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Ten Common Questions from Our Research Participants

The ALS research group receives a lot of questions from patients and family members. Below you can find the answers to some of the most asked questions we get. If you have more questions concerning our research, please get in contact through e-mail to: ALSforskning@umu.se or use the contact form further down on the page.

Please note that we cannot answer questions concerning other research groups’ results and new experimental drugs that you may have read about online or heard about on the news. We can also not answer specific medical questions (those you should ask your treating physician and the medical care unit where you live). We are a research group focused on finding out why people get ALS and if there are ways to slow or block the disease process. Therefore, we can only answer questions concerning our own research.

Pharmaceutical companies wishing to test new experimental drugs generally issue a press release once the Swedish Ethical Review Authority and the Swedish Medical Products Agency (Swedish MPA) have approved that a clinical trial can be held at a hospital in Sweden. The participating hospitals, which are chosen by the company, generally advertise about the trial, providing information about which type of ALS disease is targeted in the study, the requirements to be eligible for participation and contact information for further information. The ALS Research Team at the University Hospital of Northern Sweden is sometimes involved in such clinical trials.

In cooperation with the pharmaceutical company involved and patient organisations, we will communicate the start of any new clinical trial in a press release, as well as on our website.

1. Why do you ask for blood samples from family members?

We perform a substantial number of analyses, e.g., free radicals, proteins, and genetic analyses, on patient samples. Many of these analyses are complicated and we often end up having trouble to distinguish whether a detected change might be related to the patient's ALS disease or to other diseases that the patient might have, or have had, or to medication taken by the patient. Finding a change in a blood sample is easy, what is hard is showing that the change is related to the patient's disease. We always compare test results from patients with the corresponding sample from healthy blood donors, patients with other diseases and voluntary research subjects. In our experience, comparison with the patient’s relatives gives the analysis much greater precision than comparison to other controls. When we ask for a regular blood sample from next of kin, it is thus as a control sample for the sample collected from a diseased individual from the same family. The sample will also be used as a control sample for patients from other families. The research sample from a patient’s next of kin is thus not an ALS test. It is not possible with today’s knowledge and laboratory techniques to predict if, or when, a person might get sick from ALS. Since 1993, samples from the families of our patients have been to great use to us and given us a lot of valuable new information. We are incredibly grateful for these samples.

2. Why do you sometimes ask for blood samples from a husband/wife/partner? 

The control samples from the patient’s biological relative are valuable but they cannot always be used to answer all types of questions, e.g., concerning environmental factors or diatary habits earlier in life. Some of the substances we are exposed to in the environment or in our diet remain in our bodies many years later and can sometimes be measured in a blood sample. A blood sample from the patient’s husband/wife/partner can in many instances be valuable as a control sample where the patient’s biological relatives (e.g., siblings) have not been able to help. A person’s husband/wife/partner have often lived under nearly the same environmental conditions as the patient and eaten the same type of food.

3.  Which types of analyses will be performed and when? 

Samples from patients go through a number of standardized research analyses, often within the first three months after we receive the sample. Primarily, protein and free radical analyses and genetic analyses. Further analyses may be performed, depending on the results from the first round of analyses, new research findings, or because the patient has a certain variant of the disease. The samples we collected from patients and family members in the 1990’s are used in new research projects today. There is thus no “best before date” for research samples and a donated research sample is never fully analyzed – we may always come to need an older saved sample for new analyses.

4. Who performs the analyses? 

The majority of the analyses are performed by scientists at Umeå University. We make up a large group of researchers (about 25 people at the moment), divided on several departments at the Faculty of Medicine, the Faculty of Science and Technology, and SLU (the Swedish University of Agricultural Sciences). The Umeå Team is a part of a large international network of ALS scientists, where we send research samples to other laboratories and receive samples from patients in other countries. Single, specific analyses are performed at other laboratories in Sweden or abroad if the laboratory technique required is not available in Umeå, or even to lower costs.

Research analyses are expensive and to keep the costs as low as possible, the samples are analyzed in groups of 24, 36, 48 or 96 different samples at a time. For example: The research team in Ulm in Germany has expert knowledge about the subject of DCTN1. Earlier, samples from Swedish patients were sent to Ulm for DCTN1 analysis. In return, we received samples from German patients for SOD1 analysis (which is one of our areas of expertise). By collaborating, we could get more patient samples analyzed to a lower cost and with greater expert knowledge and precision. Samples send abroad are destroyed after analysis or returned to Umeå University.

