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Research Support Information Network
(RESIN)
Presented by: Office of the Vice Chancellor for Research
Date: March 7, 2017
Agenda
Updates & Timely Information from
Research Support:
Office of the VCR COI
RSC ORSP
IRB ORRA
IACUC DLAM
TRI Campus Operations
UAMS Library Core Facilities BioVentures Communications/Marketing
Institutional Relations
23/7/2017
New Invention DisclosuresNancy M. Gray, PhD, Director
Effective January 1, 2017, all UAMS
intellectual property will be assigned to
BioVentures, LLC
Change in assignee necessitated a change
in the disclosure and review process
Two additional changes in disclosure form to
improve quality of information
3/7/2017 3
New Invention DisclosuresNancy M. Gray, PhD, Director
Old process
3/7/2017 4
Submit disclosure
and signature
page
P&CC Review Retain
Return
New Invention DisclosuresNancy M. Gray, PhD, Director
New process
3/7/2017 5
Submit disclosure P&CC Review Retain
Return
Submit
signature
page
New Invention DisclosuresNancy M. Gray, PhD, Director
Added section for submitter to describe
the role and contribution of each
inventor/contributor
Added section for submitter to identify and
describe what facilities, equipment and
test subjects used
3/7/2017 6
Predatory PublishersSusan Steelman, MLIS
Professor | Head of Education & Reference Services
UAMS Library
Scientific Publishing: The Cast
3/7/2017 7
AUTHORS
$$
AGENCIES
PUBLISHERS
LIBRARIANS
TECH
3/7/20178
Predatory PublishersSusan Steelman, MLIS
Professor | Head of Education & Reference Services
UAMS Library
Traditional
Open Access
Predatory
P
U
B
L
I
S
H
E
R
S
INVITATION
RED FLAGS
• Form Letter Mistakes [Dr. Dr.]
• Incorrect Salutations / Credentials for You
• Incorrect Form of Closing Signature [Dr., … M.D.]
Predatory PublishersSusan Steelman, MLIS
Professor | Head of Education & Reference Services
UAMS Library
The Invitation
Image ProblemsMedical Research Archives[Accessed 1-4-17]
Predatory PublishersSusan Steelman, MLIS
Professor | Head of Education & Reference Services
UAMS Library
RED FLAGS
• Stretched / Incorrect Sizing
• Blurred
• Selfies / Podium Pics
Predatory PublishersSusan Steelman, MLIS
Professor | Head of Education & Reference Services
UAMS Library
http://ulrichsweb.serialssolutions.com/
Ulrich’s Web: Global Serials Directory
HOW TO RESEARCH JOURNALS
http://www.youtube.com/watch?v=bppnB_I6tAs
UAMS Library’s Tutorial
Reference 686-6734 [email protected]
11
Susan Sheila Louise Alice Lindsay
Freezer ID and MonitoringRobert Ray, PE, MBA - Assistant Vice Chancellor
Campus Operations
Electrical Infrastructure Engineering firm validated there is not an electrical
capacity issue in the building
Field work since the December:
Data gathering work over the last 45 days
Dedicated circuits to all the -80’s in the core areas
Freezer’s are monitored for “on-board” alarms
Gathering and updating PI contact information for the freezers
Building Emergency Generators are monitored
Validating list of all lab freezers and refrigerators in the building
3/7/2017 12
Freezer ID and MonitoringRobert Ray, PE, MBA - Assistant Vice Chancellor
Campus Operations
Electrical Infrastructure (Continued)
What we need from you?
Call 526-0000 if you need to:
Move a unit
Add or get rid of a unit
Have concerns of power or temperature issues
If the PI’s contact information changes
You must ensure the alarm parameters on the unit are set for the
tolerance for the product stored
Ensure your supervisor knows the disposition of the unit(s) if you
are leaving the institution.
3/7/2017 13
Freezer ID and MonitoringRobert Ray, PE, MBA - Assistant Vice Chancellor
Campus Operations
Campus Operations Call Center
526-0000
Robert Ray Marlon Joiner
501-686-5858 501-526-4209
[email protected] [email protected]
3/7/201714
QUESTIONS?
Using ARresearch.org for
Subject Recruitment Jean McSweeney, RN, PhD, FAHA, FAAN
ARresearch.org Participant Registry for anyone thinking about
volunteering for research.
3/7/2017 15
Using ARresearch.org for
Subject Recruitment Jean McSweeney, RN, PhD, FAHA, FAAN
ARresearch.org
Currently 2470 potential volunteers are signed
up as part of the registry.
Now available for use by researchers at UAMS!!
3/7/2017 16
Using ARresearch.org for
Subject Recruitment Jean McSweeney, RN, PhD, FAHA, FAAN
Access to the Registry To get started, submit a request through the TRI Portal
(tri.uams.edu)
3/7/2017 17
Using ARresearch.org for
Subject Recruitment Jean McSweeney, RN, PhD, FAHA, FAAN
Access to the Registry Click on “Recruitment – Participant Registry” and submit.
3/7/2017 18
Using ARresearch.org for
Subject Recruitment Jean McSweeney, RN, PhD, FAHA, FAAN
IRB Approval You need IRB approval to receive participant names from
the registry.
