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Handouts - 2017 - National - Research

Sunday, June 4 | Pre-Conference



P1 | The Most Challenging Provisions in CTAs

  • This session will discuss the most challenging provisions in sponsor template clinical trial agreements
  • The speakers will provide alternative language that institutions might consider using that are designed to protect both parties to the agreement
  • Participants will be encouraged to discuss approaches they use to negotiate these provisions

Presentation (2 slides/page)
Presentation (3 slides/page)

Michael C. Roach, Managing Director, Aegis Compliance & Ethics Center, LLP

P2 | Investigator Initiated Trials: Common Startup Struggles and Oversights

  • The administrative responsibilities involved in IIT startup are unfamiliar as they are normally taken on by industry sponsors and outside agencies. Mistakes made during the initial development and start up stages can cause compliance and financial issues
  • Provide a walkthrough of how to define and portray the intent of the objectives (interventional vs observational) and qualifying status of study in order to determine compliant billing strategy, precisely assess financial feasibility and maximize profit
  • We will also provide suggestions on how to educate PIs about coverage analysis billing designations and on their startup responsibilities as study Sponsors in order to streamline processes

Presentation (2 slides/page)
Presentation (3 slides/page)

David B. Russell, Director, Site Strategy, PFS Clinical

Liz Christianson, Senior Clinical Research Analyst, PFS Clinical

P3 | Enterprise Solutions for Implementing Effective Corrective Action and Prevention Plans (CAPA) Following Internal Audits of Clinical Research Trials

  • Review Internal Audit Debriefing Steps for Clinical Trial PIs and Study Team Members
  • Describe the Use of Self-Monitoring, Content Experts, Peer Mentors, Institutional Leaders and Novel Educational Platforms for Engaging PIs/ Study Teams in the Corrective Action Process
  • Discuss Strategies for Evaluating the Organizational Effectiveness of Corrective Action Planning

Presentation (2 slides/page)
Presentation (3 slides/page)

Ann N. Sieber, MS, CIP, CHRC, Dir, Clinical Research Services, Sponsored Program Administration, UT Southwestern Medical Center

Deepika Bhatia, MSBME, CCRP, CHRC, Assist. Director - Research & Academics Compliance, UT Southwestern

Trissi S. Gray, MBA, CHRC, Assistant Director, Health System Compliance, UT Southwestern Med Center

P4 | How Research Risks Affect Compliance

  • Research risks “need to know” for compliance officers
  • Reducing research risks using preliminary risk assessments
  • Effects of research risks on approvals, consent, indemnifications, and risk management

Presentation (2 slides/page)
Presentation (3 slides/page)

Sarah Fowler-Dixon, Education Specialist, Human Research Protection Office, Washington University School of Medicine


Monday, June 5



General Session 1 |
Research Year In Review

Presentation (2 slides/page)
Presentation (3 slides/page)

F. Lisa Murtha, Senior Managing Director, FTI Consulting

101 | Against Tradeoffs: Improving Compliance and Researcher Satisfaction

  • Research compliance is often characterized by the need to accept trade-offs between compliance and researcher satisfaction. This session will focus on opportunities to improve both
  • Excessive compliance requirements (or those perceived as such) can actually increase compliance risk given a human tendency to find ways around barriers to success
  • Some compliance requirements, sometimes even the most painful ones, cannot and should not be removed. But there are ways to reduce researcher burden

Presentation (2 slides/page)
Presentation (3 slides/page)

Matthew W. Staman, Managing Director, Huron Consulting Group

Marisa Zuskar, Director, Huron Consulting Group

Anne Pifer, Senior Director, Huron Consulting Group


102 | Compliance Implications for the Commercialization of Federally Funded Research

  • The Bayh-Dole Act imposes several policy and compliance obligations on universities and institutions receiving federal funding for research, particularly when research results in an invention
  • Many Compliance Officers are unaware of these obligations. Failure to meet all compliance requirements may result in a loss of rights or federal funding support
  • This presentation will discuss institutions’ Bayh-Dole obligations and how to implement policy and procedures to ensure that your university is and remains compliant

Presentation (2 slides/page)
Presentation (3 slides/page)

Bethany H. Loftin, Chief Operating Officer, TreMonti Consulting LLC Ann Hammersla, Dir., Div of Extramural Invent. and Tech Resources, National Institutes of Health

