Sunday, June 9
01:00 PM - 02:30 PMBreakout Sessions#P1P1 - Compliance within your HRPP Nathalia Henry, Executive Director, IRB Office, Northwestern University Leyla Erkan, Global Healthcare Risk and Compliance Lead, Protiviti
Research#P2P2 - Uniform Guidance 101 Matthew Staman, Managing Director, Huron Consulting Group Marisa Zuskar, Senior Director, Huron Consulting Group
- What is a HRPP and what do you have to comply with?
- Key HRPP components and structures.
- What mechanisms can you put in place to monitor compliance?
- Provide a (brief) background and introduction of the Uniform Guidance, including the purpose and impact of these federal sponsored project regulations.
- Review critical changes within the UG (from previous circulars) and cover major topical areas of the guidance, including: Cost Principles, Effort Reporting, Procurement, and Subrecipient Monitoring.
- Discuss the shift of the regulations towards Internal controls and institutional responsibility for ensuring compliance.
01:00 PM - 04:15 PMPre Conference - Sunday's Sessions
02:45 PM - 04:15 PMBreakout Sessions#P3P3 - Sharpening Research Compliance: Heightened Awareness with a Self-Guided Risk Assessment David Staley, Research Compliance Officer, Children's Hospital Colorado Hannah Hyland, Research Compliance Analyst, Children's Hospital Colorado
Research#P4P4 - Identifying and Managing Physician Conflicts of Interest in the Research Context Amy Joseph, Partner, Hooper, Lundy & Bookman, PC Rebecca Ryan, Compliance Officer, Yale New Haven Hospital
- Employ risk assessment philosophies and principles to heighten awareness of risks in clinical research.
- Empower research teams to weigh and prioritize self-identified risks in order to create meaningful action plans.
- Form a self-guided risk assessment tool to encourage risk preparedness and sharpen research compliance.
- Review potential compliance issues related to physician relationships in the research context, including under anti-kickback and physician self-referral laws.
- Identify factors that could increase compliance risk for such relationships based on OIG guidance and recent enforcement actions.
- Discuss best practices for how a compliance program can effectively identify and address physician conflicts of interest, including approaches to policies and screening measures.
Monday, June 10
09:45 AM - 10:45 AMBreakout Sessions#101101 - Demystifying Human Subjects Research Versus Quality Improvement: A Compliance Case Study David Staley, Research Compliance Officer, Children's Hospital Colorado Hannah Hyland, Research Compliance Analyst, Children's Hospital Colorado
Research#102102 - Tricky Clinical Trial Budget and Research Billing Compliance Issues Inherited from Mergers & Acquisitions Geoffrey Schick, Senior Consultant, PFS Clinical Ray Heller, Sr Dir Business Development, WCG PFS Clinical
- Review related laws and regulations which help define human subjects research.
- Examine real regulatory cases to distinguish quality improvement activities from human subjects research.
- Describe a governance structure that reviews quality improvement activities which aim to evaluate and enhance programs, processes, or systems.
Research#103103 - Navigating Federally Sponsored Projects Abroad: Common Compliance Challenges and Solutions Katherine Morga, Sr. Associate, Hogan Lovells Adilene Rosales, Associate, Hogan Lovells US LLP
- Session will use a "mock debate" format to present arguments on both sides of clinical trials research billing compliance challenges that arise from "inherited" studies.
- What happens when a Site "inherits" a Study - through merger, acquisition, PI relocation - that has questionable terms that have been in place from the start?
- Attendees will utilize real time voting tools to weigh in on the "winner" of each scenario.
- Identify key award terms and regulations that affect federally sponsored research abroad compliance.
- Discuss financial and administrative challenges, including engaging foreign personnel, managing foreign sub recipients, complying with U.S. and foreign human subjects research and ethical requirements, and applying cost accounting rules.
- Share practical experience and tips on how to manage risks and resolve challenges.
11:00 AM - 12:00 PMBreakout Sessions#201201 - The Intersection of Clinical Data Management and HIPAA: How to Assess Privacy and Information Security Compliance of Clinical Data Andrew Rodriguez, Corporate Privacy and Information Security Officer, Shriners Hospitals for Children
Research#202202 - Research Privacy and Security Considerations Beyond HIPAA: What are the Compliance Concerns? Marti Arvin, Executive Advisor, CynergisTek, Inc.
