Information note for the participant

Dear Sir or Madam,

By registering on this site you agree to participate, on behalf of an affected close relative, in the research project entitled:

Genetics of Intellectual Disability and Autism Spectrum Disorders (GenIDA)

The French “Institut National de la Santé et de la Recherche Médicale” (INSERM, the French equivalent of MRC or NIH) is legally supporting this project.

For any questions regarding this study and how you can participate, please contact us via the following link: https://genida.unistra.fr/contact/. If it seems necessary, you may request the establishment of a telephone call with the leader of the project, Pr. Jean-Louis Mandel, or an appropriate collaborator.

  1. INFORMATION

    This document is intended to provide you with written information required for your decision. Thank you for reading it carefully. Do not hesitate to contact us using the website (https://genida.unistra.fr/contact/) if you want more information. You can take the time to think about your participation in this research, and discuss it with your family and with physician(s) in charge of your child / relative affected by intellectual disability and / or autism spectrum disorders. If you agree to participate to this study, you must check the box «I have read the information note and give my consent to participate» when creating your account on the GenIDA website. This will attest that you agree to participate.

  2. PARTICIPATION AGREEMENT

    Your participation is voluntary: you are free to participate in this medical research. Your name, surname, date of birth, place of residence and that of your relative / child affected by intellectual disability and / or autism spectrum disorders will not be requested.

    If you decide to participate, you should know that you can withdraw your participation agreement at any time, through your profile on the website (or by contacting us directly from the website https://genida.unistra.fr/contact/ ), without incurring any responsibility or damage as a result. You do not have to justify your decision.

  3. GENERAL FRAMEWORK AND RESEARCH OBJECTIVES

    The GenIDA International Project is an online patient registry whose main objective is to gather information on the natural history, medical complications, behavioral disorders and responses to pharmacological treatments for patients affected by intellectual disabilities (ID) and / or autism spectrum disorder (ASD) of genetic origin. Our aim is to improve the understanding and management of these disorders by enabling the pooling and analysis of information provided by families at the international level.

    One of your children, brothers, sisters or relative is affected by ID and / or ASD. He (she) was diagnosed as a carrier of a genetic mutation affecting a gene or a small chromosomal segment and a specialized clinician has concluded that this mutation was causal of the ID and/or ASD. You are willing to anonymously provide medical and non-medical information that will improve knowledge and ultimately medical care, for the genetic disease that affects your child, sibling or relative: you have the profile to register on the GenIDA website.

  4. WHAT WILL YOU DO AND HAVE ACCESS TO?

    Participation in this research requires exclusively the use of the GenIDA website (https://genida.unistra.fr) within which you can access various features including:

    • A questionnaire allowing you to provide health related information on your affected child or close relative

    • A visualization interface that will allow access to relevant information gained by analyzing the cohort (group) of patients affected by the same genetic form of ID and / or ASD as your child / relative.

    • A discussion interface allowing you to exchange with other families concerned by a defect in the same gene, in a private way (out of the frame of the GenIDA website), in the form of email.

    • Various other features allowing you to change your user settings (your profileor that of your affected relative(s), your participation agreement, etc.)

    Duration of your participation: We hope for a participation for several years, optimally five years or more. This is necessary to study the course of the specific genetic form of ID/autism. You will be asked every six months to update information on your child/relative by using the same questionnaire (in order to monitor evolution of the condition). A reminder email will automatically be sent at the appropriate time. The monitoring will thus cover all data that changes over the years (e.g. weight, new symptoms, progress in cognitive abilities etc.).

  5. INFORMATION RIGHTS REGARDING THE HEALTH OF YOUR CHILD / RELATIVE

    Our system will allow you to visualize the information you provided on your child/relative and compare it to the cumulative data obtained on individuals sharing a defect in the same gene. Its content will be validated by the GenIDA Scientific and Ethics Council.

    If data analysis of the group of patients sharing the same genetic defect as your child / relative highlights any information of interest that could promote better care, the International Scientific and Ethics Committee of the project will be notified of it. No information will be sent to families without the prior agreement of the Scientific and Ethics Committee.

  6. RIGHT TO BE INFORMED OF OVERALL RESULTS

    Results of this study will be presented at conferences and in scientific publications, and you will be notified of any starting clinical studies concerning your gene of interest. You will also be informed of the overall project progress and results via the GenIDA website.

    The presentation or publication of data concerning your child / relative will no identifiable because medical data and personal data are separated and encoded following a specific process.

  7. PRIVACY AND INFORMATICS DATA PROCESSING

    In the context of this medical research managed by INSERM, an informatics processing will be implemented to analyze the health related data you provide. These data will be kept confidential and anonymous and will be only identifiable by a code number generated by computer. These data may also, under conditions ensuring their confidentiality and anonymity, be shared with appropriate French and foreign research teams working on the same pathologies.

    In case of withdrawal of your participation agreement

    You can always change your participation agreement on the GenIDA website. If you wish to end your participation, the data related to you, your child / relative that were acquired before your withdrawal may still be used in the study, unless you specifically disagree. If the latter case, all data will be entirely and definitely erased.

  8. LEGISLATIVE FRAMEWORK OF THIS MEDICAL RESEARCH

    This research is conducted according to the legal requirements of medical research and in accordance with the legal requirement in France (French law of January 6, 1978 modified by the law about the protection of individuals with regard to the processing of personal data of August 6, 2004).

    The study has been declared to the “Commission Nationale Informatique et Libertés” (CNIL) on 11/27/2015, 1907912v0 number, which allows us to implement medical and personal data analysis.