Office of Institutional Assurance (OIA)

Office of Institutional Assurance (OIA)

Application for Institutional Support of Translational Costs

A. Introduction

These instructions pertain to applications for institutional support of consent/assent document translation. These funds are governed by policy # OIA-001 and managed by the Office of Institutional Assurances (OIA). In preparing the application, read and follow the instructions carefully to avoid delays and misunderstandings.

Item1. Title of Project. This should be the title used in the IRB application and included on the approved consent document.

Item 2. Location of Research. Check all that apply.

Item 3. Principal Investigator/Program Director. Provide name of person responsible for the direction of the project. This should be the same person listed as principal investigator on the IRB application. Provide academic title, academic Department and Division. List office telephone number.

Item 4. Contact Person. The principal investigator may identify a primary contact person for issues related to this request. The contact person must be someone capable of answering technical questions related to the study; DO NOT name your program assistant. If this person should be contacted in lieu of the principal investigator, list phone number in Item 3e and check box.

Item 5. Mailing Address. Provide the mailing address at which correspondence addressed to the principal investigator should be mailed. Include Mail Stop for campus mail.

Item 6. Source of Funding. Check the box that describes the primary source of funding for the project. Note that under no circumstances will Children’s Hospital provide funding for translation costs associated with a project funded by industry; these costs should be charged to the sponsor.

Item 7. IRB Approval. The English version of consent/assent document(s) must be approved in advance of requesting translation costs. Provide IRB reference number and final approval date.

Item 8. Therapeutic Study. Check appropriate box. If this is not a therapeutic study, you must complete form page 2 or this application will be returned.

Item 9. Attachments. Attach the information requested.

Item 10. PI Signature. The principal investigator/program director listed in Item 3 must sign this document.

LEAVE BLANK – FOR OIA USE ONLY
Type: / Activity: / Number:
Funded
Not Funded / CRSC Date: / Date Received:
1. TITLE OF PROJECT (Do not exceed 81 characters, including spaces and punctuation.)
2. LOCATION OF RESEARCH (Check all that apply)
SCRI PCRC UW FHCRC Harborview SCCA Other:
3. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR / 4. CONTACT PERSON (If different from principal investigator)
3a. NAME (Last, first) / 4a. NAME (Last, First)
3b. POSITION TITLE / 5. MAILING ADDRESS (Street, city, state, zip code)
3c. DEPARTMENT
3d. DIVISION
3e. TELEPHONE / E-MAIL ADDRESS FOR CONTACT:
check here if number is for contact listed in (4)
6. SOURCE OF FUNDING:
Federal Grant Industry Foundation
Intramural Gift Fund None / 7. IRB APPROVAL
Ref #: / Date:
8. IS THIS A THERAPEUTIC STUDY? / 9. ATTACHMENTS
YES
NO (YOU MUST COMPLETE PAGE 2) / IRB approved consent/assent document(s)*
Written estimate of translation Costs*
* FORM WILL BE RETURENED WITHOUT THESE DOCUMENTS.
10. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR ASSURANCE: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. / SIGNATURE OF PI/PD NAMED IN 3a.
(In ink. “Per” signature not acceptable.)
X:______/ DATE
Principal Investigator/Program Director (Last, First, Middle):
INSTRUCTIONS: SCRI will provide financial support for translation of assent/consent documents for non-English speaking pediatric subjects who might benefit by participating in an IRB-approved therapeutic trial. Except under special circumstances, institutional support of translation costs for non-therapeutic trials will not be provided. Under NO circumstances, will SCRI provide funding for translation costs associated with an industry sponsored project. If this is not a therapeutic trial, providing compelling evidence in the space below for why institutional support should be provided. Include in your argument how many non-English subjects you expect to enroll and indicate if exclusion of non-English speaking subjects will jeopardize the statistical significance of your study.