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Summary of Major Revisions of Policies and Procedures Effective 09/01/09

 

SOP IV

  • Defined "Agents of the Organization"
  • Replaced "incompetent" with "cognitively impaired" (Guardian)
  • Modified definition of "Human Participants" to include VA regulations
  • Defined "Key Personnel"

SOP VII

  • Clarification of the Belmont Report principles - Respect for Persons, Beneficence, Justice (Sec. 4)

SOP 102B

  • Addition of residents, fellows, and graduate students to the education requirements. (Sec. 1) 
  • Removal of information specifc to Norman Campus regarding education requirements and documentation. (Sec. 1.1)

SOP 303C

  • Addition of Privacy Certificate required by NIJ (Sec. 1.3.5)
  • Administrative revisions

SOP 306

  • Revised fee for new project application and included additional fee for continuing reviews. (Sec. 1.1)

SOP 403

  • Clarified reciprocal review information. (Sec. 1.4)

SOP 404

  • Added statement regarding study inactivation requirement. (Sec. 1.4)
  • Administrative revisions

SOP 408

  • Clarified information regarding study closures. (Sec. 1.2)
  • Removed redundant information (Sec. 7.2.1)
  • Administrative revisions

SOP 412

  • New Policy – NCI Central Institutional Review Board

SOP 502E

  • Addition of the legally-effective consent requirement, exceptions to prior IRB approval (Sec. 1.2)
  • Clarification of review process (Sec. 7)
  • Administrative revisions

SOP 502H

  • Included information regarding the Genetic Information Nondiscrimination Act (GINA) (Sec. 1.4)

SOP 502J

  • Removed reference to GCRC and added reference to Privacy Certificate (Sec 1.1)
  • Condensed review process to refer to SOP's. (Sec. 7)
  • Administrative revisions

SOP 602A

  • Clarified role of Compliance Office and HRPP Office (Sec.1)
  • Clairfied Chair of Excecutive Committee (Sec. 7.2)
  • Removed HIPAA form review procedure (Sec. 7.2)

SOP 602E

  • Replaced GCRC Policy with Healthcare Billing Compliance Office

SOP 602I

  • Revised scope to only include radiation procedures performed solely as part of the research (Sec. 2)

SOP 603A

  • Clinical trials funded by the VA can now be reviewed by the VA Central IRB for both OKC and Muskogee's VA's (Sec. 1 & Sec. 2)
  • Addition of confidentiality agreement requirement for the release of IRB meeting minutes to the VA (Sec. 3.1.7)

SOP 701

  • Revised policy to be more consistent with regulations (Sec. B.1.2)
  • Addition of short form information regarding VA research (Sec. 1.8)
  • Signatures of both parents is required for research that involves more than minimal risk without the prospect of direct benefit when both are available (Sec. 1.6.A.2)

SOP 801

  • Clarified responsibilities for investigators holding IND/IDE's (Sec. 1.1.2)
  • Addition of notifying participant when removed from study for non-compliance (Sec. 1.5.9)

SOP 903

  • Reference to Faculty Handbook re: reporting allegations to Senior VP & Provost (Sec. 1)

SOP 1001

  • Addition of privacy official's role and responsibilities regarding the review of privacy issues (Sec. 1)
  • Addition of process details regarding review of privacy issues (Sec. 7.5 - 7.8)

 

 

 

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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