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Table 2 Coding sheet of findings

From: Exploring how biobanks communicate the possibility of commercial access and its associated benefits and risks in participant documents

Country

Biobank

Mention commercial interaction?*

Benefits articulated, and processes to ensure distribution of benefit

Mention and framing of risk sharing**

1. Austria

Graz biobank

Yes—states that research results can further be utilized scientifically or commercially, for example for patenting

General population benefit in terms of research and health benefits:

‘Your medical data and samples should lead to scientific knowledge of the causes, course, treatment and prevention of diseases and are eventually used for development and quality control of new diagnostic tools and methods, as well as for the training of health care professionals’

Documents mention that risks are very low, and it is the biobank’s responsibility to ensure data security

2. Estonia

Estonian biobank

Yes—states that the Genebank enables scientific and applied gene and health research

General population benefit in terms of research and health benefits, including personalised medicine. Plus:

‘Donors have right to be aware of their genetic data and other data about me stored in the Gene Bank, except my genealogy, and to genetic counselling upon accessing my data stored in the Gene Bank free of charge’

Documents state how the rights of the donor in relation to prevention of harm are derived from The Human Genes Research Act

3. Germany

BioMaterialBank Heidelberg

No—distinction was made in the PI sheet between whether those researchers who were permitted access were commercial or academic based

General population benefit in terms of research and health benefits

‘The donation of your biomaterial has no personal benefit for you at first. Financial compensation cannot and must not be for ethical and legal reasons. You can help to improve the diagnosis of cancer, infectious diseases, cardiovascular diagnosis of cancer, infectious diseases, cardiovascular diseases or other diseases or other serious illnesses and to research new treatment options’

Documents mention the biobank’s responsibility to ensure data security and an ethical review process. ‘Applications are carefully reviewed by the BMBH and the responsible ethics committee’

4. Finland

Finnish Red Cross Blood Service Biobank

Yes—states that the biobank’s resources can be used by commercial entities as per the Finnish Biobanking Act

General population benefit in terms of research and health benefits, including personalised medicine

‘Research results will be returned to the Biobank for use in future studies’

Documents state that risks of data security breaches are very low

5. Finland

THL Biobank

Yes—states that the biobank’s collaborative projects may result in commercial applications, and this is in line with the Finnish Biobanking Act

General population benefit in terms of research and health benefits, including personalised medicine. Benefits are framed as long-term and in the future due to the research nature of the biobank

Documents mention that the risk is very low, and it is the biobank’s responsibility to ensure data security

6. Finland

Finnish Clinical Biobank Tampere

No—does not mention anything about this topic on PI sheet/consent form

Benefits not mentioned. Documents state that when a study has ended, the results obtained from samples are returned to the biobank for use in future studies

Documents state that the risk of samples and data being misused is extremely low

7. Finland

Helsinki biobank

Yes—the website contained a justification for interacting with pharmaceutical companies

General population benefit in terms of research and health benefits, including personalised medicine. Documents state: ‘you also have the right to request any information about your health status that has been obtained in biobank research. However, it is seldom possible to benefit from the biobank’s research results directly in your own healthcare. If you wish, you can request analysis over the meaning of the results analysed from your samples, but a fee may be charged to cover the costs of the result verification and analysis’

Documents state that appropriate prerequisites for research are assessed in advance, so the risk of the samples and information in the biobank being misused is very low

8. Lithuania

IMI Biobank

Yes—provides a short justification of why it is important to provide access to pharmaceutical companies

General population benefit in terms of research and health benefits, including personalised medicine. Furthermore, the documents state:

‘You yourself have the right to actively contact the IMI Biobank and receive information on whether your biological sample and health information has been used. You will be able to get information about a specific biomedical research and its goals, as well as the results obtained’

This could be interpreted as relating to benefit sharing or to the right to information

Documents state the biobank will make every effort to ensure that data security is not violated. They also state that they have civil liability insurance for property and non-property damage that can ensure that those participating in the activities of the biobank are remunerated

9. Netherlands

Lifelines biobank and cohort study

No—does not mention commercial interactions, but explains that inventions might lead to intellectual property in PI sheet

