Regulatory and IRB Overview

The ETMR One registry is based at Hackensack University Medical Center where IRB approval for the study is maintained. As this is a registry protocol, we only ask that collaborating centers assist in the transfer of patient information and specimens once informed consent is obtained from the registry participants.

While we encourage collaborating physicians to notify patients of our registry, families will contact the registry on their own if interested in participating. Since the informed consent process is to be solely performed by Hackensack University Medical Center staff, institutions should not need to obtain full IRB approval.

Treatment following the consensus therapy protocol is not required for participation in the registry. The recommended therapy is not viewed as investigational, but rather as a consensus recommendation derived from available data. The Medical Advisory Board performs reviews of patient cases and provides clinical guidance and recommendations in an effort to improve patient outcomes. These reviews are not required for participation in the registry and adherence to any clinical recommendations is up to the individual treating physician. As such, collaborating institutions should not need to obtain full IRB approval to provide consensus therapy treatment or to participate in Medical Advisory Board discussions.

Regarding release of the medical records of deceased ETMR patients into the registry, per Health Insurance Portability and Accountability Act (HIPAA) regulation 45 CFR 164.512, the request for and release of decedent public health information (PHI) research purposes is permitted and HIPAA requirements are fulfilled as part of our decedent PHI request form. All PHI received by Hackensack University Medical Center will be coded. We function as the honest broker and no identifying information will be released to researchers.

For any regulatory questions regarding participation in the registry, we recommend that collaborating physicians consult with their IRB and act in accordance with institutional policy.