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Approval Information

Updates & Announcements


Significant Revision to Applicability of FDA Regulations

Effective 10/25/13, basic FDA regulations will be applied to significantly more studies that in the past 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 of more human subjects to be FDA-regulated human subjects research.

How will this impact your study?

  • A waiver of consent cannot be granted except for certain types of emergency medicine research (does not apply when medical records are screened in order to identify potential study participants).
  • The FDA requires a few additional elements in the consent form which 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.

Researchers can use the WORKSHEET Human Subjects Research to determine whether the study meets the FDA's definition of human subjects research.

Additional FDA related changes will also occur 10/25/13:

  • A mandatory application supplement for Drugs, Biologics, Botanicals and Supplements (new applications).
  • An application supplement for Medical Devices (new applications).
  • 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.

See the full announcement for additional information.


New & Updated Forms

When submitting your application packet for review, be sure you have the latest revised forms.  Download the latest forms and SOPs from the Human Subjects Division site as many documents have been revised or created, in particular the Main IRB application form the SOP Consent, SOP Consent Documentation, and the Standard Consent form template.

A checklist has been created which the IRBs now use during their review process to ensure and document applicable criteria for approval.  It would be helpful for investigators to use this checklist prior to submitting their own application.

Source: eNews IRB Review 8/16/13

Posted: 9/10/2013

Use of Central IRBs for Multi-Site Clinical Trials

There is growing national acceptance of the use of a central IRB for multi-site studies. The goal is to increase efficiency and decrease duplicate efforts and workload by both researchers and IRBs that do not contribute to meaningful human subject protection.

HSD agrees that the use of central IRBs is a sensible approach for many multi-site studies. We have recently signed agreements with some central IRBs.

  • WIRB (Western IRB)
  • National Cancer Institute (NCI) Central IRB
  • IRBShare
These processes are available only for new studies. Use of a central IRB does not necessarily reduce the amount of work required for initial review but it almost always is a faster process from submission to IRB approval. HSD is usually still involved in the process to manage and oversee local issues such as: requirements imposed by Washington State laws; and compensation for research-related injury.

Source: eNews IRB Review 8/6/13

Posted: 9/10/2013

PAVE post approval monitoring program

A new program called Post Approval Verification and Education (PAVE) is now launched. The purpose of the program is to use a collegial approach to:

  • Confirm by observation that UW human subjects research is conducted in compliance with relevant regulations, policies, and IRB-approved procedures;
  • Provide specific education and tools to researchers, to address potential or actual research problems;
  • Identify and highlight best practices of UW researchers.

Participation in the program is mandatory, if your study is selected for a PAVE visit. However, note that the program's approach is educational, not punitive. Studies will be selected for a PAVE visit based on:

  • Random selection from among studies sharing specific characteristics.
  • Requests from the UW IRBs and other sources.

Not-for-cause visits will begin in August 2013. These studies will be selected from those with all of the following characteristics:

  • Domestic (not international)
  • Studies involving the use of an investigational drug or device, for which the UW researcher has an IND (Investigational New Drug permission) or IDE (Investigational Device Exemption) from the Food and Drug Administration
  • Study is still enrolling or still providing treatment/intervention to the subjects

Source: eNews IRB Review 8/6/13

Posted: 9/10/2013

IRB Performance Metrics

Median turn-around times:

  • Full IRB review: 59.5 days
  • Minimal risk review: 25 day
  • Medical records review: 16 days
  • Exempt Status: 9 days

Source: HSD Metrics Report #18 (reporting period 1/13/13 - 6/30/13)

Posted: 9/10/2013

Archive News

New Set of Questions on Main Application Form

The Human Subjects Review Application (UW 13-11) has a new set of questions that will aid in faster and improved assignment to the appropriate IRB committee. The questions ask you to select methods, any special populations, and what type of risk you believe your research involves. The questions are simple, with easy selection boxes that should take very little time to answer and will save time once your application reaches the HSD office.

Source: eNews IRB Review 5/31/13

Posted: 9/10/2013

New Response Cover Sheet

HSD wants your responses to quickly get to the right IRB or HSD staff! We are consolidating our Deferral and Screening Response cover sheets into a single Cover Sheet. This new Cover Sheet can be used for all responses (except Conditional Approval Responses) to the IRB or HSD, including: deferral response, pre-review screening response, and responses providing requested materials such as a grant application, a Confidentiality Agreement, or a consent form. (Conditional Approval responses still have their own form.) Please begin using this cover sheet as soon as possible. As of September 30, 2013, we will no longer accept responses or other requested materials without this cover sheet.

Source: eNews IRB Review 5/31/13

Posted: 9/10/2013

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