P1 | Operationalizing Government Corrective Action Plans: Aftermath of an OCR Investigation

• Discuss key components of carrying out a CAP: People, Planning and Process
• Consider unanticipated government challenges, external resources and cost
• Discover what complex organizations should consider in their training programs

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

P2 | Clinical Research Billing Audits: It’s (Almost) All in the Planning!

• Understand how to plan and prepare to perform a research billing audit including document concordance review processes
• Review claims against the coverage analysis and the billing rules including Medicare Advantage and coding
• Identify useful data to capture during a clinical research billing audit for analysis, calculating error rates, overpayments, and underpayments

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

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

P3 | Corrective and Preventive Actions (CAPA) Plans that Guide Clinical Research Professionals in Improving Weaknesses, Deficiencies, or in Rectifying Deviation Patterns and Areas of Noncompliance

• Specify the elements that structure effective corrective and preventative action plans
• Demonstrate writing and developing effective corrective and preventative action plans
• Distinguish between a corrective action and preventative action

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

Handout 1
Handout 2

P4 | Transforming a Community Health-Based Research Organization: Strategy and Lessons Learned

• Learn about Mercy Research’s strategy in becoming a dedicated, centralized, fully integrated research organization within Mercy, a top five, large community health system headquartered in St. Louis, MO with operations in four states
• Gain insight into Mercy Research’s Supersite™ strategy and its value to clinical researchers and sponsors
• In the context of those strategies, hear about real-life challenges and lessons learned regarding (1) IRBs, (2) centralized regulatory and business operations, (3) standard start-up, business and clinical processes, and (4) change management

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

General Session 1 | Research Year In Review

• This session is designed to cover all new laws, regulations and guidance promulgated by the government in the area of research
• The session will outline new research related enforcement initiatives and settlements by the Department of Justice and the Office of Inspector General
• The speaker will describe the implications of these laws, regulations and guidance on research programs and will suggest affirmative actions to be considered to strengthen research compliance programs for universities, academic medical centers, hospitals, CROs and other research organizations

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

101 | Turn On, Tune In, Collect Data: Conducting Clinical Investigations with Controlled Substances

• Schedule I Controlled Substances such as marijuana and Ecstasy show promise in treating certain conditions like epilepsy and PTSD, but, by law, these substances are considered to have no medicinal use. How can they be used in clinical trials?
• This session will help attendees understand how to legally conduct these trials, including working with regulators, obtaining controlled substances for research, establishing security protocols, and properly disposing of test articles
• Human subjects research considerations, planning for adverse events, and communications strategies regarding these controversial studies also will be discussed

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

102 | PI Compensation: Compliant Methods, Documentation, and Execution

• Assuring compliant payments to investigators with regard to Fair Market Value (FMV), Stark Laws and Anti-Kickback Statute
• Different PI Payment Model Pros and Cons
• Compliant Investigator agreement considerations
• Appropriate budget development
• Tactics for Execution: CTMS utilization and compliant documentation

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

103 | Anatomy of a Research Misconduct Issue

• The governing statutes and policies
• What is the research compliance officer’s role in managing the process?
• Where the rubber has met the road: case studies and examples

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

201 | Community Hospital Research Programs: A Compliance Officer’s Friend or Nightmare

• Building a successful research program in a community hospital setting can be a disaster or a delight for a compliance officer depending on the level of collaboration in building/perfecting the model
• Often research was not on the Compliance Officer’s radar until processes were already in place. But a collaborative approach to FDA/OHRP Regulations, Research Billing, COI, Quality Controls, FMV, Stark and Sunshine Act Concerns will yield best practices
• Operational models centralized vs decentralized: when to consider operationalizing operations and regulatory oversight. Reporting metrics to assist Compliance Oversight

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

202 | Strategies to Effectively Monitor Researchers’ Access to the EMR

• Identify steps to initiate a data exchange between the Internal Review Board (IRB) submission process and HIPAA Privacy Officers that expands IRB forms to collect structured patient characteristics (e.g., ICD-10 codes) to define research cohorts
• Discuss ways to adjust existing HIPAA access monitoring processes to incorporate IRB-approved patient cohorts to detect accesses outside of research protocols
• Learn methods to approach research staff to facilitate a culture of compliance within your organization

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

203 | An Integrated Model for Building and Maintaining an Effective Research Compliance Program in an Academic Research Center