General population benefit in terms of research and health benefits, including personalised medicine. No direct individual benefit bar via incidental findings. Though general population benefit was framed as an in-direct individual benefit. As such, individual benefit was viewed as a long-term outcome of biobank related research in terms of improved future health care

Documents state that there is little risk and research will be conducted confidentially and in line with data protection legislation. Department of legal affairs and insurance companies are excluded from accessing the data

10. Netherlands

Radboud UMC biobank

Yes—explains in PI sheet the importance of collaboration for some research projects, as well as potential consequences for intellectual property and profit development, though stipulating that  all benefit healthcare

General population benefit in terms of research and health benefits, including personalised medicine. Specifically, benefits are articulated as gaining knowledge, which benefits certain patient groups. Actionable incidental findings will also be communicated

Documents provide an explanation about data protection and privacy, especially if data is sent to non-EU countries

11.Netherlands

Amsterdam UMC biobank

Yes—the PI sheet explains in detail the consequences and process of collaboration, especially about responsibilities and conditions. The consent form offers and option for non contribution to these research projects

General population benefit in terms of research and health benefits, including personalised medicine. No direct individual benefit bar via incidental findings and improved future health care benefitting individuals indirectly

Documents mention disadvantages/risks of taking biosamples, and articulate no to little risk regarding privacy concerns

12.Netherlands

Groningen UMC biobank

Yes—the PI sheet explains reasons, consequences and the process of collaboration, especially about responsibilities and conditions

General population benefit, with knowledge gain in health and illness coming primarily from scientific research

Documents provide an explanation about data protection and privacy, especially if data is sent to non-EU countries

13. Norway

Hunt

Yes—the biobank provides detailed information on why it is important to provide access to commercial entities

General population benefit in terms of research and health benefits, including personalised medicine. Documents state that there is no direct individual benefit bar feedback such as activity measurement and blood test results from data collection. Incidental findings are also returned, if relevant

Documents mention that data security is managed via IT solutions and strict data management

14. Poland

Wroclaw research centre EIT + biobank

Yes—states that they cooperate with commercial ventures

General population health is mentioned. Incidental findings with clinical relevance will be communicated. The document also states:

‘As part of the project, patients participating in it will be guaranteed a free panel of blood tests (levels of homocysteine, ultra-sensitive CRP, glucose, insulin, total cholesterol, triglycerides, HDL, LDL). These results will be used to better characterize the health condition of the inhabitants of the voivodship, and the results will be sent to you via Polish Post, by registered letter with acknowledgment of receipt.’

Documents state that the biobank will take all appropriate technical measures to protect personal data

15. Sweden

Lifegene

No—the biobank does not allow commercial researchers access to the biobank resource

General population benefit in terms of research and health benefits: 'In the long run, we want to be able to prevent, diagnose and treat diseases such as allergies, depression, infections, cardiovascular disease and cancer'.

The consent form states:

‘You have the right to once a year, free of charge, know what information that is registered in LifeGene about you, from where information has been downloaded and to whom the data may have been submitted. An excerpt showing this information can be obtained after a signed request made to LifeGene. If it turns out that any information is incorrect, you have the right to have that information corrected, blocked or deleted’

Documents do not mention any risks due to participation. They do state how data will be kept secure

16. Sweden

VIP/NSHDS (Umeå)

Yes—thee biobank is in collaboration with a commercial partner and they explain this-and how the resource will be used-in the PI sheet and consent form

General population benefit in terms of research and health benefits, including personalised medicine. No direct individual benefit bar via incidental findings. Population benefit framed in terms of a regional benefit, but not described in any detail

No

17. UK

Human Developmental Biology Resource***

Yes—states that research may be carried out in commercial entities

General population benefit mentioned in terms of research and health benefits. PI sheet mentions: ‘What are the possible benefits of taking part? The donated tissue may be used in a number of research projects which will hopefully lead to a greater understanding of human development and ways in which we can identify and treat genetic diseases. The results of the research may contribute to the development of new drugs and treatments. However, you would not benefit from or be entitled to any profits resulting from this work’

The PI sheet states: ‘What are the possible risks of taking part? There are no additional risks. The treatment before, during, and after your procedure will be the same whether you decide to donate or not. and …because your genetic information is unique to you, there is a very small chance that someone could trace it back to you, by matching your genetic information to other entries on the internet. The risk of this happening is extremely small, but may grow in the future.’

