Roane State Community College

1. Institutional Review Board Function
   1. The Roane State Community College (RSCC) Institutional Review Board (IRB) ensures that all research involving human subjects is conducted ethically, protecting their rights, welfare, and safety. The IRB operates under U.S. Department of Health and Human Services regulations (45 CFR 46), including the revised Common Rule effective January 21, 2019, and January 20, 2020. The IRB is guided by the ethical principles regarding all research involving humans as subjects as set forth in the April 18, 1979, report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Researcher, titled: “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” commonly known as the “Belmont Report.”
   2. The IRB regulates all human subject research activities across all campuses, conducting ethical reviews while ensuring compliance with federal and state laws. All human subject research at RSCC requires IRB approval. Certain minimal risk research may qualify for exemption or expedited review under the categories specified in the revised Common Rule, and continuing review may not be required for some types of research as specified in 45 CFR 46.109(f)(1).
   3. Roane State’s IRB will review and approve, when appropriate:
      1. Research involving human subjects conducted under the name of Roane State Community College, or by any employee of the college.
      2. Research conducted by people not affiliated with RSCC, but who are seeking to conduct human research utilizing personnel, students, or existing confidential data within the Roane State.
      3. Research reports and data analyses obtained from RSCC or the Tennessee Board of Regents (TBR) through either electronic or print media.
      4. Research using Roane State Community College students, faculty, or staff as research subjects/participants, or any members of these groups identifiable individually as being affiliated with the Tennessee Board of Regents or any of its campuses. The TNeCampus and research or data requests relevant to any TBR campus must seek approval from the TBR Office of Academic Affairs in addition to the individual college or university IRB; TBR IRB approval applies to research conducted by students, TBR personnel, and non-TBR personnel. (See TBR policy 2.08.00.00 Research Compliance and Security).
      5. If the Principal Investigator (PI) is affiliated with another institution with an active IRB, they must obtain IRB review from their home institution and submit documentation of this determination to the RSCC IRB, along with a project overview and research instruments, before conducting research with RSCC students or faculty.
2. Composition of the Board – Membership
   1. The chairperson and other members of the IRB are appointed by the president of the college, who serves as the Head Official responsible for overseeing the activities performed by the IRB. The president also serves as the signatory official on the institution’s federal wide Assurance. The IRB must have five or more members of varying expertise and diversity, including at least one individual from outside the college and one non-scientist to promote complete and adequate review of the research conducted at the college. All IRB members must undergo training in human subject protection (including ethical principles, federal regulations, and IRB procedures and policies) and sign a Member Agreement and Confidentiality Form*. The IRB chairperson and at least two board members will commit to two years of board service to ensure continuity.
      
