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Human Subjects Division (HSD)

Quick Tips from HSD

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

Oct 11, 2012 at 12:00am

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.