Informed consent should be understood as an on-going process rather than a level of legal protection for an institution. It is not intended to be a one-time act of having a participant sign a form.
Informed consent is designed to inform research participants about the purpose, risks, potential benefits and alternatives to the research that allows people to make a decision about whether or not to participate based on their own goals and values. This exchange of information should occur at enrolment and throughout the study.
Researchers are responsible for providing information during the informed consent process in a manner that is understandable to the potential participants. Researchers should be confident that the individual understands all information disclosed.
Researchers can use methods in addition to a consent form to enhance individuals' comprehension. Some examples include:
- Oral presentations that provide potential participants with the opportunity to discuss the information and ask questions.
- Providing additional educational materials, such as brochures, about the research.
- Video presentations.
The informed consent process must be delivered in language that is understandable to the participant. This may mean re-writing the documents into more simple language or translating documents and presentations into the language with which participants are most comfortable.