Study participation is a 100% voluntary activity. There are many great reasons someone may volunteer. You may have a friend or family member who is sick with the illness being studied and want to help. Or you may want to help advance medicine in general. Or you may simply want to earn extra money by participating. You should never feel forced, coerced, or enticed into participating by a desire to please your doctor, expectations of excess money, or misleading promises to cure an illness. The important thing is that you are taking part in the study because you want to, not because you feel that you have to.
After you volunteer, the next step involves a talk or series of talks with the study's Principal Investigator (PI) or other Medpace Clinical Pharmacology staff called the informed consent process. This process includes exploring your motivations, reviewing all of the information about the trial that may affect you, making sure you understand the information, and providing a full disclosure about any and all risks. Even after this process is complete, you may not be chosen for other reasons unrelated to all of the above.
Finally, the PI and medical staff must make sure you fit the study participant requirements listed in the protocol, which is written to control all or most of the factors that might affect the results or the study adversely. For this reason, all protocols have inclusion and exclusion criteria that define in clear terms who should and should not be included in the study. These criteria include, but are not limited to, age, gender, weight, body surface area, existing conditions or disease states, certain concomitant medications, allergy to medications, and other factors.
Every study is different and every effort is made to include representatives of all groups that might benefit, including genders, all races and ethnic groups, and all socioeconomic levels. Even pregnant women may be included in some studies unless there is a specific reason not to do so.
Click here to learn more about the informed consent process.