Research Compliance Conference

P1 Haven’t Seen a Conflict That Didn’t Interest Us

Speakers: Deepika Bhatia, Laila Aziz, Sefilat Ajishafe

• Emory's research portfolio and streamlining of COI infrastructure across the enterprise
• External program assessment, stakeholder collaborations for program development and redesign
• Policies, SOPs, trainings, and everything in between for a revamped compliant program

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P2 - Pursuing Research Compliance Program Effectiveness: Why It's Essential and How to Get There

Speakers: Katherine Cohen, Sarah Couture

1. Identify what effectiveness means for a research compliance program and why it matters
2. Provide a framework for evaluating your program effectiveness
3. Develop and plan a response to the evaluation and an ongoing plan for effectiveness.

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P3 – The Great Resignation, Compliance and How to Restock the Pond!

Speakers: Alexis Shaffer, Cynthia Dunn, Wendy Portier

1. Discuss the critical impact of research staff turnover on research study execution and how to mitigate potential compliance issues
2. Describe the strategies to attract, retain and motivate research staff to build a successful research program and share lessons learned
3. Identify challenges, opportunities, and successes when onboarding new staff and managing remote workers

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P4 - Privacy and data security issues in research: The ongoing struggle.

Speakers: Blaze Waleski, Marti Arvin

1. The challenges of multi-center studies, central IRBs, and approved documents. 
2. Secondary use of data by your organization or by others
3. Big data, data retention: risk and challenges.

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P5 – Navigating the Pitfalls of Research Compliance Auditing

Speakers: Dawn Pittinger, Gabriella Neff

1. Describe challenges in research compliance auditing
2. Identify and discuss opportunities to avoid pitfalls through collaboration
3. Develop a plan to improve outcomes utilizing audit results

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P6 – Identifying and Mitigating Organizational Risks in Research Compliance: A Case Example

Speakers: Cheryl Byers, Dawn Backlund

1. List the key components of a research compliance program
2. Identify the warning signs of research compliance concerns
3. Discuss ways in which an organization mitigated compliance risks

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P7 – Secondary uses of Research Data and Specimens – legal and compliance considerations

Speakers: Claire Tempel, Marcia Gonzales

1. Legal and regulatory safeguards 
2. Collaborations, consortiums and data sharing
3. Subsequent disclosures and uses by third parties

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P8 – Investigations, Root Cause, and Corrective Actions: Tools, Tips & Tricks

Speakers: Eleanor Kuszmar, Kele Piper

1. An organized approach to conducting an investigation:  checklists, timelines, scoping, and reports
2. I know what happened, how do I figure out why?  Using Root Cause Analysis to determine issues
3. How do I make sure it doesn't happen again?  Multi-level corrective action plans to address issues

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GS1 - General Session - Fiduciary Duties and Compliance Program Oversight: Helping Your Board Succeed

Speaker: Steve Ortquist

1. Understand Board of Directors’ duty of loyalty and duty of care 
2. Review recent case law and settlement developments affecting the board’s oversight duties 
3. Discuss strategies for helping your board succeed in its oversight role

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101 – Human Research Protection Programs and Research Operations: Partnering for Success

Speakers: Justin Osborne, Katherine Cohen

1. Examine the roles of the HRPP and research operations and identify overlap
2. Discuss bridging the gap between HRPPs and operations and establishing a partnership
3. Brainstorm how HRPPs and operations can support each other to ensure long term success

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102 – The CHIPS and Science Act of 2022: The New Compliance Challenges It Created, and Those That Are Still to Come

Speakers: Callan Stein, Michael Lowe

1. Identify the directives in the Act and forthcoming regulations that create new compliance challenges
2. Describe the practical/legal risks of these challenges and likely areas of high government scrutiny
3. Define compliance enhancements and risk mitigation strategies every research institute can implement

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103 – A Roadmap of Faculty External Affiliations: Investigating Disclosures and Understanding Impact

Speakers: Meredith Noto, Stacy Pritt, Vince Snoddy

1. Describe the scope of faculty relationships that create affiliations with external entities
2. Identify strategies to gather relevant context and implement appropriate oversight
3. Develop communication channels to promote internal congruence and systematic reporting of affiliations

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104 – Cardinal Sin in Research: Research Misconduct – What It Is, Relationship to Noncompliance and Responsibilities to Sponsors

Speaker: John Baumann

1. What is research misconduct and what are the processes undertaken upon receiving an allegation
2. The relationship between research misconduct and research non-compliance
3. What may be required if the research misconduct occurs in a project with an external sponsor— reporting and possible payback

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105 – Where Ethics, Compliance, Diversity and Rural Health Research Intersect!

