1. Which categories of biobanks exist and what are their goals?:
A biobank is the general term for a repository of biological tissue. But there is currently no universal classification system for biobanks. However, several categories are commonly distinguished, including tissue type, purpose, ownership, volunteer group, and size . For example:
- There are biobanks created from newborn screening blood spots by state newborn screening laboratories.
- Tumor banks are another class of biobanks, in which tumors from cancer patients are studied for biomarkers associated with disease.
- Biobanks of umbilical cord blood contains donated cells from a recent pregnancy for use in transplantation and stem cell research.
- Population-based biobanks are defined as large repositories of donated human DNA and/or its information, collected from volunteers with and without disease, used to identify genes that contribute to human disease, and to investigate possible therapies.
2. Where do population-based biobanks exist?
National population-based biobanks exist, or are being developed in many countries, including Estonia, Canada, Iceland, Japan, Latvia, Singapore, Sweden and the United Kingdom. Some of these biobanks involve the compilation of genetic, life style and genealogical information, other biobanks are more extensive, with links to individual medical records. These large biobanks range in size, from a few thousand to as many as a million volunteers. Most of them are public population-based biobanks, managed in partnership with the national government. A few also receive partial funding from research foundations.
3. Are there limits to the research that may be done?
Whenever individuals provide tissue for a biobank, they will have to explicitly consent to the use of their tissue for particular purposes. The consent may be limited (“narrow”) to the sample being used to investigate a single specific disease area, or a specific biological test. It could also be more encompassing (“broad”) permitting the use of the tissue for a number of purposes, investigating any biological marker, for any disease, at any time in the future. Most commonly, compromise between very narrow and very broad consents is used, providing both optimal use of the sample for research and consideration of the donor’s autonomy whilst also taking into account possible future uses that cannot be specified at least until the sample is taken. The nature of the consent provided defines the research that may be performed.
4. Who will be able to access the information about a specific individual in a biobank?
Participants donating tissue to a biobank should always be told who may have access to the information held about them, under what circumstances, and for what purposes, and to which degree their identity will be protected. It is usual that the person taking the samples will know personal details such as the participants name and address, but this information will be separated when the sample goes into storage and for future uses.
All researchers that use the tissues in a biobank would like to make new discoveries based on their work, and they would normally want such discoveries to be published in scientific journals, or perhaps result in reports that are submitted to regulatory authorities that review new medical treatments. However, the information in these reports or publications will not identify donors, nor permit anyone to link information to an identifiable person.
5. Will the police be able to get access?
For the reasons pointed out under Q 9, this is not possible unless a court order is issued.
6. Can the donor withdraw from a biobank after having joined one?
The right to withdraw, the implications of such withdrawal and any limitations (for example with regard to uses of samples or data prior to withdrawal) should be fully explained when the donor consents to provide a sample for a biobank. If samples have been anonymized a withdrawal is no longer possible. Withdrawal would only be possible as long as the anonymization process has not taken place.
In all other circumstances (coded, double-coded samples) a withdrawal of both specimen and data for future use is possible at any time upon the participant’s request. All future analyses will then be carried out without using this sample. Analyses already completed will not be modified (i.e. continue to contain the participant’s information as part of the overall result).
7. How long are biobanks set up to run for?
The life of the biobank depends on its intended use, and is generally specified in both the research proposal that is approved by ethical review and in the Informed Consent. Some samples that are collected for a very specific purpose may only be kept until this purpose has been achieved; others are collected for longer-term storage, for a period of say 10, 15, 30 years, or longer. Once the decision is made to remove samples from the biobank, they are destroyed, whereas data may continue to be retained. In some countries legislation exists to control the period of time that samples and data can be stored.
8. What happens when they close down?
If a biobank was created for a specific purpose that is no longer relevant, or if the establishment hosting the biobank closes, then the samples stored in the biobank should normally be destroyed. It is conceivable that the samples would be transferred to another host organisation. In that case, the accepting organisation must continue to protect the integrity of the samples and to ensure that they comply with the terms of the consent given by the original sample donors.
9. Can a donor say no to particular types of research?
Specific questions like this need to be discussed before consenting to donate a sample to a biobank, but it is likely that respecting such individual requests will be too complex for the biobank. It will therefore usually mean that participating donors wanting to restrict the use of their samples are not considered at all.
10. Will participants be told about their results?
Individual biobanks may make their own arrangement regarding communicating results to participants. However, for reasons of data protection and confidentiality, samples are coded or double-coded, precluding direct communication of individual results back to the patient. In addition, since most of the research conducted is early stage research, the medical significance of any results is still unclear, and it would be difficult or impossible to advise the participant of the meaning of the result.
11. What happens if research results show that the donor has a problem? Will he / she be told? What if the donor does not want to know?
This should be discussed when consenting to donate a sample to the biobank, because, for most biobanks, the results are not conveyed back to the participants. Biobanks do not provide information back directly to donors, but may do so to their doctor or other healthcare provider that obtained the sample. So it may be possible to ask the healthcare provider to pass on any information that they receive if it is in a form that is clinically useful. Certain research results are communicated via publications which are then used to develop new treatments or to inform clinical practice.
12. Is it safe to join a biobank?
The potential health risks from participation in a biobank might result from a mishap associated with the procedure of tissue collection. The donation of a blood sample carries the remote risk of injury, resulting in local tissue damage, and any skin puncture carries the remote chance of an infection being introduced into the body.
13. How is the provision of further information organized?
Once a person has donated his / her sample, he / she may hear nothing more. Some biobanks provide newsletters and other general updates to sample donors to keep them informed of progress. It may also be possible that their samples have helped contribute to a new medical finding or treatment that is reported in the media.
14. What if patients want to join a clinical trial but not give a sample to a biobank for further research uses separate from the trial?
When giving his / her informed consent for a clinical trial, a person may also be given the opportunity to agree separately to participate in a biobank or to decline such participation. In the vast majority of cases, if the person does not wish to participate in the biobank, it will have no impact upon his / her participation in the clinical trial.
15. Can healthcare companies obtain samples from public sector biobanks?
Some biobanks do make available their samples and/or data to any interested and approved researchers, be they from the public or commercial sector. Such access will depend on the approval of a research protocol and has to confirm that the proposed use is in line with the objectives of the biobank from whom the samples have been requested.
16. Will being in a biobank give a participant any direct benefit such as better medicinal care or a financial reward?
Donation of a sample to a biobank is almost always voluntary and undertaken for altruistic rather than for monetary motives, namely to help move research along and ultimately make progress in creating better medicines. Generally, donors will be reimbursed for expenses incurred, such as travel costs and/or time off work, but there will not be any further direct benefit for participants in terms of treatments. The hope is that new knowledge can be generated through research to reveal samples on disease causes and future treatment options.
17. How can someone find out if he / she is eligible to join a biobank?
There is an increasing number of biobanks now being established. Generally, a person will be asked directly to participate in this research by his / her health care provider, often in the context of participating in a drug trial or other clinical research which he / she is contributing to. If someone wishes to proactively volunteer, then the best source of information on biobanks operating in his / her local area is the internet. Examples of weblinks to some biobanks are given below. However, consultation with a physician is advisable in any case.