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Office of Research and Sponsored Programs Administration

East Tennessee State University

Research Compliance

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A.  Introduction

B.  Openness in Research

C.  Regulatory Requirements

Animals in Research
Human Subjects Research
Biosafety
Radiation Safety
Financial Conflict of Interest (FCOI)
Export Control Regulations
Intellectual Property
Responsible Conduct of Research (RCR)
Representations and Certifications



 

A.  Introduction

East Tennessee State University is committed to operating with integrity in full compliance with all applicable laws, regulations, and policies. Our Mission is to support the University's fundamental commitment to the highest standards of ethics, education, integrity, lawful conduct, and responsible citizenship by complying with all laws, regulations, and internal policies. We invite you to become familiar with the university's compliance requirements and incorporate them into each of your assignments and tasks.

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B.  Openness in Research

ETSU adheres to the principle of openness in research because of its missions of education, research, and public service. Therefore, ETSU does not generally conduct or permit its faculty to conduct classified or secret research at ETSU or under a grant administered by ETSU.

ETSU will generally not enter into a contract nor accept a grant to carry out research if the grant or contract restrains the freedom of the University to disclose:

  • The existence of the contract or grant,
  • The general nature of the inquiry to be conducted,
  • The identity of the sponsor, or
  • The research results

Generally, PIs must be free to publish the results of their research without prior approval of a sponsor or third party. Sponsors may be permitted a short period to review publications prior to submission in order to identify and request the removal of sponsor confidential information or to identify and take appropriate steps to protect intellectual property.

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C.  Regulatory Requirements

Sponsors, in response to legislative initiatives concerned with issues of social and fiscal accountability, have attached a variety of regulatory requirements to government assistance programs which must be satisfied in advance of, or during, the conduct of a funded project. These requirements usually call for special review processes to ensure compliance with applicable federal, state and/or University regulations and the health and safety of those involved in the project, as attested to by the signature of the principal investigator (PI) and/or the University's authorizing official. The PI is responsible for obtaining the appropriate approvals when submitting proposals involving any of the following.

Animals in Research

Contact:  , Director of the Division of Lab Animal Resources
University Committee on Animal Care

The humane care and use of animals for research and/or teaching is the concern of the University Committee on Animal Care (UCAC). All use of living vertebrates for these purposes is subject to the Committee's prior review and approval.

In order to approve proposed activities or proposed significant changes in ongoing activities, the University Committee on Animal Care ( UCAC) will conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with the Animal Welfare Act , the NIH "Guide for the Care and Use of Laboratory Animals" ( Guide), and the Public Health Service Policy on Humane Care and Use of Laboratory Animals ( PHS Policy). This same information should also be provided in the proposal as instructed in sponsor guidelines. To obtain approval, submit a Protocol Form. An assigned protocol number is necessary for the acquisition of all laboratory animals, whether or not the activity will be externally funded. Review and approval of the protocol will be verified to the sponsor by ORSPA.

Get ETSU UCAC Protocol Forms

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Human Subjects Research

Contact:  , Director, Institutional Review Board
Institutional Review Board

The Institutional Review Board administration serves as the official Human Research Protections Program (HRPP) provider for ETSU and the James H. Quillen Veterans Affairs Medical Center. All individuals engaged in research that is sponsored by ETSU, conducted by or under the direction of any faculty, staff, or student or agent of ETSU in connection with his or her institutional responsibilities; conducted by or under the direction of any employee or agent of ETSU using any property or facility of ETSU; or involves the use of ETSU's nonpublic information to identify or contact human research participants or prospective participants must obtain ETSU or ETSU/VA IRB approval before beginning any research activities.

The Institutional Review Board (IRB) must approve all proposals for projects involving the use of human subjects before a funding agency will make an award. Researchers may not begin any such research project until final, written approval has been received from the IRB.

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Biosafety

Contact:  , the Vice Provost for Research
Biosafety and Chemical Safety Committee

The ETSU Biosafety Committee is a University-wide committee responsible for developing institutional biosafety policies and for reviewing and approving research that uses biohazards and recombinant DNA. Biohazards are biological agents and materials which are potentially hazardous to humans, animals and/or plants including infectious agents, select agents and toxins. Any research or testing activity that involves the use of biohazards or recombinant DNA requires review by the ETSU Biosafety Committee before a biohazardous material is acquired and before the study begins.

