Investigator-initiated research (IIR) is independent, original research that is initiated and managed, from idea inception through data collection and analysis, by an investigator or a collaborative research group. There are many different types of research that fall into this group, including basic scientific research, clinical trials, and many Quality Improvement (QI) projects.

This type of Scholarly Activity often involves human subjects, and therefore requires Institutional Review Board (IRB) approval. Original research can often be submitted for internal (your organization) or external (outside group like the National Institutes of Health, Department of Defense (DoD), local or regional government or non-profits, etc.) funding support. The time, energy and resources involved in IIR projects can be significant. However, IIR is an invaluable tool for medical discoveries, life-long learning, and can significantly enhance your curriculum vitae (CV).

As with other types of Scholarly Activity, initiating an IIR project starts with a well-defined research questions (see “Create Your Research Question” in the Scholarly Activity Pathway).  All successful projects require a great deal of pre-planning and organization. Don’t try to “reinvent the wheel!”  The USAFP “Every Doc Can Do Research” offers a great guide and workbook to start your research study.

Quality Improvement projects, or QI projects, are a systematic approach to analyzing, and subsequently improving, practice performance in efficiency, patient safety and/or clinical outcomes.  These types of projects involving the evaluation of current practices, testing the implementation of an intervention, and determining outcomes, are essential to practice improvements. For some additional information about the importance of QI and QI basics, check out this video by Dr. Mike Evans on QI in Healthcare.

So how does one start a QI project? First, you should ask yourself three important questions: 1) what are we trying to accomplish? 2) how will we know that a change is an improvement? and 3) what changes can result in improvement?  Essentially these questions define your aim, determine the criteria for judging the changes, and identify the changes to be made.  These questions are the first part of the Plan-Do-Study-Act cycle.

  • Plan: Analyze the process, determine what changes should be made to improve the process and plan the changes
  • Do: Enact the changes on a small scale
  • Study: Determine if the changes are working
  • Act: If working, implement on a larger scale.  If not, refine and start the cycle over.

A PDSA worksheet from the National Primary Care Development Team can be helpful in organizing your QI plan.

QI is sometimes considered research as projects are data-driven and may involve human subject research, thereby needing IRB approval. So how do you know?  Considerations for whether QI projects need IRB approval are dependent on several factors, and are discussed here in a worksheet from the Children’s Hospital of Philadelphia Research Institute, to help determine whether approval may be needed.

When considering how to best present your QI project, SQUIRE offers a useful worksheet to organize your thoughts and provide a framework for reporting your results. 

After you have created a research question, performed a comprehensive literature search with appropriate critical appraisal, and identified research outcomes, it is imperative to choose the appropriate research method(s) and design your study.  This can essentially be broken down into two main parts: 1) how you will collect the data; and 2) how you will analyze the data.

First let’s talk about data collection. There are many choices for study design, which are based on the type of research being conducted.  Will your data be qualitative or quantitative (words or numbers, respectively)?  Will the data be from primary or secondary sources (i.e. your own collected data or data already collected, respectively)? Will you do an observational study, where you are not manipulating any variables, or an experimental study, where you are modifying variables?

Depending on what data you collect or how you collect the data will inform which research methods you should use to analyze the data. Data can be analyzed both quantitatively or qualitatively, and sometimes both, with is mixed-methods research (e.g. a survey can have qualitative answers, but quantitative analysis can be done for response rate).

Well-designed research is critical to efficiency, and ultimately, to successful completion of the project.  The USAFP “Every Doc Can Do Research” offers a resource for information about different study types and research design.  Additionally, there are many practical guides to designing and implementing clinical, translational, and public health research.  Listed below are two books that can be instrumental in research design:

  • Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB.  Designing Clinical Research. 4th Ed. Philadelphia: Lippincott Williams & Wilkins; 2013.
  • Dillman DA, Smyth JD, Christian LM. Internet, Phone, Mail and Mixed-mode Surveys: The Tailored Design Method. 4th Ed. Hoboken: Wiley & Sons; 2014.

An Institutional Review Board (IRB) reviews all federally-funded or regulated biomedical research on human subjects.  These administrative bodies are affiliated with specific institutions and are established to protect the rights and welfare of human research subjects.  Research proposals involving human subjects must be submitted to the IRB prior to conducting the research.  The IRB has the authority to approve, reject, modify, monitor, and/or terminate a proposed research study.  To determine if your research qualifies as human subject research, you can review the Human Subject Research Determinations Iowa IRB page.