- Conducting a Privacy Assessment on Clinical Research Data
- Conducting a Security Assessment on Clinical Research Data
- "De-identification, you keep using that word. I do not think it means what you think it means."
Research#203203 - From Paper to Electronic: Evolution of an IACUC Protocol Management System Denise Ancharski-Stutler, IACUC Administrative Director, Children's Hospital of Philadelphia
- Privacy and security concerns that are unrelated to HIPAA such a GDPR, FERPA, GLBA, and contractual.
- What education may be necessary for the IRB and others to understand these obligations.
- Practical ways to incorporate this into the process for study preparation, approval and execution.
- Provide an overview of IACUC and protocols.
- Discuss methods to transition from paper to an electronic system.
- Identify opportunities within the electronic protocol form to reduce burden
01:00 PM - 02:00 PMBreakout Sessions#301301 - Clinical Trials Compliance Collaboration Builds Effectiveness Stephanie DeRijke, Director, Clinical Trials Audit and Compliance, Emory University Anne Adams, Chief Compliance Officer, Emory Healthcare, Inc
Research#302302 - Compliance through Collaboration: Partnering with Independent IRBs to Develop and Maintain a Strong Human Research Protection Program (HRPP) Cynthia Hahn, President, Integrated Research Strategy Hallie Kassan, Director, HRPP, Northwell Health
- Outline steps to implement an independent clinical trial compliance program in a large academic medical center. Discuss reporting structure, function, responsibilities, and goals.
- Discuss strategies to connect researchers with the compliance team to develop proactive, collaborative, and reciprocal methods to achieve compliance through continuous quality assurance and improvement.
- Share Emory Clinical Trials Compliance tools: electronic audit tool in REDCap, data analytics tool to show trends, and clinical trial tools for researchers.
- Provide an overview of the current regulatory and business climate for SIRB review, including the NIH Policy on sIRB review and changes to the Common Rule at 46CFR46.
- Discuss models for sIRB review and partnership with academic and commercial IRBs, differentiating and outlining the responsibilities of the institution versus the responsibilities of the reviewing sIRB.
- Demonstrate through case studies how differing business models can both achieve and improve compliance with the new federally mandated requirements for the use of sIRB in multi center clinical research studies.
02:30 PM - 03:30 PMBreakout Sessions#401401- Exploring Observational Registries and Human Subject Research. Progress Where Ambiguity is the Only Constant Mark Fox, Privacy and Research Compliance Officer, American College of Cardiology
Research#402402 - Demystifying Partial Waivers of Consent and Authorization Andrea Seykora, Research Compliance Manager, Kaiser Permanente Melinda Bodayla, Research Compliance Program Manager, Kaiser Permanente Center for Health Research NW Kaija Maggard, IRB Manager, Kaiser Permanente
- Identify compliance considerations for secondary use of data in an observational registry.
- Navigate the applicability of the revised Common Rule to observational registries.
- Explore transparency of data use in the world of big data.
- The concept of a "partial' waiver of consent or authorization is common in IRB review, despite not appearing in the HHS, FDA, or HIPAA regulations.
- Examine the regulatory criteria for waiver and alteration of consent and authorization and learn how they may apply to different portions of a study.
- Explore strategies for collecting information from researchers to facilitate clear and compliant waiver determinations by the IRB.
Tuesday, June 11
09:45 AM - 10:45 AMBreakout Sessions#501501- ClinicalTrials.gov: Oversight and Compliance at a Diverse Academic Research Center Melanie Chladny, Research Compliance Specialist, University of Michigan Medical School Linda Mendelson, Regulatory Specialist, University of Michigan Rogel Cancer Center
Research#502502 - Research PHI in the Cloud: Human Subjects Protection Transformed Rebecca Scott, COI Specialist, HealthStream Darin Poynter, Enterprise Data Architect, UK HealthCare Information Technology
- Speakers will describe the oversight processes, management tools, and structural challenges of a diverse university and large cancer research center. We’ll explain how different administrative roles intersect to achieve effective oversight and compliance.
