Portal to Research:
Navigating International Waters
Tuesday Concurrent Sessions
Tuesday, October 25
Tuesday, October 25
T1: Emerging Role of Research Administrators Within the Culture of Research, a UK Perspective; Challenges and Solutions
Room: Matapédia
Content Level: Intermediate
Track: Professional Development
University of Bristol is a Research Intensive University in the UK. The University has a professional research development team who works closely with the Faculty Directors of Research to develop appropriate ways of supporting new research ideas. One of the most challenging areas is to attract academics into working outside of their own disciplines. We have trialed numerous different methodologies to provoke productive discussion and achieve tangible outcomes. We have adopted and adapted mechanisms used by others to be better suited to a University environment (e.g., mini–sandpit events), and also developed novel tactics (e.g., open lab events). This session will discuss the different approaches we have used, with a focus on what works and what doesn’t work for different academic communities. It will also address the key role that the professional research administrator can play.
Learning Objectives:
- Evaluate various approaches to effectively facilitate interdisciplinary research.
- Understand and describe the role of research administrators in the research culture.
Body of Knowledge: The Profession, Pre-Award
Threads:
Research Development
Prerequisites: None
Speaker: David Langley, PhD, Director of Research and Enterprise and Lorna Colquhoun, PhD, Head of Research Development, University of Bristol
Certificate: PRAM-Elective
T2: The Saint, the Legend and the Perfect World
Room: Hochelaga 5/6
Content Level: All Levels
Track: Professional Development
Are you thinking about changing jobs or have you recently done so? Is there a major change ahead for your organization? Please join us for a lively discussion about our experiences dealing with perceptions of saints and legends (the previous person in a job) operating in a perfect world (the way the office used to function). We will share our experiences and lessons learned and hope you will share yours as well.
Learning Objectives:
- Explore practices for effectively managing change.
- Explore practices for determining priorities for the research administration office in a context of a wide variety of interests, stakeholders and demands competing for attention.
Body of Knowledge:
Threads:
Nonprofit/Foundation
Prerequisites: None
Speaker: Dorothy Yates, PhD, Associate Vice President, Research & Economic Development, University of Wyoming; Marcia Landen, PhD, Director of Grant Services, Indiana University; Michael McCallister, PhD, Consultant, Consilience International, LLC
T3: International Collaboration: Is It a Cake Walk or Moving a Mountain?
Room: Péribonka
Content Level: Intermediate
Track: Sponsored Programs Administration
Successful international collaborations are challenging not only due to the time differences, language barriers, and cultural differences, but also due to the differences in regulations, definitions of tasks at hand, and the differences in policies and procedures and how different countries deal with particular items. Additional difficulties arise from the currency fluctuations, budgeting processes, and the calculation and provision of the overhead.
Learning Objectives:
- Gather knowledge on various requirements for international collaborations, especially those with institutions in the United Kingdom.
- Provide commonly encountered problems and tools to resolve those to initiate and complete successful international collaborations.
Body of Knowledge: Pre-Award, Post-Award, Clinical Trials
Threads:
International,
Research Development
Prerequisites: None
Speakers: Dhanonjoy Saha, PhD, Assistant Vice President for Research Administration and Operations, Carolinas HealthCare System
T4: Working with U.S. Funding Agencies and Foundations: Successful Strategies from Foreign Institutions
Room: Chaudière
Content Level: Intermediate-Advanced
Track: Sponsored Programs Administration
For the non-U.S. research administrator, it is often a daunting task to develop a nuanced understanding of the pre- and post-award components of U.S. federal agencies and foundations and strong working relationships with agency and foundation grants managers. The panel members will demystify the processes for interactions with U.S. research agencies and foundations and identify strategies for successful grant development and management.
Learning Objectives:
- Acquire an understanding of U.S. federal agencies funding for non-U.S. institutions.
- Identify strategies for establishing contacts with U.S. federal and not-for-profit agencies and effective pre- and post-award management.
Body of Knowledge: Pre-Award, Post-Award
Threads:
International,
Research Development
Prerequisites: None
Speakers: Colin Cooper, Research Facilitator, Liverpool Hope University; Michael Owen, PhD, Associate Provost Research, University of Ontario, Institute of Technology; Peter Townsend, Director, Office of Research, Loughborough University
T5: Working Smarter: Electronic Infrastructure as a Tool for Strategic Alignment in Research Administration
Room: Saint-Laurent
Content Level: Advanced
Track: Management and Operations
This session will present the MUHC-RI case in implementing an integrated system for compliance management. This system touches on Science, Ethics, Finance and Legal processes among others. eREVIEWS has brought process unification and automation to the complex and manual ways that were existing in different hospitals under MUHC umbrella. Best practices have emerged from this experience which has improved both quality and efficiency.
Learning Objectives:
-
1. Evaluate the benefits of implementing workflow based electronic research administration software to streamline the processes of Initial and Ongoing Ethics, Science, pharmacy, Contracts, Budget Resource Review.
2. Identify the advantages of using a single system to streamline the review of not only ethics but also science, Pharmacy, Contracts, Budget, Trial registration, Resource and Medical Record Access.
Body of Knowledge: TBD
Threads:
Nonprofit/Foundation
Prerequisites: None
Speakers: Cinzia Raponi, Director, Division of Research Grants and Data Management, McGill University Health Center - Research Institute
Certificate: PA-Elective
T6: Managing Research in a Shrinking Economy
Cancelled

T7: After the Award: Rebudgeting and Cost Transfers
Room: Jolliet
Content Level: Basic-Intermediate
Track: Financial Management
Central Administration, are you struggling with the quality of the re-budgeting requests sent by your departments? If you are new to approving re-budgeting request, do you know what level of detail you should expect? Department Administrators, are you frustrated with Central Administration's delays in processing re-budgeting requests and the continual nitpicking about the justification? What is the difference between re-budgets and cost transfers? This session provides guidance on how to write better re-budgeting justifications and cost transfer explanations that are more likely to create fewer headaches and be approved. Learn how to reduce the number of re-budgeting and cost transfer requests. The session will also explore how organizations can structure institutional systems to reduce the number of required re-budgets.
Learning Objectives:
- Write re-budgeting and cost transfer requests which will be approved. Evaluate whether sufficient detail is provided to approve a re-budgeting request or cost transfer.
- Differentiate between the need to submit a cost transfer or re-budgeting request. Recommend and/or implement financial system controls which will reduce cost transfers.
Body of Knowledge: Post-Award
Threads:
Departmental Administration,
Hospital/Medical Centers,
International,
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training
Prerequisites: None
Speaker: Kris Rhodes, Director, MAXIMUS, Inc.
Certificate: FM-Required Session; PRAM-Elective

T8: OMB Requirements Cost Allowability and Allocability and OMB A-110
Room: Richelieu
Content Level: Basic-Intermediate
Track: Financial Management
This session will provide a basic to intermediate perspective on OMB Circulars A-21 and A-110. The session will focus on post-award administration of sponsored projects and seek attendee participation to discuss how central offices and departmental administration can leverage each other as partners to effectively manage sponsored projects.
Learning Objectives:
- Understanding cost principles related to federal sponsored projects and administrative requirements related to federal sponsored projects.
- Define the role of central offices and departmental administration in sponsored projects management.
Body of Knowledge: TBD
Threads:
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training
Prerequisites: None
Speaker: Govind Narasimhan, Associate Director DoCM Research Finance, University of Texas M.D. Anderson Cancer Center
Certificate: FM-Elective

