Informed Consent

Your consent materials must include the following information in language appropriate for your population:

1. The purpose of the study, how long the study will last, and a detailed description of the tasks involved (including any experimental procedures).
2. Possible risks or discomforts the participant may experience.
3. Potential benefits to participants or others.
4. The degree of confidentiality a participant can reasonably expect, as well as relevant record retention.
5. Your name and contact information, and SU IRB contact information.
6. A statement that participation is voluntary, refusal to participate will not negatively impact the individual, and the individual may stop the study at any time without penalty.
7. (For research greater than minimal risk) An explanation about available compensation and/or medical treatments if injury occurs and where further information may be obtained.

Additional Seattle University requirements:

1. Acknowledgment of any conflict of interest in the research.
2. Terms of incentives and circumstances under which subjects would receive partial or no incentive (e.g., withdrawing from the study before completion).
3. If you are SU faculty or staff, the first page of the consent form must include the Seattle University name and logo, your name, and Department and/or College.
4. If you are an SU student, “Seattle University” must appear at the top of the first page, and along with your contact information, you must provide your adviser's name, department, and contact information.

Only the IRB may approve alternatives to the standard consent process, after determining:

• the research involves only minimal risk to participants;
• the waiver or alteration will not negatively affect a participant's rights and welfare; and
• the research could not practicably be carried out without the waiver or alteration.

The IRB may waive written consent in the following circumstances:

1. Mailed, e-mailed, or online surveys: You must provide a brief introductory overview of the study including purpose, risks, benefits, and your contact information. Then indicate that returning or completing the survey represents that the participant provides his/her/their consent (and is over 18).
2. Signed consent may increase risk to participants: After you explain the study in language appropriate for the population, you may note in your records that the participant gives oral consent to participate. If you will collect audio or video recording, you should also record the oral consent. (Examples: interviews with indigenous people who do not have a written language, or interviews with people who wish to preserve anonymity, e.g., undocumented citizens.)
3. Information Sheet: For minimal risk studies on benign topics or that do not collect direct identifiers or enough indirect identifiers (e.g., several demographics within a small population) to determine an individual's identity, you may request to give potential participants a study "information sheet" (including all standard consent information). Then, you may obtain oral consent, and an individual's decision to participate represents his/her consent.

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:

1. Deception is necessary for this particular research goal and data collection.
2. Deception will not increase risk (whether financial, physical, psychological, or social).
3. You have incorporated an appropriate debriefing session following the data collection, to inform subjects about the nature and purpose of the deception.

Complete and submit Appendix F.Use of Deception Request with your protocol application.