Collaborating Institutions Role:
The process of obtaining registered patients’ medical information, radiographic imaging, and pathological material has been developed specifically to minimize work load burden at your institution. The primary responsibility for each collaborating center is to provide the medical records of their deceased DIPG patients for abstraction into the Registry. The DIPG Registry coordinator will work with an identified designee from the referring center to obtain all pertinent source documentation including medical records, radiographic imaging on CD-ROM, pathological material (if available), and tissue for future research (if available). All data will be abstracted from the medical record by the DIPG Registry coordinator, who will be solely responsible for all CRF completion in the Registry database. Images submitted on CD-ROM will be de-identified, uploaded, and stored in the research PACS system housed at Cincinnati Children’s Hospital Medical Center (CCHMC). All paraffin blocks/slides submitted for central pathology review will be sent to CCHMC. Frozen tissue submitted for future research will be sent directly to the DIPG Tissue Repository, which includes storage locations at CCHMC, The Hospital for Sick Children, in Canada and Sydney Children’s in Australia.
A secondary responsibility is for collaborating centers to inform living patients about the Registry and provide our IRB approved brochures. Families will then contact the Registry on their own if interested in participating. The DIPG Registry coordinator will contact the patient/family to obtain written informed consent/assent. As a physician please ask your patients and/or their guardians to contact us directly.
The DIPG Registry and Repository is housed and operated at Cincinnati Children’s Hospital where the IRB approval is maintained. Our primary request is for each collaborating center to provide the medical records of their deceased DIPG patients for abstraction into the Registry. Per HIPAA regulation 45 CFR 164.512, the request for and release of decedent PHI for research purposes is permitted and HIPAA requirements are fulfilled as part of our Decedent PHI request form. Furthermore, all PHI received by Cincinnati Children’s Hospital is coded. We function as the honest broker and no identifying information will be released to researchers.
Many of the other collaborating institutions have consulted with their IRB and acted in accordance with institutional policy. Some of the submissions to IRBs have included the decedent request form (available on request) and brief explanation of use of PHI through completion of their IRB application. Most IRBs have granted a non-human subjects research determination and grant HIPAA waivers.
A secondary request is for collaborating centers to inform living patients about the Registry and provide our IRB approved brochures. Families will then contact the Registry on their own if interested in participating. Since the informed consent process is to be solely performed by CCHMC staff, institutions should not need to obtain full IRB approval.