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Informed Consent Scientific Research

At the Netherlands Cancer Institute (NKI) we collect personal data and body materials for the purpose of your diagnosis and treatment. They are valuable for scientific research. We would like to ask for your informed consent to use your data for this purpose.

We collect and store several personal and medical details from our patients, as well as biological samples, for the benefit of your treatment: scans, blood, urine, or tissue. Some data, imaging, or biological samples may be beneficial to our scientific research into cancer and related conditions, and to help improve our care. We call this "other uses". We will not need to collect additional data or body materials from you. We can use the materials we previously collected as long as you consent to this before collection.

Read more about granting us informed consent, scientific research, and its importance on this page.

We recommend reading this page carefully.

Then we will ask you to decide whether you grant us permission to use your data. You can grant us permission during your registration at the NKI with a member of our staff. he or she will register your decision in your patient file.

If you do not grant us permission, we may still ask you to participate in other specific studies. This may involve submitting a questionnaire, or participating in a clinical trial. We will always ask for additional and separate content. 

Why is your consent so important?

By granting us permission to use your data, you can help us reach our goal: a cure for every cancer. Scientific research teaches us more about the prevention, treatment, and recovery of cancer and related conditions, and how we can improve our care. Scientific research also helps us understand how we can further improve the quality of life of our patients. That is important for our current and future patients.

 

What kinds of research?

We conduct various types of scientific cancer research, including genetic research. We often conduct this research together with other researchers in the Netherlands and abroad. We want to better understand cancer and related conditions so we can treat it better. We also want to keep improving the quality of life of our patients. That's why we also conduct research in the treatment and care for patients. 

Important research results are published in scientific journals. You will be completely anonymous and the results can never be traced back to you.

For more up-to-date information about our research, check out the latest news below.

What kind of research has been conducted over the past years using stored patient data and biological samples? And what will this mean for future patients?

What kind of research has been conducted over the past years using stored patient data and biological samples? And what will this mean for future patients?

  • We have investigated whether we could find new tumor characteristics that could help predict the outcome of the treatment. This will help our physicians to find the best treatment option together with their patients.
  • We have researched new and better ways to deliver radiation to avoid damaging healthy tissue. Better radiation techniques allow us to better treat the tumor without harming the surrounding tissue.
  • We have researched the effects of cancer treatment on the quality of life of our patients. This knowledge can help us guide cancer patients and their loved ones better during and after their illness.
  • We research new ways to improve care for our patients. Small improvements can have a tremendous effect on our patient care.
  • We have looked into the reasons why certain treatment types work for some patients but don't work (as well) for others. What kinds of genetic changes cause these differences? This understanding helped us develop new treatment types.
  • We researched why treatments sometimes stop working or are less effective after a certain amount of time. How can we avoid this?

More information about scientific research using stored patient data and body materials is available here.

For which data and samples do we need your permission?

We may use the following data and samples for our scientific research: 

  • Personal data, such as your height, weight, gender, age.
  • Information about your condition(s), including the drugs you take, the treatment you are receiving, and the treatment results.
  • Imaging of your body, such as x-rays, ultrasounds, and scans.
  • Voice recordings, such as recordings of your speech during a visit to a speech therapist.
  • Biological samples, such as blood, urine (or data that can be extracted from the aforementioned, such as genetic data), or tissue removed during surgery which has been used to diagnose you.

Consent granted does not apply to scientific studies (trials). Before your participation in a trial, your consent is requested separately.

Why are my biological samples stored?

Blood, tissue, or urine can be used to determine your diagnosis. We store the remaining materials. 

If you return to the hospital with new symptoms, we can use these biological samples to diagnose these symptoms.

We will only use your biological samples if enough is left over. 

We will keep enough tissue for any potential future necessary diagnoses or treatments.

How do we use your biological samples?

  • We use the samples to research cancer and related conditions: how can we prevent, treat, and cure these illnesses? And how can we improve our patient care?
  • We collaborate with scientific researchers from other institutes or companies. Some of these researchers work from abroad. These collaborations can further improve our research results. When we collaborate with other scientists, we would like to share your data with them.
  • We would like to share your data with organizations that register medical (and other) data, including:
    • The causes of death registration of the Statistics Netherlands (CBS) 
    • The Netherlands Cancer Registry (NCR)

Find a full overview of organizations with whom we are obliged to share your data, click here.  

  • A researcher may detect something that is important for your health or that of your family. In these extremely rare cases, your physician will inform you about this.
We handle your data with care. 

Read more about how we handle your data.

