2019 Western/Southern Section Meeting

Time: 9:00am to 5:00pm

Content level:Basic

The "theory of everything" (TOE) is a hypothetical theory studied in physics; its intent is to fully explain and link together all known physical phenomena. The Introduction to Research Law workshop is similar to TOE in that it attempts to explain and link together all known issues of research administration. Legal issues arise throughout research, starting with intellectual property issues, continuing through contract and grant matters and living on in post research licensing, "derivative works disputes" and post-clinical trial liability questions. This workshop is for new research administrators who need a "boot camp" approach to recognizing the legal issues that they will face daily.

Learning objectives:

1. Identify the parties and players involved in common research activities and indicate their legal rights and responsibilities.
2. Identify common issues that arise requiring the application of legal processes and procedures to research activities.

Prerequisites:None

Speaker(s):

J. Michael Slocum, President, Slocum & Brodie

Time: 9:30am to 10:45am

Content level:Basic

Copyright laws protect the authors or creators of original works of authorship through the legal concept of copyright. Copyright can be a complex concept with many nuances. However, the primary product of research is more often a copyrighted publication than a patented invention. Research institutions and individual researchers need to understand copyright both as the creators of works and as users of works of others covered by copyright protection.

Learning objectives:

1. Participants will be able to identify the intellectual property that can be protected by copyright and the protections provided.
2. Participants will be able to manage the origination of copyright protections and transfers, licensing of works of others and navigate “fair use” issues in instructional and research situations.

Prerequisites:None

Speaker(s):

J. Michael Slocum, President, Slocum & Brodie

Time: 11:00am to 12:15pm

Content level: Intermediate

In a follow up review of a 1998 study of challenges facing institutional review boards (IRBs), Brown, Varmus and Friedman (U.S. Department of Health and Human Services, Office of Inspector General, oei-01-97-00194) further assessed these risk factors for low volume IRBs – IRBs that conduct less than 125 annual reviews and are typically housed in community-focused organizations lacking a research culture. Identified IRB risks included:

1. Review too much, too quickly, with too little expertise
2. Minimal continuing review of approved research
3. Conflicts that threaten their independence
4. Little training for investigators and board members
5. Little attention to evaluating IRB effectiveness

Many community college and primarily undergraduate institution IRBs fall into the low-volume category – some falling into what we have termed a “lower than low”-volume category – IRBs that review a handful of limited-methodology proposals on campuses, where most personnel serve dual roles, in a culture that is not compliance literate – all of which further exacerbate the challenges identified in the 1998 study.  This session focuses on a case study of a community college’s overarching process improvement effort – stimulated by the impending deadline for the Common Rule – to update their IRB materials and processes. In order to meet the needs of multiple stakeholders (research subjects, researchers, institutional offices, and regulators), the project was approached through the frameworks of the low-volume IRB challenge study, the Nuffield Council on Bioethics Public Health Policy Processes, and existing campus Higher Learning Commission continuous process improvement and risk management efforts.

Learning objectives:

1. Understand the risks faced by Low-Volume IRBs and their applicability to campus processes and practices.
2. Develop an understanding of frameworks that can be used when implementing IRB process improvements.

Prerequisites:None

Speaker(s):

Victoria Steel, PhD, Director, Sponsored Awards and Compliance, Maramie County Community College; Janice Putnam PhD, RN Chair, The Missouri Nurse Editorial Advisory Board  Professor of Nursing in the Health Studies Program, University of Central Missouri

Time: 2:15pm to 3:30pm

Content level:Intermediate

Many factors determine financial and logistical feasibility of clinical research studies. This session provides an overview of standard operating procedure and tools necessary to make this determination, developed from study examples and case studies. Tips on reviewing initial documents such as the proposed contract, sponsor budget, protocol and schedule of events and informed consent in the development of accurate internal cost assessments and cost benefit analysis will be demonstrated. Vetting and ranking of study trials will be discussed

Learning objectives:

1. Review the factors impacting financial feasibility of a clinical research.
2. Review the factors impacting financial feasibility of a clinical research.

Prerequisites:None

Speaker(s):

Renee Vaughan, MDiv, MA, CRA, Clinical Research Unit, Financial Practice Manager, Duke Univeristy School of Medicine; Monique Gregory, MRA, CRA, University of Central Florida

Time: 3:45pm to 5:00pm

Content level: Intermediate

Many research administrators find themselves working in silos, becoming very specialized with their niche within research: contracts, grants, pre-award, post-award, compliance, ethics, etc. Understanding the multiple facets across research has become extremely important to meet compliance requirements within institutions for a research administrator to succeed. Clinical trials research billing is one element that can be overlooked or is commonly considered outside of the typical research administrator's purview. This can lead to very challenging conversations when research administrators are working with institutional leaders, investigators, contract negotiators, and sponsors. This session will give a basic understanding of things to consider in clinical trials billing from the perspective of someone that has had to learn this in a very short amount of time, but has a very broad range of experience in the research setting. We will address patient care charges and how institutions typically identify what is considered “standard of care” and eligible for billing to the patient or insurance for payment versus what should be billed to the study. This will involve reviewing regulations administered by the Centers for Medicare and Medicaid Services (CMS). These lessons can be applied to any role in research to ensure that studies can be conducted efficiently and compliant with regulations as well as keeping promises to participants and paying for costs covered by the study.

