assisting residents with the research process prepared by margaret kriegel, msn, rn, cns, ccrc...
TRANSCRIPT
Assisting Residents With The
Research Process
Prepared by Margaret Kriegel, MSN, RN, CNS, CCRC
Research Education Coordinator
Scott & White
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
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.
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?
Components of a Proposal
• Specific Aims
• Background and Significance
• Research Design and Methods
Specific Aims
- Includes the broad long-term objectives.
- States the specific accomplishments the researcher hopes to achieve by conducting the study.
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.
Background and Significance
Study Rationale• Has the study been done before? • Will the study benefit patients
and/or advance understanding or influence policy?
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.
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:
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;
Research Design and Procedures
- planning of data collection and analysis;
- identification of limitations; - proposed communication of findings; - feasibility assessment.
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
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.
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)
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.
Biostats continued
• They work closely with the Photography, Illustrations and Publications Departments to produce quality graphs and figures for slides, posters and scientific publications.
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.
Publications Department
• They offer assistance with medical manuscripts, copy editing, textbook chapters, grant application editing, syllabi for CME, books, and desktop publishing.
Necessary Approvals
• Institutional Research Committee (IRC)
• Institutional Review Board (IRB)
• Institutional Animal Care and Use Committee (IACUC)
ExtramuralStudy
ApprovedPending
IRB
IntramuralStudy
IRC
Tabled
Protocol and
Application Packet
GrantsAdministration
Office
ResearchCompliance
Office
Approved
Disapproved
RESEARCH RESOURCESNAME TITLE PHONE
Sheree Atkinson Data Architecture and Decision 4-0285Support (DADS) fax: 4-8304Felicia Bagwell Senior Financial Analyst 4-7460 1507Glen Cryer Manager, Publications 4-2319 2858Worley, Stephanie, CIM, CIP Research Compliance Director 4-4072 1322John Greene, MD Director of Research! Chairman of 4-3689 0753Patty Moore Grants Administration, Director 4-5976 3030Pat Kirkpatrick, MSN, RN, Clinical Research Programs, Director 4-5556 2984Rajab, M. Hasan, Ph.D Biostatistics, Director 4-4078Theresa Strakos Research Grants & Contracts, Manager 4-5726 1981Randy Zavodny Research Tech Support Manager, 4-7774 2320Margaret Kriegel, MSN, RN, Research Education Coordinator 4-5387 1309
IRC Review
• Role of the IRC
– To determine scientific merit
– Possible internal funding
– If externally funded, IRC does not review
IRB Review
• Role of the IRB
-Protection of Human Subjects
-Compliance with Fed. Regulations
-Review for continued compliance.
Starting the Study
• No patient enrollment or data collection until written IRB approval is received.
Education of Team Members
• Always a team effort
• Protocol adherence emphasized
• Roles and responsibilities explained and understood
• May require a formal inservice
Patient Recruitment and Management
• How will patients be recruited
• Inclusion and Exclusion Criteria must be met
• Scheduling of appointments
• Medication management
Informed Consent
• Protects the rights of human research subjects
• No study interventions may occur or data gathered prior to informed consent
Manuscript Writing
• A well organized study allows for easier manuscript writing
• Assistance available in Publications
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 ([email protected])
Post test Question1
1.A proposal begins with which of the following:
A. Design
B. Question
C. Review of the literature
D. Methods
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
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.