eNews re IRB Review

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Cancer Consortium Studies and the UW Injury Compensation program

Issue:

There has been long-standing confusion about whether UW oncology studies reviewed by the Hutch’s Cancer Consortium IRB are eligible for the UW Injury Compensation program.  This program provides health care for research-related medical problems, at no cost to the research subjects.  It also provides limited reimbursement for out-of-pocket expenses incurred by subjects because of research-related medical problems.

Solution:

We have posted a simple flow chart on our website that describes the decision-making process. This will be used by the Hutch Cancer Consortium IRB when it reviews UW oncology research.

Consent:

The Hutch consent template contains the approved Injury Compensation language that should be used by investigator-initiated UW oncology studies reviewed by the Hutch Cancer Consortium IRB.  The template is available on the Hutch IRB’s forms page:

http://extranet.fhcrc.org/EN/sections/iro/irb/forms/index.html.


 

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 14, 2012, HSD will no longer accept the old "Medical Records Review" form.

Please direct any questions about the form to hsdforms@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 Cancer Consortium Studies and the UW Comp Plan
Document(s)

NEW Fred Hutch IRB and the UW Compensation Plan Flow Chart

Description Illustrates the decision making process for when UW oncology studies reviewed by the Fred Hutch IRB are eligible for the UW compensation plan.
Expected impact

Low

Related changes

None

Link for more information http://www.washington.edu/research/hsd/docs/1387
Article within this eNews
Implementation date August 31, 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

None

Link for more information http://www.washington.edu/research/hsd/docs/1377
Article within this eNews
Implementation date November 30, 2012

 


 

light bulbQuick Tips from HSD

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

HSD recently posted the beta-test version of 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.

It seems like a good time to explore when to use this form. Let’s see if Quick Tips can answer some questions.

What’s the difference between the regular Human Subjects Application and the Use of Identifiable Biological Specimens/Data form?

The form addresses research which does not include direct interaction with people; therefore, the form does not address recruitment or consent. So it follows that you will always need to complete a Waiver Request: Consent or Consent Requirements form along with this one (and when appropriate, a Waiver Request: HIPAA Authorization. See part 8 of the guidance for more detailed information.)

So why not just fill out the regular form and state that I’m not interacting with subjects?

 The regular form asks questions that are irrelevant to research involving only analysis of specimens and/or data, and may drive you a bit nuts.

When would I use this form?

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

What do you mean by identifiable?

In brief, according to federal regulations, it means that the identity of an individual is or may be readily (1) ascertained by the investigator or any other member of the study team, or (2) associated with the information. Quick Tips recommends reading the Use of Identifiable Biological Specimens/Data Guidance for more detailed information.

Okay, I’m convinced, this new form sounds great. When wouldn't I use it?

Well, if you are going to interact or intervene with subjects in any way, or if you plan to follow up with subjects whose data are being reviewed, you would complete the Human Subjects Review Application. If your data is anonymous, or coded (and no one involved with the current research will have access to the key to the code), it may be appropriate to fill out the Use of Non-Identifiable Biological Specimens/Data form if you need a determination that IRB review is not required. If you are creating a registry or repository, don’t use this form. Also, if you plan to obtain information not in records at this time, this form may not be appropriate.  In those instances, it would be best to check with HSD before you complete the application.

Quick Tips did okay (I wouldn't trust Quick Tips with my identifiable data), but if you have any other questions about this form that aren't answered in the form itself, or the guidance, please email hsdinfo@uw.edu, or call the Human Subjects Division at 543-0098.

 


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October xx, 2012

IN THIS ISSUE

Cancer Consortium Studies and the UW Injury Compensation Program

REMINDER-Revised Medical Records Form

New and Revised Documents

   CC-IRB and the UW Comp Plan

   Medical Records

Quick Tips from HSD

 


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