The Center for Research & Innovation in Patient Care

Research Opportunities:

Stanford Hospital & Clinics
Expedited Patient Care Services (PCS) Research Application & Approval Process

Introduction

The UCSF Stanford Center for Research & Innovation in Patient Care facilitates research in patient care services (PCS) at Stanford Hospital & Clinics by:

• Fostering a spirit of inquiry,
• Coordinating clinical research resources,
• Promoting studies that are aligned with strategic improvement priorities, and
• Linking investigators with clinical sites.

The Center is accountable for:

• Managing the process of PCS research review, approval and monitoring at Stanford Hospital & Clinics in order to assist investigators to gain entry and access to target patient populations or clinical settings,
• Ensuring a good "fit" between the investigator's research aims and organization's clinical resources at Stanford Hospital & Clinics,
• Fostering the integrity of proposed studies while limiting inadvertent exposure of patients/families and clinical settings to multiple concurrent studies which may compromise the quality, costs or outcomes of patient care at Stanford Hospital & Clinics.

The Center is also expected to optimize dissemination and use of research results to benefit ongoing patient care and staff development.

All nurse or health services investigators, including students, staff, or faculty affiliated with UCSF or Stanford or others, who intend to conduct research within Patient Care Services, and whose proposed study/project is not subject to review/approval by an affiliated medical school or designated Research Center, are required to apply to the Center for Research & Innovation in Patient Care for Review/Approval and complete the Expedited PCS Research Application & Approval Process at Stanford Hospital & Clinics. It is generally expected that the Expedited PCS Research Application & Approval Process will be prerequisite to advancing proposals through the Human Subjects Research Committee review process, however, concurrent review by the Center and CHR may be important to a study and would be acceptable in those instances. It should be noted that investigators will not be permitted to initiate a study in Patient Care Services at Stanford Hospital & Clinics until they have provided the Center with documentation verifying CHR approval of the proposed study.

Steps in the Center's PCS Research Application and Approval Process

1. As a first step, Investigators need to obtain a complete copy of the Expedited PCS Research Application & Approval Process Guidelines and the Research Proposal Application Face Sheet by contacting the Center at its Stanford Campus satellite office at (650) 723-7062 or at its UCSF office at (415) 502-1826 or emailing nancy.donaldson@nursing.ucsf.edu. The PCS research review application materials are available by fax, email, US mail or download Expedited PCS Research & Application.
   
   
2. It is also suggested that investigators contact the Center Director, Nancy Donaldson, RN, DNSc, for informal consultation regarding access to target patient or staff populations or clinical settings. At this time potential study sites, units, clinical managers and related data sources may be identified which will expedite the review and approval of the application when it is received by the Center.
   
   
3. Thoroughly review and complete the Research Proposal Application Face Sheet (attached to printed version of the Guidelines or avaible on this site in PDF "portable document format" by selecting PDF Face Sheet) with careful attention to the projected impact of the proposed study on direct and indirect Patient Care Services costs and attach the Face Sheet to the Committee on Human [Subjects] Research (CHR) review version of the proposal, or equivalent material extracted from an academic proposal manuscript, and then photocopy the application packet to obtain 3 complete stapled copies of the packet for the Expedited PCS Research Application & Approval Process . We ask Investigators to provide 3 copies of their application packet to help us speed distribution of packets to reviewers. You may mail or deliver your application packet to the Center at the address below.
   
   
4. For information on the required CHR application format and content, Guidelines for Research Involving Human Subjects at UCSF may be obtained from www.ucsf.edu/ora/chr. Guidelines for Research Involving Human Subjects at Stanford Medical Center may be obtained from http://humansubjects.stanford.edu/medical/. CHR staffs are available to consult with investigators preparing CHR application packets. Consult the web site or guideline materials for staff contact information.
   
   
5. When the PCS research review application packet is received by the Center, it is reviewed by the Center Director or Associate, in consultation with designated clinical administrators at UCSF Medical Center, Stanford University Hospital & Clinical and Lucile Salter Packard Children's Hospital, as appropriate, then routed for review to the clinical manager(s) and/or a clinical subject matter expert best matched to the proposed study. The purpose of this review is to evaluate the "fit" between the study aims, target population and the available clinical/data resources and to identify threats to the integrity of the study related to the clinical setting, processes of care, data access or other research-in-progress that may be unknown to the investigator. If the investigator has an ongoing relationship with the clinical manager(s), they may wish to informally discuss their study prior to submitting the application for review. However, one of the purposes of the Expedited PCS Research Application & Approval Process is to minimize the time clinical managers spend handling investigator contacts, therefore Investigators are generally discouraged from contacting managers directly. Any questions and recommendations from the reviewers will be forwarded to the Director or Associate, and immediately passed along to the investigator via email or telephone contacts.
   
   
6. Every effort will be made to complete the PCS review process within 7-10 working days from the day the packet is received, although complex proposals may require additional time for review and resolution of issues and concerns. The purpose of the review is to ensure the success of the proposed research effort through better coordination, communication and facilitation.
   
   
7. When the PCS research review process is completed, one of the following recommendations will result:

• The proposal is approved as submitted
• The proposal is approved contingent on making recommended PCS related changes
• The proposal is referred for review/approval to the PCS Vice President in consideration of the strategic nature of the study or the potential impact on resources.
• The proposal cannot be approved and the Investigator is advised to contact the Center Director or Associate for consultation.

  The Center Director or Associate will advise the Investigator and Clinical Manager of the of the review outcome and confirm those recommendations with the site specific Vice President for Patient Care Services at Stanford Hospital & Clinics.

8. After completion of the PCS proposed research review process, the Center Director or Associate will serve as a liaison, as needed, between the investigator and the CHR staff.
   
   
9. Following CHR approval, investigators must provide the Center with documentation of CHR approval before initiating the approved study in collaboration with identified PCS clinical managers/staff. Given the exceptional pace of change in the health care marketplace, if approved research is not initiated within 60 days, investigators must reconfirm approval to conduct the study with the Center, via email or telephone contact, prior to beginning research activities in the clinical setting.
   
   
10. So that the Center can maximize access to clinical settings for all applicant investigators, active investigators will be expected to update the Center on a monthly basis, via an automated email message, as to the status of the study as long as the research is in progress in the PCS clinical setting. A Summary of Research in Progress in PCS will be generated monthly based on investigator updates and routed to key PCS administrators, managers and committees who are stakeholders in the nursing research enterprise at UCSF and Stanford.
    
    
11. Upon completion of research activities in the PCS clinical setting at Stanford Hospital & Clinics, investigators need only update the center when the study is completed. As soon as it is available after completion of the study, the Investigator is expected to provide the Center with 2 copies of the "executive summary" of the final report and/or publications resulting from the study, so that materials can be shared with clinical staff.
    
    
12. Investigators are asked to commit to participate in at least one event in which their research is "presented" to PCS clinical staff who directly or indirectly supported the study in their clinical role/setting. Within 60 days of completing research activities in the PCS clinical setting, investigators are also expected to complete a one page narrative evaluation of their research experience in PCS at Stanford Hospital & Clinics and are asked to include in their evaluation any preliminary implications for clinical practice improvements in PCS emerging from their research. Narrative evaluations may be forwarded to the Center Director or Associate via email or US mail and may exceed one page, at the discretion of the investigator.