Ethics in Research

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2024 Agenda

Sat., Sept 28 10:50 to 11:35                                 Track: Ethics in Research
Ethical Considerations for Sham Surgery in Clinical Research Trials for Parkinson's Disease (PD)

Ms. McCormick will share a background and literature review regarding ethical conflicts and confusion related to sham surgery in clinical research trials for Parkinson's disease. Arguments in favor of sham surgery as a control and arguments against sham surgery will be discussed. 121

Presenter: Margaret McCormick, MS, RN, CNE, Professor Emeritus, Clinical Associate Professor, Nursing, Towson University

Sat., Sept 28 11:40 to 12:25                                 Track: Ethics in Research
Pediatric Biobanking

Biobanking refers to the collection of biological samples and information that provide important resources for translational research. Pediatric biobanking poses unique ethical challenges, including general vulnerability, balancing risks and benefits, return of results and secondary findings as well as legal and societal issues. Recent literature will be reviewed. 123

Presenter: Mary Cataletto, MD, MMM, Editor-in-Chief, Pediatric Allergy Immunology & Pulmonology

Sat., Sept 28 1:40 to 2:25                                     Track: Ethics in Research
Is the Investigator Ultimately Responsible?

Ms. Lloyd will present a case study where not only the PI was held accountable, but the entire study team was also. Hear what happened to a research organization who entered into agreements with pharmaceutical companies' sponsors, to conduct clinical trials of pharmaceutical drugs for public consumption, and then choose not to follow applicable FDA regulations and other standards set by the sponsoring agencies. 125

Presenter: Wendy Lloyd, BA, CCRP, LPN, Senior Clinical Research Quality Analyst-Education, Vanderbilt University Medical Center

Sat., Sept 28 2:30 to 3:15                                     Track: Ethics in Research
Ethical Inclusion Versus Exploitation: Including Vulnerable Populations in Clinical Research

Ms. Oeser will use the concepts of respect for persons, beneficence, non-maleficence, and justice while reviewing research scenarios to identify ways to ethically include diverse and vulnerable study participants.127

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

Sat., Sept 28 3:45 to 4:30                                     Track: Ethics in Research
Returning Genetic Testing Results in Research: Ethical Considerations and Logistics

Ms. Helvaty will discuss the ethical considerations and logistics related to deciding whether and how to return research-based genetic testing results to study participants. Discussion points will include an overview of genetic testing, current policy, consent language, and what results could be returned and who should return results.129

Presenter: Lindsey Helvaty, BA, BS, CCRP, Senior Clinical Research Leader, CV Genetics Program, Indiana University School of Medicine

Sat., Sept 28 4:35 to 5:20                                     Track: Ethics in Research
The Changing Ethics of Informed Consent and Biospecimens in Clinical Research

Ms. Snoddy will outline the historic background of informed consent for biospecimen collection and banking, discussing the current consent procedures for biorepositories including the 2018 Common Rule update, and dive into what the future looks like for the advancement of biospecimen research.131

Presenter: Casey Snoddy, BS, CCRP, Project Manager, Indiana University School of Medicine