• Research Compliance as a Shared Responsibility: Research Compliance, Research Affairs and Corporate Compliance
• Integrated Approach to Shared Goals and Diversified Implementation Practices
• Strategies for Addressing the Challenges of Research Compliance in a Small Research Program

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

301 | Optimizing Research Compliance within the Electronic Health Record (EHR) System

• Incorporating Research Within the Electronic Health Record (EHR) System
• Standardization of documentation and billing processes
• Mining of EHR for research

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

302 | Conflict of Interest 2.0: Beyond Data Collection

• Join us while we review the intricacies of COI policy evolution
• We’ll discuss updates and advancements in CMS’ Open Payments Database
• We’ll provide useful skills and tools to help you conduct investigations and implement conflict management plans

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

303AD | Thorny Clinical Research Billing and Coverage Issues

• Discuss challenges with Medicare Advantage Patients
• Review billing for screening tests
• Explore what happens when insurance rules conflict with medical necessity

No presentation or handouts available

401 | Research Compliance Risks and HIPAA Privacy Pitfalls in a Healthcare Academic Setting

• Investigator Initiated studies increase the risk for Compliance issues
• Collaboration with IRB and other affiliated groups to achieve compliance objectives
• HIPAA privacy/security pitfalls

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

402 | Integrating Research Integrity with Corporate Compliance

• Consider how research integrity fits within enterprise risk management for academic medical institutions. Acknowledge the risk profile of colleges, universities, and other recipients of public funds that conduct biomedical and behavioral research. Confirm current expectations from government stakeholders
• Identify the basic elements of a compliance program—and affiliated research integrity offices
• Share the value proposition of integrating research integrity compliance within the culture’s broader values and code of conduct to encourage reporting and corrective action. Understand the elements of a mature, integrated, effective program—suggest approaches to measure effectiveness

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

403 | Getting to Compliant: Personal Protective Equipment Use in the Non-Clinical Research Setting

• To understand the compliance concerns around personal protective equipment use in the non-clinical research lab setting
• To identify PPE compliance challenges faced by research compliance professionals in the academic medical center setting based on organizational structure and physical space
• To learn strategies for PPE compliance program and policy development

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

General Session 2 | Whistleblowers in the Research Setting

• Provide an overview of the False Claims Act and its impact in the research setting
• Review recent guidance from the OIG that OHRP should inform potential complainants on how they can seek whistleblower protections
• Discuss proactive steps and best practices for your institution to take regarding whistleblowing issues

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

General Session 3 | The Revised Common Rule: What Should We Do Now

The past few years have seen a previously-unprecedented level of change to Federal statutes, regulations, and policies applicable to human subjects research. These include the substantial changes to the “Common Rule,” the Federal regulations that protect human subjects in research. The session will:

• Describe significant recent developments in the Federal regulation of human subjects research, focusing on the revised Common Rule
• Address the challenges involved with integrating the revised Common Rule’s new mandates and flexibilities within the existing system of Federal law and policy
• Identify decision points for regulated entities working toward implementation of the revised Common Rule

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

501 | It All Starts in a Lab! Laboratory Issues and the Research Regulatory Environment

• What kinds of research are covered by research laboratory regulations: does size matter?
• What the heck is “Dual Use” and are fertilizers included?
• Tales from the crypt: you never know who might be “interested” in your institution

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

502 | Implementing a Research Compliance Program in a Large National Healthcare System

• Applying research compliance policies in many different community hospital and academic medical center environments
• Importance of communicating and collaborating with national and local division research management and compliance team members
• Oversight and monitoring of clinical trial billing, conflict of interest and research privacy and information security

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

503 | The Tissue Issue: Perspectives on Protection and Privacy Issues in Data/Tissue Repositories

• Discuss recent regulatory changes impacting use of biospecimens for research, including new Common Rule requirements
• Discuss the potential regulatory pitfalls of allowing broad consent for storage and use of biospecimens
• Identify best practices for protection of data and confidentiality while encouraging sharing in repositories

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

601 | 601 Conflict of Interest: Is it My Problem or Yours?

