Blood and Tissue Banks

A powerful way to consolidate your members' power to have an active role in research that truly benefits affected individuals is to create a repository for blood and tissue. A blood and tissue bank is an archive where specimens (DNA, blood, and tissues) can be stored for use in research to identify genes and their mutations. This research is designed to lead to new approaches to treatment for specific conditions in the future; it is not intended to yield treatment plans for individual donors. When an advocacy organization leads this effort, it can protect its members from potential conflicts of interest among researchers and corporations interested in genetic information.

Historically, the research environment has been competitive and fragmented, and blood and tissue collections have been small and inconsistently managed. A collection might contain samples only from individuals with more severe effects of the condition, since those individuals might be more motivated to participate in studies. Different collections might have different consent and confidentiality procedures, offering participants inconsistent protections. Samples have often been considered the property of the research entity that collected them, and this has hindered sharing material with other researchers and has limited reporting of outcome information to research participants.

These limitations can contribute to a sense among individuals and families with genetic conditions that they are "mined" for their biological material, perhaps without a clear benefit. This impression reduces trust between researchers and participants, especially for individuals affected by a rare condition that is not well understood.

A blood and tissue bank is not a trivial undertaking. Specimens must be collected and stored in a uniform way depending on the material and its expected use. Quality-control procedures ”such as methods of DNA extraction, archiving, and distribution ”must be established and carefully maintained. A facility may need to distribute kits and follow up with individuals and other facilities about specimen collection, as well as maintain secure physical plants with controls and backups to ensure safe, long-term storage of biological materials.

A good blood and tissue bank doesn't just have these physical attributes. It also has strong confidentiality protections, an informed decision-making process that is sensitive to research participants' needs, and a sound method for vetting researcher requests. A participant-centered bank supports the needs of individuals and families with genetic conditions” protecting their interests, responding to their goals for improved outcomes, and reporting specific information to them as appropriate. All these protections and strengths require involved and knowledgeable direction that is both supportive of research and responsible to participants.

A cooperative effort can give a broad base of organizations access to blood and tissue banking, rather than leaving blood and tissue banks in the hands of wealthy organizations or organizations with unique relationships to existing institutions. A central leadership that establishes policies and practices can release the power of a tissue bank as a consolidator of substantial collections and a clearinghouse for participant-responsive work ”even to organizations that have no ready access to facilities or research partners.

This cooperative effort can establish recruitment policies, oversee ongoing education support for member organizations, engage members in a culturally sensitive informed-consent process, and implement data-management policies and procedures that protect privacy and access ”both to specimens and to the participants that contributed them. These policies and activities can give shape and focus to research with requirements such as IRB approval and agreements to provide regular progress reports for both scientific and lay audiences.

A cooperative blood and tissue bank can speed gene discovery, build mutation databases, and improve the understanding of genotype/phenotype correlations. These cooperatives gather organizations together to share the costs of the endeavor while enjoying the reduced overhead of larger-scale operations. And it can do this in a responsible way: by advocating for member organizations in interactions with researchers, enforcing protection of specimens used, and protecting the privacy of research participants. A collective biorepository can be a lever that allows members to move research.

Collecting Specimins

Phlebotomy

Genetic Alliance has a contract with a vendor to offer phlebotomy services at outreach events through Genetic Alliance Registry & BioBank. We can offer phlebotomy services to non-members for a fee.

Know your venue

If hosting a function at a hotel, you will also want to work with the hotel to let them know what you are doing. Be discreet on the day of the event. Not all hotel staff may be comfortable around blood draws/ biological materials. Using the term “health fair” is a good general descriptor.It is best to have a room just for the blood draws, and then have it open for specific hours during the conference.

Staffing the event

You will also need to staff the blood draw event, including people who can answer questions about the project, people to manage the materials once they have been collected, and someone to manage the master list and kits so samples are not mixed up (a big concern at events). You will also need to plan around fed-ex pickups and have a plan for keeping the samples cool if hosting in a warm climate.

The estimated number of people who will participate, the number of tubes for the blood draw, and the hours that you plan to do the collection will help determine how many phlebotomists are needed. You will also need to factor in time for consent if the donors have not participated in the informed consent process (and have someone trained in the informed consent process). Explore factors of using a paid phlebotomist through a vendor vs. a volunteer who could draw blood (e.g. a nurse on our medical board who offered to do it for free). A paid phlebotomist who has insurance that covered their activities may be a better option for your organization than a volunteer (whose insurance didn’t cover activities outside of their work environment) based on your needs and financial resources.

There are a lot of moving pieces, so planning is essential. Collecting samples at a family conference can be very effective if done well.

Genetic Alliance BioBank Membership

Genetic Alliance BioBank is a centralized, advocacy-owned, biological sample repository and registry that enables translational genomic research. The BioBank provides registry and repository solutions and shared infrastructure for disease-specific organizations to pursue sophisticated, new collaborations with academia and industry to accelerate research, develop new diagnostics and therapeutics, and better understand and treat disease. The BioBank is a cooperative and currently has six member organizations. It offers web-based questionnaire tools in a user-friendly interface to allow individuals or their providers to input clinical information.

Visit www.biobank.org to learn more about the application process and Genetic Alliance BioBank.

You can also subscribe to Genetic Alliance BioBank's Bulletin to stay current with all of the news and conferences related to biobanking. Genetic Alliance BioBank sends a monthly newsletter to keep interested individuals informed of developments in the fields of registries and biorepositories. The newsletter highlights relevant funding announcements, training opportunities, scientific meetings, and recent updates from the literature.

Visit http://geneticalliance.org/about/mailinglist/biobank to see past editions of the Bulletin.

Registry and Biobank Weekly Tips

Genetic Alliance Registry and BioBank has created a new Registry and Biobank Weekly Tips series tailored for advocacy organizations interested in registries and biobanks. We hope these tips will help you in your journey of creating and cultivating your registry or biobank and foster fruitful discussion.

Internal Links

• Barriers to Rare Disease Research
• Benefits of Collaboration with Advocacy Organization Community
  • Genetic Alliance BioBank
• BioBanks
• Consumers and Researchers
• Educating Membership about Research
• Facilitating Quality Research
• Funding Research by Others
• Getting Needs onto the Research Agenda
• Genetic Privacy
• Orphan Drug Application
• Patient's Bill of Rights
• Promoting Research
• Registries
• Research Models
  • Research Model 1: Recessive Disorder
  • Research Model 2: Chromosomal Disorder
  • Research Model 3: Dominant Disorder