Here are some of the questions most frequently asked about the Repository. If you have a question not addressed on our web site, please contact Sara Loud at 781-487-0032 or email@example.com.
Why do we need a repository focused on MS?
Although MS has been actively studied for a long time, there is still much that is unknown about the causes and mechanisms of MS. Studying human samples is essential to understanding these aspects of MS.
How is the ACP Repository different from other repositories?
While other sample repositories do exist, few are focused on MS and related diseases or offer a large number of samples or significant epidemiological data on the donors, and many lack sufficient medical records to back up the diagnosis of the condition being studied.
Moreover, many repositories are established for a single purpose and are not useful to people in another discipline (e.g., samples are collected for genetics, but are not useful for other purposes). Not all repositories are shared outside the labs that created them, and most repositories collect samples from each study participant once. Our Repository has been designed to address each of these issues.
In addition, data derived from studying our Repository’s samples are returned to the database and shared with future researchers using the samples. This increases the value of the collection with each study performed, allowing us to find connections across experiments. With most other repositories, results obtained from use of the samples remain in isolated data sets.
Who is involved with the Repository?
The staff at Accelerated Cure Project is committed to the development of the Repository as a resource for researchers investigating the causes and mechanisms of MS and related demyelinating diseases. We have worked closely with the Transverse Myelitis Association to expand our original concept, initially focused exclusively on MS and Clinically Isolated Syndromes (CIS), to also include TM, ADEM, NMO and ON.
As the sponsor of the repository, Accelerated Cure Project is responsible for its design, operation and funding. We rely on our top-notch research and development advisory board for scientific guidance and review. The actual specimen and data collection process is conducted at enrolling sites across the country. We also have partnered with The Guthy-Jackson Charitable Foundation to run the Neuromyelitis Optica Repository.
In addition, we have engaged three primary vendors, SeraCare BioServices, Inc. (SeraCare), Document Solutions Group, Inc. (DSG), and Theorem Clinical Research to assist us with the sample processing and storage, data management, and site management tasks, respectively.
Are you working with the National MS Society?
Yes, we are regularly in touch with the New England Chapter, Fast Forward, and the national leadership to keep them informed of what we are doing and to look for ways we can help each other. Several of the studies that are using our samples have been funded by grants from the National MS Society.
What costs are associated with the creation and maintenance of the Repository?
To date, we have invested more than $8.7 million in the ACP Repository. The major line items are site-related collection costs, storage costs, and costs associated with management of a multi-center human study.
For more information on the costs involved in establishing our Repository, download an overview of our Repository budget.
How are ACP and the Repository funded?
Accelerated Cure Project and the Repository are funded primarily by individual donors, particularly those personally affected by MS. A portion of our funding also comes from corporate sponsors and private foundations.
Gifts are solicited and raised through annual written appeals, corporate and volunteer-driven fundraising events (such as our annual scavenger hunt), foundation grant requests, and personal interactions with donors.
Accelerated Cure Project has earned recognition as a significant player in the MS community for our innovative, problem-solving approach to curing MS and for uniting MS research institutions to work on the problem collaboratively. Our donors appreciate this approach and the focused nature of our efforts.
If you support the goals of this project, we encourage you to make a donation.
How many people have enrolled in the Repository already?
What types of studies has your Repository supported?
Do you have your own labs?
No, we don’t have our own laboratories but pursue our mission through collaborations.
How can I participate as a study participant?
Is there a collection site near me?
Our currently enrolling sites are located at:
- Beth Israel Deaconess Medical Center, Boston, MA
- UMass Memorial, Worcester, MA
- MS Research Center of New York, New York, NY
- Johns Hopkins, Baltimore, MD
- Shepherd Center, Atlanta, GA
- Ohio State University, Columbus, OH
- University of Colorado/Rocky Mountain MS Center, Aurora, CO
- UT Southwestern, Dallas, TX
- Stanford University, Stanford, CA
If you are located near a site, please contact the site's study coordinator to discuss enrollment in the study. Learn more about our collection sites.
What are my options for enrolling in the Repository if I am not located near a collection site?
Currently, we are limited to enrolling study participants at our collection sites, although if you have been diagnosed with neuromyelitis optica (NMO), you can join the study by accepting a visit from a study nurse. We continue to work toward opening new sites as funding allows. Please contact our Repository director or sign up for our mailing list to be notified if a new site opens close to you.
If you don't live near a site, but do travel near one of them, you can enroll during your travels. Please contact the site's study coordinator in advance of your travel to discuss enrollment in the study.
