Supporting Document Templates

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The following templates were developed to assist researchers planning to conduct human subjects research in the creation of their study documents. The templates are not applicable and should not be used for scholarly projects. To help researchers understand which documents they’ll need to prepare, definitions are provided:

Recruitment involves sharing information about your planned research and inviting individuals to participate.
Consent is obtaining someone’s agreement to participate in your research after they’ve received comprehensive information and had the opportunity to ask questions and receive answers.
Assent refers to a minor’s (i.e., someone under 18 years of age) agreement to be in a research study. Parental consent is generally required along with assent, but not always.
Anonymous data cannot be linked by the researcher to the individuals it is from or about. The most common example is data collected via a survey that does not request names or other identifying information. The researcher may know who was asked to participate, but when the data is received, the researcher cannot tell who participated or link survey responses to individuals.
Confidential data can be linked by the researcher to the individuals it is from or about, but the researcher will take steps, like the use of pseudonyms in place of names, to protect participants’ identities.

Above each template is a description of the circumstances for which each template should be used.

Recruitment

Consent

Researchers whose studies are categorized as exempt are excluded from the regulatory requirements regarding participant consent. Per University policy, only the IRB can make an exempt determination, and we must receive and review an IRB application submitted through the Cayuse IRB (Human Ethics) link to do so. Investigators conducting exempt research do not need to create a consent form using one of the consent templates or have participants sign a consent form. Per university policy, they do need to provide adequate study information to participants. The information sheet template attached below should be used to inform participants about your exempt study. For information on whether your research may receive an exemption from the IRB, see our study categories page.

Information Sheet Template docx

The general consent template includes wording for anonymous and confidential data collection methods and should be used if your study will involve both. For example, if each participant or one of your participant groups will complete an anonymous online survey and be interviewed, the general consent template should be used. This template is not appropriate for studies involving minors.

Consent Template (General) docx

The anonymous data collection consent template was designed for non-exempt studies involving adult participants if the only method of data collection is an anonymous survey. Minimal risk studies for which a signed consent form would be the only documentation linking participants to the research and studies involving participants from a “distinct cultural group or community in which signing forms is not the norm” (45 CFR 46.117(c)(1)(iii)) qualify for a waiver of the requirement that consent forms be signed. As a result, the below template does not contain signature lines.

Consent Template (Anonymous) docx

The confidential data collection consent template should be used for non-exempt studies if the data collection method(s) will be confidential. Examples include but are not limited to non-anonymous questionnaires, interviews, focus groups, and observations. This template is only applicable for studies involving adult participants.

Consent Template (Confidential) docx

The parental consent template attached below is needed if your participants will be minors. It can be used as a stand-alone parental consent form or as a combined parental consent and student assent form if the minor participants will be between 13 and 17 years old. For the latter case, both the minors participating in your study and one of each minors’ parents or guardians will read and sign the same form. A parental consent form and a child assent form will be needed if your minor participants will be under 13.

Consent Template (Parental) docx

If your study will involve minors and qualifies for a waiver of the consent requirement, the parental opt-out consent template should be used. You will still provide study information (i.e., the completed template provided below) to parents but only require it to be signed and returned if they prefer that their students not participate (i.e., opt-out). Additionally, if your study will involve children in a school setting, the appropriate district or school official will need to grant permission for you to utilize the opt-out procedure. To ensure parents’ receive the forms and have the opportunity to opt their children out of your study, parental opt-out forms must be sent directly to parents via email; they cannot be hand carried home by minors.

The criteria for a waiver are as follows:

Your study will “[involve] no more than minimal risk to participants”;
“The research could not practicably be carried out” if a consent form were required (e.g., circumstances would make obtaining signed consent from parents impracticable, like the implementation of a teaching intervention involving entire classes or grades); and
Not providing a normal consent form “will not adversely affect the rights and welfare of the subjects” (45 CFR 46.116(f)).

Consent Template (Parental Opt-Out) docx

A child assent form using the below template will need to be created if your participants will be 12 or under. The child assent form will be needed for your minor participants’ assent, and a parental consent form will be needed to obtain their parents’ or guardians’ agreement for the minors to be part of your study. Be sure to create and submit both forms when you submit your IRB application.

Child Assent docx

The medical consent template should be used when you are asking adult participants to undergo medical procedures as part of your data collection.

Consent Template (Medical) docx

The blood draw consent template is for research involving the collection of blood from adult participants.

Consent Template (Blood Draw) docx

To provide the information necessary under the European Union General Data Protection Regulation 2016/679 (“EUGDPR”), the below document must be used along with the general or confidential consent form as applicable when you will collect personal data for the purposes of research from citizens of the European Union (EU).

Consent Template (GDPR) docx

The debriefing template should be used when it will be necessary to deceive your participants in some way. Deception may include but is not limited to withholding the full or true purpose of the study, withholding information about experimental and controls groups, and audio or video recording or photographing participants without their knowledge.

Debriefing Template docx

Supporting Document Templates

Recruitment

Consent

Site Permission