Subject: Knowledge of Local Research Context

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to obtain sufficient knowledge of the local research context to fulfill its responsibilities under its FWA, regardless of the geographical location of the research.

1. Mayo Clinic's IRB must fulfill the responsibilities under the regulations and its FWA ^[1] with the Federal government to ensure that the IRB has sufficient knowledge of local context of the research regardless of its geographical location. ^[2]
2. When Mayo Clinic's IRB is either geographically removed from the site in which the research will be conducted, the Mayo Clinic IRB is serving as another institution's IRB of Record, or when the research involves a distinct subject population, the IRB must demonstrate that it has obtained the necessary information about the local research context through compliance with required standards.
   1. When the IRB expands or limits its jurisdiction through the use of an Authorization Agreement ^[3] or Cooperative Research Project,^[4] Mayo Clinic's IRB has a responsibility to ensure that the particular characteristics of the local research context are considered either:
   2. 1. Through knowledge of the local research context by the reviewing IRB; or
      2. Through subsequent review by appropriate designated institutional officials, such as the Chairperson and/or other members of its local IRB.

^[1] Mayo Clinic's Federalwide Assurance

^[2] 45 CFR 46.103(d), OPRR Guidance Dated August 1998 and July 2000

^[3] OHRP Website - Assurances

^[4] IRB Policy I.A