Common IRB questions
Investigational products should not be used without IRB approval. The principal investigator is responsible for educating involved healthcare professionals, and protocol discussion and consent must happen before investigational use.
- All investigational products, including medications, devices, and radiopharmaceuticals, must be approved by the IRB before use.
- The IRB is described as a committee consisting of physicians, other professionals, and an individual from the community.
- The principal investigator must educate all healthcare professionals involved in the investigational study before approval is given.
- Before an investigational product is used in a patient, the principal investigator must discuss the protocol with the patient or family and obtain consent.
- The principal investigator or designee obtains consent and administers investigational drugs.
- Ancillary services assure appropriate consent on procedures, may witness consent, and identify the patient.
- For a home medication that is investigational, the physician must supply the protocol, drug information, and signed consent form.