Administrative Policies

KCTCS Human Research Protection Program

1. Purpose

This policy establishes KCTCS’ Human Research Protection Program (HRPP), which promotes adherence to foundational ethical principles and ensures compliance with applicable federal regulations.

2. Scope

This policy applies to all KCTCS students, faculty, and staff, as well as non-KCTCS personnel conducting research in which KCTCS students, faculty, or staff are subjects.

3. Policy

1. KCTCS will ensure that all human subjects research conducted by or on students, faculty, or staff adheres to the foundational ethical principles established in the 1979 Belmont Report: respect for persons, beneficence, and justice.
   1. Respect for persons incorporates the ethical convictions that individuals should be treated as autonomous agents and that persons with diminished autonomy are entitled to protection. In nearly all cases, human subjects must participate in research voluntarily and with adequate information – informed consent. Human subjects research involving minors, justice-involved individuals, or other vulnerable populations may require additional protections.
      
      
   2. Beneficence in human subjects research is understood as an obligation to do good. Two general rules have been formulated as complementary expressions of beneficence: doing no harm and maximizing possible benefits while minimizing possible harms. The obligations of beneficence affect investigators, human subjects, and society at large.
      
      
   3. Justice seeks to ensure the burdens and benefits of human subjects research are fairly distributed. Human research subjects should not be selected based solely on ease of availability, compromised position, or manipulability. Finally, the results of human research should benefit members of the groups from which subjects were drawn.
      
      
2. KCTCS will adhere to Code of Federal Regulations (CFR) 45, Part 46, Subpart A, “Federal Policy for the Protection of Human Subjects,” also known as the “Common Rule,” which:
   1. Defines essential terms, including but not limited to, “human subject,” “institutional review board” (IRB), “minimal risk,” and “research” (45 CFR 46.102).
      
      
   2. Provides standards for institutions to determine whether research is exempt from the provisions of Common Rule (45 CFR 46.104).
      
      
   3. Sets requirements for IRB membership (45 CFR 46.107), operations (45 CFR 46.108), reviews (45 CFR 46.109), expedited reviews (45 CFR 46.110), approvals of research protocols (45 CFR 46.111), suspension of approval (45 CFR 46.113), and maintenance of records (45 CFR 46.115).
      
      
   4. Establishes general requirements for informed consent (45 CFR 46.116) and documentation thereof (45 CFR 46.117).

4. Responsible Parties

1. The Chancellor will appoint a qualified Human Subjects Administrator, who will:
   1. Serve as the point of contact for human subjects research inquiries and signature authority for appropriate institutional documents (e.g., reliance agreements).
      
      
   2. Maintain and update KCTCS’ human subjects research policies, procedures, and processes based on feedback, best practices, and new federal requirements.
      
      
   3. Appoint, oversee, and serve as an ex officio member of KCTCS’ IRB.
      
      
   4. Complete National Institute of Health-approved training on human research protection within 30 days of appointment.
      
      
   5. Recommend to the Chancellor and General Counsel research protocols that merit additional review prior to or at the time of approval by the IRB.
      
      
2. The General Counsel will appoint a Human Subjects Legal Advisor, who will:
   1. Provide legal advice on human subjects research to the Human Subjects Administrator, IRB members, staff, investigators, and subjects.
      
      
   2. Maintain KCTCS’ Federal-wide Assurance (FWA) with the Department of Health and Human Services.
      
      
   3. Serve as an ex officio member of KCTCS’ IRB.
      
      
   4. Complete National Institute of Health-approved training on human research protection within 30 days of appointment.
      
      
   5. In collaboration with the Human Subjects Administrator, IRB Chair, and/or other IRB Members, determine whether proposed research is exempt from IRB approval in accordance with 45 CFR 46.104 within one week of receiving a complete submission.
      
      
3. KCTCS faculty, staff, and students will:
   1. Submit all proposed human subjects research – as defined by 45 CFR 46.102(e) and (l) – to the IRB for review prior to initiation.
      
      
   2. Conduct all human subjects research in accordance with IRB-approved protocols.
      
      
   3. Request the IRB's permission to modify research prior to making changes to approved protocols.
      
      
   4. Request the IRB’s permission to renew a protocol if data collection will continue beyond the approved dates.
      
      
   5. Maintain records as required by all KCTCS human subjects protection policies, procedures, and approvals.

5. Institutional Review Board

1. IRB Purpose. The IRB reviews research protocols to ensure their compliance with the principles of the Belmont Report and the ethical obligations established in the “Common Rule.”
   
   
2. IRB Organization. The IRB will:
   1. Consist of at least six members: a minimum of four appointed members with varying backgrounds, including at least two faculty and two staff, plus two ex officio members.
      
      
   2. Appoint members for staggered terms of two years (August-July), with the possibility of one reappointment. Initially, one faculty member and one staff member will be appointed for terms of one year (August-July), to establish the staggered schedule.
      
      
   3. Appointed members will provide evidence of completing National Institute of Health-approved training on human research protection to the Human Subjects Legal Advisor within 30 days of appointment.
      
      
   4. Elect a Chair annually from the appointed members.
      
      
3. IRB Operations. The IRB will:
   1. Operate independently and free from all other interests.
      
      
   2. Meet at least once a year, no later than ten working days after classes start, to elect a chair, review this policy and its associated procedure, and agree upon review processes.
      
      
   3. Review submissions on a rolling basis, within timelines prescribed in this paragraph.
      
      
   4. Establish, update, and post submission forms and review processes on a public website.
      
      
   5. Support the Human Subjects Legal Advisor, as requested, in determining whether proposed research is exempt from IRB approval in accordance with 45 CFR 46.104 within one week of receiving a complete submission.
      
      
   6. Conduct expedited reviews of new submissions, as appropriate, and approve, deny, or require modifications within two weeks of receiving a complete submission.
      
      
   7. Conduct full reviews of new submissions, as appropriate, and approve, deny, or require modifications within four weeks of receiving a complete submission.
      
      
   8. Review proposed changes to previously approved human subjects research, approving, denying, or requiring modifications within two weeks of receiving a complete submission.
      
      
   9. Review active research protocols previously approved through the full process annually. (Protocols approved through the expedited process and projects in which data collection has concluded are exempt from continuing review.)
      
      
   10. Investigate allegations of noncompliance with KCTCS human subjects research policies, procedures, or processes. In cases where corrective action is necessary, issue appropriate sanctions, including but not limited to requiring changes to approved protocols, prohibiting the use of collected data in publications, withdrawing approval, disqualifying investigators from conducting human subjects research at KCTCS, and recommending further actions to the KCTCS administration. Report all such instances to the Chancellor and General Counsel.
       
       
   11. Collaborate with Marketing to promote awareness and provide information about the Human Research Protection Program to KCTCS students, faculty, and staff.
       
       
   12. Maintain records in accordance with 45 CFR 46.115.

6. Procedure

Administrative Procedure 1.8.2.3.2-P Human Research Protection Program implements this policy.