You must have Institutional Review Board (IRB) approval from the UCSF Human Research Protection Program (HRPP) to use human subjects, their tissue, imaging, or other derived data from the UCSF Fein MAC in your study. The UCSF HRPP will not review the application until the UCSF Fein MAC Executive Committee has signed off on the proposal and consent form. Therefore, please submit your proposal early enough for the UCSF Fein MAC Resource Request Executive Committee review. You can get the forms to submit your protocol on the UCSF Human Research Protection Program website.

IRB approval is not required for submitting your proposal to the MAC for review. However, you must provide us with a copy of your IRB-approved protocol and consent form approval prior to initiating your study. Multi-year studies should forward copies of renewed approval annually to the UCSF Fein MAC office.

Attn: Resource Request
University of California, San Francisco (UCSF)
Edward and Pearl Fein Memory and Aging Center MC: 1207
675 Nelson Rising Lane, Suite 190
San Francisco, CA 94143

Please include language in your consent form that permits the future use of the data you collect (e.g., ‟Your data may be used by the research team now and in the future to answer questions about health concerns, memory, and thinking.”)

Use of Subject Names

It is a violation of University policy and our UCSF Fein MAC human studies approval to link the names and scores of subjects in any way or to reveal the names of subjects in videos in any way. For video, consider requesting just the audio track if movements or facial expressions are unnecessary to understand the behavior. All individual data must be kept and filed by UCSF Fein MAC subject identification number, not the subject’s name or initials. Should you need a second unique identifier as a cross-check, we recommend you use the subject’s date of birth. Any communication (with the UCSF Fein MAC or anyone else) should use subject ID numbers, never names.

All investigators must abide by the Human Research Protection Program and HIPAA requirements regarding the securing of subject names. In the HRPP application, indicate how you will preserve confidentiality. Your approval depends on this. Violations of HIPAA regulations can carry significant penalties including fines and prosecution.

Deviations from the use of UCSF Fein MAC assigned subject ID numbers must first be discussed with the Data Management and Biostatistics Core. Such deviations create an inability to pair an individual project’s data with UCSF MAC core data.

Investigator Orientation to Use of UCSF MAC subjects

Before any testing with UCSF Fein MAC subjects can begin, the investigator and any research assistant who may be in contact with subjects will receive an orientation to procedures for contact and interaction with subjects. This orientation includes how they will receive subject information, the ‟dos and don’ts” of scheduling and testing UCSF Fein MAC subjects, reporting weekly schedules, etc.

Data from UCSF Fein MAC research projects ‟belong” to the individual investigators, but the principle of data sharing is endorsed. When data from a core are to be used by an investigator not in that core, the core leader should be informed, the contribution of the core should be acknowledged in resulting publications and co-authorship from the core should be considered when appropriate by reason of intellectual contribution. If there are concerns or ambiguous situations, please contact Karen Smith.

The LAVA Clinical Research Management System (CRMS) was developed by the UCSF Fein Memory and Aging Center (MAC) to meet the data management needs of a research center with a dynamic and varied set of patient assessment measures and many interrelated research protocols. The system includes a query tool, LAVA Query, which allows principal investigators to create specialized cohorts and generate their own data sets. The system is web-based and can host data for multisite studies. LAVA is used by several national NIH-funded Alzheimer’s Disease Research Centers (ADRCs) and includes all forms for the full Uniform Data Set (UDS) maintained by the National Alzheimer’s Coordinating Center (NACC). Programmers at the ADRC sites collaborate in an open-source manner to maintain and enhance the LAVA code base. The LAVA framework can also be used to build CRMS systems for other disciplines. LAVA database applications have been created for UCSF investigators within multiple sclerosis and surgical movement disorders. UCSF MAC makes the LAVA source code freely available. The LAVA source code is freely available under an open-source license in the ‟lava” GitHub repository. Additionally, a LAVA demo application is in the ‟lava-uds” repository. Please contact Charlie Toohey for more information about LAVA.