Please note that E & I does not control and cannot guarantee the relevance, timeliness, or accuracy of these outside materials.

Oklahoma

State Legal Structure: Comply w/ Fed. Regulations

Required Notification to State Officials: The IRB affiliated with OK DOH must, in certain circumstances, review research protocols

Protocol Requirements: Comply w/ Fed. Regulations

Legal Rep. Standards: Incapacitated adults the following will take authority. 1.Spouse 2.adult child 3.parent 4.Adult sibling 5.Adullt relative by blood or marriage

Age of Consent: 18-married minors, emancipated, or minor parents may consent

Informed Consent Requirements: Comply w/ Fed. Regulations

IRB Requirements: Clients & staff of the OK DOH may not enroll w/out the OK state IRB approval unless the outside IRB receives approval from OK DOH

Special Rules for Cancer Research: None Specified

HIV/AIDS Testing: All data that identify any person who has or may have an communicable or venereal disease shall be confidential

Payments to Subjects: None Specified

Drug Supply Requirements: None Specified

Genetic Testing: Written ICF is required before testing

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: None Specified

Phases Covered: None Specified

Organization Approved to Conduct: None Specified

Specific Conditions of CT Coverage: None Specified

Mandates for Coverage of Off-Label Rx: Individual & Group insurers AND managed care insurers are required to provide coverage, IF they provide coverage for prescription drugs in general

Medically Necessary Services: Medically Necessary Services Covered

Experimental or Contraindicated Rx NOT Covered: No Restrictions

Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified

State Codes & Links:

All codes can be found at

http://www.ok.gov/3167/3512/3384/3389/

&

http://www.oar.state.ok.us/oar/codedoc02.nsf/frmMain?OpenFrameSet&Frame=Main&Src=_75tnm2shfcdnm8pb4dthj0chedppmcbq8dtmmak31ctijujrgcln50ob7ckj42tbkdt374obdcli00_