Using human samples and personal information raises some complicated questions. We have to consider what kind of permission tissue donors should give to the biobank, what protections the biobank needs in place to prevent any wrongdoing, as well as the interests of different communities (who may benefit from biobanking or may be concerned about it).
The interests of the people giving samples, the researchers, the people who hope to benefit from medicines and treatments developed through research, and the broader community, all have to be considered and weighed up.
The following information is designed to provide a broad overview of the issues raised by biobanking. You can also read more widely about these issues by accessing articles and information through the resources tab here.
Click the following issues to explore them further:
(4) Privacy and Confidentiality
(5) Benefit Sharing
(6) Return of Results
To protect a person giving a sample, the donor must consent to giving the biobank their samples. Meaning they must give permission to the researchers to use the sample. But it isn’t quite that simple.
There are different types of consent. In biobanking, donors have to give a special type of consent called 'informed consent'. This means that you need to have been given enough information so that you understand how your sample will be used, and the research that it will be used for. This doesn't mean, though, that you have to understand all of the science.
In law, some people are unable to give informed consent. This might be because of their age or level of mental capacity.
If you didn’t have to consent then a researcher could just take the blood you gave in a blood test and use it in their research. Consent protects donors by giving them a say. It also protects researchers by making them consider how they behave and making them responsible to donors.
You might be wondering why we are talking about governance. Don’t the people paying for the biobank organize governance? Yes, funders normally have a lot to do with governance. Remember, we are talking about a publicly funded biobank. That means the government needs to set up systems to protect how the biobank functions and what it can and cannot do.
What regulates or governs biobanks?
As well as needing to meet certain standards to have research approved, all biobanks must meet standards and follow procedures to ensure they are run properly over time. This is called 'governance'. There are two levels of governance:
(1) the first level is within the biobank and involves the people who are in charge making and following procedures, as well as monitoring compliance with procedures from government bodies.
(2) The second level is the rules and regulations made by government bodies and other relevant organisations.
At this second level of governance are Human Research Ethics Committees (HRECs). As described in the section on ethics approval for biobanks, HRECs have strict rules about how biobanks interact with people who donate samples and information, and the wider community. Biobanks must follow the rules and decisions made by an HREC.
This raises the question: who should be responsible for the governance of biobanks? Who controls the funding and how the data will be used will likely impact upon what governance is appropriate.
At the first level, it could be statutory (government) bodies, independent bodies (such as hospitals), charitable organisations, or other bodies such as a trust.
When would a researcher have access to the information and samples stored by the Biobank?
When researchers wish to use the information and samples stored in a biobank, they would have to apply to the Biobank Access Committee for permission. This Committee is composed of representatives of various interests, including:
• Researchers (from a university or research institute)
• Community members
• Government representatives (such as from the Department of Health and Human Services)
This committee would review all applications to use the biobank resources (samples and information) to assess whether they are scientifically and ethically sound. The aim of the committee would be to protect participant interests.
If a biobank is established there will be clear policies and regulations regarding who governs access. The composition of representatives of the Biobank access committee would be written into these regulation.
PRIVACY AND CONFIDENTIALITY
Privacy and confidentiality are different, but related, concepts. Privacy is relevant to the collection of information and allows you to be left alone or to keep information about yourself secret. Confidentiality is relevant to the disclosure of information about yourself and protects you against people who would make public information you wish to be kept secret.
Are biobanks required to protect privacy?
Any samples or information donated to a biobank are protected by State and Commonwealth laws which require large organisations, such as the University of Tasmania, to protect private information. These laws apply to your personal information, such as name, age, address, medical history and lifestyle information, and probably to any donated samples as well.
The guidelines mentioned above, the National Statement on Ethical Conduct in Human Research, requires all biobank employees and any researchers involved in using samples and information from a biobank to protect your privacy too.
A failure to protect privacy could result in a range of penalties, including the suspension of all public funding.
Read more about privacy and confidentiality.
What is benefit sharing?
Generally, people are happy to participate in medical research for selfless reasons. That is, they participate for the good of all society. People are also happy to participate if they have personal reasons for doing so, such as family members who have been diagnosed with a disease.
There are laws in place that prevent people from making a profit out of trading in human tissue. This means that people cannot sell their own tissue, and researchers cannot sell it either. However, if, say, a company discovers a new medicine from research using your tissue, they are likely to make some profits from selling the medicine. Because of this, some people think that when commercial companies are involved in research the participants should be paid for the use of their samples. But this is not a popular view because of the strong feeling in society that tissue should not be bought and sold.
RETURN OF RESULTS
In many health research studies, researchers send the participants the results of various tests produced during the course of the study, including x-rays, bone density results, blood tests and the like.
Research projects using the biobanks will be likely to involve studies into genetic disease. Results of these studies can link a particular gene with a particular disease or multiple diseases. But return of results in genetic research is more difficult than in other research health studies, and particularly for a biobank which is established to operate as a research platform over many years.
Will I receive individual results?
No. For a number of practical reasons it is generally not considered possible for a biobank to return individual results to participants.