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Research at URI

eNewsletter

August 2013

A Message from Peter Alfonso, PhD, Vice President for Research and Economic Development:

"Welcome to the eNewsletter from the Division of Research and Economic Development.Our aim is to use this medium to keep you posted on recent and ongoing activities within the Division. Please feel free to direct your feedback to Melissa McCarthy at melissa@uri.edu"

 

In this issue:

Office of Research Development


Office of Sponsored Projects

Office of Research Integrity:
Informed Consent is a Process Not a Document

Conflict of Interest -- Updated Guidance Materials

How do you decide if you need to create a new “project” or a new “package” in IRBNet?


Office of Intellectual Property Management and Commercialization
           

Office of University Research External Relations:
Research & Innovation Research Magazine


RI NSF EPSCoR: 
RI NSF EPSCoR News


OFFICE OF RESEARCH DEVELOPMENT
Karen Markin, Director
(401) 874-5971
kmarkin@uri.edu

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OFFICE OF SPONSORED PROJECTS

Mary Kate De Marco, Director
(401) 874-2775
mdemarco@uri.edu

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OFFICE OF RESEARCH INTEGRITY (formerly Office of Research Compliance)

Ted Myatt, Director
(401) 874-2636
tedmyatt@mail.uri.edu


Informed Consent is a Process Not a Document
The process and documentation of obtaining informed consent in human subject research is required by federal regulation. We all would insist readily that participants must consent prior to participating in research.  But exactly what does this mean?  Too often PIs ask a participant to read a document and then sign, calling this an informed consent.  Researchers often forget that informed consent is a two-step process -- First, to obtain verbal consent; and next, to document that consent, so that a record may be kept of the process.

Information must first be presented to research participants in a manner that they are truly able to make an “informed consent.”  The PI is responsible for ensuring that participants fully understand the research prior to commencing their involvement.  In this first step, the purpose of the research, its risks, benefits, duration, alternatives, etc. must be presented to a participant in “lay language” to create a conversation about the research.  The researcher should avoid using acronyms and scientific language.  Any questions the participant has should be answered.  If and when the participant feels comfortable, the informed consent should be documented by having the participant sign a written copy of the informed consent.  A copy of this document should be provided to the participant.  This written consent document shall serve as reference for the participant should s/he have future questions.

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Conflict of Interest -- Updated Guidance Materials

The Public Health Service's Financial Conflict of Interest (FCOI) Regulation has been in effect for approximately one year.  Since this time, URI has instituted new procedures for disclosing financial interests at the time of grant submission and following grant award.  On the disclosure form, investigators must disclose financial interests above $5,000 that are related to their institutional responsibilities.  These financial interests include such things has stock in publically traded companies, consulting fees, and sponsored travel).  Ownership interest, stock, or stock options in non-publically traded companies must be reported regardless of value.

To better guide investigators through the disclosure process, the Office of Research Integrity has updated the Conflict of Interest website to contain new information, including a new COI training program, a FCOI process flowchart, a FCOI Quick Reference Guide, and FCOI Information for Sub-recipients.  To access the updated Conflict of Interest website go to:
http://www.uri.edu/research/tro/offices/researchintegrity/conflictofinterest

For more information about the URI COI disclosure process, please contact Ted Myatt, Director of Research Integrity.

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How do you decide if you need to create a new “project” or a new “package” in IRBNet?

Research protocols requiring review by the Institutional Review Committee (IRB), Institutional Animal Care and Use Committee (IACUC) and Institutional Biosafety Committee (IBC) must be submitted to Office of Research Integrity through IRBNet, a web-based compliance portal.

Keep in mind this useful tip a about the difference between a project and a package when submitting materials.

A project is a NEW protocol for which you are seeking approval from the IACUC, IBC or IRB Committees.  It can also be an existing protocol that does not yet have a record on IRBNet (protocol was approved prior to IRBNet - April, 2011).  A package is a submission within an existing project.  It is a subset of your project and could include continuing reviews, amendments or other submissions.  Once you create a new project on IRBNet, the project will be assigned a record number (e.g. #12345-1) and all future submissions for this project (e.g. continuing reviews, amendments) will be submitted by creating new packages in that project.  The packages will be numbered, e.g. IRBNet #12345-1, #12345-2, 12345-3 ...  The project could be compared to a file drawer and the packages could be compared to files placed in that drawer.  Please do not create new projects for projects that already have a record on IRBNet.   Those projects are considered errors and will result in delays of approval.

The following link provides IRBNet training materials for new project and new package submissions: http://www.uri.edu/research/tro/offices/researchintegrity/IRBNetesubmissions

View the slide presentation/video for “New Submission Processes/New Project Submission” -- to create a new “project” 

View the slide presentation/video “Post Submission Processes/Post Approval Topics” to create a new “package”

Also, the Office of Research Integrity staff is always available for one-on-one training or to answer any questions you may have while working in IRBNet.  You can contact us at (401) 874-4328.

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OFFICE OF INTELLECTUAL PROPERTY MANAGEMENT AND COMMERCIALIZATION

James Petell, Ph.D., Patent Agent
Associate Vice President Intellectual Property Management & Commercialization
(401) 874-4807
jkpetell@uri.edu

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OFFICE OF UNIVERSITY RESEARCH EXTERNAL RELATIONS

Melissa McCarthy, Director
(401) 874-2599
melissa@uri.edu

The current issue of the Division of Research and Economic Development's research magazine Research & Innovation is on-line.

 

cover

Featured articles include:

Rhode Island's Knowledge Based Economy: The Role of Pharmaceutical Science

The Smallest State Offers Big Cyber Protection

Addressing the Needs of Older Adults: Way Behind Where We Need To Be

Graduate Student Conference: Talking Beyond Disciplines Rising Tides and Sea Changes

The Big Difference Five Minutes Can Make

A Passionate Advocator

Enhancing Ecosystem Services for Rhode Island Farmers

Explosives Expert

Enhancing Rhode Island's Community: The Stage is the Thing!

Innovations in Aquaculture from Rhode Island to Asia

Highly Trained Workforce: Vital to Rhode Island Economic Development

Why Invest in Rhode Island Marine Resources?

Engineers for a Sustainable World

The Office of Marine Programs: Impacting Rhode Island

Rhode Island Science and Technology Council Collaborative Research Grant Awards

The Joy of Jazz

URI Faculty Book Publications 2012

URI Research Honors & Awards 2012

The Impact of Funded Research by the University of Rhode Island on the Rhode Island Economy in Fiscal Year 2011

URI Research Enterprise at a Glance

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RI NSF EPSCoR

Jennifer Specker
(401) 874-6858
jspecker@mail.uri.edu


RI NSF EPSCoR News

Please welcome our new staff:

NSF EPSCoR has a new Communications Coordinator: Amy Dunkle, 874-6234, AmyDunkle@mail.uri.edu

NSF EPSCoR has a new Project Administrator: Sally J Beauman, 874-6880, SBeauman@mail.uri.edu

NSF EPSCoR has a new Track-2 Collaborative Agreement with Vermont and Delaware for $6 million to study Water Resources using field and laboratory science and Resource Economics. Participating members of the faculty are Art Gold, Chris Roman, Emi Uchida, and Jason Dwyer along with Jameson Chace from Salve Regina University.

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