that the research should not be approved for continuation.
Investigators are expected to provide the IRB with all relevant information regarding the conduct of the research. In order to ensure that no material changes occurred during the IRB designated approval period, the IRB may require verification of information from sources other than the investigator. Such independent verification may be considered in the following:
Complex protocols involving unusual levels or types of risks to subjects;
Protocols conducted by Pls who previously have failed to comply with federal regulations or the requirements or determinations of the IRB;
Protocols where concern about possible material changes occurring without IRB approval have been raised based on information provided in continuing review reports or from other sources.
The IRB will determine which projects need verification from sources other than the investigators regarding material changes on a case-by-case basis. When the IRB finds the need for independently verified information, it will notify the investigator in writing. The IRB will not give final approval for a protocol until it has received and reviewed the independently verified information and found it to be satisfactory.
In accordance with federal regulations, the IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less frequently than once per year. The IRB should decide the frequency of continuing review for each study protocol necessary to ensure the continued protection of the rights and welfare of research subjects. The IRB may set a shorter approval period for protocols that they have determined are high-risk or have a high risk to potential benefit ratio. The IRB should consider the following factors in determining the frequency of review: the nature of the study; the degree of risk involved; and the vulnerability of the study subject population.
Continuing review of research must occur at intervals appropriate to the degree of risk but not less frequently than once per year. A lapse in IRB approval of research occurs whenever an investigator has failed to provide continuing review information to the IRB or the IRB has not conducted continuing review and re-approved the research, with or without conditions, by the expiration date of IRB approval. The investigator and IRB should plan ahead to ensure that continuing review and approval of research occurs prior to the end of the approval period specified by the IRB. However, it is the responsibility of investigators to provide in a timely manner the information needed by the IRB to perform