Donor

Donor


Q1: Why are human tissues and body fluids vital for research?

By studying human tissue, cells or fluids, scientists can learn about health, how diseases develop and why individuals respond to treatments differently. They can also test new drugs on tissues to see whether they are safe and whether they work before trying them in human volunteers (clinical trial). These studies may lead to the development of new medicines, diagnostic tests and other treatments.
Biospecimens such as blood, surgical tissue, saliva, and urine contain genetic material that researchers analyze to identify gene variations associated with human diseases. By identifying the role that genes play in disease formation, researchers may be able to develop new diagnostic tests and targeted treatments for specific diseases and to investigate how genes interact with environmental factors. This research may also open the way to “personalized medicine”—treatments that are customized to a person’s genetic profile.

Q2: Why Biobanks?

Scientific biobanks are indispensable for scientific investigation and study of certain disorders and biologic phenomenon.

In the modern biobanks, tissue samples are stored and conserved in several different ways in order to allow as many analyses as possible. An integral part of scientific biobanks is the clinical database with detailed data about the general health condition, medical history, progression of disease and treatment, etc…. The discoveries and observations need analysis in order to be interpreted in an optimal way.

Biobanks give researchers access to data representing a large number of people. Samples in biobanks and the data derived from those samples can often be used by multiple researchers for cross purpose research studies.

Biobanks have emerged as a significant research tool, gaining support from both the scientific community and regional, national and international research funding agencies.

Q3: Where are biological samples coming from?

Biological samples (or biospecimens) in these collections are taken for diagnostic purposes and, according to the official regulations, they are stored even after the establishment of diagnosis. Most of these biospecimens are collected during routine clinical and surgical procedures. In this case, individuals did not give consent for those biospecimens to be used in research but the Belgian law has adopted what we call the "presumed consent": research based solely on this residual human corporal materiel can proceed based on the approval by the ethical committee and the fact that the patient/donor did not oppose. Of course, the patient has the right to oppose to the use of this residual human corporal materiel for research by simply letting this known to the hospital, without any justification.

Donating samples to a biobank can happen on a be voluntary basis. During a hospital visit, a patient can be asked whether he or she would be interested in donating his or her samples to the hospital’s biobank for a specific research. The potential sample donors will receive detailed information about biobank research and data privacy issues, after which they can decide whether to donate their samples. Sample donors can also at any time withdraw their consent and prohibit further use of their samples.


Q4: Why am I being invited?

You are being invited because you have, previously had, or recently have been invited, to visit hospital for a biopsy, surgical procedure, or a clinic that involves the removal of a body samples, e.g. blood or a tumour. We are asking you to donate material removed as part of, or alongside, your routine care or treatment, and left over after diagnosis, to the clinical trial or research project.
We are asking you and other individuals attending the clinic, taking part on the clinical trial or research study to donate an additional sample.


Q5: What will happen if I agree to take part?

  • You will be asked to give your written permission by signing a consent form.
  • If you need to undergo surgery or a clinical procedure which involves the removal of tissue or body fluids, these samples will usually be sent to the pathology laboratory in the hospital to help with your diagnosis. In many cases some of the sample will be left over. Part of this is normally stored, for example, in case new diagnostic tests become available in the future, while the rest may be disposed of. With your permission, the hospital will give some of the tissue or bodily fluid that is not needed for diagnosis to the biobank.
  • We may contact you in the future to update this information or invite you to take part in a new study.
  • We would also like to access your medical record. This is because information about your condition, other disease(s) and your treatment will greatly increase the usefulness of your donated samples in research. Information from your medical records that could identify you (such as name, full address, full date of birth) will not be passed to researchers.
    • We request that researchers give us data from any studies carried out using donated samples and information from the biobank. This adds to the richness of information linked to your sample(s).
    • Your information and related research results may be shared with other biobanks, research groups or institutions or placed in scientific databases in a way that does not identify you.
    • Researchers will not be provided with any identifiable personal information such as your name, full address or phone number.

