As a new or established Biobank you face many challenges and considerations. These include financing, ongoing cost recovery, collection logistics and where you will store your biological samples. In addition, you may need to manage distribution and usage agreements, intellectual property issues and decide what system you will use to track the data and manage your growing dynamic asset. One important thing that cannot be overlooked is the ethical considerations for Biobanks.
The importance of ethics
Ethics are important to instil confidence in your Biobank and any resulting research. This could be public (donor) confidence that your Biobank will treat biological samples with respect and use any biological materials for the purpose for which they were collected (typically important, valid research). In addition, this could be confidence from collaborators that you have the same values and are working towards the same goals.
There are many different professional associations and industry-bodies that have guidelines for managing ethics and these can cover a broad range of areas. But where do you start? If you have not already, you should establish your own ethics oversight committee whose role is to make informed, practical decisions about how you will operate and monitor progress. This will help you be clear about your ethical approach, incorporate this into your procedures and highlight issues for swift resolution.
Outlined below are some of the common ethical challenges and considerations that we have encountered whilst working with our customers.
Donor informed consent – all or nothing?
One big decision relating to how you manage donor informed consent for your biological samples is whether you give them any opt out choices. Some Biobanks find this issue so complex to manage that they simply refuse samples from a donor who is not willing to approve everything. Although this can simplify the management of your biological samples and remove doubt you could lose many prospective donors. However, opt-outs or opt-ins are increasingly being used as donors come to expect to be able to make informed choices about the usage of their valuable donations.
Broad consent versus specific
The wording of your informed consent is very important. If you make the research descriptions too broad the ethics committee may challenge you as to whether it is “fully informed” consent. However, if not, the consent will be invalid. In addition, if you ask the donors for every piece of research this can be complicated and risks annoying donors, so they withdraw consent anyway. Therefore, getting the balance right is very important.
Biobank approval or project-specific approval?
If you can have your Biobank ethically approved by the Health Research Authority (HRA) then you will not have to obtain individual ethics approval for each research project. However, while this is not legally mandated, there are other big advantages. It gives advice and ethical opinions and helps to avoid duplication between Biobanks. The HRA also recommends that consent includes approval for biological sample use on future ethically-approved research. Further, it is worth stating in the consent process that donors explicitly consent for the collection and use of future patient data.
Give due consideration to how you expect to handle biological samples from donors who have subsequently died. You might want cover this in a section of your informed consent form. The donor can decide whether you can continue using their biological samples or must destroy them.
What about clinical findings?
Another ethical challenge is: What would you do if your research discovered something that was clinically relevant to the donor? What if that were bad news or would influence their ongoing health? Would you withhold that information from the donor, go back to them directly or approach their clinician? If there is any chance of this happening, then you should cover this in the donor informed consent. You could build it into your defined Standard Operating Procedures (SOPs) and have it approved by your ethics oversight committee.
Use a database system to store consent
Modern sample tracking software or laboratory sample management systems can store details of each donor’s informed consent. That might be just details of what has been consented, although, this could include opt-outs, the location of the physical signed form and the version used for each donor. Further, it might extend to being able to store scanned images of the signed consent forms. You could consider storing redacted scans where researches do not have sight of patient identifiable data (PID). Alternatively, you could ensure sensitive (non-redacted) versions are only available to pre-approved users, for example, clinic nurses.
In addition, some systems will also support any digital formats. Therefore, you should also consider re-consenting by phone and saving the recording as an MP3 file in your database system. Some of our customers are already using this technique. As a result of this, they report that re-consent uptake levels are far higher than for traditional paper-based consent.
A final thought
There are many ethical considerations for Biobanks. However, with some forethought you can design SOPs and oversight structures that will keep your donors on board, demonstrate best practice and keep your options open for biological sample usage in new and innovative future research.
- NHS Health Research Authority (HRA) – https://www.hra.nhs.uk