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

Informed Consent Process: The WSU IRB Roadmap

About Informed Consent Options for Research (PDF)

Required Elements of Informed Consent (update 10/2019) (PDF)

Key Information Guidance (RCR)

How to Check the Reading Level of a Consent (.doc)

Sample Lay Language for Risks (.doc)

Waivers of Consent or Alteration of Consent 

Plain language Guidance from NIH

Templates are to be used for drafting study specific consent forms (Word Documents)

For eProtocol submissions attach the completed consent documents under the Protocol Information-Consent 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)

VA Consent Form Template with HIPAA  &  VA Combined Consent and HIPAA Instructions 

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.

COVID-19 Phone Script (revised 10.2022)

COVID-19 Participant Information Sheet(revised 10.2022)

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. 

Adolescent (ages 13-17) Assent Template - Medical Research (updated 2/2021)
Adolescent (ages 13-17) Assent Template - Behavioral Research (updated 2/2021)

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.

Humanitarian Use Device Informed Consent Template (04/2015)

For non-english speakers

Consent Translation Requirements for Non-English Speakers (PDF)

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, ArabicBengaliChinese-SimplifiedChinese-TraditionalFarsiFrench-CanadaFrench-EuropeGermanGreekHindiItalianPolishRussianSerbian,Spanish-MexicoSwahiliTamil,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.