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SUPPLEMENT Site Application No Contact v1.01 2022.03.31

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6 views4 pages

SUPPLEMENT Site Application No Contact v1.01 2022.03.31

Uploaded by

gamtamara
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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SUPPLEMENT Site Application

(No Contact)

The Human Subjects Division (HSD) strives to ensure that people with disabilities have access to all services and content. If you
experience any accessibility-related issues with this form or any aspect of the application process, email
[email protected] for assistance.

PURPOSE & INSTRUCTIONS


 Use this form ONLY if the site involvement in the research will involve no contact with human subjects (for example, the site is
receiving funding only, or the activities involve obtaining and using data or specimens from some source other than the subjects).

 Purpose of this form: Your institution is participating in a study where the UW IRB will be the reviewing IRB. When relying on
the UW IRB, institutions must provide study-specific information that allows the UW IRB to review on their behalf. This form
collects that information.
 Who should complete this form: This form should be completed as a collaborative effort between your institution’s research
team and an institutional representative such as a HRPP/IRB office contact or the Institutional Official who signed the
institution’s Federalwide Assurance.
 How to complete this form: Carefully review any study materials approved by the UW IRB (provided by the UW study team and
may include the approved protocol, UW IRB application materials, and approved consent materials) prior to completing this
form. Make sure to accurately answer every question. For questions about this form, contact the HSD Reliance Team at
[email protected].
 Answer all questions. If a question is not applicable to the research or if you believe you have already answered a question
elsewhere in the application, state “NA” (and if applicable, refer to the question where you provided the information). If you do
not answer a question, the IRB does not know whether the question was overlooked or whether it is not applicable. This may
result in unnecessary “back and forth” for clarification. Use non-technical language as much as possible.
 The completed Supplement should be provided to the UW study team and uploaded to the SITE submission in the UW Zipline
system on the Local Site Documents SmartForm under “Other Attachments”.

Study Title:

1 GENERAL INFORMATION
1.1. UW PI Name.
Click or tap here to enter text.
1.2. Site Name.
Click or tap here to enter text.
1.3. Site PI Name.
Click or tap here to enter text.
1.4. Site PI Contact Information.
Phone: Click or tap here to enter text.
Email: Click or tap here to enter text.

Document Date & Version Researcher Date & Version


03/31/2022 SUPPLEMENT Site Application mm/dd/yyyy
Version 1.01 Version x.x
Page 1 of 4
1.5. Affiliates. Please name any affiliates of your institution (i.e. separate legal entities not under your FWA) whose
personnel will be conducting research activities for this study. This information will allow us to confirm that all sites
engaged in the research are covered by a reliance arrangement and to identify relationships between institutions.

There are no affiliates


There are affiliates, they are:

Click or tap here to enter text.

2. RELYING SITE STUDY TEAM


2.1. Are there any investigations, audits, or findings (e.g. OHRP, FDA, or local audits) specific to the site Principal
Investigator (PI) over the past three years that would be relevant to the conduct of the research?
No
Yes → Please explain:

Click or tap here to enter text.

2.2. Are all involved individuals at the institution for this study credentialed and/or appropriately qualified to meet the
institution’s standards for eligibility to conduct research?
Yes
No → Please explain:

Click or tap here to enter text.

2.3. Are all involved individuals at the institution appropriately qualified to perform their study-specific tasks under your
institution’s policies?
Yes
No → Please explain:

Click or tap here to enter text.

2.4. Have all involved individuals at the institution met all applicable required training as described in your institutional
requirements?
Yes
No → Please explain:

Click or tap here to enter text.

2.5. Does the institution or any member of the study team have a financial conflict of interest with respect to this
study?
No
Yes → If yes, please provide any necessary explanation below and attach a copy of any institutionally developed
conflict management plan. NOTE: Institutions that are conducting research under a Phase I SBIR/STTR
award do not have to provide a management plan.

Click or tap here to enter text.


Document Date & Version Researcher Date & Version
03/31/2022 SUPPLEMENT Site Application mm/dd/yyyy
Version 1.01 Version x.x
Page 2 of 4
3. LOCAL IMPLEMENTATION
3.1. Is there any funding for this research that is supporting the activities of only your institution? In other words,
funding that distinct from mechanisms like subawards from a primary award that supports the whole study.
This funding should also be entered into the Additional Local Funding Sources SmartForm within the Site submission in Zipline.
No
Yes → Please describe:

Click or tap here to enter text.

3.2 Are there any other unique requirements that the UW IRB should consider for how the research will be
implemented by your institution?
Examples include limited participation in the research overall, a unique compensation scheme, non-participation in optional
components, or different data security and/or privacy practices.
No
Yes → Please explain:

Click or tap here to enter text.

4. APPLICABLE LOCAL LAWS, POLICIES, & CONSIDERATIONS


4.1. Are there any state or local laws that the IRB should consider when reviewing this study?
No
Yes → Please describe:

Click or tap here to enter text.

5. ATTESTATION
By typing or signing your name below, you are attesting that all information provided in this form is accurate and that
you are responsible for and will comply with all applicable local policies, procedures, and institutional requirements in
addition to the requirements of the UW IRB. If you are not the site PI, you are also attesting that you are authorized to
provide this information on behalf of the site PI and that the PI is aware of the information contained in this form.

Click or tap here to enter text. Click or tap here to enter text.
________________________________________ _________________________________________
Site PI Name Site HRPP/IRB Office Representative Name

Click or tap here to enter text. Click or tap here to enter text.
________________________________________ _________________________________________
Site PI Signature Site HRPP/IRB Office Representative Signature

Document Date & Version Researcher Date & Version


03/31/2022 SUPPLEMENT Site Application mm/dd/yyyy
Version 1.01 Version x.x
Page 3 of 4
HRPP/IRB Rep Contact Information

Phone: Click or tap here to enter text.


Email: Click or tap here to enter text.

Document Date & Version Researcher Date & Version


03/31/2022 SUPPLEMENT Site Application mm/dd/yyyy
Version 1.01 Version x.x
Page 4 of 4

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