#101

101 - 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 View Description

• 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

#102

102 - 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 View Description

• 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.

Research

#103

103 - Navigating Federally Sponsored Projects Abroad: Common Compliance Challenges and Solutions Katherine Morga, Sr. Associate, Hogan Lovells Adilene Rosales, Associate, Hogan Lovells US LLP View Description

• 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.

Research

#201

201 - 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 View Description

• 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

#202

202 - Research Privacy and Security Considerations Beyond HIPAA: What are the Compliance Concerns? Marti Arvin, Executive Advisor, CynergisTek, Inc. View Description

• 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.

Research

#203

203 - From Paper to Electronic: Evolution of an IACUC Protocol Management System Denise Ancharski-Stutler, IACUC Administrative Director, Children's Hospital of Philadelphia View Description

• 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

Research

#301

301 - Clinical Trials Compliance Collaboration Builds Effectiveness Stephanie DeRijke, Director, Clinical Trials Audit and Compliance, Emory University Anne Adams, Chief Compliance Officer, Emory Healthcare, Inc View Description

• 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.

Research

#302

302 - 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 View Description

• 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.

Research

#401

401- 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 View Description

• 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.

Research

#402

402 - 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 View Description

• 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.

Research

#501

501- 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 View Description

• 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

#502

502 - 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 View Description

• 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.

Research

#503

503 - Mining the Sunshine Data: Finding Potential Conflicts of Interest Charles Wolf, Director, Conflict of Interest, Intermountain Healthcare Paul Papagni, Executive Director of Research, Holy Cross Hospital Trinity Health View Description

• 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.

Research

#601

601- 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 View Description

• 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

#602

602 - "GDP - What? How the European Union General Data Protection Regulations Impact Research" Karen Hartman, Division Chair, Research Administration, Mayo Clinic View Description

• 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.

Research

#603

603 - Export Controls in Medical Research: Compliance Considerations for International Collaborations Scott Long, Chief Compliance Officer, St Jude Children's Research Hospital View Description

• 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.

Research

#701

701- 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 View Description

• 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

#702

702 - 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 View Description

• 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.

Research

#703

703 - The Dos and Don’ts of Investigating Research Misconduct Cases Sarah Archibald, Research Integrity Officer, Univ of Maryland-Baltimore View Description

• 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.

Research

#801

801 - Importance of Ensuring Blockchain Compliance For Your Institution Wendy Charles, Research Compliance Manager, Denver Health View Description

• 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

#802

802 - 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 View Description

• 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.

Research

#803

803 - Radioactive Drug Research Committees- Do you have one? Do you need one? Do you want one? Katherine Cohen, Chief Compliance Officer, Southern Illinois University Medicine View Description

• 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.

Research

#W1

W1- Two Offices Divided by a Common Goal: CoI and IRB Review John Baumann, Associate Vice President for Research Compliance, Indiana University View Description

• 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.

Research

#W2

W2 - 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 View Description

• 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.

Research

#W3

W3 - 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 View Description

• 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.

Research

#W4

W4 - Stage Two! - Applying Concepts Learned at the HCCA Research Academy over Consecutive Years Anne Daly, Chief Compliance & Integrity Officer, Children's Hospital of Chicago Medical Center Kimberly Zajczenko, Senior Director of Audit and Enterprise Risk Management, Ann & Robert H. Lurie Children's Hospital of Chicago Elizabeth Hernandez, Senior Privacy Analyst, Ann & Robert M. Lurie Children's View Description

• 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.

Research