UW Directories | Calendar | Map | MyUW
UW logo
Skip to Main
Human Subjects Division (HSD)

Topics

Modify or Renew an Application

How do you modify or renew a study?

 

Modification - Changing Your Research

Changes to your research require prior IRB approval. A Modification Form describing the proposed changes must be submitted and approved before the changes can be implemented.

Examples of changes made with a modification form:

  • Add or remove research team members
  • Change the consent form
  • Add or remove populations

Modifications to applications that have been reviewed by a full IRB receive full IRB review when the change is substantive and may increase risks to subjects who participate in the research. When changes are minor and will not increase risks to subjects, the modification may receive "expedited" review by a sub-group of the IRB.

Modifications to applications that have been reviewed by a sub-committee receive sub-committee review unless they make the activity ineligible for "expedited" review.

Form:

 

NOTE:

Research that has been determined to be "Exempt" cannot be modified. See the SOP Exempt Determination for more information.

 

 

Continuing Review (Renewal via Status Report Form)

Once it is approved by the IRB, your application must be reviewed at least annually, except as allowed by the Flexibility Policy. Submit a Status Report Form 6 weeks before the expiration date. (Exempt research does not need continuing review, but approval only lasts for 5 years, at which time you must re-apply for exempt status.)

Form:

NOTE:

To renew a Delayed Onset Human Research (DOHR) determination, use the Delayed Onset Human Research Determination Form. See the DOHR web page for more information.

Change Notes

  • Noted 05/31/2012 @ 01:07pm
    Keyword newly added.
    - sherrye