Single IRB & Resource Sharing
The National Dental PBRN Central IRB serves as the single IRB of record for network studies
The National Dental PBRN Central IRB serves as the single IRB of record for network studies. This IRB is based at the University of Alabama at Birmingham. The National Dental PBRN Central IRB was established in September 2014. Its mission is to reduce administrative burden on local institutions and allow for local context review to provide a high level of protection for study participants in network protocols. This Central IRB functions as a single IRB for the network because all studies use this IRB as the single IRB. A Central IRB also is a Single IRB if it serves as the IRB for all of the network’s studies. We have a substantial history with the National Dental PBRN Central IRB, having operated numerous network studies through it. These key advantages have been realized with the National Dental PBRN Central IRB:
- Streamlines the process by providing a centralized review.
- Provides an already-reviewed application and review packet to each region or other relying sites as part of the review for local context considerations.
- Makes the process easier if a protocol amendment or revision has to be made after an initial protocol has already been approved.
- Eliminates the requirement that regional and other relying sites submit annual renewals or amendments to their regional IRBs.
Central IRB Process and Responsibilities
The National Dental PBRN Central IRB Process is in the National Dental PBRN Operational Procedure Manual (NOP). Information outlining the responsibilities of the National Dental PBRN Central IRB, local institutions, local institution IRBs, and local institution PIs is provided in the NOP. The primary responsibility of the local institution in this process is the Local Context Review.
The National Dental PBRN Central IRB has the responsibility of conducting initial review. Additionally, the National Dental PBRN Central IRB has the responsibility to request changes in the protocol and sample informed consent in an effort to improve human subjects protection. The National Dental PBRN Central IRB is responsible for review of the protocol and associated documents including, but not limited to amendments; continuing reviews; recruitment or educational materials intended for use by current or potential study participants; and review of unanticipated problems distributed by the Network Program Manager to local institution PIs.
Transfer of IRB Responsibility to National Dental PBRN Central IRB
Once a local institution has conducted the Local Context Review and the PI has reported it to the National Dental PBRN Central IRB via the Network Program Manager, the National Dental PBRN Central IRB becomes the IRB responsible for that specific protocol. Because the National Dental PBRN Central IRB is responsible for all subsequent reviews, the local institution is relieved of the responsibility to conduct reviews of amendments; continuing reviews; reviews of recruitment or educational materials intended for use by current or potential study participants; and review of unanticipated problems distributed by the Network Program Manager to local institution PIs.
IRB Benefits
Central IRB Process Handbook Overview
A National Dental PBRN Central IRB Process Handbook was developed before the Central IRB was established. The handbook assists local institutions in understanding the purpose of the National Dental PBRN Central IRB and the design of the IRB review model. Information outlining the responsibilities of the National Dental PBRN Central IRB, local institutions, local institution IRBs, and local institution PIs is provided in the handbook, as well as suggestions to consider when incorporating the National Dental PBRN Central IRB Review Process into local institution processes. The primary responsibility of the local institution in this process is the Local Context Review.
The National Dental PBRN Central IRB has the responsibility of conducting initial review. Additionally, the National Dental PBRN Central IRB has the responsibility to request changes in the protocol and sample informed consent in an effort to improve human subjects protection. The National Dental PBRN Central IRB is responsible for review of the protocol and associated documents including, but not limited to amendments; continuing reviews; recruitment or educational materials intended for use by current or potential study participants; and review of unanticipated problems distributed by the Administrative Unit to local institution PIs.
Once a local institution has conducted the Local Context Review and the PI has reported it to the National Dental PBRN Central IRB via the Administrative Unit, the National Dental PBRN Central IRB becomes the IRB responsible for that specific protocol. Because the National Dental PBRN Central IRB is responsible for all subsequent reviews, the local institution is relieved of the responsibility to conduct reviews of amendments; continuing reviews; reviews of recruitment or educational materials prepared by the Administrative Unit and intended for use by current or potential study participants; and review of unanticipated problems distributed by the Administrative Unit to local institution PIs.
The National Dental PBRN complies with the NIH Data Sharing Policy
The policy stipulates that data are shared in a timely manner, defined as no later than the acceptance for publication of the main findings from the final data set. A list of studies for which data collection has ended is provided on the “Studies” tab. Dataset(s) and data dictionaries are maintained by the network and made available after publication of the main findings.
Information about each study is available at the “Studies” tab. The network is currently converting limited data sets to de-identified data sets. If the study in which you are interested does not currently have a de-identified data set posted, please contact the National Network Director, Dr. Gregg Gilbert, and he will ask that de-identification of data from that study be prioritized.
Although not required, the network encourages persons interested in study data to contact Dr. Gilbert, who can link you to network personnel to better inform you about the data and the procedures used for that study.
