Patient-oriented HIV research is a rapidly growing area of investigation within the UCLA AIDS Institute. Over the past several years the regulations that protect human subjects have become more complex and have required more time and effort from investigators who propose to conduct patient-oriented research. During the recent restructuring process of the UCLA AIDS Institute there was overwhelming support from clinical and translational faculty for more centralized resources for assisting investigators in meeting the regulatory requirements of conducting patient-oriented research. Delays in receiving Institutional Review Board approval for clinical research has been identified as a barrier for many investigators at UCLA, especially junior and new investigators. Many investigators do not have the resources within their research groups to hire personnel to assist with the multitude of requirements for the conduct of patient-oriented research. The core is a resource for AIDS Institute investigators to improve the productivity of the behavioral, clinical and translational research efforts of the Institute by coaching new and junior faculty through submissions and by assisting established faculty with their submissions. Junior faculty and fellows will not be charged for core services.

Services of the Core
Faith Landsman is the Administrator of the HIV Research Facilitation Core. Faith works under the supervision of the Core Director, Dr. Judith Currier and in collaboration with the Office of Clinical Trials to assist investigators with meeting the regulatory requirements of conducting patient-oriented research. The HIV Research Facilitation Core is housed in the administrative unit of the Center for AIDS Resarch and Education (CARE). The core provides the following services:

For junior faculty and fellows:
 Train junior faculty on a broad range of clinical trials topics and in a variety of formats in collaboration with the Staff of the Office of Clinical Trials.
 Trainees (junior faculty, fellows, AIDS Institute seed grant awardees) will be instructed on how to complete the required process at no charge. Coaching services will include:
o Protocol preparation if needed (a protocol is required for no-cost service)
o HS1 and Informed Consent
o GCRC application as necessary
o ISPRC application as necessary
o Radiation safety application as necessary

For established faculty:
 IRB submissions will be prepared for established faculty with grant support and a recharge mechanism will be developed for this service.
 Review protocols, identify study specific requirements and potential issues, consult to PI/research staff on requirements, issues, and expectations
 Serve as the primary point of contact for the PI and research staff for pre-study facilitation
 Perform pre-study services (i.e., IRB submission support, other regulatory submissions, etc.) as needed.
 Facilitate required regulatory submissions
 Referral of investigators to other resources currently available within UCLA as needed (other core services, GCRC)
 Assure consistency among informed consent, budget and contract documents
 Serve as a liaison between AI investigators and the IRB

Established investigators will be able to use the service through the re-charge mechanism. Recipients of AI Seed Grants will also receive instruction from the core. The cost for completion of IRB submissions will be based on the complexity of the study. The average cost is estimated to be $1500 for an initial IRB submission.