Before you decide to participate, volunteer for research, or discard the idea entirely, be sure to read over all of the information supplied.
Ask questions and make sure you make a well-informed decision based on facts and what is right for you.
Each clinical trial protocol has a list of criteria that each participant must meet (inclusion criteria). Every potential study participant receives the same high level of care during a comprehensive screening process which includes:
• telephone/internet pre-screening questions
• medical history
• current medications
• screening exams such as lab tests, EKG, and physical exam
• study-specific diagnostic tests such as X-rays and MRI
In addition, the following may also be required:
• a copy of your medical records
• approval by your personal physician
The goal of our careful screening process is to ensure that you meet the study’s enrollment criteria. The enrollment criteria are chosen by the developers of the protocol (study plan) for the safety of the study participants and to ensure that the study produces accurate, high-quality data.
In deciding whether to participate, read the informed consent form and ask questions. Be sure you evaluate the following:
• the purpose of the study, the type of investigational medication, and the study procedures
• the study design, including the number and frequency of study visits (appointments) and your ability to adhere to the visit schedule
• the total length of the study and your expected availability to complete the trial
• the location of the research facility and your available transportation
• any costs associated with trial participation versus any financial compensation received for participating
• any potential discomforts/risks versus potential benefits of participating
The Food and Drug Administration (FDA), and like similar regulatory authorities in other countries worldwide, are charged with ensuring the safety and effectiveness of all prescription drugs marketed in the U.S. Before the FDA gives the drug manufacturer approval to market a new drug, it considers two primary points:
• whether the clinical trials provide substantial evidence that the drug is effective
• whether the clinical trials show that drug is safe under the conditions outlined in labeling
Ultimately, what the FDA considers is whether the benefits of the drug outweigh its risks.
Informed consent refers to the process by which potential volunteer study participants learn the details about the clinical trial. Volunteers must be provided all known facts about a trial prior to giving consent to participate, including details about the investigational drug or device and possible risks and benefits. The informed consent form must be signed by the participant prior to study-specific screening procedures. In a sense, the informed consent process continues throughout the clinical trial, as participants are promptly informed when any new information becomes available which might affect their decisions about whether to continue in the trial or not. When significant new information becomes available or the study protocol is changed, study participants will be required to sign a revised informed consent form in order to continue in the trial. Each study participant will receive a copy of any informed consent document he/she has signed.