Wayne State University

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

About Informed Consent Options for Research (PDF)

Required Elements of Informed Consent (PDF)

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

Sample Lay Language for Risks (.doc)

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

Research Informed Consent for Adults - Behavioral Research (04/2015)
Research Informed Consent for Adults - Medical Research (04/2015)
DMC/Tenet Research Informed Consent - All Research Using DMC Services (07/2015)
McLaren Research Informed Consent (08/2016)

Research Information Sheet for Adults - Participant Signature Not Required (04/2015)

Parental Permission/Research Informed Consent - Behavioral or Medical Research (04/2015)
School Parent Supplemental Information Letter - Requires a Waiver of Parental Permission (04/2015)
School Parental Permission/Research Informed Consent (04/2015)

Adolescent (ages 13-17) Assent Template - Medical Research (04/2015)
Adolescent (ages 13-17) Assent Template - Behavioral Research (04/2015)

Humanitarian Use Device Informed Consent Template (04/2015)

*Oral Child (ages 7-12) Assent - Currently, no template is provided for obtaining oral assent from children ages 7-12. The IRB suggests starting with the Adolescent Assent template which uses the use of the question and answer format. The content of each section must be written at an age-appropriate level for the intended population. Remove the initial lines on the bottom of each page and the signature lines on the back page. For oral child assent, the child does not sign or initial the document. The person obtaining oral assent must sign the Parental Permission/Research Informed Consent on the appropriate signature line.

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: 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 its use requires IRB approval prior to.

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.