Updates to IRB Standard Operating Procedures and UI, VA, and DoD Researcher Guidance

The Human Subjects Office has made a number of revisions to IRB standard operating procedures and guidance materials.  A track change and clean version of the guidance materials are now available for review.  The majority of the changes are as a result of feedback from the University of Iowa Human Research Protection Program reaccreditation review. 

Updates to Section I, Part 3.B. are as a result of ongoing work with the University of Iowa Office of the Registrar clarifying University of Iowa policy regarding the human subjects research use of student data categorized under the Family Educational Rights and Privacy Act (FERPA). Stay tuned for a presentation this fall regarding the FERPA related updates. 

Please carefully review all updates to determine if they apply to your research. A summary of the changes for each SOP/Guide include:

UI IRB Standard Operating Procedures & Researcher Guide

• Section I changes:
  • 2.H.iv  VA Research Compliance Officer (VA RCO): clarification of RCO role
  • 3.B.i  Family Educational Rights and Privacy Act (FERPA) all NEW subsections
    • 3.B.ii Access to Education Records for Research Purposes
    • 3.B.iii Obtaining Consent to Access Records for Research Purposes
    • 3.B.iv Use of Electronic Signatures
    • 3.B.v Subject Recruitment 
    • 3.B.vi Access to Educational Records for Research Purposes Without Obtaining Consent  
  • 7.H Department of Justice (DOJ)\National Institutes of Justice (NIJ): Funder expectations for research with NIJ funding
  • 7.J Department of Energy (DOE): Funder expectations for research with DOE funding.
  • 9.C  IRB Determinations Requiring Reporting: IRB reporting requirements for studies under IRB-03
  • 9.C.ii Noncompliance Investigations and Actions: IRB reporting requirements for studies under IRB-03
  • 9.C.ii.a Allegations of Noncompliance: IRB reporting requirements for studies under IRB-03
  • 9.C.iii  Review of Unanticipated Problems Involving Risk to Subjects of Others: IRB reporting requirements under IRB-03
  • 10.B.ii.b Suspension or Termination of IRB Approval: IRB reporting requirements under IRB-03
  • NEW: Part 24: Periodic Evaluation of the Human Research Protection Program: explanation of periodic HRPP review
• Section II changes:
  • 9.D.v Emergency Settings: Research in the Emergency Setting (Planned Emergency Research): DoD clarification regarding emergency research
  • 23: Record Retention Requirements: clarification regarding record retention requirements for research following full ICH-GCP

VAHCS (IRB-03) Researcher Guide Changes:

• 5.A.i Exempt Approval: clarification of limited IRB review for certain exemption categories of review
• 8.E.ii Collaborative Research responsibilities when the Iowa City VAHCS is involved: required disclosures when the VAHCS is involved in collaborative research
• 9.D.vi.a Exemption from Prospective IRB Approval: clarification emergency use of a test article does not require R&D approval
• 11.B  The Full Informed Consent Process: VA requirements when using a survey research firm
• 18.A.i Consent materials: expectation of documenting how the consent process will be presented in the IRB application

Department of Defense (DoD) Researcher Guide Changes:

• 1. Required Review(s) by the DoD Human Research Protection Office or Other DoD Component: DoD expectations for research subject to DoD review
• 8. Prohibited Research: update for consistency with University of Iowa policy manual 27.2(b)
• 10. Vulnerable Populations: DoD expectations when research involves pregnant women and when a subject becomes incarcerated
• 14. Research Monitor: removal of the requirement for a medical monitor 
• 15. Military Participants: additional DoD requirements for DoD affiliated personnel enrolled in research studies