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:
- ROC application for research at UW VMC form
- IRB Authorization Agreement, or waiver. The IRB Authorization Agreement documents the IRB of record.
- 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.
- IRB documentation – either IRB approval documentation or documentation of IRB exemption
- Protocol
- Informed consent form(s), if applicable
- HIPAA form(s), if applicable
- 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