Data Use Committee

Purpose

Cottage Health uses the following two convened groups to review research and data requests:

• The Data Use Committee (DUC) is an institutional committee designed to review requests for Cottage patient data and protected health information (PHI) in order to maintain compliance with the HIPAA Privacy and Security Rules. The DUC works in conjunction with the IRB on regulatory matters involving Cottage patient data. If the data request does not meet the definition of research, it will only need review by the DUC (no IRB review).
• Institutional Review Board (IRB): A federally mandated board designed to review, approve, and monitor human subjects research. No research may commence without IRB approval.

Project Request Form

All research and non-research (Quality Improvement, Evidence Based Practice or Evaluation) projects that request the use of Cottage patient data are required to be reviewed by the DUC. If your project involves the use of Cottage patient or employee data, then you will need to complete the Project Request Form. The information presented in the Project Request Form will be reviewed and evaluated by the DUC to confirm the scope of the project and to ensure that all HIPAA Privacy and Security regulations are in place prior any collection of data

Download the Project Request Form

Case Report Request Form

Case reports/series involve the collection and presentation/dissemination of detailed information about a particular patient or a group of patients in order to highlight an interesting condition, treatment, presentation or outcome.

If your case report/series involves the use of Cottage patient data, then you will need to complete the Case Report Request Form. The DUC does need to review the request prior to the individual obtaining the data, in order to ensure that no other HIPAA or institutional/operational considerations are required. While HIPAA authorization from the patient(s) may not always be required, there may be instances in which individual authorization from the patient may be needed to use their health information. The DUC will assist you in making this determination. Regulations require that IRB review and approval will also be necessary if your case series includes 3 or more patients.

Download the Case Report Request Form

Internal Requests (Cottage Employees and Physicians):

1. Meet with your Manager or Director to determine the quality and feasibility of the project.
2. Contact CHRI at CHRI@sbch.org to discuss your project and determine what steps are necessary to begin the project (e.g. which departments will be involved, staff requirements, access to data needed, statistical support, etc.).
3. Submit the completed Project Request Form for review by the DUC.
4. Attend DUC meeting to answer committee questions.
5. After the DUC meeting, you will be contacted with next steps.
6. Depending upon the scope of the project, you will either receive written notification that the DUC review is complete; be asked to provided additional documents; or receive IRB application materials.

External Requests (Non-Cottage Employees):

1. Non-Cottage Employees, complete items #3– 7 above.

Application Procedure

Internal Requests (Cottage Employees and Staff):

1. Meet with your director to determine the quality and feasibility of the study.
2. For protocol development assistance, contact at CHRI@sbch.org
3. Additional meetings may be necessary, depending upon the scope of the study, to determine what steps are necessary to begin the research (e.g., which departments will be involved, staff requirements, access to data needed, statistical support, etc.).
4. Submit the completed Project Request Form for review by the Data Use Committee (DUC). You may email the completed Project Request Form to research at CHRI@sbch.org.
5. Attend DUC meeting to answer committee questions.
6. After DUC meeting, the Project Request Form will be routed for approval by Administration, as needed.
7. Depending upon the scope of the project, you will either receive written notification that the DUC review is complete; be asked to provided additional documents; or receive IRB application materials.

External Requests (Non-Cottage Employees):

1. Non-Cottage Employees, complete items #4 – 7 above.

Data Use Committee Instructions

By routing a Project Request Form through upper management, institutional suitability can be assessed, as well as the type of support required. The DUC works in conjunction with, and on behalf of, the IRB on regulatory matters involving HIPAA and research.

Project Request Form

The information contained in this form will be reviewed and evaluated by the Data Use Committee (DUC) to ensure that all HIPAA and Privacy and Security regulations are in place prior any collection of data.

Download the Project Request Form