DCP: Medical Marijuana Research Program

Medical Marijuana Research Program

 

Who Can Apply?

What Are Appropriate Research Topics?


The Department may approve a program that is intended to increase knowledge or information regarding the growth, processing, medical attributes, dosage forms, administration or use of marijuana to treat or alleviate symptoms of any medical conditions or the effects of such symptoms.

What Is Meant by an “Institutional Review Board”?


An Institutional Review Board (“IRB”), for purposes of the State’s medical marijuana program, means a “specifically constituted review body established or designated by an organization to protect the rights and welfare of persons recruited to participate in biomedical, behavioral or social science research.”  In assessing whether a research program meets the requirement of having IRB oversight, DCP will be guided by the role that IRBs play in federal research programs as set out in 45 CFR 46.  An IRB, however, need not be registered with HHS for DCP approval of a research program.

Do Purely Observational Studies Need to be Registered?

No.  If you will simply be documenting the effects of medical marijuana on registered patients, your research program does not need to be registered with DCP.  If, however, someone other than a registered patient will be using medical marijuana or someone other than a registered caregiver or licensed medical marijuana business will acquire, possess, deliver, transport, distribute or administer medical marijuana for purposes of your research program, it should be registered.    


Step by Step Guide for Obtaining Approval of a Research Program

STEP 1: Obtain DCP Approval of the Research Program

·         Complete the online application.  Click on the icon below to be directed to our licensing website.

  {apply online button}

·         On the application you will be asked to:

o    Identify the lead research institution

o    Identify the lead investigator and any sub-investigators

o    Provide a brief synopsis of the research study that DCP can publish

o    Upload a detailed research protocol

o    Identify the lab you intend to use (if applicable)

o    Upload the informed consent form you intend to use (if applicable)

o    Identify the study duration

o    Identify the maximum number of study participants

o    Identify the members of your institutional review board

o    Upload Curriculum Vitae for the lead researcher(s)

o    Upload your drug disposal protocol

o    Pay the applicable fee of $200

 

STEP 2: Upon program approval, employees should apply for a license

·         Research program employees include all persons, other than research program subjects, who will have access to medical marijuana in connection with the research program, including independent contractors or agents who may be involved with purchasing, transporting, testing, administering or storing medical marijuana.

·         An employee need not apply as a research program employee if such person is already licensed as an employee at a licensed medical marijuana business.

STEP 3: Register research program subjects

·         A physician associated with the research program must:

o    Create an account with the DAS Business Network to access the online registration system.  This is a one-time registration process.

o    Log-in to the DAS system again using the email address and password used to establish the account.

o    Select the “I am a Physician” option and provide the requested identifying information.

o    Select “Add a New Patient.”

o    In the online form identify the “patient” as a “research program subject.”

o    Complete the online application form.

o    This process must be repeated for each research program subject.

·         Provide each research program subject written confirmation that their registration was approved.

·         DCP will not be providing cards to research program subjects, although law enforcement will be able to confirm their status on a secure online system.    

 

 



Content Last Modified on 12/20/2016 2:23:52 PM