June 2004 Research protocols developed by industry often involve development and testing of Investigational New Drugs (INDs). The proposal developed by an industry sponsor to test an investigational agent will include a protocol and an Investigator's Brochure. FDA regulations [21 CFR 312.23 (5)] state that an Investigator's Brochure must contain the following information:
1. A brief description of the drug substance and the formulation.
2. A summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.
3. A summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans.
4. A summary of information relating to safety and effectiveness in humans obtained from prior clinical studies.
5. A description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or with related drugs, and or precautions or special monitoring to be done as part of the investigational use of the drug.
Applications for IRB approval must include a copy of the most current Investigator's Brochure from the sponsor. The content of the Investigator's Brochure may change during the course of the study, and the sponsor will issue a new brochure to investigators. Sponsors expect investigators to submit the revised brochures to the IRB as they are issued. The IRBs require submission of the revised brochure with a covering letter to an explain any changes in (i) to (v) above and,when applicable, a revised consent form(s) to reflect updated information. The IRB P&T Liaison will be able to review the noted information in the revised brochure, and the IRBs will review any recommended changes in the study based on new information and communicate the outcome of the review to the principal investigator. If an Investigator's Brochure is revised for administrative reasons only (i.e., information unrelated to the items listed above under (i) - (v) above), the IRB will accept the revised brochure with a covering letter that states: "I have reviewed the revised Investigator's Brochure and believe that the risk: benefit ratio remains acceptable to continue the study in its current configuration. Further, I believe the information in the revised brochure does not require a change in the protocol or the consent form." The principal investigator of record for the study must sign this letter. The JHM IRBs will acknowledge administrative revisions to brochures that are submitted with the cover letter. Questions regarding submission of Investigator's Brochures may be directed to the Associate IRB Managers.
| 