T9: Copyright and Data Rights under Government Contracts and Grants
Room: Saint-Maurice
Content Level: Intermediate
Track: Research Law
Rights in advanced technology and software are at risk whenever an institution enters into an agreement as a vendor or as a grantee. The federal government gets broad rights in intellectual property developed with even partial government funding, and the rules governing the relationships vary from civilian agencies to the Department of Defense. It is critical that the institution be knowledgeable about what constitutes proprietary intellectual property, who owns the property, the applicable regulations and how to avoid inadvertently abandoning its intellectual property rights. Understanding the potential for a national security rationale to come into play in the government’s approach to controlling rights is increasingly important. The purpose of this focused session is to provide the most practical information possible on issues arising from government funding for development of copyrighted works, including computer software, from the perspective of the Government, contractors, grantees, and their professional advisors.
Learning Objectives:
- Be familiar with the types of data rights contract clauses and the impact of the classification of data on how the rights are allocated and protected.
- Understand the nature of authorship in the institutional context and how copyrights are licensed or assigned.
Body of Knowledge: TBD
Threads:
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training
Prerequisites: None
Speaker: Marsha Hoover, Senior Counsel, Marshall, Gerstein & Borun, LLP
Certificate: RL-II&III

T10: International IP Issues: Canada as an Example
Room: Gatineau
Content Level: Intermediate
Track: Research Law
While the U.S. economy remains by far the largest in the world, it represents only 20-25% of the total world economy and this percentage is declining as other markets develop. Cost-effective protection of IP and successful commercialization increasingly demands an understanding of intellectual property regimes outside the U.S., especially as common U.S. practices can be fatal to IP rights in other markets. Canada, a market roughly 10% the size of the U.S., is illustrative of some of the differences that will be encountered in the Commonwealth and many other key markets in both patent and copyright law.
Learning Objectives:
- Patents: A summary of the key differences between US law and other key jurisdictions, with emphasis on patentable subject matter, ownership issues (Bayh-Dole/rights of funding bodies, first to file instead of first to invent, co-ownership, employer/employee rights) and absolute novelty requirements.
- Copyrights: A summary of the key differences between US law and other key jurisdictions with emphasis on works subject to copyright, fair use & infringement, ownership issues, and enforcement.
Body of Knowledge: TBD
Threads: TBD
Prerequisites: None
Speaker: Neil Milton, Partner, Miltons IP
Certificate: RL-II


T11: RCR for Research Administrators
Room: Duluth
Content Level: All Levels
Track: Research Ethics
Research administrators and research staff members (i.e. coordinators, data management specialists, assistants, etc.) play an important part in promoting the integrity of the research enterprise. Frequently, those in a nonscientific, supporting role encounter ethical decisions in an environment of competing obligations and responsibilities. In order to function effectively and make appropriate ethical decisions, administrators need to be aware of the prevailing rules, regulations and guidelines. It is not enough to just know where a certain policy is posted on the web or sitting in a binder on the shelf. All of those involved in research must abide by a core of ethical principles in order to do their jobs properly and to contribute to the overarching "culture of responsibility."
Learning Objectives:
- Raise awareness, in order to be able Identify when situations present ethical dilemmas or conflicts.
- Reason among possible courses of action and effectively implement the best solution to the problem.
Body of Knowledge: The Profession, Infrastructure, Pre-Award, Post-Award, Public Responsibility
Threads:
Commercial/Industry,
Departmental Administration,
Hospital/Medical Centers,
International,
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training,
General
Prerequisites: None
Speakers: Debra Schaller-Demers, Director, Research Outreach and Compliance, Memorial Sloan-Kettering Cancer Center
Certificate: RI-VI; PA-Elective; HRP-Required; IRAM-Elective; PRAM-Elective
T12: TBA
T13: NSF Research.gov: Powering Knowledge and Innovation
Room: Bersimis
Content Level: All Levels
Track: Sponsors and Agencies
Come to the Research.gov session to learn how Research.gov can benefit you and your organization! This session features a high-level overview of Research.gov, the National Science Foundation (NSF)-led initiative that provides organizations and grantees with easy access to research-related information and grants management services from multiple federal agencies in one location. In the session, participants will find out how NSF is modernizing the FastLane system through Research.gov, learn about current and upcoming services and grants management tools for the research community, hear about updates on NSF and partner agencies, and find out how Research.gov helps to alleviate administrative burden and increase transparency.
Learning Objectives:
- Use Research.gov's grantee services to help manage their grants portfolio, such as complete reporting requirements, and check the status of grant applications.
- Identify Research.gov’s informational public services that provide the latest research award information, headlines, policies, and events.
Body of Knowledge: Pre-Award, Post-Award, Public Responsibility
Threads:
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training,
Research Development,
General
Prerequisites: None
Speakers: Adrienne Deitemeyer, IT Communications Specialist, National Science Foundation
T14: Setting Up an Office of Research Administration
Room: Harricana
Content Level: All Levels
Track: Select Topics
Prospective chief research officers confront several challenges. The first is to negotiate a fair salary and operating budget. After accepting the position, the newly appointed chief research officer must organize the office properly. Initially, this involves determining the position’s authority and coupled responsibilities. The next step is to ensure the availability of adequate staff support and to establish effective reporting lines. This session explores these important first steps in setting up a smoothly functioning research administration office.
Learning objectives:
- Establish a fair start-up package
- Determine the office staffing requirements.
Body of Knowledge: TBD
Threads: TBD
Prerequisites: None
Speakers: Dean Smith, Professor, Texas Tech University
Tuesday, October 25
T15: The Seven Habits of Highly Successful Research Administrators
Room: Gatineau
Content Level: Basic-Intermediate
Track: Professional Development
This session was inspired by Steven Covey's widely popular book, “The Seven Habits of Highly Effective People ”though the presentation contains none of Covey's writings. Attendees will be exposed to seven broad principles that will lead them down the road to constant success as research administrators. The broad and interactive discussion focuses on seven topics: financial pre-planning, the Golden Rule, assumptions, e-tools, clear communications, PI's style, and personal/customized professional development needs. The overall purpose of this session is for the attendees to walk away with additional confidence, more awareness, and a greater sense of purpose in their daily research administration tasks.
Learning Objectives:
- Understand how a person’s work habits influence other's trustworthiness in their abilities. Mirror successful traits of veteran research administrators. See their role in grand scheme of things.
- Realize that, no matter which habit is being exercised, each situation is unique. There is no "one size fits all."
Body of Knowledge: The Profession
Threads:
Departmental Administration,
Hospital/Medical Centers,
International,
Nonprofit/Foundation,
Academic/Training,
Research Development,
General
Prerequisites: None
Speakers: Denise Moore, Operations Manager, Office of the Dean, College of Arts and Letters, Michigan State University
Certificate: LD-Elective; PRAM-Elective

