What is informed consent and when is it needed?
In almost all cases, consent must be obtained from the research participants or their legally authorized representatives (parents or guardians) before participation in research begins. The informed consent process is a basic ethical obligation for researchers. It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to the questions the subject may have and ensuring that the subject or the legal representative understands the information. In addition, the process includes obtaining the subject’s voluntary agreement to participate in the research, typically indicated by the subject’s signature on the written consent document. After the subject’s signature is obtained, the informational process should continue as required by the situation or the subject, both during and after the study. For exempt research involving anonymous minimal risk survey data collection , the consent process may be as simple a
