Informed Consent for Screening Survey

Study Title: A Double-blind Randomised Sham-controlled Proof of Concept Study of Non-Invasive Brain Stimulation in Adults with Attention Deficit Hyperactivity Disorder (ADHD)

Short title: Non-Invasive Brain Stimulation in Adult ADHD

Principal Investigator: Prof. Michael Kohn

Introduction:

You are invited to participate in a screening survey for a research study conducted by Neurode Labs Pty. Ltd. Before you proceed, it is essential to read and understand the information provided below. Your participation in this survey is voluntary, and you have the right to withdraw at any time without providing any reason. A total of 90 participants will be recruited to participate in this study.

Purpose of the Survey:

The purpose of this screening survey is to determine your potential eligibility to participate in our study, which aims to assess the efficacy of a wearable medical device for brain imaging and stimulation as a potential treatment for ADHD. By completing this survey, you are giving us permission to collect and use the information provided for screening purposes only.

Data Collection and Use:

During the survey, we will collect the following information:

•      Name

•      Email

•      Phone number

•      Demographic information (age, gender, etc.)

•      Whether you have an ADHD diagnosis

•      Whether you are taking medication for ADHD

•      Whether you meet the eligibility criteria for the study

Your personal information will be kept confidential, and we will only use it for the purpose of screening potential participants for this study. We will not share your information with any third parties unless required by law.

Voluntary Participation:

Participation in this survey is entirely voluntary. Your decision to participate or not will not affect your relationship with Neurode Labs Pty. Ltd.

Potential Risks and Benefits:

There are no direct benefits to participating in this screening survey. However, it may help us determine whether you are eligible for the study. As part of the online forms, you will be asked to complete the Depression, Anxiety and Stress Scale (DASS) and the Conners Adult ADHD Rating Self-Report (CAARS). You may experience distress while completing these online questionnaires. If you do experience distress during the completion of online forms you can contact support services such as Lifeline 13 11 14 or Headspace 1800 650 890.

Contact Information:

If you have any questions or concerns about the survey or the clinical trial, you can contact the Co-Investigator, Arthur Kary at 0424 848 569 or arthur@neurode.com.au.

Consent:

By continuing with the survey and providing your responses, you acknowledge that you have read this consent form, understood its contents, and freely consent to participate in this screening survey.

Withdrawal of Consent:

You have the right to withdraw your consent at any time during the survey by closing the browser or exiting the survey. If you have already submitted the survey and wish to withdraw your consent, you can contact Arthur Kary at 0424 848 569 or arthur@neurode.com.au.

Advice and Information:

The Bellberry Human Research Ethics Committee has reviewed and approved this study in accordance with the National Statement on Ethical Conduct in Human Research (2007) – incorporating all updates. This Statement has been developed to protect the interests of people who agree to participate in human research studies. Should you wish to discuss the study or view a copy of the Complaint procedure with someone not directly involved, particularly in relation to matters concerning policies, information or complaints about the conduct of the study or your rights as a participant, you may contact the Operations Manager, Bellberry Limited on 08 8361 3222.

By clicking "I agree" below, you are indicating that you have read this consent form, understood its content, and voluntarily agree to participate in the screening survey.