Research Navigation at MMC

Wendy Y. Craig, Ph.D.Research NavigatorMMCRI-Center for Outcomes Research & Evaluation

• What is Research?

• What is Research Navigation?

• The Research Pathway: Navigation in Action

• Research Resources at MMC

• How to Access Help

• General Advice

Research Navigation at MMC

What is Research?

“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

In other words……..

A formalized expression of intellectual curiosity

Research at MMC• Basic• Translational• Clinical• Educational• Outcomes

Small scaleShort termSingle questionUncomplicated design

Large scaleMulti-yearMulti-questionComplex design

All well-designed projects that ask a useful question have value

What is Research Navigation?

• Demystify and simplify the research pathway

• Provide guidance and assistance in all phases of research from conceptualization to publication

THE PURPOSE OF RESEARCH NAVIGATION IS TO:

Expertise in the Research Navigation Team

• Epidemiology/study design• Study Feasibility and logistics• Database management• Biostatistics• Writing and presentation• Hands-on experience in:

– Clinical/ human subjects research– Clinical laboratory science– Basic Research

MMC’s Navigation Team

• Ivette Emery, Ph.D.– Translational Scientist– Protocol development/

identification of resources

– Based at MMCRI

• Kahsi A. Smith, Ph.D.– Behavioral Scientist– Navigation

Consultant: Statistical analysis/study design

• Deanna Williams, B.A.– Navigation Coordinator– Database development

and management

• Wendy Craig, Ph.D. – Research Navigator– Education & Outreach/

Proposal & manuscript development

• Lee Lucas, Ph.D.– Epidemiologist– Statistical analysis/study

design

• Residents• Fellows • Faculty• Scientists or staff members

@ MMC and affiliated academic healthcare centers

MMC’s Navigation Team is available to:

1. Preparation2. Develop proposal3. Submit proposal for

review 4. Conduct Research5. Analyze Results6. Publish Results

The Research Pathway: Navigation in ActionWhat and when?

**

Preparation1. Develop a question

– You find yourself asking “How?” or “Why?”

2. Is there an answer already out there?

– Library

3. Seek input about your question; conceptualize the study

– Identify a Mentor– Navigation

4. Training

1.Next slides

Training - 1

• Human subjects - RequiredCollaborative Institutional Training Initiative (CITI) www.mmcri.org see link to CITI on IRB page

Training - 2

• MMCRI Research Course– Spring (1 day) and Fall (2 day)– Topics covered include:

• Study design• Protecting human subjects and animals in research• Biostatistics• Writing a proposal/getting funding• Navigating MMC’s research pathway

• Online education– MMC is affiliated with Tufts

Clinical & Translational Science Institute (CTSI)

– Seminars & workshops are available online

• Research Design and Data Analysis Seminars – free!

Training - 3

http://www.tuftsctsi.org/Calendar.aspx

http://ilearn.tuftsctsi.org/courses/courseCatalog.aspx

More PreparationWorking with retrospective data?

Send Review Preparatory to Research (RPR) request to IRB

• An RPR allows you to count the number of patients eligible for your study – will there be enough to answer your question? Is the information you need in the medical record?

• The RPR does not allow you to record or analyze any data

• Submit to the IRB; fast turnaround but you can start looking at records as soon as you submit the form

The RPR is a one-page form

www.mmcri.org/irb (forms and templates)

Develop Proposallogical and structured – Navigation can help

• Focus the Question• Study Design• Human subjects• Logistics• Expected Outcome

BackgroundHypothesisSpecific AimsMethodsResearch Plan/TimelinePotential problemsSignificance

Remember that a reviewer will not know the subject as well as you do – explain everything clearly so that you can “sell” your idea.

Organize your Time

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov DecPrepare study materials

Staff Training

Database development

Collect data

Finalize database

Data analysis

Manuscript preparation

Team Meetings

Submit Proposal for Review

Ethics review (IRB)– Human subjects research?– Greater than minimal risk?– Informed consent?

Scientific review–Department–Scientific review committee (SRC)

Funding- Mentored research grant- Research project

management (budget)

Conduct ResearchNever start a project before you have official approval!

• Department• Collaborators• IRB• Funding source• Project management*

*Must meet with project management team before funds are released

Confirm Logisticswhat, who, how

• Communication

• Informed consent

• Sample collection/methods

• Data collection

• Research staff/training

• Timeline goals

Collect Datathe goal is “clean” data – accurate, consistent, well documented, complete

• Organized codes, variables, units, categories, format

• Crosscheck entries

• Reliable results depend on this step!

Navigation has developed a database tool to help

Analyze Results

• Demographics• Differences• Relationships• Interactions• Adjustments• Significance

Never underestimate how long this takes!

Publish Results

Presentation - Abstract - Poster - Manuscript

• Choose venue/journal

• Create draft

• Circulate for input

• Edit, edit, edit

• Submit

How to Access Help

• Navigation

• Other

1. Email Deanna Williams at: navigation@mmc.org

2. Deanna will send you the “Navigation Request Form”

3. Complete & return the form; in your e-mail include:• meeting availability • any research materials

4. Request is triaged

Requesting Navigation Assistance

Other Research Resources at MMCPreparation• Library

• Center for Outcomes Research & Evaluation

Research Compliance• Human Research Protection Program

• Quality Research Tools and Support

Project Assistance• Clinical Trials

• Laboratory/ Biobank

Budget & Funding• Research Budgeting Assistance

• Grant Specialist

• Contract Specialist

Brochure with complete information available via a separate MERC link

General Advice

• Start early– Allow at least 6 months for the process of planning,

proposal development and approval. Depending on the nature of your project, it may take longer than this.

• Seek input along the way (not at the last minute!)– Mentor– Colleagues– Navigation– IRB/compliance

wcraig@mmc.orgnavigation@mmc.org

Questions?

Office hours in library:Monday 10:00AM-4:00PMTuesday 10:30AM-4:00PM

Wendy Craig Ph.D.Research Navigator