NCURA Region II Spring Meeting - April 27-29, 2008
Presentations
Current Issues
at the National Institutes of Health
What's new at NIH? This session will provide an update on the NIH
budget, funding priorities, new laws and policies, hot topics, and
eRA. Some interesting topics include the focus on new investigators,
efforts to enhance peer review, and Financial Conflict of Interest.
Implementation of new laws concerning ClinicalTrials.gov and Public
Access Policy will be addressed, as well as the latest information
about the Grants.gov transition to Adobe forms.
David Curren, Division of Grants Policy, Office of Policy
for Extramural Research Administration, National Institutes of Health
Assessing the Grants Office
The Chronicle of Higher Education has featured numerous articles
about assessment and accountability in higher education. More
colleges and universities are requiring departments to submit not
only annual reports, but assessment plans. How does this call for
accountability and assessment impact our grants offices? Often we are
asked the bottom‐line dollar amount of what we procured in a
given year, but this can vary depending on whether the grants faculty
chose to submit to and funding availability. What about the other
functions of our grants offices, such as assisting new faculty in
submitting grants, assisting with press announcements, conducting
workshops, and drafting policies? What are other measures and
benchmarks that grants offices can use to demonstrate our
contribution to our colleges and universities and evaluate our
success? This session will explore the topic of assessment, examples
of assessment models, and practices for assessing the office. This
session will focus primarily on pre‐award offices at
Predominantly Undergraduate Institutions, but all are welcome to
attend. Discussion will be encouraged.
Danielle Woodman, Director,
Office of Academic Grants, Daemen College
Technology Transfer –
Partnerships in Progress
A brief presentation of a product developed by a university and
purchased by almedtrac LLC under a contract guaranteeing exclusive
marketing rights, intellectual property protection and royalty fees.
A discussion of the advantages and issues of such an arrangement as
conditions and the product change and recommendations needed to
create a win‐win relationship through negotiated agreements
will follow.
Michael J. Malley, Senior
Partner, almedtrac LLC; Kenneth C. Malley, Executive Vice President
for Business Development, almedtrac LLC; Max Fedor, Informatics
Executive, LSGH
National
Science Foundation Update
A comprehensive review of what is new and developing with the
National Science Foundation's programs, policies, people and budgets.
Come learn about changes affecting your institution and researchers,
new programs of interest, and NSF electronic initiatives.
Beth Strausser, Senior
Policy Specialist, Policy Office, Division of Institution and Award
Support (DIAS), Office of Budget, Finance and Award Management (BFA),
National Science Foundation
IP and Industry Agreements –
Is It OK to Say ‘Yes’ Sometimes?
The Rochester Institute of Technology's President has proposed a new way of providing research and
development services for industry in a relatively IP‐friendly
environment. Session presenters will elaborate on the rationale for
this initiative, its rollout, and practical details.
David Bond, Director,
Sponsored Research Office, Katherine Clark, Associate Director of
Grants and Contracts and Intellectual Property, Sponsored Research
Office, Rochester Institute of Technology; George R. McGuire, Chair,
Intellectual Property Practice Group Bond, Schoeneck & King,
PLLC
Workshop: Train the Trainer
Bootcamp
In this short two‐and‐one‐half hour session, you
will learn about common presentation pitfalls and actions you can
take to improve your instructional skills. We will discuss items that
can cause audiences to disengage and techniques for keeping
participants engaged. Other discussion items will include how to best
organize your presentation, why practicing is so important, and the
use of visual aids. The final part of this presentation will provide
attendees with common resources that can aid in further improving
their skills.
Ronald J. Placone, Director
of Learning and Development, Carnegie Mellon University
Growing an Academic Grants Office
at a Small PUI
At small PUIs, research administrators are often in the role of
marketing the services of the grants office and encouraging faculty
members, most of whom have a heavy teaching load, to apply for
grants. The office may also serve many additional functions, such as
developing policies and procedures to ensure compliance. This session
is targeted at the research administrators who are working to
increase the number of faculty who are submitting proposals and who
are also juggling others duties, such as compliance. This session
will offer strategies for engaging faculty members and administrators
in applying for grants. It will address some of the challenges and
prospects of increased grant activity, as well as strategies for
adapting to change and sustaining growth. Discussion will be
encouraged.
Danielle Woodman, Director,
Office of Academic Grants, Daemen College
Small
Business Technology Transfer Program (STTR)
The US Small Business Administration Small Business Technology
Transfer (STTR) program, including level of activities of the five
participating federal agencies, will be discussed. The three phase
program will be explained, as well as criteria for nonprofit research
institutions for eligibility that can potentially lead to other
technology transfer opportunities.
