Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.
She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.
Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices.
FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance.
According to current statistics, more than 90 million people in the United States have a hard time understanding and using health information. This is as many people as there are in France, Belgium and the Netherlands. To respond to this growing needed, President Obama signed the Plain Writing Act of 2010 and two other executive orders to cover the use of plain language. Use of Plain Language gets researchers closer to the historically used 6th to 8th grade level as the target for written consent documents. There are other tips as well that can improve the readability and acceptably of a consent document.
The Federal wide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an institution who has filed such an agreement. One of the terms deals with written agreements for non-affiliated investigators and institutions.
The consent document tends to be the source of much frustration for both research participants, research team members, and the IRB reviewers who must review and approve the document and process before it is implemented. Although the regulations default to a written consent document, consent is more than just a document, it is a process.
When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others.
Recruitment of research participants into clinical trials is critical. As the trials are designed for human subjects or use of a person's private identifiable information, a human subject's research study cannot occur with people. Yet, enrollment issues continue to be one of the reasons why trials are held open longer than anticipated and why modifications to the study are needed to increase enrollment.