Research Oversight Committee: New Study Submission

A new study submission is required when a study would like to open at UW Medicine | Valley Medical Center – either physically at VMC or utilizing VMC patients. Submissions are electronic and include the following:

  1. ROC application for research at UW VMC form
  2. IRB Authorization Agreement, or waiver. The IRB Authorization Agreement documents the IRB of record. 
    1. UW Medicine can use the UW Medicine IRB authorization agreement.
    2. Veteran’s Association does not sign IRB authorization agreements. VMC ROC will document an IRB Authorization Agreement waiver on a study by study basis. 
     
  3. IRB documentation – either IRB approval documentation or documentation of IRB exemption
  4. Protocol
  5. Informed consent form(s), if applicable
  6. HIPAA form(s), if applicable
  7. Study materials (such as case report forms, telephone scripts, advertisement/flyers, educational tools, surveys, questionnaires, etc.), if applicable

Forms:

Use the Application to Conduct Research form for all ROC new study applications. 

The ROC New Study Submission Checklist is a tool for investigators and/or study staff to utilize 

An IRB AUTHORIZATION AGREEMENT form is required for all submissions that are not IRB exempt

  • UW Medicine can use the UW Medicine IRB authorization agreement.
  • Veteran’s Association does not sign IRB authorization agreements. VMC ROC will document an IRB Authorization Agreement waiver on a study by study basis. 

Submit new study submission electronically to the ROC Coordinator at: Research@ValleyMed.org

Full ROC study submission is due 2 weeks prior to the ROC meeting. Study review and ROC determination will be withheld until the ROC Coordinator verifies the submission is complete.  

Day of ROC meeting:

A study staff representative is required to present the study, either in person or over the phone. A study staff representative is expected to give a brief synopsis of the study and be available to answer ROC questions. Study staff must leave prior to ROC voting. 

Documentation of ROC determination:

The ROC coordinator will emails study staff the preliminary results. Formal letter will be sent to study staff via email within 1 week of the ROC meeting.  

If you have any questions regarding ROC or the review process, contact the ROC coordinator at Research@valleymed.org