12:00 – 12:15 - Program Welcome, Wendy Lloyd, BA, LPN, CCRP, Program Chair
Senior Clinical Research Quality Analyst, Vanderbilt Coordinating Center
Vanderbilt University Medical Center
12:15 - 1:30 - Research in the Virtual World, Michelle Brignac, MPA, CIP, CCRP,
Manager of Clinical Research Operations Hematology, St Jude Children’s Research Hospital
In March of 2020, St. Jude Children’s Research Hospital closed all research interventions, other than those for therapeutic care, due to COVID-19. For the next year, no patients were allowed in St. Jude clinics and no research interventions were allowed on campus that were not related to direct patient care or therapeutic studies. To maintain study funding mandates and timelines, study coordinators and research teams had to get creative on how to do research virtually. In this presentation Ms. Brignac will present St. Jude’s experience during COVID.
1:30 – 1:45 – Break
1:45 – 3:00 - The Informed Consent Process and the Role of the Research Participant Advocate, Wendy Hayes, MSN, RN, CPHON, Research Participant Advocate, Office of Human Subjects Protection, St. Jude Children’s Research Hospital
It is not good enough that we just inform possible participants of the required information about research studies. We must also ensure understanding. Ms. Hayes will detail the informed consent process and describe the role and responsibilities of the Research Participant Advocate during this discussion. As a result of attending this session, attendees will understand the required elements of an informed consent discussion and be able to describe the role and responsibilities of the Research Participant Advocate.
3:00 – 4:15 - Informed Consent for Non-English Speakers, Eric Pittman, MBA, Program Division Director, BIMO-W, US Food and Drug Administration and Courtney Bratina, MS, Consumer Safety Officer, US Food and Drug Administration
Informed consent is required by regulations to insure human subjects have adequate information to make an informed decision about participation in a clinical trial. IC helps facilitate the participants understanding of what they will encounter during the trial. What happens if the subject does not speak English or has a limited understanding of it? In this program we will discuss the requirements of Informed Consent and address those additional requirements for participants who do not speak English.
4:15 – 5:00 – Q&A
12:00 – 1:00 - The Current Gene Therapy Research Boom and Future Challenges, Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Executive Director, Biosafety Services, Advarra
Less than a decade ago clinical trials of investigational products containing engineered genetic materials were limited to early phase studies in major academic medical centers. Use of engineered genetic materials in clinical trials has boomed. As of the SOCRA abstract submission deadline all COVID-19 vaccines with emergency use authorization contain engineered genetic materials (either mRNA or recombinant adenovirus) and are being administered throughout the country. Another boom is taking place in oncology research with CAR T cells and oncolytics. This presentation will: illustrate the growth and summarize the science; Highlight current challenges and risks facing gene therapy research; Outline the next wave of gene therapies on the horizon.
1:00 – 2:15 - Revised Common Rule: 2 Years Out, Brian Stage, JD,CIP, Research Compliance Consultant, Indiana University
The final Revised Common Rule was implemented in January of 2019. Now that researchers and IRBs have 2 years of working under the new rules, we can clearly see that some changes have worked to make regulatory review faster and easier. However, there are still regulatory issues that exist, and will require more changes, guidance, and creative solutions in the future.
2:15 – 2:30 – Break
2:30 – 3:30 - Ensuring Patient Safety through Risk Based Auditing, Krista Vermillion, MS, MPM, CCRP, Division Manager, Investigator Initiated Trials, Vanderbilt University Medical Center
In the changing environment of clinical research, there are areas in every research program where patient safety is at a higher risk. Ms. Vermillion will discuss these areas and provide tips on how to mitigate the risk through auditing techniques. This discussion will also review some process improvement tools that can be used in conjunction with risk based auditing.
3:30 – 4:30 - Health Disparities in the United States and Implications for Clinical Trials Research, Cynthia R. Davis, PhD, Associate Center Director/Study Director, US Department of Veterans Affairs
This session will begin with a brief overview of health disparities in the United States and a presentation of cultural components of health, including physician approaches to medical decisions, patients, and potential participants based on racial, ethnic, and social factors. It will highlight the problem of under-representation of racial and ethnic minorities in clinical trials research and include a discussion on how we can improve the status of racial and ethnic minority health and representation. Addressing unconscious biases, engaging with cultural communities, recruitment and enrollments strategies, and promoting diversity among health care and clinical trials research professionals will be considered.
4:30 – 5:00 Q&A
12:00 – 1:00 - Remote Consent via Electronic Informed Consent (eIC), Wendy Lloyd, BA, LPN, CCRP, Senior Clinical Research Quality Analyst, Vanderbilt University Medical Center
Ms. Lloyd will highlight informed consent regulations and the fact, regardless of the format used, such as electronic informed consent, consenting subjects follow these same regulations. At the conclusion of the presentation participants will be aware of different types of electronic signatures, the need for more detailed consent documentation and the requirement for access to both paper and electronic consents for subjects.
1:00 – 2:00 - Are You Really FDA 21 CFR Part 11 Compliant?, Debbie Hunter, RN, BSN, CCRP, Manager, Research Projects: Quality Assurance and Education, Vanderbilt University Medical Center
FDA 21 CFR Part 11 describes the regulations surrounding electronic documents and electronic signatures that are acceptable per the FDA. This presentation will break down each of the categories in easy to understand descriptions. Awareness of best practices to help ensure that your electronic systems are within the FDA regulations, how open and closed systems are defined and the SOPs your institution should have in place to ensure compliance.
2:00 – 2:15 – Break
2:15 – 3:15 - REDCap for Electronic Consent, Gail Mayo, RN, CCRP, Research Nurse Specialist, Vanderbilt University Medical Center
Ms. Mayo will discuss the REDCap eConsent framework, related regulatory requirements, and resources for setting up and using REDCap for eConsent. Following the presentation, attendees should be able to describe how REDCap eConsent supports human subject’s protection in research, how REDCap consent framework supports eConsent, compliance requirements related to REDCap eConsent (including 21 CFR Part 11) and locate resources to support setup and use of REDCap eConsent
3:15 – 3:45 – Q&A