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Summary of Major Revisions of Policies and Procedures Effective 01/15/10

 

SOP IV, Glossary

  • Defined "Prisoners of War in Research”. (Item #142)
  • Defined "Research Involving a Human Being as an Experimental Subject". (Item #158)

SOP VII, Statement of Authority

  • Added statement that the University applies 45 CFR 46, subpart A (the Common Rule) and the Department of Defense (DoD) Directive 3216.02. (Section 5, paragraph 3)
  • States the Senior Vice President and Provosts for each campus have signatory authority for the OHRP FWAs and FWA addendum for DoD research. (Section 6.1.2)

SOP 304, Documentation, Document, and Data Management

  •  Added to the first paragraph concerning records for VA research:(regardless of whether it is approved or cancelled without participant enrollment)”. (Section 1.1.B)
  • Addition of Department of Defense section that states DoD-sponsored research may require submitting records to the DoD for archiving. (Section 1.1.D)

SOP 406, Determination of Human Research

  • First sentence was revised to include “Experimental Subjects” after human participants.   (Section 1)

SOP 412, National Cancer Institute – Central IRB

  • Two new sections were added to SOP 412:
    • The first section pertains to HIPAA and states that compliance with HIPAA regulations are considered local context issues and remain with OUHSC.  (Section 1.5)
    • The second section pertains to Special Populations, specifically Children, Incompetent Adults, and Prisoners. For Children, the CIRB will make the determination whether assent of the child is required and the OUHSC will make the determination on whether and how to document assent.  For Incompetent Adults, CIRB will make the determination whether individuals with impaired decision-making capacity as a category are eligible for a study.  For Prisoners, if an investigator requests enrollment of prisoners on a study, the OUHSC IRB will review the study by the convened IRB since CIRB is not constituted to review studies eligible for prisoners. (Section1.6)

SOP 501, Special Populations

  • Two new sections were added to SOP 501, under 1.1, Prisoners:
    • The first section pertains to VA Research which states that research involving prisoners as participants is not approved unless a waiver has been granted by the Chief Research and Development Officer. (Section 1.1.4)
    • The second section pertains to DoD-sponsored research which states that research with prisoners of war (POW) is prohibited.  It also states that the definitions of prisoners of war for the DoD components are located in SOP IV, Glossary.  (Section 1.1.5)
  • One new section was added under 1.2, Children:
    • This section states that VA Research involving children as participants in not approved unless a waiver has been granted by the Chief Research and Development Officer.  (Section 1.2.9)
  • One new section was added under 1.3, Pregnant Women and Fetuses:
    • This section states that VA research involving pregnant women as participants is not approved unless specific adequate provisions and considerations have been met which includes: 1) monitoring the risks to the participant and the fetus, 2) the manner in which potential participants are selected, and 3) monitoring the consent process.  A complete description of the provisions and considerations are described in Section 1.3.5 of the policy.

SOP 603B, Office for Human Research Protection (OHRP)

  • Added a paragraph which states that the University shall complete a DoD addendum to its FWA when human research is conducted or funded by the DoD.  A reference to SOP 603F, Department of Defense was included. (Section 7.2)

SOP 603F, Department of Defense (DoD)

  • New policy for research conducted or funded by the DoD.  Specific policies describe requirements for multi-site research, survey research, DoD addendum, education, records, research monitor, prisoners of war in research, international populations, U.S. Military Personnel, waiver of consent and provisions for research-related injuries.

SOP 701, Consent Process and Documentation

  • Added a paragraph for DoD research which states DoD components may have stricter requirements than the Common Rule for research-related injuries.  (Section 1.1, A, 2)
  • “The amount and schedule of payments” was added as an AAHRPP requirement under the additional elements of consent. (Section 1.1, A, 3, g)  
  • “The research must not be subject to FDA regulations, as the FDA has no provision for waiver or alteration of consent” was added to the list of examples of research that might quality for a waiver of informed consent. (Section 1.3, B after 4)
  • One new section pertaining to DoD-research was added under 1.3, Waiver of Informed Consent which states that a waiver of consent is prohibited unless a waiver is obtained from the Secretary of Defense when a research participant meets the definition of experimental subject. (Section 1.3, D)

SOP Attachment 801-A, Investigator’s Manual for Research Involving Human Participants

  • Added “Investigators and research staff are required to promptly report non-compliance to the IRB”.  (Non-Compliance Section, page 23)

 

 

Institutional Review Board (IRB) - OU Health Sciences Center
Library Building, Room 176
Phone: 405/271-2045 - Fax: 405/271-1677
IRB@ouhsc.edu

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