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IRB From Both Sides: ResearcherFaculty

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Send the agenda to researchers by email so that they know when their project will be reviewed ... to include teaching tools for researchers. virtual classroom, ... – PowerPoint PPT presentation

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Title: IRB From Both Sides: ResearcherFaculty

1
IRB From Both Sides Researcher/Faculty
Research Administrator

Jacqueline E. Poore, C.I.P.
Coordinator,
Committee Review and Compliance
Rhode Island Hospital, Providence, RI

The Lifespan healthcare system
Rhode Island Hospital
The Miriam Hospital
Bradley Hospital
Newport Hospital

The Lifespan Office of Research Administration
(ORA) is responsible for the oversight of all
research operations that is performed by Lifespan
personnel or conducted within Lifespan
facilities.

4
The main areas of responsibility within the
Office of Research Administration are

Grants and Contracts (pre and post award)
Committee Review
Research Finance (research accountants)
Central Research Facilities (animal facilities
and Core services such as electron microscopy)

5
The Lifespan Office of Research Administration
Research Committee Review

Responsible for the administration of 6 review
committees.
3 IRBs (RIH IRB panels 1 2, TMH IRB)
Animal Welfare Committee (IACUC)
Recombinant DNA Committee (IBC)
Biohazards and Laboratory Safety Committee

6
IRB division of responsibilities

In addition to reviewing projects that are
conducted on their respective campuses,
The RIH IRBs review all new Lifespan pediatric
studies and projects conducted at Bradley
Hospital.
The TMH IRB is constituted to review any protocol
that proposes to use prisoners, and is also the
IRB for Newport Hospital.

7
Cooperative Review

Under an IRB authorization agreement
Either IRB can review new applications for the
other institution.
Reduces duplication of effort when projects are
to be conducted at multiple Lifespan sites.

8
The IRBs are not interchangeable

Once a project has received an initial review
by one of the IRBs, all future actions including
continuing reviews and revisions to protocol must
be reviewed by the IRB of record.

9
Office Statistics

1,365 active protocols among all 6 committees.
1,197 current active human subject (IRB)
projects
420 new applications were reviewed by the IRBs in
2004
3,217 IRB review actions were processed by the
office in 2004

10
Committee Review Support Staff

1 Manager
2 Coordinators
3 Committee Assistants

11
So how do we handle this volume?

Prior to 1998 the office used a system of index
cards and type writers to keep track of all
projects.

12
Welcome to the 20th Century!

1999- Microsoft Access database system was
created to improve office efficiency and
accuracy.
The original version of the database
stored protocol specific information
tracked all committee review activities.
generated agendas,
generated progress report forms,
Merged with MS Word documents to generate project
specific approval letters.

13
Committees database
14
Record of all committee review activity
15
Technological Enhancements

Major improvements to enhance our human
subject protection program were added over the
past two years with support from an NIH grant
(SO7 RR018131-01).
Database enhancements
Website redesign
Continuing Reviews on the web
Human Subject Protection Certification

16
In addition to the original functions, the
database is now used to

Automate approval letter selection for every
committee review activity.
Generate IRB member Conflict of Interest reports
for each meeting

17
Send email reminders when progress reports are
due for continuing review

Janice Muratori
Re Barry Sharaf, M.D.
CMTT 0143-01
Dr. Sharaf's study, Committee 0143-01, titled
A Multicenter, Randomized, Double-Blind, Placebo
Controlled Study to Evaluate the Efficacy and
Safety of Ad5FGF-4 in Patients with Stable
Angina. Protocol 304386 " will be due for
continuation review in June.
The Progress Report form with the specific due
date has been sent by mail.
Please contact Jacqui Poore for additional
information.

18
Send email notices when the status of a project
has changed

Lance Dworkin
Ldworkin_at_lifespan.org
Re Lance Dworkin, M.D.
CMTT 0032-05
The status of your study, Committee 0032-05,
titled A Multicenter, Open-Label Randomized
Phase II Study to Assess Safety Duration of
Treatment (up to 72 hours), and Preliminary
Efficacy with the Renal Assist Device (RAD) in
Patients with Acute Renal Failure. Protocol
RAD-002 " has changed. Your study is now
approved. Written documentation will be sent by
mail shortly.
Please contact Jacqui Poore for additional
information.

Send the agenda to researchers by email so that
they know when their project will be reviewed

20
Web Based Changes

Our NIH grant was also used to enhance the
overall structure and design of our website
www.Lifespan.org/research/

21
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22
Technological Improvements - Continuing Reviews

Old system
PIs provided 25 copies of the progress report
application.
ORA staff prepared separate mailings to all IRB
members with the progress report forms

23
Continuing Review System

New system
PIs provide 2 copies of the progress report.
ORA staff send one copy to the primary reviewer
ORA Staff scan the original progress report and
post it to a secure website
IRB members log onto the password protected
website from any computer to view the progress
report submissions