UW Research

Delayed Onset Human Research (DOHR)

Contents

What is DOHR?

Regulations give federal agencies and their grantee institutions the discretion to allow a limited release of federal human subjects research funding to investigators without IRB approval or exempt status, when specific criteria are met. The National Institutes of Health (NIH) refer to this as delayed onset human research (DOHR) and the UW has adopted the same terminology.

A DOHR determination is only to be used in the specific circumstances described below and at the explicit request of the sponsor. A DOHR determination may not be used: 1) to delay submitting an IRB application; 2) to satisfy urgent federal agency requirements for IRB approval, nor 3) solely to release funds that will be used to hire staff to prepare the IRB application (except possibly for studies involving multiple participating sites and the use of a Single IRB).

A DOHR determination is not IRB approval, nor is it a substitute for IRB approval, and no human subjects activities described in the award can begin until exempt status or IRB approval has been obtained for the research.

An award will likely qualify for DOHR status if it meets any one of the following criteria:

  • Human subjects involvement will depend upon completion of significant pre-human subjects development activities, or
  • The award is for a clinical research network or consortium that plans to add new protocols over the course of the award, or
  • The award will fund specific projects that will be selected and funded by the awardee (e.g., a pilot project program; some training grants).

Apply for a DOHR

DOHR status is available only for funding that is processed by the UW Office of Sponsored Programs (OSP) and when the researcher has documentation from the sponsor stating that the sponsor requires UW determination of DOHR status before funds can be released. In most cases, a simple assurance from the award’s Principal Investigator (PI) to OSP that their human subjects work qualifies as “delayed onset human research” and that funds will not be spent on human subjects activities until IRB approval or exempt status is obtained, is sufficient to allow OSP to release funds.

Only HSD has the authority to determine whether the award meets the criteria for a DOHR determination.

If an award is eligible for and requires a DOHR determination, submit an application in Zipline (see application form below for submission instructions). If DOHR status is granted, the duration of the determination is one year. The investigator will receive a letter documenting the determination that can be shared with the sponsor and/or UW OSP. Investigators may request renewal of DOHR status for another year if explicitly required by the funding agency. When an investigator has obtained exempt status or IRB approval for the project, DOHR status is no longer needed and the application will be administratively closed by HSD staff.

References

National Institutes of Health Notice NOT-OD-12-130 “Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards)”; August 2, 2012

National Science Foundation Proposal & Award Policies & Procedures Guide (NSF 17-1), section II.D.5; January 30, 2017

Delayed Onset Human Research