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Human Subjects Division (HSD)

Quick Tips from HSD

UW-GS 7 - not just another HSD term...

Jun 22, 2012 at 12:00am

The IRB and the Human Subjects Division have all sorts of advice, guidance and directives on how to handle your human subjects data while you are conducting your research, but there is another UW department that is concerned about what you are doing with all those records and paperwork once the study is closed.

UW Records Management

Take a quick trip through the retention schedule for research documents at: http://f2.washington.edu/fm/recmgt/retentionschedules/gs/general/uwgs7 and you'll see that there is an entire records retention schedule just for records associated with research, grants and contracts - UW-GS 7.

These retention schedules are established by Washington State Law (RCW 40.14).

Records Retention and Research Data

Keep in mind that for different types of research data, there are different retention schedules.  For example, research data from a study that was determined to be "Exempt" needs to be kept for 6 years after the close of the study.  Other types of data may need to be kept longer.  Up to 30 years for some!

Records Retention and the Consent Form

The key to developing an accurate retention statement for the consent form is to state how long the data will remain identifiable.  There are no requirements to state how long the data will actually be kept, but you do need to state for how long the data will be linked to the identities of the subjects.

The IRB also wants to make sure that you don't make any promises in your consent form documents that you cannot keep - such as, "We are going to shred this consent form as soon as the study is over." Consent forms also have a retention schedule.  For example, consent forms for biomedical treatment or intervention studies need to be retained for 30 years after the close of the study.

Don't hesitate to contact Records Management for more information: urc@uw.edu, or visit their website.  They have lots of great advice, a cool instructional video, and order numbers for those Office Depot boxes you might need!

Some of the Human Subjects related documents that have official records retention schedules are:

  • Certificate of Exemption (now referred to as: Exempt Status Determination)
  • Clinical Trials Phase I-IV Research Data - Investigator
  • Consent Forms for Research - Biomedical Treatment or Intervention
  • Consent Forms for Research - Adults
  • Consent Forms for Research - Minors
  • Data Collection Form
  • Human Subjects Review Committee Applications - Approved
  • Human Subjects Review Committee Applications - Denied
  • Human Subjects Review Committee Applications - Withdrawn
  • Registry Consent Forms
  • Repository Consent Forms
  • Research Data - Biomedical Treatment or Intervention (Drug, Device or Surgical Procedure/Intervention)
  • Research Data - Drug Development
  • Research Data - Non-Biomedical Treatment or Intervention (Non Drug, Device or Surgical Procedure/Intervention)
  • Research Data - Sponsor Required Contractual Obligation
  • Research Data - Exempt from Human Subjects Review