What is a Clinical Trial?
Clinical trial is the scientific term for a test or a study of a drug or medical device in people, and is therefore human subject research.
- The terms clinical trial and human subject research are often used interchangeably.
- These tests or studies are done to see if the drug or device is safe and effective for people to use.
Doctors, health professionals, and other researchers run the tests or studies according to strict rules set by the federal Office for Human Research Protections (OHRP) and the federal Food and Drug Administration (FDA).
What is human subject research?
Human subject research is any scientific experimentation, examination, exploration, or investigation that involves the use of living human beings as test subjects in order to find out more information about them, their disease or condition, and/or how they react to a certain drug, device, or treatment.
Perhaps the most important thing to remember about human subject research is that it is completely voluntary, which means that it is entirely up to you to decide whether you want to participate.
- No one can make you participate and you are free to decide not to participate or stop participating at any time.
- You should never feel pressured or expected to participate in a research study.
What are my rights as a human research subject?
- To be completely respected as a human being as well as a research subject
- To be treated fairly, justly and with understanding
- To have your decisions, feelings and wishes treated with the highest respect
How will I be protected?
Each research project at Scott & White involving human subjects has to be reviewed and approved by the Institutional Review Board (IRB).
- An IRB is a group of people such as doctors, nurses, pharmacists, scientists, ethicists and people from the local community who are committed to ensuring that human research is well-planned and ethical.
- An IRB is used to ensure the rights and welfare of people participating in research studies both before and during their participation.
These impartial review panels perform the job of risk and benefit assessment, ensuring that the risks are both minimized and fairly disclosed to study participants.
IRBs are monitored by the federal Office for Human Research Protections (OHRP) and the federal Food and Drug Administration (FDA) to protect and ensure the safety of participants in medical research.
If you have any questions about Scott & White’s IRB, please call the IRB Administrator at 254-215-9025.