201 | The Intersection Between Medicare Coverage Analysis, IRB Review, and Informed Consent

  • Review the Medicare Clinical Trial Policy and FDA/HHS regulations governing IRB review and the protection of human research subjects, highlighting the intersections between them
  • Describe one institution’s approach to integration of the Medicare Coverage Analysis (MCA), IRB review and creation of the consent form
  • Present a process where risks of the study and financial obligations are integrated into the consent form based on the MCA

Presentation (2 slides/page)
Presentation (3 slides/page)

Linn Defensor, Sr. MCA Analyst, Cedars-Sinai Medical Center

Keren Dunn, Manager, Research Compliance & QI, Cedars-Sinai Medical Ctr.

202 | Managing Preclinical Risk to Protect Data Integrity, Animal Welfare, and Human Subject Safety

  • Understand the laboratory development of biomedical technology from the bench to the bedside
  • Understand how compliance oversight, and risk management can help lead to quality, reproducible data, increased animal welfare, and safe foundational knowledge for early phase clinical trials
  • Review and discuss relevant cases that exemplify researcher and subject risk, and how they affect bench research, animal studies, and early phase clinical trials

Presentation (2 slides/page)
Presentation (3 slides/page)

Stephen A. Frattini, DVM, Preclinical Research Compliance Manager, Northwell Health

Alison Powell, Research Compliance Manager, Northwell Health

301 | Want to Participate in Research? There’s An App for That: Security and Privacy Issues with the Increased Use of Connected Devices, Apps and Social Media In Research

  • What are the ways apps, medical devices, and social media are being used in research?
  • What are the privacy and information security issues around this?
  • How can you help researchers minimize the risk?

Presentation (2 slides/page)
Presentation (3 slides/page)

Marti Arvin, Vice President, Audit Strategy, CynergisTek, Inc

David Mata, Senior Associate, Aegis Compliance and Ethics Center

302 | Managing Research Compliance Utilizing an Electronic Compliance Database System

  • The use of an electronic compliance database manager we developed provides a real-time method for coordinating managing, and documenting aspects of compliance for research related activities in the health-care setting
  • The electronic compliance database manager provides the tool to organize individual research related activities of compliance, tailored to the demands required based on the research project being conducted
  • The use of an electronic compliance database manager provides the compliance specialist to ability to organize, validate, audit, report, trend, and assess all research compliance requirements, in an effort to ensure compliance to research conducted

Presentation (2 slides/page)
Presentation (3 slides/page)

Mike Jensen, Intermountain Healthcare

Good Clinical Practice: Interactive Discussion On Maintaining GCP in a Compliant Driven World

  • A discussion of challenges between academic medical center environments and affiliated hospitals and possible solutions
  • Understand implications for human subject research conducted “outside” of HIPAA covered entities
  • Understand compliance challenges when issues arise that impact two separate legal entities

No presentation or handouts available

Kelly Willenberg, Owner, Kelly Willenberg and Associates

401 | Where Is the Data? Risks of Data Location, Storage and Protection of Sensitive Protected Health Information (PHI)

  • This session focuses on locating sensitive data and PHI and tips for safeguarding the institution when these types of data both enter and exit the institution
  • What is a Research Data Security Plan and how can sensitive paper, electronic data and PHI be monitored across an institution?
  • As faculty come and go, what considerations should be discussed with regard to the transfer of data between institutions?

Presentation (2 slides/page)
Presentation (3 slides/page)

Margaret M. Groves, Associate Compliance Officer, HSRC, Duke University Office of Audit, Risk and Compliance

Holly B. Benton, Director, Privacy Compliance, Duke University Office of Audit, Risk and Compliance

402 | Finding Flexibility in the IRB Regulations: How to Reduce Burden

  • Flexible IRB review allows for greater efficiency while maintaining legal requirements. Learn how to identify where you can be flexible in your review
  • Hands on flexible policies will be presented to showcase how institutions have chosen to apply the federal rules
  • A discussion of HIPAA and single IRB of record will occur and how to implement this at your institution

Presentation (2 slides/page)
Presentation (3 slides/page)

Handout 1 (2 slides/page)
Handout 2 (3 slides/page)

Mariette Marsh, Director, Human Subjects Protection Program, The University of Arizona