T16: Post-Submission to Award Acceptance
Room: Duluth
Content Level: Basic
Track: Sponsored Programs Administration
The pre-award office is responsible for dealing with a variety of issues that arise after proposal submission and lead to acceptance of the award. The pre-award administrator should be able to deal with publication restrictions, intellectual property, indemnification, facilities and administrative costs questions, and know how to address such special situations as international agreements and JIT requirements. The session will identify troublesome clauses and discuss how to determine what to accept and what to reject, and other difficult contract review topics.
Learning Objectives:
- Review different types of award terms and conditions, including Federal Acquisition Regulations and different grants policy manuals.
- Negotiate acceptance of awards.
- Review revised budgets.
- Prepare no cost extensions.
Body of Knowledge: TBD
Threads:
Departmental Administration,
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training
Prerequisites: None
Speaker: David Hollingsworth, CRA, Director Grants and Contracts, Texas A&M University System
Certificate: PA-Required
T17: Building the Research Development Enterprise: Effective Practices and Strategies in an Increasingly Competitive Environment
Room: Bersimis
Content Level: All Levels
Track: Sponsored Programs Administration
This session will provide an overview of the scope of research development strategies and practices for enhancing success in obtaining research funding in an increasingly competitive environment. The presenters will give examples and case studies of the types of practices that have been developed at a number of universities, with a particular focus on strategies and practices to increase institutional capacity in targeted areas, including early career faculty and to facilitate interdisciplinary research collaboration. Specific strategies and activities to be discussed include: incentives and seed funding; support for institutional centers; training activities; use of limited submission reviews to increase proposal competitiveness; institutional priority setting and strategic planning; mentoring of early career faculty; inter-institutional collaborations and outreach and communication.
Learning Objectives:
- Engage the administration and faculty in effective research development practices to enhance research funding.
- Apply specific case study examples of effective practices in capacity development to increase their institution’s competitiveness in seeking research funding.
Body of Knowledge: The Profession, Infrastructure, Pre-Award
Threads:
Predominantly Undergraduate Institutions (PUIs),
Academic/Training,
Research Development
Prerequisites: None
Speakers: Gina Betcher, Research Officer and Proposal Developer, Western Michigan University; Susan Carter, JD, Director, Research Development Services, Office of Research, University of California, Merced; Ann McGuigan, PhD, Director of Research Development, Office of Research Development, George Mason University
Certificate: PA-Elective
T18: So You Think Your Emergency Preparedness Plan is Adequate
Room: Saint-Maurice
Content Level: All Levels
Track: Management and Operations
Research Administrators are not exempt from emergency preparation and recovery planning. Every organization is vulnerable to disasters. Floods, earthquakes, hurricanes, pandemics, terrorists, riots, fires, hazardous materials incidents and fanatics are potential disasters that can strike any institution at any time. Research Administrators should develop departmental plans that parallel their university preparedness plan. Preparation should encompass alternative methods of communications with their university administrators, researchers and staff. The plan should include accessing contact information, grant information, and personnel information without access to local phone numbers, internal e-mail addresses and office computers. Emergency preparations should also include proactive strategies for returning to work immediately after the disaster, even if the site is inaccessible. Providing support to staff and researchers is critical to the recovery after a disaster. Planning is the key to success.
Learning Objectives:
- Analyze current long-term emergency plans to identify weaknesses and evaluate comprehensiveness in order to develop more thorough plans.
- Identify disaster recovery strategies from resuming business with minimum delay to identifying regulatory, management, educational, and health care issues.
Body of Knowledge: The Profession, Infrastructure
Threads:
Departmental Administration,
Nonprofit/Foundation,
Academic/Training,
General
Prerequisites: None
Speakers: Shanna Labranche, Business Manager, Neuroscience Center of Excellence and Karen Jorgenson, Business Manager, Departments of Pharmacology and Biochemistry, Louisiana State University Health Sciences Center

T19: Fostering a Team Approach to Cost Sharing: A Pre- and Post-Award Perspective
Room: Jolliet
Content Level: Basic-Intermediate
Track: Financial Management
Cost sharing in proposals is a common issue for research administrators. What is cost sharing? What is mandatory vs. voluntary? What are the do's and don'ts? Are some costs better than others for institutions to offer? How does cost sharing affect the project once it is awarded? What types of documentation are sufficient? This session will cover these topics as well as provide examples of documentation and cost sharing policies and procedures to participants.
Learning Objectives:
- Gain an understanding of the basic concepts of cost sharing.
- Learn an example of a cost sharing policy to take back to his/her institution.
- Learn about the cost sharing process from conception to closeout.
Body of Knowledge: Pre-Award, Post-Award
Threads:
Departmental Administration,
Hospital/Medical Centers,
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training,
General
Prerequisites: None
Speaker: Sandra Nordahl, CRA, Co-Director, Sponsored Research, Contracting and Compliance and Joanne Cobble, Sponsored Programs Coordinator, San Diego State University Research Foundation
Certificate: FM-Required

T20: Successful Financial Monitoring of Sponsored Projects
Room: Hochelaga 5/6
Content Level: Basic-Intermediate
Track: Financial Management
Successfully monitoring the finances of a sponsored project requires a good background knowledge of the award, diligence in reviewing expenditures, and management tools that enable the busy research administrator to focus in on key information to proactively identify problems status and needed actions. This session will share best practices and some management tools that have worked for our staff.
Learning Objectives:
- Identify ways to improve financial management of sponsored projects by effectively and proactively monitoring budgets, expenses and balances.
- Understand how management tools that provide key information about projects can assist with financial management.
Body of Knowledge: Post-Award
Threads:
Departmental Administration,
Nonprofit/Foundation,
Academic/Training,
General
Prerequisites: None
Speaker: Kim Carter, CRA, Associate Director, Office of Sponsored Programs, Ohio State University
Certificate: FM-Elective; PRAM-Elective

T21: National Security Law for the Research Administrator
Room: Saint-Laurent
Content Level: All Levels
Track: Research Law
This presentation will cover key national security regulations that impact the research administrator, including export controls, security classification issues, Foreign Corrupt Practices Act, and related regulations and statutes. Attendees will have a basic introduction to the area of law, an understanding of how these laws affect research institutions, and key compliance mechanisms. At the end of the presentation, participants will be able to spot key issues and determine whether their institution should focus more on compliance with these issues.
Learning Objectives:
- General awareness and issue-spotting ability for issues relating to export controls, security classification, and anti-corruption laws and regulations.
- Understanding of how national security laws and regulations might impact your organization's work.
- Basic understanding of the Foreign Corrupt Practices Act and similar laws outside the U.S.
- Basic understanding of the U.S. export controls system.
- Awareness of U.S. national security laws (e.g., PATRIOT Act).
Body of Knowledge: TBD
Threads:
Nonprofit/Foundation
Prerequisites: None
Speakers: Michael Lowell, JD, Senior Associate and Leigh Hansson, JD, Partner, Reed Smith, LLP
Certificate: RL-I&IV


