What Is a Clinical Research Team?
A clinical research team is a group of people who work together on a research study to learn about human health or determine the safety and effectiveness of new treatments.(1) While the goal of a clinical research team is to answer specific health questions, they are also responsible for making sure studies are done ethically and according to their approved research plan.(2) They also ensure that study sites follow the rules and regulations around human subject research.
Who makes up a Clinical Research Team?
A study requires a team of people with a variety of skills. The make-up of study teams may vary by location, type, design, and purpose, but often include:
· Principal Investigator: Often referred to as the “PI”, the Principal Investigator manages the entire study and makes sure the research being done is ethical.(3)
· Co-Investigator: Someone who manages the research along with the PI is considered a co-investigator (co-I). They make study-related decisions and may perform study-related procedures.(4)
· Other key study personnel are members of the research team other than the PI or co-Investigators.(4) They, along with the PI and co-I decide participant eligibility and risk, handle day-to-day operations, manage participant recruitment and consent, administer assessments, record data, and conduct follow-ups with study participants. Key study personnel can include the following:
· Clinical research physicians act as “sub-investigators” for a specific site. They work with the PI and co-I’s to watch and care for people enrolled in the study.(5)
· Research coordinators/nurses manage study activities and work with the entire team to ensure that guidelines and protocols are followed. They also explain study details to patients, staff, and health providers in the community, and are often the ones recruiting for the study, administering assessments, and conducting follow-ups.(6)
· Many studies include medications still being researched. In these types of studies, the research pharmacist watches the effects of new and existing drugs by collecting data like health impact or changes, analyzing it, and taking steps to prevent negative effects. They help package and distribute medications being researched.(7)
· Medical statisticians/biostatisticians are responsible for the appropriate presentation and the correct interpretation of the study results.(8)
· Study participants are the most important part of a research study. Without them, clinical research isn’t possible!(9)
· Research participant advocates may help participants understand their rights and what they’re volunteering for as well as address any questions or concerns related to study participation.(5)
A volunteer’s perspective — interacting with the research team
A volunteer’s experience will vary from study to study. However, their journey might look something like this:
A patient arrives at an appointment with their doctor for a routine blood pressure checkup.
Their doctor — who also serves as a clinical research physician for a study investigating a new therapy for high blood pressure — mentions that the study is recruiting adults. Intrigued, the patient says they’re interested in learning more.
This marks the first step in the informed consent process, where the patient learns about all aspects — including risks and benefits — of taking part in the study.
After the appointment, the research coordinator and research participant advocate meet them in the clinic to explain the study’s details, their rights as a participant and that participation is voluntary. The patient asks a few questions about the study, including details about how data from the research will be gathered and used. They then agree to participate, and answer a few questions about their health to confirm they are eligible for the study. Afterward, the patient reviews and signs the study consent form, which describes the study and tells who the Principal Investigator is.
The coordinator then schedules the patient’s first research visit for later in the week. At this visit, the patient — now a study participant — meets the research nurse, who gives them medication prepared by the research pharmacist and watches for side effects. The participant also answers a few more questions and surveys to help assess the new treatment.
The research nurse explains that, in the coming months, the participant will receive phone calls from the research coordinator to see how they’re doing, and will also be mailed additional questionnaires to complete.
After completing those forms, their participation is complete. At the end of the research study, the participant will receive an update informing them of the study’s findings.
In conclusion
As you can see, a research participant may meet several members of a research team while taking part in a study. Each team member plays a key role, making sure the study is conducted according to study plans and in an ethical manner, and that it answers important questions about health and well-being.
References
1. What Are the Different Types of Clinical Research? U.S. Food & Drug Administration. Published January 4, 2018. Accessed December 13, 2023. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research
2. What does a clinical researcher do? New Scientist Jobs. Published May 8, 2019. Accessed December 8, 2023. https://jobs.newscientist.com/article/what-does-a-clinical-researcher-do-
3. Research Personnel Definition, Roles and Training. LSU Health New Orleans. Updated December 9, 2021. Accessed December 8, 2023. https://www.lsuhsc.edu/administration/academic/ors/irb/docs/P&P5.03_%20Research%20Personnel_V12.09.21.pdf
4. Quick guide: Research Personnel. Indiana University. Accessed December 8, 2023. https://research.iu.edu/training/guides/human-subjects/research-personnel.html
5. Clinical Research: Team Members and Their Roles. Johns Hopkins Medicine. Accessed December 8, 2023. https://www.hopkinsmedicine.org/research/understanding-clinical-trials/clinical-research-team#:~:text=Conducting%20clinical%20research%20requires%20a,all%20aspects%20of%20a%20study.
6. Responsibilities of the Research Team. The Ohio State University. Accessed December 8, 2023. https://ccts.osu.edu/content/responsibilities-research-team
7. Davis L, Bhattacharjee S. Chapter 44 — Role of the pharmacist in research. ScienceDirect. https://doi.org/10.1016/B978-0-12-820007-0.00043-X
8. Zapf A, Rauch G, Kieser M. Why do you need a biostatistician? BMC Medical Research Methodology. https://doi.org/10.1186/s12874-020-0916-4
9. Why participants are so important to health research. Evidation. Published November 2, 2022. Accessed December 8, 2023. https://evidation.com/blog/why-participants-are-so-important-to-health-research
