This SOP outlines the standardized processes for the conduction of nursing research for both internal and external studies.

Transcription

1 3/5/14 Standard Operating Procedures (SOP)* For the conduction of nursing research at UPMC Shadyside (*based on resources provided by Dr. Lynda J. Dimitroff, PhD, MSEd, BSN, RN, MCHES) Scope: This SOP applies to all who conduct nursing research at UPMC Shadyside. In addition, any nurse participating in research where the PI: is not a nurse (i.e. MD or postdoc) or is of another discipline (i.e. psychology or pharmacy) or is collaborating with external studies. (individuals are not from UPMC Shadyside) or in collaboration with Industry Background: Definition of nursing research: Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR d). This SOP outlines the standardized processes for the conduction of nursing research for both internal and external studies. All nursing research at UPMC Shadyside must involve at least one nurse on the research team. INITIAL STEPS 1. Consult with representative of the Department of Nursing Research at UPMC Shadyside Jan Cipkala-Gaffin Dr PH, RN Hopwood Library. 2. The nurse notifies their Unit Director about the study and Clinical Director of their department or their immediate supervisor. 3. Curriculum Vitae is to be submitted. 4. The nurse will discuss with Dr. Cipkala-Gaffin who is being considered for assuming the role of Principle Investigator (PI). 5. Co-investigators will be identified 6. Mentorship will be discussed 7. Prepare and submit the research proposal electronically to Dr. Cipkala-Gaffin cipkalaj@upmc.edu following the guidelines for internal staff. See sample template, Appendix A. 8. The study will be sent to the internal Nursing Advisory Committee for UPMC. This committee meets the second Tuesday of the month. You will be notified of the date of the proposal review by the Nursing Research Advisory Committee. See attached policy for research and flow chart to submit to the Research Advisory Committee at UPMC. See Appendix B. 9. Submit CITI module certificate. 10. After obtaining approval from the Nursing Advisory Committee for UPMC, the PI will submit to the IRB. 1

2 Appendix A. Template for Research Proposal for UPMC Nursing Research Advisory Committee Recommend following format of specific journal if considering publication in future TITLE OF STUDY Title should match actual research study protocol Principal Investigator Mentor Credentials and address Credentials and address ABSTRACT Background Design Methods Proposed analyses INTRODUCTION BACKGROUND Briefly describe previous findings or observations that provide the background leading to this proposal. SIGNIFICANCE Why is it important that this research be conducted? What gaps in existing information or knowledge is this research intended to fill? OBJECTIVE What is the overall purpose of the study? AIMS/HYPOTHESES List the goals of the prosed study (e.g., describe the relevant hypotheses or specific problems or issues that will be addressed in the study). METHODS DESIGN SAMPLE Inclusion/Exclusion Criteria RECRUITMENT Screening Include # for screening and # for subjects approved for study. MEASURES Report reliability and validity PROCEDURES Detailed description of all research activities. Duration of procedures TIME TABLE ANALYSES Projected statistical analyses. MAIN OUTCOME VARIABLES/ENDPOINTS Cipkala-Gaffin 8/2013 2

3 Appendix B. UPMC PRESBYTERIAN SHADYSIDE NURSING POLICY AND PROCEDURE Policy Title: Initiating Nursing Evidence Based (EBP), Quality Improvement QI), and Research Projects at UPMC Presbyterian/Shadyside Policy Number: PGen29 Last Review Date: June 2012 POLICY It is the policy of UPMC Presbyterian Shadyside that all nursing lead EBP, QI, and Research projects conducted at UPMC Presbyterian Shadyside must be approved by the appropriate oversight committee as noted below. A. EBP Projects need to be reviewed by the Nursing EBP Committees at PUH and Shadyside. Contact Committee Chair. An Evidence-Based Project is the integration of best research evidence with clinical expertise and patient/family values to facilitate clinical decision making. Melnyk & Fineout-Overholt, (2011). B, QI Projects need to be reviewed by the QI Review Committee. Contact QI chair. A Quality Initiative Project is a project that is focused primarily on improving patient care within a given patient care environment (e.g., hospital or health care organization) and, as such, the outcome of the project may not be generalizable to other patient care environments. Publication of a quality assurance project does not, per se, render that project research ; however, if the outcome of a Quality assurance project is published, attention should be given to avoiding the terminology research in the publication. C. Research Projects need to be reviewed first by the system Evidence based Nursing Council, Nurse Research Advisory and then the University of Pittsburgh Institutional Review Board (IRB) prior to project initiation. Contact EBP Committee at PUH and Research/EBP Council at Shadyside EBP. Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR d). Thus, a case report on a single individual would not meet the definition because one could not generalize from that single case. A completely unstructured discussion with several people ( tell me what it was like to be a feminist in Berkeley in the 1960s ) would not meet the definition because the investigation is not systematic. On the other hand, an open-ended interview that includes a number of probing questions to ensure that all interviewees address the same topics would be considered to be systematic and would meet the definition of research so long as sufficient people were interviewed to provide some assurance that the resulting information was generalizable. D. Submissions for funding must be approved by the Office of Grants and Contracts. E. At Presbyterian, all requests for staff participation in surveys or questionnaires must be approved by the CNO of Nursing and/or the appropriate V.P. for other service areas. 3