Darwin Molnar, Vice
President of Wheeling Operations, Wheeling Jesuit University/National
Technology Transfer Center
Washington Update
As politicians jockey for jobs and power this year, the Federal
agencies continue to promulgate regulations, policies and guidance to
manage the research relationship. This session will focus on recent
Federal regulations and implementation challenges for research
universities. The discussion will examine what a research
administrator is or will see come in award documents and agreements,
and some strategies for responding to these changes in terms and
conditions. Topics will cover questions such as: what do you need to
do about the FAR Code of Business Ethics and Conduct (if anything)
and who is responsible for meeting the NIH Public Access requirement?
There will be warnings and predictions of things to come about
research administration.
Carol Blum, Director,
Research Compliance and Administration, Council on Governmental
Relations
Clinical Trials: From (Phone) Call
to Completion: Everything an Academic Researcher Should Know About
Working with Government and Industry
This session will include a discussion of the various issues to
consider when negotiating and then entering into an agreement with
industry (or the NIH) to conduct a clinical trial for the PI or
administrator. Specific topics to be addressed include the following:
a) Confidentiality Agreements: sponsor‐investigator,
coordinating center‐site, investigator‐ vendors and
others
b) Conflict of Interest
c) Contracts: "sticky" clauses or how to protect the PI (and your
institution's) interests. (Subject injury, indemnification,
publication, intellectual property)
d) Getting to "Go": hurdles to clear prior to recruitment, how much
time it may take, and tips to speed up the process!
e) Key issues concerning Clinical Trials and biological specimen
banking NCURA Region II 2008 Expected outcomes include: a greater
understanding of the legal issues surrounding the conduct of clinical
trials, confidentiality concerns, subcontracting of responsibilities,
and key language in clinical trial agreements. After this session,
attendees should have a better knowledge base regarding the
contractual and documentation requirements prior to starting a
clinical trial.
M. Aileen Shinaman,
Instructor, Clinical Trials Coordination Center, University of
Rochester
Proposing and Administering
Federal Contracts: A Primer for the Department Administrator
Just when you think you have finally learned it all, your Chair tells
you the department is going to submit a proposal to a federal
contract RFP. Now you have a whole new language to learn. This
workshop will look at federal contracts from the point of view of
those administrators who have to make it all happen. We'll take you
through the life of the project: (1) reading (and understanding) the
100+ page RFP, (2) preparing the VERY DETAILED budget and cost
documentation, (3) the final proposal revision and small business
subcontracting plan, (4) work of coordinating the reports, (5)
getting Contracting Officer's approval for what seems like
everything, and (6) understanding how FARs differ from typical grant
terms and conditions. Central research office administrators will
also find it valuable to learn how they can advise and assist their
campus partners.
Jeanne Galvin‐Clarke,
Contract & Grant Administrator Office of Research &
Development; Janet Simons, Director, Research Administration and
Development, and Gloria J. Smedley, MARCE Research Administrator,
Center for Vaccine Development, University of Maryland,
Baltimore
Research Financial Compliance
Issues
Compliance issues are getting attention in Federal reviews and
audits. What should we know and remember when development of
institutional practices?
Mark Davis, Managing
Director, Bearing Point, Inc
Basics
of Grants.gov
Back to the basics. With an increased use of the Grants.gov
submission process, this session will update users on the current
Grants.gov initiatives while providing common tips to help with a
smooth submission.
Joseph Sullivan, Manager,
Preaward Systems and Administration, Carnegie Mellon University; Ruth
Tallman, Associate Director and Compliance Officer, Lehigh
University
Mixing Bowl: Universities, Industry, and
Federal Funds
Research Administrators face unique challenges when federal agencies
fund industry, who, in turn, fund academic institutions. This session
will explore the SBIR/STTR funding mechanism and other types of
flowdown contracts. It will focus on applicability of terms and
conditions oftentimes flowed down to the academic institution in
error, provisions that need to be modified for universities to
incorporate A‐21, A‐110 and A‐133, as well as
problematic clauses typically encountered in these types of
agreements. Panelists will also discuss office procedures for
developing, negotiating and processing these types of awards.
Deborah Fisher, Director,
Preaward Administration, University of Pennsylvania; Jill Fabbri,
Contract Negotiator, The Pennsylvania State University; Janet Simons,
Director, Research Administration & Development, University of
Maryland, Baltimore; Heather Lewis, Preaward Associate Director,
University of Pennsylvania
Trial by Fire: How to Navigate
Clinical Trial Billing Compliance
2007 saw a flurry of activity around CMS' Clinical Trial Policy. This
policy has a significant impact on hospital processes for clinical
research billing and budgeting for patient care procedures between a
hospital and an academic institution. This panel will discuss:
1) A high level overview of the Policy and its requirements
2) Challenges complying with the Policy
3) Frameworks that hospitals and academic medical centers use for
implementing compliant billing processes for patient care cost in the
context of research
4) A Case Study: West Penn Allegheny Health System
Christina Panos, Director of
Patient Financial Services Department, and Robert Michalski, Vice
President and Chief Compliance Officer, West Penn Allegheny Health
System; and Allecia Harley, Manager, Clinical Research Solutions and
Healthcare Compliance, Huron Consulting Group
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