POLICY 08:02:01

CONDUCTING RESEARCH AT PELLISSIPPI STATE

1. Protection of Human Subjects in Research
   1. Research involving human subjects must comply with the standards concerning the conduct of research involving human subjects established by the United States Department of Health and Human Services (HHS) within the “Protection ofHuman Subjects” (Title 45 CFR, Part 46).
   2. To ensure compliance with these federal research standards as well as Board policy, Pellissippi State, has placed into effect an Institutional Review Board (IRB), including a process for reviewing research proposals for requirements and compliance, and the necessary procedures to ensure that the rights and welfare of human subjects are properly protected.
      1. Research involving Pellissippi State employees or students as subjects conducted by personnel affiliated with Pellissippi State must be reviewed and, when appropriate, approved pursuant to 45 CFR § 46.111 by all appropriate IRBs.
      2. Research conducted by persons not affiliated with Pellissippi State who are seeking to conduct human research utilizing individuals, groups, or existing confidential data within the College must obtain IRB approval pursuant to 45 CFR § 46 .111 from Pellissippi State.
      3. Researchers publishing data analyses or reporting from data obtained from Pellissippi State, either electronically or in print, must comply with the federal requirements in the protection of editable, small cell data, including but not limited to the federal Gramm Leach Bliley Act, 15U.S.C. §§ 6801-6809. (See B-090 Safeguarding Nonpublic Financial Information.)
   3. All researchers utilizing human subjects or their personally identifiable data must submit requests for IRB approval and administrative approval to the executive director of Institutional Effectiveness, Assessment, and Planning, who serves as chair of the Pellissippi State IRB in accordance with College processes and procedures.
   4. All requests for TBR system confidential data for research purposes must be reviewed by the TBR Office of Policy and Strategy, involving the TBR IRB as appropriate.
2. Policy for Use of Animals for Research
   1. Researchers must comply with applicable criteria for the humane treatment of animals used in scientific research in accordance with the Guide for the Care and Use of Laboratory Animals (2011 or the most current version published by the Institute for Laboratory Animal Research, Division on Earth and Life Studies, National Research Council) and/or the Animal Welfare Act (Title 9 CFR Chapter 1 Subchapter A).
   2. Each researcher engaged in research using animals is personally responsible for complying with applicable provisions of the Guide and/or Animal Welfare Act.
   3. To ensure compliance with federal requirements and Board policy, Pellissippi State has also established an Institutional Animal Care Use Committee (IACUC), also chaired by the executive director of Institutional Effectiveness, Assessment, and Planning.
3. Technology Transfer
   1. The College must comply with federal laws concerning the protection of national security and military secrets by preventing foreign governments from accessing military and other technologies via the research processes of American colleges and universities.
   2. The College’s IRB must implement, to the extent necessary, a process relating to the transfer of technology, which must comply with the provisions of the Arms Export Control Act, 22 U.S.C. § 2778.
4. Research Security
   1. Pursuant to T.C.A. § 49-7-188, this Section IV is designed to safeguard research from foreign adversaries, to promote a culture of research security, to further national security interests, and to mitigate against threats to the security of research activities.
   2. To ensure that the College remains eligible for federal funding, the College and individuals conducting research at Pellissippi State must comply with applicable laws, regulations, and contractual obligations for securing and protecting research. The principal investigator for each research matter has primary responsibility for ensuring that the research is conducted in accordance with applicable legal and contractual requirements.
   3. Any research that is funded by a source other than a federal or state agency and that a reasonable person would believe potentially implicates national security interests must be reviewed and approved by the Chancellor or designee. Such review does not replace any required IRB or other administrative approvals.
   4. Research activities must comply with the cybersecurity requirements established by the College.
   5. Any individual who performs research on an export- controlled technology must complete training on U.S. export control and compliance requirements.
   6. The executive director of Institutional Effectiveness, Assessment, and Planning is responsible for:
      1.Maintaining publicly accessible contact information for the IRB and
      2.Facilitating the distribution of communications designed to enhance research security.
