Tuesday Sessions

Tuesday, October 2

• 9:30 - 10:45 AM
• 11:15 AM - 12:30 PM
• 2:00 - 3:15 PM
• 3:45 - 5:00 PM

Monday, October 1
Wednesday, October 3

 

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9:30 - 10:45 AM

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T1: The ARMA Professional Development Framework
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Content Level:  All Levels
The Association of Research Managers and Administrators (ARMA) UK has developed and launched a Professional Development Framework for research managers and administrators, as a guide to individuals' career development, as a tool for managers, and as an indicator for providers of courses and other development opportunities. This session will present the Framework, explaining its purpose, and demonstrating its use by individuals and organizations.  There will also be discussion about professional accreditation based on the Framework and the challenges that this poses.
Learning Objectives:
1. Understand the range of skills, knowledge, activities and behaviors that make up the research management and administration profession.
2. Consider their own development in the context of the Framework.
Prerequisites: None
Speaker: Ian Carter, PhD, Director of Research and Enterprise, University of Sussex, United Kingdom

T2: Effective Delegation Skills for Leaders
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Content Level: All Levels
Positive delegation skills are one of the most effective ways for leaders to enhance their organizational position. However, leaders frequently find themselves at odds when it comes to delegating; after all, what made them a leader was their ability to get the job done and giving their strength away seems counterintuitive to success. This session will teach you some of the important aspects of effective delegation that will make your office more successful and effective in the current workplace.
Learning Objectives:
1. To introduce leaders at all levels to the principles of effective delegation and the various forms of delegating.
2. Provide attendees with systematic ways to stay on top of delegated activities so that things do not stop just because they are delegated.
Prerequisites: None
Speaker: David Mineo, Managing Director, DLMineo Consulting
Certificate: Leadership - Required Session

T3: Clinical Trials and Research Grants: Diverging Trails
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Content Level: Intermediate
This session will present a primer on clinical trials. It will be of special interest to those research administrators who are new to clinical trials, those who need to work side-by-side with colleagues who work on clinical trials and/or those who are just curious about what their colleagues do in a clinical trials office. Emphasis will be placed on how corporate - sponsored clinical trials contracts are developed and negotiated. The presenters will highlight how they differ from garden variety NIH or NSF grants and where there are transferable skills. Experienced clinical trial administrators are also welcome to attend since current hot topics in clinical trials will be discussed.
Learning Objectives:
1. Identify the fundamental differences between corporate sponsored clinical trials versus federally funded grants and how they fit into the research enterprise and overall research management.
2. Describe steps required to assess feasibility of placing a trial, how to get set up, and what financial and operational data to track over time.
Prerequisites: None
Speakers: Eric Tomasini, Manager, Health Industries Advisory, PricewaterhouseCoopers LLP; Kumar Mukesh, Director, Grants Accounting, University Hospitals Case Medical Center
Certificate: CTRA101 - Elective

T4: Training New Hire Research Administrators
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Content Level: Advanced
Remember when you first got started in this business? Maybe you were one of multiple people providing research administration support, maybe you were the only one with a single senior level administrator to turn to for help. Remember the struggle to comprehend and the fear of making a “bad” decision? Getting people off to a good start in this business can be challenging. Typically the first three months on the job staff are thinking “what did I get myself into? I’m destined to fail.” When we start new folks we are generally struggling to provide the training they need, while juggling 20 or more obligations of our own. We tend to train on process, but understanding the foundation and background for processes is what determines success in this business. This session is an interactive discussion of how participants can improve training and new hire retention in the profession.
Learning Objectives:
1. Expand one's toolkit of approaches for training new hires.
2. Expanded ability to use 1) online training, 2) mentoring, and 3) resource research skill development in training new hires.
Prerequisites: None
Speakers: Kris Rhodes, Director Sponsored Project Enhancement Services, Higher Education Practice, MAXIMUS; Nancy Spice, Assistant Director for Training, Office of Research, University of Pittsburgh

T5: Improving the Research Administration Office: Conducting an Internal Review
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Content Level: Intermediate
In the ever changing environment of research administration there are challenges in setting up, managing and leading a successful research administration office. New offices in higher education institutions can face particular challenges in terms of integration of work previously performed by other offices, staffing requirements and new grants management processes. This session will describe how a new centralized research administration office underwent a comprehensive review of processes to improve its effectiveness. Participants will find out how the office engaged graduate business process innovation students, faculty and campus administrators in analyzing office processes and workflows. Review outcomes and impacts on the work of the office will be discussed.
Learning Objectives:
1. Identify ways faculty and student expertise can inform the work of the office and support institutional review.
2. Describe ways an institutional review can enhance the work of the office and collaborations with other administrative offices.
Prerequisites: None
Speakers: Elizabeth DeFrancisco, Assistant Director, Office of Sponsored Programs and Research, and Brigitte Valesey, PhD, Assistant Provost, Widener University
Certificate: Leadership - Elective

T6: A Case Study for Pre and Post-Award Technology Solutions
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Content Level:  All Levels
Indiana University has devoted significant resources to the development of technological tools to ease the pain of some research administration functions. Using IU as a case study, this session will look at the decision process in determining if technology will ease the pain in pre- and post-award areas, using functional and technical teams for decision-making, communicating changes in tools and process to staff and researchers and evaluating priorities.
Learning Objectives:
1. Identify key components required for determining if a technology solution is appropriate for the problem to be solved.
2. Compare the strategies used at IU with possibilities at their home institutions.
3. Describe the basic roles of functional staff and technical staff in the design, implementation, and communication segments of a project.
Prerequisites: None
Speakers: Marcia Landen, Assistant Vice Provost, University of Southern Mississippi; Lora O’Connor, Executive Director, Research Administration Systems and Decision Support, Indiana University

T7: Research Quality Assurance through Coverage Analysis: A Case Study
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Content Level:  All Levels
Medicare’s Clinical Trial Policy (CTP) outlines the criteria that research studies must meet in order for Medicare to cover certain costs related to an individual’s participation in a research study. An analysis of a research study to assess billable items using the CTP rules is called a Coverage Analysis (CA). Since many studies may enroll Medicare beneficiaries, it is important for institutions conducting research to understand the CTP and determine an appropriate process to operationalize this policy. This session will provide an overview of the CTP and CA process, identify departments/areas involved in and affected by Medicare’s CTP, review the potential risks of not having a process implemented to comply with the CTP, and reference a case study to provide recommendations for streamlining the CA process, increasing communication between all stakeholders, and achieving compliance. Specific examples from an academic medical center perspective will be provided regarding implementation of Coverage analysis.
Learning Objectives:
1. Understand the CTP and to know the steps of creating a coverage analysis.
2. Identify processes and stakeholders key to implementation in their respective institutions.
Prerequisites: None
Speakers: Philip Cola, PhD (cand), Vice President, Research and Technology, University Hospitals Case Medical Center; Madeleine Williams, Director, Huron Life Sciences
Certificate: CTRA201 - Elective; Financial Management - Elective

