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 Wayne State University 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

Required Elements of Informed Consent (update October 2019)

Key Information Guidance (RCR)

Consent and Assent Readability Guidance (New September 2023)

Sample Lay Language for Risks (.doc)

Plain language Guidance from NIH

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. 

As of June 21, 2024 a number of consent templates have been updated, previous version will be accepted until September 6, 2024.

Research Informed Consent for Adults - Behavioral Research (updated June 2024)
Research Informed Consent for Adults - Medical Research (updated June 2024)
DMC/Tenet Research Informed Consent - All Research Using DMC Services (updated June 2024)
McLaren Research Informed Consent (updated June 2024)

VA Combined Informed Consent Form and HIPAA Authorization (updated June 2024) & VA Informed Consent Form Template (June 2024)

VA Waiver of HIPAA Authorization Request Form (version updated July 2024)

Pregnant Partner Consent Template (updated June 2024)

Research Information Sheet for Adults - (updated July 2024 - minor corrections) 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 documentation 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 July 2022)

COVID-19 Participant Information Sheet (revised February 2023)

Parental Permission/Research Informed Consent - Behavioral or Medical Research (updated June 2024)

Parental Permission/Research Informed Consent-DMC Template (version June 2024)
School Parent Supplemental Information Letter - Requires a Waiver of Parental Permission (updated August 2022)
School Parental Permission/Research Informed Consent (revised March 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 February 2021)
Adolescent (ages 13-17) Assent Template - Behavioral Research (updated February 2021)

Oral Assent Script (ages 7-12) (updated February 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 (April 2015)

For non-English speakers

Consent Translation Requirements 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 must be translated in to that language and IRB approval of the translation prior to use.

Recruitment Template Language

Recruitment Email/Letter Template (NEW). This template can be used for minimal risk research studies (expedited and exempt).

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.