   7. Research security protocols shall be continuously improved to address new and emerging research security threats.
   8. Any person who has a concern about research security or undue foreign influence must report the concern to the College IRB, the TBR IRB, or the TBR Office of System-wide Internal Audit.
5. Foreign Talent Recruitment Programs
   1. Disclosure by Covered Individuals
      1. Any College faculty or staff member defined as a Covered Individual who is engaged in U.S. federally funded research activities must disclose participation in a Foreign Talent Recruitment Program. If participating in a Foreign Talent Recruitment Program, a Covered Individual must certify that they are not participating in a Malign Foreign Talent Recruitment Program.
      2. For federal grant applications, investigators and senior/key personnel will be required to disclose any Foreign Talent Recruitment Program participation at the time of grant submission. The principal investigator, as well as any co-principal investigators and others identified by the principal investigator, are also required to certify that they do not participate in any Malign Foreign Talent Recruitment Program.
      3. Disclosures must be made to the College, both annually and uponsubmission of any federal grant application, through the College’s IRB.
      4. In accordance with Board policy, the College has made the executive director of Institutional Effectiveness, Assessment, and Planning responsible for:
         1. Reviewing disclosures by Covered Individuals and verifying the accuracy and completeness of the information provided, and assessing whether participation in the Foreign Talent Recruitment Program aligns with TBR and College policies and complies with federal regulations;
         2. Providing guidance to Covered Individuals on compliance with this policy;
         3. If potential involvement with a Malign Foreign Talent Recruitment Program is identified, undertaking further investigation, and taking appropriate action, which may include obtaining legal advice from the Office of General Counsel, recommending suspension of certain activities, and taking corrective measures;
         4. Maintaining accurate records of all disclosures and taking action to ensure ongoing compliance with Section V of this policy, including reviews of research activities as necessary; and
         5. Providing training to faculty and staff about disclosure requirements, the implications of participation in a Foreign Talent Recruitment Program, and the implications of non-compliance.
      5. Covered Individuals are prohibited from participating in a Malign Foreign Talent Recruitment Program, in accordance with the CHIPS and Science Act of 2022 and National Security Presidential Memorandum-33.
   2. Definitions Related to Foreign Talent Recruitment Programs
      1. “Covered Individual” means any College faculty or staff member who is funded by a federal award and contributes in a substantive, meaningful way to the scientific development or execution of a research and development project proposed to be carried out with a research anddevelopment award from a federal research agency and is designated as a covered individual by the federal research agency concerned. The College considers the principal investigator, as well as any co-principal investigators to be Covered Individuals and requires that they provide applicable disclosures and certifications.
      2. “Foreign Talent Recruitment Program” means any program, position, or activity that includes compensation in the form of cash, in-kind compensation, including research funding, promised future compensation, complimentary foreign travel, things of non de minimis value, honorific titles, career advancement opportunities, or other types of remuneration or consideration directly provided by a foreign country at any level (national, provincial, or local) or their designee, or an entity based in, funded by, or affiliated with a foreign country, whether or not directly sponsored by the foreign country, to an individual, whether or not directly or indirectly stated in the arrangement, contract, or other documentation at issue.
      3. “Malign Foreign Talent Recruitment Program” means any Foreign Talent Recruitment Program that meets both Subsections V.B.3(a) and (b).