T8: F&A and Salary Recoveries Discussion:  What Does Your Institution Do With All That Money?
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Content Level: Intermediate-Advanced
Most often research administrators are at the front lines of ensuring that the institution they work for gets every single possible penny from the sponsor to cover the cost of the sponsored program to which they are applying.  We all know that sharing in the costs of the projects can have negative impacts on the F&A rate your institution can get and acknowledge the tension between the institution's mission and the PI's mission.  But what happens to all that money that we recover in the end?  In this discussion session we will look at some basic uses of these funds and compare and contrast different perspectives that we find.  Come prepared to share what you know of your institution's practices.
Learning objectives:
1.  Discuss different models from different institutions using hypothetical institutions: a PUI, a large medical/research university, and a hospital.
Prerequisites: None
Speakers: Stephanie Endy, Assistant Vice President Extramural, Funding, North Shore-Long Island Jewish Health System; Judy Bristow, Director, Office of Sponsored Programs Grants Administration, University of Louisville 
Certificate: Financial Management - Elective

T9: Conflict of Interest: The Year in Review
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Content Level: All Levels
Companies and nonprofit organizations alike have been buffeted for the last fifteen years with issues of conflict and ethics ranging from simple questions of self-dealing (can the individual researcher profit from work done on “company time”) to complex socio-religious issues. Governmental authorities have periodically established proscriptive and prescriptive laws and regulations promoting ethical behavior and criminalizing common activities. Most recently, much attention has been paid to legislation and regulation limiting the activities of medical personnel and organizations. Other issues that have arisen and that are still bubbling include the conflicts arising between inventors/authors and their employers, the duty to disclose wrongdoing, and the rights of the accused in non-judicial proceedings. This session will address the NSF/NIH policies, the Stark legislation, procurement integrity, the effect of the SEC rules, etc., on the enforcement of strictures against conflicts of interest and the mandated imposition of ethics rules on research organizations.
Learning Objectives:
1. Identify and mitigate conflicts of interest.
2. Develop and administer conflicts of interest policies and procedures.
Prerequisites: None
Speakers: J. Michael Slocum, JD, President, Slocum & Boddie, PC; Ann Mathias, JD, Assistance Vice President, Research Compliance, Carnegie Mellon University
Certificate: Research Law - Required Session

T10: Mitigating Financial Fraud in Sponsored Research
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Content Level: Basic
Fraud occurs in all industries, and universities and other research institutions are no exception. In addition, economic downturns raise the potential for occupational fraud. Combine these facts with the growing scrutiny institutions are facing from regulators and it becomes clear that every employee (especially research administrators!) needs to understand the basics of why fraud occurs, how s/he can help prevent or detect it and what to do if fraud is discovered. The presenters will discuss common indicators of fraud, potential controls to help mitigate opportunity for fraud and what to do if fraud is discovered at your institution. This session will include specific examples of how to work with federal agencies, internal and external counsel and consultants to effectively respond to instances of fraud on research awards.
Learning Objectives:
1. Identify the basics of why employees may use their position to commit fraud, red flags of potential fraud, and how to appropriately escalate concerns.
2. Review what can be learn from real-life examples of fraud, including best practices for working with federal agencies, internal and external counsel, and consultants.
Prerequisites: None
Speakers: Kim Ginn, Principal, Baker Tilly; Kathleen Taggart, CRA, Associate Vice President for Research Compliance, Creighton University; Michael Vernick, JD, Partner, Hogan Lovells
Certificate: Research Law - Required Session

T11: Optimizing Ethical Practice in Research Administration through Positive Leadership
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Content Level: Advanced
Research administrators promote a form of ethics bound by rules, regulations and audit, otherwise known as Ethical Formalism. The tendency evolved through government mandate and laws created in response to watershed events in ethical history, such as the ethically deplorable Tuskegee syphilis study. It was a societal necessity, and through the force of law, ethical formalism now provides the foundation for professional legitimacy for the research administrator. As research administrators, then, we find our choices are limited when it comes to leading positive change in the research environment and we are often viewed as the 'police' rather than helping advance the research endeavor. This session will identify ways research administrators can enhance their professional legitimacy not only through following the law, but also by analyzing the concept of moral agency and the virtuous organization and how these concepts contribute to advancing the research endeavor.
Learning Objectives:
1. Identify the weaknesses of ethical formalism in research administration and describe ways to enhance ethical practice from a professional and corporate perspective.
2. Describe the issues of moral agency and the virtuous organization by analyzing current research in positive organizational scholarship.
Prerequisites: An expert understanding of the Research Environment and the issues surrounding the Responsible Conduct in Research (RCR).
Speaker: Tim Atkinson, Assistant Provost, Sponsored Programs, University of Central Arkansas
Certificate: Research Integrity - Required Session; Leadership - Elective

T12: When Clinical Trials Close Before Completion
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Content Level:  All Levels
A majority of clinical trials fail to meet their anticipated accrual or close before they have been completed. Most of the discussion about this has focused on the financial impact to the institution or sponsor. However, there are also complex ethical concerns when we explore the impact to the subjects, who have incurred the risks of the research, but now without any hope of benefit. This session will highlight the various reasons for early clinical trial closure, the impact of these closures and possible mechanisms to aid in reviewing a clinical trial to avoid early closure. In addition, it will explore how this knowledge informs an IRB's deliberative ethical discussions regarding: (1) risk/benefit calculations, (2) any additional protocol review requirements/assurances from researchers with poor enrollment track records and (3) most importantly, moral obligations to those who have enrolled and exposed to risks of harms and burdens without a social benefit.
Learning Objectives:
1. Identify the various reasons for early clinical trial closure, and understand the financial, ethical, and scientific impact of these early closures.
2. Explore possible mechanisms to avoid studies that will not meet accrual.
Prerequisites: None
Speakers: Chris Asmann-Finch, Program Development Specialist and Medical Humanist, and Paula Bistak, Executive Director, Human Subject Protection Program, University of Medicine and Dentistry of New Jersey
Certificate: CTRA201 - Elective; Research Integrity - Required Session

