From: Doug Bauer, MD, Director of DGIM Research Programs

Date: October 3, 2007

Thank you for inquiring about research studies that are potentially based within DGIM or wish to recruit participants from our medical practice. The purpose of this letter is to inform investigators about our procedures to obtain DGIM faculty approval for recruitment of participants from our practices. We would also like to describe what resource are and are not available within the Division.

DGIM has a long history of clinical research by both our own investigators and non-DGIM investigators recruiting from our practice. Currently, in General Medical Practice (located at the Parnassus and Mount Zion campuses) we follow approximately 18,000 patients who make approximately 40,200 annual patient visits. These patients are seen by 21 faculty physicians, 42 primary care resident physicians, 28 categorical resident physicians, and 4 nurse practitioners. The patients represent a diverse ethnic mix, with a majority non-White: 49% White, 24% Asian/Pacific Islander, 15% Latino, 11% African American, and 1% American Indian. The payer mix is also diverse: 32% Medicare, 34% managed care, 15% Medi-Cal, 13% contracts, 4% non-capitaled insurance plans, and 2% self-pay. Administrative and clinical data are available from the medical center s computerized information system (STOR) and other databases. Although our medical records are not yet electronic, they are available on site. In general, funding to access these databases must be provided by each project.

To better utilize DGIM patients and resources, we strongly encourage outside investigators to consider formal collaborative relationships with DGIM faculty, fellows, and residents. Each year most of our Primary Care Internal Medicine Residents participate in research projects and many have some training or experience in research methods. DGIM research faculty may also be available on an informal basis to discuss methodologic issues.

We welcome outside proposals that wish to recruit from our patient population and would like to improve our ability to quick respond to requests. Our goal is to review potential projects and notify investigators within three weeks of receipt of the complete application packet. In return, we ask that Investigators keep us updated on the status (and results) of their projects. The review process will not begin until the following has been submitted to us: the final study protocol, CHR approval letter, and the short DGIM Project Summary (see attached). Recruitment materials, questionnaires, and other instruments should be submitted if available. Please submit all materials for this packet electronically (if possible) to Yvonne Kwok. Lastly, we require that you periodically update us as to the status of your project and agree to notify us when recruitment is completed.

All applications and administrative questions should be directed to Yvonne Kwok in the DGIM Administrative Office, tel: 415/476-0853, fax: 415/476-7964, e-mail: ykwok@medicine.ucsf.edu. Please contact Alka Kanaya directly with other questions or issues: Alka.Kanaya@ucsf.edu.

Name of Project:

Investigator(s). (Include phone numbers and email address, indicate PI and primary contact)

Research question(s):

Brief Background/Significance:

Inclusion/exclusion criteria (list)

Method of contact/recruitment (be specific)

Benefits/burden for participants (clearly identify potential for harm)

Any benefits or burden to DGIM practitioners?

Timeline for recruitment (projected start and stop dates)

Funding source

Potential for DGIM collaborators? (We encourage DGIM resident and fellow involvement in particular)

Do you agree to notify us when recruitment is completed?

Date form completed