IRB-HSD

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This page is intended to be a repository of information on IRB applications, including how to go about applying for the first time, what to expect, and what to do when you run into problems.

Understanding the IRB Process

What is below is a simple guide to understanding the IRB review process, especially the exempt and expedited review processes. This guide is in no way exhaustive, and this is not meant to circumvent the IRB process. It is strongly recommended that you consult the Human Subjects Division website that provides a detailed account of the IRB process and criteria you need to understand before applying. On the HSD website you will find general information about research and the IRB process, including whether your research is considered exempt, which is true for many linguistic studies. (This is not guaranteed--it depends on your research.)

Exempt Status

(Excerpted from HSD webiste)

If HSD determines that your human subjects research qualifies for exempt status, you do not need to obtain Institutional Review Board (IRB) approval. This determines which regulations and requirements govern your research.

Criteria for exempt status (summary)

  • Your research involves no more than minimal risk to your subjects.
  • Your research methods must fit into one of seven categories. File:GUIDANCE-Exempt-Research.docx
  • Your research is not governed by the regulations of the Food and Drug Administration.
  • You will obtain consent from subjects for accessing or obtaining their identifiable health care information maintained in Washington State (for example, from UW Medicine) or their identifiable records from certain Washington State agencies and public institutions of higher education (including the UW).
  • There are some limits on the use of deception, prisoner subjects, children subjects, and newborn dried bloodspots.

If you believe your research may qualify for exempt status: Follow these directions for a determination about whether your research qualifies for exempt status. HSD staff are the only individuals authorized at the UW to make exempt determinations.

  • Complete the circled questions on the standard IRB Protocol form or on the No Contact version of the form. Please note that you will still use the standard IRB Protocol form, just answer the circled questions.
  • In Zipline, create a new application by clicking on the Create a New Study button and following the instructions. Attach your completed IRB Protocol form at the indicated place.
  • HSD will assess your application and issue a formal determination.

Minimal Risk (Expedited) Review

(Excerpted from HSD website)

You may find that your research does not qualify for exempt status, but is still minimal risk. Minimal Risk generally means that the probability and magnitude of physical or psychological harm anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life, or in routine medical, dental, or psychological examinations. In order to be considered Minimal Risk, research must meet this definition and fall within one or more of the federally-defined categories that qualify for “Expedited” review. The definition of “minimal risk” is somewhat different for research involving prisoners of the Department of Defense.

The following File:SOP-Expedited-Review.docx describes the process for conducting expedited review, including the criteria and process for determining eligibility for expedited review.

Under an expedited review procedure, the review may be carried out by the IRB chair or by one or more experienced reviewers designated by the chair from among members of the IRB. The following File:WORKSHEET-Expedited-Review-Eligibility.docx is a tool that describes the expedited categories and additional details about the definition of “minimal risk”.

Faculty Advisor Review

If you are a student, you are required to have a faculty advisor review your study. The faculty advisor review may occur concurrently with HSD review; however, final IRB approval will not be issued until the required faculty advisor review is completed. This is discussed further on the Creating a new study page.

Submitting an Application

The Creating a new study page is a guide that walks you through the application process using the Zipline SmartForms. Be advised that this guide assumes that you already understand the IRB criteria concerning the regulations and requirements that govern your research. This guide will not help you determine whether or not your research is exempt or minimal risk. You can also download this file here: Media: ZiplineGuide.docx

Before creating a new study, you should register with Zipline, the current online submission system in use at UW. If you have questions regarding Zipline, you can search the official Zipline Online Help Library for both general help and researcher specific questions. You can also look at the Zipline FAQs, which is a collection of FAQs about Zipline and submitting an application to the IRB more generally. Finally, f you're still unsure or having trouble, you should contact HSD. They're always happy to help.

Departmental Experience

If your study is exempt or minimal risk, lab members in the past have found a fairly quick turnaround. You should still give yourself at least a month. Your turnaround is more likely to be quick if you take the time to read the IRB materials carefully to ensure that you are accurately filling out the IRB materials. Keep in mind, that this is not a guarantee. The quick turnaround is only a reflection of past experience of lab members.

Tips

  • Take the time to read the instructions on the IRB website and the instructions on the IRB Protocol Application.
  • Model your application on a similar one from someone else who's gotten approval in the past.
  • Keep copies of all your materials. You'll need them for status reports.
  • Follow up on your application if things are taking a while.
  • Contact HSD if you have any questions.
  • Give yourself plenty of time for the process, especially if you're dealing with a sensitive population/matter.
  • Talk to others who have filed applications in the past.