eNews re IRB Review

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New Required Data Elements for ClinicalTrials.gov

Public Law 110-85 took effect in September 2008, which expanded the types of clinical trials that must be registered with ClinicalTrials.gov.

New requirements increase the number of data elements that must be submitted to ClinicalTrials.gov for each initial trial registration. Effective December 1, 2012 the following data elements will be required to post a new study record:

  • Responsible Party;
  • Primary Completion Date; and
  • At least one Primary Outcome Measure.

If you have general questions, please contact the UW Compliance Administrator, Stefan Shipman, at sshipman@uw.edu

 


 

REMINDER & NEW TIMELINE - Medical Records Review Form Substantially Revised!

If you will be conducting research that only involves identifiable biological specimens and/or data, a substantially revised form with new guidance has been created titled: Use of Identifiable Specimens/Data. These replace the old "Medical Records Review" form and instructions.

The form is limited to researchers who are not directly interacting with people, but who are reviewing identifiable private information about individuals and/or analyzing identifiable specimens.

When should you complete this application? Here are some examples of projects that involve review of identifiable information or specimens (either retrospective or prospective) that are appropriate for this form:

  • medical records;
  • protected health information (PHI);
  • employment data;
  • study records;
  • pathology specimens;
  • data and/or specimens from a repository.

The deployment of a revised Use of Identifiable Specimens/Data form and guidance will involve a beta-testing phase:

Step 1 - Friday, 8/10/2012 - a PDF version of the Use of Identifiable Specimens/Data was made available for beta-testing, along with the guidance document.

Step 2 – Friday, 8/10/12 through Thursday, 11/15/12 – Please direct comments/questions about the form to hsdinfo@uw.edu

Step 3 - Friday, 11/30/2012 (target date) – All received comments will be incorporated.  A finalized PDF form and guidance will be made available.

The form is available on the HSD website:

http://www.washington.edu/research/hsd/docs/1377

and should be used in direct conjunction with the guidance:

http://www.washington.edu/research/hsd/docs/1357

As of December 31, 2012 (deadline extended), HSD will no longer accept the old "Medical Records Review" form.

Please direct any questions about the form to hsdforms@uw.edu.

**NEW - the form will also be available in Word.**



 

New Metrics Available

The 16th Report of HSD Performance Metrics (for reporting period 4/1/12 to 9/30/12) has been posted to the HSD website.

This report includes a new metric and analysis of "Minimal Risk" reviews. Turn-around times are now distinguished by type of application form.

  • The standard application has a median turn-around time of 23 business days.
  • The medical records review form (soon to be replaced by the Use of Identifiable Data/Specimens form) has a median turn-around time of 14 business days.

This information should prove to be very helpful to those researchers in the School of Medicine who do outcomes research using medical records.

Information about turn-around times and other key aspects of the IRB review process can be found in the report at http://www.washington.edu/research/hsd/docs/1476 along with reports from previous quarters.

 

 


 

2013 Update to the International Compilation of Human Research Standards

The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations. The Compilation is designed for use by IRBs, researchers, sponsors, and others. Many of the listings embed hyperlinks to the source document.

The 2013 edition is now available, and can be accessed in both Word and PDF formats: http://www.hhs.gov/ohrp/international/index.html. One new country is featured in the 2013 Edition: Ecuador.

As in the past, the new edition updates the human research standards based on information provided by in-country experts.

 


New and Revised Documents

You may have noticed that HSD has been releasing new or revised policy, procedure, and guidance documents at a brisk pace. This is a major effort that will continue during the coming year, due to:

  • Campus requests
  • HSD's goal of increasing transparency and knowledge about the IRB review process
  • The increased frequency of federal regulatory changes

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 hope you like our format for presenting the information, and we welcome feedback and suggestions. (hsdforms@uw.edu)

 

Topic Adverse Event Reporting
Document(s) REMODELED Adverse Event Report Form
Description Remodeled to PDF. No content was changed.
Expected impact Low
Related changes None
Link for more information http://www.washington.edu/research/hsd/docs/755
Implementation date November 30, 2012

 