Q6: What is the 'consent'?

There is international consensus that for research with humans to be ethical, at least two key requirements must be met: an ethical committee must review and approve a study before researchers recruit participants, and participants must voluntarily consent to be in the study. In other instances, individuals may have given consent for specific types of research with their biospecimens, but later on researchers want to use them for other types of studies. The Belgian BioBank has a process that lets researchers recontact individuals to obtain consent for new research with their stored biospecimens as the need arises.
Sometimes, stored biospecimens were collected for purposes other than research, for example during routine clinical and surgical procedures. In this case, individuals did not give consent for those biospecimens to be used in research but the Belgian law has adopted what we call the "presumed consent": research based solely on this residual human corporal materiel can proceed based on the approval by the ethical committee and the fact that the patient/donor did not oppose. Of course, the patient has the right to oppose to the use of this residual human corporal materiel for research by simply letting this known to the hospital, without any justification.

Q7: Who will access my samples and data?

Your sample(s) and associated information may be used immediately or stored until released to researchers for use in ethically and/or scientifically approved research.
Scientists who use your samples and data may work in universities, hospitals, industries or commercial companies that do biomedical or pharmaceutical research, and may be part of large groups of scientists working together.
We may charge researchers a fee for access to your samples and data to cover the costs of collection, storage and transportation. If scientists develop a beneficial new test, treatment or drug, tested or developed in part using your samples, a commercial company or other research organisation may then make a profit out of the product they have developed by producing it on a large scale in order to improve health of a large number of persons. However, we regard your sample as a gift and you will not receive any personal financial reward for your donation or from the results of the research, either now or in the future.

Q8: How are the data protected?

The privacy of biobank participants' information is protected by removal of personal identifiers before data are made available to researchers. Removing fields that include names, addresses, birthdates, phone and fax numbers, driver's license and identification numbers, URLs, IP and email addresses, photographs, fingerprints, and other biometric identifiers is often viewed as an effective de-identification of data.
To protect the professional interests of scientists and the rights of research participants, biobanks are increasingly making use of a variety of access agreements. Usually some of the data from the biobank (a limited amount of de-identified clinical data annotation fields) will be made available to researchers while the more sensitive data and samples, if accessible at all, will be made available only to researchers who agree to comply with the strict terms of these access agreements.

Q9: How will my samples and data be stored?

To keep your information and samples confidential, we have put many safeguards in place. In particular, we will:

  • Remove personal identifiers such as your name, full address or full date of birth from your samples and health information.
  • Assign codes to your samples and health information.
  • Keep your identifiable personal details separate from your health information and samples.
  • Only provide researchers with the coded information and samples.
  • Ensure that relevant agreements and data security measures are in place to protect your data and samples.
  • Ensure that researchers sign a contract with the Biobank that includes provisions on how the data and samples may be stored and used, which applies even if the data and samples are transferred abroad.
  • Use stringent data security measures to prevent unauthorized use, including: strict access controls, computer security and data encryption techniques, confidentiality agreements and staff training.
  • Not allow third parties, such as employers, insurance companies or other family members, to access any of your information.
  • Not identify you in any resulting publications.
  • Be able to re-link your personal details with your samples and information, should you want to withdraw from a future study.
  • Store samples in a secure facility meeting high security and safety standards. The same coding and security measures that are in place for your data will also apply to your samples.
  • Ensure that your biological samples and data are stored, used and disposed of in accordance with legal requirements. In Belgium, storage of human cells and tissue for research is governed by the Human Tissue Act (2004) and the law on the obtaining of Human Corporal Materiel (HCM) for medical research from December 19th, 2008. Data confidentiality must meet the requirements of the Data Protection Act (1998).

Q10: What if I change my mind?

Withdrawal of consent to use of your samples and data in research does not affect your access to treatment or standard of care. You are free to withdraw consent at any time without giving a reason.

