SEKESC-IRB Participant Information
Rights & Consent
A potential participant is likely to be presented with an informed consent form indicating approval by the IRB. This document is intended to provide you with relevant information necessary to decide whether or not to participate. This form itself should be coupled with a letter or video of the proposed research. The United States Office for Human Research Protections offers comprehensive resources for the public to learn about research participation HERE. You are encouraged to visit the HHS website to view informational videos, access a list of questions you may want to ask researchers before volunteering for a study, and learn about the regulations in place to protect research volunteers.
Do not sign the form agreeing to the research until all questions have been answered to your satisfaction. Signing this form does not waive any legal rights or alter your ability to stop participating at a later time. A copy of the form should be provided in case there are questions later.
You are likely to be presented with an informed consent form indicating approval by the IRB. This document is intended to provide you with relevant information necessary to decide whether or not you want to participate. This form itself should be coupled with a letter or video of the proposed research.
Generally, informed consent will involve a description of the following:
- An explanation of the purpose of the research.
- A description of what you will be asked to do and how long it will take should you participate and whether or not you will be compensated for your time.
- A description of any risks involved in participating. These risks could be physical, psychological, social or criminal. The steps taken to minimize these risks should also be described.
- A description of any benefits to you or to society as a whole.
- The degree to which the information will be kept confidential.
- Who to contact should you have questions about the research or about your rights as a participant.
- A statement that you are free to not participate and can stop participating at any time.
You should not sign the form agreeing to the research until all of your questions have been answered to your satisfaction. Signing this form does not waive any of your legal rights or alter your ability to stop participating at a later time. You should be given a copy of the form to take with you in case you have questions later.
Any participation in a research study is completely voluntary. You are free to decline to participate for any reason. You may also stop participating at any time or refuse to answer any individual questions. Even after you sign the consent form, you can stop. Should you decide to decline or stop participating, this decision will in no way influence any services to which you are otherwise entitled. For example, if you are a student, your teacher or professor cannot hold this against you when determining your grade. If you are receiving treatment, that treatment cannot be withheld if you do not agree to participate.
Legally, children are not able to give true informed consent until they turn 18. So, before taking part in a clinical research, they are asked for their assent. Assent means that they agree to take part. They may also dissent, which means they do not agree. Unlike informed consent, assent is not always required by law. IRBs may require it.
To take part in the assent process, children must be mature enough to understand the research and what they are expected to do. Some children as young as 7 years old may be able to take part. But, this age varies depending on the child and the institution running the research.
During the assent process:
- Parents or guardians give informed permission for their child to join the clinical research.
- The research team explains the research to the child in language the child can understand, including what it means to take part and what the child can expect.
- The research team may use written forms, videos, graphics, and other visual aids to help explain the research.
- The child is encouraged to ask questions.
It may take several sessions before the research team feels that the child has a clear understanding of what the research involves. At that point, the child is asked to show assent or dissent by signing a form or checking off a box that says “yes” or “no.”
Both Parents Need to Give Permission
Usually, both parents will need to give permission for the child to take part in the research unless one parent:
- Has died
- Is unknown
- Is incompetent
- Is not reasonably available
- Has sole legal custody of the child
When Assent is Not Required
Assent must be obtained from children unless:
- The child is not capable of assenting.
- The child might benefit from the treatment or procedure being studied in the research.
- The treatment or procedure that may benefit the child is only available in clinical research.
Even if assent is not required, children still benefit from going through the assent process. Doing so can help children feel more in control and engaged in the research. It shows that they have a say in what happens to them and that their questions and input are valid.