There are three types of IRB review: full committee, expedited or exempt. Generally, expedited reviews involve no more than minimal risk to participants and must fall into specifically defined categories.  Exempt reviews involve no risk to human subjects and fall into one of the defined exemption categories. Full committee reviews are the most time-consuming and usually are completed for studies that involve potential risk for patients/subjects. Most IRB submissions will likely require some modifications or revisions. In some cases, IRB submissions can be done electronically (at Iowa, via HawkIRB). All research projects, including QI projects, must be submitted to the IRB for review. Even if you or another investigator believes the project to be exempt, it is the IRB which determines exemption status.

The Iowa Human Subjects Office website provides useful information on the IRB process, including the different research categories. The FAQ page for how to get started with the Iowa IRB process may be useful, as well as an overview of the IRB process itself. Additionally, several IRB educational tools are available to help with the consent process, IRB exemption determination and other parts of the process.

In many cases, funding your research through either an internal (within your institution) or external (outside your institution) grant is a necessary (or at least a helpful) component to successfully completing the proposed research study.  At the very least, being the recipient of a competitive research grant sets a precedent for future successful grant funding and can significantly strengthen your academic portfolio and your appeal to other hiring agencies.

There are many resources available to help you write a competitive grant application, including the sponsor’s (e.g. NIH, AAFP, etc.) grant application instructions.

The Research Development Office (RDO) offers several excellent resources to assist. The RDO Resource Library (HawkID required) has examples of successful grant proposals (from both federal and private agencies), budget justifications, data management plans, and other research documents.  The RDO also offers external review of grant proposals to provide feedback prior to submission. Another terrific resources is the Division of Sponsored Programs, which offers assistance in the grant application process, budget preparation, and other research services.

As a first step, it is critical to identify the sponsor or funder and what their goals/aims are through the request for applications (RFA).  These strict protocols and requirements will set the guidelines for the proposal moving forward.  The Iowa Office of the Vice President for Research and the UI Carver College of Medicine websites offer internal funding opportunities, PIVOT (login required) which is one of many search mechanisms for external funding, and additional research resources.

You can also find a list of some of the most common extramural funding organizations for primary care below.

Additionally, Grants.gov which covers all federal grant funding, and other websites, such as the Rural Health Information Hub, which specifically covers funding opportunities for rural communities by state and other parameters, can be useful for a 20,000-foot-view of available opportunities.

Now that you have spent the time (often years) and the resources (too many to count) to complete your research study, it is time to publish and make your research available to the medical community!

For information about presenting your research, refer to the “Poster Presentation section”. 

For information about publishing your work in an appropriate journal, refer to the “Selecting a Journal” section.

A variety of journals publish QI projects, and lists can be found at The Institute for Healthcare Improvement and at Yale School of Medicine Center for Healthcare Innovation, Redesign and Learning (CHIRAL).

To maximize your chances of an accepted publication, you need to carefully select your target journal, and then follow all directions in preparing your manuscript. The ICMJE has recommendations for how to prepare a manuscript for publication.

The “Instructions for Authors” unique to each journal will provide technical information on how the manuscript should be formatted. The journal may offer multiple submission options (e.g. Brief Reports, Original Research, etc.). Each of these options will have different instructions. Make sure you are following the correct instructions for your submission type.

Several questions to consider when reviewing the Author Instructions for manuscript preparation:

  • Can my paper be shorter? If so, always shorten it.
  • Is there any information in the “Results” section that could be turned into a table, graphor figure? If so, do this!
  • Does my “Discussion” restate information found in the “Results” section? Avoid this. The Discussion section should expand on results, not restate them.
  • Are my citations in the proper format? Refer to the section on citation management options.
  • Are my tables and figures in the proper format? Always have a heading and make sure that you have a legend or description and citations and references when appropriate.

After reviewing your submission with these questions in mind, the final step before submission should be to ask others for help. Ideally, have someone who can review for content and another person who can review for grammar/punctuation/spelling. 

The University of Iowa Office of Faculty Affairs and Development offers editing consultant services.  There are additional editing fee-for-services available through the Scientific Editing and Research Communication Core.  Finally, it is time to submit the manuscript, which is usually accompanied by a cover letter.  Congratulations!