The following policies/procedures were approved recently. Final documents will be available on the website soon; the final drafts are attached below:
Authorship Criteria (Guidance)
This document was primarily based on the International Committee of Medical Journal Editors (ICMJE) criteria for authorship. This identifies the criteria for authorship as well as those who do not qualify to be listed as author. Primarily, the individual has to substantially contribute to the conception and design, acquisition of data, analysis or interpretation of data, or the individual has drafted the article or revised it critically for significant intellectual content. One author must assume responsibility for managing and developing the manuscript. The co-authors’ responsibilities are outlined. There is no specific order of authorship, but should be described. Contributors should be acknowledged. Authorship disputes should be referred to the chair or head of the administrative unit most directly involved; further mediation may be required by the school dean or designee, Faculty of Graduate Studies, Provost or designee.
Adverse Event / Unanticipated Problem Reporting & Reviewing (Policy/Procedure)
Examples of Unanticipated Problems (Guidance)
Federal regulations require the reporting of adverse events and unanticipated problems that occur during a research study. The distinction between adverse events and unanticipated problems is an important. Adverse events may be unanticipated problems, but not all unanticipated problems are adverse events. To help the research community better understand the subset of unanticipated problems that do not overlap into an adverse event category, a guidance document has been drafted. The IRB will send out the protocol specific reporting requirements with the IRB approval. The IRB will review all reported events and make recommendations, as appropriate.
*Training on the reporting requirements of unanticipated problems and adverse events will be provided at the February 21st CRC Networking Meeting. Investigators and Coordinators are strongly encouraged to attend this training to learn about these requirements and obtain guidance on how to report these events.
Training related questions should be directed to the Research Education Coordinator, JR Krausz at x87463 or jrkrausz@llu.edu.
Use of Devices in Human Subject Research (Policy)
Significant Risk (SR) / Non Significant Risk (NSR) Device Determination (Procedure)
Loma Linda University Device Study Worksheet
The IRB must review the proposed use of the device in the context of the research study, its associated risk and benefits, whether such use is investigational, and whether it is FDA-approved. Investigational devices must be used in accord with the IRB approved protocol, under the direction of approved investigators, in compliance with FDA and institutional requirements, and must be appropriately labeled, stored, and controlled. The IRB must determine the appropriate device category. In certain cases, an Investigational Device Exemption is required, and unless exempt by IDE regulations, the investigational device must be categorized as either a significant risk (SR) or non-significant risk (NSR) device.