Anesthesiology & Pain Medicine >> Research >> Institutional Review Board (IRB) Approval >> Updates & Announcements
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Institutional Review Board (IRB)
Approval Information

Updates & Announcements

Current

Revised IRB Policy: Delayed Onset Human Subjects Research (DOHR)

Provides for release of research funds prior to IRB approval in limited circumstances. The DOHR determination allows investigators to have access to funding to begin significant aspects of the research that do not involve human subjects:

  1. Single project awards: human subjects involvement will depend upon completion of significant pre-human subjects development activities
  2. Research networks or consortia that will create protocols over the course of the award
  3. Award mechanisms whose only human subjects research is funding for small projects or trainees that will be selected and funded by the awardee

Important Facts

  • DOHR status is available only for funding (federal or non-federal) that is processed by the UW Office of Sponsored Programs and when the terms of the funding award are compatible with DOHR status
  • NOT to be used to delay submitting an IRB application, nor to satisfy urgent federal agency requirements for IRB approval prior to awarding the funds.
  • Submit an IRB application as soon as possible after funding notice or the award being forfeited due to lack of timely IRB approval (if the award does not qualify for DOHR status or if the federal agency will not accept the DOHR status).
  • DOHR status cannot be granted solely to release funds that will be used to hire staff who will prepare the IRB application
  • DOHR status is not a type of IRB approval and is not a substitute for IRB approval
  • NO HUMAN SUBJECTS ACTIVITIES CAN OCCUR UNDER DOHR STATUS – NO:
    • Advertising
    • Pre-screening records
    • Pre-tests

If DOHR applies to your project – submit the Delayed Onset Human Research Determination Form

Source: eNews IRB Review 4/30/13

Posted: 5/16/2013

Minimal Risk Delays

HSD has many new staff, particularly among the Minimal Risk teams. Unfortunately, this has occurred at the time of year when we have the highest volume of Minimal Risk applications.

Turnaround time for many (but not all) Minimal Risk reviews is significantly longer right now.

Patience is appreciated while HSD continues to hire and train new staff.

Source: eNews IRB Review 3/29/13

Posted: 5/16/2013

Quick Tips from HSD - Encryption

Encrypt your research data! UW Medicine IT has a few great web pages outlining how you can easily encrypt Microsoft Office files, and with a little more effort encrypt your emails, and your mobile devices:

Source: eNews IRB Review 3/29/13

Posted: 5/16/2013

IRB Performance Metrics

Median turn-around times:

  • Full IRB review: 55 days
  • Minimal risk review: 18 day
  • Medical records review: 10 days
  • Exempt Status: 6 days

Source: HSD Metrics Report #17 (reporting period 7/1/12-12/31/12)

Posted: 2/6/2013

Archive News

IRB Quick Tips - Dropping a Research Procedure

A modification is required for the removal of a research procedure or a group of subjects (except when necessary to eliminate apparent immediate hazards to subjects). Submit a modification for this change so the IRB is able to review changes to the risk/benefit analysis of your research.
Source: eNews IRB Review 2/1/13

Posted: 2/6/2013

Use of Identifiable Specimens/Data form

The " Updated Use of Identifiable Specimens/Data" form officially replaced the old "Medical Records Review." As of December 31, 2012, HSD will no longer accept the old "Medical Records Review" form.

Use this form for: medical records, protected health information (PHI), employment data, study records, pathology specimens, data and/or specimens from a repository.

Posted: 11/30/12

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