T22: Addressing Subject Injury: Informed Consent, Contract Language and the Interplay with Third Party Payers
Room: Harricana
Content Level: Intermediate
Track: Research Law
Subject injury language is addressed as a part of the clinical trial agreement and in the informed consent documents. While not the same language, legal concepts must be communicated to others and the essence of the two should be in harmony. Subject injury provisions are also not immune to carve-outs, leading to the challenge of explaining the intricacies of technical legal language such as to those who are often unfamiliar with and are faced with the daunting task of developing an informed consent document understandable at an eighth grade reading level. Insurance coverage and the issues of third party payer billing rules contribute to the complexity. Participants will learn how to provide clear information to research subjects, allowing them to make an informed decision about study participation while identifying who is responsible for what coverage to satisfy the site and sponsor.
Learning Objectives:
- Review some of the more common subject injury provisions seen in clinical trial agreements.
- Discuss how these legal, contractual provisions might be meaningfully translated to ultimately provide clear information to research subjects.
Body of Knowledge: TBD
Threads:
Clinical Trials,
Nonprofit/Foundation
Prerequisites: None
Speakers: David King, JD, Director, Office of Industry Contracts and Assistant University Counsel, University of Louisville; Angelique Dorsey, JD, Research Compliance Director, MedStar Health
Certificate: RL-I&III; CTRA101-Elective; CTRA201-Elective

T23: Authorship: Role of Institutional Guidelines and RCR Training for International Collaborations
Room: Mackenzie
Content Level: Intermediate
Track: Research Ethics
This session will first review guidelines and conflicts related to how recognition as an author on research publications is occurring. Issues of co-authorship, ghost writing, and honorary authorships will also be addressed. The second focus will be a case study – a review of the Johns Hopkins University School of Medicine experience in drafting a policy on the responsible conduct of research, with a focus on authorship guidelines. The third focus will pay particular attention on how attribution for authorship can become a much more difficult issue when conducting research with colleagues from a different country. We will explore how RCR programs will need to focus on training researchers to consider how someone from another culture may have very different educational experiences, standards and skills, methods of data collection, rules for compliance, and expectations on who deserves to be recognized as an author.
Learning Objectives:
- Recognize plagiarism.
- Articulate the elements commonly required for authorship.
- Develop an institutional policy on authorship.
- Consider elements necessary in RCR programs to promote ethical collaborations internationally.
Body of Knowledge: The Profession, Infrastructure, Public Responsibility
Threads:
Nonprofit/Foundation,
Academic/Training,
Research Development
Prerequisites: None
Speaker: Sheila Garrity, JD, Director, Division of Research Integrity, Johns Hopkins University School of Medicine
Certificate: RI-V; HRP-Elective; PRAM-Elective

T24: How Fraud Happens (And How to Prevent It at Your Institution)
Room: Péribonka
Content Level: All Levels
Track: Research Ethics
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 and how s/he can help prevent or detect it.
Learning Objectives:
- Gain an understanding of the basics of why employees may use their position to commit fraud.
- Identify the red flags of fraud, and how to escalate issues and concerns as necessary. Learn how to lower your institution’s risk for fraud.
Body of Knowledge: TBD
Threads:
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training
Prerequisites: None
Speaker: Kimberly Ginn, Director and Raina Rose Tagle, Partner, Baker Tilly
Certificate: RL-IV
T25: Navigating the NIH Grants Policy Statement - Guidance for Foreign Institutions
Cancelled
T26: The Rick Hansen Institute: Lessons Learned from Developing a National Registry into an International Clinical Research Network
Room: Matapédia
Content Level: Intermediate
Track: Sponsors and Agencies
Fuelled to become a catalyst for societal change for accessibility and making a difference for people living with spinal cord injuries, in the last 25 years Rick Hansen has helped to generate $200 million for spinal cord research and quality of life programs. To facilitate research, in 2004, the Rick Hansen Spinal Cord Registry (RHSCIR) was established. The registry is currently collecting data at 35 major Canadian hospitals and is in the process of expanding internationally. In 2009, with funding from Health Canada and other partners, the Rick Hansen Institute (RHI) was incorporated as a non-profit research organization to sponsor international clinical trials in spinal cord injury research. This presentation will outline the lessons learned as our organization moved from a granting agency to a sponsor of clinical trials. These lessons include grant and study administration, clinical research operations, clinical research informatics, sponsor obligations, and regulatory, legal and privacy requirements.
Learning Objectives:
- Identify the operational challenges of a start-up academic research organization as it transformed from a granting agency to clinical research sponsor.
- Describe the operational, informatics, legal, regulatory and privacy requirements of an academic research organization as the sponsor of clinical trials.
Body of Knowledge: The Profession, Infrastructure, Clinical Trials
Threads:
Clinical Trials,
Hospital/Medical Centers,
Nonprofit/Foundation,
Academic/Training,
Research Development
Prerequisites: None
Speaker: Erin Cherban, Director, Clinical Research Operations, Rick Hansen Institute
Certificate: PRAM-Elective
T27: Trials and Tribulations of Latin American Research Implementation
Room: Chaudière
Content Level: All Levels
Track: Select Topics
Trauma is a leading cause of disability and death worldwide and Traumatic Brain Injury (TBI) is the leading cause of morbidity and mortality from trauma. The University of Washington Department of Neurological Surgery is conducting an NIH-funded, randomized control trial of intracranial pressure monitoring devices in Bolivia and Ecuador and a five-nation TBI observational study with investigators who are part of the 14-nation Latin American Brain Injury Consortium. This presentation will explore the complexities and challenges of implementing a rigorous clinical trial in the context of low and middle income countries (LMIC). In addition, it will emphasize the scientific return and rewards of working with highly motivated indigenous co-investigators. Culturally relevant and resource-appropriate global health solutions are best developed through research sited in LMICs. This experience is relevant to research administration because of increasing global interactions as well as the growing number of clinical trials conducted in LMICs.
Learning Objectives:
- Identify the leading barriers to clinical research implementation in low and middle income countries.
- Identify culturally relevant and resource appropriate approaches to research administration problem solving in low and middle income countries.
Body of Knowledge: The Profession, Infrastructure, Clinical Trials
Threads:
Clinical Trials,
Hospital/Medical Centers,
International,
Research Development
Prerequisites: None
Speaker: James Pridgeon, Lecturer, Department of Neurological Surgery and Kelley Chaddock, Research Coordinator, University of Washington
T28: Picking the Winners: Comparing the Grant Review Process in the U.S. and the United Kingdom
Room: Richelieu
Content Level: Intermediate-Advanced
Track: Select Topics
The process by which funding agencies decide to award or decline proposals is often seen as a mysterious one, to both grant writers and their research administrators. This session will compare and contrast the grant review process in two major US agencies, the National Science Foundation and the National Institutes of Health, with a system recently adopted by the leading Research Councils in the United Kingdom. A particular focus will be on the UK’s use of full economic costing as a key criterion in their peer review system, a requirement that insists on greater fiscal efficiency and accountability from researchers, and plays a critical role in the funding decision.
Learning Objectives:
- Identify critical areas where the U.S./UK peer review processes are similar and where they differ.
- Recognize how full economic costing has impacted peer review in the UK.
Body of Knowledge: TBD
Threads: TBD
Prerequisites: None
Speakers: Robert Porter, PhD, Director, Research Development, University of Tennessee; Gareth MacDonald, Head of Assurance, Research Councils, UK
Tuesday, October 25
T29: Research Development: A New Paradigm in Pre-Award Preparation
Room: Saint-Laurent
Content Level: Advanced
Track: Professional Development
A new trend is emerging among research institutions to deal with the challenges of the current funding environment and the complexities of today’s research projects, which often span multiple fields, campus units and institutions. Research development professionals – academic staff who work to facilitate faculty research efforts through comprehensive pre-award grant preparation support and a variety of other means – are being employed by a growing number of universities and research-performing institutions - and are helping to guide individual and campus research strategy, while greatly improving faculty efficiency and funding success. This session will describe activities and structure of highly functional research development offices, including presentation of case studies and descriptions of effective practices. A particular emphasis will be placed on issues associated with pre-award preparation for larger projects. An introduction to the newly formed National Organization of Research Development Professionals (NORDP) will be included.
Learning Objectives:
- Understand the field of research development, gain tools to deal with potential pitfalls in pre-award preparation, and share past experiences and lessons learned.
- Have awareness of the professional organization NORDP and how it might interact with SRA and its members.
Body of Knowledge: The Profession, Infrastructure, Pre-Award
Threads:
Departmental Administration,
Nonprofit/Foundation,
Academic/Training,
Research Development
Prerequisites: None
Speakers: Jacob Levin, PhD, Assistant Vice Chancellor, Research Development, University of California, Irvine
T30: European Union Research Programme Fundamentals
Room: Matapédia
Content Level: Basic
Track: Sponsored Programs Administration
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. The session will cover mobility grants and funding opportunities in the fields of health and science. Speakers from a European research support office will provide the research administrator with a fundamental understanding of the EU research application process. The 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 submission of proposals.
Learning Objectives:
- Identify relevant EU funding opportunities.
- Describe the application process.
Body of Knowledge: Pre-Award
Threads:
International
Prerequisites: None
Speaker: John Westensee, Head, Research Support Administration, Aarhus University Hospital
Certificate: PRAM-Elective
T31: Biosafety Basics for the Research Administrator
Room: Péribonka
Content Level: Basic
Track: Management and Operations
This presentation has been developed to help participants enhance their awareness of biosafety issues in biomedical and research laboratories and to improve existing biohazard control programs at their institutions. Basic biosafety principles including risk groups, biosafety levels and controls will be discussed in addition to the importance of conducting thorough and meaningful risk assessments. Emphasis will also be placed on successful training programs and involvement in new or established institutional biosafety committees.
Learning Objectives:
- Understand basic concepts of biosafety in a laboratory setting.
- Become familiar with how to initiate and implement successful biosafety training.
- Become familiar with the responsibilities of institutional biosafety committees.
Body of Knowledge: TBD
Threads:
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training
Prerequisites: None
Speakers: Christina Kulakowski, Safety and Industrial Hygiene Coordinator, ARUP Laboratories, Inc.
T32: Service Centers in Action
Room: Richelieu
Content Level: All Levels
Track: Management and Operations
The speaker has been operating a recharge center for many years and works with others that operate service centers on campus. Many rules and regulations are required as part of operating a service/recharge center. The speaker will review the federal guidelines and limitations, and the process required by university policy to get a service/recharge center up and running as well as the requirements to keep it running.
Learning Objectives:
- Starting a service or recharge center, where do you begin?
- What Federal regulations should be considered when talking about service or recharge centers?
- Once a service or recharge center is started some things to avoid and things to pay attention to.
- How to keep your service or recharge center running.
Body of Knowledge: TBD
Threads:
Academic/Training
Prerequisites: None
Speakers: Edward Black, Manager, Grants and Accounting, University of Utah, Scientific Computing and Imaging (SCI) Institute


