What is informed consent?
Informed consent is the process by which a research participant confirms their willingness to participate in a research study. This involves a discussion with the study’s research coordinator and/or the principal investigator about all aspects of the research that are relevant to their decision-making. Throughout the discussion, the participant will have an opportunity to ask questions and have them answered to their satisfaction. The participant will also be allowed adequate time to thoroughly consider the information presented. Informed consent is documented by a signed informed consent form.
What do informed consent forms include?
Informed consent forms contain information about the study’s purpose, experimental procedures, duration, risks, benefits, and alternatives to participation. The form will also explain how confidentiality is maintained and a list of entities that have access to the information collected by researchers. Informed consent forms should always be written in language that is understandable to those being asked to participate and should avoid the use of scientific jargon or legalese.
What is the goal of informed consent?
The goal of informed consent is to present information about the study in a way that is easy to understand, allows participants ample time to consider, and imparts no undue pressure to participate. When giving consent, the participant should be willingly and voluntarily choosing to participate in the research study and should have a clear understanding of the study’s purpose, procedures, risks, and benefits. Participants should understand their rights as research participants. Research participation is a voluntary act, and they have the right to withdraw participation at any point. Choosing to decline a procedure or withdraw participation will not impact the benefits or care received at the institution.
What is a Legally Authorized Representative (LAR)?
A legally authorized representative, or LAR, is any person legally authorized to consent on behalf of a prospective research participant. This person must be legally authorized to make medical/healthcare decisions on behalf of the participant and must provide documentation as such (a Medical Durable Power of Attorney or court-appointed guardianship). A LAR is required to sign when the research participant lacks the capacity or competency to consent to research on their own, often called decisional or decision-making capacity.
What is decisional capacity?
Decisional capacity refers to the ability to retain information presented during informed consent and weigh this information long enough to make a decision. The participant should understand what the decision is about, why they are being asked to make it, and what the consequences of the decision are. They should also be able to understand the study’s purpose, what they are being asked to do, as well as the risks and benefits, and understand how participating might affect them personally. A series of questions may be asked during the consent process, or the principal investigator may review medical records and use their clinical judgment to help make this determination. In some cases, decisional capacity may be intact at the beginning of the study but decline over the course of the study. This is a consideration for longitudinal research over multiple years and is particularly relevant when working with participants with neurodegenerative diseases. This is why informed consent is a process that must be continued throughout the duration of the study.