Sunday, June 9
01:00 PM - 02:30 PMBreakout Session 1 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#P1P1 - Compliance within your HRPP Nathalia Henry, Executive Director, IRB Office, Northwestern University Leyla Erkan, Director, 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 Session 2 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#P3P3 - Sharpening Research Compliance: Heightened Awareness with a Self-Guided Risk Assessment David Staley, Research Compliance Officer, Children's Hospital Colorado Hannah Gilbert, 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 Session 1 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#101101 - Demystifying Human Subjects Research Versus Quality Improvement: A Compliance Case Study David Staley, Research Compliance Officer, Children's Hospital Colorado Hannah Gilbert, 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, 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 Session 2 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#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 Session 3 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#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 Session 4 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#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 Allie, Quality Improvement Compliance Coordinator, 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 Session 1 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#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, Privacy Manager, UK Healthcare, Univ of KY 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, Senior Compliance Executive, Healthicity 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 Session 2 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#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 Session 3 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#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, Human Subjects, Indiana University
Research#702702 - Investigator Initiated Trials (IITs): Addressing the Challenges of Auditing IITs for Compliance and GCP Wendy Portier, Independent Consultant, Kelly Willenberg and Associates 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, Research Integrity Officer, 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 Session 4 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#801801 - Importance of Ensuring Blockchain Compliance For Your Institution Wendy Charles, Research Compliance Manager, Denver Health
Research#802802 - Dealing with Data: Non-technical Thoughts Concerning Data Security and Management John Baumann, Associate Vice President for Research Compliance, Indiana University Bethany Johnson, University Director, HRPP, Indiana University Hospital
- Blockchain technology is coming to your institution soon. It is important to learn the common research use cases of blockchain and understand why this technology will create advances in clinical research.
- The blockchain itself is secure, but there are still legal and security risks to your institution, such as uses of smart contracts.
- This presentation will teach how to oversee blockchain technology with regard to IRB submissions, FDA and HIPAA Security Rule regulations and considerations for state statutes.
Research#803803 - Radioactive Drug Research Committees- Do you have one? Do you need one? Do you want one? Katherine Cohen, Research Compliance Director, MedStar Health
- Review and identify challenges and obstacles for data security and protection of confidentiality
- Identify best practices for IRBs in the review of researchers plans for protection of data and confidentiality.
- Identify strategies for institutions to work with researchers and IRBs to develop and implement data management/ security strategies.
- Understand what a Radioactive Drug Research Committee (RDRC) is and what types of studies need RDRC review.
- It’s not just radiation safety! Overview of the requirements of an RDRC, including membership, committee operations, committee documentation and record keeping.
- If you don’t have an RDRC and decide you don’t want one, there are alternatives! Understand what those alternatives are to help you evaluate whether you can support an RDRC.
Wednesday, June 12
-Post Conference - Wednesday's Sessions Post Conference
08:30 AM - 10:00 AMBreakout Session 1 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#W1W1- Two Offices Divided by a Common Goal: CoI and IRB Review John Baumann, Associate Vice President for Research Compliance, Indiana University
Research#W2W2 - Mindful Cross Training: Framing an Effective Approach in the Present to Assist Your Institution’s Research Compliance Risks for the Future Ianthe Bryant-Gawthrop, Director, Research Regulatory Affairs and Human Research Protection Program, Purdue University Ryan Fayhee, Partner, Hughes Hubbard & Reed
- Identify points of overlap and divergence in the CoI and IRB processes.
- Identify best practices for CoI and IRB review of outside financial interests related to human subjects research.
- Assess the integrity of your institution’s CoI-IRB processes.
- Learn how research regulations can be interconnected. Presenters will develop strategies with workshop participants to engage in interactive examples using export controls and collaboration risks in non-traditional settings as a model.
- The group will develop framework to spark research compliance cross-training ideas appropriate for their institution and move past silos in research compliance efforts.
- The constantly changing landscape of research compliance demands awareness in many topics to identify when subtle signs can lead to larger concerns. Teach staff to identify bigger picture concerns early, including how and when to request a subject matter expert.
10:15 AM - 11:45 AMBreakout Session 2 Robyn Shapiro, Founder, Health Sciences Law Groups LLC#W3W3 - Integrating Community Hospital Based Research in a System Wide Network: Just Mix in Compliance, Collaboration, Billing, HIPAA, Central IRB, then Stir Until Done Paul Papagni, Executive Director of Research, Holy Cross Hospital Trinity Health Harriet Kinney, Director, Research Integrity & Compliance, Trinity Health
Research#W4W4 - Stage Two! - Applying Concepts Learned at the HCCA Research Academy over Consecutive Years Anne Daly, Chief Compliance and Integrity Officer, Children's Hospital of Chicago Medical Center Kimberly Zajczenko, Senior Director of Audit and Enterprise Risk Management, Children's Hospital of Chicago Medical Center Elizabeth Hernandez, Senior Privacy Analyst, Ann & Robert M. Lurie Children's
- Clinical Research on a Multi-site/Multi-state scale is not a Compliance Officers favorite undertaking, irrespective of financial and staffing resources available. Build an expert team with Collaboration and Communication as central themes.
- Integrating a successful Community Hospital Model across an entire Healthcare Network creates a whole new set of workflows and challenges to overcome.
- Operational models centralized vs decentralized: when to consider centralizing operations and regulatory oversight and what needs to remain decentralized? Establishing Compliance Oversight and Metrics.
- After presenting last year on using the HCCA Research Academy as a starting point, presenters will share the experience of assessing and building new infrastructure and connection between Research and Corporate Compliance.
- Presenters will engage with attendees to identify and categorize obstacles and opportunities that present in building a cooperative model of Research Compliance between clinical and research entities.
- Presenters will encourage discussion and assessment of tools and activities that enable effective collaboration and help avoid or mitigate risk of research noncompliance.
Agenda subject to change.