         1. Where compensation or remuneration from any foreign country is provided to the Covered Individual in exchange for any of the following:
            1. Engaging in the unauthorized transfer of intellectual property, materials, data products, or other nonpublic information owned by a U.S. entity or developed with aU.S. federal research and development award to the government of a foreign country or an entity based in, funded by, or affiliated with a foreign country regardless of whether that government or entity provided support for the development of the intellectual property, materials, or data products;
            2. Being required by a foreign country to recruit trainees or researchers to enroll in such program, position, or activity;
            3. Establishing a laboratory or company, accepting a faculty position, or undertaking any other employment or appointment in a foreign country or with an entity based in, funded by, or affiliated with a foreign country if such activities are in violation of the standard terms and conditions of a U.S. federal research and development award;
            4. Being unable to terminate the Foreign Talent Recruitment Program contract or agreement except in extraordinary circumstances;
            5. Through funding or effort related to the Foreign Talent Recruitment Program, being limited in the capacity to carry out a research and development award or required toengage in work that would result in substantial overlap or duplication with a federal research and development award;
            6. Being required to apply for and successfully receive funding from the sponsoring foreign government’s funding agencies with the sponsoring foreign organization as the recipient;
            7. Being required to omit acknowledgment of the recipient institution with which the individual is affiliated, or theU.S. federal research agency sponsoring the research and development award, contrary to the institutional policies or standard terms and conditions of the U.S. federal research and development award;
            8. Being required to not disclose to the U.S. federal research agency or employing organization the participation of a Covered Individual in such program, position, or activity; or
            9. Having a conflict of interest or conflict of commitment contrary to the standard terms and conditions of the U.S. federal research and development award.
         2. Where a Covered Individual is sponsored or supported either:
            1. by a foreign country of concern (currently, China, North Korea, Russia, or Iran) or an entity based in a foreign country of concern (whether or not directly sponsored by the foreign country of concern); or
            2. An academic institution or foreign talent recruitment program on the list developed under §1286 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (10 U.S.C. 4001 note; Public Law 115–232) available at https://basicresearch.defense.gov.
      4. Acceptable International Collaboration Activities. A Foreign Talent Recruitment Program does not include the following international collaboration activities, so long as the activity is not funded, organized, or managed by an academic institution or a Foreign Talent Recruitment Program identified in Section V.B.3.b.
         1. Making scholarly presentations and publishing written materials regarding scientific information not otherwise controlled under current law;
         2. Participating in international conferences or other international exchanges, research projects, or programs that involve open and reciprocal exchange of scientific information, and which are aimed at advancing international scientific understanding and not otherwise controlled under current law;
         3. Advising a foreign student enrolled at an institution of higher education or writing a recommendation for such a student, at such student’s request;
         4. Engaging in the following international activities:
            1. Activities that are partly sponsored or otherwise supported by the United States such as serving as a government appointee to the board of a joint scientific fund (e.g., theU.S. – Israel Binational Industrial Research and Development Foundation); providing advice to or otherwise participating in international technical organizations, multilateral scientific organizations, and standards setting bodies (e.g., the International Telecommunications Union, Intergovernmental Panel on Climate Change, etc.); participating in a Fulbright Commission program funded in whole or in part by a host country government; or other routine international scientific exchanges and interactions such as providing invited lectures or participating in international peer review panels.
            2. Involvement in national or international academies or professional societies that produce publications in the open scientific literature that are not in conflict with the interests of the federal research agency (e.g., membership in the Pontifical Academy of Sciences or The Royal Society).
            3. Taking a sabbatical, serving as a visiting scholar, or engaging in continuing education activities such as receiving a doctorate or professional certification at an institution of higher education (e.g., the University of Oxford, McGill University) that are not in conflict with the interests of the U.S. federal research agency.
            4. Receiving awards for research and development which serve to enhance the prestige of the U.S. federal research agency (e.g., the Nobel Prize).
            5. Other international activities determined appropriate by the U.S. federal research agency head or designee.

Approved: President Allen G. Edwards, February 25, 2002 Editorial Changes, July 2008
Editorial Changes, April 30, 2009, July 1, 2009
Reviewed/Recommended: President’s Staff, September 13, 2010
Approved: President Allen G. Edwards, September 13, 2010
Reviewed/Recommended: President’s Council, April 27, 2015
Approved: L. Anthony Wise, Jr. April 27, 2015
Reviewed/Recommended: President’s Council, March 4, 2019
Approved: President L. Anthony Wise Jr., March 4, 2019
Editorial Changes, April 19, 2019
Editorial Changes January 24, 2020