How can people without MS or any of the specified demyelinating diseases participate as controls?
If you are related to or have some other personal connection with a Repository participant who does have a demyelinating disease, you may be eligible to enroll as a control. Please contact the study coordinator at the relevant collection site to discuss participation. We are not currently enrolling control participants who are not related or connected to an existing participant, but we may in the future. Contact our Repository director to express your interest.
How do you enroll participants?
Enrolling sites conduct a pre-screening process by evaluating their current patients against the inclusion/exclusion criteria and determining which of their patients may be eligible for participation in the repository.
Those patients are approached and provided with a copy of the informed consent document, a paper copy of the case report form and a copy of any pre-visit checklists that site personnel have prepared to instruct the patient what they would need to bring to a study visit.
Some sites also display or send out advertisements or flyers to attract interested potential study participants.
Do you require study participants to sign an informed consent form?
Yes. Prior to performing any study procedures, the principal investigator or study coordinator conducts the consent process by reviewing the written form with the study participant and also giving an oral description of the procedures.
Once potential study participants have had all of their questions answered and feel as though they fully understand what participation in the study means, they may choose to give their consent or choose not to participate. If they do wish to participate they must sign the informed consent form, if they can, or provide oral consent to a witness who will then sign the form for them.
A copy of the signed informed consent form is given to the study participant, a copy of the signature page is made for Accelerated Cure Project, and the original consent form is kept in the study participant's study file.
How do you maintain study participant confidentiality?
Each collection kit used in the repository is marked by SeraCare with a unique alphanumeric barcode which will become the unique identifier for a study participant. All collected samples and data are marked with that barcode in lieu of the study participant's name.
In order to establish the link between the study participant's identity and his/her barcode, the study coordinator fills out a confidential contact sheet (CCS) which documents the barcode and the study participant's contact information. This allows the study participant to be contacted in the future by the site in order to participate in the longitudinal visits. The site makes a temporary copy of the CCS (which they will only keep for six months) and sends the original to Accelerated Cure Project where we keep the information in a secure location.
Because we at Accelerated Cure Project maintain the link between the study participant's identity and this original barcode, a second barcode is also generated by SeraCare for each study participant. This secondary barcode and its link to the first barcode are known only by SeraCare and DSG personnel (who have no knowledge of the link between the first barcode and the study participant identity). The DSG system holds the link between these two barcodes and presents the second barcode as the study participant identifier when anyone from Accelerated Cure Project logs into to the EDC system. This prevents the stored data from ever being associated with a study participant's identity.
Can study participants refer relatives or others to participate in the study?
All cases are asked to refer others to the study. Essentially, we seek to enroll any affected blood relatives, any identical siblings (affected or unaffected) and then one or two first degree blood relatives (parents, siblings, etc.). If a study participant does not have any available blood relatives to refer, he or she may be asked to refer a closely matched unrelated friend.
When the study participant's referrals are enrolled into the study, the site coordinator fills out the participant unit form via the data collection system which links the study participant's barcode with the barcodes of their referrals. If any referrals also meet the case inclusion criteria of this study, their barcodes are also entered into new PUFs so that they may then refer their relatives and other controls.
All study participants are reimbursed a site-specific nominal amount for time, travel, transportation, etc.
How do you follow up with study participants?
Study participants may be contacted by site personnel approximately every 1-2 years for a follow-up visit which may include additional blood draws, a new CRF interview and/or the updating of medical status. As indicated in the informed consent, the study participant may elect to not participate in these follow-up visits.
Will brain tissue and/or cerebrospinal fluid (CSF) be collected?
We began with the collection of blood because it is readily available. We intend to add CSF in future but this will be optional for participants.
How are collection site locations selected?
What is required for sites to participate in the repository?
To participate in our repository, sites must receive approval to enroll study participants and have the necessary regulatory documents in place. For example, each participating site has had an Institutional Review Board approve the protocol, informed consent form, and any additional materials given to study participants.
Each site has also received training on the protocol, collection, and shipping procedures from SeraCare BioServices, Inc. (SeraCare) and on the use of the electronic data capture system from Document Solutions Group, Inc. (DSG).
How do you monitor the repository sites?
Each enrolling site participates in weekly monitoring with the Theorem Clinical Research site monitor. During these calls, the site monitor and the study coordinator discuss how the study is progressing at the site. They review any personnel changes that have occurred at the site, address any factors that are affecting the site's ability to enroll, and discuss any issues associated with the protocol, electronic data capture system, etc.
How do investigators obtain samples and/or data from the repository?