  • No further use option: If you choose to withdraw your consent we will destroy all tissue and other samples we hold that have not been distributed or used. We will also destroy all information we have collected about you apart from a small amount of data we must hold for archival or audit purposes. We will no longer access your medical records and will not contact you again. However, if some time has passed your samples and information may have already been transferred to or used in research projects. We cannot get these samples back nor remove related information from studies that have already started. This is because scientists need to keep records of all data and samples they have used to allow their results to be checked.
  • No further contact: If you choose this option, the biobank would no longer contact you directly, but we would be able to use the samples and data you provided previously and to obtain and use information from your medical records.
  • No further access: If you choose this option, the biobank would no longer contact you directly or obtain further information from your medical records in the future, but we would be able to use the samples and data you provided previously.


Contact details:

  • Contact us: +32(2) 555.48.74
  • Email:info@biotheque-wallonie-bruxelles.be
  • Q11: Who has approved the research?

    The collection and storage of biological samples and the research protocol have been approved by an appropriate research ethical committee. We only release tissue and data to scientists from the public and private sector if the research they are undertaking falls within the remit of our ethical approval or is approved following submission by the researchers to an appropriate ethical committee.

    Q12: What is an 'ethical committee'?

    The members of the Ethical Committee come from a wide variety of medical and non-medical fields: such as doctors, nurses, social workers, ethicists, lawyers…
    They safeguard the rights, safety, dignity and well-being of research participants, independently of research sponsors.
    Click here to see the text from the law on human experimentation form May 7th, 2004 (in French).

    Q13: Why an 'ethical committee'?

    The purpose of ethics review is to ensure that persons independent of the research determine that the study’s potential benefits to participants outweigh the potential risks of research participation. The informed consent rule is to ensure that individuals who enroll in a study understand its purpose and voluntarily agree to expose themselves to potential research risks.

    Q14: Will my samples be used in genetic research?

    Your biological samples may be studied as part of research into genetic disorders, diseases (such as some cancers) that may be influenced by genes, or characteristics that could be inherited. This research may range from looking at one gene to examining all of your genes. The biobank, clinical trial or research project will not disclose information about your genetic make-up to third parties in any way that could affect you. Researchers studying genes will not have any information that could be used to identify you.
    Other genetic research may look at characteristics that are not normally inherited, e.g. to discover ways in which cancer cells have changed compared with healthy cells.


    Q15: Are the research results published?

    Not all research results are published, and even those that are usually appear long after the study began and in specialized science journals. Thus, people who provide biospecimens for research—along with the general public—might never learn the outcome of that research. There are reasons for not disclosing some findings. Preliminary or inconclusive results might not have clinical value and could provide misleading information about the causes of disease, especially when the research involves analysis of genetic materials. Genetic research results have privacy implications for family members who did not provide biospecimens for research.
    Despite these concerns support is growing for the principle that researchers and study sponsors have an obligation to disclose both positive and negative research results, provided that certain conditions are met. Yet how and when to do this remains unclear.
    Some international medical and scientific working groups recommended that researchers disclose results of genetic studies when the associated risk for the disease is significant, when the disease has important health or significant reproductive implications, and when proven therapeutic or preventive interventions are available.


    Q16: How long will my sample and date be stored?

    Tissue preservation techniques ensure that tissue and cells remain usable in research for many years. Your samples and data may be stored ten years or more unless an ethics committee decides otherwise.


    Q17: Can I donate cells or tissue after death?

    Donating tissue and cells after death can make a significant contribution to our understanding of the causes of disease and in developing new treatments.
    If you are interested in donating, you will need to complete and sign a ‘Statement of Intent to Donate’. If you are interested in becoming a donor, please discuss this with your family and friends and share your decision with them too. This is important as it will enable them to carry out your wishes after your death. Unless you have made your wishes known, they may not be carried out.


    Q18: Will I receive any compensation for being involved?

    Your involvement is on a voluntary basis. There will be no payment for the donation of tissue, fluids, data. However, you will receive reimbursement for travelling expenses and other inconveniences related to taking part, when visiting the clinic, etc… .