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Radiation Safety

Contact:  , Radiation Safety Officer
Office of Radiation Safety

The mission of the Radiation Safety program is to assist East Tennessee State University personnel and students in the safe acquisition, handling and disposal of radiation sources. Our goal is to keep radiation exposure to University personnel, members of the public, and the environment As Low As Reasonably Achievable (ALARA) and in compliance with state and federal regulations.

Radiation Safety Forms

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Financial Conflict of Interest

Contact:  , ORSPA
ETSU FCOI Policy and Forms

Key personnel on all sponsored program proposals must assess their significant financial interests and disclose any interests that may represent a potential financial conflict of interest to the Office of Research and Sponsored Programs. Only personnel who meet the definition of "Investigator" on proposals for sponsored research funding are required to submit a Significant Financial Interest Disclosure Form prior to the submission of the proposal, regardless of the nature of their significant financial interests.

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Export Control Regulations

Contact:  , ORSPA
ETSU Export Control Information

ETSU is committed to complying with all applicable laws and regulations regarding federal export controls, including those implemented by the Department of Commerce's Export Administration Regulations (EAR), the Department of State's International Traffic in Arms Regulations (ITAR), and the Treasury Department's Office of Foreign Assets Control (OFAC).

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Intellectual Property

Contact:  , Vice Provost for Research and Sponsored Programs
ETSU Intellectual Property Inforamtion

It is the policy of East Tennessee State University to encourage inventions, discoveries, and the production of copyrightable and trademarkable materials by members of the institution; facilitate the utilization of such discoveries and materials to the benefit of the public, the University, and members of the University community through dissemination of results; and provide for the equitable sharing of any proceeds derived from the commercial exploitation of inventions, discoveries, copyrightable and trademarkable materials in which, pursuant to the ETSU policy on Patents and Copyrights, the University is deemed to have an interest

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Responsible Conduct of Research (RCR)

Contact:  , the Vice Provost for Research and Sponsored Programs
ETSU Research Ethics Information

East Tennessee State University recognizes that maintenance of the highest standards of ethics in research is essential to the advancement of knowledge and to retaining public trust in the research and scholarly activities conducted by its faculty, students and staff. To this end all faculty, staff and students engaged in research and scholarly activities are strongly encouraged to read the "ETSU Guidelines on the Responsible Conduct of Research" and the "ETSU Policy on Misconduct in Research and Scholarship." The former provides the context for ethical conduct of research at ETSU and every person conducting research at ETSU should be familiar with the Policy on Misconduct in Research and Scholarship.

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Representations and Certifications

Sponsors often require applicant organizations to provide signed affirmation of compliance with a variety of federal, state, local and University policies, whether or not they may be directly applicable to the proposed project. Consult ORSPA whenever such form affirmations are required. Normally the following representations and certifications are included in application materials or incorporated by reference, and, unless otherwise noted, call only for the signature of the University's authorizing official:

a. Debt, Debarment, and Suspension
The University must certify that it is not delinquent on the repayment of any federal debt before an award can be made. In addition, PIs are individually required to certify that they are neither debarred nor suspended from doing business with the federal government.

b. Drug-free Workplace
The University is required by federal regulation to maintain both a drug-free workplace and formal drug and alcohol abuse prevention programs. The Policy Statement on Drug Free Campus is distributed by the Office of Human Resources. Applicants for individual fellowships must also certify that, as a condition of award, they will not engage in unlawful actions involving a controlled substance in conducting any funded activity.  ETSU Policy

c. Lobbying
Federal rules prohibit the use of federal funds to influence officials of Congress and Executive Branch agencies in connection with a specific award. University funds may be used for such activities; however, any lobbying by individuals other than regularly employed staff must be disclosed to the agency in writing.

d. Civil Rights, Handicapped Individuals, Sex Discrimination, Age Discrimination
With most proposals, sponsors also require the University to certify that it has on file an assurance of compliance, or will comply, with various federal, state or local nondiscrimination statutes.

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