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. Often, this type of Scholarly Activity requires Institutional Review Board (IRB) approval, as any research involving human subjects requires 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 are significant. However, IIR is an invaluable tool for medical discoveries and 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. 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.
RESEARCH METHODS
After you have created a research question, performed a literature search with critical appraisal, and identified research outcomes, it is imperative to choose the appropriate research method(s).
There are many choices for study design which are based on the type of research being conducted. Examples include an observational study, where you are not manipulating any variables, or an experimental study, where you are modifying variables. 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.
IRB APPLICATION
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.
There are three types of IRB review: full committee, expedited or exempt review. Generally, expedited review can be used for research involving no more than minimal risk to participants and must fall into specifically defined categories. Exempt review is generally for research that involves no risk to human subjects and falls into one of the defined exemption categories. In some cases, IRB submissions can be done electronically (e.g. USU eIRB). 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. Chapter 10 of The Recipe contains useful information on the IRB process, including the different research categories
Many of the continental United States (CONUS) residency sites defer their IRB process to the IRB affiliated with The Uniformed Services University of the Health Sciences (USU) or another service-specific IRB. The USU Human Research Protections Program Office (HRPPO) is a great resource on general and specific IRB questions. It is recommended that you determine which IRB will review your research study and directly contact the appropriate IRB office with questions about the process and timeline. If using the USU IRB, you can find information about electronic IRB (eIRB) submission here (CAC-required access).
FUND YOUR RESEARCH
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.
The NIH offers a primer on grant basics to provide information on NIH grant programs and applications, eligibility, and finding the right fit for your research.
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. Chapter 11 of The Recipe can help walk you through the most important point to consider when preparing a grant proposal.
- Recommendations for Writing Successful Grant Proposals: An Information Synthesis by Wisdom et al.
- How to write an educational research grant: AMEE Guide No. 101 by Blanco et al.
- The Jewel in the Crown: Specific Aims Section of Investigator-Initiated Grant Proposals by Santen et al.
EXTRAMURAL FUNDING OPPORTUNITIES FOR PRIMARY CARE
As a first step, it is critical to identify the sponsor or funder. As grant proposals have strict protocols and requirements, identifying the sponsor and the grant mechanism will set the guidelines for the proposal moving forward. You can find a list of some of the most common extramural funding organizations for primary care below.
- Health Resources and Services Administration (HRSA)
- Center for Health Research and Transformation (CHRT)
- Uniformed Services Academy of Family Physicians (USAFP)
- American Academy of Family Physicians (AAFP)
DISSEMINATE YOUR RESEARCH
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 selecting an appropriate journal, refer to the “Select a Journal” section.
PREPARING YOUR MANUSCRIPT
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 “Instructions for Authors” 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.
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, graph or 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.
Finally, 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.
UPCOMING DEADLINES FOR SUBMISSIONS
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