  • We comply with the rules and legislation concerning data processing and protection (General Data Protection Regulation) and the scientific research codes of conduct as agreed upon by physicians, researchers, and patients associations. These agreements can be found in the codes of conduct for good use and good practice ('Codes Goed Gebruik en Goed Gedrag'; Federa-COREON).
  • All data is stored electronically in your patient file in a secure way. Only authorized personnel can access your file.
  • If we need any data from your patient file for scientific research, we work with encoded data as much as possible so our researchers cannot trace any of the information back to you. All research using patient data or biological samples will first be evaluated by an ethics committee.
  • When collaborating with researchers outside of the EU, we will only share your data if they handle your data as securely as researchers within the EU. 
  • Before sharing your personal data or biological samples with other researchers, we establish written agreements about the use of the material, every single time.
  • If one of our researchers writes an article about the results of a study using your personal data or biological samples, none of the readers will be able to tell that the data or samples belong to you.

Read more about the way we handle your data and samples, as well as your rights, in our privacy statement

Do we make a profit from the research?

We do not make a profit from our scientific research. We do not sell your personal data or biological samples to third parties looking to make a profit. Any funding we generate through our research will be used for patient care or further scientific research.

Until when does the informed consent apply?

Your informed consent will remain valid for as long as you want. It will apply until you withdraw it. Your permission will also apply to any personal data or biological samples we collect in the future.

Would you prefer not to consent or would you like to withdraw your consent?

Your treatment or contact with us will not be affected if you do not consent to the use of your data and samples. You do not need to give us a reason behind your choice. 

Your physician will continue to provide the same care as before. We will still store your biological samples for use in your treatment, now and in the future. But we will never use your data for scientific research.

An employee from the clinic or department you are visiting will register your choice in your patient fle during your next visit. 

You are free to withdraw your consent at any time. 

Withdrawing your consent does not mean that any research based on your personal data will be withdrawn as well.

For more information, please contact your physician, or call +31 (0)20-5129111 during weekdays or send an email to privacy@nki.nl.

What will be registered in my patient file?

  • All patients can view the status of their consent in their patient file on MijnAVL. For more information, please visit www.avl.nl/mijnavl.
  • You can submit or withdraw your consent at any time. Please notify a desk employee at the clinic or department of your decision during your next visit. 

Frequently asked questions

In May 2019, all patients at the NKI received a letter. Why? 

If you are a patient at our hospital, we collect personal data and biological samples to help with your diagnosis and treatment. 

Some data, imaging, and biological samples may benefit our scientific research into cancer and patient care if you give us permission to use this data. This is called "other usage".

We will not need to collect any additional data or samples. There are no additional steps involved for you.

Why do we this, what is the importance of your informed consent?

Your data and biological samples help us reach our goal: finding a cure for every cancer.

Scientific research shows us how we can prevent, treat, and cure cancer and related conditions.

It also offers us opportunities to improve our care. Scientific research gives us more insight into ways in which we can improve the quality of life for all current and future patients.

What exactly am I consenting to?

We collect and store several personal and medical details from our patients, as well as body materials, for the benefit of your diagnostics, treatment, or additional diagnostics.

Some data, images, or body materials can be beneficial to our scientific research into cancer and related conditions, and to help improve our care.

We call this "other uses". We will not need to collect additional data or body materials from you. This will not require any additional steps.

Why does the NKI ask for this informed consent??

We want to actively ask our patients whether they want to take part in, and consent to, scientific research.

Patients wish to be better informed about the use of their personal data and samples. Since 2016, the NKI has been working towards that goal. Research from the NKI has shown that 71 to 84% of patients prefer a clear consent procedure with clear information.

The NKI wishes to offer all its patients full transparency.

Can I give or withdraw my consent at any time?

You can give or withdraw your consent at any time. You can change your consent by notifying the staff at the desk of the clinic you are visiting.

or change your choice by emailing toestemming@nki.nl. Please include your choice, your name, and your date of birth. A member of our staff will add your decision to your patient file. 

Your decision will not affect your treatment or contact with our staff. You will receive the same care from your practicing physician, no matter what.

What kind of research has been conducted over the past years using stored patient data and biological samples?

  • We have investigated whether we could find new tumor characteristics that could help predict the outcome of the treatment. This will help our physicians to find the best treatment option together with their patients.
  • We have researched new and better ways to deliver radiation to avoid damaging healthy tissue. Better radiation techniques allow us to better treat the tumor without harming the surrounding tissue.
  • We have researched the effects of cancer treatment on the quality of life of our patients. This knowledge can help us guide cancer patients and their loved ones better during and after their illness.
  • We research new ways to improve care for our patients. Small improvements can have a tremendous effect on our patient care.
  • We have looked into the reasons why certain treatment types work for some patients but don't work (as well) for others. What kinds of genetic changes cause these differences? This understanding helped us develop new treatment types.
  • We have researched why treatments sometimes stop working or are less effective after a certain amount of time using patient data from their files. How can we avoid or solve this problem?
  • We have used biological samples from patients to research the immune system. How can we use the immune system to defend against cancer? This knowledge has led to the newest immunotherapy treatments. 
  • One of the techniques used in research is whole genome sequencing, which maps out the complete DNA code. There is an increase in demand for informed explicit consent before using these kinds of diagnostic tests. 

