Information Sheet Guidance for Exempt Human Subjects Research

Many ETSU studies (about 75%) are ultimately found by the IRB to qualify for exempt status consistent with federal regulations. Importantly, researchers may not self-determine exemption. All human subjects research must be submitted to the IRB for review and formal determination before starting the study. ETSU still requires exempt studies to meet ethical standards, including informing participants:

1. that the study involves research,  
2. a description of the procedures to be followed,  
3. that participation is voluntary,  
4. the name and contact information for the investigator, and  
5. if the study records identifiable data, information about risk of loss of confidentiality.

The PI can decide to include additional information about the study in the disclosure if they believe it is something the participant would want to know, e.g. incentives, study purpose, potential discomforts, etc.  

Disclosure is most easily accomplished by using a participant information sheet in the place of an informed consent document. An information sheet is typically half of a page in length or less and can be delivered in a number of ways (e.g. verbally, in email, over text, on social media, etc.).  

Here is an example of an information sheet for an IRB-exempt anonymous survey research study. Please note how it addresses each required element listed above. 

Below you will find additional examples for various study types and methods. You can use these to help create your own exempt study documentation in lieu of using the Informed Consent Document templates. 

• Example 1: Survey (social media post) 

  Have you ever been surprised when you meet a date in-person after connecting on a dating app? We have! To figure out why this happens, ETSU is conducting a research study on how dating apps impact dating behaviors in young adults.

  If you’re interested in participating, all you would do is click the link below to fill out a 10-minute online survey. Everyone can only complete it once. If you’re not up for it, no worries!  

  The survey will ask for your email address if you’d like to enter a drawing for a $25 electronic gift card. Entering the raffle is completely optional. If you choose to enter, there is a small risk of loss of confidentiality. To mitigate this risk, we will keep your email address separate from your survey responses and only use it to contact you if you are selected during the drawing. We will also purge your email address immediately after the winner is contacted.  

  If you have any questions about the study, please contact Bucky Buccaneer at 423-439-1000 or buccaneer@etsu.edu.

  Research Study Survey Link - [URL] 

• Example 2: Interview (email)

  You are invited to participate in a research study entitled “Go Appalachia!”, conducted by Pepper Pirate, a health sciences researcher at East Tennessee State University. This study is designed to learn more about the exercise habits of middle-aged adults in the southern Appalachian region.  

  If you decide to join this study, we will ask you to participate in one, 30-minute online interview over Zoom with the Principal Investigator. During the interview, you can share as much or as little as you feel comfortable with, and you can also say that you would prefer not to answer questions that make you uncomfortable. You can decide to stop and withdraw your responses at any time during the interview. The interview will be recorded as audio only; there will be no video recording. Your name and/or any other information that could be used to identify you will be removed from the recording and any further reports or publications. Once your name and identifying information have been removed from the recording transcripts, we will be unable to withdraw your responses.

  Participation in this study is completely optional. By replying to schedule an interview, you are consenting to participate. If you have any questions about this study, you can contact Pepper Pirate at 423-439-1000 or pirate@etsu.edu. If you have any questions or concerns about your rights as a research participant, you can contact the ETSU Human Research Protection Program at 423-439-6053 or hrpp@etsu.edu. 

• Example 3: Educational Research Study

  • For Parents, Legal Guardians, and/or Caregivers (notification letter) 

    The ETSU IRB does not require parental permission for exempt studies; however, some schools/educational sites may require it for research with minors.  

    Your child has been invited to participate in a voluntary research study by Captain Kidd, an educational researcher at East Tennessee State University. This study is meant to evaluate the effectiveness of the curriculum’s current lesson plans on cellular structures and functions.

    In this study, I will observe and take written notes on the cellular structure lesson during the regularly scheduled Biology class period. After the lesson, the participating students will be asked to complete a brief, ungraded assessment to evaluate their understanding of cellular structures and functions. There will be no audio or video recording, and I will not record any of the students’ names or identifiable information. The survey will not have any impact on your child’s grade.

    During class time later this month, I will provide your child with an information sheet outlining the details of this study, and they will be able to decide whether or not they wish to participate. Your child's participation in this study is completely voluntary, and their choice will not impact their grade or class time. However, you may opt your child out of this study if you do not wish for them to participate. If you do not wish for your child to participate, please let me know by writing that in the space below, then signing this form and sending it in with your child or to my email noted below by 123 date.  

    If you have any questions about this study, you can contact Captain Kidd at 423-439-1000 or kidd@etsu.edu. If you have any questions or concerns about you or your child’s rights as a research participant, you can contact the ETSU Human Research Protection Program at 423-439-6053 or hrpp@etsu.edu. 

  • For Students (delivered verbally) 

    Hi! I'm Captain Kidd and I'm a faculty researcher at ETSU. I'm here today to collect information for a research study where I'm trying to learn how well your school teaches students about cellular structures and functions. 

    Today, I will observe your regular Biology class and take written notes during the lesson on cellular structures and functions. After the lesson, I will hand out a short assessment to see how well you understand cellular structures and functions. I won’t know who has completed each assessment because there won’t be anything to identify you on the paper. The assessment will not be graded, and it won’t have any impact on your Biology grade. In fact, your teacher won’t even see it!  

    By filling out the assessment at the end of class, you agree to participate in this study. If you do not want to participate, just turn in a folded blank paper. At this point, I’m going to give you a 10-minute break for you to come up and ask any study questions. If you don't feel comfortable talking with me in person, you can email me at kidd@etsu.edu and I will respond in the next 10 minutes. Thank you! 

• Example 4: Benign Behavioral Intervention (email)

  Please read the below information on participating in a research study.

  Principal Investigator: Jean Paul LeBucque, 423-439-1000 or lebucque@etsu.edu

  Study Purpose: This study is intended to learn how background noise can affect problem solving abilities in college-aged adults.

  Research Procedures: You will be asked to complete 4 beginner-level sudoku puzzles and a brief interview. In total, participation is estimated to take 60 minutes.

  1. You will complete two sudoku puzzles in a quiet room.  
  2. You will move to a room with background noise meant to mimic a coffee shop setting, including instrumental music and low-level chatting.  
  3. You will complete an additional two sudoku puzzles.
  4. You will be asked a few questions to describe whether or not the background noise impacted your ability to solve the puzzle.

  Confidentiality: The interview will be audio recorded only. Your name and any other information that could identify you will be removed from the recording after transcription and will not be included in any further reports or publications.

  Participation in this study is completely optional. By replying to schedule a session, you are consenting to participate. If you have any questions about this study, please contact the Principal Investigator at the phone number and email listed above.