This section contains questions that are commonly asked about the Expanded Access Program and the physician’s role and responsibilities in participating.
The Mayo Clinic IRB serves as the central IRB for this study in the United States at the request of the U.S. Government.
To participate, you and your hospital need to rely on the Mayo Clinic IRB for this EAP protocol. In accordance with 45 CFR 46.103(e), agreeing to participate in the program by registering on this website serves as documentation of each participating institution’s reliance on Mayo’s IRB.
A separate IRB reliance agreement is not required. The Mayo Clinic IRB is a nationally recognized IRB that is Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) certified.
Your participation signifies your agreement to rely upon the Mayo Clinic central IRB. We will email you a confirmation of your agreement. You may print the form as your confirmation of agreement for your records.
If you or your hospital have questions about this, email firstname.lastname@example.org.
The sponsor of this Expanded Access Program (EAP) will limit the publication of any partial data collected by any participating treating physician or site without prior written authorization.
With rare exceptions, such authorization will likely come after the sponsor has closed program enrollment, completed the data analysis, and evaluated the final data set for the primary safety outcomes.
The rationale for this approach is that the data being collected under the Convalescent Plasma EAP will be used to assess safety and help guide regulatory decision making. Thus, per FDA guidance, the data should not be subdivided until the sponsor has completed key safety (and to the extent possible) efficacy analyses.