Privacy statement

Download the privacy statement for the C6 research project

University Medical Centre Groningen
Statement on Recruitment of Research Participants

December 2015

Dear Potential Research Participant,

We would like to invite you to participate in a research study on chromosome 6. This study is being conducted at the Department of Genetics, University Medical Centre Groningen (UMCG), in Groningen, the Netherlands. You are eligible to participate if you or your child has been diagnosed with a chromosome 6 deletion or duplication, or a ring chromosome 6.

Although this is a rather long document, it is very important that you read it all. We want you to read this so that you know what we are planning to do with your or your child’s information. Please read the whole statement before agreeing to participate in our study.

This statement explains the following points:

  1. Background of the research project
  2. Who can participate?
  3. What is the procedure for participation?
  4. What am I agreeing to?
  5. How will my data be used?
  6. How will my data be protected and my privacy safeguarded?
  7. How long will this study last? Can I withdraw from this study?
  8. What are the benefits and risks of participating?
  9. Who do I contact if I have questions?
  10. I do want to participate, so what do I have to do now?

 

  1. Background of the research project

The aim of this project is to record more detailed and better information about chromosome 6 deletions and duplications and to make this information available to families and health care professionals. To achieve this we want to:

  • Collect information on people with chromosome 6 deletions and duplications of all ages from all over the world. (Also patients with a ring chromosome 6 can be included.)
  • Follow individuals with chromosome 6 deletions and duplications over time to see what problems come up at different ages.

We have designed a web-based questionnaire to collect information on people with chromosome 6 deletions and duplications. This information will be analysed and the results will be made available (anonymously) via publications on the Chromosome 6 Facebook page, in patient information leaflets (in collaboration with Unique, a patient organisation), and in medical journals. In the future, we hope to be able to create an interactive webpage with a detailed map of the genetic information and symptoms of chromosome 6 disorders, i.e. a genotype-phenotype map. This information can be used by parents and professionals to give tailored advice to patients.

This project is being financially supported by ZonMw (The Netherlands Organisation for Health Research and Development) and by the Chromosome 6 Foundation.

  1. Who can participate?

You can participate if you are an adult with a chromosome 6 deletion or duplication or if you are a parent or guardian of an individual with a chromosome 6 deletion or duplication.

All patients with a ‘pure’ chromosome 6 deletion or duplication can participate. The diagnosis should have been made with a detailed chromosome analysis (microarray, oligo array, SNP array, or whole genome array). Unfortunately, patients without a detailed chromosome analysis or more complex chromosomal changes (i.e. with other chromosomes also involved) will not be able to participate in the study. This is because we need to be sure that the chromosome 6 aberration is the cause of the features seen in you or your child.

You can participate if you have a copy of the report of the detailed chromosome analysis that has been performed in you or your child. If you don’t have a copy of the report, you can ask your geneticist/paediatrician for one using the template (example request) that can be found on the webpage.

If detailed chromosome analysis has not been done yet, you can discuss the options with your own or your child’s general practitioner, geneticist or paediatrician. It may be possible to get a detailed chromosome analysis performed. However, a detailed chromosome analysis is not possible in all countries and it may not be paid for by your health Insurance.

  1. What is the procedure for participation?

If, after reading this information about the project and the privacy statement, you want to participate in the project you can register. To participate in this study you need to have a valid email address and access to the internet.

When registering with your e-mail address and name, you will be able to upload the report of the detailed chromosome array-analysis. The array report will be uploaded to a secure environment and the database manager will check the document within a week. If your child is not eligible for the study, you will be sent an email explaining why we will not be inviting you to participate. If your child is eligible to continue in the study, you will be sent an email with a personal user name and password. You will be asked for your own or your child’s date of birth. After this you will be able to give your consent.

According to Dutch law;

  • Parents/guardians can give consent for children under 12 years old, and for persons who are incompetent.
  • Children between 12 and 16 years of age are asked to give co-consent, if mentally competent.
  • From the age of 16 the child or adult must give their own consent, if mentally competent.

After participating chromosome 6 patients become independent adults, they will be asked to consent to continuing their participation in the project if they wish to still provide information.

After consent is given you can start filling in the questionnaire on our protected website.

  1. What am I agreeing to?

Your participation in this research project is completely voluntary. When you check the “I ACCEPT” box, you agree to let the Chromosome 6 researchers use the information you enter for research purposes. “Information” (or data) covers all your answers to the survey questions and the information about the chromosomal abnormality from the detailed chromosome analysis. The Chromosome 6 researchers may use this information anonymously for their research and publications.

The Chromosome 6 research project is being coordinated in the Netherlands, so the project is subject to stringent Dutch law.

The questionnaire

The questionnaire has several sections: these cover diagnostic testing, medical, behavioural and developmental information. There are currently 14 sections in the questionnaire. Descriptions of what is in each section can be found on the sections descriptions page.

Completing the whole questionnaire may take several hours, depending on your own or your child’s symptoms and problems. You can fill the questionnaire in over several weeks and continue giving your answers over several sittings. The answers can be saved and continued later. When you have completed all the sections you can submit the whole document.

