|
Institutional Review Board
(IRB)
The Swedish IRB Office no longer accepts
paper! The office has transitioned to a new system called iRIS™ in
order to review and process research applications electronically.
Access IRIS™ at:
https://swedish.imedris.net
You will need an iRIS™ User ID and Password in order
to submit research to the Swedish IRB. All information regarding
research will be handled through iRIS™.
Contact the SMC IRB Office at (206) 215-2536 to set up an iRIS™ user
ID and password or for questions regarding iRIS™ use.
IRB
Fee Information:
|
Effective January 1st, 2010 the Swedish
Research Center has updated the fees which will be charged to External (non-Swedish)
researchers and organizations for Swedish IRB review services.
|
Swedish IRB Fee Schedule
Effective January 1, 2010
Fees subject to change without notice
Internal
researchers will not be charged a review fee unless the
following apply:
- Federal
grant with no-indirect fee paid to Swedish Medical Center
- Industry
supported grants and contracts
Charges for
External (non-Swedish) researchers and organizations including those
not primarily awarded (grants and/or staff support) through the
Swedish Research Center:
IRB review,
Full Initial Review: $1,000
IRB review, Full Continuing Review: $500
IRB review, Expedited Initial Review: $500
IRB review, Expedited Continuing Review: $250
IRB review, Cooperative Initial Review: $500
IRB review, Cooperative Continuing Review: $250
Protocols withdrawn after review and then
resubmitted will be charged as if they are new protocols.
No charge for
review of amendments/modifications, recruitment materials submitted
after initial or continuing review, adverse event reports, protocol
deviation/violation reports, emergency use requests.
Swedish
Affiliated IRBs:
|
SMC IRB:
The Swedish Medical Center Institutional Review Board (SMC
IRB) reviews all applications for research activities
involving human subjects, regardless of funding source. |
Continuing IRB review of approved
research projects is required no less than every 365 days.
Continuing Review Information.
Research activities that present no
more than minimal risk to human subjects and involve only
procedures listed in the expedited review categories may be
reviewed by the IRB through the Expedited review process.
Expedited Review Information.
Certain research is exempt from
federal regulations.
Information about Exempt Status.
Unexpected Hospitalization:
Contact the IRB office if an individual who is participating in
a non-Swedish IRB approved study (i.e. a study that has been
approved somewhere other than Swedish) is unexpectedly
hospitalized at Swedish Medical Center.
|
|
Western IRB (WIRB): Investigators conducting research at
SMC may use the services of WIRB for review of commercially
sponsored studies and must use the services of WIRB for device
related studies. Investigators who wish to use WIRB for studies
sponsored by federal or other funds must contact the Director of the
Swedish Research Center prior to submission of the review documents
(206-215-3100).
Please review the
Swedish Medical Center Research Center Policy
and Procedures for use of Western Institutional Review
Board (WIRB). |
|
|
|
Cooperative IRBs: Swedish
maintains Cooperative IRB Agreements with:
-
Fred
Hutchinson Cancer Research Center (FHCRC), and
- The Benaroya Research
Institute at Virginia Mason (BRI).
- Swedish
maintains a limited Cooperative IRB Agreement with the University of
Washington (UW).
SMC
IRB Cooperative Review Information. |
top
General
IRB Information:
The IRB is charged with the protection of the rights and welfare
of human research subjects, and to assure that ethical standards of
care have been established and are in compliance with federal, state
and local regulations.
IRBs review many kinds of research
projects, including clinical trials, qualitative, social, behavioral
and ethnographic studies. Research is defined as a systematic
investigation (including research development, testing and
evaluation) designed to develop or contribute to generalizable
knowledge (rather than to produce information for internal use in
the management of individual patients or in the assessment and
improvement of specific processes within the organization), and/or
when the intent of an activity is to publish the results.
The IRB has the authority to approve,
require modification of, or disapprove any research project that
falls within its jurisdiction, as specified under the Swedish Health
Services' Federal
wide Assurance (FWA) held with the Federal Office
for Human Research Protections (OHRP), and local institution
policy. It also has the authority to suspend or terminate research
that is not conducted in accordance with IRB requirements, or has
been associated with unexpected serious harm to subjects.
In its review (both of new proposals and of previously approved
research), the IRB is responsible for giving consideration to:
- The risks to the subjects,
- The anticipated benefits to subjects and others,
- The importance of the knowledge that may reasonably be
expected to result, and
- The informed consent process to be employed.
Continuing IRB review of approved research projects
is required no less than every 365 days.
top
Education
in Human Subjects Research:
The IRB encourages education for ethical conduct in human
subjects research and the necessary regulatory requirements, and is
a participant in the University of Miami
Cooperative
IRB Training Initiative (CITI), "A Course in the
Protection of Human Research Subjects", which is a web-based
tutorial available to researchers and IRB members.
top
SMC IRB
Contacts:
For questions or further information,
please contact the Institutional Review Office at (206) 215-2536 or
by email at review.board@swedish.org
top
Main
| Administration
| IRB
| Budget
| Education
| Forms
| News
Last update: 03/10/2009
If you have questions about this web page, please contact
thomas.gengler@swedish.org
|
