Research Integrity

Research Registration

Those conducting research, under an approved protocol, must apply under one of two processes:

A.    Non Practitioner Application

A Non-practitioner, in the State of Indiana, is anyone that performs research and does not have a practitioner's license. A researcher is classified as a non-practitioner and can only be registered as such. A non-practitioner cannot dispense or write prescriptions with a researcher registration, but can purchase and/or administer a controlled substance. A researcher works under an approved research protocol, which specifies the exact procedures and drugs that may be used.

DOCUMENTATION NEEDED FOR THE NON-PRACTITIONER APPLICATION PROCESS:

  1. Applicant will need to verify their identity by providing their social security number for the DEA application.
  2. Applicants curriculum vitae
  3. Copy of approved IRB, IACUC, and/or IBC protocol letter
  4. One-page summary listing the procedures to be performed using the controlled substance, the types and quantities of drugs to be stored on site specific protocols for monitoring drug usage, inventory control destruction, security, storage, and access, and a research objective: This can be accomplished using the ORI Controlled Substance Registration Protocol Summary Form.
  5. Names of people who will be handling or have access to storage of controlled substance inventory
  6. Any additional documentation that may be requested by the Indiana State Board of Pharmacy or Drug Enforcement Administration

Registration Process:

Step 1: Complete the "Non-Practitioners" application process for the Indiana State Board of Pharmacy Controlled Substance Registration (CSR).

Step 2: Upon State approval, an Indiana Board of Pharmacy compliance officer will inspect the storage facility listed on your application.

Step 3: After you receive your approved Indiana Controlled Substance Registration (CSR), you can initiate the DEA Form 225 application process.

(NOTE: MAKE SURE YOU SELECT FORM 225 (second from the top) WHEN YOU BEGIN THE DEA APPLICATION PROCESS)

B.    Practitioner Application

A practitioner means a physician, dentist, veterinarian, pharmacy, hospital, or other institution or individual licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in the State of Indiana.

Step 1: Complete the "Practioners" application process for the Indiana State Board of Pharmacy Controlled Substance Registration (CSR).

Step 2: Upon State approval, an Indiana Board of Pharmacy compliance officer will inspect the storage facility listed on your application.

Step 3: After you receive your approved Indiana Controlled Substance Registration (CSR), you can initiate the DEA Form 224 application process.