Is this a result of the GDPR?

No, although this new law has been an impetus. There is a lot of research that we can do without explicit consent. 

We adhere to the Medical Treatment Contracts Act (Wet op de Geneeskundige Behandelingsovereenkomst; WGBO). This act concerns the relationship between patient and health care provider. We also follow the Federa code of conduct for good use and good practice ('Codes Goed Gebruik en Goed Gedrag'; Federa-COREON).

This code of conduct contains guidelines for scientific research using biological samples taken for diagnostic tests. 

The NKI has decided to be a little more clear and actively inform its patients and requesting their informed consent. This allows us to continue to conduct innovative research.

Does this consent apply to research which asks patients to fill out a questionnaire?

No. Scientific research that requests patients to do additional tasks requires separate permission. 

If you do not consent to "other uses" of your data and biological samples that have been collected as part of your diagnosis, we may still invite you to take part in specific studies. 

Does this consent apply to clinical trials?

No. We need additional permissions for clinical trials - scientific research involving, for example, an additional procedure or a different cancer drug.

If you do not consent to "other uses" of your data and biological samples that have been collected as part of your diagnosis, we may still invite you to take part in specific studies. 

Who can access my data?

We store your data electronically in your patient file. All data is stored securely. Only authorized personnel can access your patient file and they all need to sign a non-disclosure agreement before receiving access,

If we need any data from your patient file for scientific research, we work with encoded data as much as possible so our researchers cannot trace any of the information back to you.

All research using patient data or biological samples will first be evaluated by an ethics committee.

Why are my biological samples stored no matter what?

We use blood, tissue, or urine samples to determine your diagnosis. We store all samples that are left.

If you return to our hospital with new symptoms, we can use the biological samples to analyze and compare your current symptoms.

It also allows our researchers to conduct research, under condition, into your illness - for example, to develop new cancer drugs.

For which data and samples do we need your permission?

  • Personal data, such as your height, weight, gender, age.
  • Information about your condition(s), including the drugs you take, the treatment you are receiving, and the treatment results.
  • Imaging of your body, such as x-rays, ultrasounds, and scans.
  • Voice recordings, such as recordings of your speech during a visit to a speech therapist.
  • Biological samples, such as blood, urine (or data that can be extracted from the aforementioned, such as genetic data), or tissue removed during surgery which has been used to diagnose you.

Can insurance providers view my data?

No, we do not share your data with other parties unless we are legally obliged to share your data with quality regulation authorities or other qualified authorities.

Your data will not be used to assess your insurance fee (premium) by insurance physicians or company doctors.

Why do some patients refuse consent?

In October and November, the NKI asked a small sample of patients refusing consent why they did not want to give us permission to use their data. Three types of responses were especially noteworthy:

(1) patients who based their decision on inaccurate information or misunderstanding.
(2) patients who mentioned having too much on their minds, which is entirely understandable. 
(3) a small percentage of patients noted privacy concerns.

Can you use my patient data and biological samples in any way you want once I consent?

No. All proposals for scientific research need to be assessed. This concerns two main points:

Patients need to be provided with the best care possible for their specific situations. Research can never prohibit this level of care. All research will need to be beneficial for the patients' conditions.

The usefulness of the research is reviewed by a committee: IRB (Institutional Review Board) or METC (Medical Research Ethics Committee).

Why don't you ask for consent for every study conducted with the data?

It is unethical, impractical, and highly inconvenient to request the patient's permission for every single study. The NKI is a hospital as well as a research institute.

Every week, our internal data desk sends out dozens of encrypted data files or biological samples for research purposes.

You would receive dozens of nearly identical requests for participation every year. Some patients may even receive a request every week.

This would take labor and money that will not be used for scientific research.

Most patients consent to the use of data or samples in scientific research.

What will happen to my data if I pass away?

After a patient passes away, we still fully adhere to the rules and legislation when handling and processing their data and samples in accordance with data protection laws (such as the General Data Protection Regulation)

There may not be enough biological samples left for my treatment. I do not want that.

Scientific research using biological samples will only take place if we have enough left over.

We always make sure that sufficient biological samples are stored for any potential future diagnosis or treatment.

The ethics board at the NKI will not consent to research that would use or destroy all of your stored samples.

To review whether this would be the case, a pathologist or clinical chemist will de on the board to help assess the research proposal.