By Research Participants:
- What will happen between now and July 1st 2011 – do I still attend my REGISTRY/COHORT visit?
Yes. Please attend your scheduled REGISTRY or COHORT visit. Your continued participation in HD clinical research is important to finding treatments and we greatly appreciate your effort!
- Will I still see the same doctor for my study visit?
Yes in all likelihood. All REGISTRY and COHORT study sites are most welcome to continue to participate in Enroll-HD. If for some reason the study site you are attending does not continue in the study every effort will be made to facilitate your participation at another convenient study site.
- What will happen to my samples and the information collected about me?
They will continue to be available to advance HD research. Your samples will continue to be safely stored in the same biorepositories where they are now kept and all information about you will be securely stored in accordance with applicable local laws and regulations regarding the protection of your privacy.
- Can my other family members still take part in the study?
Of course, we hope they do! No need to wait until next July to start. Anyone who enrolls in REGISTRY or COHORT before then will be automatically welcome to continue in Enroll-HD.
- If my current site does not participate in Enroll-HD can I go to another site?
Yes. During the transition period you will be given information on exactly how you can access a participating site should your current site choose not to participate.
- As an investigator in REGISTRY or COHORT, what do I do from now until July 2011?
You should continue to see your participants in COHORT and REGISTRY without interruption. We will communicate on a regular basis with all the COHORT and REGISTRY sites to outline the steps needed to make the transition to Enroll-HD. We want this to be a smooth transition for you and your study participants.
- Will I need to get IRB/ERB approval for Enroll-HD? How about informed consent?
It is intended that Enroll-HD- will incorporate the best of COHORT and REGISTRY, which will result in a new protocol and informed consent. This means that reapproval by your IRB/ERB will be necessary and research participants will need to re-consent at their first Enroll-HD study visit. Every effort will be made by the transition team to make this as simple as possible for the site investigator and coordinator.
- Will I have to re-negotiate my contract? Will I receive the same reimbursement?
Yes, in most cases a new contract will be necessary. Because there will be changes to the study and the administration of the contracts, new contracts will need to be signed. We do not anticipate major changes to the site budgets or payments. There may be some changes in how payments are broken down by the actual work performed at each visit – this will provide for more flexibility and consistency across all the regions.
- I submitted a data/sample request to COHORT/REGISTRY – what will happen to my request?
Your request will be processed according to the steps outlined for the COHORT and REGISTRY studies. Eventually, a new process for handling the requests for samples and data access will be implemented for Enroll-HD. The new process will take the best practices from COHORT and REGISTRY to ensure the data and samples collected in Enroll-HD are put to their best scientific use and there is the same rigorous ethical scrutiny.
- How can I get involved in the planning process for Enroll-HD?
To facilitate the combination of REGISTRY and COHORT studies, working groups will be formed to address the following topics: protocol development, ethics/regulatory, site management, participant/site recruitment, data management, bio-repositories, data and sample sharing, and publication and communication. If you are interested in participating in one or more of these working groups please send an email to that effect to Joseph.Giuliano@CHDIFoundation.org.
- How can I receive more information about Enroll-HD?
Send an email to Info@EnrollHD.org. Email updates of progress and plans will be sent out periodically, and a dedicated website for Enroll-HD is planned.