Research Resources
Research Resources
NEW!! - ITHS Application and Clinical Research Center
Network Scientific Review Committee Process – REVISED and STREAMLINED!!
Effective July 10th, 2008, the ITHS application and CRCN Scientific Review Committee
(formerly the Scientific Advisory Committee – SAC) process has been revised to improve
efficiency and reduce turnaround time. Please make sure you are using the current forms
and check back periodically for any updates. Old submission forms will continue to be accepted
until October 10th, 2008 (Children’s) or October 25th, 2008 (UW) after which the new forms must
be used. For more detailed information regarding our new processes please click on the First-time
users of ITHS resources link below.
ITHS Resources Application Forms
New Users: Your First Application to ITHS
Investigator Assistance
Let us help you make your application a success. We can start by helping you with your protocol.
Please consult with ITHS faculty and staff while you are writing your protocol before you apply
to make use of our resources.
We strongly encourage that an ITHS biostatistician from the
Center for
Biomedical Statistics help you with the design of your study. The biostatistician will work
with you to create the plan that produces the best chance of your study producing solid evidence
to elucidate your scientic questions.
It is also recommended that you consult with the
Regulatory Support
and Bioethics (RSB) Core before applying to use resources. All clinical trials or studies using human
subjects require an assessment of risk of the study and a plan to ensure patient safety.
That plan may be very simple for low risk studies such as simple blood draws. However, for high risk
studies such as potentially toxic new therapies to treat a serious disease, the plan must be more extensive.
Regulatory agencies have suggested types of components that need to be in each plan and we can help you
assess your protocol and put together a Data and Safety Monitoring Plan (DSMP). Please contact our RSB
faculty/staff to talk about a DSMP as you write your protocol and before you submit your ITHS application.
For studies being conducted at the UW, please contact the
Finance Manager,
Tram Tran for budget planning. For budget planning related to studies conducted at Children’s please contact
Finance Manager,
Michelle Palmer at (206) 884-5617.
Please contact the individual ITHS cores if you plan to use resources from any of our specialized cores.
We encourage you to contact the cores as early as possible, ideally while you're preparing your primary grant
application to the NIH or other peer-reviewed funding agency.
For most of the specialized cores and affiliated programs, final application for approval can be coordinated
through the CRCN submission process.
ITHS Core Contacts
| Core Resource |
Name |
Email Address |
Phone Number |
| Biomedical Informatics Core (BMI) |
| Access to Electronic Health Data |
Peter Tarczy-Hornoch |
pth@u.washington.edu |
(206) 685-8093 |
| Clinical Data Management |
Jim Brinkley |
brinkley@u.washington.edu |
(206) 543-3954 |
| Clinical Study Systems Architecture |
Daniel Ach |
dach@u.washington.edu |
(206) 598-6816 |
| Access to Scientific Instrumentation Data |
Jim Brinkley |
brinkley@u.washington.edu |
(206) 543-3954 |
| Clinical Data Integration |
Peter Tarczy-Hornoch |
pth@u.washington.edu |
(206) 685-8093 |
| Research Collaborations |
Nick Anderson |
nicka@u.washington.edu |
(206) 685-0249 |
| Center for Biomedical Statistics (CBS) |
| Study Design/Data Analysis/Sample Size and Power Calculation |
Patrick Heagerty, Ph.D. |
heagerty@u.washington.edu |
(206) 616–2720 |
| Development of Novel Clinical and Translational Methodologies (DNCTM) |
| Drug and Device Development |
Lynn M. Rose |
lynn.rose@seattlechildrens.org |
(206) 987-7540 |
| Community Outreach Programs |
Kim Folger Bruce, Ph.D. |
kim.bruce@seattlechildrens.org |
(206) 884-7533 |
| Evaluation Research Core (ERC) |
| Program Evaluation |
Fred Wolf, Ph.D. |
wolf@u.washington.edu |
(206) 221-3322 |
| Program Evaluation |
Doug Brock, Ph.D. |
dmbrock@u.washington.edu |
(206) 221-3367 |
| Program Evaluation |
Lynne Robins, Ph.D. |
lynner@u.washington.edu |
(206) 616-9874 |
| Regulatory Support and Bioethics (RSB) |
| Regulatory Support |
Leonard Sanchez |
leonards@u.washington.edu |
(206) 598-6477 |
| Bioethics |
Leonard Sanchez |
leonards@u.washington.edu |
(206) 598-6477 |
| Translational Technologies and Resources Core (TTRC) |
| Center for Array Technologies |
Roger Bumgarner |
rogerb@u.washington.edu |