Topic Limited Activities Determination
Document(s) UPDATED Limited Activities Determination Form and Guidance
Description Slight changes were implemented in both the form and the guidance to make it more clear that the LAD form is a multipurpose form to be used for initiating, renewing and closing a Limited Activities Determination.
Expected impact Low
Related changes None
Link for more information Form:
http://www.washington.edu/research/hsd/docs/1307
Guidance:
http://www.washington.edu/research/hsd/docs/776
Implementation date November 30, 2012

 

Topic Exempt Status Request
Document(s) UPDATED Initial Application: Exempt Status Request
Description Instructional text has been added to the PDF version regarding the use of Category 4: Existing Data in Part 3: Exempt Category Selection. No such instruction exists on the Word version, it was updated to have the version and dates match to avoid confusion.
Expected impact Low
Related changes None
Link for more information PDF:
http://www.washington.edu/research/hsd/docs/1254
Word:
http://www.washington.edu/research/hsd/docs/1207
Implementation date November 30, 2012

 

 

Topic Medical Records Review
Document(s) NEW Use of Identifiable Biological Specimens/Data Form and Guidance
Description The Use of Identifiable Biological Specimens/Data form will replace the Medical Records Review Form on December 14. The new form will be in beta test from August 10 - November 15.
Expected impact High
Related changes **NEW-all documents and web pages that refer to the Medical Records Review form will be modified to refer to the Use of Identifiable Biological Specimens/Data form and guidance.**
Link for more information PDF Form:
http://www.washington.edu/research/hsd/docs/1377
Word Form:
http://www.washington.edu/research/hsd/docs/1343
Guidance:
http://www.washington.edu/research/hsd/docs/1357
Article within this eNews
Implementation date November 30, 2012

 

Topic Status Report Information for Researchers
Document(s) DELETED Status Report Information for Researchers (J-384)
Description This information sheet has not been updated in several years, and is no longer useful. It has been deleted from the HSD website.
Expected impact Low
Related changes None
Link for more information None
Implementation date November 30, 2012

 


 

light bulbQuick Tips from HSD

How to use the new form: Use of Identifiable Biological Specimens/Data

HSD has officially released the new form and guidance the Use of Identifiable Biological Specimens/Data. The form and guidance pertain to using identifiable data and/or specimens for research. This application will replace the Medical Records Review form.

Last eNews we talked about when to use the new form - this time, let's look at how to use the PDF smart form.

The PDF is intended to guide you through the questions, hiding the questions that you don't need to answer, and revealing follow-up questions that you do. This will save everyone time in skipping over empty boxes, and maybe save a few trees along the way.

Quick Tips is well aware that in some cases, the form is used as a communication tool between research coordinators and researchers to fine tune their application, and make sure all questions are answered appropriately. Word may have an advantage in "Track Changes," but PDF can accept comments. The comment tools will take you back to the days when you turned in a paper and got it back full of red pen and sticky notes! (Or maybe that was just me...)

Here's how you do it:

  • Flatten the document by selecting "Print" and changing the printer to Adobe PDF. You will want to save this flattened version with a different name if you are not done with the original form, as flattening is just like printing it to a piece of paper. The fields will no longer be editable.
  • You will now be able to make all kinds of comments on the form using the commenting tools.
  • If you have the full version of Adobe Acrobat, you could even experiment with shared reviews, collaborating live, and track reviews.

See the Adobe website for more information: http://www.adobe.com/products/acrobat.html

Before you say "Hey, is this just some Adobe endorsement?", know that Quick Tips finds some things about PDF frustrating as well. That's why we'll also be putting out a Word version of the Use of Identifiable Biological Specimens/Data form. 

So check it out, and send Quick Tips an email if you find new and exciting ways to collaborate with PDF. We'd love to share them with the research community.


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November 30, 2012

IN THIS ISSUE

New Required Data Elements for ClinicalTrials.gov

REMINDER & NEW TIMELINE-Revised Medical Records Form

New Metrics Available

International Compilation of Human Research Standards

New and Revised Documents

Quick Tips from HSD

 


Help from HSD

We're here to help and want to hear from you.

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hsdinfo@uw.edu

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hsdtrain@uw.edu

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hsdforms@uw.edu

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Training Completion