IRB Approval Letter

IRB APPROVAL OF APPLICATION
June 8, 2020
Dear Joanne D. Stekler:
On 6/8/2020, University of Washington IRB Committee J reviewed the following application:
Type of Review: Initial Study
Title of Study: The GAIN (Greater Access and Impact with NAT) Study: Improving HIV
Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care
Nucleic Acid Tests (NATs)
Investigator: Joanne D. Stekler
IRB ID: STUDY00010387
Funding: Name: Centers for Disease Control and Prevention (CDC), Grant Office ID:
A142378, Funding Source ID: 6 U01 PS 005196-01-01
IND, IDE, or HDE: None
IRB Approval
Under FWA #00006878, the IRB approved your activity.
 Depending on the nature of your study, you may need to obtain other approvals or
permissions to conduct your research. For example, you might need to apply for access to
data or specimens (e.g., to obtain UW student data). Or, you might need to obtain
permission from facilities managers to approach possible subjects or conduct research
procedures in the facilities (e.g., Seattle School District; the Harborview Emergency
Department).
 NOTE: While IRB approval for this project has been granted, the University is requiring a
temporary halt of some research activities that involve in-person interaction with
participants. The temporary halt will remain in effect until HSD or the Office of Research
informs campus that the halt has been revised or ended. For information about which inperson activities are currently allowable, see the HSD website.
 Your application qualified for expedited review (“minimal risk”; Categories 1, 2, 5, 6, & 7).
 Under the Revised Common Rule this IRB approval is valid until study completion. In other
words, there is no expiration date and you are not required to submit Continuing Review
Reports to maintain your approval. However, you are still required to (1) obtain IRB
approval before making any changes (modifications) to your research, and (2) provide the
IRB with any Reportable New Information such as breaches of confidentiality or
unanticipated problems.
 This approval applies only to the activities described in your application (including any
references to specific grant sections). It does not include other activities that may be
described in your grant or contract.
 This approval applies only to the generic protocol and the UW site. You will receive a
separate approval notice for each additional participating site.
4333 Brooklyn Ave. NE, Box 359470 Seattle, WA 98195-9470
main 206.543.0098 fax 206.543.9218 [email protected] www.washington.edu/research/hsd
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Your study automatically has a Certificate of Confidentiality (CoC), because you have CDC
funding. A description of the CoC protections and responsibilities has been placed in your
study’s Documents section.
If you plan to continue data collection past the expiration of your NIH funding and the CoC,
contact the Human Subjects Division prior to the end of your funding. We will help you
determine whether you need to apply for a CoC extension.

Determinations, waivers, and regulations
The IRB made the determinations and waivers listed in the table below. Note that any granted
waivers of consent do not override a subject’s refusal to provide broad consent.
Requirement
Consent
Documentation of consent
HIPAA Authorization

Determination or Waiver
Waived for recruiting procedures and baseline group
procedures
Waived for multi-Nat and provider group procedures
Waived for recruiting procedures and baseline group
procedures

Location of documents
Use the consent forms that were approved and stamped by the IRB. They can be downloaded from
the Final column under the Documents tab in Zipline.
In addition, HSD has uploaded the following documents to the Documents tab in Zipline:
 Certificate of Confidentiality Acknowledgement Letter
Thank you for your commitment to ethical and responsible research. We wish you great success!
Sincerely,
Jenny Maki
IRB Reliance Administrator
[email protected], 206-543-4798

4333 Brooklyn Ave. NE, Box 359470 Seattle, WA 98195-9470
main 206.543.0098 fax 206.543.9218 [email protected] www.washington.edu/research/hsd
Implemented 01/07/2020 – Version 2.3 - Page 2 of 2