(206) 732-6137 |
| Gene and Cell Therapy Lab |
Catherine Lindgren |
lindgren@u.washington.edu |
(206) 598-7038 |
| Center for Clinical Genomics |
Michael J. Bamshad, MD |
mbamshad@u.washington.edu |
(206) 221-4131 |
| Center for Clinical Genomics |
Sarah Ruuska, MPH |
sarahruu@u.washington.edu |
(206) 685-4985 |
| Nutrition Research |
Holly Callahan, MS, RD |
hcal@u.washington.edu |
(206) 598-4529 |
| Body Composition Lab |
Holly Callahan, MS, RD |
hcal@u.washington.edu |
(206) 598-4529 |
Scientific Review
In some cases, the application process to the ITHS involves a scientific review. In
reviewing new requests for use of the ITHS CRCN and associated core resources, the
CRCN Scientific Review Committee will ensure that the proposed study has undergone a
thorough scientific and ethical review. Study protocols are evaluated according to
the following criteria:
- Scientific merit
- Compliance with current ethical standards for human subjects research
- Feasibility
The CRCN Scientific Review Committee accepts evaluations of scientific merit completed by
qualified external peer scientific review committees. Some examples are:
- ITHS partner institution Scientific Review Committees (e.g. Fred Hutchinson/Cancer
Consortium Scientific Review Committee, Office for Nursing Research Clinical Studies Unit)
- NIH study section review
- Multi-center cooperative group studies with internal review systems
(e.g. Cooperative Oncology Group)
Please consult the complete list of currently
approved qualified committees. (If your committee
is not on the list and you would like it to be considered for future submissions, please provide the
following documentation about the external scientific review committee with your application:
- The committee’s standard operating procedure or review process guidelines
- The committee’s review template/application
- A roster of the committee members
The committee will review these materials along with your application and if approved, include
it on their qualified list.
Determination as to whether or not your specific protocol received a qualified
external review by one of the pre-approved committees is conducted by the
Medical Director of the CRC unit you are applying to use. You will be asked to
provide proof of the external review and to complete a
short
form.
It is important to note that the CRCN Medical Directors have the option to forward to the CRCN
Scientific Review Committee for full review, even if that study has undergone independent scientific review.
This might occur because the review was conducted for the aim of a grant rather than of a specific
protocol, or there have been extensive modifications made to the study since the last review.
Currently our scientific review is performed in the style of the National Institutes of Health.
We evaluate the significance of the work proposed, the innovation of the study, and the validity of
your approach. Investigators are welcome to attend the portion of the meeting during which their application
is discussed. Please contact us in advance if you are interested
in attending.
Which CRC Should I Apply To?
Normally, you should apply to the center where you plan to see subjects. However, if your study proposal
involves research subjects under 14 years of age (with the exception of infants who are involved in a study
of their mothers), then you must apply through the
Pediatric CRC so that the Clinical Research Center Network (CRCN) Scientific Review Committee (Children’s)
may review your study, regardless of where you plan to perform your research.
Submitting Your Application for Review
To initiate the application process, please submit the following:
- Copy of the IRB application [including non-ITHS partner IRBs (e.g. WIRB)]. NOTE:
A completed draft is acceptable for submission.
- Protocol [including any supplemental information providing basic requirements
(e.g. statistical design, sample size)].
- Data Safety and Monitoring Plan (DSMP) Form. NOTE: If your IRB application is from the
Fred Hutchinson Cancer Research Center, this information is included in the IRB application.
In this case, you do not need to complete the DSMP Form.
- Consent/assent form(s) (current drafts acceptable).
- ITHS Services Form and applicable appendices.
- Prior Scientific Review Form and supporting documentation (if applicable).
IMPORTANT NOTE: If you are applying to the pediatric CRC at Children’s a joint IRB-ITHS application exists that
incorporates the ITHS Services Form and some appendices. Please
click here to access this application and special instructions.
