Templates and guidance for Informed Consent Documents
The IRB must ensure that the documents and process for obtaining research informed consent satisfies adequate standards for the protection of human participants. The use of templates can assist the investigator in preparing the consent documents for research by including the requirements outlined by the Common Rule for the protection of research participants and the requirements in WSU policy.
The following templates are guides. Instructions are incorporated into the templates to indicate which elements are required and which sections can be modified to fit individual protocols. In general, the language should make sense for the particular research project while satisfying the regulatory requirements for informed consent.
Informed Consent guidance and tools
Required Elements of Informed Consent (update 10/2019) (PDF)
Key Information Guidance (RCR)
Consent and Assent Readability Guidance (New 9/2023)
Templates are to be used for drafting study specific consent forms (Word Documents)
For eProtocol submissions attach completed consent documents under the Protocol Information-Consent Information section & attach Assents under the Protocol Information-Assent Information section.
Research Informed Consent for Adults - Behavioral Research (updated 2/2021)
Research Informed Consent for Adults - Medical Research (updated 2/2021)
DMC/Tenet Research Informed Consent - All Research Using DMC Services (revised 3/2019)
McLaren Research Informed Consent (updated 2/2021)
Pregnant Partner Consent Template (updated 2/2021)
Research Information Sheet for Adults - (updated 2/2021) Participant Signature Not Required. Request a waiver of documentation of consent from the IRB must be included with the submission. This is the recommended document for for exempt submissions.
Using a Research Information Sheet: A Waiver of written documenation of Consent is required for minimal risk research study that uses a Research Information Sheet (unsigned consent).
To request the waiver of written documentation of consent, complete the following steps for eProtocol:
- Consent Information section select "Add" and complete the pop-up window
- Title: type the name of the requested waiver: "Waiver of Written documentation of consent"
- Consent Information Type: select the waiver type for the pop-up window of:
- "Waiver of 'DOCUMENTATION' of Consent or Parental Permission"
- Respond to the listed waiver/alteration statements and Save
COVID-19 Phone Script (revised 10.2022)
COVID-19 Participant Information Sheet (revised 2.2023)
Parental Permission/Research Informed Consent - Behavioral or Medical Research (updated 2/2021)
School Parent Supplemental Information Letter - Requires a Waiver of Parental Permission (updated 8/2022)
School Parental Permission/Research Informed Consent (revised 3/2019)
For eProtocol submissions attach the completed assent documents under the Protocol Information-Assent Information section.
Oral Assent Script (ages 7-12) (updated 2/2021)- The person obtaining oral assent must sign the Parental Permission/Research Informed Consent on the appropriate signature line.
For non-english speakers
Short form consent
A short form consent and oral translation of the English consent is required if an individual approached for consent is not fluent in English, a written translated version of the full consent is not available, and this was unanticipated.
Available Short Form Versions: Albanian, Arabic, Bengali, Chinese-Simplified, Chinese-Traditional, Farsi, French-Canada, French-Europe, German, Greek, Hindi, Italian, Polish, Russian, Serbian,Spanish-Mexico, Swahili, Tamil,Thai, and Ukrainian
If the short form is needed in a language other than these 18, the English Version of Short Form Consent (PDF) must be translated in to that language and IRB approval of the translation prior to use.
Clinical Trial registration requirements
For all investigator initiated studies and sponsored studies
Clinical Trial research studies are required by law to be registered on the clinicaltrials.gov website [U.S. Public Law 110-85 (FDAAA)] and a statement must appear in the informed consent document stating that it is registered. For more information about this law and requirements for sponsors and/or investigators, visit the Protocol Registration System (PRS) and U.S. Public Law 110-85 Information Page.