Clinical research tests the safety and effectiveness of treatments, devices, and health practices. Through clinical research, we can get a better understanding of how humans respond to new clinical practices so we are more informed to treat patients in the future.

Types of clinical research studies range from basic to complex. Basic studies may only need people to answer questions or fill out diaries. Complex studies may ask volunteers use a device that has never been tested before or to stay in the hospital while they take a certain medicine. All studies are guided by the same basic principle: to understand and improve human health.

The person or people who lead research studies are called Principal Investigators (PIs). Some are clinicians such as physicians, nurses, physical therapists, dentists or pharmacists. They take care of patients in their clinics in addition to finding new ways to improve the care they provide. Others complete training as scientists such as chemists, biologists and engineers. They work on developing new drugs and devices that they hope one day will save a life. Still others focus on the health of the public as a whole, studying the environment people live in and how it affects disease and wellness. All researchers have one thing in common – they want to contribute to a healthier future for everyone!

The Institutional Review Board (IRB) reviews and approves studies conducted at UNC.

The Institutional Review Board, or IRB, is a committee of concerned people from the medical, scientific and local community that review all research conducted at UNC before it begins and on a regular basis. A research study cannot be conducted at UNC if the IRB does not review and approve it. The United States government has rules and regulations that the IRB must follow.

The IRB makes sure that the rules set up by the Department of Health and Human Services and the Food and Drug Administration are followed. All research listed on Research for Me is IRB approved.

More information about the IRB and volunteer rights and protections can be found at:
http://research.unc.edu/offices/human-research-ethics/participants/

There are a number of members of a study team. Some key players include the Principal Investigator (PI), who oversees the research and the study coordinator(s) who oversee the day to day operations and activities of the study.

Researchers need volunteers who are generally healthy to compare with persons who have a condition or disease. Healthy volunteers who don’t have the condition or disease receive the same treatment as people who do have it. Volunteers are often paid for their participation. If you are in generally good health, you may qualify as a volunteer for one of these studies.

It depends!  There are different incentives for different studies.  Some studies are longer and require many visits, so they may have a larger incentive.  Sometimes, the incentive isn’t money.  For example, an exercise study might involve free personal training. Other studies, like short online surveys, don’t always offer an incentive, but researchers are always grateful for the volunteers that participate.

All of the information researchers collect from you during a study is kept confidential.  Usually, researchers will assign you an ID number at the beginning of the study and use this on all documents, data, and specimens, instead of your personal information.  This means anything from your name to your medical information is protected. Only certain members of the study team can view it. 

Study teams are happy to answer any questions you have at any point in the study. Click here for a list of good questions to ask when you are considering participating.

Informed consent is a document given to you before you begin participating in a clinical trial or research study. This document gives a summary of the study, explains what you will be asked to do as a participant, and explains the benefits and risks of participating. You may revoke consent at any time.

Your informed consent should have the contact information of the study team member you should reach out to.

The answer to this question is different for every study. In the Research for Me study listing, check the “What will be asked of you” section for more information about the studies you are interested in. If you reach out to a study team, the informed consent for the study will have additional information about study activities.

Study doctors closely monitor the health of research participants through labs and other tests.  They look at all the data from all the participants to make sure that the drug isn’t causing any unexpected issues.  If you have a problem with the medication, the study doctor may choose to end your participation to keep you safe.

You won’t! Placebo is an important part of drug research that lets researchers test if the drug is more helpful than nothing at all.  In order for the test to work, the participant can’t know what they’re getting.  Sometimes, you might know the answer at the end of the study.  Even if you get the placebo, your participation is so important to helping researchers find new and better treatments for diseases.

The Participant Bill of Rights outlines the protections you have as a research participant.