What is a Research Project?
A research project is a study that tests a research question or hypothesis. In general, research studies are aimed at developing generalized knowledge that is intended to be disseminated through publication. These elements are important in helping to distinguish from quality assurance or quality improvement studies (QA/QI).
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).
Please review the cases, to help you understand the difference between research requiring an approved protocol, and QA/QI.
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. You cannot begin any clinical research until the protocol has been approved by the IRB.
Scholarly Activity vs. Research Rotation
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 patient interactions, surveys, interventions, etc.) can qualify as “scholarly activity” and require a different form, to be signed by the Associate Dean of Assessment and Evaluation Kendrick Davis.
Studies that qualify as research must use the Research Rotation Form, signed by Dr. Lo.
Who Can Mentor a Research Rotation?
For research projects requiring an IRB approved protocol, the campus policy is that only faculty with principal investigator (PI) status" (i.e., full-time faculty with an Academic Senate appointment) can submit protocols for review. This includes UCR faculty who 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.
Requirements to Receive Credit for a Research Rotation
The most important thing to remember is that it is critical to plan ahead. In addition, follow these steps:
- Make sure your human subjects training is up to date and that you have the certification of completion to show with the Research Rotation Form. Training is good for two years before you will need to take a refresher course.
- Identify a faculty member who can 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. In some cases this review can take months.
- Write out the plan, obtain signatures from the mentor, and schedule a meeting with Dr. Lo at least one month before the rotation block starts. Your goals should include a two-page write up of the research rotation to be submitted to Dr. Lo for review and approval by the end of the rotation.
- Do the research rotation and enjoy it. At the conclusion, get your mentor to submit an evaluation.
- Complete the write up as described in the approval form and submit it to Dr. Lo so that you can get credit. You cannot receive credit without the submitted and reviewed write up.