Consent is a complex issue because firstly, consent needs to be informed and secondly, the nature of biobanking makes it very difficult to be informed.
Why is this?
1. Consent needs to be informed.
Consent needs to be informed so participants need to be given information about the research going to be done and understand it. This is an obvious problem with public biobanks because they are created so that data can be stored and used for lots of different research projects at the same time and also in the future. The problem is, that you can’t know all the different research projects that your samples might be used for, and neither can the biobank.
In addition, a biobank can store tissue indefinitely. There really is no end to the number of projects your samples can potentially be used for. This means that consent is a continuing process.
What sort of information do you need to be informed?
• The purpose of the biobank
• The ethics and governance arrangements of the biobank
• Access which will be allowed for research and other purposes
• Disclosure of information to participants
• The communication strategy of the biobank
• The commercialisation of the tissues stored and benefit sharing
• That there is a right to withdraw consent
• Where your tissue is being stored and disposed
• Whether you would like to be re-contacted regarding your tissue and personal information
Can everyone give informed consent?
No. When someone is a child, or a person does not have the capacity to consent they cannot give informed consent at law. A guardian may consent upon their behalf. It is also problematic where the individual (participant in the biobank) is no longer contactable, incapacitated or dead.
2. It is difficult to give informed consent to a biobank because the nature of biobanks mean no one can know of and understand all the research your samples may be used in.
Consent is generally required when new samples and information are collected. It may also be required when an existing sample or information will be used for a new purpose, such as a new type of research.
Biobanks are large-scale, long-term projects. Generally, you would have to ask each participant to consent to each individual research project. This would be too difficult for the biobank to do. As such, there are ways to consent more broadly so your samples and data can be used in lots of research projects without you having to be re-contacted. However, participants retain the right to withdraw consent to any future use of their samples and data.
So, how do you consent?
There are different types of consent so that participants can give biobanks permission to use their samples to varying degrees. The broader the consent that a participant gives, the more research the biobank can use your samples for without you needing to be re-contacted and asked to renew your consent (to the new purpose or type of research.)
Below is a table of the different types of consent. A biobank would make a decision about the type of consent that they would want you to give upon donating samples.
Name of Consent Limit of Consent
Option 1: Specific Consent Consent is asked for every single instance of research. It requires participants to constantly re-consent.
Option 2: Broad Consent Participant consents to everything with a certain type of research eg. genetic research.
Option 3: Blanket Consent Participants consent to any/all types of research including research currently not known.
Option 4: Sunset Clause Consent Broad or blanket consent is given on the condition that it will be reviewed at a later date, subject to feedback provided to the donor about how their samples and information have been used.
Option 5: Ethics Committee Approval Consent is initially given by the participant to the biobank. But subsequent decisions about consent to different research or new purposes of research are made by the Ethics Committee.
What does ‘broad’ consent really mean?
If you give general or ‘broad’ consent, this means you consent to use of samples in certain types of research (eg. research into the genetic factors for common diseases.) That means that your consent is valid for lots of research projects, so you don’t have to be contacted to consent to each individual research project.
When you give such broad consent you have options that pre-determine your decisions in the case of certain events. For example:
• On the death of the participant will consent be continuing, withdrawn or given with the condition that a nominated person has the right to withdraw consent?
• If there can be return of individual genetic results, does the participant want to be contacted and their results returned?
• If an incapacitated person becomes able, or a child becomes an adult, they have power to revoke any consent that a guardian has given.
Can you withdraw broad consent?
The consent is not irrevocable. The biobank would publicise new research projects before they commence (eg. in the media and on the biobank website) giving participants the opportunity to withdraw their consent to participate in particular or any future research.
Once consent is withdrawn the participant's tissue and information will not be used in any future research. Generally identifying information will be deleted from the code holder's database. The sample can be located and destroyed. however where that sample has already been used for research; the data cannot be withdrawn as it has been de-identified or it has been aggregated with other data for research purposes.
No matter what type of consent is given, the limitation is the same (ie. consent cannot be withdrawn if samples have already been used in research regardless of the type of consent you give.)
Now you know about informed consent and the different types of consent. What is your opinion on broad consent? Give us your opinion, or take our survey or read more about the issues involved with biobanking.