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GenomeDenmark > Ethics FAQ

Ethics FAQ

Here, you will find information concerning common ethical issues and answers regarding research within the field of genomics.

Via the link below, you can also find the National Research Ethics Committee guidelines regarding genome mapping projects.
Guidelines for genome mapping projects (Danish)

Donors partaking in research

● How is personal information protected
GenomeDenmark scientists don’t know which donor’s sequences or data sets they are working on, since samples and sequences are either fully anonymous or coded to remove any references to specific individuals. Data is generated, archived and analysed on computers with limited access, meaning only certified staff members are granted access. Furthermore, data from selected individuals isn't published - instead, only average data based on many donors are published, since this does not allow data to be traced back to individual donors by researchers from outside GenomeDenmark.

● Can donors retract their tissue samples after the donation
Patients can request that tissue removed in connection with treatments in hospitals isn’t used for research purposes. This will not harm the patient in any way. Donors who voluntarily take part in research projects can always retract their consent. This, however, only covers future projects. Scientists will still have the rights to use the tissue and data within projects already begun.

● Who can access my information
Scientists and official partners if they come from a country with a sufficient level of data safety (according to the European guidelines for data management). In the case of cooperation with other countries, a contract must be formed regarding the data safety requirements. On the Danish Reference Genome Project, data analysis must only take place on Danish servers./span>

● Do I have the rights to know what researches find out about me
No. Researchers won’t inform individuals about their data, since the researchers don’t know whose data they are working on. Only in extreme cases, donors may be contacted by the researchers, if the donors can be identified. This will only happen if the researches discover unknown genetic variations by pure chance (this is called an incidental finding) and these variations are likely to cause a serious illness. At the same time, a treatment solution has to exist. If a treatment cannot be identified for an identified incidental finding, it is not considered ethically acceptable to contact the donors and cause worries.

● Do I have the rights to not know what researchers find out about me
Generally, yes. The Danish Research Ethics rules do, however, contain certain instances, in which donors will be contacted. If researches discover unexpected genetic variations by chance, which is likely to lead to serious illnesses, and such an illness can be prevented and/or treated, the donor will be contacted. This will, however, only happen once a certified council has evaluated the case and communicated with the donor’s doctor.

● Can my family become involved
In the situation mentioned above concerning incidental findings, identified genetic variations could also be shared with the donor’s family. Thus, there might be a need to include also the family in follow-up actions - typically genetic counselling.

● What can we conclude from Genomcis today/span>
Actually, we’ve only just begun exploring what can be concluded from genomics data. Even so, we have already traced some illnesses and physiological trademarks in individuals. In any case, much information derived only from genomics can be quite complex and therefore still allow only uncertain interpretation and prediction. In general, prediction of monogenic disorders (diseases that occur due to a single gene defect) is still the only area where prediction from genomics information is safe.

● Can my tissue be exploited for new research projects
If researchers are interested in using your tissue for new research projects, they will have to clear this with the Danish Research Ethics Committee as well as the Data Protection Agency. The committee will determine if you need to renew your consent, or new research is ethically acceptable without contacting you. When the Research Ethics Committee is involved, main ethical questions concern whether or not the objectives of the new project are different from the objectives of the original projector whether incidental findings may occur.

How is my data secured

● How is personal/genomic data secured
First and foremost, the projects only include anonymous or coded samples, so the researchers won’t be able to identify the individual behind the data set they are analysing. Data is generated, archived and analysed on computers with limited access, and only approved staff members are granted access. Furthermore, data from selected individuals aren't released - only an average results based on many individuals published.

● Who can access the research data
Researchers on the project and certified partners. Acceptance from the Danish Research Ethics Committee and/or the Data Protection Agency must exist. These authorities must also approve new partners joining the project.

● How large a part of my genome is unique to me
Every person’s genome is unique, as no other individual has the exact same sequence - not even identical twins. Still, human genomes share many features. There are many common features between parents and children, but also entire populations within geographic areas that haven’t experience migration for a while. Only when a person’s genome has been sequenced, it is possible to determine how different the said genome is from an average one, such as the Danish reference genome. As an illustrative example, it can be mentioned that the human genome is on average only 4 % different than that of chimpanzees.

● Will it be possible to trace me if this data is made public
Individual donor genomes are not made public by GenomeDenmark. Sequences or other information are only published as average data from many individuals that doesn’t allow data from individuals to be extracted or traced. However, for arguments sake, one can imagine that the donor genomes were individually published. In such a situation and under normal circumstances, it would also not be possible (e.g. by a forensic genetics expert or by an insurance agent) to trace back the sequence to an individual and thus to identify the donor, without access to other sources of personal information. For normal persons, it is simply not possible to predict enough physiological features from the genome to identify a specific individual without any other information. However, examples do exist, where sequence information from individuals had been published without personal identifiers and where identification was possible anyhow because close relatives had published their own sequences in databases searching for distant relatives. Such sequences turned out to be sufficient to demonstrate a family relationship with the anonymous donor. In this way, information published by private persons turned out to reveal the identity of donors partaking in research and expecting anonymity. In the future, it might be wanted and feasible to make the genomes of many Danes available to doctors and hospitals, in turn making it possible to exploit genomic data to achieve a better healthcare system. Should this become possible, data storage solutions with very high security standards would have to be instated to protect the personal informations.

Can genomes be bought and sold

● Who is in charge of genomics information from individuals
This question doesn’t have one clear answer, as most of our genomes are shared between humans and particularly families. It is often a consideration trying to balance the needs and rights of the individual against the needs and rights of close family members, doctors needing a clear diagnosis or societal needs for information relevant to entire healthcare system.

● Are genomes patentable
Natural genes or entire genomes aren’t patentable. Yet, synthetic sequences (for instance bio-technological production) or discoveries based on knowledge from genome studies or specific genes are patentable.

● Can genomics data be exploited commercially
Knowledge from genome studies might be patentable, and can perhaps be utilized commercially if new knowledge has emerged during the studies of genomics data which might turn into specific products such as diagnostics or medicine.

● Does GenomeDenmark support commercial activities
The GenomeDenmark platform focuses primarily on basic research which can’t be expected to be directly commercialized, perhaps only through further development. The private firms Bavarian Nordic and BGI-Europe do, however, take part in GenomeDenmark to, if possible, bring the results into practical application. Through interaction with public institutions, these firms receive input with regards to their internal research and development. Furthermore, knowledge transfers are carried out which can potentially aid the firm’s commercial activities. If new results are found or inventions are made bearing commercial value, the firms will be able to negotiate taking over said inventions based on regular market terms.

● Who owns genomics inventions done by GenomeDenmark
If inventions are made during the project, these are collaboratively owned by the institutions, whose personnel contributed to it. This also covers inventions made based on results derived from tissue samples or genomics data from specific donors. Yet, the inventor won’t be able to claim the donor genome – only specific inventions derived from knowledge based on tissue donations are patentable.

● Are donors paid when their data is used commercially
No. Payments aren’t offered, as it’s a scientific principle not to pay participants in such research projects. Participation is purely voluntary and shouldn’t be affected by a possible gain. As such, the donors won’t receive any rewards. Instead, the effort translates into usable knowledge for society which might eventually help the health care system treat illnesses more effectively or help pharmaceutical companies develop new types of medicine for treatment.