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Exempt Research: Study Information Sheets

Consent for Exempt Research

Exempt studies are studies that meet one of the categories described in the W&M Procedure for Exemption.

Exempt studies do not require signatures of participants, but a study information sheet (SIS) should be provided to participants before enrolling in the study.

The information sheets linked on this page can only be used with exempt studies. 

Study Information Sheet Requirements

• If you are conducting interviews, be sure to write whether/how the interviews will be recorded (audio or visual) and procedures for ensuring confidentiality with those recordings. 
• If you are proposing to use an electronic survey (e.g. in Qualtrics), the informed consent can be included as an electronic document before the survey. A question should be set up asking participants if they agree to the terms of the consent. The question should also be set so that participants cannot continue unless they have agreed to the terms. Those participants that click “I disagree” can be led to a page that thanks them.
• The application and consent must reflect the VA State Law and W&M Data Storage Guidance of maintaining study documentation for five years following study completion. Forms that are not signed do not need to be archived, although one copy should be saved for your records for five years.
• They are usually half a page in length and include the following information:
  • Study Purpose
  • Procedures
  • Risk and Benefits
  • Confidentiality of Data
  • Name of PI and official W&M contact information including phone numbers.
    • Student-led research: The contact information for the faculty PI and student should be listed in the consent. 
  • Statement about the research being voluntary
  • IRB Office Contact information
• You can use the "Exempt Information Sheet Checklist" below to confirm your document has all the required elements. It is expected that researchers use the W&M templates listed below. 

Exempt Templates

Select each topic below to view templates that can be used. 

Note: The linked "templates" provide a skeleton of what should be included in your consent forms. Please adjust as you see fit.

Exempt research templates

Study Information Sheet for Use with Adults (18+) For use with adults (18+) only and falls into one of the exempt categories.

Study Information Sheet for Use with Parents/Guardians and Minors (<18)  See Section E of the Exemption Procedure to learn which procedures can involve minors.  While signed consent is not required, parents/legal guardians should be informed that their minor will take part in a research study. When parents or legal guardians are also participants in the study in addition to providing permission for their minor to participate, the document should be worded appropriately to clearly state what they're giving permission for their child to do versus what the parents/legal guardians will be doing themselves.    Minors aged 7 or older can be given the document below. Additional methods for consent are slide shows, videos, graphics, etc. If using an alternative consent process, the information presented to the minor should still match what would be included in the assent document below.

Use or Creation of Educational Records for Research (Adults and Minors) Occasionally, research involves accessing, using, or creating educational records subject to FERPA. When this occurs, researchers need to get permission to use the records under FERPA and IRB procedures. For more information, review the Guidance: Using Educational Records for Research.

Oral/Verbal Consent IRB does not have a template for Oral/Verbal Consent as researchers should develop a script that suits their population but still covers the required components.  Researchers may use one of the templates from the categories above to create their script. The script must be attached within the IRB application.  Recommended but not required: Participants should be given an IRB-approved information sheet about the study.