Institutional Responsibilities for Research Supported by the Department of Defense - duplicate - duplicate

• Institution ID #

• WIRB Protocol #

• PI

• Date Monitored

  Date

• Monitor

  Anne Alberhasky, BS, CIP

  Therese Barenz, BSN, CCRC, CIP

  Sarah Heady, BS

  Cena Jones-Bitterman, MPP, CIP

  Kelly O'Berry, BS, CIP

• Chair of Record

  Select Herb Berger, MD J. Andrew Bertolatus, MD Dixie Ecklund, RN, MSN, MBA John Wadsworth, PhD Janet Williams, PhD, RN, FAAN Catherine Woodman, MD

  • Herb Berger, MD
  • J. Andrew Bertolatus, MD
  • Dixie Ecklund, RN, MSN, MBA
  • John Wadsworth, PhD
  • Janet Williams, PhD, RN, FAAN
  • Catherine Woodman, MD

• Study Title

• Was this study reviewed by UI IRB-01, IRB-02, or IRB-03?

  Yes

  No

Institutional Responsibilities

• This institution assures it shall comply with the following laws, regulations, and guidance when conducting, reviewing, approving, overseeing, supporting, or managing DoD-supported research with human subjects.

• Has the Institution complied with the following assurances?

  Yes

  No

• The Belmont Report

  Yes

  No

• Title 32 Code of Federal Regulations Part 219 (32 CFR 219), Department of Defense Regulations, "Protection of Human Subjects"

  Yes

  No

• Title 45 Code of Federal Regulations Part 46, (45 CFR 46) Department of Health and Human Services Regulations, "Protection of Human Subjects", Subparts B, C, and D as made applicable by DoDD3216.02

  Yes

  No

• Title 21 Code of Federal Regulations 50, 56, 312, 812, Food and Drug Administration (FDA) Regulations

  Yes

  No

• DoD Directive (reissued Nov. 2011 as DoD Instruction (DoDI)) 3216.02, "Protection of Human Subjects and Adherence to Ethical Standards in DoD-supported Research"

  Yes

  No

• Title 10 United States Code Section 980 (10 USC 980), "Limitation on Use of Humans as Experimental Subjects"

  Yes

  No

• DoDD 3210.7, "Research Integrity and Misconduct"

  Yes

  No

• DoDD 6200.2, "Use of Investigational New Drugs in Force Health Protections"

  Yes

  No

• Comments

  Yes

  No

• Comments

• Findings

  Yes

  No

• Findings

Finding

Institutional Responsibilities (DoN Addendum to the DHHS FWA)

• Has the IO, IRB and/or investigator complied with the following requirements?

  Yes

  No

• Initial and continuing research ethics education and for all personnel who conduct review, approve, oversee, support, or manage human subjects research

  Yes

  No

• Written determination by a designated institutional official (other than investigators) whether research meets criteria for exemption

  Yes

  No

• New research and substantive amendments to approved research shall undergo scientific review prior to ethics (IRB) review

  Yes

  No

• Additional protections for military research subjects to minimize undue influence

  Yes

  No

• Provisions for research-related injury

  Yes

  No

• Requirements for reporting unanticipated problems, adverse events, and research related injury

  Yes

  No

• Appointment of a Medical Monitor

  Yes

  No

• Additional safeguards for research conducted with international populations

  Yes

  No

• Additional protections for pregnant women, prisoners, and children

  Yes

  No

• Limitations on research where consent by legally authorized representatives is proposed

  Yes

  No

• Limitation on exceptions from informed consent in emergency medicine research

  Yes

  No

• Limitations on dual compensation for U.S. military personnel

  Yes

  No

• Additional review for DoD-sponsored survey research or survey research within DoD

  Yes

  No

• Addressing and reporting allegations of non-compliance with human research protections

  Yes

  No

• Addressing and reporting allegations of research misconduct

  Yes

  No

• Procedures for addressing conflicting and competing interests

  Yes

  No

• Prohibition of research with prisoners of war (POW) and detainees

  Yes

  No

• Provisions for research with human subjects using investigational test articles (drugs, device, and biologics)

  Yes

  No

• Record keeping requirements

  Yes

  No

• Oversight by the sponsoring DoD Component (which may include DoD Component review of the research and site visits

  Yes

  No

• Comments

  Yes

  No

• Comments

• Findings

  Yes

  No

• Findings

Finding

Institutional Responsibilities

• This institution assures it shall comply with the following laws, regulations, and guidance when conducting, reviewing, approving, overseeing, supporting, or managing DoD-supported research with human subjects.

• Has the Institution complied with the following assurances?

