2019 Research Compliance Conference

1. Integrating Community Hospital Based Research in a System Wide Network: Just Mix in Compliance, Collaboration, Billing, HIPAA, Central IRB then Stir Until Done

   2019 Research Compliance Conference  | Presenter(s): Paul Papagni, Harriett Kinney  | June 12, 2019 

   • Clinical Research on a multi-site/multistate scale is not a Compliance Officer’s 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

2. Mindful Cross Training: Framing an Effective Approach in the Present to Assist Your Institution's Research Compliance Risks for the Future

   2019 Research Compliance Conference  | Presenter(s): Ianthe Bryant-Gawthrop, Ryan P. Fayhee  | June 12, 2019 

   • 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

3. Stage Two! - Applying Concepts Learned at the HCCA Research Academy over Consecutive Years

   2019 Research Compliance Conference  | Presenter(s): Anne Daly, Kimberly Zajczenko, Liz Hernandez  | June 12, 2019 

   • 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

4. Two Offices Divided by a Common Goal: CoI and IRB Review

   2019 Research Compliance Conference  | Presenter(s): John Baumann  | June 12, 2019 

   • 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

5. Importance of Ensuring Blockchain Compliance for Your Institution

   2019 Research Compliance Conference  | Presenter(s): Wendy Charles  | June 11, 2019 

   • 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

6. ClinicalTrials.gov: Oversight and Compliance at a Diverse Academic Research Center

   2019 Research Compliance Conference  | Presenter(s): Melanie Chladny, Linda Mendelson  | June 11, 2019 

   • 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

7. GENERAL SESSION: HHS OIG and Research Compliance

   2019 Research Compliance Conference  | Presenter(s): Gregory Demske  | June 11, 2019 

   • OIG’s Role

   • Risk Areas

   • OIG Civil Money Penalties

   • OIG Grant Self‐Disclosure Program

8. Dealing with Data: Nontechnical Thoughts Concerning Data Security and Management

   2019 Research Compliance Conference  | Presenter(s): John Baumann, Bethany Johnson  | June 11, 2019 

   • 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

9. Mining the Sunshine Data: Finding Potential Conflicts of Interest

   2019 Research Compliance Conference  | Presenter(s): C.J. Wolf, Paul Papagni  | June 11, 2019 

   • 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

10. Export Controls in Medical Research: Compliance Considerations for International Collaborations

    2019 Research Compliance Conference  | Presenter(s): Scott Long, Wendy Epley  | June 11, 2019 

    • 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

11. GDP - What? How the European Union General Data Protection Regulations Impact Research

    2019 Research Compliance Conference  | Presenter(s): Karen Hartman, Robyn Shapiro  | June 11, 2019 

    • 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

12. GENERAL SESSION: Case Studies in Clinical Research Billing Risk

    2019 Research Compliance Conference  | Presenter(s): Ryan Meade  | June 11, 2019 

    • Review “hard cases” in clinical research billing

    • Discuss guiding principles when stuck in the “gray area”

    • Explore what to do when the rule do not seem to fit

13. Investigator Initiated Trials (IITs): Addressing the Challenges of Auditing IITs for Compliance and GCP

    2019 Research Compliance Conference  | Presenter(s): Wendy Portier, Gabriella Neff  | June 11, 2019 

    • 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.

14. Radioactive Drug Research Committees: Do you have one? Do you need one? Do you want one?

    2019 Research Compliance Conference  | Presenter(s): Katherine Cohen  | June 11, 2019 

    • 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

15. Relying on Someone Else's IRB: Why, When, and How for Hospitals and Academic Medical Centers

    2019 Research Compliance Conference  | Presenter(s): Amy Waltz, Bethany Johnson  | June 11, 2019 

    • 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.

16. Research Billing Compliance Program - From Zero to 100 in 60 seconds!

    2019 Research Compliance Conference  | Presenter(s): Isai Senthil, Kelly Ritter  | June 11, 2019 

    • 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 two short years

17. Research PHI in the Cloud: Human Subjects Protection Transformed

    2019 Research Compliance Conference  | Presenter(s): Rebecca Scott, Darin Poynter  | June 11, 2019 

    • 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

18. GENERAL SESSION: Reflecting on the Revised Common Rule: Lessons Learned and Deep Thoughts

    2019 Research Compliance Conference  | Presenter(s): Laura Odwazny, Heather Pierce  | June 10, 2019 

    • The rollout of the revised Common Rule and interpretative agency guidance

    • Challenges involved with integrating the revised Common rule’s new mandates and flexibilities within the existing system of human subjects research law and policy

    • Key decision points for regulated institutions responsible for implementing the revised Common Rule’s requirements

19. Adapting to New Hazardous Drug Requirements in Research Settings

    2019 Research Compliance Conference  | Presenter(s): Anita Austin, Carrie B. Dunford  | June 10, 2019 

    • New safe handling and storage requirements for research hazardous drugs

    • Key components of a research hazardous drug risk assessment

    • Cost considerations for research centers to achieve compliance with new USP 800 regulations

20. Clinical Trials Compliance: Collaboration Builds Effectiveness

    2019 Research Compliance Conference  | Presenter(s): Stephanie deRijke, Anne Adams  | June 10, 2019 

    • 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

21. Compliance through Collaboration: Partnering with Independent IRBs to Develop and Maintain a Strong Human Research Protection Program (HRPP)

    2019 Research Compliance Conference  | Presenter(s): Cynthia Hahn, Hallie Kassan  | June 10, 2019 

    • Provide an overview of the current regulatory and business climate for IRB review, including the NIH Policy on IRB review and changes to the Common Rule at 46 CFR 46

    • Discuss models for IRB 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

22. Demystifying Human Subjects Research Versus Quality Improvement: A Compliance Case Study

    2019 Research Compliance Conference  | Presenter(s): David Staley, Hannah Gilbert  | June 10, 2019 

    • 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

23. Demystifying Partial Waivers of Consent and Authorization

    2019 Research Compliance Conference  | Presenter(s): Andrea Seykora, Melinda Allie, Kaija Maggard  | June 10, 2019 

    • 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

24. GENERAL SESSION: Research Year in Review 2019

    2019 Research Compliance Conference  | Presenter(s): Lisa Murtha  | June 10, 2019 

    • 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

25. Exploring Observational Registries and Human Subject Research: Progress Where Ambiguity is the Only Constant

    2019 Research Compliance Conference  | Presenter(s): Mark Fox  | June 10, 2019 

    • 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