eNews re IRB Review

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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 will be made available for beta-testing, along with the guidance document.

Step 2 – Friday, 8/10/12 through Friday, 9/7/12 – Please direct comments/questions about the form to hsdinfo@uw.edu

Step 3 - Friday, 9/14/2012 (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 September 17, 2012, HSD will no longer accept the old "Medical Records Review" form.

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



 

New Assistant Director of Social-Behavioral Operations

HSD is pleased to announce that Emily Guthrie has accepted the position of Assistant Director of Social-Behavioral Operations, beginning August 16th.

This new position will oversee operations of the Social/Behavioral committees C, G, and J, as well as the Minimal Risk teams EC and EG.

In addition to her experience as IRB Committee J administrator, Emily brings her knowledge and understanding of a wide array of social/behavioral research methods and international research. She has a PhD in Anthropology and was a graduate teaching fellow in several courses at the University of Oregon. She has both field and research experience in several African countries and Greece, including coordinating relevant permits, permissions, and affiliations.

Shannon Sewards will continue as Assistant Director of Biomedical Operations and will oversee operations of the Biomedical committees A, B, D, the hybrid committee K, and the Minimal Risk teams EA and EB. Many thanks go to Shannon for running all operations as the office underwent tremendous growth and change. She has done an extraordinary amount of work with grace, good humor and high standards.

Congratulations, Emily, and welcome to your new role at HSD.

 


 

HSD Home Page Improvements

A new interface will soon be added to the HSD home page. This guide is designed to help those new to research, and those new to the UW begin to navigate their way through the HSD/IRB process by helping them decide:

  • if a project is research
  • if a project involves human subjects
  • if the UW IRB is the right IRB for review

We hope the new interface will help answer basic questions and be an introductory resource for the HSD/IRB process.

Please send any comments or questions to hsdweb@uw.edu.

 


 

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 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 September 14.  The new form will be in beta test from August 10 - September 7.
Expected impact

High 

Related changes

None

Link for more information http://www.washington.edu/research/hsd/docs/1377
Article within this eNews
Implementation date September 14, 2012

 


 

light bulbQuick Tips from HSD

Registry and Repository

Have you ever wondered why HSD refers to a collection of data sometimes as a "Registry"and sometimes as a "Repository?" Even though a registry is a type or subset of a repository, it is because the purposes of the data are different.

A registry refers to a list of names and contact information of people who are willing to be contacted about research related to a specific topic. A registry might include information that would assist in selecting candidates appropriate to recruit for a specific study.

A repository is a collection of data, samples or both made available to researchers for analyses intended to answer various research questions.

A repository could also be used for recruitment purposes IF the subjects whose data are in the repository have given permission for that specific purpose.

However, a repository does not intrinsically or automatically provide for recruitment into other studies. A "dual use" must be specified in the Repository Application.

More information is available on our website.

 


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August 10, 2012

IN THIS ISSUE

Revised Medical Records Form

New Assistant Director

HSD Home Page Improvements

New and Revised Documents

   Medical Records

Quick Tips from HSD

 


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