FaceBase Biorepository: Overview

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Presentation transcript:

FaceBase Biorepository: Overview Goal: To create a biorepository of samples from patients with craniofacial anomalies to serve as a resource for investigators studying these disorders Collect biological samples and data from 5,000 individuals International database for sample management and distribution

FaceBase Biorepository: Methods Recruit and Enroll participants Collect biological samples and data Pedigree Medical history Pregnancy history (teratogenic exposures) Pictures Recruitment: networking, genetest, facebase, research match, etc. Also mechanism for other researchers to share specimens (no identifiers)- Confidentiality Agreement template from UI IRB, along with IRB/ethics board approval, blank copy of informed consent document Recontact past research participants Coded samples and data will be shared with other researchers (no identifiers) Documents: Personal Information Release Form: to allow outside records to be obtained Subject Data Collection Tool: Demographics, gender, ethnicity, race, diagnosis, syndromic/NS, genetic testing, features Family History Date Collection Tool: questionnaire and pedigree Pregnancy Data Collection Tool PhotoConsent

FaceBase Biorepository: Methods Make samples available to other researchers Investigator submits a Protocol Proposal for use of specimens and fills out a Usage Agreement Data Access Committee (DAC) reviews proposal Proposal is either accepted or denied If proposal is accepted sample and data are transferred to investigator Protocol follows University of Iowa Biorepository guidelines provided by IRB Addition of Data Access Committee as described in the grant Coded samples and data will be shared with other researchers (no identifiers) DAC: Jamie L’Heureux, Michael Cunningham, David Fitzpatrick Documents: Protocol Proposal for Use of Specimens Usage Agreement – a template provided by UI IRB DAC review letter

FaceBase Biorepository: Timeline Progress Obtained IRB approval from the University of Iowa Obtained a Certificate of Confidentiality Future Awaiting review by NIDCR’s Clinical Study Oversight Committee (CSOC) Then start enrolling participants Make samples and data available to investigators Need to discuss priorities and recruitment strategies