OHRP’s Thinking on Key Revisions to the Common Rule
Yvonne Lau, MBBS, PhD
Director, Division of Education and Development, U.S. Department of Health and Human Services, Office of Human Research Protections
Compliance to the revised Common Rule became effective on January 21, 2019. Dr. Lau will provide updates on OHRP’s thinking on key revisions.
Creating and Sustaining Diverse Study Enrollment: Towards a Quantifiable Science of Recruitment
Jonathan Jackson, PhD, Director, CARE Research Center, Massachusetts General Hospital & Harvard Medical School
Many, if not most, clinical trials struggle to complete study enrollment on time and within budget. Similarly, diversity in clinical trial enrollment remains elusive for most study teams, in spite of determined, thoughtful, and concerted efforts. Common barriers to recruitment as well as recent efforts to concretize a scientific study of applied research recruitment will be discussed. Dr. Jackson will illustrate how recruitment science operationalizes efforts to develop, compare, and generalize best practices in study accrual, drawing on principles of engagement with underserved communities to improve recruitment and retention for all populations in clinical research.
Applying the Principles of the Science of Safety to Improve Subject Safety in Clinical Research: Actionable Practices to Identify and Minimize Risk
John Kessler, PharmD, BS Pharm, Chief Clinical Officer, SecondStory Health, LLC
Dr. Kessler will use case studies to illustrate and describe 1) selected practices in the management of investigational drugs and the consent process that are potentially unsafe and increase the risk to subjects, 2) enhanced reporting strategies to identify potential risks, and 3) enhanced ways to learn from deviations/mistakes that occur.
The Evolution of Vulnerability – The Ethics of Equitable Subject Selection
Quincy Byrdsong, EdD, CCRP, CIP Executive Director for Research Administration WellStar Research Institute
In April of 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Belmont Report. The Report summarized ethical principles and guidelines for research involving human subjects. Three core principles were identified: respect for persons, beneficence, and justice. While all three principles consider the rights of the research subjects, the justice principle focused primarily on subject selection. The spirit of the justice principle describes the protection of subjects vulnerable to unethical research. However, vulnerability in 1979 is markedly different from vulnerability today. This talk will chronicle the history of vulnerability in human subjects research and compare and contrast how this vulnerability is now manifested in today’s research environment.
The Reality of Enrollment Expectations
Harvey Arbit, PharmD, MBA, CCRP, RAC, President, Arbit Consulting, LLC
Louis Lasagna was the founder of the Tufts Center for the Study of Drug Development at Tufts University where he became Dean of the Sackler School of Graduate Biomedical Sciences. Lasagna’s Law states “The incidence of patient availability sharply decreases when a clinical trial begins and returns to its original level as soon as the trial is completed.” Why is this true? Can it ever be changed? If not, why not?
Including Vulnerable Subjects with Cognitive Impairment in Research
Laura Holtz, MS, CCRP, Senior Research Manager, IU Center for Aging Research, Regenstrief Institute
This talk will review the new common rule definition of vulnerable subjects including “individuals with impaired decision making ability.” It will discuss why inclusion of this vulnerable population is needed in research studies, especially for diseases such as Alzheimer’s research. Finally, it will review the ethical guidelines and discuss practical strategies for obtaining informed consent for subjects who may lack decision making capacity.