We solicit proposals requesting biological samples from investigators studying the causes and mechanisms of MS and related demyelinating diseases.
Written proposals are initially reviewed by ACP staff for completeness, alignment with the goals of the repository, and our ability to fulfill the request. Any issues with the proposal are conveyed to the investigator who is given an opportunity to make changes.
The proposal is then reviewed by the repository oversight committee which assesses the proposal against a variety of factors including the scientific merit of the application and the potential benefit to people with MS and related diseases. The committee then makes a recommendation regarding whether to approve the sample request.
ACP makes a final decision on providing the samples and associated data and communicates that decision to the investigator.
Investigators who receive samples from the repository agree to submit their data generated from use of the specimens back to the repository for incorporation into the sample database.
- Review the application procedure, proposal form, and sample material transfer agreement.
- Learn more about how you can request access to biospecimen samples and data.
How do you decide what samples to collect?
In deciding what samples to collect, we consulted with our research and development advisory board and other experts. The major points of consideration were which types of samples would be most useful to the research community and would maintain integrity during storage. We also needed to consider the limits to the amount of blood that can be drawn from an individual in this type of study (110 milliliters for adults 18 years and older, lesser amounts for children and adolescents).
We then worked with SeraCare BioServices, Inc. (SeraCare) to further refine the kit contents and to define the processing and shipping procedures needed to ensure the highest quality of the samples. We have also built some flexibility into the kit and are able to modify its composition (by adding one or more tubes) to respond to specific research proposals.
What type of data collection instrument do you use?
Our data collection instrument, the case report form (CRF), was also developed in consultation with our research and development advisory board. We undertook a fairly extensive process of asking other scientists for their questionnaires, laying all the options out, and deciding which questions made the most sense in our context.
Our pilot project helped us identify questions that were and were not working well. In addition, from our experiences on the pilot study which used a paper CRF, we decided to utilize electronic data capture (EDC) for the main study. Using an EDC system results in cleaner data more quickly.
We selected Document Solutions Group, Inc. (DSG) as our EDC vendor and have worked together to convert our paper questionnaire into a computer based CRF. DSG has designed and implemented the software necessary to check the study participant's answers as they are entered during the interview. DSG also performs the rest of the data management tasks associated with the repository—storing of all of the anonymized study participant data, distribution of data upon request, and others.
How are samples and data collected from study participants?
The study coordinator uses the tubes in the collection kit (currently nine tubes that contain up to 66 ml of blood for adults) to collect blood from the study participant. These tubes are marked with the study participant's barcode and date and time of draw, processed according to the specimen handling instructions and shipped to SeraCare BioServices, Inc. (SeraCare) for further processing and storage.
The study coordinator also interviews the study participant and completes the case report form (CRF) on the computer. During this interview, the study coordinator collects information about the study participant's environmental, geographical and medical history, demographic data, and current clinical status. All data is stored at Document Solutions Group, Inc. (DSG) under the assigned barcode.
If the study participant is unable to complete the entire interview during that first visit, the site can complete the interview during a later visit; provided that a minimum subset of questions needed to characterize the blood sample itself have been answered on the day of the blood draw. Sites are encouraged to complete the interview with the study participant as soon as possible to minimize the need for follow-up.
During the interview, any discrepancies or errors in the entered data will be caught by the electronic data capture software. In addition, after the data is entered into the system, it reviewed for completeness and correctness by Theorem Clinical Research and Accelerated Cure Project staff.
The site coordinator next gathers all supportive diagnostic reports (MRIs, lab reports, etc.) from the study participant's medical records. These reports are anonymized at the site, marked with the study participant's barcode and faxed to Theorem where they are uploaded into the EDC system.
As the last step in the data collection process, the enrolling physician completes the last several pages of the CRF which document how the study participant was diagnosed with his/her disease and the results of standard clinical tests and assessments that have been performed for that study participant.
How can I set up my own repository?
There are many effective ways to set up a repository and we are frequently asked what steps we took in designing ours. We began with a pilot project at two sites: Beth Israel Deaconess in Boston, MA and University of Massachusetts Medical School in Worcester, MA. We believed that the learning associated with going through the process on a smaller scale would prove invaluable, and it was. Upon successful completion of the pilot, we incorporated the lessons learned into the design of the main repository.
We evaluate potential collection sites based on their interest in performing the study as described in the study protocol document, ability to meet the collection requirements as described in the site qualification checklist, geographic location, the population of patients served, and the availability of site staff to conduct the study. Review our page on how to establish a collection site or contact our Repository Director for more information.