General Session 2 |
Update on the Revisions to the Common Rule

  • Provide an overview of the final rule, published January 20, 2017, revising the U.S. Federal human subjects protection regulations (the “Common Rule”)
  • Discuss the planned effective date of the final rule provisions and implementation considerations for research institutions
  • Address how the revised Common Rule intersects with requirements of the 21st Century Cures Act

Presentation (2 slides/page)
Presentation (3 slides/page)

Laura Odwazny, Senior Attorney, Public Health Division, Office of the General Counsel, U.S. Department of Health and Human Services


Tuesday, June 6



General Session 3 | 
Cause and Effect: False Science = False Claim

  • Discussion of the amendments to the False Claims Act that pertain to the research arena
  • Examples of False Claims Act liability in the research arena
  • Lessons learned from False Claims Act research cases

Presentation (2 slides/page)
Presentation (3 slides/page)

Margaret (Peg) Hutchinson, Chief, Civil Division, U.S. Attorney’s Office for the Eastern District of Pennsylvania

501 | Creating Infrastructure Support for Investigator-Initiated Research

  • Share best practices in providing support to investigators and study teams for investigator-initiated, FDA regulated studies
  • Discuss support activities including tools and templates for FDA submissions, creation of a database for tracking FDA submissions, resources for reporting, and monitoring activities
  • Describe models of support using a case example approach from one Academic Medical Center

Presentation (2 slides/page)
Presentation (3 slides/page)

Karen A. Hartman, Administrator - Research Compliance, Mayo Clinic


502 | Defining and Streamlining Review of Reportable Events

  • Review regulatory requirements for IRB review of important events in research (AEs, UPs, NC)
  • Share best practices to streamline investigator reporting to IRBs and IRB review
  • Discuss work flow to promote efficiency of IRB review and consistency of IRB determinations

Presentation (2 slides/page)
Presentation (3 slides/page)

Emily Smotherman, Research Comp Mgr, Children’s Healthcare of Atlanta

Sarah Marie Huban, IRB Manager, Children’s Healthcare of Atlanta

Interactive Coverage Analysis Workshopping: Three Case Scenarios

No presentation available

Ryan Meade, CHRC, CHC-F, Director of Regulatory Compliance Studies, Loyola University Chicago, School of Law

601 | Effectively Managing and Monitoring Controlled Substances in Research

  • Key regulatory and policy considerations for laboratory, animal and clinical research programs
  • Working effectively with environmental health and safety, researchers, security, pharmacy and administration on controlled substance management in research
  • How to integrate controlled substance reviews into your compliance program

Presentation (2 slides/page)
Presentation (3 slides/page)

Emmelyn Kim, AVP, Research Compliance & Privacy Officer, Northwell Health

Ji-Eun Kim, Research Pharmacist, Northwell Health

602 | The Federal What…? 
Using the FSG as Organizing Principles for a Research Compliance Office

  • Propose a modified version of the FSG as organizing principles for an Office of Research Compliance
  • Illustrate how the standards of the major research compliance accrediting bodies (AAHRPP and AAALAC) map onto the FSG.
  • Illustrate how the FSG can be used to develop standards for other research compliance areas such as the IBC and Export Control

Presentation (2 slides/page)
Presentation (3 slides/page)

Robert S. Bienkowski, Director of Research Compliance, Central Michigan University

701 | Navigating Animal Research Compliance and Managing Risks

  • Describe trends and challenges of Post‑Approval Monitoring Programs (PAM)
  • Identify risks affecting animal research and discuss strategies to implement corrective and preventative actions
  • Discuss strategies for minimizing and mitigating risks

Presentation (2 slides/page)
Presentation (3 slides/page)

Denise Ancharski-Stutler, Assistant Director, Post-Approval Monitoring, Children’s Hospital of Philadelphia

702 | Sharing Is Caring: HHS Final Rule on Clinical Trials Registration and Results Information Submission

  • Provide an overview of the HHS Final Rule’s new requirements for registering certain clinical trials and submitting summary results information to
  • Discuss the complementary policy issued by NIH on registering and submitting summary results information to for all NIH-funded trials
  • Consider how the Final Rule and the NIH policy will impact various organizations and entities performing research

Presentation (2 slides/page)
Presentation (3 slides/page)

Anne Ruff, Attorney, Hall, Render, Killian, Heath & Lyman, PC

801 | The Push for More Transparency, and How Your Institution Can Keep Up with the Expanded Requirements, Tackle Systematic Changes, and Prepare for Enforcement