      Per the federal authorization and guidelines, IRB membership must include:
      1. Community/Outside member—At least one member who is NOT affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
      2. Scientist—At least one member should have expertise in research/scientific methods.
      3. Non-Scientific member—At least one member should have a background in primarily a non-scientific area members of more than one profession/discipline.
   2. No IRB member will be able to participate in an IRB review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. If needed, the IRB will be at liberty to invite any individual(s) with competence in special areas to assist in the review of issues requiring expertise beyond that of the board members. For instance, if research involves vulnerable subjects (e.g., children, mentally handicapped or disabled), the IRB may request outside review by a person with expertise in that area. When research subjects include prisoners, a prisoner or prisoner representative is required to serve on the Board. If outside expertise is needed, invited people may provide information and feedback, but they may NOT vote with the IRB except in the case of research involving prisoners.
   3. The IRB shall maintain a current list of members identified by name; earned degrees; representative capacity; indications of experience sufficient to describe each member's chief anticipated contributions; and any employment or other relationship between each member and the institution. This list must be kept up to date, and any changes must be reported to OHRP within 90 days.
3. Definitions
   1. A human subject is a living individual about whom an investigator conducting research obtains: 1) data through direct intervention or interaction (e.g., interviews, examinations), or 2) identifiable private information or biospecimens through indirect means (e.g., observation, files, data banks) (45 CFR 46.102(e)).
   2. Research is a systematic investigation, including development, testing, and evaluation, designed to contribute to generalizable knowledge. This includes FDA-defined clinical investigations (21 CFR 50.3(c)).
      1. Research may include pilot studies, interviews, focus groups, surveys, observation, case studies, oral histories, secondary data analysis, and biospecimen research.
      2. Non-research or excluded activities includes: RSCC student ratings of instruction; Institutional/program evaluation related to employee's primary duties; RSCC employee performance evaluations; Classroom-only student studies; State-mandated evaluations; Accreditation-mandated assessments; Certain RSCC grant evaluation activities; Scholarly/journalistic activities focusing on specific individuals; Public health surveillance by authorities; Criminal justice/investigative data collection; National security operational activities.
   3. An investigator is an individual conducting human subject research who:
      1. Obtains information through direct interaction with living individuals.
      2. Obtains identifiable confidential information about living individuals.
      3. Obtains voluntarily informed consent from research subjects.
      4. Studies, interprets, or analyzes identifiable confidential information/data.
   4. Minimal risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during routine physical/psychological examinations or tests.
4. IRB Review Process
   1. All human subjects research requires an Application for Exemption or Application for Review. Investigators uncertain about review requirements should contact the IRB chairperson. Service project directors are encouraged to consult with the IRB chair regarding research classification.
   2. External researchers must first obtain IRB approval from their home institution before submitting to RSCC. If the Principal Investigator (PI) is affiliated with another institution with an active IRB, they must submit to the RSCC IRB: 1) documentation of their home institution's IRB determination, 2) a brief project overview, and 3) any research instruments before conducting research with RSCC students or faculty.
   3. Both internal and external research requests require proper submission. Faculty and staff conducting research beyond their normal duties must obtain IRB approval before beginning. For multi-institutional U.S. research, a single IRB must be used unless exceptions apply under 45 CFR 46.114(b)(2). Approval is required regardless of funding status. This policy applies to student research under faculty advisement except for classroom-only instruction. Only the IRB chair or designated members may exempt proposals or determine expedited review eligibility. Non-compliant research will be reported to the college president.
   4. After application submission, the IRB chair determines if the study is: 1) exempt under 45 CFR 46.101;2) eligible for expedited review; or 3) requires full review per DHHS regulations. Some exempt categories may require limited IRB review as specified in 45 CFR 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8). The chair will contact investigators if additional information is needed.
   5. Roane State's IRB ensures subject protection by evaluating: 1) risk minimization; 2) reasonable risk-benefit ratio; 3) equitable subject selection; 4) informed consent procedures; 5) proper consent documentation; 6) data monitoring provisions; and 7) subject privacy and data confidentiality protections.
   6. The IRB chair or designees may certify exempt research or approve expedited reviews. Full-board reviews require an IRB meeting, possibly with investigator attendance. The IRB may: 1) approve without reservation; 2) approve with modifications; 3) defer pending resubmission; or 4) disapprove with written explanation and opportunity for investigator response.
   7. Per 45 CFR 46.109(f)(1), continuing review is not required for: (i) expedited review research; (ii) limited IRB review research; (iii) research at the data analysis stage or involving only clinical care follow-up data, unless otherwise determined by the IRB.
   8. Submitting an Application for IRB determination: For initial review, submit the IRB application form found on the RSCC Institutional Research page: Institutional Review Board - Roane State Community College*
5. Categories of Research Review
   Research involving human subjects falls into four categories: 1) exempt from IRB review; 2) eligible for expedited review; 3) requiring full-board review; and 4) continuing review of previously approved projects. Projects in the first two categories must involve no more than minimal risk.
   1. Exempt Research: Must meet criteria in one of eight categories under 45 CFR 46.104(d). Some categories require limited IRB review per 45 CFR 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8). Exempt research still requires ethical compliance and informed consent.
   2. Expedited Review: Available for minor changes to approved research or minimal risk projects falling within nine federally established categories. Review conducted by IRB chair or designee without full committee meeting.
   3. Full Board Review: Required for projects involving more than minimal risk or not eligible for exempt/expedited review. Requires majority approval at convened meetings with quorum including one nonscientific representative.
   4. Continuing Review: Under revised Common Rule (45 CFR 46.109(f)(1)), not required for: (i) expedited review research; (ii) limited IRB review research; (iii) research at data analysis stage only. All other research requires continuing review at appropriate intervals.
6. Investigator Responsibilities
   
   Investigators must:
   1. Obtain and document informed consent unless waived
   2. Secure prior IRB approval for modifications
   3. Submit progress reports for continuing review when required
   4. Report unanticipated problems promptly
   5. Report serious/continuing noncompliance
   6. Report suspension/termination of IRB approval
   7. Maintain records for at least three years
   8. Comply with single IRB requirements for multi-institutional research
   9. Ensure informed consent includes all required elements
7. Informed Consent
   Informed consent is legally required and must begin with concise key information. The revised Common Rule requires additional elements when collecting identifiable information/biospecimens. For subjects under age 18, parental permission and child assent are required. "Broad consent" for secondary use of data/biospecimens is allowed under 45 CFR 46.116(d). Recording participants requires additional consent via Recorded Media Addendum*. Electronic signatures are acceptable.
8. Research Changes
   All changes to study conduct or documents require prior IRB approval except when necessary to eliminate immediate hazards. Changes are reported via Research Change Form*.
9. Continuing Review
   Under 45 CFR 46.109(f)(1), continuing review is not required for: 1) expedited review research; 2) limited IRB review research; 3) research at data analysis stage only. For research requiring continuing review, approval expires after one year. Investigators must submit Continuing Review Form* one month before expiration. Exempt research needs no continuing review unless scope changes.
10. Unanticipated Risks
    Immediately report via Reportable Event Form*.
11. Study Closure
    Submit Research Closure Form* within 30 days of completion for expedited/full review studies.
12. Cooperative Research
    1. In accordance with 45 CFR 46.114(b), for cooperative research conducted in the United States that involves more than one institution, each institution engaged in such research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.
    2. For cooperative research not subject to the single IRB requirement, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with policy. Per 45 CFR 46.114, cooperative research projects are those projects covered by this policy which involves more than one institution.
13. Technology Transfer
    1. TBR colleges 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. Colleges 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.
14. 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. If the college or primary investigator affiliated with the college wishes to engage in research with animals, the college must establish an Institutional Animal Care Use Committee (IACUC), if required by federal law or regulation.
       1. The college should review the United States Department of Agriculture (USDA) policy and consult with the TBR Office of General Counsel as needed, to determine the need for an IACUC.
       2. The college should be aware of the need to file an assurance with the agency prior to obtaining funds with said agency.
       3. Colleges should be aware that there are reporting requirements with the USDA for all animals that fall under its definition.

*All forms and information designated with an asterisk are available under the IRB link on the Institutional Effectiveness and Research web page.

The director of Institutional Research shall be responsible for development and maintenance of this policy for issuance by the VP of Institutional Effectiveness, Planning and Student Success Initiatives.