Steps for Initiating a Research Project

Identify clinically relevant research questions Does it pass the “so what” test? Can it be practically studied in the context of the existing environment? Does it meet the mission of St. John’s Mercy Research Institute?

Literature review

• Contact the Thomas F. Frawley Medical Library at St. John’s Mercy for a comprehensive review; telephone is 314-251-6340 or e-mail is medlib@mercy.net.

Consult with statistician

• A power analysis may be required to determine required sample size to answer the research question. (Is this feasible?)

Prepare a rough budget estimate

• Contact the Office of Research Administration at 314-251-6841 for contract pricing (i.e., Lab, Radiology).
• Verify labor costs regarding number of patient visits.

Explore possible funding sources

• Contact the Office of Research Administration at 314-251-6841 for information.
• Consider potential corporate sponsors.
• Consider federal sponsors such as the NIH, NCI, NSF, etc.

Identify and assemble the research team

• Determine who will function as the principal investigator for the research project.
• Determine who will function as the clinical coordinator for the research project.
• Identify other researchers, clinicians, statistician, etc., required for the research project.
• Meet with the research team to ensure consensus of roles.

Prepare research proposal

• Specify exactly what is going to happen and when.
• Specify what constitutes data that will be recorded.
• Prepare St. John's Mercy IRB's Informed Consent Document.

If a Nursing Project

• Submit proposal to the St. John’s Mercy Nursing Research Committee.
• Submit proposal to Chris Crain, chief nurse executive.

Meet with clinical leaders and Department Chair

• Review study protocol with all team members.
• Review any department resources that will be utilized.
• Identify institutional resources that will be required.
• Identify where the study will be conducted.
• Obtain sign-off by department chair.

Submit for funding

• Submit proposal to sponsor.

When Funding Obtained

• If a device study, please send study information to Karon Dunovon, Dept. of Surgery.
• Send the following documents to Office of Research Administration which will forward to Legal and Finance:
  • Research Tracking Form
  • Clinical Trial Agreement from Sponsor
  • Budget Proforma
  • Schedule of Contract Charges
• After approval by Legal and Finance, submit study to Institutional Review Board (IRB) via IRBNET.com.

Post New Positions with Human Resources

• Work with St. John’s Mercy Human Resources to post open positions for research nurses and study coordinators.

Hire New Research Personnel

• Verify completion of orientation with St. John’s Mercy Human Resources.
• Verify that personnel hours will be billed to the research account and that staff members know how to clock in correctly to ensure proper billing.
• Ensure that all research team members completed the required human subjects education, and obtain a copy of their certificates.

Meetings with Research Team

• Begin meeting with the research team to prepare for data collection.
• Review protocol.
• Solidify and review roles and expectations of each team member.
• Anticipate barriers.
• Develop staff incentives to promote identification and notification of appropriate potential research subjects and their cooperation.

Project Implementation

• Recruit subjects, and monitor informed consent process.
• Enter data and analyze data.
• Evaluate results.
• Review monthly financial statements.
• Report any adverse events and deaths, per IRB policy.

Prepare Materials for Continuing IRB Review

• Review required materials and deadline requirements.

Prepare Manuscript for Publication

• Review St. John’s Mercy administrative policy on publication.