eNews re IRB Review

IMPORTANT ANNOUNCEMENT

Approval in Principle is becoming Limited Activities Determination

Approval in Principle (AIP) is a mechanism developed many years ago by the Human Subjects Division (HSD) to allow new federal awards to be released before IRB approval was obtained for the research project, with the limitation that the released funds could not be used for any activities involving human subjects.  For example, a researcher might use the money to begin hiring and training research staff.  

Researchers have been increasingly, and inappropriately, asking for Approval in Principle as a temporary substitute for IRB approval that allows federal funds to begin flowing.  HSD has learned from several federal agencies that Approval in Principle, as historically implemented at the UW, is inconsistent with federal regulations and is no longer acceptable.

 

Effective immediately, HSD is replacing Approval in Principle with an easier but more restricted process called Limited Activities Determination (LAD). Far fewer grants will qualify for LAD status than qualified for Approval in Principle.

 

How is LAD different from AIP?

  • Criteria.  LAD criteria are more restrictive.  Fewer grants will qualify for LAD status than qualified for AIP status. By federal law,  LAD status can be granted only when human subjects activities cannot begin until significant and lengthy development work has occurred.  The need for the development work must be documented in the grant application.  Examples include:
    • Development of specific procedures, questionnaires, or research instruments
    • Completion of animal studies also funded by the award
    • Purification of compounds
    • Development of an assay or diagnostic test
    • Development of a device
  • Application process.  Researchers apply for LAD status by completing a short and simple form that has only three questions in addition to the usual contact and award information.  To obtain AIP status, Researchers had to prepare as much as possible of a full IRB application form.
  • Review process.  LAD review is an administrative review performed by a single HSD staff person.  AIP review required IRB review by a full IRB or an IRB subcommittee.
  • Communication with federal granting agencies.  HSD will provide researchers with a formal letter granting LAD status and a copy of the LAD policy, both of which should be submitted to the federal funding agency.  These materials should improve communication and understanding with the agencies.

 

How is LAD similar to AIP?

  • Restriction on the use of funds. The released grant funds cannot be used for any activities involving human subjects.  This includes any recruiting and "prescreening" activities.

 

Important warning

Funding agencies are not required to release funds with LAD status.  HSD has observed that NIH and NSF are increasingly reluctant to release awards unless the investigator has exempt status or full, unconditional, IRB approval.  In short, LAD status may not be sufficient for receiving an award.

It is the investigator's responsibility to begin the IRB application process in a timely way so that funding agency requirements can be met.  This may mean beginning the IRB review process before the funding agency has made a definite decision about whether to fund a grant or contract.  The UW IRBs do everything possible to provide timely reviews, but the principal investigator is responsible for starting the process so as to allow sufficient time.  See turnaround time table, below.

  Average business days from HSD receipt of application to completion of review process Range
Exempt review 61 0 - 74
Minimal Risk review 232 1 - 218
Full IRB review 623 12 - 347

1 Turnaround time at peer institutions: 16
2 Turnaround time at peer institutions: 28
3 Turnaround time at peer institutions: 46

 

For more information

Contact: hsdinfo@uw.edu or 206.543.0098

HSD Website documents:

Policy: Limited Activities Determination for Funding

Form: Limited Activities Determination

Webpage: Limited Activities Determination (LAD)

 

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July 28, 2011

IN THIS ISSUE

Approval in Principle is becoming Limited Activites Determination

 

 



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