Tag Archive: IRB

Trial Innovation Network


The Trial Innovation Network (TIN) is a collaborative initiative within the CTSA Program. The Trial Innovation Network (TIN) is composed of three key organizational partners – the CTSA Program Hubs, three Trial Innovation Centers (TICs) and one Recruitment Innovation Center. The TIN is designed to support innovation in multi-center clinical trials and studies. In 2017, the Brain Injury Outcomes Division (BIOS) and the ICTR received a seven year, $25 million grant from the National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences (NCATS) to form, along with the Tufts University School of Medicine, the Johns Hopkins-Tufts TIC. The […]

Data Management Advisory Board


The ICTR Data Management Advisory Board is designed to focus on data management within clinical research studies, including ways in which data management impacts study efficiency and the value of the data for both primary and secondary uses. Within Johns Hopkins there are a wide range of approaches to data management, with most of the responsibility centered within the individual studies. There are a few centers of expertise related to database management that have not generally met with each other or collaborated with each other to create institutional approaches and standards. The Data Management Advisory Board will work to answer […]

Protection of Patient Data


Johns Hopkins has multiple IT policies regarding the protection of patient data. Diana Gumas, Senior Director for Clinical Research Information Technology, is responsible for working with the Johns Hopkins Medicine Data Trust, the Institutional Review Boards, and the clinical research community to facilitate compliance with policies and address and resolve special data protection needs. The goals of our data protection policies are to ensure compliance with all applicable federal, state, and local law; to safeguard and protect all IT Resources from anything other than authorized and intended use; and to provide protection to academic, clinical, financial, research, and all other […]

Research Ethics Consultation


The Research Ethics Consultation Service helps to raise awareness of, and to assist investigators in resolving ethical issues throughout the entire research process. Consults may be requested for ethical issues arising during study development, conduct, analysis and publication. Our consultants offer ethical guidance on topics such as: Determining appropriate interventions and controls to include in studies; Maintaining confidentiality in recruitment; Using alternative approaches to informed consent; and Responding appropriately when an unforeseen event occurs during data collection. Note: The service is not designed to “pre-review” submissions to the IRB nor to review or draft consent documents. Research Ethics Consultation Service […]

Data Managers Interest Group


Data managers are an integral part of most research teams, and their services have a profound impact on the quality and efficiency of the research process. The goal of this group, formed at the recommendation of the ICTR Data Management Advisory Board, is to create an environment where data managers from throughout Johns Hopkins can meet to share expertise and discuss the challenges of their unique roles in the research enterprise. If you wish to subscribe to the Data Managers Interest Group listserv, click on the link below and select ‘Subscribe’ from the menu on the left side of the […]

Advantages of the JHCRN


The JHCRN provides a unique collaborative research infrastructure that enhances the flow of scientific information and expands the capacity to conduct clinical and translational research.  By providing an integrated approach, the network is positioned to foster research collaborations across the entire continuum of healthcare and to facilitate new research partnerships.  All members of the JHCRN have invested in Electronic Health Records, which facilitates access for patients and researchers alike. Single Principal Investigator: A Johns Hopkins University faculty member will function as the Principal Investigator (PI) of a network study.  A “Site Investigator” is designated at the non-Hopkins network sites.  The […]

Applying to Use the CRUs


All investigators must submit an application to a Johns Hopkins Institutional Review Board (IRB) before beginning their ICTR Clinical Research Units (CRUs) application. There are two ways to submit an application to the ICTR Clinical Research Units (CRUs)– one method applies if you are using the School of Medicine eIRB system, while the second applies if you have submitted to another Johns Hopkins IRB. Please read through the materials below. If you need assistance with your budget before you apply, please contact Shernice Madison (smadison@jhu.edu, 410-550-7033) or Nicole Cooper (ncooper2@jhmi.edu, 410-550-1880).   First Method For investigators who apply to the […]