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 New Drug (IND) will include a protocol and an Investigator's Brochure. FDA regulations [21 CFR 312.23 (a)(5)] state that an Investigator's Brochure must contain the following information:
- A brief description of the drug substance and the formulation, including the structural formula, if known.
- A summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.
- A summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans.
- A summary of information relating to safety and effectiveness in humans obtained from prior clinical studies. (Reprints of published articles on such studies may be appended when useful)
- 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 review and 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 document summarizing any changes in eIRB by submitting a Further Study Action, Change in Research activity. When applicable, revised consent forms that reflects the updated information must be uploaded in eIRB for IRB review. The IRB P&T Liaison will review the noted information in the revised brochure, and the IRBs will review any recommended changes in the study based on new information. The outcome of the review will be communicated to the Principal Investigator (PI).
If an Investigator's Brochure is revised for administrative reasons only (i.e., information unrelated to the items listed above under (1) - (5) above), the IRB will accept the revised brochure with an explanation from the PI that states:
"I have reviewed the revised Investigator's Brochure and believe that the risk-to-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(s)."
The PI of record for the study must upload the above explanation in the eIRB Further Study Action, Change in Research activity. The JHM IRB will acknowledge administrative revisions to brochures that are submitted with the above explanation.