What's New

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)