Responsible Division

Research, Analytics, and Planning

Related Sources

TBR Policy 2.08.00.00 General Policies Regarding Research

TBR Guideline A-110 Institutional Review for Research

Purpose

This policy addresses the operations and review procedures for Northeast State Community College’s (NeSCC) Institutional Review Board (IRB) to ensure adherence to the regulations for the protection of human subjects in research established by the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) – (45 Code of Federal Regulations Part 46). This policy outlines expectations that research involving human subjects conducted at Northeast State Community College is subject to reviews, procedures, policies, and regulations, as well as approval and oversight by the college’s IRB.

Definitions

For this policy only, the following definitions will apply:

Cabinet: A standing committee that discusses and advises the President about matters concerning the institution. The Cabinet is responsible for reviewing and endorsing policies and recommending final drafts to the President for signature.

FWA: Federalwide Assurance (FWA) for the protection of human rights is the
documentation of an institution’s commitment to comply with federal regulations and maintain policies and procedures for the protection of human research participants.

HHS: The U.S. Department of Health and Human Services (HHS) oversees the Office for Human Research Protections (OHRP) which provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

Initiator: An individual within the Responsible Division who has the responsibility of identifying the need for a new policy, revision, or archival. The Initiator evaluates risk and key personnel or departments affected by the policy, creates necessary forms, and outlines any budget implications.

IRB: The college’s Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

NeSCC: Northeast State Community College (NeSCC)

OHRP: The Office for Human Research Protections (OHRP) provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research to ensure the protection of human research participants.

RAP: Research, Analytics, and Planning (RAP) is the institutional effectiveness/ institutional research office of the college.

Responsible Division: The person or group charged with oversight, development and implementation of policies related to their area of responsibility.

Scope

1. All Northeast State Community College policies are binding for all students, faculty, staff, and visitors unless a policy explicitly states otherwise.
2. This policy does not apply to governance documents, such as the Tennessee Board of Regents (TBR) policies.

Policy

1. Compliance
   
   
   1. Research involving human subjects conducted at Northeast State Community College is subject to reviews, procedures, policies, and regulations, as well as approval and monitoring by the college’s IRB.
   2. The review procedures by the college’s IRB ensure adherence to the regulations for the protection of human subjects in research established by the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) – (45 Code of Federal Regulations Part 46).
   3. The college's application and review procedures regarding research requests are also designed to facilitate meaningful research, maintain consistency in the processing of research applications, and ensure the best interests of the college and its students and employees with an emphasis on complying with the Family Educational Rights and Privacy Act (FERPA) – (20 U.S.C. § 1232g; 34 CFR Part 99).
       
2. Roles and Responsibilities
   
   
   1. Research, Analytics, and Planning (RAP)
      1. The RAP Coordinator is designated as the IRB staff coordinator.
      2. The RAP Coordinator manages the application process and facilitates
         an application’s review among the President’s Cabinet, the college’s IRB, the Office of the Registrar, and the researcher.
      3. The Assistant Vice President for RAP maintains responsibility for relevant federal reporting to the Office for Human Research Protections (OHRP) and for its related Federalwide Assurance (FWA) documentation.
   2. President’s Cabinet
      1. The Cabinet conducts an administrative review of proposed research applications to ensure that research conducted at the college is in the school’s best interests as it relates to being consistent with the college’s mission, does not adversely affect the college’s image and standing, and is suitable given the college’s available resources.
      2. The Cabinet does not address matters of human research protections; this responsibility lies solely with the college’s IRB.
   3. Institutional Review Board (IRB)
      1. Following approval by the President’s Cabinet, the IRB decides whether to approve, deny, or request modifications of research applications as a result of its reviews to ensure human research protections.
      2. The IRB’s structures and operations will be consistent with Health and Human Services (HHS) regulations for the protection of human subjects in research (45 Code of Federal Regulations Part 46).
   4. Registrar
      1. The college’s Registrar reviews proposed research studies and provides approval based on requirements of the Family Educational Rights and Privacy Act (FERPA) – (20 U.S.C. §1232g:34 CFR part 99).
         
         
3. Membership of the IRB
   
   
   1. The IRB will consist of the following members designated by the Assistant Vice President for Research, Analytics, and Planning with approval of the supervising vice president or equivalent:
      1. One member who is from a scientific area of study.
      2. One member who is from a non-scientific area of study.
      3. One member who is not affiliated with the institution.
         Institutional members may be faculty, staff, or students (with no more than one member being a student).
   2. The RAP Coordinator and the Assistant Vice President for Research, Analytics, and Planning will annually review membership of the IRB. This review is to ensure that membership is compliant with federal regulations (45 Code of Federal Regulations Part 46) and that the IRB is sufficiently qualified through members’ experience, expertise, and diversity to be able to review the research activities commonly conducted at the college. The Vice President for Institutional Excellence and Student Success will acknowledge this annual review. Additionally, the Assistant Vice President for Research, Analytics, and Planning will brief the college’s Academic Council each year on the annual review of IRB membership.
   3. Members of the IRB will serve for three-year renewable terms. Members are required to complete prescribed training at the beginning of each service term. The Chair of the IRB, recommended by the IRB membership, also serves a three-year term. Additionally, IRB members are required to review and sign an annual conflict of interest attestation form. No IRB member may participate in the review of a project where there is a conflict of interest except to provide information requested by the IRB. Additionally, the IRB may invite individuals with competence in specific areas to assist in the review of proposed research studies, but those individuals may not vote with the IRB.
   4. Invitations to serve on the college’s IRB typically replace out-going members and/or to ensure the IRB membership is compliant with federal regulations and institutional policy. The Assistant Vice President for Research, Analytics, and Planning and the Chair of the IRB will send invitations to prospective members to serve on the IRB after consulting with the Vice President for Academic Affairs or the relevant vice president/Cabinet member.
      
      
4. Procedures
   
   
   1. Northeast State Community College is not a research institution; however, the college regularly receives requests for permission to conduct research among its students and employees. Persons interested in conducting research at Northeast State Community College are instructed to contact the college’s Office of Research, Analytics, and Planning (RAP) for application procedures.
   2. A proposed research study is first reviewed by the President’s Cabinet, which conducts an administrative review of the application. This administrative review is to ensure that research conducted at the college is in the school’s best interests (see Section II, B, 1 above). The Cabinet does not address matters of human research protections; this responsibility lies solely with the college’s IRB. Approval by the President’s Cabinet does not guarantee approval by the IRB.
   3. If the Cabinet approves the proposed research study based on its administrative review, the application materials will be forwarded to the IRB for its review. If the Cabinet does not approve the proposed research study based on its administrative review, the application will not proceed.
   4. The IRB will decide whether to approve, deny, or request modifications as part of its review to consider human research protections. Following the decision of the IRB, the Assistant Vice President for Research, Analytics, and Planning (or designee) will relay the IRB’s decision regarding the proposed study to the President’s Cabinet.
   5. Additionally, the college’s Registrar will review the proposed research study and provide approval based on requirements of FERPA (20 U.S.C. § 1232g; 34 CFR Part 99).
   6. The RAP Coordinator will communicate the final decisions of the President’s Cabinet and the IRB to the researcher along with the appropriate documentation of the review process.
   7. All decisions by the college’s Institutional Review Board and the President’s Cabinet are final and not subject to appeal.