1. IRB approval for the entire study.
2. IRB approval specifically detailing the use of
ARresearch as a recruitment method.
You will need to provide specifics/examples in
your new submission on how you plan to contact
persons listed in the registry (i.e. phone, mail, email).
3/7/2017 19
Using ARresearch.org for
Subject Recruitment Jean McSweeney, RN, PhD, FAHA, FAAN
IRB Approval If you already have IRB approval, but did not specify
ARresearch in your original submission, you will need to
submit an amendment adding the tool as a recruitment
method.
Once you have the appropriate approvals, you can
receive your participant list in ~48 hours!
You are free to contact the participants directly as
detailed in your IRB approval. TRI staff will provide you
with instructions for tracking your contacts.
3/7/2017 20
Using ARresearch.org for
Subject Recruitment Jean McSweeney, RN, PhD, FAHA, FAAN
New Studies Your participant list may only be used for the
designated study.
If you start a new study and would like to utilize the
registry, you need to begin the process all over again.
3/7/2017 21
Using ARresearch.org for
Subject Recruitment Jean McSweeney, RN, PhD, FAHA, FAAN
Questions?
Contact TRI!
Sandra Hatley
+1 (501) 686-5417
Jean McSweeney, PhD
+1 (501) 296-1982
3/7/2017 22
TRI SeminarsNia Indelicato, Sr. Project Mgr., TRI
3/7/2017 23
Research & Career Development Seminar Series
Ashley Acheson, Ph.D., Associate Professor of Psychiatry
March 10th 8:30 - 10:00 a.m. PRI 136
Renee Raines, CRA, Director, OSPAN
March 24th 8:30 - 10:00 a.m. PRI 136
Blackboard Collaborate – Sign-up via Training Tracker
K Award Informational Discussion Roundtable Discussion (Dr. Aitken, Dr. Swindle, Dr. Kennedy)
March 29th 11:00 a.m. – 1:00 p.m. Jo Ellen Ford Auditorium
Blackboard Collaborate – Sign-up via Training Tracker
Office of Research Regulatory
Affairs Jennifer Hixon, Research Compliance
Officer, ORRA
ORRA Functions
Reviews clinical research involving FDA
regulated products
Determine the need for an IND or IDE
Submits IND/IDE applications on behalf
of the investigator
Maintains IND/IDE files
Submits annual progress reports (APRs)
to FDA
3/7/2017 24
Office of Research Regulatory
Affairs Jennifer Hixon, Research Compliance
Officer, ORRA
ORRA Functions
Provides assistance with Quality
Assurance functions
SOP training and assistance
Monitors ongoing studies conducted
under an IND or IDE
Assists with trial registration and
maintenance on ClinicalTrials.gov
Good Tissue Practice (Eye Bank, ART
Program)3/7/2017 25
Office of Research Regulatory
Affairs Jennifer Hixon, Research Compliance
Officer, ORRA
ORRA Staff Members
3/7/2017 26
Suzanne Carlisle (Monitoring Manager):686-7976
Shawna Owens (Monitoring): 603-1206
Laura Adkins (Monitoring): 686-6092
Mandi Tarte (Regulatory): 686-5190
Catrenia Banks (Administrative Coordinator):
526-6876 (ORRA main number)
Office of Research Regulatory
Affairs Jennifer Hixon, Research Compliance
Officer, ORRA
ORRA Contact Information
3/7/2017 27
Main telephone number: 501-526-6876
Location: Biomedical Research Building I,
Room B105
Tom Wells (Director): 603-1638
Jennifer Hixon (Regulatory Affairs): 526-7437
Larry Parker (Quality Assurance): 686-6284
Suzanne Carlisle (Monitoring): 686-7976
TRI CTIU Research Finance
Team Modification PilotAlison Oliveto, PhD, CTIU Director
Modifications requiring CLARA matrix budget
changes, consent form changes and/or needing
contract renegotiation have bypassed RFT / Legal
Potential downstream effects:
Protocol Deviations
Lost revenue, with UAMS covering costs not renegotiated
Medicare Fraud
If prior modifications that needed RFT activities are caught
later on, the following consequences may occur:
More time spent in RTF/Legal review process
Audit
3/7/2017 28
TRI CTIU Research Finance
Team Modification PilotAlison Oliveto, PhD, CTIU Director
Modification Pilot (Jan-Feb 2017)
Except for staff only modifications, all protocol
modification submissions with an approved
CLARA budget are automatically routed to TRI
Research Finance Team (RFT) for review
Catch prior modifications that needed RFT activities
Determine how many require RFT activities
Determine efficiency of process
Identify ways to streamline the routing process
3/7/2017 29
TRI CTIU Research Finance
Team Modification PilotAlison Oliveto, PhD, CTIU Director
Questions?
3/7/2017 30
Cynthia Spinks, MSE, CCRC
(501) 526-4619
Alison Oliveto, Ph.D.
CTIU [email protected]
(501) 772-8249
Next RESIN
Next RESIN
April 4, 2017 @ 12:00 p.m.
Location - Walton Auditorium, Winthrop P.
Rockefeller Cancer Institute, 10th floor
All RESIN presentations archived on the UAMS
Research website
http://www.uams.edu/research/RESIN_Achive.asp
3/7/2017 31