Event Calendar

Agenda

Hot Topics and Practical Considerations for Protecting Human Research Participants

For a printable PDF 2019 agenda form, click here.


2019 Agenda


8:15 - 8:30 Welcome and Introduction
8:30 -10:30 Translating Reading Level to Health Literacy to Improve ICF language. Meaningful Use of Each and Every Dry Word
Stephanie Zafonta, DNP, Senior Project Manager, Novella Clinical
This presentation focuses on history, ethics, and regulatory aspects of informed consent, as well as the challenges affecting the consent process. Topics will include confusing laws, ethical dilemmas, and effective practices. Several ethics case studies will be presented for discussion.
10:30 -10:45 Break
10:45 -12:30 Group Activity in Informed Consent Writing
Cheryl Jacobs, CCRP, 
Wendy Lloyd, BA, LPN, CCRP, Translational Research Navigator, Vanderbilt University Medical Center
Participants will be given a short, simple protocol for which they will develop sections of the informed consent. They will break into small groups with each group assigned to write a specific section of the ICF. Readability software and the entire group will be used to analyze the ICF sections.
12:45 -1:45 Lunch (Provided)  
1:45 - 3:00 An Introduction to Gene Therapy Research and the Evolving Regulatory Requirements in The U.S.
Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Director of Biosafety Services, Schulman IRB
Gene therapy is a quickly growing area of research as the U.S. and other countries have begun issuing approvals. Recent regulatory changes, scientific advances and demographics have combined to create ideal conditions for a boom in gene therapy research, particularly in oncology. In this presentation, Advarra’s Director of Biosafety Services, Daniel Eisenman, will provide an introduction to the field of gene therapy research and discuss the evolving regulatory environment as well as strategies for institutions interested in conducting gene therapy research, including considerations for IRB and IBC review. 
3:00 - 3:15 Break
 
3:45 – 4:45 Educating Medical Professionals in the Conduct of Human Research
Kathleen Price, MBA,RN, CIP Office of Human Subjects Protection OHSP Director, St Jude Children’s Research Hospital
Day One - Thursday

8:00 - 8:15 Registration and Continental Breakfast

8:15 - 8:30 Welcome and Introduction

8:30am – 9:30am How to Satisfy 46.111 Criteria for Approval Including Protections for Vulnerable Populations

Michelle Brignac, CIP, CHRC, OHSP Coordinator III, Office of Human Subjects Protection, St.Jude Children’s Research Hospital

Ms. Brignac will address various dilemmas in consenting vulnerable populations. The session will look at three case studies and identify tools that can help to ensure the rights and welfare of subjects are protected. As a result of the session, attendees will be able understand 45 CFR 46.111 and the challenges to consent vulnerable populations and identify tools to help the participant in the consent process.

9:30am- 10:30am Implementing the Ethical Principle of Justice: Policy and Practical Implications of Including Women and Minorities in Research

Cynthia Davis PhD, Associate Center Director, Clinical Trials Operations Cooperative Studies Program, Massachusetts VA

Ms. Davis will reference the Belmont Reports principle of justice. She will explain how it mandates the equitable selection of subjects for research. An ethical and scientific argument will be made to justify the inclusion of women and minorities in research. Some of the policy and practical implications of including women and minorities in research will also be discussed.

10:30am – 10:45am Break

10:45am-11:45am An overview of the Law and its Impact on Clinical Research

Sheila Sokolowski, JD, Partner, Hogan Marren Babbo & Rose, Ltd

Ms. Sokolowski will provide an overview of the law and the American legal system. It will include history and evolution and the interplay between law and research.

11:45am-12:45PM Lunch provided

12:45pm – 1:45pm Recruitment and Retention of Human Subjects in Clinical Research

Carrie Dykes, PhD, Research Engagement Specialist, Clinical Trials Science Institute, University of Rochester

Recruitment and retention of research subjects typically focuses on determining eligibility, minimizing risk to research subjects and designing protocols that are not overly burdensome for the respondent, subject or the community. While these concerns are important, successful and sustainable recruitment extends well beyond protocol design. Dr. Dykes will focus on models, strategies and tactics to effectively recruit and retain human subjects and will provide resources and tools to aid participant recruitment.