• Where does your COI for research sit? The session will examine the pros and cons of your research COI sitting with research vs. an integrated approach with the general hospital process
• Session will look at how to integrate COI review into your IRB processes when the IRB isn’t the responsible body for the review
• Logistics for managing conflicts and setting internal guidelines, including institutional conflicts of interest outside of an academic setting

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

602 | Self-Imposed Regulatory Burden in Animal Research Oversight

• Review why self-Imposed regulatory burden is pervasive in animal research oversight
• Identify self-imposed regulatory burden in animal research oversight policies and procedures
• Determine how to decrease or eliminate self-imposed regulatory burden by incorporating appropriate risk mitigation strategies in animal research oversight

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

AD603 | FDA Compliance at-a-Glance

• Enforcement trends and hot issues in the Agency’s bioresearch monitoring efforts
• Recent Agency initiatives in the regulation of clinical trials
• Best practices and tips for achieving compliance and avoiding enforcement issues

No presentation or handout available

701 | Strategies to Promote Physician Investigator GCP Compliance

• Examine common GCP compliance errors made by physician investigators
• Explore underlying causes of GCP compliance errors
• Discuss strategies to promote physician investigator GCP compliance

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

702 | Does the Thought of International Research Keep You Up at Night?

• Identify areas of risk for your organization such as research activities, foreign nationals, shipping, travel, etc
• Discuss institutional strategies for assessment of risk for international research activities
• Describe strategies to identify, manage, and monitor international research activities

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

AD703 | The IRB and Research Compliance: A Crucial Partnership

• To what extent does the: IRB have a compliance function, does the larger organization have oversight over the IRB
• What is the relationship between your IRB and your research compliance program
• What is the ideal partnership between the IRB and Compliance

No presentation or handout available

801 | Auditing in a Post–Common Rule World

• Understanding the retroactive application of the revised Common Rule
• Highlighting key areas where pre and post rules will make a difference when auditing study and IRB committee files
• Top three areas to focus audit activity in post–Common Rule world

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

802 | Outcome Unknown: The Ethics and Mechanics of Informed Consent in Research Involving Genomics, Questionable Pre-clinical Results, and the Risk of Death

• The Current and Revised Common Rule framework for obtaining Informed Consent
• Ethics of obtaining Informed Consent for research that involves the unknown and currently unknowable, including genomic research, future undefined research, significant risk studies involving death as a risk
• Case study: When a healthy volunteer died in a European clinical trial for a new FAAH Inhibitor pain and mood disorder medication, the Temporary
• Specialist Scientific Committee’s call for further clarification regarding use of healthy volunteers in light of troubling animal study results

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

803 | Facilitating Compliance with 21 CFR Part 11

• Identify purpose and scope of 21 CFR Part 11, including who must comply and risks of non-compliance
• Best practices for expanding organizational awareness and facilitating compliance
• Understand steps and elements of auditing a site for 21 CFR Part 11 compliance, including inspection readiness

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

General Session 4 | Clinical Trial Agreements and Unintended Compliance Issues

• Discuss fair market value and research rates
• Explore strategies for efficient CTA negotiations

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

W1 | A Case Study of the Implementation Process

• Presenters will review the infrastructure and activities presented and recommended at the HCCA Research Conference and describe how the conference program recommendations were assessed for applicability in their entity’s environment
• Presenters will describe how program recommendations were prioritized for implementation and staged for rollout
• The presenters will describe obstacles encountered and solutions deployed to overcome prioritize activities and overcome challenges to enhancing research compliance program activities

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

W2 | Grant Compliance for Dummies

• Of course there are no dummies in compliance. This session is aimed at those (fairly) new to sponsored research compliance
• The session will start with the basics and review the Uniform Guidance and the cost principles and how these regulations shape sponsored research administration
• We will talk about how these, and other, regulations drive requirements for grant funded activity and how you can apply them in your day-to-day responsibilities

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

W3 | Patient Privacy In Research Under HIPAA and the Additional HIPAA and Privacy Issues Related to Big Data Sets

• Discussion of the relative risks under HIPAA among research stakeholders including the PI, IRB, grants and contracts, sponsors and more
• The additional issues when discussing HIPAA, privacy and big data
• Other considerations when thinking about creating and maintaining big data sets

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

W4 | Dissecting the Clinical Trial Agreement: Avoiding Compliance Pitfall in Clinical Trial Agreements

• Briefly review the Medicare research billing rules, the Federal False Claims Act, and other Federal laws
• Discuss how those laws and regulations can impact the CTA negotiations
• Analyze some real cases to learn what they teach us about CTA drafting and structure

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