After you have completed and submitted the questionnaire, you will still be able to see the answers you have filled in.

Contact by email

We will use your email address to contact you. Here are the time points when we will contact you by email:

  • We will send monthly emails to remind you to complete the questionnaire, as long as you have not submitted it.
  • We will send emails once a year to ask for updates on your child.
  • When we add a new section to the questionnaire, we will send you an email inviting you to fill it in.
  • If there is a chromosome 6 research project that may interest you, we will send you an email to let you know about it. No information will be released to researchers outside the University Medical Centre Groningen (UMCG) without asking you for your additional consent.

If you no longer wish to receive emails from us, you can send us an email to unsubscribe.

In summary, if you choose to participate, you are agreeing to: (1) provide a report with the results of detailed chromosome analysis, and information/answers to questions, (2) allow the Chromosome 6 research team to use all that information anonymously for research and publications, and (3) allow the Chromosome 6 research team to contact you by email until you notify us that you no longer wish to receive our e-mails.

  1. How will my data be used?

The information collected will be used to better understand the effect of chromosome 6 deletions and duplications. We hope the results will eventually help make more information available to parents and professionals. Findings based on the information collected in this project may be published in medical journals and other channels, and/or presented at medical or patient conferences. The Chromosome 6 research team may collaborate on research with external parties. These external parties will only have access to pooled, anonymous information, i.e. which has been compiled together and stripped of any personal identification. No names and identities will be revealed and all records will remain confidential.

  1. How will my information be protected and my privacy safeguarded?

The Chromosome 6 research project is being coordinated in the Netherlands, so the project is subject to Dutch law.

The information will be stored on a secure computer system at the University Medical Centre Groningen (UMCG). Individual or identified data will not be released except in the following, very specific, circumstances:

  • Only if we ask you for, and receive, your explicit agreement, we (the Chromosome 6 researchers) may release your contact information and/or individual information to a third party.
  • If required to do so by Dutch law, and only then, Chromosome 6 investigators may release information at an individual level.
  • The UMCG’s Institutional (Ethics) Review Board and the government officials responsible for monitoring this study may need to inspect the study records and the manner in which they are being handled. They are subjected to strict confidentiality, according to Dutch law.
  1. What are the benefits and risks of participating?

Benefits: Participation in the Chromosome 6 research project will probably not offer any direct benefits to you or your child. We hope, in the future, our work will make it easier for parents and professionals to find useful information about the various problems caused by chromosome 6 deletions and duplications.

There are some potential risks to participating in the Chromosome 6 research project, these are described below:

  • Some questions may make you feel uncomfortable. The questionnaire is very extensive and contains questions about almost every aspect of a person’s medical and other history.
  • In the event of a security breach, your questionnaire responses and/or information that can be personally identified may be stolen. The Chromosome 6 research project information is hosted on Molgenis servers. Molgenis is a system that is audited and it meets all the privacy standards imposed on health care records by Dutch law. All the information is hidden behind password-secured walls.
  • This project is neither invasive nor experimental. The procedures do not involve more than the minimal risks described in parts (1) and (2) above. There is no compensation or treatment available as a result of your participation.
  1. How long will this study last? Can I withdraw from this study?

Your participation is voluntary at all times. You can choose to stop participating in this Chromosome 6 research project at any time. Even if you consent to participate in this project, you may still choose not to complete any question or section of the questionnaire. At any time, you may choose to withdraw from the project. To withdraw, please send an email to chromosome6@umcg.nl.

However, any research that has been performed or published on your information prior to this date will not be reversed, undone, or withdrawn. Information that you have already submitted will remain in the database, unless you explicitly ask us to remove this. As already stated, information already used in analyses and publications cannot be withdrawn or undone.

The Chromosome 6 research project is intended to be a long-term project and there is no stated end-date. We hope to gather information over a long period of time (longitudinal data), including into your or your child’s teen and adult years.

  1. Who do I contact if I have any questions?

If you are interested in learning more about this project, or if you have any questions, please send an email to chromosome6@umcg.nl.

  1. I do want to participate, so what do I have to do now?

If you have read the whole Recruitment Statement and wish to participate in the study, please register your email address. You will be asked to:

  • Upload the report of the detailed chromosome (array) analysis in a secure environment.

After the database manager has checked the chromosome report, you will be sent a user-ID by email and a webpage link to access the questionnaire in the secure environment.

  • Confirm you are an individual with a chromosome 6 aberration, or the parent/guardian of an individual with a chromosome 6 aberration.
  • Give your or your child’s date of birth.
  • Consent to all of the information in the Privacy Statement by choosing “I agree”. According to Dutch law;
    • Parents/guardians can give consent for children under 12 years old, and for persons who are incompetent.
    • Children between 12 and 16 years of age are asked to give co-consent, if mentally competent.
    • From the age of 16 the child or adult must give their own consent, if mentally competent.

Professor Conny van Ravenswaaij, MD, PhD

Head of Chromosome 6 project

Department of Genetics CB50, University Medical Centre Groningen, P.O. Box 300001, 9700 RB Groningen, the Netherlands

Email   chromosome6@umcg.nl

December 2015