  • The Federal Regulatory Landscape under FDAAA: 42 CFR§11. With new deadlines, results reporting requirements, protocol uploads, enforcement, and PRS system changes, what do regulatory specialists and investigators need to know?
  • The new NIH policy and clinical trials definition: What trials are covered? What additional obligations apply?
  • What Are Your Pain Points? Building on attendees’ shared areas of concern, presenters will share solutions and best practices gleaned from scores of hours with top administrators around the country and staff

Presentation (2 slides/page)
Presentation (3 slides/page)

Diane Wilson, Compliance Specialist, Lead, University of Michigan Med School

Emily Ouellette, QI Program Assistant Director, FDA and Regulatory Support, Partners HealthCare

802 | Re-Organize the Research Program to Minimize Legal Risk and Maximize Compliance: A Case Study

  • The current state of clinical research and where risks are present
  • The research strategy/re-organization plan
  • Optimizing and growing the clinical research portfolio while managing change

Presentation (2 slides/page)
Presentation (3 slides/page)

Emma A. Meagher, MD, Vice Dean for Clinical Research & Chief Clinical Research Officer, Perelman School of Medicine, University of Pennsylvania

General Session 4 |
Progression of the Profession: Formal Education Trends In Developing and Recruiting Compliance Professionals

  • Learn about new programs and methods for developing the next generation of compliance professionals
  • Discuss benefits and challenges in hiring new graduates
  • Review approaches for recruiting new talent

Presentation (2 slides/page)
Presentation (3 slides/page)

Ryan Meade, CHRC, CHC-F, Director of Regulatory Compliance Studies, Loyola University Chicago, School of Law

Melanie R. Kay, Director, Daniels Fund Ethics Initiative, University of Colorado Law School

Alice M. BrightSky, Senior Director, Compliance Programs, Fordham Law School

Colleen Dorsey, Esq., Director, Organizational Ethics & Compliance, University of St. Thomas


Wednesday, June 7 | Post-Conference



W1 | Understanding and Applying the Guidance in Part 6: Internal Controls of the OMB Compliance Supplement

  • During this training session, we will be discussing the Office of Management and Budget (OMB) 2 CFR 200, Subpart F – Compliance Supplement. The session will incorporate an overview of Compliance Supplement, including important updates to Part 6 – Internal Controls.
  • We will break down Part 6, including answering questions such as:
    • How is Part 6 different from its predecessors?
    • How can your institution evaluate its internal control structure?
    • What should your institution consider when developing or supplementing the control environment?
  • Participants will gain insight on the application of Part 6 to the Single Audit, the role of internal controls in the compliance environment and specific strategies to evaluate the sufficiency of internal controls in light of Part 6.

Presentation (2 slides/page)
Presentation (3 slides/page)

Matthew W. Staman, Managing Director, Huron Consulting Group

Marisa Zuskar, Director, Huron Consulting Group

W2 | A Primer on Human Subject Protection Regulations for the Compliance Professional

  • Review the regulatory framework applicable to human research protections
  • Describe the responsibilities and requirements of the human research protection program
  • Identify common and high risk compliance areas related to human research protections

Presentation (2 slides/page)
Presentation (3 slides/page)

Scott Lipkin, DPM, CIP, Managing Director, Research & Compliance, FTI Consulting


W3 | Research Compliance Structures and Quality Systems

  • The constantly evolving field of clinical research—changes in regulations, guidance documents, increased oversight by regulatory agencies, and the increasing sophistication of research subjects—require us to pause and rethink current practices
  • The current climate requires awareness, implementation of a robust compliance structure, use of quality systems, and risk management approaches in short, a proactive rather than a reactive approach
  • Examples of positive changes, heightened awareness, and strategies for the implementation of new and strengthening of existing compliance structures and quality systems will be discussed and that compliance professionals should be seen as change agents

Presentation (2 slides/page)
Presentation (3 slides/page)

Johanna J. Stamates, Executive Director, University of Miami

W4 | Research Compliance Programs: Always a Work in Progress

  • Assess current state and evaluate opportunities for improvement
  • Identify the desirable enhancements and potential obstacles
  • Re-engineer the existing program and launch the new

Presentation (2 slides/page)
Presentation (3 slides/page)

Dwight Claustre, Director, Aegis Compliance & Ethics Center, LLP

Karen Mottola, Research Compliance Officer, Sutter Health