Clinical research studies are conducted according to strict guidelines and regulations that are designed to protect participants’ rights and well-being. Although participation in a clinical trial can bring great benefit, there are always risks and possible side effects in research. However, some of these same risks are common during routine medical treatment.
Participants are made aware of any known risks before agreeing to take part in a trial and kept up to date if more become known. If new information reveals that the study risks outweigh the potential benefits, participants will be contacted with this information and the trial may be closed. Regardless of the risks, study participants can withdraw from participation at any time.
When participating in a research study, you have several rights as a research subject:
- You have the right to be informed about the research study.
- You have the right to ask questions about the research study.
- You have the right to decide not to participate in the research without coercion, undue influence or pressure, and without penalty or loss of benefits.
- You have the right to leave the study at any time without penalty or loss of benefits.
- You have the right to get a copy of the consent form.
- You have the right to know what other options are available.
- You do not waive any of your legal rights by joining a research study or signing a consent form.