Category Archive: Child of Patient Safety & Reg.

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 … Continue reading

Research Participant Advocacy Program

The Research Participant Advocacy Program offers consulting expertise on human subjects and regulatory issues, IRB applications, the informed consent process, study feasibility and good clinical practice (GCP). Our advocates serve as a resource to research teams and research participants by reviewing applications to the Clinical Research Unit to assure high standards for human subjects protections. Contact our team to review consent forms, protocol or data and safety monitoring plans. Advocates Are Available to Provide Information on how to administer the best consent Help with Good Clinical Practice (GCP’s) Assistance on how to report an unanticipated study event Guidance with assembling … Continue reading

Drug and Device Resource Service (DDRS)

The Drug and Device Resource Service (DDRS) provides Johns Hopkins University investigators and project teams access to resources needed to help manage the development and use of investigational drugs, biologics devices and software in clinical research. The DDRS offers the following: Consultation Service This service includes a complimentary eight-hour consultation for those seeking help with managing the external (i.e. FDA) regulatory requirements of their research projects. For assistance, please submit an ICTR Connection Request . Read more.   Resources Information about complying with and managing the regulatory requirements for studies with investigational drugs, biologics, devices and software, are available outside … Continue reading