Clinical trials evaluate the safety and effectiveness of new medical products such as medications, vaccines, and devices. As these are developed, there are many practices put in place to make sure the product is safe for each participant and that each participant is aware of what they are signing up for.
For someone to participate in a study, they must receive an informed consent form that will give them information about the study. This includes information about why the research study is being done, what participants in the study will experience, how their information will be used, the risks of participating, any potential side effects, and the potential benefits of participating. Additionally, the form will also go over any payments or reimbursements which may be received during the study.
It’s important to note that the form will state that participants can withdraw consent at any time and discontinue the study. It is essential that you read this information carefully and write down any notes you may have for the study coordinator or study doctor.
During this process, the research team makes sure that you know as much as possible about the study. This helps you determine if you would like to continue in the process of participating in the study. The informed consent process is ongoing, as there are times when there are changes to the study and we want to make sure the person participating knows what has changed and wants to continue in the study. Below are some of the topics that are covered in the consent form:
- The purpose of the study?
- What phase the study is in?
- Who can participate?
- What you may need to do during the study?
- How you will be monitored?
- How long you will be in the study?
- The tests/procedures that may need to be done?
- Potential benefits
- Potential benefits
- Who to contact
- Your rights, such as withdrawing from the study at any time
- Payment you will receive/ Reimbursements
The informed consent process is meant to give you information to help you make the decision about whether you would want to participate in the study. We want to ensure that you have all the information regarding the study!
If you would like to learn more about clinical trials at AIH Research, visit aihresearch.com or call 713-795-5964 to talk to one of our research professionals!