T33: Sub-contracting and Sub-recipient Monitoring: Best Practices
Room: Mackenzie
Content Level: Basic-Intermediate
Track: Financial Management
This session will cover the fundamentals of sub-awards, sub-contracts and sub-recipient monitoring. What is required by 2 CFR Part 215 (OMB Circular A-110) and OMB Circular A-133? How do you know what terms to flow down to different types of sub-agreements? How do you and how much can you vary the FDP sub-agreement for particular circumstances? What do you do when part of an award is cost reimbursable and another part is fixed price? How do you deal with commercial sub-awardees and sub-contractors? What rules apply to what parties? Once the agreement is issued, what do you need to do to monitor the sub-recipient’s activities?
Learning Objectives:
- Develop a general understanding of the nature of sub-awards, the terminology used for various types of sub-awards and the federal rules that apply to them.
- Develop a general understanding of what kind of sub-recipient monitoring is necessary to fulfill award requirements and expectations.
Body of Knowledge: Infrastructure, Pre-Award, Post-Award
Threads:
Departmental Administration,
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training
Prerequisites: None
Speakers: Cindy Kiel, JD, CRA, Executive Associate Vice Chancellor for Research, Office of Research, University of California, Davis; Stephanie Endy, Director of Sponsored Programs, Lehman College CUNY
Certificate: RL-I&III; FM-Required; PRAM-Elective

T34: Effort Reporting at Academic Medical Centers
Room: Hochelaga 5/6
Content Level: All Levels
Track: Financial management
Many differences and complexities exist in the administration of research programs in a clinical setting compared with those in a traditional university environment. This session will explore some of these differences and expand on issues related to academic medical centers and clinically based research programs. For example, universities often complain that it is difficult for institutions to account fully for the time spent by physician scientists because the boundaries associated with teaching, research, and patient care are blurred. Moreover, these activities are accounted for differently by specific federal agencies. This session will cover topics such as appointment letters, the definition of institutional base salary, clinical practice plans, affiliated vs. non-affiliated hospitals, what constitutes 100% effort, distinguishing between clinical effort and clinical trial effort, how to manage effort commitments on K Awards, VA appointments, and Medicare time reporting. This session is designed to facilitate dialog among the participants.
Learning Objectives:
- Gain knowledge about compensation and effort reporting requirements within academic medical centers and clinically based research programs.
- Articulate federal guidance that governs faculty appointments at academic medical centers with a focus on guidance applicable to university-VA joint appointments.
Body of Knowledge: Infrastructure, Pre-Award, Post-Award
Threads:
Hospital/Medical Centers,
Departmental Administration,
International,
Academic/Training
Prerequisites: None
Speakers: Matthew Staman, Managing Director, Huron Consulting Group
Certificate: FM-Required; PRAM-Elective

T35: Canadian & International Copyright Issues
Room: Gatineau
Content Level: Intermediate
Track: Research Law
Canada and the United States are similar neighbors, with heavy cross-border traffic in people, ideas, research, products and services. Yet there are substantial differences in the copyright law regimes in the two countries that can have significant consequences for the scope of protection (especially compilations of data), what use of the works of others constitutes fair use, issues related to ownership (rights of authors and deemed assignment, rights of funding bodies) and enforcement. Differences between U.S. and Canadian law are illustrative of differences between U.S. law and copyright law in a number of other key jurisdictions, including, but not limited to, other Commonwealth countries.
Learning Objectives:
- Key differences between U.S. and Canadian copyright law, including moral rights.
- Key differences between U.S. copyright law and other key jurisdictions.
- Trends, pending developments, and reforms in international copyright law.
Body of Knowledge: TBD
Threads: TBD
Prerequisites: None
Speakers: Neil Milton, Partner, Miltons IP
Certificate: RL-II
T36: International Efforts to Combat Research Misconduct
Room: Bersimis
Content Level: All Levels
Track: Research Law
Science has grown increasingly international and collaborative. Although the U.S. took the lead in developing regulations to address research misconduct, there is a recent push by many other countries to develop policies and procedures for misconduct. This presentation will explore those developments and the various positions taken by governmental entities and the scientific community.
Learning Objectives:
- Identify international resources and interested parties.
- Rapidly analyze a misconduct allegation in the context of the regulations and case law.
Body of Knowledge: Pre-Award, Post-Award, Public Responsibility
Threads:
Departmental Administration,
Hospital/Medical Centers,
International,
General
Prerequisites: None
Speakers: Debra Parrish, JD, Founder, Parrish Law Offices
Certificate: PRAM-Elective



