MS 40 clearly defines rules of conduct for interaction of healthcare vendor representatives (HCVRs) with Nebraska Medicine staff. This also governs representatives who are on campus for visits related to Clinical Trials, i.e. Site Monitors. The policy includes registration and appropriate identification and pertains to all Nebraska Medicine facilities and entities. During visits related to clinical trials Representatives: Contact is restricted to Nebraska Medicine staff… Continue Reading

The Honest Broker Policy was established to create standard operating procedures for de-identification of PHI for the purpose of safely and securely linking together or sharing clinical data to support research in compliance with HIPAA and IRB requirements. Both Nebraska Medicine (IM40) and UNMC (6074) have Honest Broker Policies. Honest Brokers facilitate access to patient health information. Honest Brokers are workforce members who are Neutral… Continue Reading

The UNMC IRB allows the use of Central IRBs (CIRBs) under certain circumstances. Currently the use of three CIRB processes is routinely allowed: NCI CIRB for oversight of oncology trials sponsored by the NCI National Cooperative Groups Greater Plains Collaborative (GPC) PCORI studies NEW—Chesapeake IRB, an independent commercial IRB, for review of certain categories of commercially sponsored clinical studies There are also other less frequently… Continue Reading

One of the initiatives being promoted during October’s Cyber Security month was the formal project at UNMC to minimize the use of social security numbers (SSN). Policy 6085  governs the use of SSN within the UNMC campus and does include research subjects. The SSN of a research subject is considered confidential information and should not be used to identify a research subject unless legally mandated. If… Continue Reading

The Center for Clinical and Translational Research (CCTR) Pilot Grant program is available to faculty who need to obtain preliminary data for grant applications or who have budget shortfalls for extramurally funded clinical trials. Nebraska Medicine in partnership with UNMC College of Medicine and the Center for Clinical and Translational Research has established a write-off fund that allows investigators to waive hospital-based costs of clinical… Continue Reading