The CRCN reviews new applications monthly. Submissions including all elements listed above
must be received by the 25th of the preceding month for the UW and by the 10th of the preceding
month for Children’s in order to be reviewed for the upcoming month [e.g. June 10th (Children’s) and
June 25th (UW) for a July review (reviewed 1st Thursday in July for Children’s, 3rd Thursday for the UW)].
Missing or incomplete materials could result in a delay in the review of your study.
IMPORTANT NOTE: Make sure to email your completed applications to
ithsapps@u.washington.edu
regardless of which CRC facility you will be using.
Requirements for Industry-Sponsored Studies
The CRCN can be used for industry-sponsored studies. Industry-sponsored studies are those studies with a for-profit
organization sponsoring the study. The for-profit organization is expected to pay for the use of ITHS facilities at
the same rates that it would pay for any hospital bed or clinic usage and ancillary charges at the CRC used. ITHS member
discounts do not apply. Investigators who are receiving industry support for projects conducted in the CRCN must be free to
publish or distribute data from such studies without restriction.
All industry-sponsored projects are subject to the same requirements and levels of review as noted above.
Application Review and Approval
Prior to the CRCN Scientific Review Committee meeting, the resource utilization portions of
your application will be reviewed by the unit Medical Director and applicable core directors
or designees. If these reviewers have questions or concerns about the application, they will
likely contact you or your designated study staff to resolve them.
Decisions are usually sent out within a week of the CRCN Scientific Review Committee meeting
(sooner if no scientific review is required). There are four possible decision outcomes:
- Approved: The materials are approved as submitted. No modifications are required.
When an application is approved, we will provide you with instructions on the next steps
for getting your study activated and up and running.
- Approved with Contingencies: The application is approved with contingencies that
require modification to the materials submitted or a formal response to questions posed
by one or more reviewers. You will have 90 days to prepare and submit your response.
Please contact us if you have questions or concerns. Responses are typically reviewed in
an expedited fashion and do not normally require re-review by the CRCN Scientific Review Committee.
You will be informed if full committee review is required.
- Tabled: The CRCN Scientific Review Committee or resource reviewers have determined that
there are significant concerns or outstanding information sufficient to preclude an adequate
evaluation of the application. A tabled application must be resubmitted and if CRCN Scientific Review
Committee review is required, standard submission deadlines will apply.
- Disapproved: The proposed study lacks sufficient scientific merit or requires
resources or support beyond those available within the CRCN and/or ITHS.
The decision letter may also include two additional results of the review:
- Post-Approval Clarifications: Clarifications include items or questions that do not
impact the approvability of the study but must be resolved prior to activation of the
study (e.g. the protocol says a pregnancy test will be performed but doesn’t specific
whether it will be blood or urine).
- Further Recommendations: Recommendations are provided as helpful information.
They are suggestions that do not require a response or revision to the application in
order to activate the study. However, if you decide to implement any recommendations
that result in revisions to your protocol or IRB approval please be sure to submit a
copy of the final revised documents.
If you have any questions or concerns regarding the outcome of your review please don’t
hesitate to contact us.
Requests for changes to core services and/or an increase in the number of subjects must
be reviewed and approved prior to implementation on the CRC. Most of these can be handled
administratively. However, significant changes to the scientific design of the study may
necessitate another review by the CRCN Scientific Review Committee. This requires a
Modification Memorandum and the resubmission of the study application with appropriate
sections revised indicating the changes (highlighted). If applicable, documentation of IRB
approval of these changes will also be required. The Modification Memorandum and application
must be submitted by the Friday before the regularly scheduled CRCN Scientific Review
Committee meeting (i.e. first Thursday of the month for Children’s, third Thursday of the
month for the UW).
Please address the Modification Memorandum to the CRCN Review Committee Chair and the ITHS Administrative Director
and email to ithsapps@u.washington.edu.
Please address the Modification Memorandum to the CRCN Review Committeee
Chair and the ITHS Administrative Director and email to
and email to ithsapps@u.washington.edu.
ITHS Resource Use Application Forms
Select an Application Form
Please note that you must submit a study protocol with your application. The ITHS requires a protocol for every
study so that clinical staff (nurses, techs, etc.) can understand the procedures a subject will experience, research
procedures can be performed to the investigator's specifications, and so consent requirements can be met accurately.
If you do not have a study protocol prepared here is a sample
template for your use.
You can submit your application before you receive approval from your IRB.