Research in a Clinical Setting

The information on this page will assist you in planning your research and help to make it a rewarding experience. If you have additional questions or need clarification, please contact Senior Associate Dean David Lo.

What is a Research Project?

A research project is a study that tests a research question or hypothesis. For the purposes of federal regulations and human subjects protocols, any study that may involve patient information, any intervention (medical or otherwise; randomization or not), qualifies as a human subjects research study that requires a human subjects protocol reviewed and approved by the campus Institutional Review Board (IRB).

In general, research studies are aimed at developing generalizable knowledge and is intended to be disseminated through publication. These elements are important in helping to distinguish from quality assurance or quality improvement studies (QA/QI). Please review the cases (attached below) to help you understand the difference between research requiring an approved protocol, and QA/QI.

In most cases, it is recommended to have your research protocol reviewed in advance by the IRB even if you believe it is a QA/QI project. In some cases, the IRB may determine that the proposed study is “exempt”, for example if it involves de-identified or historical patient data, but it is best to let them make that determination.

Other types of studies falling into the QA/QI category include studies of internal processes not intending to be published, such as an examination of procedures in a clinic, aimed at developing more efficient procedures, etc. It is important to note that you cannot begin any clinical research until the protocol has been approved by the IRB.

Scholarly Activity Versus Research

In some cases, you may prefer to do a literature review or other project that does not classify as research. Such cases (that do not involve access to patient data, patient interactions, surveys, interventions, etc.) can qualify as “scholarly activity” and might not require a human subjects protocol. However, when in doubt, ask.

• See an example of a Scholarly Activity Case Report publication from a past UCR SOM student

Who can be a Mentor for a Research Project?

For Research projects requiring an IRB approved protocol, the campus policy is that only faculty with “Principal Investigator status” (i.e., full time faculty with an Academic Senate appointment) can submit protocols for review, including UCR faculty that are not in the SOM. You should find a research mentor among this group. In some cases, clinicians that do not have PI status at UCR SOM can be a research mentor, but this is generally in cases where they are PI/faculty at an academic institution with an active IRB (e.g., UCI, UCLA, UCSD). If there is a question, please ask Dr. Lo.

What is Required to do a Research Project?

1. Make sure your human subjects training is up to date (it is good for two years before you have to refresher training), and that you have the certification of completion to show with the Research Rotation Form.
2. Identify a faculty member able to mentor your project and meet to discuss a research project with a clear research question and objectives. The objectives do NOT have to be so ambitious such as getting a paper published; it can be more limited, such as identifying challenges in developing a clinical study protocol, or writing a new human subjects protocol for review (actual review can take months in some cases).
3. Do the research project and enjoy it.

Most importantly, it is critical to plan ahead.

Resources

• Does your research project require approval of a Human Subjects Protocol?

Protocols and Data Analysis

• Writing Human Subject Protocols - Email Jo Gerrard
• Research Design and Biomedical Statistics - Email Shaokui Ge

Survey-Based Research Projects

• A Guide to Health-Based Survey Instruments

Dean's Research Innovation Fund

Designed to promote clinically-relevant research by medical students, residents, fellows, and junior clinical faculty in the School of Medicine, the Dean’s Research Innovation Fund will award up to five grants per year for up to $10,000 per award. Eligible projects include those designed to produce preliminary data to support larger extramurally funded research pursuits, to stimulate collaborations between learners and faculty “sponsors,” and to advance research projects by junior investigators.

• Learn more about the fund