Federal Regulations mandate that no research involving human subjects, including enrolling new subjects, conducting interventions, or analyzing subject-identifiable data, may be performed without ongoing IRB approval and no research involving vertebrate animals may be performed without ongoing IACUC approval. If at any time your IRB or IACUC approvals expire for the protocols associated with a project, research involving human subjects and/or vertebrate animals under the expired protocol(s) must be halted and expenses for such research may not be incurred. Failure to observe the policies and procedures governing human subjects research and research with vertebrate animals at UMB will be considered serious misconduct subject to sanctions including possible termination of faculty appointment. The UMB policy for the creation of an account which involves either human subjects or animal subjects requires that an active IRB or IACUC approval be in place at the time the award is processed for an account number. If it is not, in exceptional circumstances ORD may waive that requirement on a case-by-case basis. When can the requirement for IRB/IACUC approval be waived? Under some circumstances, a project involves preliminary work, including protocol development, prior to recruitment and enrollment of human subjects or initiation of research using animals. Review of the file by ORD normally is initiated as the result of a request from the Principal Investigator or the PI’s administrator with an explanation of the special circumstances. If the special circumstances are confirmed by ORD, the award may be processed for an account number; however, the PI and administrator are notified that no expenses may be charged for human subjects research or animal research until the relevant protocol has been approved.
IMPORTANT NOTE: projects involving IRB and IACUC protocols
FAS accounts cannot be established for projects that involve human subjects and/or vertebrate animal use until the pertinent protocols have been fully approved by the IRB and/or IACUC. However, the end date of the FAS account is not related to IRB and IACUC protocol expiration dates.
Multisite clinical trials: Accounts are set up only after IRB approval is obtained. The only activities supported by multisite clinical study agreements are those that involve human subjects. Therefore, regardless of other dates referenced on the contract (signature dates, etc.), the earliest possible date for the account will be the date of IRB approval. Noncompeting continuation years of projects: ORD assumes that IRB/IACUC approval is ongoing and active, but reserves the right to request the approval document. If the approval documentation that ORD has on file clearly has expired prior to receipt/processing of the award notice, ORD requires active IRB/IACUC approval documentation. Temporary accounts: The policy for authorization of temporary accounts with regard to IRB/IACUC approvals is the same as that for processing of awards. Documentation available to ORD: - ORD has electronic access to IRB documentation but only if the protocol number is provided.
- ORD does not have electronic access to IACUC documentation from any of the schools; therefore, upon request, the IACUC document must be provided to ORD by the PI or administrator.
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