Research Ethics

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2020 Agenda

Thursday, September 24, 2020 2:30 PM ET

Pay-to-Play:  The Ethics of Volunteers Paying to Participate in Clinical Trials

The FDA allows for charging for investigational products used in clinical research under certain circumstances. The federal regulations also state that participants should be informed of any additional costs that may result from participation in research.  Recent “research studies” are using this guidance as a loophole to charge participants for studies that may not create generalizable knowledge. Ms. Oeser will review the ethical issues involved in recent pay-to-participate “research studies” and how these may violate the pillars of respect of persons, beneficence, and justice. 715

Presenter: Annette Oeser, BS, MLAS, CCRP, Clinical/Translational Research Coordinator III, Vanderbilt University Medical Center

Track: Research Ethics

Friday, September 25, 2020 11:00 AM ET

Regulatory Aspects of Clinical Research – A Lesson in History

Ms. Tungol will provide a detailed overview of the history of regulatory aspects of clinical research, and what our history has taught us about running clinical research.  The presentation will provide a detailed account of the historical events that paved the way for our current clinical research practices – not only the well known major events in history, but also the minute details in between. 417

Presenter: Joyce Tungol, BS, CCRP, Clinical Research Associate, Duke University

Track: Research Ethics

Friday, September 25, 2020 11:50 AM ET

Regulatory Inspections of Research Sites: What to Expect, What to Do & What Not to Do!

The primary reason the FDA performs inspections is to support its mission to protect the public by ensuring the safety and efficacy of drugs, biologics, and medical devices.  Faced with an impending audit or inspection, how do you prepare? This session will provide an overview of what to expect and how to prepare for an audit or inspection. This course will prepare you and your site for expectations from the FDA and provide concrete steps you can take to prepare before, during and after the inspection. 419

Presenter: Janet Ellen Holwell, BA, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant

Track: Research Ethics

Friday, September 25, 2020 1:40 PM ET

Good Reporting Practices: Describing Your Research So Other Researchers Can Replicate and Clinicians Can Implement

Transparency in reporting research findings is vitally important. Reporting standards, guidelines that inform the content to be included in a well-written journal article, are available for numerous study types including case reports, systematic reviews, and randomized trials. Dr. Selfe will briefly introduce various reporting standards, then focus on those most relevant to randomized trials, the Consolidated Standards of Reporting Trials (CONSORT) statement, as well as the Template for Intervention Description and Replication (TIDieR) guide. Using these guidelines, authors can ensure they maintain good reporting practices (“GRPs”) and readers can evaluate the rigor of the study design, identify potential sources of bias, and determine if the research is replicable in their population of interest (other researchers) and/or generalizable to their patients (clinicians). 421

Presenter: Terry Selfe, PhD, DC, CCRP, Translational Research & Impact Librarian, University of Florida HSC

Track: Research Ethics

Friday, September 25, 2020 2:30 PM ET

The TB Trials Experience in the United States, Africa, and South America

Recruitment and retention is an essential part of any successful research project. Potential challenges and ways they have been addressed effectively will be presented based on more than eleven years of experience in tuberculosis trials conducted in the United States, Africa, and Latin America. The speaker will discuss practical and cultural differences between research sites and how to optimize participant enrollment and reduce ineligibility. Strategies to reduce withdrawals and maximize retention will also be explored. Ms. Wright will examine challenges that are unique to infectious disease research with implications in public health, included impact from COVID-19 Pandemic. She will include scenarios, the roles played by team members across functional areas of the research project, collaborations, and the importance of a Quality Management Program to improve patient recruitment and retention. 423

Presenter: Alicia Wright, MS, CCRP, Program Manager, Vanderbilt University Medical Center

Track: Research Ethics