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So you may be considering participating in a clinical trial, but you still have reservations about joining. Perhaps you are wondering who is protecting your interests and the safety of volunteering to take investigational medications. In reality, the pharmaceutical and clinical industry is very well regulated and the safety of all volunteers is paramount.

Every trial begins with intense laboratory testing before it is considered safe enough to be tested on a live specimen. Once a drug has passed lab, it often undergoes animal testing and then it can be submitted for human testing. Each trial is written as a protocol, strictly outlining and defining the study. The protocol explains what the drug is intended to do, why this is important and how the study is to be conducted. Every trial must be approved by an ethical review board called an Institutional Review Board (IRB). The IRB is made up of scientists, doctors and members of the general population to ensure that risks are as low as possible and the potential benefits outweigh the potential risks. The Food and Drug Administration (FDA) is also involved with protecting patients ensuring that sites are not deviating from the protocol. The FDA regularly inspects clinics, records, and research sites.

The FDA also requires that every patient has the opportunity to make an informed decision about participating in a clinical study. This means that every patient that participates is given all the information about a study and the investigational medication prior to starting the study. This is called ‘informed consent’. This information is given in a written format that explains the study drug or device, the reason for the study, what is being asked of the participant, possible risks and benefits, and any other pertinent information. It is important to ask any questions you may have as a volunteer when reading the informed consent. The informed consent is not a contract; at any time participants have the right to discontinue participation in the study for any reason.

Ultimately the most important part of clinical research is the well-being of our patients. Heartland Research Associates, LLC shares the values of The Center for Information and Study on Clinical Research Participants (CISCRP) a non-profit organization dedicated to educating, informing and empowering patients about research and promoting the greater awareness and understanding of clinical research. CISCRP has constructed The Clinical Trial Volunteer’s Bill of Rights to inform volunteers of their rights, Heartland Research Associates, LLC agrees with and strictly adheres to this Bill of Rights.