A clinical research study (or clinical trial) is a closely supervised evaluation by a doctor and drug company to determine the safety and effectiveness of a medication.
All clinical research studies must follow a strict set of rules, or "protocol." Before any study begins, the protocol must be reviewed and approved by proper authorities, including an Institutional Review Board (IRB). An IRB is an independent committee of medical and non-medical professionals brought together to assess a study's potential benefits and risks to ensure that (1) participants are fully informed and (2) their rights and welfare are fully protected.
Participants in a clinical research study have certain rights before the study begins and while it is in progress. Participants are allowed and encouraged to ask questions at any time about the study or medication involved, and are allowed to decline participation or withdraw from the study at any time without prejudice or loss of future treatment.
Participants are also entitled to an explanation of any risks, benefits and available alternative treatments, plus any significant findings made during the study that could affect their willingness to continue as a participant.
How are investigational medications tested?
In compliance with government laws and regulations, a drug must undergo a series of clinical research studies to prove that it is an effective treatment for a particular medical condition and safe for use by people. Drugs must be studied for each new use, even when the drug is approved for another condition. Based upon the collected data from the clinical research studies, marketing approval may be granted if the regulatory agencies determine the drug or treatment is safe and effective.
What is informed consent?
Informed consent is a process that anyone who participates in a clinical research study will go through. The informed consent process informs those considering a clinical research study of the objectives, procedures, anticipated risks and benefits of the study. The informed consent document is a written agreement, signed by participants or their designated representatives, that certifies they have been fully informed about the nature of the research and are willing to participate in the study. Only after a prospective participant is fully informed and signs the informed consent document can he or she enroll in the study.
Reprinted with permission of Dr. Henry W. Lahmeyer
