Policies Concerning Drugs for Research Use

Policies Concerning Drugs for Research Use
Both Children's and UA Hospital have policies and procedures regarding the storage and distribution of drugs (INDs and FDA-approved drugs) to be used in research on humans.

Children's of Alabama and Use of Drugs for Research

All research conducted at Children's involving dispensing of drugs to human participants must be registered with the Children's Department of Pharmacy (1600 7th Ave. S.). Medications provided by the study sponsor are defined as study drugs, and all study drugs dispensed to participants who are seen at Children's must be stored at and dispensed from the Children's pharmacy. Questions may be directed to the Pharmacy Department at 939-9718 or 939-5918 (Investigational Study Pharmacist). Before applying for IRB approval, investigators should complete The Children's Release of Drugs for Human Research Use and submit it to the Children's Department of Pharmacy. Attach a copy of the form, signed by the investigator and Children's Pharmacy Director, when submitting the Human Subjects Protocol for IRB review.

UAB, University of Alabama Hospital, and Use of Drugs for Research

All research conducted at UAB involving dispensing of drugs to human participants requires that the drugs be registered with the Department of Pharmacy and the Pharmacy and Therapeutics Committee. One purpose of this policy is to insure that there is a central location in the hospital where information can be obtained regarding any drugs being used for research purposes in the hospitals and clinics. Second, the policy is intended to provide the Principal Investigator with the procedures relating to the storage and distribution of drugs in order to improve efficiency and accuracy. Hospital policy states that all drugs for patient research use within the University of Alabama Hospital shall be stored and dispensed from the Pharmacy. Investigators planning drug studies are asked to contact the Drug Communication Division, Department of Pharmacy (extension 4-2162) for a complete copy of the policy and to make arrangements for the proper storage and distribution of the drugs. A copy of the complete research protocol must be delivered to the Department of Pharmacy. The release form will be signed once arrangements for receipt, storage, and dispensing of the drug have been agreed upon. A standard fee for services will be charged either to patient-participants or to appropriate grant funds. The Pharmacy Department may be reached at 934-2162 for further information. The Release of Drugs for Human Research Use (UAB), when signed by the Director of the Department of Pharmacy, signifies adherence to these policies. The signed release form is a prerequisite for IRB review.

Page updated: May 8, 2013