4 PROCEDURE I. PROJECTS PROCEDURE KEYPOINTS STEP I: Project Initiation 1. Contact a mentor: a. Chair of hospital EBP committee b. Director of Nursing Education at Presbyterian or Shadyside, respectively or c. An Advance Practice Nurse for project information and a mentor assignment. 1. The mentor will provide applicant with information, guidance and support during the development and approval process. 2. The mentor will assist in determining the type of approval necessary based on the topic (EBP, QI, and Research). 3. If a student, the student must work with a faculty advisor, in addition to UPMC Presbyterian Shadyside mentor. 4. If research, the mentor is also required to complete research education modules as noted in the University of Pittsburgh IRB reference manual and submit proposal to System EBN Council. [ Step II. Project Development 1. Complete a written proposal for the project according to guidelines for oversight committee. a. QI 1) Complete UPMC QI vs. Research Study Review Application.(Appendix A) 2) Submit to mentor before submitting to QI Review Committee. 3) Receive approval from mentor 4) Submit to QI Review Committee. b. EBP 1) Present/submit to Nursing EBP Committee, Presbyterian or Shadyside campuses, respectively. 2) Work with mentor to develop project. 3) Receive approval from EBP Committee 1. EBP (EBP Committee), QI (QI Review Committee), and Research (Research Guidance Committee and University of Pittsburgh IRB). a. See UPMC Policy Review of Quality Improvement Projects versus Research. Policy HS-PS EBP Model (Rosswurm and Larrabee, 1999) a. Assess the need for practice change b. Link problem with interventions and outcomes c. Synthesize best evidence d. Design practice change e. Implement and evaluate change in practice f. Adopt or reject change 2. Include timeline for project completion. 4

5 PROCEDURE c. Research 1) Complete IRB investigator modules 2) Submit to System EBN Nurse Research Advisory for scientific review before submitting to IRB.(See Appendix B) 3) Receive Nurse Research Advisory approval. Nurse Research Advisory is a sub group of Nursing EBN Committee. 4) Submit to UPMC fiscal review (if applicable). 5) Submit to IRB. Step III. Grant Submissions 1. If submitting for external funding: Submit grant submission forms to Office of Grants and Contracts for approval and sign off prior to submitting for external funding. 2. Forms are available from EBP/Research Committee chairs. KEYPOINTS 1. All investigators listed on an IRB proposal must complete IRB investigator modules. Go to for information regarding module completion. a. There are required modules, but module requirements may vary depending on the type of research being performed. 1. Mentors, EBP Committee, Research Guidance Committee can assist with process for grant approval. a. Allow 4 weeks turn around time for Office of Grants and Contracts to reply. b. External funding includes but is not limited to industry sponsored grants, government, professional organizations STEP IV. Surveys 1. AT PRESBYTERIAN, Prior to administering any survey or questionnaire to staff, submit a request for approval to: a. Nursing CNO for all nursing or clinical related projects b. The V.P. of the appropriate service area for projects involving non-patient care areas Step V. Post Approval 1. Communicate all project approvals (EBP, QI, and Research) to Nursing EBP Committees at Presbyterian or Shadyside, respectively. 2. Report progress on the project to the Nursing EBP Committee bi-annually for the duration of the project.. 3. Submit a written / verbal report to the EBP/Research Committee at UPMC Presbyterian or Shadyside respectively no greater than one month after project is completed. 1. If any work or project includes the request for survey or questionnaire completion by UPMC staff appropriate administrative approval is required and must be obtained prior to making any requests of staff. 1. EBP committee members maintain a list of all current projects. 2. Maintain contact with mentor on regular basis to assess progress. 3. Contact the Chair of the EBP Committee of Presbyterian or Shadyside, respectively, at least one week in advance of the meeting to be placed on the agenda. The PUH Committee meets on the first Monday of 5

