A potential participant must fully understand the purpose, risks, and benefits of a research study before agreeing to participate. But because participants must always be allowed to withdraw freely from a study, you should consider informed consent not as a one-and-done stage, but an ongoing process continuing even after you have collected the data (because a participant may reconsider and wish to withdraw responses, if possible).
See the Protocol Forms, Sample Templates, and Appendices page for sample informed consent, assent, and permission templates.
Your consent materials must include the following information in language appropriate for your population:
Additional Seattle University requirements:
Only the IRB may approve alternatives to the standard consent process, after determining:
The IRB may waive written consent in the following circumstances:
You must obtain parental permission for research studies with minors (under 18 in Washington State). For studies involving greater than minimal risk, both parents must sign the permission form, unless only one parent has legal responsibility for the child, or if one parent is deceased, unknown, or incompetent. Minors themselves do not provide "consent" but assent.
For certain minimal risk studies, the IRB may grant a “waiver of parental permission” if it will yield significant benefits to the study population or a public program, and/or if obtaining parental permission would pose considerable risk to potential subjects or be inappropriate. For example, research involving older adolescents who, under applicable law, may consent on their own behalf for selected treatments. Or research where the child's interests may conflict with the parents' interests (e.g., research on child abuse or neglect). In these cases, you must ensure alternative consent procedures to protect the rights and interests of the minor participants.
To document parental permission, use the standard adult consent template but substitute “your child” for “you.” Then, obtain the child's agreement via an “assent form,” a child-friendly document outlining essential information about the research. Most children 8 years old and above can understand a research project and provide assent. Some children under the age of 8 may also be capable of granting or withholding assent; the IRB requires sensitivity to the needs of these children on an individual basis.
For benign, minimal risk studies (e.g. curricular or pedagogical research), the IRB may consider allowing "passive parental permission." In these cases, you must provide parents with detailed information about the study, and then parents respond only if they wish to opt their child out of the research.
For research involving non-English speaking participants, your protocol submission must include consent forms in their language with English translations. (The IRB may consult with language experts or require a “back-translation” into English.) If you will engage a translator, your submission must also include a confidentiality agreement to be signed by the translator.
You may wish to use a shorter, simpler consent document for certain populations. If so, you should explain your rationale in your protocol submission.
For oral consent, you must provide a script in both languages of the consent information that you (or a translator) will present to participants.
In some cases, you may wish to employ deception (deliberately withholding information from subject participants) to engage subject participation and/or to collect data not influenced by the participant's knowledge about the research objective.
Before approving protocols involving deception, the IRB will determine whether the study meets the following conditions:
Complete and submit Appendix F.Use of Deception Request with your protocol application.