T13: NSF-OIG Case Studies: Best and Worst Practices of Federal Grantees
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Content Level:  All Levels
National Science Foundation, Office of Inspector General Investigative Update: PIs Indicted for Diverting NSF Grant Funds for Personal Use!  Prison Imposed Upon University Administrators For Theft!  Grantees Pay Out Millions!  Join us for a dynamic and interactive discussion of recent significant cases investigated by NSF OIG. We are responsible for the prevention and detection of fraud, waste and abuse associated with NSF programs and award funds. Special Agents, Investigative Attorneys and Investigative Scientists conduct proactive and reactive investigations into wrongdoing affecting NSF grant funds, including fraud, theft, mismanagement of funds and research misconduct. This presentation will provide information regarding applicable laws, rules and regulations associated with the use of federal grant funds and the increased imposition of government-wide suspensions and debarments to prevent fraud. We will identify the greatest sources of potential problems faced by federal grantees and provide practical tips for avoiding criminal and civil liability in administering grant funds.
Learning Objectives:
1. Describe the benefits of a voluntary compliance program and list the seven key elements of an effective voluntary compliance plan.
2. Describe expectations and best practices of federal grantees, identify the biggest challenges faced by grantee institutions, and analyze how to avoid, recognize and handle them.
Prerequisites: None
Speaker: Fara Damelin, JD, Investigative Attorney, Office of Inspector General, National Science Foundation
Certificate: Research Law - Required Session

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11:15 AM - 12:30 PM

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T15: Communication:  The Way We Think and Its Consequences in our Workplace!!!
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Content Level: All Levels
Have you ever wondered why one supervisor likes lots of detail, while another may say “just provide me with the broad details?”  This session will introduce individuals to four broad thinking styles used in our daily lives to process information; things we like and those we don’t when processing information and communicating.  This session deals with a broad introduction to Right Brain and Left Brain thinking as well as the use of the cerebral versus limbic thinking activities.  The bottom line, there are not “right” or “wrong” ways of thinking; however, there are consequences for the way we think.  These can and do impact the workplace we live in!
Learning objectives:
1. Introduce the different ways we tend to process information based on our experiences and how those impact on our day to day decisions in the workplace.
2. Provide some tools for dealing with difficult communication challenges based on the recognition of the styles supervisors and subordinates like to process information.
Prerequisites: None
Speaker:  David Mineo, Managing Director, DLMineo Consulting

T16: 86,400 Seconds in a Day:  Tools for Time Management
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Content Level: All Levels
There never seems to be enough time in a day to get everything on your "list" accomplished.  You may think, "If I only had more time, I could…." Why does it seem like some people can get a lot done and others talk about what they still need to finish?
Learning Objectives:
1. Learn how to work in our timeframe, and take a look at the value of time.
2. Look at some tools and techniques to help manage time effectively.
Prerequisites: None
Speaker: Domenica Pappas, CRA, Director, Sponsored Research and Programs, Illinois Institute of Technology
Certificate: Leadership - Required Session

T17: Lessons Learned from Building a Satellite Grants and Contracts Office
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Content Level:  All Levels
This session will discuss in the detail, steps involved in: establishing a local grants and contracts office, integrating it into the university system-wide OSP, building working relationships with PIs and departmental administrators, offering a multitude of proposal and budget development services, and providing grant management training and general support to all faculty and administrators. Participants will be provided with information on how to foster teamwork at all levels. The presenter will also discuss how the grants and contracts office functions two years later by reviewing which tools and strategies were most helpful. Finally, this session will look toward the future by examining strategies for continued growth and expanded support services.
Learning Objectives:
1. Identify and understand steps involved in building a GCO at the local campus level and how to integrate it into the university system.
2. Identify tools and strategies to increase teamwork amongst departmental administrators, PIs, OSP, and the GCO.
Prerequisites: None
Speaker: Susanne Van Weelden, Director, Grants and Contracts, Texas Tech University Health Sciences Center, El Paso

T18: The Differences Between Gifts, Grants, Cooperative Agreements and Contracts
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Content Level: Basic
This session will address the differences in the various funding mechanisms encountered within a sponsored programs office. While the laws, rules, policies and guidelines for each are diverging, the lines between them are blurring. Therefore, it is important that we develop the tools and relationships with other offices to ensure we are appropriately categorizing the awards and, most importantly, managing the money in accordance within the applicable constraints. This session will provide a broad overview of how to categorize the awards and the consequences of such classifications - legal, procedural, financial and personal.
Learning Objectives:
1. Develop the tools, and understand the relationships, required to identify the various sources of funding for sponsored programs.
2. Understand the broad implications of each funding mechanism.
Prerequisites: None
Speaker: Tammie Bain, JD, Director, Grants & Contracts Administration, Office of Research, Wake Forest University Health Sciences

T19: Research Administrator’s Healthcare Clubhouse
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Content Level: Advanced
WANTED! Research Administrators and Directors from Healthcare Systems and Hospitals! This session is an invitation to attend an in-person benchmarking exchange. Benchmarking defined: The practice of being humble enough to admit that someone else is better at something and being wise enough to learn how to match and even surpass them at it. From regulatory compliance to operational effectiveness as a group, this session is about sharing and learning from like minded professionals who manage research in a hospital and/or healthcare system.
Learning Objectives:
1. Describe how research is organized and prioritized within healthcare system operations while sharing and discussing critical research resource gaps and solutions.
2. Evaluate and exchange research compliance needs and complexities for hospitals and hospital systems.
Prerequisites: None
Speakers: Peggy Reed, Clinical Trials Manager, and Tonya Edvalson, Research Regulatory Coordinator, Women and Newborn Clinical Trials, Intermountain Healthcare
Certificate: CTRA201 - Elective

T20: Using Metrics to Analyze Post-Award Staff Workload
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Content Level:  All Levels
This session will describe the system used by the University of Akron to determine the workload of its post-award grants accounting staff. Each post-award activity is scored based on set criteria such as whether the activity is a grant or contract; whether cost share is involved, whether the activity has associated subcontracts, etc. Work assignments are made based on the results of the data analysis.
Learning Objectives:
1. Use the techniques learned to analyze the workload of post-award (and other) staff.
2. Make informed decisions on the work assignments of each employee based on the results of the data analysis.
Prerequisites: None
Speakers: Heather Kraus, Associate Controller, and Kathryn Watkins-Wendell, CRA, Director, Office of Research Administration, University of Akron

