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Human Subjects Division (HSD)


eNews re: IRB Review, September 30, 2013

Oct 1, 2013 at 7:01am


Applicability of FDA Regulations

Effective October 25, 2013

A revised UW policy, implemented at the end of next month, will cause the basic Food and Drug Administration (FDA) regulations to be applied to significantly more studies than in the past. These basic FDA regulations are 21 CFR 50 (informed consent requirements) and 21 CFR 56 (IRB review requirements). This will be in addition to the basic "Common Rule" federal regulation of 45 CFR 46, and any other applicable regulations, that are already being applied by the UW IRB.

Why is this change occurring?

The UW IRB is adopting a slightly different interpretation of the FDA's definition of "human subjects research", to bring the UW IRB into alignment with most other IRBs and with federal agency discussions. The primary change is for studies involving drugs. The FDA considers "any use of a drug outside of medical practice" that involves one or more human subjects to be FDA-regulated human subjects research. The following issues are irrelevant in determining the applicability of the FDA regulations:

  • Whether or not the drug is investigational or already approved by the FDA;
  • Whether or not the study is assessing the safety or efficacy of the drug;
  • Whether or not the study data will be submitted to the FDA;
  • Whether or not the purpose of the study is to support commercial development of the drug.

Does this mean that more studies will need an IND or IDE?

IND and IDE are the acronyms that refer to obtaining permission from the FDA to do research with an investigational drug or device. Being subject to FDA regulations does not necessarily mean that a study needs an IND or IDE. INDs and IDEs are a separate issue that is governed by other FDA regulations (21 CFR 312, for investigational drugs, 21 CFR 812, for investigational medical devices). The interpretation and application of these other regulations is not changing. However, HSD will be releasing worksheets at the end of October that guide researchers through the process of determining whether they need to apply to the FDA for an IND or IDE.

What impact will this have?

The basic FDA regulations are very similar to the basic federal human subjects regulations that are already applied by the UW IRB. This means that being governed by the basic FDA regulations does not have much impact on the study or how it is reviewed by the IRB. The most important differences are listed here. They are also described in a new procedures document called SOP FDA-Regulated Research that will be released on October 25, 2013.

  • A waiver of consent cannot be granted except for certain types of emergency medicine research. Note that the FDA does not consider it to be human subjects research when medical records are screened in order to identify potential study participants, so a waiver of consent can still be granted for this activity, under the other federal human subjects regulations.
  • The FDA requires a few additional elements in the consent form. These were already incorporated into HSD's standard consent form template within the past few years.
  • Serious non-compliance, unanticipated problems, and suspensions of IRB approval must be reported by the IRB to the FDA as well as to other agencies and the study sponsor.

Is there a way to determine whether the FDA regulations apply to a study?

HSD posted the WORKSHEET Human Subjects Research to its website at the end of June. Researchers, HSD staff, and the IRB can use this worksheet to determine whether the study meets the FDA's definition of human subjects research. If it does, then the basic FDA regulations apply. If the study is FDA-regulated, the researcher can then use the upcoming worksheets about INDs and IDEs to determine whether an IND or IDE is needed.

Will any other FDA related changes occur at the same time?

Yes, HSD will also be releasing on October 25, 2013:

  • A mandatory application supplement for Drugs, Biologics, Botanicals and Supplements, for any new IRB application involving such items.
  • An application supplement for Medical Devices, for any new IRB application involving medical devices.
  • Single Patient Emergency Use instructions, a form, and a significantly streamlined procedure.
  • Compassionate Use of Devices instructions and a form.
  • Humanitarian Use Device procedures and consent template.

These new documents will provide the IRB with more initial information, thereby reducing the need for some back-and-forth correspondence. They will also provide clear, step-by-step instructions for UW physicians who want to use an investigational drug or device to treat a seriously ill patient when there are no other options.

Contact HSD through hsdinfo@uw.edu if you have any questions or concerns.



Subject Payment and Income Tax


The HSD guidance document about income tax, Social Security numbers, and paying subjects for their participation in research has been significantly revised. Some of the information about specific income tax requirements was out-of-date or inaccurate. This includes the information about paying foreign nationals (i.e., non-U.S. citizens) for participation in domestic research.

The guidance document now points the reader directly to the appropriate Financial Management websites, so that the reader can be assured of always having access to correct information. Questions about subject payment, income taxes, and Social Security should be directed to the Financial Management staff identified on those websites instead of HSD staff.

See: Subject Payment Confidentiality and Income Tax See the Financial Management website for details.



IRBshare: A New Central IRB Model

What is IRBshare?

IRBshare is a centralized, electronic joint IRB review model for federally-funded multi-site studies that accelerates the review process by enabling a temporary reliance between member IRBs for initial review while maintaining UW IRB oversight for all subsequent aspects of a study (such as Status Reports and Modifications).

What are the benefits of IRBshare to researchers?

The expected advantage for researchers is that there will be quicker turnaround times and fewer clarifications or contingencies requested by the UW IRB.

How does IRBshare change my workload?

Not much. IRBshare is primarily an internal tool for IRBs and their staff. Researchers are still required to:

  • Provide all initial IRB application materials to HSD, using UW forms.
  • Provide ongoing Status Reports.
  • Provide Modifications for UW approval.
  • Meet all local reporting requirements to the IRB/institution (e.g. notification of serious adverse events, unanticipated problems or non-compliance).

Which studies are eligible for IRBshare?

Federally-funded multi-site studies are eligible. For the first year, the UW will use IRBshare to rely on other institutions (rather than allowing others to rely on us). This means that at least one IRBshare member institution must have performed its IRB review and uploaded the review materials into the secure IRBshare server.

When will IRBshare be available at UW?

IRBshare is being piloted now and should be fully available by November 1, 2013.

How do I obtain more information or submit a study?

See the procedure SOP IRBshare or contact Shannon Sewards, Assistant Director for Biomedical Operations (ssewards@uw.edu; 206-543-2254) Your study coordinating center may also have information.



Update: Revision of the Modification Form

A couple of months ago we announced a pending revision of the Modification Form. The revision involves (1) conversion to a “smart” Adobe PDF form with branching logic, and (2) improvements in the questions about changes in investigators, staff, and involvement of other institutions. The complexity and length of this form have created some larger-than-expected technical and logistic challenges. Our new expected implementation date is the end of November.



HSD Office Closed for Training

The HSD office will be closed so that HSD staff may attend an all-day training session on October 21, 2013. The reception desk will still be open for the Office of Sponsored Programs, and can accept submissions for HSD and the IRBs, but nothing will be processed on that day. If you are aware of any impending deadlines, please take our office closure into account, and plan ahead.



HSD Forms: A New Naming Convention

HSD is implementing a new naming convention for our forms, to make them both more consistent, and easier to find on our website.

The naming scheme will generally follow this formula: ACTION: Event, Audience. For example, the "Status Report - Renewal or Closeout - Form" becomes: "APPLICATION: Continuing Review (Status Report), Renew or Close". The Human Subjects Review Application: UW 13-11 will become: "APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee.

The main keywords will remain in the title of the form, and the alphabetical forms list on our website will become much easier to scan and navigate. Look for the change mid-October.

Send your questions or comments to Sherry Edwards, Information Manager at sherrye@uw.edu or 206-221-0994.