What is a clinical research study?
A clinical research study is a carefully designed study in which participants are asked to take an investigational medication under the supervision of a doctor and other research professionals.
Clinical research studies must be approved by an institutional review board (IRB) or ethics committee (EC). An IRB or EC is a group that is responsible for helping to protect the rights and welfare of study participants. In addition, every study participant is monitored with medical tests and study-related exams before, during, and sometimes even after the study.
What is expected of study participants?
Both the patient and the caregiver will take part in this study. Before participation can begin, a detailed description of the study, including any risks and benefits, will be provided to you in writing in an “informed consent document” and discussed with you and your loved one. You and your loved one will be asked to review and sign the informed consent document prior to participating. Your loved one’s medical history will be reviewed, and he or she will be given a study-related physical exam and laboratory tests.
If your loved one qualifies, he or she may be enrolled in the study. As the caregiver, you will also be asked to attend the study visits. Once enrolled, feel free to discuss his or her research care with the study doctor or research staff members at any time during the course of the study. Information collected during a clinical research study may or may not ultimately lead to the investigational medication being approved by the FDA or other regulatory health authorities, and may or may not result in future developments of new drugs.
It is important for you and your loved one to:
- Attend all scheduled visits
- Describe his or her physical state, feelings, and well-being accurately and honestly to the study doctor
- Use the investigational medication as prescribed
- Discuss any questions regarding the study with the study doctor
As the caregiver of a study participant, you will have the right to contact the study’s IRB or EC representative regarding your loved one’s rights as a research participant. Your loved one will also have the right to leave the study at any time.
See if your loved one may qualify