6 each month. The Shadyside Council meets on the second Thursday of the month. 4. Dissemination of results is encouraged. 4. The project leader and mentor will identify appropriate dissemination methods; journal club, poster, QI fair, etc UPMC All Rights Reserved. References: (L-1) Kring, D. (2008). Research and Quality Improvement: Different Processes, Different evidence. MEDSURG Nursing, 17 (3), (L-2) Melnyk B.M. & Fineout-Overholt, E. (2011). Evidence-Base Practice, 2 nd edition. Wolters Klower Health-Lippincott, Williams & Wilkins. Reviewed/Revised: 5/09, 6/10, 6/11, 6/12 Addendix C: Grant Application GRANT SUBMISSION FORM Please submit to: cgsubmissions@upmc.edu Name of Grant Sponsor: Date Submission Due: Name of applicant: 6

7 Project Name: Period of Performance (dates): Department of applicant: Department Head Name: Grant Administrator Name: Contact information for Grant Administrator: Sponsor contact name: Mailing Address: Telephone Number: FAX Number: Address: Any other information: Appendix D. Please attach RFP, complete grant application, and any other applicable documents, such as IRB approval (or application), etc. Date of Submission: Title of Project: UPMC Health System Quality Improvement Projects vs. Research Studies Quality Improvement Review Screening Tool Sponsor: Department: Co-Sponsors: Facility(UPMC entity): Anticipated Start Date: Anticipated End Date: 7

8 Estimated Duration of Entire Project: Referred for QI review by IRB staff YES NO 1. Goal(s) of project: 2. Is there a commitment to implementing a corrective plan based on the outcomes of the project (check one)? No Yes If Yes describe in brief. 3. Is the project being funded by an external agency (check one)? No Yes if yes, specify agency: 4.What is the primary intent of the project (answer one): Publication or Quality Improvement What improvements do you hope to implement in the local environment? 5. If patient data is being collected, please indicate how data is going to be collected (check all that apply and Circle the Database being used): Chart review through medical records (i.e., Access Anywhere and hardcopy records) Chart review through electronic medical records (i.e, Powerchart,MARS, Stentor OR Other please specify database): Data collection from the UPMC Network Cancer registry database.(if using other registry database - Pease specify database): Patient interviews/observations Please attach a sample data collection form. All patient identifiable data collected and stored for this study needs to comply with UPMC Policy HS MR1000 regarding the privacy and security of clinical data. 6. Provide a brief summary (one page) or abstract of your proposed project and attach it to this page. 7. If the project involves a therapeutic intervention, is the intervention to be delivered in a blinded fashion? No Yes 8. Does the project involve withdrawing or holding back any needed and generally accepted treatments for the patients condition: 8

9 No Yes 9. Does the project involve prospective assignment of patients to different procedures or therapies based on predetermined plans such as randomization? No Yes 10. Is the project evaluating a drug, biologic or device which is not currently FDA approved (i.e., off label use)? No Yes 11.Are Patients involved in the project exposed to additional risks or burdens (ie. Other than the completion of patient satisfaction surveys) beyond standard clinical practice No Yes 12. What outcomes are being evaluated? 13. Describe briefly why you think this is a QI project and not a Research study: For completion by QI Review Committee designee: Date of Review: Date Approved: Approved as Quality Improvement Project - Agree: Disagree: Date to be presented to Total Quality Council: Prospective date for feedback to TQC on outcomes: Comments: QI Review Number: Completed by: 9

10 Appendix E: EBN Nurse Research Advisory Review Nursing Research Advisory Council (NRAC) Flowchart EBN Representative receives proposal from PI Send to NRAC 2 weeks prior to meeting No new recommendations Letter sent to CNO & EBN Representative Proposal reviewed by NRAC NRAC to return within 1 week with recommendations 1 Week Revisions Recommended PI & EBN Rep communication to occur CNO & EBN Rep BU Permission PI response to recommendations requested Time frame dependent on PI Project Conducted at BU Response from NRAC within 2 weeks PI disseminates results of project at EBN Council Meeting PI disseminates results at BU according to BU process 3/ nd Review by NRAC Revisions Recommended PI & EBN Rep mentored at NRAC meeting 10