Supplemental documents must accompany an application to the IRB. The types of supplemental documents necessary will become apparent, as the application is completed by the investigator. One or more of the following supplemental documents will be needed:
Research project protocol: A research project protocol must be submitted at the time of a new application. Normally, this will be a grant application prepared by the Principal Investigator for submission to either an external funding source or to PCC. Occasionally it might be a device study protocol prepared by the manufacturer or inventor of the device.
Manufacturer information on devices if they have an impact on human subject protection must be submitted to the IRB. Generally, such a document is made available by the manufacturer in conjunction with a clinical trial to be performed at PCC. In the case of an investigator-initiated trial, or of an “in-house” developed product, the investigator must prepare the document to provide the IRB with technical information sufficient to judge the benefits and risks involved with the use of the product.
Text of written informed consent documents: The text of the document must contain all of the necessary elements for informed consent as described in this Guideline and contained in the College policy on the protection of human subjects from research risk.
More than one written informed consent document may have to be used in conjunction with some research projects, depending on the specific information to be given the individual groups of research subjects, and legal requirements. For example, in project involving healthy volunteer subjects as well as patients, the information given for each group may differ substantially. Another example is if the patients to be studied include both adults and children. This might occur if the investigator is studying asthma. In the case of children, the documents would differ in that consent would b given by the parent or legal guardian. The written consent documents must be submitted to the IRB for review and approval.
Text of oral informed consent: The verbatim text is to be prepared as a condensed version of a written consent document. It must be submitted to the IRB for review an approval.