Frequently Asked Questions
IRB FREQUENTLY ASKED QUESTIONS
- HOW ARE INVESTIGATIONAL TREATMENTS APPROVED?
All investigational products (medications, devices, or radiopharmaceuticals) must be approved by the Institutional Review Board (IRB) which is a committee consisting of physicians, other professionals, and an individual from the community. Without approval, no investigational product should be used.
- HOW DO YOU KNOW THAT INDIVIDUALS PREPARING, DISPENSING, OR ADMINISTERING AN INVESTIGATIONAL PRODUCT ARE KNOWLEDGEABLE TO DO SO?
The primary investigator is required to educate to all health care professionals involved in the investigational study. Until he or she documents that this has been completed, approval of the study will not be given by the IRB.
- WHAT ELSE MUST BE DONE BEFORE AN INVESTIGATIONAL PRODUCT IS USED IN A PATIENT?
The primary investigator must discuss the protocol with the patient and/or patient’s family and must obtain a consent form.
- WHAT IS THE RESPONSIBILITY OF THE PHYSICIAN AND ANCILLARY PERSONNEL IN AN INVESTIGATIONAL TRIAL?
Primary Investigator or Designee: Obtains consent from patient and administers investigational drugs.
Ancillary Services: Assures appropriate consent on procedures, may witness consent and identify patient.
- WHAT IS NEEDED IF THE HOME MEDICATION IS AN INVESTIGATIONAL DRUG?
The physician must supply a copy of the protocol, drug information, and the signed consent form.