Ascension Providence Hospital Guide to Research

GUIDE TO CONDUCTING RESEARCH AT ASCENSION PROVIDENCE HOSPITAL

 
** For help in any of the following areas, please reach out to the associates listed at the end**

There are 2 basic phases for successfully completing a research proposal for a retrospective chart review study at Providence: developing the research idea and submitting an IRB application.

DEVELOPING THE RESEARCH IDEA

Get the idea!
     • Self-generated questions
     • Observations in the emergency room, operating room, floor rounds
     • Statements in textbooks, research articles
     • Suggestions of fellow trainees, mentors, faculty

Refine the idea to an objective(s) or testable hypothesis (most studies are driven by a hypothesis)

Do a literature review on your own
     • Has it been done before?
     • Do you have a new question?
     • What parameters did these other studies look at?
     • If the study still seems like it has not been done before, talk with our librarian (Alexia Estabrook, alexia.estabrook@ascension.org) and have her perform a search to confirm your search results

Determine if the project can be done
     • Does the patient population exist to study? Before you fill out an IRB application, you are allowed to contact the Data Warehouse Online Report Request (left margin of hospital’s intranet page) to determine the NUMBER (but no protected health information!) of patients with a certain diagnosis, ICD-10 code, etc.
     • Is the time available?

Determine if the project is worth doing
     • Is the central question of value to your colleagues (i.e., clinically significant)?

Execution – who will be your collaborators and part of your team?
     • Will you do it alone or in concert with another trainee/faculty member?
     • Does it require the collaboration of a resident/attending from another department?
     • Who will be your faculty sponsor (required for trainees only)?


SUBMITTING AN IRB APPLICATION

Login to IRBNET.org (if new, go to “New User Registration” first and create a profile; be sure to pick “Ascension Providence Hospital” for the institution; more details here)
     • All submissions and correspondence are done via this online system
     • Regardless of study type, ALL projects involving humans MUST be reviewed by the IRB

Start a new project (details here)
     • Click on "Create New Project" to get started 

 

Click on “Forms and Templates” button in left margin to access all relevant documents. In particular,
     • “CITI Training Instructions – Human Subjects Training Certification
          o All members of research team need to complete
          o Training is good for 3 years
     • “A-1-Initial Application
          o This is the main application form. DO NOT FILL OUT YET!
          o Go to last page (“Key Elements of a ‘Research Protocol’ Checklist”) and use the checklist as a guide to create a 2-3 page research protocol
          o Use “Research Protocol (Sample)” document from IRBNET.org as necessary
          o Have all team members work on protocol and agree on content
          o Once research protocol completed, fill out “A-1 Initial Application
          o Note: if this is a retrospective chart review study, use “Chart Review-A1 Initial Application (sample)” to help with content later in the A-1 application (just copy and paste)
     • “A-2 Team List-Updated Ascension
          o List yourself as Principal Investigator and first member of team
          o Add all team members
          o Indicate role and other responsibilities for all
     • “A-3 Department Chair Signature (Updated Ascension Providence)
          o Have Department Chair (for faculty) or Program Director (for trainees) sign the form, along with the Research Director for the program

Use the first page of the “A-1-Initial Application” as a reminder of other relevant elements to include with your application:
     • Create data collection sheet
          o Do this in Excel. Each column should have a header that describes the data to be collected. Each line should be an individual patient.
          o Save file on hospital’s network servers, rather than on flash drive or laptop
          o Use “A-6 Data Capture Sheet (Sample)” for guide

When you are ready to submit, use the “Read Me First” file for guidance. In general,
     • Upload all files into a single package
     • “Sign” then “Submit” package
     • Use “Share” to add all team members, which allows their access to project

The “IRB NET USERS HANDBOOK” may be a useful guide for how to do other tasks


DATA COLLECTION CAN BEGIN ONCE IRB APPROVAL IS RECEIVED!

     • Exempt and Expedited studies take up to 2 weeks for approval
     • Full board studies require 6-8 weeks for approval

For information about how to conduct research studies other than retrospective chart review studies, go to our "Research Application and Review" page

 

Other research and IRB-related information can be found on the Medical Education’s Research website at https://medicaleducationsjp.com/medical-education-at-ascension-providence-hospital/research


If you have any research or IRB-related questions, please do not hesitate to reach out to
     • Jeffrey C. Flynn, PhD, Director of Scholarly Inquiry, ph: 248-849-2590 or Jeffrey.Flynn@ascension.org
     • Nancy M. Jackson, PhD, Associate Medical Researcher, ph: 248-849-3302 or Nancy.Jackson2@ascension.org
     • Nicole Bolda, IRB Coordinator, ph: 248-849-8889 or Nicole.Bolda@ascension.org