Institutional Review Board

 

The Institutional Review Board of Cloud County Community College, although not federally registered, adheres to federal guidelines as described in Federal Code of Regulations (45 CFR 46, revised Jan. 2019) to review all “human subjects” related research activities conducted by faculty members, students, staff, or outside researchers using college students, personnel, or facilities. A non-research clearance form is available to document projects that do not meet the definition for research involving human subjects.

 

Membership of the Board is approved by the VPAASS. The Board consists of five members with varying backgrounds, diversity, and expertise. Board membership may expand to include the use of experts, and a non-affiliated member when needed.

 

The IRB has the following responsibilities and authority:

  1. Conducting Initial and Continuing Review of Research and Reporting IRB Findings and Actions to the Investigator and the Institution [45 CFR 46.103(b)(4)(i), 21 CFR 56.108(a)(1)]
  2. Determining Which Projects Require Review More Often than Annually and Determining Which Projects Need Verification from Sources Other than the Investigator that No Material Changes Have Occurred Since Previous IRB Review [45 CFR 46.103(b)(4)(ii), 21 CFR 108(a)(2)]
  3. Ensuring Prompt Reporting to the IRB of Proposed Changes in a Research Activity, andEnsuring that Changes in Approved Research, During the Period for Which IRB Approval Has Already Been Given, May Not be Initiated Without IRB Review and Approval Except Where Necessary to Eliminate Apparent Immediate Hazards to the Human Subjects [45 CFR 103(b)(4)(iii), 21 CFR 56.108(a)(3) and (4)]
  4. Ensuring Prompt Reporting to the IRB, Appropriate Institutional Officials, Any Department or Agency Head, OHRP and FDA of Any Unanticipated Problems Involving Risks to Human Subjects or Others, Any Instance of Serious or Continuing Noncompliance with the Applicable HHS and/or FDA Regulations, or the Requirements or Determinations of the IRB, and Any Suspension or Termination of IRB Approval [45 CFR 46.103(b)(5)(i) and (ii), 21 CFR 56.108(b)(1)(2) and (3)]

All procedures, guidelines, and documents required by researchers can be found on the college IRB website. Questions regarding procedural or regulatory content not included in college IRB documents, will be referred to federal code 45 CFR 46.

 

IRB Membership:

 

Dr. Gwen Carnes, Chair Mathematics gcames@cloud.edu

Beth Whisler Psychology, Counseling, & Guidance bcarlgren@cloud.edu

Dr. Todd Leif Math, Physics, Science Education tleif@cloud.edu

Dr. Abu Hossion Medicinal Chemistry ahossion@cloud.edu

Dr. Bruce Douglas Student Engagement bdouglas@cloud.edu