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The Relationship of Epilepsy, Endocrine Disorders, and Immune Dysregulation in Adult Women with Autism

Consent Waiver


Study to be Conducted at:
Greenville Health System
Patewood Medical Campus
200 Patewood Dr.
Suite 200A
Greenville, SC 29615

Principal Investigator:
Manuel Casanova, MD

Emily Casanova, PhD

You are being asked to participate in a research study. The Institutional Review Board of the Greenville Health System has reviewed this study for the protection of the rights of human participants in research studies, in accordance with federal and state regulations. However, before you choose to be a research participant, it is important that you read the following information and ask as many questions as necessary to be sure that you understand what your participation will involve.

Purpose and Procedures:
The purpose of this research study is to investigate a relationship between epilepsy and hormone/immune disorders in women with Autism Spectrum Disorder (ASD). You are being asked to participate because you are either a woman with an ASD over the age of 25 or you are the legal guardian of a woman who fits these criteria. If you or your ward don't have a professional ASD diagnosis but suspect the presence of an ASD, we encourage you to participate too. Please also consider participating regardless of whether you or your ward have any of the above listed medical conditions (epilepsy, hormonal, immune), as we are hoping to also better understand the frequency of these conditions in the female population of the spectrum.

We plan to enroll at least several thousand people in this study. Your participation will involve answering an online survey to the best of your abilities. This should take approximately 15-25 minutes.

Possible Risks and Benefits:
There are no known medical risks related to participation in this study. The greatest risk is the possible release of your personal information with the investigators. However, this survey is anonymous and we will not be collecting any identifying information. Your survey answers are considered confidential, but absolute confidentiality cannot be guaranteed. This study may result in presentations and publications. There are no direct benefits to you that would result from your participation in the study.

Although you will not receive compensation for participating in this study, this research may help us to understand these conditions better. This knowledge can help scientists and doctors develop better treatments for co-occurring medical conditions in ASD that may affect you or your family.

Voluntary Participation:
Participation in this study is completely voluntary (your choice). You may refuse to participate or withdraw prior to submitting your survey. If you refuse to participate or stop the survey, you will not be penalized or lose any benefits. However, because your submission is anonymous, we will not be able to remove your data from the study afterwards. So please be certain you want to participate prior to submission. Your decision will not affect your relationship with the investigators or any relationship you may have with the Greenville Health System.

Contact for Questions:
For more information concerning this study and research-related risks or injuries, or to give comments or express concerns or complaints, you may contact the principal investigator, Manuel Casanova, at (864) 454-4595. You may also contact a representative of the Institutional Review Board of the Greenville Health System for information regarding your rights as a participant involved in a research study or to give comments or express concerns, complaints, or offer input. You may obtain the name and number of this person by calling (864) 455-8997.

An additional survey about your experience with this informed consent process is located at the following website: Participation in the above survey is completely anonymous and voluntary and will not affect your relationship with the Greenville Health System. If you would like to have a paper copy of this survey, please tell the principle investigator.

1. Do you agree to participate in this survey study? *This question is required.
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