1. Research Navigation at MMC Wendy Y. Craig, Ph.D. Research Navigator MMCRI-Center for Outcomes Research & Evaluation

2. 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

3. 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

4. Research at MMC Basic Translational Clinical Educational Outcomes Small scale Short term Single question Uncomplicated design Large scale Multi-year Multi-question Complex design All well-designed projects that ask a useful question have value

5. 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:

6. 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

7. 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

8. Residents Fellows Faculty Scientists or staff members @ MMC and affiliated academic healthcare centers MMC’s Navigation Team is available to:

9. 1.Preparation 2.Develop proposal 3.Submit proposal for review 4.Conduct Research 5.Analyze Results 6.Publish Results The Research Pathway: Navigation in Action What and when? * *

10. Preparation 1.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 –Next slides

11. Training - 1 Human subjects - Required Collaborative Institutional Training Initiative (CITI) www.mmcri.org see link to CITI on IRB pagewww.mmcri.org

12. 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

13. 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

14. More Preparation Working 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

15. The RPR is a one-page form www.mmcri.org/irb (forms and templates)

16. Develop Proposal logical and structured – Navigation can help Focus the Question Study Design Human subjects Logistics Expected Outcome Background Hypothesis Specific Aims Methods Research Plan/Timeline Potential problems Significance Remember that a reviewer will not know the subject as well as you do – explain everything clearly so that you can “sell” your idea.

17. Organize your Time JanFebMarAprMayJunJulAugSepOctNovDec Prepare study materials Staff Training Database development Collect data Finalize database Data analysis Manuscript preparation Team Meetings

18. 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)

19. Conduct Research Never 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

20. Confirm Logistics what, who, how Communication Informed consent Sample collection/methods Data collection Research staff/training Timeline goals

21. Collect Data the 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

22. Analyze Results Demographics Differences Relationships Interactions Adjustments Significance Never underestimate how long this takes!

23. Publish Results Presentation - Abstract - Poster - Manuscript Choose venue/journal Create draft Circulate for input Edit, edit, edit Submit

24. How to Access Help Navigation Other

25. 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

26. Other Research Resources at MMC Preparation 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

27. 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

28. wcraig @mmc.org navigation@mmc.org Questions? Office hours in library: Monday 10:00AM-4:00PM Tuesday 10:30AM-4:00PM Wendy Craig Ph.D. Research Navigator