T21: Clinical Trials Budget Negotiations
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Content Level: Intermediate
Budgets for clinical trials should be based on sound accounting principles and an accurate analysis of the protocol. Often, establishing the costs for procedures is relatively straightforward, but accurately estimating hidden costs, such as investigator time and start-up costs, can be more difficult. A systematic process for analyzing protocols, determining costs and negotiating budgets will be discussed, along with relevant aspects of contract negotiations and establishing payment schedules. Tips to optimize budgeting for clinical trials will also be presented.
Learning Objectives:
1. Learn the four components of a clinical trial budget.
2. Explain the differences between budgeting for clinical trials funded by industry versus federal sources.
Prerequisites: None
Speaker: Bruce Steinert, PhD, Administrative Director, Clinical Trials Center Research Institute, NorthShore University HealthSystem Research Institute
Certificate: CTRA201 - Required Session; Financial Management - Elective

T22: What Price Research? - The Myths and Challenges
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Content Level:  All Levels
This novel research investigated how to develop a sustainable model for funding research at universities. The first part of the project carried out a detailed transparent and defensible analysis of the full cost of research at the University of Melbourne. However, policy implementation theory suggests that successful policy change requires the acceptance and support of the key actors. In our context, this means researchers and funding bodies. The second and most novel aspect of this research investigated barriers to implementation. The University of Melbourne interviewed over 60 academic staff members to understand their views, beliefs and attitudes about the price of research. The results were illuminating, showing there is a significant level of misunderstanding, inaccurate assumptions and myths about university finances in the minds of many staff. All of these are barriers to the successful implementation of the new policy.
Learning Objectives:
1. Recognize barriers to academics' ability and willingness to charge a price to cover full costs, and plan courses of activity to address them.
2. Identify the attitudes and constraints to pricing and overhead cost recovery from the point of view of academics and funding agencies.
Prerequisites: None
Speaker: Janette Hocking, Consultant, Australasian Research Management Society
Certificate: Financial Management - Elective

T23: Clinical Trials: The Industry Perspective
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Content Level: All Levels
This is a presentation of the process of drug development from the pharmaceutical industry’s perspective Timelines, quality and cost will be driving factors for discussion. The pharmaceutical industry’s general organizational structure will be introduced. The clinical trial protocol development process and clinical study conduct will be presented. Pharmaceutical drivers for study site selection will be highlighted. Site-based contracts, including budgets, publication rights and intellectual property will also be discussed.
Learning Objectives:
1. Understand the drug development process including pharmaceutical industry drivers.
2. Understand how sites are selected and contracts are negotiated for clinical trials.
Prerequisites: None
Speaker: Belinda Vandersluis, Executive Director Gilda’s Club Southeastern Ontario
Certificate: CTRA101 - Required Session

T24: Social Media and The FDA Regulated Entity
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Content Level: Basic
This session will provide an overview of social media and the implications for the FDA-regulated entity. Topics will include monitoring adverse events, subject recruitment, responding to negative comments on third party and institutional websites.
Learning Objectives:
1. Identify the various ways FDA regulated entities can effectively utilize social media in the clinical trial process
2. Identify ways in which to manage negative comments in order to minimize impact on public image.
Prerequisites: None
Speaker: Penny Smith, JD, Attorney, and Stephanie Goddard, JD, Life Science Law Group, LLC
Certificate: Research Law - Required Session

T25: A Hard Look at Research Misconduct
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Content Level:  All Levels
This session will clearly define the concept of 'research misconduct', introduce the Office of Research Integrity (ORI), as well as other federal agencies. In a world of tenure, publishing practices, outside funding sources, cultural diversity and competition, this presentation will look at mentoring opportunities to foster an environment for the responsible conduct of research. 
Learning Objectives:
1. Identify 'research misconduct' as defined by the Office of Research Integrity.
2. Explore the tenants underlying academia and opportunities for mentoring on the responsible conduct of research.
Prerequisites: None
Speaker: Maria Garner, JD, Associate General Counsel, Vanderbilt University
Certificate: Research Integrity - Required Session; Research Law - Required Session

T26: Responding to Serious Wrongdoing in Research
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Content Level: Intermediate
A recent survey conducted by our training team indicates that research institutions in the U.S. investigate an average of 3-5 cases of serious wrongdoing per year. The most common responses include sending a letter of reprimand and offering some ethics education at the institution. However, there is little reason to believe that these measures are effective in reducing rates of recidivism. The National Institutes of Health (NIH) recently funded the Restoring Professionalism and Integrity in Research Program, which is designed specifically to provide remediation training. This session will examine the special needs of those who engage in research wrongdoing and will present an evidence-based model for providing remediation training that addresses maladaptive mental models, faulty ethical decision making strategies and inadequate work management skills.
Learning Objectives:
1. Identify when a researcher's wrongdoing can be addressed adequately using traditional means, and when more specialized interventions are required.
2. Describe the kinds of interventions that research data indicate may be effective in reducing recidivism rates.
Prerequisites: None
Speaker: James DuBois, PhD, Hubert Maeder Professor of Health Care Ethics and Director of the Bander Center for Medical Business Ethics, Saint Louis University
Certificate: Research Integrity - Required Session; Research Law - Required Session

T27: Washington Update: What is happening to the FY13 R&D Budget?
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Content Level:  All Levels
After the failure to reach a spending compromise late last year, sequestration may be imposed. The presidential campaign is going full force toward its November conclusion.  The lame-duck legislative calendar will be jam packed.  These political dynamics will have an impact on the FY13 budget in general and on the R&D budget in particular. This session will describe the political dynamics and their likely impact on R&D funding. It will also discuss the impact on future budgets.
Learning Objectives:
1. Understand the political dynamics which impact future R&D funding.
2. Anticipate changes in funding levels and plan appropriately  in their organization.
Prerequisites: None
Speaker: William Schweri, Director of Federal Relations, University of Kentucky