- Presenters will share lessons learned, best practices, and tips to pro-actively manage ClinicalTrials.gov records at a large institution.
- We’ll demonstrate how institutions can adapt to ongoing regulatory and policy change using ClinicalTrials.gov: uploading informed consent documents for the Common Rule, meeting the ICMJE’s new data sharing policy, and monitoring NIH funded clinical trials.
Research#503503 - Mining the Sunshine Data: Finding Potential Conflicts of Interest C.J. Wolf, Faculty, BYUI Paul Papagni, Executive Director of Research, Holy Cross Hospital Trinity Health
- Discuss the need for a secure cloudbased environment in which to manage PHI from research studies.
- Outline a process to create a secure cloud environment in which to facilitate large PHI data set sharing and manipulation.
- Ponder questions regarding research PHI data governance and data ownership in an academic medical center environment.
- Get the most out of mining publicly available sunshine data.
- What nuances exist in the data that might raise red flags for COI or other compliance risks.
- Discuss scenarios and case studies of industry influences gone badly.
11:00 AM - 12:00 PMBreakout Sessions#601601- Research Billing Compliance Program - From Zero to 100 in 60 Seconds! Isai Senthil, VP Associate General Counsel, Summit Medical Group Kelly Ritter, Manager, Clinical Research, Summit Medical Group
Research#602602 - "GDP - What? How the European Union General Data Protection Regulations Impact Research" Karen Hartman, Division Chair, Research Administration, Mayo Clinic
- This presentation will focus on how to develop a research billing compliance program and how to select the key stakeholders who need to be involved along the way.
- Research billing compliance encompasses several functional areas - all of which must come together in order to develop and successfully implement a research billing compliance program.
- The presenters will speak to their experiences in the development of a research billing compliance program at a large, multi-specialty private physician practice which tripled its participation in clinical trials in just 2 short years.
Research#603603 - Export Controls in Medical Research: Compliance Considerations for International Collaborations Scott Long, Chief Compliance Officer, St Jude Children's Research Hospital
- Review the scope of the EU GDPR and impact to clinical research.
- Identify best practices for implementation, including gap analyses and working with teams external to research.
- Share practical considerations for compliance with GDPR through case studies.
- Gain an understanding of export control regulations and their impact to medical research.
- Explore risks of export controls in medical research through case-study examples (including interactions with sanctioned countries)
- Discuss mitigation techniques and best practices for managing risk.
01:00 PM - 02:00 PMBreakout Sessions#701701- Relying on Someone Else’s IRB: Why, When, and How for Hospitals and Academic Medical Centers Bethany Johnson, University Director, HRPP, Indiana University Hospital Amy Waltz, Associate Director, Research Integrity Office, Indiana University
Research#702702 - Investigator Initiated Trials (IITs): Addressing the Challenges of Auditing IITs for Compliance and GCP Wendy Portier, Independent Consultant Gabriella Neff, Research Compliance Officer, Moffitt Cancer Center
- Why IRB reliance is valuable: the landscape of IRB reliance including the NIH single IRB policy, why it matters, and what it means for hospitals and academic medical centers.
- When you should rely: defining your institutional risk tolerance and when you should accept an external IRB’s review, drafting your institutional policy for reliance, and identifying the information you need to rely.
- How to rely: understanding the responsibilities of your institution, investigators, and IRB and implementing processes to fulfill them; drafting reliance agreements based on your risk tolerance; collecting and providing local context information.
Research#703703 - The Dos and Don’ts of Investigating Research Misconduct Cases Sarah Archibald, Director, Office of Accountability & Compliance, Univ of Maryland-Baltimore
- Identify the unique regulatory and operational challenges of IITs, as well as, the associated risks.
- Discuss suggestions for risk-based audit plans, sampling and testing techniques for IITs.
- Share success stories and lessons learned conducting IIT audits at a designated cancer center.
- What is required for a research misconduct investigation.
- Some of the pitfalls at each stage of a research misconduct investigation.
- Dos and don’ts when conducting a research misconduct investigation.
02:15 PM - 03:15 PMBreakout Sessions#801801 - Importance of Ensuring Blockchain Compliance For Your Institution