Event Calendar

Opening Plenary

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2018 Agenda

2019 Agenda Coming Soon! 


Friday, September 28, 8:30 to 9:15

Welcome and Introduction

The speakers will describe issues related to the practice of clinical research in the current regulatory environment and how SOCRA works to promote education and training within the clinical research community. 001 

Presenter: Tammy Neseth, MA, CCRP, CIP, Operations Manager, Mayo Clinic Integrity and Compliance Office
Presenter: Jamie Harper, MHA, CCRP, Director of Clinical Research, Illinois CancerCare PC 


Friday, September 28, 9:15 to 10:00

Rethinking Research Ethics: Considerations for Pragmatic Clinical Trials 

Pragmatic clinical trials, including comparative effectiveness research, are becoming increasingly prevalent. These trials aim to answer important research questions for multiple stakeholders and may be less expensive than conventional clinical research. In addition, these “real-world studies”, which are typically embedded in health care settings, often pose minimal incremental risks and burdens to participants. This suggests that the full range of protections employed for conventional research subjects may not be appropriate. However, designing and conducting pragmatic research has been associated with a surprisingly vexing array of ethical and regulatory challenges. Dr. Sugarman will describe the nature of pragmatic clinical trials, some of these challenges, and ways to address them. 002

Presenter: Jeremy Sugarman, MD, MPH, MA, Professor of Bioethics and Medicine, Johns Hopkins University 


Friday, September 28, 10:30 to 11:15

Precision Medicine versus Precision Health: Transformative Opportunities in the Digital Era

Advances in precision medicine are accelerating treatment discoveries that are more targeted and effective. Yet successful interventions for diseases such as Alzheimer’s disease remain elusive. Consider that in the US about 86% of diseases treated are chronic diseases, which means that the path from normal to disease is a long one – taking years if not decades to progress to the level of severity in which medical treatment is needed. Emerging technologies offer the opportunity of preventing disease from happening altogether and potentially lead to a paradigm shift in healthcare from a focus on precision medicine to one on precision health. Further, centering on optimizing brain health as an alternative to disease treatment may prove the most efficacious route for not only solving the problem of Alzheimer’s disease but also other common chronic disorders. 003

Presenter: Rhoda Au, PhD, MBA , Professor of Anatomy and Neurobiology, Neurology and Epidemiology, Boston Univeristy Schools of Medicine and Public Health 


Friday, September 28, 11:15 to 12:00

Improving Informed Consent 

In January, 2017, a final rule was published in the Federal Register to revise a variety of provisions of the Common Rule (the main set of federal regulations designed to protect research participants). In particular, some of those changes relate to improving informed consent. This session will discuss the ways in which the most significant of these changes are intended to operate and how they will lead to a more ethical process for obtaining informed consent from prospective research participants. 004

Presenter: Jerry Menikoff, MD, JD, Director, Office for Human Research Protections, Department of Health  Human  Services 


Pragmatic clinical trials, including comparative effectiveness research, are becoming increasingly prevalent. These trials aim to answer important research questions for multiple stakeholders and may be less expensive than conventional clinical research. In addition, these “real-world studies”, which are typically embedded in health care settings, often pose minimal incremental risks and burdens to participants. This suggests that the full range of protections employed for conventional research subjects may not be appropriate. However, designing and conducting pragmatic research has been associated with a surprisingly vexing array of ethical and regulatory challenges. Dr. Sugarman will describe the nature of pragmatic clinical trials, some of these challenges, and ways to address them.