T37: Human Research Protection Program: Beyond the IRB
Room: Chaudière
Content Level: All Levels
Track: Research Ethics
Recent experience and best practice in the field of human research protections has indicated that IRB review is not sufficient to ensure adequate protection of the rights and welfare of human participants in research. In order to ensure that the organizations are meeting the ethical principles and regulatory requirements for the protection of human participants, research sites must have a “Human Research Protections Program” (HRPP). An HRPP is a comprehensive and organized system to ensure the protection of human volunteers participating in research. The HRPP clearly delineates the shared responsibilities of all of those involved in human research and includes written policies and procedures, adequate education and training, adequate IRB review, internal study monitoring, overall program assessment and participant education. This session will explain the need for HRPPs and how to implement an HRPP at an organization.
Learning Objectives:
- Identify the difference between an HRPP and an IRB and describe the elements of an effective HRPP.
- Describe the value of an effective HRPP to an organization.
Body of Knowledge: The Profession, Infrastructure, Pre-Award, Public Responsibility, Clinical Trials
Threads:
Clinical Trials,
Commercial/Industry,
Hospital/Medical Centers,
International,
Nonprofit/Foundation,
Academic/Training,
Research Development,
General
Prerequisites: None
Speaker: Jeffrey Cohen, PhD, Chief Executive Officer, HRP Consulting Group, Inc.
Certificate: RI-II; RL-Elective; CTRA101-Elective; CTRA201-Elective; HRP-Required
T38: National Science Foundation Office of Inspector General: Who We Are. What We Do.
Room: Harricana
Content Level: Basic-Intermediate
Track: Research Ethics
This session will provide a primer on the role of Inspectors General, with specific focus on the roles and responsibilities of the NSF OIG. A major part of this presentation will be numerous case studies, from NSF/OIG case files, covering such topics as fraud, embezzlement, research misconduct, conflicts of interest, IACUC/IRB issues, and cases involving small business grants obtained by university faculty. The case studies will offer insight into weaknesses in internal controls that allow violations to occur. This presentation is guaranteed to be both enlightening and entertaining.
Learning Objectives:
-
1. Understand the role and responsibilities of Inspectors General.
2. Understand focus areas of NSF/OIG investigations.
Body of Knowledge: TBD
Threads:
Predominantly Undergraduate Institutions (PUIs)
Prerequisites: None
Speaker: Kenneth Busch, PhD, NSF Office of the Inspector General
Certificate: PRAM-Elective
T39: Washington Update: Political Shift and the 2012 Presidential Race: The Impact on Research Funding
Room: Duluth
Content Level: All Levels
Track: Sponsors and Agencies
Much has changed in Washington D.C. This session will focus on the major changes that will impact research and R&D funding in the US. Topics will include the FY 12 budget and the interaction between the new Congress and White House.
Learning Objectives:
- Develop an understanding of the major federal issues that will impact research.
- Get a forecast of R&D funding.
Body of Knowledge: The Profession, Infrastructure, Pre-Award, Post-Award, Public Responsibility, Clinical Trials
Threads:
Commercial/Industry,
Hospital/Medical Centers,
International,
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training,
Research Development,
General
Prerequisites: None
Speaker: William Schweri, Director of Federal Relations, University of Kentucky
Certificate: IRAM-Elective
T40: Combined International Health Research Funding Opportunities: National Institutes of Health, Canadian Institutes of Health Research, Medical Research Councils UK
Room: Jolliet
Content Level: All Levels
Track: Sponsors and Agencies
This session will compare and contrast funding opportunities as well as joint funding programs by three international health research funding bodies represented by the National Institutes of Health, the Canadian Institutes of Health Research and the Medical Research Council United Kingdom. Various examples of funding will be presented and discussed.
Learning Objectives:
- Gain an understanding of joint funding efforts by the three granting agencies.
- Discuss and research possible funding opportunities.
Body of Knowledge: TBD
Threads:
Clinical Trials
Prerequisites: None
Speakers: Ruth Lee, Director, Research Councils of the UK, U.S. Office; Bruce Butrum, Chief Grants Management Officer, Fogarty International Center, National Institute of Health, Nancy MacLellan, Deputy Director, Canadian Institutes of Health Research
Certificate: PRAM-Elective
T41: Clinical Trials Registries – The Importance of Registering and Following Throughout the Lifecycle of a Trial
Room: Saint-Maurice
Content Level: Intermediate
Track: Select Topics
This session describes requirements for clinical trials registration and results disclosure. It provides an overview of the evolution, importance and current state of clinical trials registration and results disclosure, and regulatory requirements. It also describes various platforms in U.S., Canada, Europe, India, as well as issues regarding pharma industry-specific registries and requirements. This session will also provide suggestions for research administrators to track and follow up on their institution’s responsibilities and registrations.
Learning Objectives:
- Understand the importance of registering trials, providing updates and trial results, including consequences of non-compliance.
- Know where to find instructions and guidance for specific countries' and organizations' registries.
- Share knowledge with other research administrators and their institutions about clinical trials registries.
Body of Knowledge: TBD
Tracks:
Clinical Trials,
Nonprofit/Foundation
Prerequisites: None
Speakers: Belinda Vandersluis, CCRP, Effector Consulting
Certificate: CTRA201-Elective
T42: TBA
Tuesday, October 25
T43: Stressors, Stress Perception and Stress Resiliency in Academic Research Administrators
Room: Matapédia
Content Levels: All Levels
Track: Professional Development
Working in a deadline-driven, highly regulatory environment can be taxing on research administrators. In both 2007 and 2010 we, as an occupational group, reported feeling high levels of stress. In this session, we will use the 2010 Research Administrators Stress Perception Survey (RASPerS) data to learn what stressors are associated with higher stress perception and, more important, what behaviors are associated with lower stress perception in the presence of those stressors. As a research administrator, it may be helpful to you to know what may lower your own levels of perceived work-place stress. As a leader or supervisor, this session may also be helpful in building a better workplace environment for your colleagues.
Learning Objectives:
- Identify the accepted theories of the primary causes of work-place stress and those most frequently reported by research administrators in the 2010 RASPerS.
- List behaviors that research administrators have reported are most highly associated with lower perceived stress when working in a stressful environment.
