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

• Proposal

• Resources

• Conduct of the study

THE PROPOSAL

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.

HELP!!

RESOURCES

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.

CONDUCT OF THE STUDY

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

Correspondence

• Must be retained

• Easily accessible

Completion of the Study

Manuscript Writing

• A well organized study allows for easier manuscript writing

• Assistance available in Publications

Publication

• EXPECTED

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)

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.

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