Learning objectives:

1. Identify resources to complete a Medicare Coverage Analysis and appropriately determine how charges are billed to the study or patients during a research study.
2. Discuss basic billing issues with other stakeholders in research to ensure that budgets are appropriately negotiated to cover costs in research.

Prerequisites: None

Speaker(s):

Tonya Edvalson, Clinical Research Compliance Officer, University of Utah

Time: 11:00am to 12:15pm

Content level: Intermediate

Compliance personnel have thankless jobs, most often feeling overwhelmed by what needs to be done. The Office of Inspector General (OIG) has outlined seven particular elements that compliance programs should include. While this was written with healthcare in mind, it can be translated to any compliance program that needs to be put into place, including research in any realm be it biomedical or behavioral/social science. The use of these elements can strengthen departmental policies and improve accountability of researchers and staff. At the end of the day, implementing a strong compliance program can provide research programs with a culture of integrity and meaningful research outcomes. 

Learning objectives:

1. Identify seven elements necessary for a strong compliance program.
2. Discover ways to implement specific areas that can be addressed in local programs so that a culture of compliance can integrated into day-to-day operations.

Prerequisites:None

Speaker(s):

Tonya Edvalson, BS, CCRP, CHRC, Clinical Research Compliance Officer, University of Utah

Time: 11:00am to 12:15pm

Content level:Intermediate

Compliance personnel have thankless jobs, most often feeling overwhelmed by what needs to be done. The Office of Inspector General (OIG) has outlined seven particular elements that compliance programs should include. While this was written with healthcare in mind, it can be translated to any compliance program that needs to be put into place, including research in any realm be it biomedical or behavioral/social science. The use of these elements can strengthen departmental policies and improve accountability of researchers and staff. At the end of the day, implementing a strong compliance program can provide research programs with a culture of integrity and meaningful research outcomes. 

Learning objectives:

1. Identify seven elements necessary for a strong compliance program.
2. Discover ways to implement specific areas that can be addressed in local programs so that a culture of compliance can integrated into day-to-day operations.

Prerequisites:None

Speaker(s):

Tonya Edvalson, BS, CCRP, CHRC, Clinical Research Compliance Officer, University of Utah

Time: 2:15pm to 3:30pm

Content level:Intermediate

Attendees will learn the critical differences between the Pre-2018 Common Rule and the 2018 Common Rule which is effective as of January 21, 2019. Attendees will also learn the steps a university in Southern California used to transition to and implement the 2018 Common Rule.

Learning objectives:

1. Describe the crucial new elements of 2018 Common Rule and identify how if differs from Pre-2018 Requirements.
2. List the steps a university used to transition to and implement the 2018 Common Rule.

Prerequisites:None

Speaker(s):

Anne Dodge-Schwanz, BA, CIP, Senior Research Affairs Analyst, San Diego State University; Patricia Gordon, BS, MBA, CIP Research Affairs Analyst/Educator, San Diego State University

Time: 3:45pm to 5:00pm

Content level: Basic

Primarily from a University and Federal Award perspective. What are you committing to when you accept an award? What are major compliance issues that you have to be award of and be to abide by? What is the best way to make sure you are catching everything applicable to a particular project? What is the best way to make sure you are catching everything applicable to a particular project? What can you learn from the award document itself? Are all award compliance issues the same? What other offices must you work with at your institution to fulfill the requirements?

Learning objectives:

1. Know the basic compliance requirements of an award.
2. Know where to find the information you need to successfully complete an award.

Prerequisites:None

Speaker(s):

Lisa Asch, Director, Office of Research Administration, OUHSC

Time: 9:15am to 10:30am

Content level:Intermediate

On occasion, research administrators unknowingly accept terms that are unfavorable, and once the discovery is made, it’s too late.  Or is it?  

Learning objectives:

1. Identify troublesome clauses, and why they are deemed as such.
2. Strategize using proven methods to collaborate with Sponsor to eliminate or reduce problematic contract terms.

Prerequisites:Yes, Award negotiation experience

Speaker(s):

Miesha Bailey, CRA, Contract and Grant Officer, UCLA;