The reviewing IRB is responsible for all IRB actions during the life of the protocol including:

• continuing review;
• review of all protocol amendments;
• review of any unanticipated events;
• handling participant questions and complaints;
• consideration and required review of deviations and noncompliance; and
• closure of the protocol upon completion of the study.

The relying institution remains responsible for ongoing local context review throughout the life of the study. This may include:

• review of protocol amendments if a local context issue is triggered, such as:
  • the amendment requires additional review by an institutional ancillary committee;
  • the amendment involves addition of new research staff that require review of credentials, training, or conflicts of interest;
  • the amendment has implications for local state laws or institutional policies and adherence with regulatory or policy requirements must be addressed;
• coordination with the reviewing IRB for addressing incidents of noncompliance if local institutional research personnel are involved in the possible noncompliance or if the noncompliance results in changes to or termination of the research;
• coordinating with the reviewing IRB to handle local participant questions and/or complaints; and
• maintaining records of institutional research activity (meaning that relying institutions must be aware when the research is completed or otherwise terminated).