Exempt Research: Study Information Sheets
Exempt Research
Exempt studies are studies that meet one of the categories under 46.104 and involve minimal risk.
Exempt studies do not require signatures of participants, but a consent or study information sheet should be provided to participants prior to 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 5 years following study completion. Forms that are not signed are considered information sheets and do not need to be archived, although one copy should be saved for your records for 5 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
Click on each header 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.
Adult Study Information SheetFor use with ADULTS (18+) only and falls into one of the exempt categories. |
Parent/Guardian and Minor Study Information SheetExempt studies involving minors can only be approved under Exempt Category 1. Exempt Category 1 Requirements:
Minor Study Information Sheet (2025) Parent/Guardian Study Information Sheet (2025) Combined Parent/Guardian and Minor Study Information Sheet (2025) |
Oral/Verbal Consent
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