Before biobanking projects can be carried out they must be approved either by a Research Ethics Committee (REC), who also regulate other medical research studies, or by the Human Tissue Authority.
The role of RECs is to ‘safeguard the rights, safety, dignity and well-being of people participating in research in the National Health Service. They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical.’ (NHS National Research Ethics Service).
The Human Tissue Authority also has a role in licensing and inspecting organisations that remove, store and use human tissue for research. The Human Tissue Authority aims to maintain confidence by ensuring that human tissue is used safely and ethically, and with proper consent.
Participants must be given information sheets explaining in detail what their involvement entails, what side effects (if any) they may experience and whom they can contact to make a complaint. (See also ‘Information and questions
’, and ‘What is involved in taking part?
’). They should also have the opportunity to ask questions if they wish.
Before taking part, participants are required to sign a consent form to indicate their agreement to take part and to confirm they understand what they have agreed to do. This includes knowing how to withdraw from the project if they change their mind.
There may be different options for withdrawing; for example participants may choose whether to remove their sample, data or both from the biobank, or to allow the biobank to continue to have access to it, but to have no further contact with them. If someone requests that their sample is destroyed this will be done. However, for practical reasons as well as to protect confidentiality and anonymity, samples and/or data already distributed by the biobank to other researchers may be untraceable. The biobank may therefore not be able to guarantee that samples or data will be completely destroyed.
Some people felt that there was too much emphasis placed on giving people a lot of information, particularly if taking part involves very little effort or risk, as is usually the case with biobanking. Vincent, for example, said he took ‘a leap in the dark’ and just wanted to trust the researchers. Karen and Claire admitted they did not read the leaflets, but recognised not everyone would feel the same way.
However, others thought it was very important to ensure properly informed consent, especially after incidents that received a lot of media attention, such as the discovery that a pathologist at Alder Hey children’s hospital had been retaining organs without consent after post mortems in the 1980s and 1990s. The investigation into this case was one of the factors which led to the setting up of the Human Tissue Authority.
Future use of samples and confidentiality
The main ethical concern that most people raised was how their sample would be used. Information and samples gathered in biobanks can be shared with researchers in other countries across the world. This may include researchers in universities, government institutes or industry (such as pharmaceutical companies researching new drugs), though samples cannot be sold for profit. This means people don’t always know what type of research will be conducted using their sample in future, even in cases where it was originally collected for one particular project.
It is also possible that samples could be linked to the donor’s medical records, so that their future health could be tracked and that they could be invited to participate in further research in the future. However, it was evident that a few people had not fully understood this, or could not remember what they had agreed to. For example, one woman said her understanding was that she would be asked for permission each time her data was used.
Not knowing how their sample was going to be used worried some people who thought that their privacy could be breached resulting in their data being misused. One man said this was the reason he decided not to take part. (See also ‘Deciding not to take part in biobanking
Others who did take part were also concerned about the implications of their data falling into the wrong hands. For example, a couple of people worried that if insurance companies got hold of it, they could use the data against them.
Secure storage of their data was generally important to people we talked to. However, like Colin, most trusted that biobanking was governed by strict rules regarding data sharing and protection. They had been told it would be made anonymous and their confidentiality would be maintained.
Some felt concerns about privacy were a bit exaggerated.
Data sharing with commercial companies
People had different feelings about their data being shared with commercial companies. Some thought it was a good idea as it might help in the development of new treatments for illnesses. However, they felt it was important that their data remained anonymous, and it would depend how it was going to be used. Others preferred publicly funded research to research conducted by commercial companies.
Other responsibilities to participants
There was some discussion about whether researchers had a duty to let people know about the findings of any research conducted using their sample. (See ‘Getting feedback
’). Whilst this may not always be possible in very long term biobanking projects, some saw it as a way for researchers to show respect for people’s involvement.
Others wanted staff to show respect for their involvement by not misusing the data and ensuring the results were accurately represented.