Subject
SFA Policy 8.4, Human Research Subjects Protection
SFA Policy 8.8, Payments to Human Research Subjects

IRB Chair: Dr. Pauline Sampson
Phone: 936.468.2908, SFA Box 13018, sampsonp@sfasu.edu

ORSP Compliance Contact: Amanda Romig, Federal Compliance Coordinator
Phone: 936.468.1067, romigad@sfasu.edu

U.S. Department of Education's web site on protection of human subjects in research.

Training for SFA affiliates: CITI web site

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E. Animal Care and Use (IACUC)

All projects involving the use of live vertebrate animals must be reviewed by the Institutional Animal Care and Use Committee (IACUC) prior to the initiation of any research. Precautions must be taken to protect the user as well as the particular animal species involved. Only properly trained personnel are allowed to handle and dispose of animals. Radioactive animals receive special handling according to federal, state, and campus guidelines on radiation safety; see the section which follows (Section IV. H.). The use of radioactive materials in animal research must be approved prior to submission of a research protocol to the IACUC.

Most federal agencies require that protocols using animals be reviewed and approved by the IACUC prior to proposal submission.

IACUC Committee
IACUC Application - short form - Application for Approval of Research Involving Animal Subjects; abridged protocol
Animals in Research Protocol - Application for Approval of Research Involving Animal Subjects; full protocol
SFA Policy 8.6 - Institutional Animal Care and Use Committee (IACUC)

Committee Chair: Dr. Robert Polewan
Phone: 936.468.3601, polewanrj@sfasu.edu

ORSP Compliance Contact: Amanda Romig, Federal Compliance Coordinator
Phone: 936.468.1067, romigad@sfasu.edu

Guide for the Care and Use of Laboratory Animals, Eighth Edition, NIH
Office of Laboratory Animal Welfare (OLAW) web site, Public Health Service
IACUC.org web site for guidance on the protection of animal subjects in research

Training for SFA affiliates: CITI web site

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F. Export Control Regulations

Export control regulations are federal laws that prohibit the unlicensed export of certain goods, products, or information for national security and to protect trade. The interpretation of these regulations requires a certain level of expertise because they require classification of commodities, and export and licensing determinations.

Export controls are usually associated with the destination of the export (country, organization, etc.) and the potential use of the export (military or economic use). Exports can occur through shipping, oral communications, written documentation (including e-mails), and visual inspections of any technology, software or technical data to any non-U.S. citizen, whether in the U.S. or abroad. For further information, refer to the EAR or ITAR regulations.

Travel outside the U.S. also can present export control issues for SFA employees, specifically if you take items from work such as lap tops, data, technology, blueprints/schematics, and similar items. The destination country and the individuals or entities you interact with also may present export control issues and may require a license from the Departments of Commerce, State, or Treasury. Shipping certain items outside the U.S. also could require a license.

Export Administration Regulations (EAR) - U.S. Department of Commerce
http://www.access.gpo.gov/bis/ear/ear_data.html  (Commerce Control Database or List)

International Traffic In Arms Regulations (ITAR) – U.S. Department of State
http://www.pmddtc.state.gov/regulations_laws/itar_official.html (Defense-related items/services)

Most, if not all, research activities at SFA are exempt from export control regulations because the results meet the definition of fundamental research (e.g., the results will be in the public domain, and published or otherwise shared broadly in the scientific community).

However, you must contact SFA’s General Counsel to determine if you have an export control issue if one or more of the following applies to your research:

General Counsel: Damon Derrick
Phone: 936.468.4305, derrickdc@sfasu.edu

ORSP Compliance Contact:Amanda Romig, Federal Compliance Coordinator
Phone: 936.468.1067, romigad@sfasu.edu

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G. Biosafety and Select Agents

Select agents include biological agents and toxins that have the potential to pose a severe threat to public health and safety or pose a potential threat to animal and plant health or to the safety of animal or plant products. These items are regulated by the Centers for Disease Control (CDC) and the U.S. Department of Agriculture (USDA).

Select Agents and Toxins List

Biosafety Committee - Research involving biohazards, such as novel recombinant DNA, blood-borne pathogens, and carcinogens (including select agents) requires protocol review in compliance with National Institutes of Health (NIH) guidelines prior to the submission of a proposal or the start of the research.

Contact Chair: Ronald Havner
Phone: 936.468.3601, havnerronal@sfasu.edu

ORSP Compliance Contact:Amanda Romig, Federal Compliance Coordinator
Phone: 936.468.1067, romigad@sfasu.edu

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H. Environmental Safety and Health/Radiation

The University's Radiation Safety Officer is responsible for ensuring the effective use of safety measures relating to radioactive materials and radiation devices, consistent with the Radiation Control Program of the Texas Department of Health, the Texas Radiation Control Act, and the Federal Radiation Control for Health and Safety Act of 1968. This Radiation Safety Officer regulates the receipt, possession, use, transfer, or acquisition of any source of ionizing or non-ionizing radiation or radiation-producing device. Compliance is required regardless of the source of funds used to support the research.

There are two additional safety officers that can provide information regarding environmental safety, emergencies, and the handling and disposition of hazardous materials.

Radioactive or Radiation-Producing Materials or Equipment policy 13.17
Contact Officer: Dr. Bea Clack
Phone: 936.468.6908, bclack@sfasu.edu

Health and Safety policy 13.10
Emergency Operations Plan policy 13.8
Contact Officer: Jeremy Higgins
Phone: 936.468.4514, higginsjkg@sfasu.edu

Hazardous Materials and Chemical Removal
Contact Officer: Matt Romig
Phone: 936.468.6034, romigmatt@sfasu.edu

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I. CITI - Collaborative Institutional Training Initiative (Research Ethics Training Programs)

SFA has subscribed to the CITI Program, which provides research ethics education courses in the areas of Human Subjects Research (HSR), Responsible Conduct of Research (RCR), Financial Conflict of Interest (FCOI), and Animal Care and Use (ACU).

All SFA faculty, staff and students are encouraged to create a CITI account and register for applicable CITI courses for the purpose of their research, activities and coursework.

Each CITI course contains a set of modules, and most modules are typically 20 minutes in length and contain a quiz. The number of modules in each course varies.

Once a course has been started, the learner can leave and re-enter the course at any time. To pass a course, the learner must receive an average of 80% on module quizzes. If needed, module content can be revisited, and quizzes can be retaken to achieve a higher score until a passing score is achieved. If the learner needs to submit proof of completion to a supervisor, Project Investigator or professor for course credit, he/she has the ability to print out a completion report directly from his/her account.

List of available CITI courses of most interest to SFA:

Human Subjects Research (HSR) courses. Courses include: Biomedical Research Investigators; Social & Behavioral Research Investigators; IRB Members; Students – class projects; Research with Data of Laboratory Specimens Only.

Responsible Conduct of Research (RCR) courses. Courses include: Biomedical RCR; Social & Behavioral RCR; Physical Science RCR; Humanities RCR; Research Administrators RCR.

Financial Conflict of Interest (FCOI) course

Animal Care and Use (ACU) courses. Courses include: Working with the IACUC for Investigators, Staff and Students; Essentials for IACUC Members; Working with Mice; Working with Amphibians; Working with Rats; Working with Hamsters; Working with Gerbils; Working with Guinea Pigs; Reducing Pain and Distress in Laboratory Mice & Rats.

Informational Flyer

CITI website (https://www.citiprogram.org)

CITI Website Registration Instructions

ORSP Administrative and Compliance Contact: Amanda Romig, Federal Compliance Coordinator
Phone: 936.468.1067, romigad@sfasu.edu

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