The decision to participate in the donation of tissue for procurement and storage in biorepositories opens up a host of ethical and legal issues. Patients and donors should educate themselves as to how and for what their samples can be used. Privacy, consent, remuneration, confidentiality and compensation should all be considered. Below we discuss these consideration and provide information necessary to make decisions about becoming a donor.
If you donate your tissues or blood, you will need to give consent to use these samples for research purposes. The kind of consent will place restrictions on the types of research that can be done with your samples. Blanket consent often results in a situation where the donor does not obtain much information about how the samples are used. Furthermore, patients should reserve the right to withdraw their samples at any time. You can reserve the right to opt out of certain kinds of research but often the decision is complex and it might be wiser to reconsider donation.
Whether you are told about the results of the research that is carried out with your samples depends on the collector and the details of the agreement signed. In some cases, no information is given and, in others, the donor may agree to receive results from the studies. The facility should provide information about all the research that is going to be carried out with your material so that you can make the right decision about whether to participate and if results are available. In some cases, diagnosis of a disease might lead to early treatment so the donor might want to obtain results. But in the case that no treatment is available for a disease, the donor may want to consider opting out of the results.
Donors should always be provided a list of all those that can access their samples and information. It is common for only the biobank that takes your sample to have access to the patient's data. Data is most often anonymized so that no one can access the personal information about the clients. Only in very extreme cases does law enforcement have the right to access the identities of the donors.
In the instance of insurance companies, the rules for data dispersement depend on the type of testing done. Results need to be reported for diagnoses based on predictive and diagnostic testing. Insurance companies are not notified for diagnoses based on genetic research. Some facilities provide information to healthcare organizations. Public collection agencies may charge a fee for an organization to access your data. Check the details of your agreement to determine whether third parties can access your data.
Whether you can leave a biobank depends on the details of the agreement signed upon consent. If samples are anonymized, it might be impossible to leave. If samples have not been anonymized, it is less challenging to extract the data from the database. Patients and prospective donors should always ask if they have the option to leave the biorepository after their samples have been donated.
Biobanks and the collection of human tissue samples are subject to a number of ethical and legal considerations. It is important for patients to stay informed so that they know how their data is collected and used.