Information note for the participant

Dear Sir or Madam,

By registering on this website, you agree to participate 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 physician in charge 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. WHAT IS GenIDA?

    The GenIDA International Project is an online cohort study 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.

  3. PARTICIPATION AGREEMENT

    You must be more than 18 years old to participate at this project.

    Your participation is voluntary: you are free to participate or not in this medical research.

    Your name, surname, date of birth, place of residence will not be requested. Nevertheless, a number of information concerning your relative / child affected by intellectual disability and / or autism spectrum disorders will be necessary: his birth year and month (not the exact birthday) and his country of residence (not the exact living place).

    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. It is not necessary to inform the physician in charge of the project or any administrators of the GenIDA website, they will be automatically notified of the withdrawal of your participation agreement. You do not have to justify your decision.

  4. RESEARCH PROCEEDINGS

    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 allows 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 (still under development) will allow 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 profile or that of your affected relative(s), your participation agreement, etc.)

    Duration of your participation: The duration of participation is optimally five years with a follow-up every 6 months. A reminder email will be automatically sent to you before every deadline. This follow up concerns all data that are susceptible of changing over the five years period (in example: the weight, the outbreak of a symptom, etc.). Nevertheless, the participation is based on volunteering and you are free to fill in the questionnaire at the frequency of your choice.

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

    A functionality on the GenIDA website allows you to visualize the results of the analysis of your data. Its content will be validated by the GenIDA Scientific 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 Committee of the project will be notified of it. No information will be sent to families without the prior agreement of the Scientific Committee.

  6. RIGHT TO BE INFORMED OF OVERALL RESULTS

    Results of this study will be presented at conferences and in scientific publications, and might promote the initiation clinical studies. You will be informed of any starting clinical studies. 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 encryption process.

  7. PRIVACY AND INFORMATICS DATA PROCESSING

    In the context of this medical research managed by INSERM, an informatics processing of the data concerning your relative / child affected by intellectual disability and / or autism spectrum disorder will be implemented in order to fulfill our research objective.

    In this context, the data concerning your relative / child will be transmitted to the Pr. Jean-Louis Mandel or his collaborators. These data will be kept confidential only identifiable by a code number generated by computer. These data may also, under conditions ensuring their confidentiality, be shared with the French Health authorities or with appropriate French and foreign research teams working on the same pathologies.

    A specific care is taken in the medical and genetic data securing. These confidential data will be stored and analyzed using a strict protocol guaranteeing your private life at best.

    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 by the physician in charge the project, 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 in France. This research is carried out in accordance with the French legal provisions concerning informatics, files and liberties (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, number 1907912v0. It has been reviewed and approved by the Ethics Evaluation Committee of INSERM (IORG0003254, FWA00005831), the Institutional Review Board (IRB00003888) of the French Institute of Medical Research and Health on 15/11/2016, number 16-338.