No. The IRB must review and approve any materials you plan to use before you begin recruiting individuals. This includes advertisements that appear in the newspaper, on radio or television or on the Internet, and flyers.
In almost all cases, informed consent must be obtained from the research participants or their legally authorized representative (s) before participation in research begins.
It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to questions the subject may have and ensuring that the subject or the legally authorized representative (s) understands the information.
In addition, the process includes obtaining the subject’s voluntary agreement to participate in the research, usually indicated by the participant’s or their legally authorized representative (s) on the written consent document.
The IRB may approve a waiver of consent or documentation of consent in limited circumstances.
See the Investigator Manual and protocol documents HRP-90 and HRP-91 for more information.
Federal regulations require that there are adequate provisions made for soliciting the assent of children when they are capable of doing so. Age, maturity and psychological state need to be taken into account when determining whether to ask for assent. Usually children who are age seven and older are asked to sign an assent form, and adolescents age 13 and older sign the consent form. Both forms should be written at an appropriate reading level.
Because children have not yet attained legal age to provide consent, the parent or legal guardian is also asked to give permission for participation when a child is asked to take part in research.