What is a Research Subject?
A subject is the individual who agrees to participate in research. A subject can be either a healthy volunteer or a patient.
What is a Sponsor?
The sponsor is a person or entity that initiates a clinical investigation of a drug. The sponsor may be a drug or device manufacturer or a research institution that developed the drug. The sponsor initiates, funds, or is responsible for a clinical trial. The sponsor also assumes responsibility for compliance with applicable laws and regulations. The sponsor, for example, is responsible for obtaining FDA approval to conduct certain trials and for reporting the results of the trial to the FDA.
Who is the Investigator or Principal Investigator?
The investigator is the individual who is responsible for the proper conduct of the clinical trial at the trial site. If a team of individuals conducts a trial, the lead investigator may be called the principal investigator. The principal investigator may also be called the study doctor.
What is the Informed Consent Form?
The informed consent form is a document that describes a research study, including a clinical trial. It includes the purpose, duration, procedures, risks, benefits, alternative treatments, costs, confidentiality, and study withdrawal information. The informed consent document is reviewed and approved by the IRB.
What is an IRB?
Institutional Review Board; a committee designated by an institution to review, approve and monitor research involving human subjects. The primary purpose of an IRB is to assure the protection of the right of human subjects. IRBs are composed of a diverse group and can include; doctors, lawyers, nurses, pharmacists, and members of the local community. Federal regulations that govern clinical trials require that an IRB review and approve clinical research studies before they can start, and must conduct ongoing reviews of clinical research studies.
Is the IRB made up only of scientists?
No. The IRB may include doctors and researchers, but also must include members of the community – average people just like you. The IRB must be a diverse group of people that offer different perspectives about research, not just the medical or scientific perspective. It is very important for the IRB to include people who are not trained in research so that the viewpoint of the types of people who might volunteer to participate in a research study will also be considered.
Do all clinical trials offer a direct benefit to the participants?
No. Some clinical trials are designed to find out if a test article (a new drug or new device) can be tolerated by humans. These trials often involve trying new drugs/devices in healthy volunteers to see if they can be used. Some consider the benefit of these trials to be advancement of the knowledge and science for the future treatment of the condition being studied.
Are the researchers being paid for my participation in a clinical trial?
There is no one answer to this question for every trial. The IRB reviews the relationship of researchers to the research sponsors to try to make sure there is no conflict of interest. Most researchers conduct clinical trials to help provide more information about diseases, medications, and treatments – in essence, they are trying to help people by advancing science. Research sponsors usually provide funding to the researchers based on the cost of conducting the study.
Will I be paid for participating in a clinical trial?
Study subjects are volunteers who agree to participate based on the information provided during the informed consent process. Some clinical trials do include reimbursement for time and travel expenses. The research sponsor usually provides study-related procedures, tests, and drugs/devices to the subject at no cost. In some cases, a portion of the costs involved in participating in a clinical trial may be covered by your health care benefit program.