1. Assisting Residents With The Research Process Prepared by Margaret Kriegel, MSN, RN, CNS, CCRC Research Education Coordinator Scott & White

2. OBJECTIVES The participant will be able to: –identify the process for developing and writing a research proposal –identify resources/support available at S&W for research –guide the resident to the correct resources

3. Proposal Resources Conduct of the study

4. THE PROPOSAL

5. The proposal begins with a question! Encourage the resident to discuss the research question with senior staff. Encourage the resident to discuss the research question with research staff.

6. What the Resident Should Consider Do I have the time? Can I enlist the needed cooperation of others? Are space and facilities available? Can I get funding?

7. Components of a Proposal Specific Aims Background and Significance Research Design and Methods

8. Specific Aims -Includes the broad long-term objectives. -States the specific accomplishments the researcher hopes to achieve by conducting the study.

9. Background and Significance Study Problem Articulates the problem to be addressed. Gives information supporting why it is a serious problem. Study Purpose Summary of the overall study goal.

10. Background and Significance Study Rationale Has the study been done before? Will the study benefit patients and/or advance understanding or influence policy?

11. Background and Significance Review of Relevant Literature It is a critical summary of research pertaining to your topic of interest. Is prepared to put your research problem in context. It should identify gaps and weaknesses in prior studies so as to justify a new investigation.

12. Background and Significance -thorough and complete; -logical; -recent; -based upon original research; -from primary sources; -a critical appraisal; -and builds a case for your study. A good literature review is:

13. Research Design and Procedures Should include the: - identification of research design; - description of the population and sample; - setting for data collection; - presentation of ethical considerations;

14. Research Design and Procedures - planning of data collection and analysis; - identification of limitations; - proposed communication of findings; - feasibility assessment.

16. RESOURCES

17. Support Available for Writing the Proposal Research Coordinator and/or Assistant Database access Biostatistics Department Grants Administration Office Publications Department Research Compliance Office Laboratory Technical Support Research Finance Library

18. Research Coordinator available for Senior Staff, Residents, Fellows, and Non-physician Scientists conducting research. has additional training in the conduct, development and coordination of research studies. has expertise in protocol development and editing.

19. Databases Data Analysis and Decision Support (DADS) –CPA - more than EMR, looks at all patients –MIDAS - billing, demographic (SMS) –TSI - costingHBSI - medical information, further back than others (like MIDAS) –ClinTrac - cpt, ICD, primary dx. Billing (billing)

20. Biostatistics Department The biostatistics staff consult with investigators on study design and provide analysis of study results. They are data management specialists, who design data forms, key study data and maintain close contact with study coordinators and research assistants.

21. Biostats continued They work closely with the Photography, Illustrations and Publications Departments to produce quality graphs and figures for slides, posters and scientific publications.

22. Grants Administration Office Role of the Grants Administration Office –Identify external funding sources. –Provide grant writing technical and educational support to any investigator. –Central administration office for processing all grant applications for internal and external funds.

23. Publications Department They offer assistance with medical manuscripts, copy editing, textbook chapters, grant application editing, syllabi for CME, books, and desktop publishing.

24. Necessary Approvals Institutional Research Committee (IRC) Institutional Review Board (IRB) Institutional Animal Care and Use Committee (IACUC)

26. RESEARCH RESOURCES NAME TITLE PHONE Sheree Atkinson Data Architecture and Decision 4-0285 Support (DADS) fax: 4-8304 Felicia Bagwell Senior Financial Analyst 4-7460 1507 Glen Cryer Manager, Publications 4-2319 2858 Worley, Stephanie, CIM, CIP Research Compliance Director 4-4072 1322 John Greene, MD Director of Research! Chairman of 4-3689 0753 Patty Moore Grants Administration, Director 4-5976 3030 Pat Kirkpatrick, MSN, RN, Clinical Research Programs, Director 4-5556 2984 Rajab, M. Hasan, Ph.D Biostatistics, Director 4-4078 Theresa Strakos Research Grants & Contracts, Manager 4-5726 1981 Randy Zavodny Research Tech Support Manager, 4-7774 2320 Margaret Kriegel, MSN, RN, Research Education Coordinator 4-5387 1309

27. IRC Review Role of the IRC –To determine scientific merit –Possible internal funding –If externally funded, IRC does not review

28. IRB Review Role of the IRB -Protection of Human Subjects -Compliance with Fed. Regulations -Review for continued compliance.

29. CONDUCT OF THE STUDY

30. Starting the Study No patient enrollment or data collection until written IRB approval is received.

31. Education of Team Members Always a team effort Protocol adherence emphasized Roles and responsibilities explained and understood May require a formal inservice

32. Patient Recruitment and Management How will patients be recruited Inclusion and Exclusion Criteria must be met Scheduling of appointments Medication management

33. Informed Consent Protects the rights of human research subjects No study interventions may occur or data gathered prior to informed consent

34. Correspondence Must be retained Easily accessible

35. Completion of the Study

36. Manuscript Writing A well organized study allows for easier manuscript writing Assistance available in Publications

37. Publication EXPECTED

38. THE END To earn joint conference credit: Continue to the post test Download the post test Complete the post test Return the post test to Dr. Sandra Oliver R407 I (skoliver@swmail.sw.org)

39. Post test Question1 1.A proposal begins with which of the following: A. Design B. Question C. Review of the literature D. Methods

40. Post test Question 2 2. Which of the following DOES NOT accurately describe a review of the literature: A. Thorough and complete B. Logical and recent; C. Based upon secondary sources

41. Post test Question 3 3.Research Design and Procedures includes which of the following? A. Identification of research background; B. Description of the population and sample; C. Significance of the problem; D. Research findings.

42. Post test Question 4 4. The function of the IRB is to: A. Protection of human subjects B. Determine scientific merit C. Provide internal funding D. Determine external resources