Research Oversight Committee (ROC)

The UW Medicine | Valley Medical Center Research Oversight Committee (ROC) protects the safety of patients participating in investigational, clinical research or observational research trials by ensuring that these activities are adequately controlled and supported in its purview. All studies that will occur at VMC or utilize VMC patients are required to be reviewed and approved by the Committee prior to any research occurring at VMC or utilizing VMC patients. 

If you are unsure if your study needs ROC review or have any questions, contact the ROC Coordinator at: Research@ValleyMed.org

Research Oversight Committee does not charge fees associated with any submission or review. 

ROC review and approval is required for all research activities in which VMC is engaged. Review is required before beginning a research project at VMC (new study submission). Quality improvement projects to improve clinic processes and are not research in nature do not need ROC review.

  1. Prospective approval. Review and approval must be obtained before implementing the activities at VMC or utilizing VMC patients. Approval cannot be granted retrospectively. 
  2. Materials reviewed. UW Medicine Valley Medical Center Research Oversight Committee reviews the materials provided by the investigator, study staff and any other sources. As needed, the ROC asks the investigator for additional information, materials or clarification. 

Types of review. The review may be conducted by the full convened ROC or by the expedited process. These two types of review differ only with respect to who performs the review. Both types of review: (1) require the same materials for review; (2) apply the same criteria for approval; and (3) have authority to take the same actions.

Fully convened ROC review: All studies that do not meet the guidelines for expedited review must be reviewed by the fully convened ROC review. Meetings are held bimonthly. Meetings start at 12:30 on the first Friday of the following months: January, March, May, July, September and November. Meetings may be rescheduled due to conflicts. Contact Research@valleymed.org to confirm upcoming ROC dates. ROC submissions are required 2 weeks prior to the scheduled ROC meeting.

Expedited ROC review: Eligibility for expedited review is accessed by the ROC Coordinator and submissions are reviewed by the ROC Co-Chairs. Expedited review can occur independently of scheduled ROC meetings.

  1. Guidelines for expedited review (ALL guidelines listed below must be met) 
    1. Study is IRB exempt
    2. Research does not involve direct patient care
    3. Research is limited to retrospective or prospective review
    4. Research does not require consenting patients
     

There are four types of ROC submissions and corresponding submission requirements:

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

Annual renewal submission occurs annually, or unscheduled as appropriate. Studies must apply for annual renewal in order to continue the research at UW Medicine | Valley Medical Center (annual submission), notify ROC of a significant adverse event (unscheduled submission), notify ROC of a significant protocol amendment (unscheduled submission) or to close the study with ROC (annual or unscheduled submission). Submissions are electronic and include the following:

  1. ROC annual renewal to conduct research form 
  2. Current IRB approved renewal (status report)
  3. If the study has patient consents and/or HIPAA forms: send a copy of all signed VMC patient consents to the ROC Coordinator (since the last ROC submission)
    1. Consent submission is required on a quarterly basis. The ROC Coordinator will submit copies of all consents to VMC HIM.
    2. Send a copy of all signed VMC patient HIPAA forms to the ROC Coordinator (since the last ROC submission). Submission of signed HIPAA forms are required on a quarterly basis. The ROC Coordinator will submit copies of all HIPAA’s to VMC HIM.
     
  4. If updated since the last ROC submission
    1. Protocol
    2. Informed consent form(s), if applicable
    3. HIPAA form(s), if applicable
    4. New or updated study materials (Such as case report forms, telephone scripts, advertisement/flyers, educational tools, surveys, questionnaires, etc.)
    5. IRB Authorization Agreement
     

Quarterly submission of VMC signed research informed consent forms and research HIPAA authorization forms is required when VMC patients sign a research consent and/or HIPAA form.

  1. Send a copy of all signed VMC patient consents to the ROC Coordinator since the last ROC submission (quarterly submissions are based on the last ROC approval date or the first VMC patient signed consent or HIPAA date)
    1. Submission of consents are required on a quarterly basis. The ROC Coordinator will submit copies of all consents to VMC HIM.
    2. Send a copy of all signed VMC patient HIPAA forms to the ROC Coordinator (since the last ROC submission). Submission of HIPAA forms are required on a quarterly basis. The ROC Coordinator will submit copies of all HIPAA’s to VMC HIM.
         

Study closure submission occurs when the study will no longer recruit from or perform study procedures at UW Medicine | Valley Medical Center. Submissions are electronic and include the following:

  1. ROC annual renewal to conduct research form
  2. Current IRB approved renewal (status report) or documentation of study closure

 

Failure to comply with the Research Oversight Committee policy will result in consequences which may include, but are not limited to:

  1. Warning letter to the researcher(s) by the ROC
  2. Notification of the study sponsor and/or governing IRB
  3. Audit of the researcher files, conducted by a ROC appointee
  4. Termination of the research in non-compliance at VMC