T28: European Union Research Programme Fundamentals
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Content Level: Basic
This session will give a broad overview of European Union (EU) funding opportunities open for American researchers. EU projects are different in nature from NIH projects and a good understanding of the rules and nature of EU projects is important to grasp before applying. This session will cover mobility grants and other funding mechanisms relevant to researchers within medical sciences. Speakers from a European research support office will provide the research administrator with a fundamental understanding of the EU research application process. This session will give an introduction to the funding mechanisms that are relevant to American researchers and will address the funding rules and the preparation and the submission of proposals.
Learning Objectives:
1. Identify relevant EU funding opportunities.
2. Describe application process.
Prerequisites: None
Speakers: Birgit Christensen and Anne Birgitte Lindgren, Research Support Officers, Research Support Office, Aarhus University Hospital, Denmark
Certificate: Research Law - Required Session

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2:00 - 3:15 PM

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T29: How to Deal with Difficult People
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Content Level:  All Levels
This session will cover understanding some of the common types of difficult people and situations that can impact your relationships with them.  Tips on recognizing and defusing or derailing obstacles caused by difficult people will be discussed. Input from the audience will be encouraged for examples of difficult people/situations and solutions that mitigate their impact.
Learning Objectives:
1. Acquire an understanding of the different types of difficult people and their impact on sponsored research activities.
2. Identify strategies for coping with difficult people to improve working relationships.
Prerequisites: None
Speaker: M. Fran Stephens, CRA, Proposal Development Specialist, University of Oklahoma
Certificate: Leadership - Elective

T30: Research Administration Arena: Welcoming New Staff, Training For Practical Understanding
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Content Level:  All Levels
Research Administrators are still a limited resource. Most Institutions need to “home-grow” their personnel. There are many approaches used and training and mentoring varies substantially, depending on numerous factors, including institution size. Developing a practical understanding of grants management in your personnel is truly to teach them to navigate in a strange land. What global positioning systems do you have available at your institution and what resources are available externally to lead your staff on the preferred path? Experienced research administrators may have to pause to think how they learned to process transactions, prepare proposals, administer sponsored awards for faculty members and oversee others in the above responsibilities. This session will give practical tools to train new personnel in research administration. The presenters will help you organize skills that are universal and quantify knowledge new personnel need to learn to effectively navigate your Institution’s GPS: to Grow, Evolve and Flourish.
Learning Objectives:
1. Be able to analyze their internal resources, organize them into training material and routinely assess their effectiveness.
2. Be able to identify external resources, evaluate how to incorporate them into their training programs and calculate how training impacts an individual’s effectiveness.
Prerequisites: None
Speakers: Kate McCormick, CRA, Senior Grants Administrator, Harvard Medical School; Sandra Mancuso, Senior Director Research, School of Medicine, Temple University

T31: Clinical Research Consortia: Challenges and Lessons Learned Along the Way
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Content Level:  All Levels
The conduct of clinical research and trials is constantly evolving and changing. The importance of a uniform strategic approach for evaluation of new compounds in clinical trials, for example, has created a new concept for collaboration that is being implemented in many different fields of medicine. This has led to the creation of many types of consortia, all focused on expediting the goals of providing better care to a potentially large patient population, and of finding the cure for our society’s medical illnesses and diseases. There are many advantages to a consortium that benefit both pharma/device companies and the consortium members. During this interactive session the presenters will discuss their experience in working together to establish and maintain a consortium that functions efficiently and address the challenges and lesson learned along the way.
Learning Objectives:
1. Define a consortium: What is its function? What tools are needed to run an effective consortium (e.g. engaging the participants, working on unified budget and contract templates)?
2. Identify the funding challenges and understand the contracts negotiation process for a consortium: supporting infrastructure costs, developing budgets, negotiating for everyone, and getting to yes with all the stakeholders.
Prerequisites: None
Speakers: Oshrat Doriocourt, Corporate Agreements Manager, Duke University; Cynthia Morin, Administrative Manager, and Gayle Walters, Associate Director, Research Administration, Johns Hopkins University
Certificate: CTRA201 - Elective; Research Law - Required Session

T32: Whether, When and How to Use a Professional Grant Writer
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Content Level: Intermediate
Are you overwhelmed with huge, complex proposals and looming deadlines? Is your institution submitting more large-scale center grants or collaborative projects? Is it time to call in a professional grant writer for help or even add one or more to your staff? This session will help you to learn what a grant writer can and cannot do and how to decide if grant writing help is justified, needed, ethical and cost-effective.  Participants will also learn strategies for finding a skillful grant writer and forming an efficient, functional grant-writing team. The presenter is an experienced university research administrator who has been both an external and internal grant writer.  Audience participation and questions will be highly encouraged.
Learning Objectives:
1. List the pros and cons of engaging a professional grant writer and evaluate whether a grant writer meets their institutional needs.
2. Describe strategies for identifying and making best use of a professional grant writer while avoiding mistakes and problems.
Prerequisites: None
Speaker: Marjorie Piechowski, PhD, Director of Research Support, University of Wisconsin, Milwaukee

T33: Research as a Business: A View Through an Income Statement
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Content Level: Advanced
Depending on a research organization's financial system, it can be difficult to view research from a profit and loss or income statement perspective. With the massive financial burden most of us are feeling, how can we better manage our research operations if we can't clearly see their financial performance? This session will detail an approach that PricewwaterhouseCoopers has repeatedly used to create an income statement for the research enterprise. This session will walk through a sample line of business reports that were built for a client, highlighting how the numbers fed the various buckets. The presenter will also discuss an abbreviated methodology for performing this analysis. This session will conclude with a focus on the key cost takeout opportunities that we've seen in the market.
Learning Objectives:
1. Understand a standard approach for putting together an income statement of research operations.
2. Review below the line vs. above the line income statement considerations.
3. Discuss basic revenue enhancement and cost takeout opportunities based on the income statement.
Prerequisites: None
Speakers: Keith Graff, Grants Management Practice Leader and John Case, Higher Education Strategy Leader, PricewaterhouseCoopers LLP

T34: Export Controls and Patriot Act: Impacts on Research
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Content Level:  All Levels
This session will address the impact of export control guidelines and the Patriot Act on sponsored research activities.  The session will also address the impact on collaboration with international colleagues and faculty members.
Learning Objectives:
1.  Have a basic understanding of the key aspects of export controls guidelines
2. Have a basic understanding of the Patriot Act
3. Understand how to legally collaborate with international colleagues
Prerequisites: None
Speakers: Nicholas Long, Director, Higher Education, and John Sites, CRA, Manager, Higher Education Consulting, Huron Consulting Group; Aleksandar Dukic, Partner, Hogan Lovells US LLP

