WHAT IS A BIOBANK/BIOREPOSITORY?
[Click to view PowerPoint presentation 14_1221_GA_Biobank.pdf]
A biobank is a collection of human tissue samples and medical information about donors, which are stored for long periods of times and are used for research studies.
A ‘biorepository´ is the collection and storage of human blood or tissue samples. They are kept in large freezers to keep the samples usable. Usually, people who donate blood or tissue samples to a biorepository will also fill out a questionnaire. When the researchers go to use the samples for research studies, the samples are not very useful unless they know something about the person it came from.
The samples and the information come from donors. Donors are people who voluntarily decide to take part in the biobank. They give a blood or tissue sample or information about themselves for free. Usually, when someone wants to donate tissue or information about him or herself to a biobank, it’s because they have a disease or condition and they want to help researchers who are looking for new treatments or for a cure for their disease.
WHY ARE THEY IMPORTANT?
Biobanks are a way in which ordinary people, as well as patients, can become involved with medical research. By donating biological samples and specimens, participants can help accelerate research studies and find treatments for diseases.
Furthermore, the structure of biobanks fosters cross-collaboration between disease advocacy organizations and research scientists. Biobanks produce a synergy that hastens the research process. Making treatments or cures to genetic conditions attainable in the near future.
If you or your loved ones are diagnosed with an illness or disease tomorrow, you will want to go to the pharmacy and pick up the right prescription. However, an effective treatment may not be available yet. Discovering and developing the right treatments requires volunteers to step forward and offer their health information to researchers. Imagine if all of us offered all of our health information so that there was no lack of health data?
Right now health data are not readily available. Let’s offer this great resource to all, and not lock it down with one researcher or company!
To see where biobanks/biorepositories fit into the drug development process, visit NETS! NETS stands for Navigating the Ecosystem of Translational Science and provides a webmap of drug development complete with descriptions and resources for each step of the process! Click here to access the full view of NETS.
Contacting Biobanks and Biorepositories
Patients, unaffected participants, and citizen scientists have access to many biobanks and biorepositories through online databases. Independent biobanks often have their own webpages where the public can initiate contact. These biobanks usually have secure pathways for participants to donate biological specimens for research use. Visit our resources page to find a handful of accessible online biobanks and biorepositories.
Starting a Biobank
Likewise, advocacy organizations play a key role in the advancement of therapies and treatments for diseases and are in the best position to create a biobank that can help accelerate solutions. In the beginning, a lot of planning is required to guarantee your biobank’s success and sustainability. Consider the following:
- What information should be collected? How?
- How/where will the information be stored?
- Who will manage the collection?
- Who can access the collection?
- Data only or data with biological samples?
- Who will advise you?
- Resource considerations
- Financial considerations
Prospective participants for registries and/or biobanks may be concerned about privacy. Some worry that health information could be shared in a way that will harm them, and negatively affect their career, family and insurance. To address some of these concerns, Congress passed the Health Insurance Portability and Accountability Act (HIPAA) in 1996 and the Genetic Information Nondiscrimination Act (GINA) in 2008 to help protect health information.
It is important to ask the biobank or registry what regulations they follow. These vary greatly from institution to institution and there are no set standards for all institutions.
Participants should ask about the privacy and confidentiality policies of the biobank or registry and make sure they understand them.
There have been many concerns in the news recently about discrimination, privacy and the appropriate use of samples. A donor’s information is confidential, meaning that their name is usually in their records but is kept secret. No insurance companies or employers will ever see any of the questions that the donor answers or know that their tissue was used in any experiments. Nothing that is donated will be used for anything besides research. If a donor is suspected of a crime, for example, the police cannot use DNA from their donated sample in their investigation. All of their information, answers to questions and their samples are kept carefully locked up and protected by computer firewalls and alarm systems.
When the donor first decides to give information or a sample, one of the forms they have to read and sign is an Informed Consent document. The document will tell them how their information and sample will be used, how it will not be used, where it will be kept, how it will be protected, and who will be able to see or use it. If the donor understands all of this information and agrees to donate, then they can sign the document and go on to give their sample and information. Informed consent is extremely important to read and understand. It protects the donor from having something done with their donation that they do not approve of, and it protects the researchers using their donation to make sure they are following the law and not breaking the established rules about their research study.
Click here to learn more about Genetic Alliance Registry and BioBank’s Boot Camp.
The Biotrust Ethics Team members are gathered from around the world to provide guidance for biobanking, registry, and research initiatives hosted by Genetic Alliance. The team works through dialogue to find the principles that guide and inform our practices and policies, permeating our interactions, our invitations, our systems. The BioTrust Ethics Team provides input on high level mission statements and on-the-ground daily decisions in operating the research resources. Our expertise includes governance, data access, data sharing, engagement, and trustworthy research practices.
Kelly Edwards, University of Washington, Chair
Nicholas Anderson, University of Washington
Greg Biggers, Genomera
Leila Jamal, Johns Hopkins University
Jane Kaye, Oxford University
Kieran O’Doherty, University of Guelph
Suzanne Vernon, CFIDS Association of America
David Winickoff, University of California at Berkeley