Effective Date: May 1, 2017

CONSENT FORM

BLOOD COLLECTION FROM SUBJECTS FOR IMMUNOLOGICAL STUDIES

INTRODUCTION

The purpose of this form is to provide you, as a prospective research study participant, information that may affect your decision as to whether or not to participate in this research and to record the consent of those who agree to be involved in the study.

RESEARCHERS

Phillip Stafford (Professor) at The Biodesign Institute, Arizona State University have invited your participation in a research study to investigate whether a blood test is possible that distinguishes Fibromyalgia and ME/CFS (and other autoimmune disorders).

STUDY PURPOSE

The purpose of the research is to study the immune response to autoimmunity vs. otherwise healthy people and people with other autoimmune disorders. You are being invited to participate voluntarily in this research study because you are willing to donate a fingerstick of blood, sent by mail on a blood spot card. You are not anemic according to current measures and should take precautions to sterilize your finger prior to administering the auto-lancet.

DESCRIPTION OF RESEARCH STUDY

If you decide to participate, then you will join a new, spontanous study that is currently unsponsored but should provide information for expanding the current clincal trial, as well as convincing NIH and other funding agencies that a blood diagnostic is both feasible and economical for ME/CFS. Researchers are developing a generalized diagnostic that may involve comparing persons with illness against a cohort of healthy persons.

After you send your blood card in, it will be transferred to the laboratory of the Center for Innovations in Medicine and stored for no longer than 1 year. Serum is very stable on blood cards, keep in mind that your blood may be available for testing for at least 1 year. If you sign this consent form, your blood may be stored for 1 year for repeated testing. You might be called back to donate blood again, depending on whether your symptoms lessen or worsen. There is no other participation that you will be requested. Approximately 140 individuals will be participating in this small study.

RISKS

Minor risks that may occur to you from participating in this study include lightheadedness or fainting, pain or development of a bruise at the lancet site. The chances of these risks occurring are less than 1% for most people.

BENEFITS

There are no benefits to you for participating in this study. There may be benefits to society if new approaches to diagnosing ME/CFS or Fibromyalgia result from the research.

NEW INFORMATION

If the researchers find new information during the study that would reasonably change your decision about participating, then they will provide this information to you.

CONFIDENTIALITY

All information obtained in this study is strictly confidential as required by law. The results of this research study may be used in reports, presentation, and publications, but the researchers will not identify you. In order to maintain confidentiality of your records, your blood specimens will be identified only by number and not by name. The link between your identity and your sample number will be maintained and kept confidential by the Principal Investigator of this study. The results of the testing on your samples are for research purposes only and may not be revealed to you and will not be placed in your medical records.

WITHDRAWAL PRIVILEGE

It is OK for you to say NO even if you say yes now. You may withdraw from the study at any time. Your decision will not affect your relationship with Arizona State University.

COSTS AND PAYMENTS

The researchers want your decision about participating in the study to be absolutely voluntary. There will be no financial benefits to you if therapeutic agents are developed from your blood or if new, commercially profitable treatments or diagnostic approaches are developed. There will be no costs to you for participating in this study.

COMPENSATION FOR ILLNESS AND INJURY

If you agree to participate in the study, then your consent does not waive any of your legal rights. However, no funds have been set aside to compensate you in the event of injury. Known side effects have been described in this consent form. However, in the event of harm, injury or illness arising from this study neither Arizona State University nor the researchers are able to give you any money, insurance coverage, free medical care, or any compensation for such injury.

ACCESSING IMMUNOSIGNATURE ON INTERNET

If your blood is used for a study, investigators will email the participant the data portion of the immunosignature. The data is completely de-identified. The participant will be able to see where they lie relative to others with the same disease, and relative to those with a different disease.

VOLUNTARY CONSENT

Any questions you have concerning the research study or your participation in the study, before or after your consent, will be answered by Phillip Stafford (phillip.stafford@asu.edu).

If you have any questions about your rights as a subject/participant in this research, or if you feel you have been placed at risk, you can contact the Chair of the Human Subjects Institutional Review Board through the ASU Office of Research Integrity and Assurance at (480) 965-6788.

This form explains the nature, demands, benefits and any risk of the project. By signing this form you agree knowingly to assume any risks involved. Remember, your participation is voluntary. You may choose not to participate or to withdraw your consent and discontinue participation at any time without penalty or loss of benefit. In signing this consent form, you are not waiving any legal claims, rights, or remedies. You may print a copy of this electronic consent form at any time.

Your e-signature below indicates that you consent to participate in the above study.

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