T35: Optimizing Revenue and Risk Management in Post-Award Administration
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Content Level: Intermediate
Institutions that have grants from multiple federal agencies face increasing complexity and risk in post-award grant administration. This session will explore the major elements of inconsistency in management and reporting and discuss major trends for post-award grant administration. In particular, this session will focus on major areas of reporting burden that are going to change dramatically over the next two years – financial and progress reports. This session will also address federal agency inconsistencies in expenditure guidance and auditing. Third, this session will look at federal and commercial initiatives that affect post-award burden and spending, highlighting items that research administrators should track.
Learning Objectives:
1. Identify specific federal agency differences in post-award grant administration and how to address them while maximizing allowable expenditures.
2. Develop a timeline and key roll-out plan elements for coming federal grant administration changes in order to maximize revenues and minimize compliance risks.
Prerequisites: None
Speaker: Mark Forman, President and Co-Founder, Government Transaction Services, Inc.
Certificate: Financial Management - Elective

T36: Today’s F&A Rate Proposal Process Based Upon 2 CRF Part 220 (A-21): What Central/Departmental Administrators Should Know
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Content Level: Basic
This session will provide an overview of the Facilities & Administrative (F&A) rate calculation and rate negotiating process. Sections to be presented include the history of federal cost reimbursement; the present environment faced by universities; a review of terminology found in the OMB Circulars with a focus on OMB Circular A-21 (including a description of direct, indirect, and unallowable costs); an overview of the long form process from submission to cognizant agency to eventually rate agreement; the structure and components of an F&A rate proposal (with examples for each cost pool); and the negotiating process, including a typical federal desk and on-site review. Clay Hestor of the University of Alabama at Birmingham (UAB) will provide his insights into the UAB's most recent experience with the entire process from an administrator's point of view.
Learning Objectives:
1. Describe to their peers and researchers how an F&A rate is calculated, a typical negotiation timeline, and its financial impact on the institution.
2. Identify direct, indirect, and unallowable costs, which is of particular interest to departmental administrators working with researchers.
Prerequisites: None
Speakers: Hank Kirschenmann, Manager, Higher Education and Academic Medical Centers, Attain LLC; Clay Hestor, Director, Cost and Space Analysis, University of Alabama, Birmingham
Certificate: Financial Management - Required Session

T37: From Chaos to Control: Surviving a False Claims Act Investigation
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Content Level: Intermediate
Surviving a False Claims Act investigation is a daunting experience for any academic research institution. The end of an investigation does not mark the end of your challenges. This session will start with an overview of the False Claims Act and some of the “hot button” topics that are most often the focus in the area of sponsored research. The financial penalties are naturally at the top of any institution’s concerns when it comes to resolving a False Claims Act investigation. It is also important to keep other non-monetary sanctions in perspective, including suspension/debarment, special award terms or conditions, institutional compliance agreements, and/or enhanced sponsor oversight. The panel will provide practical tips that will mitigate the likelihood of your institution becoming subject to those types of non-monetary sanctions. This session will also review the Mayo Clinic response following a U.S. Department of Justice investigation and subsequent NIH inquiry.
Learning Objectives:
1. Develop a basic understanding of the False Claims Act.
2. Learn about the impacts of penalties and sanctions.
Prerequisites: None
Speakers: Elizabeth Galezio, JD, Associate, Hogan Lovells LLP; David Lynch, Director, Office of Sponsored Projects Administration, Mayo Clinic; Anne Sullivan, Director, Huron Consulting Group
Certificate: Research Law - Required Session

T38: Intellectual Property Basics for the Research Administrator
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Content Level: Basic
What does a research administrator need to know about intellectual property? This session lays the foundation for new administrators by teaching the main intellectual property classes, common terminology and measures to protect the intellectual property. This session will teach basic concepts related to ownership, assignment and exclusive and non-exclusive licensing. Discover how U.S. federal funding can alter the intellectual property ownership and impose disclosure and reporting requirements, including an introduction to the Bayh-Dole Act. This session will cover how research administrators can protect their institution's intellectual property, including steps they can take during the proposal development, award acceptance, PI project management, technology transfer and contract negotiation process.
Learning Objectives:
1. Be able to explain the difference between copyrights, patents, trade secrets, trademarks, materials and data.
2. Be able to explain how to protect the intellectual property from.
3. Understand that U.S. federal funding has specific protocols and reporting requirements, and explain where the Research Administrator can go for more information.
Speakers: Marsha Hoover, JD, Senior Counsel, and Randall Rueth, JD, Partner, Marshall, Gerstein & Borun, LLP
Certificate: Research Law - Required Session

T39: Rebuilding a Research Ethics Committee
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Content Level: Intermediate
Ethics committees and boards have responded to changes in research management and this review of practice looks at the impact on an Australian committee. The principal ethics committee in Australia's capital, Canberra, has undergone major revision, based on changes debated in the literature. The consumption of paper is noted: prompt adoption of electronic documentation was successful. Timelines for ethical review differ but 60 days is common: tighter subcommittee timing has helped to reduce delays. Delegated review of low or minimal risk projects offers rapid handling and relieves main committees. Committee or Board structure varies widely, regulations determining minimum size and membership. Australian rules are the most rigorous. Critics write of growing bureaucracy, discrepancy in ethics decisions, and poor applications. Better communications have proved helpful. A national program to overcome problems of multisite research is underway in Australia; ethical review and research governance are separated though these proceed in parallel.
Learning Objectives:
1. List 4 principal causes of delay in ethical review.
2. Describe the main difficulties in ethical review of multisite research and identify solutions for each.
Prerequisites: None
Speaker: John Biggs, Chairman, Australian Capital Territory Health Human Research Ethics Committee, Australia
Certificate: CTRA201 - Elective; Research Integrity - Required Session

T40: Responsible Authorship: The Key to Professionalism in Science
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Content Level: All Levels
In the academy, the publication of scholarly activity in prestigious journals is the “Coin of the Realm” for investigators.  Publication brings recognition by peers, it is the measure of scientific productivity and thus, a major determinant in whether an investigator receives grants and promotions a timely fashion.  The research administrator is often involved in the preparation and submission of manuscripts and peer reviews.  To do this professionally and to be of maximal assistance to the investigator, the administrator needs a clear understanding of the tenets of Responsible Authorship and Peer Review. 
Learning Objectives:
1. Through didactic presentation, obtain a better understanding of the authorship and publication process. 
2. Through the discussion of case studies, obtain a better understand of how the research administrator can promote research integrity and help their investigators be more productive.
Speaker: Paul Braunschweiger, PhD, CITI Program Director, University of Miami
Certificate: Research Integrity - Required Session

