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Human Subjects Division (HSD)


eNews re: IRB Review, July 2, 2013 - Special Edition, New SOPs, Tools, and Policies

Jul 2, 2013 at 12:28pm


HSD Changes are Here!

Welcome to a special edition of the HSD eNews. It's a bit longer than usual, but we have many improvements and changes that we'd like to share with you.

NEW SOPs, Tools, and Policies

This spring HSD started a major project to write and/or revise procedures (i.e., standard operating procedures, or SOPs). This was prompted by two major federal audits. The project is also driven by the desire to increase clarity about requirements, IRB review consistency, and efficiency in training HSD staff and IRB members.

We are very pleased to announce the implementation of our first group of SOPs. Many of them are completely new; for example, we have never before had a document about expedited ("Minimal Risk") review, or about IRB review when more than one institution is engaged in a research project.

In parallel, we:

  • Developed several Worksheets as tools for researchers, HSD staff, and IRB members. For example, there is now a Worksheet about Human Subjects Research that will guide researchers through a self-determination about whether their project meets the regulatory definition of "human subjects research". See the New and Revised Documents at the end of this newsletter for a complete list of new/revised SOPs and new Worksheets.
  • Examined and revised some specific policies. Many (but not all) of these policies are relatively minor. However, these changes collectively should significantly reduce the time and/or requirements associated with IRB review for many researchers. The major changes are summarized below.

We look forward to releasing additional SOPs, tools, and policy changes during the next six months! One of these will be the revised Modification Form we described in the March eNews, and the policy about which investigators are to be listed on applications and forms.  We expect these to be implemented later this summer.



Summary of Policy Changes

Definition of Research

Activities that are not "research" as defined by the federal human subjects regulations do not require IRB review or exempt determination. The UW allows researchers to self-determine whether their projects are "research".

Policy change. Revised or new definitions (interpretations) are now available for each component of the federal definition of "research". (See the WORKSHEET Human Subjects Research, Section 2.)

Significance. It will be easier for researchers to self-determine whether their activities are "research".

Eligibility for Exempt Status

Exempt status means that a project is human subjects research but that it doesn't need to comply with the federal human subjects regulations. Research qualifies for exempt status when it involves no more than minimal risk to the participants and all of the research procedures fall into one or more specific categories.

Policy changes. Changes related to the interpretation of "minimal risk" are being implemented:

  1. Research involving prisoners is no longer automatically excluded from exempt status, although several important limitations apply. (See SOP Exempt Determination, Section 6.2.1.)
  2. Research involving "third party" subjects is no longer automatically excluded from exempt status. (See SOP Exempt Determination, Section 6.6.)
  3. Research involving deception is no longer automatically excluded from exempt status, although some limitations apply. (See SOP Exempt Determination, Section 6.7.)
  4. Though HSD continues to promote the use of a consent process in exempt research, HSD no longer requires exempt research to provide subjects with certain specific information.

Significance. Collectively, these changes mean that more research will qualify for exempt status.

Eligibility of Modifications for Expedited Review ("Minimal Risk" Review)

Federal regulations allow modifications for studies that are normally reviewed by a full IRB committee to be reviewed by a single IRB member (expedited or "Minimal Risk" review) instead of the full IRB, when the modification involves no more than a minor change. The regulations do not define "minor change".

Policy change. HSD has developed a definition of "minor change". (See SOP Expedited Review, Section 3.3.)

Significance. This means increased predictability in how modifications are reviewed.

Triage Process

HSD Staff assess IRB and exempt applications before review, to ensure that applications are complete. Occasionally the staff notice that an application qualifies for a "lower" level of review. For example, the project described in a Minimal Risk application might qualify for exempt status.

Policy changes.

  1. All new IRB and exempt applications will now be routinely assessed by HSD staff, to identify the "lowest" appropriate level of review. Whenever possible, that review will be conducted using the materials provided by the researcher, even when the application form is not the "correct" form.
  2. All new applications reviewed by a full IRB: when the IRB grants approval, it will also determine whether the subsequent Status Report and Modification reviews can be reviewed by the expedited (Minimal Risk) procedure instead of requiring the full IRB.
  3. All Status Reports reviewed by a full IRB: when the IRB grants approval, it will also determine whether subsequent Status Reports can be reviewed by the expedited (Minimal Risk) procedure instead of requiring the full IRB, or whether the IRB file can be closed.

Significance. Unnecessary applications (i.e., for activities that are not Human Subjects Research) will be triaged and returned before beginning the review process. More studies will qualify for exempt status or expedited (Minimal Risk) review.

Research Collaborations or Multiple Performance Sites

UW research projects may involve multiple non-UW institutions, locations, and individuals. The default position of the federal regulations and the UW is that each institution engaged in a research project must provide IRB review and approval of its own participation in the research. This is called "dual review". Until now, the UW has been willing to reduce dual review by allowing other institutions to rely upon the UW IRB but we have been unwilling to defer review to other IRBs.

Policy change.

  1. The UW is committed to reducing (as appropriate) duplicate reviews due to the engagement of multiple institutions, through the use of cooperative agreements, central IRBs, and study-specific agreements with IRBs at other institutions. (See SOP Research Collaborations or Multiple Performance Sites, Section 2.4.)
  2. The UW IRB is willing to rely upon the review of another institution's IRB, in certain circumstances. (See SOP Research Collaborations or Multiple Performance Sites, Section 7.)
  3. When dual review is unavoidable, UW researchers will no longer be required to provide documentation of the other IRB's approval in order to obtain UW IRB approval. However, UW researchers are still responsible for obtaining and maintaining documentation of all required IRB approvals in their research records, which are subject to post-approval monitoring by HSD.

Significance. More UW studies involving non-UW collaborations will require review by only one IRB. When more than one IRB must be involved, there will be fewer intractable inconsistencies between the IRBs. UW IRB approval will be granted more quickly because the prior need to provide the UW with documentation of approval of other IRBs was typically the rate-limiting step in the UW IRB approval process.

Grant Applications

Federal regulations require the IRB to compare for consistency the information contained in the IRB application with the information in the grant application that is funding the research.

Policy changes.

  1. It is no longer necessary for every discrepancy between a grant application and an IRB application to be identified and resolved by the IRB. Instead, the consistency review will focus only on the specific information relevant to IRB review and approval. (See SOP Funding Review, Section 5.1.1.)
  2. It is no longer necessary to provide a complete copy of a center, program, or institutional training grant application when such grants provide support for a research project. Instead, specific sections are required. (This will significantly reduce the amount of paper and copying required for these projects.)

Significance. There will be reduced "back and forth" on the consistency issue. Also, there will be a significantly reduced amount of paper and copying for center, program, and training grants (which are exceptionally large).

New and Revised Documents

Please see our eNews online for the full list of updated documents.