Speakers: Kylie Sands, Wendy Portier

1. Describe the current landscape of rural health research and identify key stakeholders
2. Understand where rural health research intersects with human subjects protections (IRB review), compliance, diversity, and ethical principles
3. Identify actionable steps for sites, sponsors, and other key stakeholders for engaging and supporting rural sites

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106 – Unraveling Current US and Foreign Legislation Affecting International Research

Speakers: Kristin West, Xinning Shirley Liu

1. Take a deep dive into current US and international laws, regulations and related governmental policies affecting international research activities, with a focus on Chinese laws and regulations. Covered topics will include recent US efforts to protect research from foreign influence, China’s Personal Information Protection Law (PIPL) and other laws impacting privacy and data transfer, PRC Regulations on the Management of Human Genetic Resources and China’s Export Control Law.
2. Discuss practical implications of US and foreign laws and policies on international research
3. Share strategies and best practices on how to navigate complex issues such as monitoring research integrity in international collaborations, complying with data privacy regulations when conducting human subjects research, managing conflicts of interests and conflicts of commitment to address inappropriate foreign influence, enhancing export control compliance and other security considerations.

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107 - Managing and Auditing Federal Grants

Speaker: Summer Buchanan

1. Understand the various phases of the grant life cycle.
2. Identify key risks in post-award management.
3. Discuss various audit procedures to implement in your organization.
4. Review case study examples of non-compliance and discuss financial impact.

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108 - Navigating Data Protection Requirements and Participant Rights in Research Studies

Speaker: Andrew Mahler

1. Understand the current data protection and privacy rules that could apply to research data
2. Understand when and how research participants have rights to data collected about them
3. Discuss evolving rules and laws and the foundational ethical considerations

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GS2 - General Session: Research Year in Review

Speaker: F. Lisa Murtha

• This session will present relevant new laws, regulations, and guidance from federal and state government agencies on the conduct of research; and
• We will review new OIG Workplan and it’s research initiatives as well as key enforcement initiatives and settlements related to research.
• We will discuss novel approaches to addressing these new government initiatives within research compliance programs.

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GS3 - OHRP Compliance Oversight: What’s New

Speaker: Laura Odwazny

1. What’s new at OHRP
2. Ending of the COVID-19 public health emergency
3. Update on OHRP’s compliance oversight activities

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111 – Increasing Diversity in Clinical Research

Speaker: Jason Johnson

1. Identifying and understanding the importance and benefits of diversity in research 
2. Discussing recent FDA/NIH/state/industry laws, guidance and requirements for addressing diversity in research 
3. Practical strategies for increasing diversity in research to meet laws, guidance and requirements

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112 – Supercharge Your Compliance Infrastructure: Strategies for Data Management and Sharing (DMS) Policy Support

Speakers: Melissa Torres-Altoro, Stacy Pritt

1. Identify the administrative infrastructure to support the NIH Data Management and Sharing Policy
2. Learn how to effectively communicate new policy requirements to researchers
3. Discuss the latest developments with the NIH Data Management and Sharing Policy

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113 – Did Someone Say DIVERSION? What to Do When Controlled Substances Go Missing

Speakers: Eleanor Kuszmar, Kele Piper

1. Don't panic!  What to do first: Discuss how to review the situation and determining next steps
2. After the first 24 hours...what to do next?  Interviews, investigations, audits, and immediate action.
3. The aftermath, implementing corrective actions, working with regulators, and proactive precautions

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114- Implementing Foreign Influence Screening to Address Research Security Concerns: Applied Strategies for Research Applicant Screening Procedures in Response to Institutional or Regulatory Change

Speakers: Adrienne Lindsay, Maggie Rubrecht-Scaffe

1. Techniques and tools for publication/grant reviews and education/employment verifications 
2. Approaches for restricted party screenings and export control assessments
3. Strategies for risk evaluations of non-disclosures, licenses, and leadership review

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115 – Compliance Considerations for Decentralized Clinical Trials

Speakers: Adam Samson, Selena Evans

1. Ethics & Equity
2. Technology Adoption & Implementation
3. Control Design for Decentralization

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116 - Facilitating Innovation in a Post-COVID19 World

Speaker: Dr. Joe Perez

1. How can you avoid stagnation without sacrificing quality and security in the process?
2. Did COVID19 make you see the need to adopt a more agile way of thinking to recover from this global pandemic?
3. Do you FACILITATE innovation with solutions, or do you FRUSTRATE it with problems?

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117 – Investigational Device Exception (IDE) Clinical Trial Reimbursement

Speaker: Kelly Willenberg

1. Overview of clinical trial coverage and Medicare coverage pathways
2. Medicare investigational device exemption (IDE) coverage requests
3. Compliance considerations, risks for billing/payment, and example enforcement actions

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118 - Not Just a Research Issue: Building a University-Wide Export Control Program

Speakers: Amanda Ferguson, Naomi Coll

1. Review the basics of export control regulation and recent federal guidance addressing university export control
2. Identify common university-wide stakeholders of export compliance programs, addressing the naturally distributed processes that impact export control and strategies for implementing compliance controls across a wide variety of university functions
3. Discuss approaches to building a comprehensive program through collaboration and shared ownership, addressing obtaining leadership buy-in, educating the broader university administration and faculty, and shared process development

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GS4 -General Session: Compliance with Psychedelics and Emerging Therapies

Speakers: Kelly Willenberg, Kristin West, Linda Iovanni

1. This session will discuss emerging therapies including clinical trials and the future of psychotherapy. 
2. The panel will discuss steps that can be taken to mitigate risk and increase protective factors for the subjects. 
3. This program will review integration techniques, resources, legal and ethical issues with these emerging therapies.  

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