Research Regulatory – IRB and DUC

Research Compliance Department

The Research Compliance Department at Cottage Health is a component of the Cottage Health Research Institute and oversees:

• The Santa Barbara Cottage Hospital Institutional Review Board (SBCH IRB)
• The Data Use Committee (DUC)
• Human Subjects Research Education & Training
• The Tissue and Biospecimen Research Program

To review research and data requests, Cottage Health uses these two convened groups, the Institutional Review Board (IRB) and the Data Use Committee (DUC):

Institutional Review Board

The Santa Barbara Cottage Hospital Institutional Review Board (SBCH IRB) reviews proposed research protocols involving human subjects, human biological materials, and/or protected health information (PHI). PHI is defined as a combination of health information and personally identifiable information.

The primary goal of SBCH IRB is to review research studies to ensure that the following parameters are met:

• Risks to research subjects are minimized and reasonable in relation to anticipated benefits and/or the importance of knowledge that may reasonably be expected to result
• Selection of subjects is equitable
• Informed consent is obtained and documented
• Data collection is monitored to ensure the safety of subjects
• Adequate provisions are made to protect the privacy of subjects and maintain confidentiality of the data
• Subjects are protected from coercion or undue influence
• Regulatory requirements (FDA, DHHS, OHRP etc.) are met and adhered t

The IRB is a federally mandated board designed to review, approve, and monitor human subjects research. No research may commence without IRB approval.

For more information on the Santa Barbara Cottage Hospital Institutional Review Board or to request an IRB application to conduct research, contact research at CHRI@sbch.org.

Data Use Committee

The Data Use Committee (DUC) is an institutional committee designed to review requests for Cottage patient data and PHI to maintain compliance with the HIPAA Privacy and Security Rules. The DUC works in conjunction with the IRB on regulatory matters involving HIPAA and research. If the data request does not meet the definition of research, it will only need review by the DUC (no IRB review).

Researcher Study Process

1. Contact CHRI@sbch.org to request assistance from CHRI staff.

2. CHRI will assign support staff to the requestor depending on the type of project.

3. CHRI and requestor work together to determine if review by Data Use Committee (DUC) and/or Institutional Review Board (IRB) is required and will review appropriate guidelines and required documents, including these items:

   • How do you define “research” and “human subject?”

   • Does the DUC or IRB need to look at this project?

   • To whom do I submit my project?

   • Are other approvals required?

   • Should a QI/QA project be presented to the DUC?

   • What is the difference between Full Board, expedited, and exempt review?

   • What is the deadline for submitting new protocols?

   • Are there fees for the IRB review?

4. Requestor/investigator submits appropriate documents.

5. Study becomes active if it is approved and required training is completed.

   • What if my project is not approved?

   • Who is required to complete the training on protection of human subjects in research?

   • What must I report to the IRB (if applicable) while my study is active?

   • How does the IRB ensure compliance?

   • Are reviews of my ongoing research conducted?

   • What about an Emergency use situation?

     • What is the difference between emergency use and compassionate use?

6. IRB checks in with researcher periodically to determine the status of the project.

7. Investigator closes study when all data analysis is complete.

   • How do I close my study?

   • How long must I keep my records?