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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review - March 4, 2014

Mar 5, 2014 at 3:18pm

Reporting Research Problems to the IRB

NEW procedure, NEW form, NEW policy

Implemented 2/28/14

The procedures used by researchers for reporting problems to the IRB have been significantly changed. "Problems" includes, for example: unanticipated problems, certain types of adverse events, non-compliance, data breaches, subject complaints, laptop thefts, etc.

Instructions. The new document SOP Reporting by Researchers now provides complete information about:

  • What needs to be reported (and just as important, what doesn't need to be reported)
  • When to report it
  • How to report it
  • What happens after something has been reported.

Policy change. The reporting procedures include a major policy change: researchers are no longer required to report minor non-compliance to the IRB except in very limited circumstances. "Minor non-compliance" is defined in the document. This policy decision is consistent with federal regulations. It is based on an extensive analysis of non-compliance reported to the UW IRB in the past year.

Forms. There were previously three different forms for reporting; each for a different purpose. These have now been consolidated into a single new PDF form called the REPORT: Problems form. There are still some situations that should be reported by using the APPLICATION: Modification, Approved Project form. A table in the SOP Researcher Reporting Requirements clearly describes which of the two forms to use for which types of situations.

Send reports by email. Instead of using campus mail or in-person delivery, the REPORT: Problems is sent to the IRB by email, using the address hsdinfo@uw.edu

Management of reported problems. A new document SOP Management of Research Related Problems describes the HSD and IRB procedures for managing problems reported by researchers.

Benefits. The primary purpose of these changes is to improve compliance with federal regulations. The changes also reduce the number of reports required, and make it easier and faster to report problems.

 


Emergency or Compassionate Use

NEW procedure, NEW form, NEW policy

Implemented 2/28/14

Physicians who wish to use an investigational drug, device, or biologic for clinical treatment of a single patient must comply with specific Food and Drug Administration (FDA) requirements and UW medicine policies.

Changes

The procedures to ensure compliance with these requirements have been significantly revised and improved.

  • IRB concurrence not required: it is no longer necessary to obtain the concurrence of an IRB chair or to inform the Human Subjects Division (HSD) before the emergency or compassionate use.
  • Complete detailed instructions are now provided in a single document for each type of use.
  • A required template consent form is now available.
  • Single easy-to-find location: The instructions and the template are located together on a single HSD webpage. Single Patient Emergency Use ButtonClick on the big red button labeled "Single Patient Emergency Use" on the HSD home page.

Benefits

  • The instructions guide physicians through every step, including UW Medicine requirements.
  • All requirements and documents are together, in an easy-to-find location.
  • The process is now simpler and faster.
  • The required template consent form is:
    • Easy and fast to complete;
    • Compliant with all FDA requirements;
    • As short and as simple as possible, to improve patient comprehension.

 


Genetics Supplement

NEW application form supplement

Implemented 2/28/14

A new application supplement is now available. Its purpose is to provide genetics-specific information necessary for IRB review and approval. In the past, this information was obtained through "back and forth" correspondence. HSD expects that receiving this specialized information at the same time as other information will eliminate some "back and forth" and speed up the review process. Also, it will be easier for the IRB to ensure that appropriate subject protections are provided in genetics research.

The new supplement should be attached to:

  • Any new (initial) application that involves genetics research.
  • Any Modification that proposed new or revised genetics-related procedures for an already-approved study.

 


Clarity about CLIA Lab Certification

NEW information

Implemented 2/28/14

Federal regulations (called CLIA) require certification of any facility (including research labs) that performs tests on "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings". The HSD website has a new document called SOP Lab Certification (CLIA) that describes the federal requirement.

Researchers are responsible for deciding whether their laboratories require certification. The Human Subjects Division and the IRB do not play any role in the interpretation, implementation, or enforcement of CLIA requirements at the UW except to inform researchers about the requirements and how to fulfill them.

IRB approval is not conditional upon obtaining CLIA certification, even when CLIA certification is appropriate. However, the IRB carefully considers all aspects of a researcher's plan to return specific research laboratory results to individual research subjects before granting IRB approval for the plan. This includes consideration of the two issues underlying the CLIA regulations:

  1. Information about the validity and reliability of the laboratory test.
  2. Information about the procedures for ensuring that the correct results will be returned to the correct individuals.

 


Performance Metrics

A new edition of HSD Performance Metrics has been published to the HSD webpage. It describes the turnaround times for steps and sequences of the IRB review process for the period 7/1/13 through 12/31/13.

 


WIRB News

Western IRB (WIRB) reviews most UW industry-sponsored-and-initiated research, on behalf of the UW IRB. Before researchers send their IRB applications to WIRB, they must first obtain an institutional assessment and authorization from the Human Subjects Division (HSD).

