Informed Consent

Phelan-McDermid Syndrome International Registry Informed Consent

On July 15, 2014, the Phelan-McDermid Syndrome Foundation made important updates to the Registry in response to new research opportunities in Phelan-McDermid Syndrome. For more details click here.

For the purpose of this document "you," "your," "me," and "I," refers to the registrant, either the individual affected by PMS/SHANK3 (the patient) or the parent, guardian or family member providing the information on behalf of the patient. 

1. Please indicate that you have reviewed and that you understand the "Understanding Your Participation" page and that you do not have any questions about your participation in the Registry.

2. When you create an account in the Registry, you will be assigned a unique numeric identifier that will be used in place of your personal, identifying information. This code allows researchers to access information you have entered into the Registry without knowing who you are.

I give permission for the information I share in the Registry to be provided to other registries or databases using my unique numeric identifier. This includes sharing information for the purposes of participating in the Phelan-McDermid Syndrome Data Network (PMS_DN) with Harvard Medical School.

3. I would like to be contacted by the Registry if researchers learn anything new about PMS.

4. I would like to be contacted by the Foundation if I, or my family member, becomes eligible for a clinical trial.

(Please note that even if the coordinators of a clinical trial believe that you might be eligible for the trial, based on the data about you stored in The Registry, it is still possible that later on it will turn out that you do not meet the trial inclusion criteria after all. Please also be aware that if we inform you about the existence of a trial, this does not imply that we endorse it. In order to participate in any trial, you will need to fill out a separate informed consent form.)

5. I give permission to the Foundation to contact me at least once a year to ask about changes to my medical condition, to request that I upload particular attachments, or to complete forms associated with my participation in the Registry.

6. I understand that my participation in the Registry is voluntary, and that if I change my mind and wish to withdraw my data from The Registry, that I will be free to do so without having to provide any explanation.

7. I understand this informed consent form, and I understand that I can return to this page at any time in the future if I want to review it.

8. I have had the opportunity to ask questions of the Registry Coordinator. All my questions have been answered to my satisfaction.