Clinical research at Cottage Health follows federal and state regulations to protect patients and ensure objectivity. The Research Compliance Department at Cottage Health is a component of the Office of Research and oversees the Cottage Health Institutional Review Board (CH IRB) and Data Use Committee (DUC).
Data Use Committee
Projects and requests for data begin at the Data Use Committee. Investigators should complete a Pre-Assessment Tool (PAT) (link to attached) and submit it via e-mail to Tamara Norton to be reviewed by the DUC.
The Purpose of the Data Use Committee is:
- To prescreen data requests and potential research projects in order to classify the purpose/scope of the project and identify regulatory considerations, such as HIPAA requirements;
- To route a Pre-Assessment Tool (PAT) through upper management so that a request’s institutional suitability can be assessed, as well as the type of support required.
- Meet with your director to determine the quality and feasibility of the study.
- For protocol development assistance and statistical considerations, contact Jonathan Grotts (email@example.com).
- 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, etc.).
- Submit the completed PAT to Tamara Norton (firstname.lastname@example.org) for review by the Data Use Committee.
- Attend DUC meeting to answer questions.
- After DUC meeting, PAT will be routed for approval by Administration, as needed.
- Depending upon the scope of the project, you will either receive written notification that the DUC review is complete; be asked to provide additional documents; or receive IRB application materials.
Institutional Review Board
The primary goal of the Cottage Health Institutional Review Board (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
For more information on the Cottage Health Institutional Review Board or to request an IRB application to conduct research, contact Leilani Price, PhD, CIP
Office of Research
Santa Barbara Cottage Hospital
P.O. Box 689
400 W. Pueblo Street
Santa Barbara, CA 93102
Telephone: (805) 569-7439
FAX: (805) 569-7440
Leilani Price, PhD, CIP
Research Compliance / IRB Administrator
Tamara Norton, MHS, CIP
Research Compliance & Project Development Specialist / IRB Coordinator
(805) 682-7111 ext. 53336
Jonathan Grotts, MA
Research Analyst & Project Development Specialist / Statistician
John Petrini, MD
Cottage Health IRB Chair
Data Use Committee Instructions
Pre-Assessment Tool (PAT)
Specimen Collection and/or Tissue Banking Consent Form