Iowa State University is committed to protecting the health, safety and rights of participants in research projects. The federal codes that Iowa State University must follow are 45 CFR 46 and 21 CPR 50, Protection of Human Subjects. Within those laws, there are rules that apply not only to what the participant should be told about a study, but also how a participant should be given the information. These rules ensure that participants make an informed decision and give informed consent to take part in the research.
Participants should be given information about the purpose of the study and what they will be asked to do. They should also be informed of any risks from participating. Participants are to be given sufficient time to decide if they would like to participate and should not be coerced. In addition, the information presented to participants must be in a language understandable to them or their legal representative.
The process and the participant's willingness to take part in the study are documented by the participant's signature on the informed consent document, along with the date that they agreed to participate. All participants are to receive a copy of the informed consent document that they signed.
No informed consent, whether oral or written, can require that a participant waive or appear to waive any of their legal rights, or release or appear to release the investigator or institution of their liability for negligence. Therefore, informed consent is more than the signed document; it is the communication process that helps participants learn about a study and allows them to make an educated decision about participating. It is an ongoing process that begins before enrollment in the study and continues through the completion of the study and sometimes through follow-up.
For more information about being a research participant, click here.