What You Need to Know to Participate
This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks and benefits of participating.
"Consent" generally refers to the agreement or permission given by a person before they undergo some kind of intervention, such as a medical procedure, or participate in research. Consent is important because it respects an individual's autonomy and right to make decisions about their own body and personal information.
Here are a few key points about consent:
- Informed Consent: This is the most common form used in medical and research contexts. It requires that the person giving consent is fully informed about the nature of the procedure or study, the risks involved, the benefits that may result, and the rights of participants, including the right to withdraw consent at any time.
- Explicit Consent: This involves a clear, affirmative action by the individual to indicate their approval. This can be in the form of a signed document, an oral agreement in the presence of witnesses, or a clear affirmative response.
- Implicit Consent: Sometimes assumed if the context reasonably implies consent. For example, a diner in a restaurant implies consent to pay for the meal by ordering food.
- Voluntary Consent: The decision to give consent must be made freely and voluntarily, without any undue influence, coercion, or manipulation.
- Competence: Consent must be given by individuals who are capable of making decisions and understanding the consequences of their actions. This typically excludes certain groups, such as children or adults with significant cognitive impairments, unless appropriate legal representatives are involved.
- Duration: Consent is generally considered to be time-bound and specific to the particular situation for which it was given. It may need to be renewed or can be revoked depending on the circumstances.
Understanding these principles can help ensure that consent is ethically and legally valid.