By Terry Novchich
Research is an important mission at Penn State Hershey, not only in the science laboratories, but also in the hundreds of clinical research trials currently under way. Volunteers for these studies are always needed, whether healthy or with a specific disease.
Volunteering to participate in a clinical research study is one way you can contribute to the understanding of human diseases and the development of new drugs, devices and procedures.
A clinical research study is carefully designed to test the effects of a drug, medical procedure, or device on a group of people. Clinical research studies are an important step in making these new therapies available because they measure the therapy’s ability to treat a condition, its safety, and its possible side effects.
The amount of risk varies greatly depending on the type of study. Studies asking you to complete a survey may involve minimal risk, such as uneasiness when answering the questions. Studies that ask you to participate in an exercise regimen may involve some muscular discomfort. Studies using an experimental medical procedure or drug can involve more risk, as you could experience a bad reaction. The researcher will clearly explain to you what the possible risks of the study are before you agree to participate. The risks also will be identified in the consent form that you will be asked to sign.
Some studies are randomized, meaning some participants may receive a new treatment, while others may receive the standard, current treatment for comparison or no treatment at all if the study has a placebo as part of the design. So even if a volunteer has a specific disease and wants to participate in a study to be exposed to new treatments, in a randomized study, they may or may not receive treatment.
Some clinical research studies may directly benefit the individuals who participate. For example, a diet and exercise study may offer certain health benefits. Most studies cover the cost of examinations and procedures required for the study, and these exams may uncover unknown medical conditions. Other studies are designed to offer greater benefit to society. If individuals join a study that compares treatments, they may or may not benefit directly.
All research requires informed consent – an agreement to participate in the study. Study risks, benefits, and procedures are explained to volunteers during the informed consent process. This process allows the volunteer to ask questions and exchange information freely with the researchers. The principal investigator, the physician or health care provider who is responsible for managing the study, must ensure that informed consent is obtained from each research volunteer before that person participates in the clinical research study.
All studies also are reviewed and monitored by an Institutional Review Board (IRB). The IRB is an institution’s group of health care professionals and community members charged with reviewing and approving a clinical study before it begins. The IRB carefully reviews study-related activities, including procedures and documentation, because its primary responsibility is to protect the safety and the rights of study participants.
To be considered for a clinical research study or to learn more about volunteering, visit here or call 717-531-3779. In addition, interested volunteers can talk to their family doctor about potential research studies that they may be eligible to participate in.
Additional studies throughout the University are available here.
Terry Novchich is director of the Clinical Trials Office at Penn State Milton S. Hershey Medical Center.