1. Partnering with Nursing in Research in Clinical Settings Patti Radovich, PhD, CNS, FCCM Director Nursing Research Loma Linda University Hospitals

2. Initiating Nursing Support When considering a research study involving clinical units or nurses in hospital based clinics  Early in the process have a 1:1 discussion with the Nursing Leadership of the area (Manager or Director) Provide an overview of the study What the requirements are of nursing If the study is receiving outside funding or internal Collaboration requires understanding

3. Nursing Considerations  Nursing is support of research and we want your study to be successful however it is important to:  maintain fiscal responsibility for the unit  maintain nurse/patient ratios (legislative mandate)  adhere to labor laws regarding time/payment  Evaluate the acuity of the patients/subjects and the complexity of the interventions  Timed blood draws  Investigational drugs  Additional assessments/ documentation needed  Changes from current regulatory requirements or hospital policy  Evaluate special education needs/time (investigational drugs, specific labeling of specimens, transportation of specimens), FDA or HSE requirements

4. Letters of Acknowledgement or Agreement  Depending on the study:  Letters of acknowledgement or agreement are needed regardless if it is a sponsored study or and internally funded study  Letters of acknowledgement  No changes in care provided by nursing  Allows for awareness of study and study personnel  Letters of agreement  When services will be provided by nursing staff  Outlines expectations  Outlines costs/charges  Outlines education and support that will be provided

5. When Studies Involve Multiple Nursing Units  Tracking of research interventions, specimens  Use of tracking forms optimizing hand off between units  Research contact name/numbers for additional questions  Follow up by member of research team to ensure that nothing was lost in transfer

6. LLEAP  Ensure that you have met CTC to discuss the needs of hospital billing and finance  Ensure that CTC (or other designated staff) has established the Research Navigator tab with information on the study and contact information for the principal investigator  Ensuring that procedures are in place to identify patients who are participating in research ensures good communication  Regulatory bodies require that nursing and other healthcare providers be able to identify patients involved in research studies during their hospital course

7. LLEAP Banner & Navigator for Research

8. Collaboration in Research & Publication  Collaboration is important to examining the varied aspects of patient care and outcomes.  Collaboration is needed for research funding  We have the unique opportunity as a university and an academic hospital system

9. Who can help?  Patti Radovich, PhD, CNS, FCCM, Director of Nursing Research can assist in the facilitation of these discussions  Email: pradovich@llu.edupradovich@llu.edu  Phone: 909-651-7050  Pager: pradovich@my2way.compradovich@my2way.com “The real voyage of discovery consists not only in seeking new landscapes but in having new eyes.” Marcel Proust