18. UK

UK Biobank

Yes—the consent form requires a participant to declare that they will not benefit financially from taking part (e.g. if research leads to commercial development of a new treatment). The PI sheet, states in several places that commercial companies will be able to access the bioresource for approved research

Consent form mentions that participants will not receive financial benefits and frames future generations as main recipients of benefit.

The consent form has a section stating: 'I understand that none of my results will be given to me (except for some measurements during this visit) and that I will not benefit financially from taking part (e.g. if research leads to commercial development of a new treatment)'. The

PI sheet mentions: 'Like giving blood for transfusions, UK Biobank is not intended to help directly those who take part—but it should give future generations a much better chance of living their lives free of diseases that disable and kill'

PI sheet states:'the risks of participants suffering harm as a result of taking part are minimal, and UK Biobank has insurance in place to provide compensation for any negligent harm caused by participation'.

The PI sheet also states: 'Taking part in UK Biobank should not cause you any harm. The project aims to observe what happens to participants over the next few decades so that future generations can benefit. It is not intended to change directly what happens to people who take part: in particular, the initial assessment visit is not a “health check”. Apart from providing you with the results of some standard measurements made during that visit, none of your results will be given to you or your doctors (even if the results do not seem to be normal).

This is because such feedback outside of the normal clinical setting is of questionable value, and might even be harmful (for example, causing undue alarm and having potentially adverse effects on insurance status), especially when given without prior counselling or support...

Participation involves a minimal risk in relation to the use of personal information. Great care will be taken to ensure the confidentiality of all data (see below) and the risk to participants of a breach of confidentiality is considered very low."

In a different section about potential risks the PI sheet states:" Over the coming years, a very wide range of tests will be done on your blood, saliva and urine samples for approved medical and other health-related research. Details that might identify you will be removed from any information and samples provided to researchers in order that they cannot be traced back to you. None of your particular test results will be fed back to you, your doctors or anyone else. So, taking part should not have any adverse effects on you (including your employment status or ability to get insurance)'

19. UK

Generation Scotland

Yes—the consent form requires the participant to declare that they understand that 'the Universities and funders involved in this project have a financial interest in using the results to develop new treatments and that this may involve commercial companies (e.g. drug companies)'.

The PI sheet elaborates further on the subject of commercialisation and has a section on 'What about commercialisation? Will industry be involved in any way?'

The PI sheet explicitly has a question about comemrcialisation in which they expand on benefit sharing. A part of this states:

"This project is designed first and foremost to further public good….Any health-related benefits of this work may take many years to develop and successful developments may give rise to intellectual property rights, such as patents. Individual contributions do not have any financial value by themselves and you will not receive any financial gain from taking part. However, some of the revenue from any successful commercial projects will be returned to support the NHS and health research"

Also, the consent form states: I understand that

". The Universities and funders involved in this project have a financial interest in using the results to develop new treatments and that this may involve commercial companies (e.g. drug companies)

. I am giving blood as a gift and I will not have any legal claim on it

. I am giving consent for my blood and materials prepared from it (e.g. DNA) to be used for genetic studies. The results of these studies may be used for making patent applications, without any payment to me or my family"

The PI sheet only mentions disadvantages /risks to taking part in terms of the risks of sampling blood from the potential participant

  1. *Commercial interaction here only referred to commercial access to a biobank’s resource, rather than with regard to a biobank’s operational management. Note: this information does not tell us whether (or not) biobanks interact with commercial companies, only whether it was stated in the recruitment documents
  2. **Risk is all risk associated with participation, excluding acute risk from the physical action of taking biosamples or completing health questionnaires
  3. ***We were only able to obtain the PI sheet for this biobank, and not the consent form