Clinical Research: Team Members and Their Roles
Conducting clinical research requires a team of people with a variety of skills and experience. If you decide to participate in clinical research, you may interact with scientists, medical experts, and others who work together to coordinate all aspects of a study.
Who Makes Up a Clinical Research Team?
At Johns Hopkins Medicine, research team members vary by study site, type, design, and purpose, but may include:
Also called a primary investigator, this person oversees all aspects of a clinical research study. They develop the study concept; write a detailed description of how the study will be conducted; and submit it for approval to the site’s institutional review board (IRB). In addition, this person oversees participant recruitment and making sure participants understand their rights and agree to take part. They also supervise the collection, analysis, interpretation, and presentation of research results. The PI is ultimately responsible for everything in the study.
These doctors work with the PI to monitor and care for people who take part in the study. They treat patients according to the clinical trial design, evaluate and record patient responses, and document side effects.
This team member often explains study details to patients, staff and health providers in the community who might refer their patients. The person also helps with giving the study medicines and assists the PI in monitoring for side effects.
The study coordinator handles many of the activities for a research study. Study coordinators may be involved in recruitment and ensure participants understand the requirements of the study and agree to participate. Study coordinators also may schedule research visits and complete research interviews. They work with the PI, the research institution, and others involved to make sure that the study follows research regulations.
Many studies include medications under research. Research pharmacists ensure that research medications are delivered to Johns Hopkins safely and are given in the best way to evaluate effectiveness.
Participants are also a part of the team! We consider clinical research participants as partners in the process. Without participants, clinical research is not possible.
To promote access for all people, Johns Hopkins Medicine strives for diversity among the research team. From the PI to the study nurses and physicians, we want our teams to reflect our community, so that all people feel comfortable participating.
Other People Can Be on the Team, Too
When you participate in a clinical trial, you may want to involve your usual health care providers. Our goal is that everyone who cares for you is aware of both your research experience and clinical care.
Clinical trials do not provide long-term, comprehensive health care. They offer only temporary, condition-specific treatments or procedures. Including your current health care team may help with receiving comprehensive care. If you choose to include your other health care team, you can also be sure that any existing treatments or conditions will not conflict with the study treatment or protocol.
Research participant advocate: Johns Hopkins Medicine’s Research Participant Advocacy Group focuses on improving the experience of people who participate in clinical research. The advocate strives to make sure participants understand what they are volunteering for and their rights as a research participant. The advocate can also address any concerns participants have.