T41: National Science Foundation (NSF) Update
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Content Level: All Levels
This session will cover new developments at NSF - programs, policies, people and budgets. Senior NSF staff will provide a comprehensive review of what is new and developing at NSF.
Learning Objectives:
1. Learn about the NSF FY 2012 and 2013 budgets and administration priorities for NSF programs.
2. Understand how NSF has implemented recent changes to proposal and award policies and procedures.
Prerequisites: None
Speaker: Jean Feldman, Head, Policy Office, National Science Foundation

T42: The Federal Policy and Department of Veterans Affairs Policies Governing Research Misconduct
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Content Level: Intermediate 
This session will provide an overview of the Federal Policy and U.S. Department of Veterans Affairs (VA) policies and procedures governing research misconduct. The session will review the definition of research misconduct and policies and procedures for handling allegations; evaluate cases; discuss common pitfalls; and present strategies for preventing and/or detecting research misconduct.
Learning Objectives:
1. To develop a working knowledge of the definition of research misconduct.
2. To become familiar with VA policies governing the handling of allegations of research misconduct.
Prerequisites: None
Speaker: Doug Bannerman, PhD, Health Scientist, Research Misconduct Oversight Program, VA Office of Research Oversight

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T43: Training for the Masses: A One Woman Show
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Content Level:  All Levels
What happens when you are faced with building a research administration training program with few to little resources in an environment that is ever changing? Success can be found in these five key elements. You must be able to determine what the priority training needs are. You need to establish and maintain program credibility and value. You need to ensure that a strong base of support exists. You must evaluate internal and external resources and how best to use them. Finally, you need to be able to withstand the flying cow in the middle of the chaos tornado.
Learning Objectives:
1. Utilize resources to help evaluate your institutions training needs.
2. Understand the steps needed to get a training program off the ground.
Prerequisites: None
Speaker: Cynthia Lysen, Training Manager, Fred Hutchinson Cancer Research Center

T44: Transforming Learning From Lecture to Online
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Content Level:  All Levels
Pressure from numerous sources is pushing organizations to use technology to address the learning needs and expectations of our current population of research professionals. One challenge facing administrators is to access the support and training necessary to design and deliver high-quality online products, in part because the process often requires the adoption of new approaches. This session will explore several team-initiated approaches undertaken by the presenters to create online learning modules. Session attendees will review best practices in instructional module development, discuss the role of administrative support in meeting projected outcomes, and explore ways of effectively transforming educational materials into online learning formats. Commonly encountered benefits and pitfalls will also be explored.
Learning Objectives:
1. Identify attributes associated with best practices in the design of online instructional materials.
2. Describe methods of containing development costs and improving module quality.
3. Apply knowledge/skills from this session to projects within their host organizations.
Prerequisites: None
Speakers: Leslie Wimsatt, PhD, Education Specialist, Department of Family Medicine, University of Michigan; Nancy Spice, Assistant Director for Training, Office of Research, University of Pittsburgh; Rhonda Reese, Assistant Administrator, Sponsored Projects, Johns Hopkins University

T45: Bronco Bucksheet: An Innovative Web-based Proposal Submission and Approval System
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Content Level:  All Levels
The Bronco Bucksheet facilitates internal review and approval of external funding applications, while serving numerous functions: identifying PIs and Co-PIs; summarizing sponsor, project, and budget information; articulating distribution of recovered F&A costs and intellectual credit; providing assurances regarding compliance and conflicts of interest; and gathering administrative approval for submission. Linkage with other WMU databases allows personnel information to be auto-loaded. An approval tree with designated approvers and alternates facilitates on-line approval, even when individuals are not on campus. Status feedback provides real time information about where a proposal is in the process. Other features allow a PI to copy and edit an existing 'bucksheet' so s/he does not start from scratch for a new proposal. Proposal information is gathered in a database to provide descriptive information regarding project characteristics, useful in preparing annual reports. This session will demonstrate the Bronco Bucksheet and describe strategies for design, development, and implementation.
Learning Objectives:
1. Identify key characteristics and benefits of a Web-based proposal approval system.
2. Develop strategies to design, develop, and implement a Web-based proposal approval system.
Prerequisites: None
Speaker: Paula Kohler, PhD, Associate Vice President for Research, Western Michigan University

T46: An Administrator's Role in Initiating a Scientist's Research Career
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Content Level: Intermediate
Among the rewards of professional research administration is helping new faculty make the transition from being a graduate student or postdoctoral trainee to becoming an independent research investigator. In research-intensive universities, the pressure on young faculty to get extramural funding gives research administrators many opportunities to help them get off to a good start. This session will review 'best practices' for developing productive partnerships with new research faculty while helping them navigate the unfamiliar administrative systems of complex universities and funding agencies.
Learning Objectives:
1. Examine the characteristics and objectives of new faculty who are beginning their independent research careers.
2. Identify ways department and school research administrators can contribute significantly to the research careers of new faculty.
Prerequisites: None
Speaker: James Wrenn, PhD, President & CEO, IT Works

T47: Using Metrics to Drive Research Administration Performance
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Content Level: Advanced
What comes to mind when you hear the word “metrics?” Operational improvement? Efficiency? Benchmarking? Time-consuming data entry? When properly planned and developed, performance metrics can drive performance, change behavior, and support the need for investments in research administration infrastructure. To best support an institution’s research mission it is imperative for research administration offices to have meaningful information about what they do, how much they do, how they do it and how long it takes to do it – in the form of performance data and metrics. This session will focus on the central questions around how to effectively develop, collect and use metrics to monitor and improve performance in your research administration functions.
Learning Objectives:
1. Understand which metrics are most useful for research administration management and how to operationalize metrics at your institution.
2. Use metrics to support requests for resources and how to use metrics to motivate staff in the right way.
Prerequisites: None
Speakers: Marcia Smith, Associate Vice Chancellor for Research, and Patti Manheim, JD, Director, Office of Contract & Grant Administration, University of California, Los Angeles; Nathan Haines, Senior Director, Huron Consulting Group