Body of Knowledge: The Profession
Threads:
Nonprofit/Foundation,
Academic/Training,
General
Prerequisites: None
Speaker: Jennifer Shambrook, PhD, Director, Grant & Contract Management Office, St. Jude Children's Research Hospital
T44: Motivating Faculty and Maximizing Resources: The Sisyphean Task for PUI Research Administrators
Room: Gatineau
Content Level: Basic-Intermediate
Track: Professional Development
This session provides some practical insight into motivating faculty to write proposals as well as stretching limited resources for the most benefit with an interesting ‘mirror’ twist!
Learning Objectives:
- Understand better what drives faculty while looking at practical means to stretch their support dollars at a smaller PUI.
- Gain insight into how their attitudes and operations significantly impact the success of both researcher and sponsored programs offices.
Body of Knowledge: TBD
Threads:
Predominantly Undergraduate Institutions (PUIs),
Academic/Training
Prerequisites: None
Speaker: Maggie Bryan-Peterson, CRA, Director, Office of Sponsored Programs, Grants Administration and Research, SUNY Fredonia
Certificate: PRAM-Elective
T45: Working with an Inexperienced Collaborator: They Want to Do What?
Room: Mackenzie
Content Level: Basic-Intermediate
Track: Sponsored Programs Administration
YOU know what you’re doing but you’re not so sure the collaborating organization does. Join us for a discussion about leading a proposal or award through the weeds when your organization isn’t the lead. Discussion will center on the factors that become “sticking points” in proposal submission, award negotiation, ensuring accurate reporting, issues in communication, and ways to help the newbie learn how to be a responsible steward of sponsor funds. There will also be plenty of time for discussions (horror stories, blood curdling tales of woe, etc.) and activities that center on group problem-solving.
Learning Objectives:
- Describe the most common issues that contribute to problems in this type of arrangement and evaluate the potential solutions of a variety of situations.
- Identify alternative approaches to working with the collaborator in setting up an effective relationship to support the goals of the project.
Body of Knowledge: Pre-Award, Post-Award
Threads:
Predominantly Undergraduate Institutions (PUIs)
Prerequisites: None
Speaker: Marcia Landen, PhD, Director of Grant Services, Indiana University; Michael McCallister, PhD, Consultant, Consilience International, LLC
Certificate: PRAM-Elective
T46: A Year in the Life of a Subagreement: Making Partnerships Work
Room: Jolliet
Content Level: Intermediate-Advanced
Track: Sponsored Programs Administration
This session with follow the life of a sub-agreement from the proposal stage to full execution and beyond. The session will focus upon the way it is "supposed" to work and what can go wrong along the way. Strategies for dealing with atypical partnerships will be reviewed, including international partners and small agencies with limited resources and infrastructure.
Learning Objectives:
- 1. Identify the factors that impede and strategies that enhance the timely establishment of sub-agreements.
- Develop a sub-recipient commitment form that helps to distinguish between a sub-awardee and a vendor.
- Develop procedures to assist with advance payments and international agreements.
Body of Knowledge: Pre-Award
Threads:
Commercial/Industry,
Departmental Administration,
International,
Nonprofit/Foundation,
Predominantly Undergraduate Institutions (PUIs),
Academic/Training,
General
Prerequisites: None
Speaker: Pam Miller, PhD, Director of Sponsored Projects, University of California, Berkeley; Sandra Nordahl, CRA, Co-Director, Sponsored Research, Contracting and Compliance, San Diego State University Research Foundation
T47: Merging Interests: Sponsored Offices and Corporate Research Offices
Room: Saint-Maurice
Content Level: Intermediate
Track: Management and Operations
Sponsored Research Offices and Corporate Research Offices are natural allies, although the culture of universities often creates tensions between the two. Recent developments have seen a merging of interests between these offices. These developments have become more obvious during the economic downturn and recovery as business seeks to rationalize activities and demonstrate the value of partnerships. Thus, the natural ties between philanthropic corporate giving to universities and corporate sponsored research have pushed sponsored research offices and corporate research offices to consider ways of working together as well as measuring the impact of their outreach to business partners -- in research and in philanthropy. More recently the Network of Academic Corporate Research Officers (formerly National Association of Corporate Research Officers) has initiated a research study on developing and assessing metrics to evaluate their effectiveness and sponsors’ expectations. The presenters will report on the outcomes of this research and present lessons learned.
Learning Objectives:
- Develop strategies for aligning the interests of these offices.
- Develop metrics for evaluating sponsored research and corporate research activities.
Body of Knowledge: The Profession, Pre-Award, Post-Award, Public Responsibility
Threads:
Commercial/Industry,
International,
Nonprofit/Foundation,
Research Development
Prerequisites: None
Speaker: Michael Owen, PhD, Associate Provost, University of Ontario Institute of Technology; Sacha Patera, PhD, Associate Director Corporate Relations, Northwestern University
T48: Strategies for Effective Partnerships with MSIs
Room: Saint-Charles
Content Level: Intermediate
Track: Management and Operations
Partnering with minority institutions offer increased interactions with historically black colleges and universities (HBCUs), Hispanic serving institutions (HSIs) and other minority institutions (MIs). Successful partnerships require strategies to identifying research expertise at HBCUs, HSIs, and MIs nationwide and approaches to involve faculty from these institutions in research and development proposal efforts. Come to this session to share your best practices for building partnerships! And come join us if you want to hear about successful practices and solutions that will build and sustain true partnerships!
Learning Objectives:
- Building upon prior experience with minority-serving institutions.
- Establishing new partnerships.
- Generating additional support for innovative research and educational efforts.
- Sustaining and supporting existing partnerships.
- Discussing perceived impediments to partnering with minority institutions.
- Sharing successful strategies that research administrators can use to support these efforts.
Body of Knowledge: TBD
Threads: TBD
Prerequisites: None
Speaker: Theresa Bailey, PhD, Director, Office of Research and Sponsored Projects, University of Texas-Pan American; Marcus Shute, PhD, Vice President of Research, Clark Atlanta University; Sandra Garcia, Executive Director of Office of Research and Sponsored Programs, Texas A&M University, Kingsville; Theodore Callier, Assistant Vice President, Dillard University

