Participating in research may be a new experience for you or you may have participated in a clinical trial in the past. Participation in a clinical trial is voluntary. The research could involve a new drug or device which will require close monitoring or a study of a device or drug already approved by the FDA for use and the manufacturer (study sponsor) is just gathering more information on the product. It is important for you to understand any new clinical trial (also called clinical or research study).
Things you should know before deciding to participate include:
- What is being researched
- What will happen to me if I participate
- What are the possible risks or side effects
- Will this study help me personally
- What if I decide not to participate
- When and what will I need to do to participate
- How long will my participation last
If you think you would like to participate after hearing about the study, you will be given an informed consent to read. This form and this study have been approved by an Institutional Review Board or Committee (IRB or IRRC). The IRB is a group of physicians, scientists, non-scientists and community members that review research to make sure that risks are reasonable compared to the possible benefits. They also review the study design and purpose. The IRB continues to review the study and its’ conduct throughout the study period.
Any possible risks should be explained in the consent but you are also encouraged to ask staff and investigators if anything is not clear. The consent may also indicate that there can be unanticipated risks. A person who joins a research study may benefit directly and their disease or problem will be helped. But these benefits vary from study to study and also from participant to participant. Some studies may not help you personally but will help future patients with your medical condition.
If you choose to participate in a study you will have responsibilities such as coming in for study visits or being available for study phone calls. You will need to alert the study staff if you think you are having any side effects and you must follow all instructions provided by the study team.
Participation in a specific study is not for everyone. The IRB approves a study but it is your decision whether to participate. One study might not feel right for you but if you are offered a different study the next time, you may feel that study is for you. Either way, you will continue to receive appropriate care from your physicians.