T48: So What’s New?  Pretty Much Everything
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Content Level:  All Levels
As Roseanne Roseanna Danna used to say, “You know, it’s always something.”  We often talk of the rate of change in sponsors and their expectations or of technology and the flux within disciplines and research topics.  But how much have you considered the rapid changes in society— the so called “generations?”  Changes in values, colloquial language, professional expectations and other professional and social factors are having profound influences on research administration.  This panel discussion will include Boomers, Gen Xers, Millenials and others who will discuss the stereotypes, characteristics and strategies involved in working together and with a changing client base in research.
Learning Objectives:
1. Identify characteristics of generational communication issues and professional expectations within the research administration environment.
2. Match potential solutions for a variety of professional situations, social interactions and other issues with problem-solving strategies.
Prerequisites: None
Moderator: Michael McCallister, PhD, SRA Past President and Principle, GrantStreet Services Consulting, LLC

T49: Effort Reporting: Understanding the Requirements
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Content Level: Basic
Effort reporting is a continual area of focus for Offices of Inspectors General and the Justice Department and is a constant hot topic within the research community. Federal regulations and guidance in this important area are often vague and open to varying interpretations. This session will review recent audit and investigation findings related to effort reporting, discuss common pitfalls/red flags for auditors and offer some best practices on how to avoid them. Among the topics that will be covered in this session are effort reporting fundamentals, as well as some of the more challenging aspects of effort reporting, including what’s in and what’s out of institutional base salary and total professional effort, supplemental compensation, what constitutes a “suitable means of verification” and what exactly is an “independent internal evaluation” of the effort reporting process. Additionally, the presenters will address any changes enacted by the A-21 Task Force.
Learning Objectives:
1. Understand the federal requirements of effort reporting and identify industry best practices for designing and implementing an effective effort reporting process.
2. Learn what federal auditors and investigators look for when auditing effort reporting, and techniques to mitigate risks of non-compliance at your institution.
Prerequisites: None
Speaker: David Clark, Manager, Baker Tilly; Michael Vernick, JD, Partner, Hogan Lovells
Certificate: Financial Management - Required Session

T50: A Proven Approach for Positive Resolution of Federal Audits
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Content Level:  All Levels
When faced with a federal audit or program review, what should you and your university do? In most cases, universities are not exposed to federal audits and reviews with any frequency and therefore do not have preformed plans as to how they should react and manage the process. This session will detail a proven process for managing the audit, meeting the auditors’ needs and at the same time safeguarding your institution from disallowances, potential paybacks or worse. During this session the presenter will also give a quick update on current areas of audit by the federal government.
Learning Objectives:
1. Recognize their position with regards to potential audits and develop a plan for when they are audited.
2. Have a good understanding of current Federal Audits and potential issues.
Prerequisites: None
Speaker: Dan Hamlin, Senior Advisor and Partner, Attain LLC
Certificate: Financial Management - Elective

T52: Research Misconduct Review and Update
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Content Level: Advanced
This session will review the highlights of the 20-year body of research misconduct cases, including cases that have resulted in the return of grant monies and cases that resulted in criminal charges. This session also will examine the current enforcement actions and focus of the relevant federal agencies, including the sanctions against those found guilty of misconduct. Finally, this session will review the compliance actions taken against institutions deemed to have conducted deficient investigations or policies or procedures.
Learning Objectives:
1. Identify factors that converted a misconduct allegation into a monetary recovery or criminal charges.
2. Identify factors likely to result in a finding that the institution conducted a deficient investigation and resulted in a compliance action.
Prerequisites: None
Speaker: Debra Parrish, JD, Attorney, Parrish Law Offices
Certificate: Research Law - Required Session

T53: Biological Specimens in Industry Sponsored Research
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Content Level:  All Levels
The legal and regulatory requirements associated with the collection, storage and use of biological specimens are becoming increasingly complex.  Compliance requires familiarity with the underlying legal and regulatory landscape associated with informed consent, federal and state privacy requirements, ownership of specimens and intellectual property issues, as they apply to biological specimens.  This session will present an overview of current case law and regulations and trends/recent developments.
Learning Objectives:
1. Understand differences between HHS and FDA Informed Consent requirements and their applicability to biological specimens.
2. Understand the issues surrounding 'ownership' of biological specimens under current case law and applicable legislation.
Prerequisites: None
Speaker: Rosemary Farr, JD, Counsel, Reed Smith LLP
Certificate: CTRA201 - Elective; Research Integrity - Required Session; Research Law - Required Session

T54: Principles of Data Management
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Content Level: Intermediate
Researchers will encounter a variety of ethical issues throughout their careers. The principles, professional norms, and debates that surround those issues will be examined in order to better understand how to ensure responsible conduct of research. Because the integrity of the research depends on the integrity of the data, how can the researcher ensure that appropriate data management principles are being observed in every stage of the scientific process? Which data sets are to be included or excluded in publications? When does relying on the previous research of others become plagiarism? Who will be listed as an author on collaborative research, and how will the names be ordered? What are the responsibilities of a mentor to his/her trainees? What are the duties and obligations of the trainee to his/her mentor? In this energetic and interactive session, participants will engage and discuss some key questions in these essential areas of RCR.
Learning Objectives:
1. Discuss a variety of ethical issues encountered by researchers and research administrators in data management and publication practices.
2. Better understand the potential pitfalls in data management and publication practices and be able to identify and respond to key compliance challenges.
Prerequisites: None
Speaker: Tony Onofrietti, Director of Research Education, University of Utah
Certificate: Research Integrity - Required Session

T55: The Federal Demonstration Partnership: What Are They Up To?
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Content Level: All Levels
A representative from the Federal Demonstration Partnership (FDP) will give a brief explanation about what the FDP does and its structure. This will be followed by an update on FDP’s current activities and what to expect in the future.
Learning Objectives:
1. Understand the FDP.
2. Learn about their current activities.
Prerequisites: None
Speaker: David Wright, Executive Director, Federal Demonstration Partnership

T56: The Secrets of the NIH
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Content Level: All Levels
Rebecca had 19 years of university research administration experience at three large universities before coming to the NIH in 2001.  She will share her unique perspective to dispel some of the myths of the NIH and to help grantee research administrators gain insights into the workings of the NIH and dealing effectively with NIH grants management.
Learning Objectives:
1. Learn about NIH policies.
2. Learn about NIH practices.
Prerequisites: None
Speaker: Rebecca Claycamp, CRA, Chief, Grants Management Officer, National Institute of Mental Health

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Monday, October 1
Wednesday, October 3