T49: Key Considerations and Lessons Learned When Implementing Compliant Research Billing Practice in a Large Academic Medical Center
Room: Saint-Laurent
Content Level: Intermediate
Track: Financial Management
Governmental detection and remediation of Medicare fraud has increased significantly over the past few years. Any large academic medical center is at risk for false claims associated with research clinical services unless they are clearly aware of requirements and have a robust system in place that includes checks and balances. This session will address a basic overview of requirements for research clinical billing, as well as items to consider, challenges encountered, and possible solutions for the successful implementation of such a system.
Learning Objectives:
- Describe the Centers for Medicare and Medicaid (CMS) requirements associated with compliant clinical research billing.
- Identify the necessary components to build a successful and compliant research billing practice.
Body of Knowledge: The Profession, Infrastructure, Pre-Award, Post-Award, Public Responsibility, Clinical Trials
Threads:
Clinical Trials,
Departmental Administration,
Hospital/Medical Centers,
Academic/Training
Prerequisites: None
Speaker: Katherine Hammerhofer, Finance Director, Center for Clinical Research and Technology, University Hospitals Case Medical Center
Certificate: FM-Elective; CTRA201-Elective; PRAM-Elective

T50: Planning and Managing NIH-Funded Foreign Contracts
Room: Richelieu
Content Level: Intermediate
Track: Financial Management
National Institutes of Health (NIH) policy requires that all contracts with foreign research partners have the review and approval of the United States Department of State prior to project initiation. If your institution is the prime recipient of an NIH award and you intend to subcontract with foreign research partners, it is essential to anticipate the time, effort, and resources required to secure foreign clearance. This session provides an overview of the NIH foreign clearance process from the perspective of the NIH awardee, highlights prospective research design considerations that can facilitate the process, and identifies budgeting and cost considerations to keep in mind during proposal planning.
Learning Objectives:
- Evaluate the need for foreign clearance in NIH-funded research projects, and describe how to initiate the process.
- Identify budget and timeline implications of foreign research partnerships.
- Understand the role of the NIH program office and Fogarty International Center on facilitating the foreign agreement.
Body of Knowledge: Pre-Award, Post-Award, Clinical Trials
Threads:
Departmental Administration,
International,
Research Development
Prerequisites: None
Speaker: Kathleen Tietje, PhD, Project Manager and Toni Lindquist, Project Administrator, Ultra Rice Projects, Program for Appropriate Technology in Health
Certificate: FM-Elective

T51: Recent Developments in U.S. Export Controls
Room: Hochelaga 5/6
Content Level: All Levels
Track: Research Law
This presentation will focus on key developments in U.S. export controls and on those This presentation will focus on key developments in U.S. export controls and on those issues that affect research institutions. This is a dynamic area of law that is undergoing a substantial revision as the current Administration considers new policies and mechanisms for achieving U.S. goals. At the end of the presentation, participants will be able to advise colleagues on recent developments and apply those changes to their current export compliance programs.
Learning Objectives:
- Understanding of the Export Control Reform (ECR) Initiative, including upcoming milestones, the current status, and changes to date.
- Awareness of key enforcement actions during the last year.
- Understanding of the U.S. Visa I-129 Form requirements.
- Understanding of developments in U.S. export controls during the last year.
- Understanding of the new Strategic Trade Authorization (STA) license exception.
Body of Knowledge: TBD
Threads:
Nonprofit/Foundation
Prerequisites: None
Speakers: Michael Lowell, JD, Senior Associate and Leigh Hansson, JD, Partner, Reed Smith, LLP
Certificate: RL-I&IV; PRAM-Elective


T52: Negotiating Clinical Trial Agreements with For-Profit Companies
Room: Duluth
Content Level: All Levels
Track: Research Law
This session will offer tips, traps and tricks of negotiating clinical trial agreements, including a discussion of conducting negotiations via email versus teleconference discussions. Presenters will role play to illustrate tactics and strategies.
Learning Objectives:
- Develop strategies for negotiating contractual provisions.
- Develop an understanding of compromise, its benefits for win-win contracts and tools to help finding it.
- Practical tips and examples of how to conduct negotiations in person, over the phone and via e-mail communications.
Body of Knowledge: TBD
Threads:
Clinical Trials,
Nonprofit/Foundation
Prerequisites: None
Speaker: Rosemary Farr, Esq., Counsel, Reed Smith LLP; Penny Smith, Esq., Attorney/Owner, Life Science Law Group, LLC
Certificate: RL-I&III; CTRA101-Required; CTRA201-Elective

T53: Case Studies in Research Misconduct: A Historical Perspective on Ethics
Room: Bersimis
Content Level: Intermediate
Track: Research Ethics
The proper conduct and reporting of research is of paramount importance to our institutions. Noncompliance can result in severe penalties to the organization, the individual(s), and their reputations. The modern definition of research misconduct, however, in the context of responsible conduct of research training, reflects an evolution of hundreds of years of social and ethical issues that have arisen in the practice of scientific research. What may have been acceptable practice a century ago may be considered unacceptable practice by today’s standards. An examination of the global history of biology, chemistry, physics and medicine provides some insightful examples of both responsibly and irresponsibly conducted research by many famous scientists. In this highly interactive session, participants will become familiar with an international case history of research misconduct and will discuss how these prominent cases have shaped contemporary perspectives on the responsible conduct of research.
Learning Objectives:
- Describe a variety of famous cases involving ethical issues in research and apply modern RCR standards to better assess and work through those issues.
- Discuss the relevant rules and regulations of modern RCR standards and the ethical principles and cases that justify current institutional compliance policies.
Body of Knowledge: The Profession, Public Responsibility
Threads:
Commercial/Industry,
Departmental Administration,
Hospital/Medical Centers,
Nonprofit/Foundation,
Academic/Training,
General
Prerequisites: None
Speaker: Tony Onofrietti, Director of Research Education, University of Utah
Certificate: RI-I; HRP-Elective; PRAM-Elective
T54: The Role of the Medical Humanist in Human Subject Protection Programs
Room: Harricana
Content Level: Intermediate
Track: Research Ethics
Medical Humanities intersects human experience, medical practice and scientific technology, facilitating our understanding of health care within cultural and social contexts. This session will explore how the Medical Humanist can enlighten researchers and research review boards on the subject's perception of the research activities. This session will also offer practical tools to ensure a more informed consent process.
Learning Objectives:
- Identify areas where a medical humanist may be of value in the research enterprise.
- Explore ways of incorporating humanist strategies to improve subject/researcher dialog.
Body of Knowledge: The Profession, Infrastructure, Public Responsibility
Threads:
Clinical Trials,
Departmental Administration,
Hospital/Medical Centers,
Nonprofit/Foundation,
Research Development
Prerequisites: None
Speaker: Paula Bistak, Executive Director, Human Subject Protection Program and Christine Asmann-Finch, Medical Humanist, University of Medicine and Dentistry of New Jersey
Certificate: CTRA201-Elective; HRP-Elective
T55: Funder's Dilemma: Peer Review vs. Scientometrics
Room: Chaudière
Content Level: Intermediate
Track: Sponsors and Agencies
This session will be devoted to the eternal dilemma of a funding agency - assessing proposals by using peer review and/or various forms/combinations of bibliometric/scientometric data. The session will focus on the various recent developments in this area, e.g., UK (from RAE to REF), Australia (REA 2010), European Research Council's starting advanced grant assessment procedures and more.
Learning Objectives:
- Learn about the recent international trends in assessing funding proposals.
- Better understand the pros and cons of using scientometric/bibliometric data in the assessment process.
Body of Knowledge: The Profession
Threads:
International,
Nonprofit/Foundation,
Research Development
Prerequisites: None
Speaker: Madis Saluveer, PhD, Estonian Research Council
T56: The Role of Research Management Systems in fulfilling Institutional Repository Mandates
Room: Péribonka
Content Level: Basic
Track: Sponsors and Agencies
We will explore technologies and approaches that are emerging to help institutions address the problems associated with fulfilling the requirements of instructions and funders with open access.
Learning Objectives:
- Understand the broad range of approaches to filling repositories.
- Understand the sources of bibliographic data and copyright data sources available.
Body of Knowledge: TBD
Threads:
Academic/Training
Prerequisites: None
Speaker: Daniel Hook, PhD, Imperial College London and Washington University in St. Louis