NEW Procedure. A new document SOP WIRB Review - Researcher Procedures is now available to help researchers and study teams obtain the required HSD assessment and authorization. It replaces more than a dozen previous documents that each described one component of the process. The new document:

  • Consolidates all previous documents
  • Describes current procedures, which have been significantly revised and simplified in the past year
  • Is organized according to the sequence that the researcher and study team should follow, so it can be used as a checklist

A similar document: SOP WIRB Review - HSD Procedures describes the internal procedures that HSD follows for the assessment and authorization.

REVISED WIRB fees. The WIRB review fees are usually charged directly to the industry sponsor. WIRB's Fee Schedule was revised on January 1, 2014, and is posted to the HSD website.

NEW Metrics. The HSD assessment and WIRB's IRB review are part of the industry clinical trial start-up process. HSD has recently developed the ability to measure the turnaround time for the HSD and WIRB components of this process. These metrics are now included in HSD's semi-annual metrics report. They provide useful information for researchers to consider when planning and navigating the start-up process. They are reproduced here:

Industry Clinical Trials: Turnaround Times1 for Specific Start-up Processes

From

To

Median
(Business Days)

Range
(Business Days)

HSD receipt of researcher’s materials

HSD initial screening response

0

0 to 12

HSD receipt of researcher’s materials

Completion of HSD screening

232

0 to 125

Completion of HSD screening

IRB application submitted to WIRB

33

0 to 42

Application received by WIRB

WIRB approval granted

84

0 to 67

1 These turnaround times are based on about 60 WIRB-reviewed studies that were approved by WIRB in the six months 7/1/13 through 12/31/13.

2 This step requires information from other offices before HSD can complete its screening and institutional sign-off for WIRB. It includes the time required for: HSD's screening activities; sponsor response time and edits to consent forms and other documents; completion of contract negotiations by the Office of Sponsored Programs (OSP); and completion of the study budget by the Clinical Research Budget and Billing (CRBB) Office.

3 This step is performed by the study team and/or study sponsor.

4 This step represents the turnaround time for WIRB review.

 


IRBshare: A Central IRB Model Ready to Use!

The Human Subjects Division (HSD) has teamed up with the Institute of Translational Health Sciences (ITHS) to bring you IRBshare. IRBshare is NOW fully ready for your use.

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 do I obtain more information or submit a study?

  • Check the IRBshare website for available studies. Available studies may be identified here - http://irbshare.org/#studies
  • See the procedure SOP IRBshare
  • Contact Shannon Sewards, Associate Director for Biomedical Operations (ssewards@uw.edu, 206-543-2254)
  • Or, check with your study coordinating center for more information

 



New and Revised Documents

We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

Topic Reporting Research Problems to the IRB
Document(s) NEW: REPORT: Problems; SOP Reporting by ResearchersSOP Management of Research Related Problems 
Description New SOPs and one single form for problem reporting. Clearer instructions regarding what does and does not need to be reported.
Expected impact High
Related changes Related SOPs altered.
Link for more information See article in this eNews, or documents themselves, linked above.
Implementation date February 28, 2014

 

Topic Emergency or Compassionate Use
Document(s) NEW: INSTRUCTIONS and NOTIFICATIONs: Compassionate Use, Device; Emergency Use, Device; Emergency Use, Drug or Biologic NEW: SOPs: Device Compassionate Use; Expanded Access; Single Patient Emergency Use; NEW: TEMPLATE: Consent Form, Emergency and Compassionate Use
Description All new instructions and documents regarding how to use an investigational drug, device, or biologic for clinical treatment of a single patient.
Expected impact High
Related changes Red button added to home page.
Link for more information See the documents linked above, or the article in this eNews.
Implementation date February 28, 2014

 

Topic Genetics Supplement
Document(s) NEW: SUPPLEMENT: Genetic Research; SOP Lab Certification (CLIA) REVISED: APPLICATION: Human Subjects Review (13-11), Full Board or SubcommitteeAPPLICATION: RepositoryAPPLICATION: Specimen or Data Use, Identifiable
Description A new supplement has been added for Genetics Research, along with a new SOP describing CLIA requirements.
Expected impact High
Related changes All initial applications have been updated to add pointers to the Genetic Supplement if needed.
Link for more information See the article in this eNews, or the forms themselves, linked above.
Implementation date February 28, 2014

 

Topic WIRB
Document(s) NEW: SOP WIRB Review - Researcher Procedures; SOP WIRB Review - HSD Procedures REMOVED: Old policy documents.
Description Consolidates old policy documents.
Expected impact Medium
Related changes REQUEST AUTHORIZATION: UW/WIRB altered slightly to harmonize with new SOPs
Link for more information See the article in this eNews, or documents themselves, linked above.
Implementation date February 28, 2014