Informed Consent and Assent Guidance
Informed Consent is a process in which researchers provide information to participants regarding the details of a research study prior to their enrollment in the study. Topics covered during this process include: the purpose of the study, the procedures involved, how their privacy will be protected, as well as information about any risks, benefits, or compensation. Consent forms document that the informed consent process took place. A signed consent form is certification that the participant agrees to participate in the study.
Unless the IRB has determined that a study meets federal and ethical requirements for a waiver of informed consent, no investigator may involve a human being as a subject in research without obtaining consent of the subject.
The following basic elements are required (per federal regulations) for all informed consent forms:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of procedures which are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others which may reasonably be expected from the research. If none, so state.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- For research involving more than minimal risk, statement as to whether there is any compensation and whether medical treatments are available if injury occurs. If so, specify the extent and nature of the compensation and treatment.
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
The Informed Consent Template
To assist investigators in creating consent forms, the IRB has prepared an Informed Consent Template that addresses the elements discussed above.
Assent Form Guidance
For research projects involving children, the IRB requires consent from the parent/legal guardian and, if the children are aged 7 years or older, assent from the children.
Assent is defined as a child’s affirmative agreement to participate in research. (Failure to object is not considered assent.) The child should be given an explanation of the proposed research procedures in a language that is appropriate to the child’s age, experience, maturity, and condition.
The assent document should also discuss the study purpose, any discomforts or inconveniences the child may experience if he/she agrees to participate, and that participation is voluntary. If the child’s decision-making capacity is impaired, a researcher may propose to use a surrogate.