1:45pm- 2:45pm Given Models, Strategies and Tactics to Effectively Recruit and Retain Human Subjects Create the Research Design within a Protocol

Wendy Lloyd, BA, LPN, CCRP, Clinical Research Quality Consultant, Vanderbilt University Medical Center

In order for a research project to be successful a sound research plan is required. The informed consent process begins with advertising, identification, initial contact, screening and recruitment of potential human subjects. The research team, the study sponsor, and the IRB share the responsibility for creating a recruitment environment that is not only effective but is also ethical and that complies with the federal regulations and guidance. Ms. Lloyd will present a protocol for review and the development of recruitment plans will be discussed.

2:45pm-3:00pm Break

3:00pm – 4:00pm Wait, WHAT? My Subject is Unable to Give Assent - I Need to Obtain Permission from the CIRB Prior to Enrollment? Understanding Different Requirements for Different IRB’s

Debra Cunningham, RN, CCRP, Hematology/Oncology Research Nurse, Dayton Children’s Hospital

Assent Waiver approved by the Central Institutional Review Board(CIRB) must be obtained prior to the child’s enrollment in a study. Many local IRB’s allow 90 days to complete amendments; the CIRB requires completion within 30 days. Ms. Cunningham will discuss the IRB record requirements.

Day Two - Friday

8:00 - 8:15 Continental Breakfast

8:15am – 9:15am 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.

9:15am-10:15am An Introduction to Gene Therapy Research and the Evolving Regulatory Requirements in The U.S.

Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Director of BioSafety Services, Advarra

Gene therapy is a quickly growing area of research as the U.S. and other countries have begun issuing approvals. Recent regulatory changes, scientific advances and demographics have combined to create ideal conditions for a boom in gene therapy research, particularly in oncology. Mr. Eisenman will provide an introduction to the field of gene therapy research and discuss the evolving regulatory environment as well as strategies for institutions interested in conducting gene therapy research, including considerations for IRB and IBC review.

10:15am-10:30am Break

10:30am – 11:30am A Changing IRB World: Understanding the Revised Common Rule and its Impact on You

Brian Stage, CIP, Research Compliance Consultant for Regulatory Affairs, Reliance, and Outreach,, Indiana University Human Subjects Office

Mr. Stage will summarize the New Common Rule, why it was implemented, and what clinical research professionals need to know. The presentation will identify the 3 major ways it will affect researcher interaction with the IRB, including new exempt research categories, changes to the informed consent document and process, and changes to the renewal process. Mr. Stage will also discuss plans to transition the changes into your site.

11:30am- 12:30pm Lunch Provided

12:30pm- 1:30pm The Changing Regulatory Landscape: Taking Clinical Trials Monitoring in a New Direction

Kathleen Howard, DNP, BSN, RN, Quality Assurance Nurse Specialist, U.S. Department of Veterans Affairs, Boston, Cooperative Studies Program Coordinating Center

The regulatory environment pertaining to clinical trials is dynamic, as evidenced by a recent update to ICH E6 Good Clinical Practice Guidelines and implementation of the revised Common Rule. The Cooperative Studies Program at the U.S. Department of Veterans Affairs has responded to these changes by modifying our approach to monitoring. Ms. Howard will focus on integrated, risk-based monitoring, and the clinical input provided by the Quality Assurance Nurse within the Quality Management System to support the protection of human research participants, high quality data, and compliance with applicable requirements and standards.

1:30pm – 2:30pm Increasing Innovation and Integrity in Clinical Research

Sam Gannon, EdD, MS, MCRP, Director of the Vanderbilt Program in Research Administration Development, Vanderbilt University

Despite recent calls for increased rigor, transparency and reproducibility, and mandatory Good Clinical Practice training for those engaged in clinical research, poor scientific integrity still undermine research quality. Poor research quality is not only evident in our regulatory decision-making processes, but also in the effectiveness of individual physicians in clinical settings, who rely on our research. We can also see the outcomes of our research quality in patient outcomes. Those of us engaged in clinical research have a unique balancing act, in which our multiple constituencies (sponsors, regulators, patients and the public) all want speedy and cost-effective research results that are transparent, have rigor and are easily reproducible while also maintaining the highest standards of research integrity. As a result of attending this session, attendees will: Understand the landscape of research integrity in clinical research; Know the areas of intersection at which poor research reduces patient outcomes; Identify best practices and strategies that can improve transparency, rigor and reproducibility in clinical research; Utilize tools to enhance clinical research trial effectiveness

2:30pm – 2:45pm Break

2:45pm – 3:30pm Case Study: Research Fraud: Does the Punishment Fit the Crime?

Research Fraud case studies will be provide with discussion surrounding consequences for the researcher, the research community and research subjects.