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Last modified March 2, 2009.

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Maryland

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: An Appointed guardian, Spouse, Adult child, parent, adult sibling, close friend

         

Age of Consent: 18-minors who are married, are parents. 16+ can consent for mental health

         

Informed Consent Requirements: Comply w/ Fed. Regulations

         

IRB Requirements: Upon request & w/in 30 days of an IRB meeting, minutes must be available for inspection. IRB may redact any PHI before disclosure

         

Special Rules for Cancer Research: Insurance requirements only, see insurance section

         

HIV/AIDS Testing: Labs report findings of HIV/AIDS to DOH. Info includes a system of HIV code numbering to not use PHI. Test results can't be disclosed through the mail, phone, or any other type of electronic communication. Counseling must be available

 

Payments to Subjects: Insurers, non-profit health service plans, & HMO's are required to reimburse costs for CT's if therapeutic, prevention, or early detection of cancer.

         

Drug Supply Requirements: Sponsors must obtain a signed agreement from PI stating that the PI is responsible for subject & will not supply drug to any other person

 

Genetic Testing: ICF (written) is required before info can be disclosed.

 

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: Managed care and individual and group insurers required to provide coverage

         

Phases Covered: All (1-4)

         

Organization Approved to Conduct: FDA, NCI & VA ONLY. NIH & DOD is NOT

         

Specific Conditions of CT Coverage: Personnel providing treatment are doing so within their scope of practice, experience, and training AND no clearly superior, non-investigational treatment exists AND data provide a reasonable expectation that the treatment will be at least as efficacious as a non-investigational treatment.

 

Mandates for Coverage of Off-Label Rx: Have enacted off-label drug use laws that do not explicitly address cancer treatment, instead they refer to life-threatening conditions or generic off-label indications

 

Medically Necessary Services: None Specified

 

Experimental or Contraindicated Rx NOT Covered: None Specified

         

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

         

State Codes & Links:

All codes can be found at

http://www.dsd.state.md.us/comar/AnnotIndex.htm

 

 

Last Updated ( Wednesday, 16 September 2015 14:42 )