Developmental Approval or "118 Designation"
Where human subjects will be used in research, awards will no longer be made prior to IRB approval. This change in procedure will bring us into compliance with 45 CFR 46.103, which states "Under no condition shall research using human subjects be supported prior to receipt of the certification that the research has been reviewed and approved by the IRB".
One exception to this mandate exists in the federal regulations (45 CFR 46.118). Where definite plans for involvement of human subjects is not available at the time of funding, 118 designation may be sought. Whether a project receives 118 designation is at the discretion of the IRB. To request 118 designation, the following procedure should be followed:
Background: Federal funding requires IRB approval prior to funding of an awarded grant or contract. Many times this funding is needed to develop and finalize instruments and procedures for human subject use. This presents a dilemma regarding the responsibility to thoroughly review human subject research submissions. In accordance with 45 CFR 46.118 (and all correlating federal subparts distinct to each "Common Rule" agency), the following procedure is proposed:
Procedure: When a project plans to use human subjects in research, the human subjects field of the IAS should be checked. A Regulatory Compliance Memo is sent to the PI when the grant proposal is processed alerting them to the need for IRB approval before a fund may be established. An IRB application should be submitted with all relevant information known at that time. Please indicate the application is a request for 118 designation and provide a timeline for development of instruments and procedures.
The application will be assigned a docket number. The SPA Administrator will be notified an IRB application has been received. A standardized letter will be sent to the funding agent, if IRB approval has been requested, stating both our adherence to 45 CFR 46.118 and verifying the IRB application has been received and will be reviewed when complete. The file will then be placed in PENDING status. It will not be reviewed or approved with contingencies. When instruments and procedures have been developed, they should be submitted. At that time, an IRB review will occur. No human subjects may be used until IRB approval has been granted. Like all PENDING files, a pending notice will be sent on a quarterly basis reminding the PI that the IRB approval has not been obtained and additional items are needed for review.
Finding of non-compliance: If a PI is found to be conducting human subject research without obtaining IRB approval, the IRB Chair, the Regulatory Compliance Officer and the Director of Sponsored Programs will be alerted immediately. A proper course of action will be pursued and could include the halting of all funds and research associated with the project.
Approved by the IRB, August 10, 2000
Any questions regarding these changes should be directed to Christine Williams, IRB Administrator at 325-5220 or email@example.com.