If subjects are to be solicited through advertising, a copy of the ad must be submitted to the IRB for approval. For studies involving multiple sites, report the number of subjects at Oklahoma Health Center sites, and specify how many will be studied on an inpatient or an outpatient basis. Early Termination Criteria Methods and Procedures Describe in detail research procedures involving human subjects. The IRB must have sufficient information to determine that procedures are consistent with sound research design and do not unnecessarily expose subjects to risk. The IRB must have sufficient information to determine that the safety and the privacy of subjects will be protected, and that procedures will yield meaningful research findings to justify the use of human subjects.
References Provide a list of references which support the protocol.
The IRB is responsible for ensuring the equitable selection of research subjects and therefore must review methods that investigators use to recruit subjects. Prior IRB approval is required for all print, radio and television advertisements. For clinical trials, no claims should be made either explicitly or implicitly that the drug or device is safe or effective for the purposes under investigation or that the drug or device is in any way equivalent or superior to any other drug or device. Such representation is misleading and in violation of FDA's regulations concerning the promotion of investigational drugs and devices. Press releases which include any phone numbers or imply solicitation for enrollment must also be approved by the IRB prior to publication.