  Yes

  No

• The Belmont Report

  Yes

  No

• Title 32 Code of Federal Regulations Part 219 (32 CFR 219), Department of Defense Regulations, "Protection of Human Subjects"

  Yes

  No

• Title 45 Code of Federal Regulations Part 46, (45 CFR 46) Department of Health and Human Services Regulations, "Protection of Human Subjects", Subparts B, C, and D as made applicable by DoDD3216.02

  Yes

  No

• Title 21 Code of Federal Regulations 50, 56, 312, 812, Food and Drug Administration (FDA) Regulations

  Yes

  No

• DoD Directive (reissued Nov. 2011 as DoD Instruction (DoDI)) 3216.02, "Protection of Human Subjects and Adherence to Ethical Standards in DoD-supported Research"

  Yes

  No

• Title 10 United States Code Section 980 (10 USC 980), "Limitation on Use of Humans as Experimental Subjects"

  Yes

  No

• DoDD 3210.7, "Research Integrity and Misconduct"

  Yes

  No

• DoDD 6200.2, "Use of Investigational New Drugs in Force Health Protections"

  Yes

  No

• Comments

  Yes

  No

• Comments

• Findings

  Yes

  No

• Findings

Finding

Institutional Responsibilities (DoN Addendum to the DHHS FWA)

• Has the IO, IRB and/or investigator complied with the following requirements?

  Yes

  No

• Initial and continuing research ethics education and for all personnel who conduct review, approve, oversee, support, or manage human subjects research

  Yes

  No

• Written determination by a designated institutional official (other than investigators) whether research meets criteria for exemption

  Yes

  No

• New research and substantive amendments to approved research shall undergo scientific review prior to ethics (IRB) review

  Yes

  No

• Additional protections for military research subjects to minimize undue influence

  Yes

  No

• Provisions for research-related injury

  Yes

  No

• Requirements for reporting unanticipated problems, adverse events, and research related injury

  Yes

  No

• Appointment of a Medical Monitor

  Yes

  No

• Additional safeguards for research conducted with international populations

  Yes

  No

• Additional protections for pregnant women, prisoners, and children

  Yes

  No

• Limitations on research where consent by legally authorized representatives is proposed

  Yes

  No

• Limitation on exceptions from informed consent in emergency medicine research

  Yes

  No

• Limitations on dual compensation for U.S. military personnel

  Yes

  No

• Additional review for DoD-sponsored survey research or survey research within DoD

  Yes

  No

• Addressing and reporting allegations of non-compliance with human research protections

  Yes

  No

• Addressing and reporting allegations of research misconduct

  Yes

  No

• Procedures for addressing conflicting and competing interests

  Yes

  No

• Prohibition of research with prisoners of war (POW) and detainees

  Yes

  No

• Provisions for research with human subjects using investigational test articles (drugs, device, and biologics)

  Yes

  No

• Record keeping requirements

  Yes

  No

• Oversight by the sponsoring DoD Component (which may include DoD Component review of the research and site visits

  Yes

  No

• Comments

  Yes

  No

• Comments

• Findings

  Yes

  No

• Findings

Finding

Institutional Responsibilities (DoD Institutional Agreement)

• Has the IO complied with the following requirements?

  Yes

  No

• Ensure that all institutional personnel involved in the research (covered within the scope of this agreement) have completed education and training requirements

  Yes

  No

• Verify that scientific review of the research protocol has been conducted and that the IRB considered the feedback from the scientific review

  Yes

  No

• Verify that the IRB has reviewed the research protocol in accordance with DoD requirements, including those identified in the research contract or agreement

  Yes

  No

• Ensure institutional personnel comply with the requirements and oversight established by the IRB

  Yes

  No

• Ensure institutional personnel follow the approved research protocol

  Yes

  No

• Ensure institutional personnel report to the IRB and DoD:

  Yes

  No

• -Unanticipated problems involving risks to subjects or others
  -Serious of continuing non-compliance
  -Suspension or termination of IRB approval and
  -Any other events or circumstances requiring notification

• Ensure institutional personnel maintain current copies of the IRB approved research protocol (initial review, continuing review, amendments, adverse event reports, and final report), all communications with the IRB, this Agreement, and other relevant information in accordance with DoD record keeping requirements

  Yes

  No

• Verify the IRB has the expertise, policies, and procedures needed to review and oversee the research submitted by the institution (in accordance with 32 CFR 219.107, 103(b)(3) and (4) and 115)

  Yes

  No

• Comments

  Yes

  No

• Comments

• Findings

  Yes

  No

• Findings

Finding

Signatures

• I have reviewed the information provided on this checklist.

• IRB Chair/HSO Executive Director

• Institutional Official University of Iowa

• Does the VA participate in oversight?

  Yes

  No

• Institutional Official Iowa City VA Healthcare System