HDTrials.org Charter

HDTrials.org has been formed by a consortium of members of the HD Community—both organizations and individuals. It was created for the sole purpose of developing a mechanism to accelerate the recruitment of participants for HD clinical studies and HD clinical trials.

HDSA will be responsible for the administration of the website/data base—however the website/data base will be hosted remotely from all other HDSA websites, data bases and networks—and will be managed by an individual who has no other involvement with HDSA, its website, network and data bases. The purpose of this is to protect confidentiality and the overall integrity of the information provided by the registrants. An HDSA senior staff member will be designated to oversee the outside manager and maintain all passwords. Initially this will be Fred Taubman, who will report to the HDTrials.org committee.

Registrants will be asked for two pieces of information—an email address and a zip code. Upon completing this very simple registration process, the registrant will receive:

• A confirmation email—that will include the list of participating organizations and sources for more detailed information on HD Clinical Trials
• Notices of clinical research in their area as they are announced, with information on how to contact the clinical study/trial administrator to enroll/find out more information

Registrants will be able to opt-out of the list at any time.

HDTrials.org will act in accord with all applicable laws and regulations. An Evaluation sub-committee (made up of HDTrials.org members) will review notices from researchers/ clinicians investigators wishing to utilize the system to recruit participants. Researchers/investigators will be asked to complete a registration form that will be reviewed by the Evaluation sub-committee to determine if the study meets the requirements for distribution through HDTrials.org.

Upon the Evaluation sub-committee’s approval, email notices will be sent to all HDTrials.org members registrants within the appropriate geographic area, notifying them of the study/trial so they may enroll/contact an appropriate person to express their interest in participating.

HDTrials.org will never release email addresses or geographic information to any entity. HDTrials.org will use geographic information only to help an investigator to determine if there are enough potential registrants (for a proposed study) available through the system in a particular geographic area. Registrants will receive email notices directly from HDTrials.org only.

The privacy and confidentiality of all registrants are of primary concerns to the organizers of HDTrials.org and the site has been created and will be managed with focus. The website will be hosted on a separate server, completely apart from the websites and databases of any of the participating organizations, including HDSA. HDSA will hire an administrator to create and manage the site who has no involvement and no responsibilities with any HDSA website, database or program. Instructions on how to create an anonymous email account (through Yahoo, Gmail, Hotmail and other providers) are available in the website.

HDTrials.org will ask researchers/clinicians investigators to report back with the number (only, no other information) of registrants or potential registrants they received via HDTrials.org

HDTrials.org committee will meet by phone at least once every 6 weeks to monitor progress, evaluate progress and discuss any changes to the process. New members will be added as needed.