Informed Consent
Resources
Download the Pacific University proposal and consent form templates
What is informed consent?
Informed consent is not just a signed form, but a process of communication between researchers and participants that conveys respect for the individual.
For adults able to exercise full autonomy in making choices about participating in a research study, the informed consent process should include the following:
- a statement that the study involves research, an explanation of the purposes of the research, and a description of what participation in the study will involve;
- a description of any reasonably foreseeable risks and benefits to the participant;
- if the study involves health treatments, the participant must be informed of alternative procedures or courses of treatment;
- a statement describing the extent to which confidentiality of records or data identifying the subject will, or will not, be maintained;
- for research involving more than minimal risk (see below), an explanation of the treatment or resources available if any harm occurs;
- identification of whom to contact for further information about the study (e.g., the Principal Investigator), and about participants' rights in the event of research-related harm (usually the Institutional Review Board);
- a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant in otherwise entitled, and that the participant may discontinue participation at any time.
For individuals with "diminished autonomy" (for example, children), informed consent procedures typically involve obtaining consent from an individual who has the legal authority to make decisions about the individual's participation in research. In the case of children, The Ethical Standards for Research with Children of the Society for Research in Child Development suggest that informed consent should be obtained from parents, legal guardians or those who act in loco parentis (e.g., teachers, school superintendents). Where feasible, children should also be given the opportunity to assent to participate, even if they do not fully comprehend the full significance of such assent, as well as the opportunity to refuse to participate. The assent form should have the same content as listed above for adults, but be simplified to the appropriate age.