5. What right to identity protection to I have as a research subject? 

All researchers are obligated to observe professional secrecy according to the privacy legislation. The majority of scientists will only know you (your sample) by a code, e.g., “Bxx”. This code is in our data base and on the test tubes you filled. Only a few researchers have access to the registry where the name and personal identity number of the person connected to the sample Bxx can be found. Additional privacy protection is observed in certain projects, e.g., when we send samples for analysis in laboratories abroad. The samples sent abroad are re-labelled with a new code and cannot be associated with you as a person by our research partners.

6. Do I have the right to access my information and research test results? 

According to the Swedish Personal Data Act, PUL (1998), and the General Data Protection Regulation, GDPR (2018), you can access all database records we have on you (a so-called extract from the register) once a year. Since it involves research analyses, the results are usually hard to interpret, and we cannot assess the risk for a relative to get the disease later in life.

You may choose to access your data and get a transcript of the results from the research analyses performed on your sample, but you also have the right to wish to not receive this information. You as a research subject decide whether you want to access research data, how much, and when.

A particular situation occurs if we from a sample from an ALS patient can identify the cause of that patient’s disease. In such cases, we always contact the patient’s local physician for an assessment of whether it is appropriate to notify the patient. On the information sheet to be filled in when the blood sample is collected there is an option for the patient to declare whether they want to be informed if the cause of their disease should be discovered. If that is the case, we will send a letter containing information to the patient’s physician. Some patients choose not to be informed by potential findings and their wish will of course be respected.

7. Can others access my register data and research test results? 

For this type of medical research absolute confidentiality is observed and only the referring physician and the person donating a sample can access the results from the analyses performed. Should a patient wish that, e.g., their adult children, should be allowed to access the results, we would need to receive written information about this directly from the research subject. Without written consent, research data cannot be released to next of kin.  

It has come to our attention that there have been single research subjects who have disclosed their genetic research data in social media channels on the internet. Even if this, from a legal standpoint, is allowed, we recommend that all research subjects accessing their research data regard those as strictly private and personal, and do not spread them on e.g., Facebook. Once information has been uploaded on social media, it will not always be possible to completely delete it. 

The donated research samples, and the personal information and results connected to the samples, cannot be used in research projects other than those the research subject has consented to. Our research cannot be shared with other researchers without written consent from Umeå University.

The Swedish Data Protection Authority, The Swedish Ethical Review Authority, the National Board of Health and Welfare, or other government agency or authority can carry out an inspection to check that we obey the Swedish Personal Data Act, the Public Access to Information and Secrecy Act, or other laws.  

8. If I’m a healthy family member/control subject, can I know the results of my genetic test, and can that test result be used to predict whether I will get ALS in the future? 

The blood samples collected from patients and family members by us are only meant for research about how the disease arises and develops. Research samples are not to be confused for the samples taken in connection with clinical examinations in a hospital or healthcare center. Our research analyses are thus not a “test for ALS”, and since these are research samples the results are often hard to interpret. With the knowledge we have today, it is not possible to predict and calculate the risk of getting sick later in life. 

9. If I belong to a family with several cases of relatives with ALS (so-called familial ALS or F-ALS), can I get tested to find out if I’m a carrier of the gene and are at risk of later developing the disease? 

If a disease-causing gene variant has been identified in your family and you as a healthy relative want to find out whether you are a carrier of that variant, we recommend that this is done through a genetics clinic within the healthcare system. It is called a pre-symptomatic genetic test, and through a standardized healthcare program you will receive genetic counseling before deciding whether you want to find out if you are a gene carrier. You will then leave a new blood sample. Through your healthcare center you can get a referral to a genetics clinic. 

It will always be within your rights to access your personal research data, including genetic testing results, but we recommend that you first get genetic counseling at genetics clinic in a hospital.

10. If I belong to an ALS-family where the disease-causing gene has been identified, can use fetal diagnostics if my partner and I wish to have children?

Fetal diagnostics is possible if the disease-causing gene in your family is known. Before fetal diagnostics, the genetic variant that causes the disease in your family thus must have been identified. You should also be in contact with a physician at a genetics clinic for genetic counseling. The fetal diagnostic testing is then handled by the specialist prenatal care. 

Answering Questions Sent Through Contact Form

Tina Björn
Research nurse
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Lena Bylund
Research nurse
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Latest update: 2023-09-21