ImVitro is promoting a research under the MR-004 called “Development and improvement of a predictive algorithm aiming at minimizing the number of In Vitro Fertilization (IVF) attempts per patient” declared to the Commission Nationale de l’Informatique et des Libertés (CNIL) in collaboration with partner clinics. The aim of this study is to increase the success rate of IVF using artificial intelligence. This is a non-interventional study, requiring only the simple reuse of data already collected (called “retrospective”) and involving no impact or risk for patients.
To carry out this research, the promoter ImVitro needs to recover a large amount of data concerning IVF attempts. This data will never directly identify patients. Patients whose pseudonymized data is used by ImVitro are informed by the clinics that provided them with care for a medically assisted procreation procedure by mail or email.
1) What is the purpose of this research?
This research focuses on the analysis of data collected during IVF attempts. The goal is to develop a tool to assist in the performance of IVF using the full force of artificial intelligence. This multicenter research is based on data obtained from 2011 by the participating centers.
With this study, ImVitro seeks to optimize certain IVF-specific decisions using artificial intelligence to increase the chances of success and minimize the number of attempts required to achieve pregnancy. In particular, this study seeks to optimize the evaluation of embryos grown in the laboratory to help embryologists select the embryo(s) with the best chance of leading to a pregnancy and birth. To perform this research and obtain viable results, ImVitro needs to collect and analyze data from an important number of IVF cycles.
By allowing ImVitro to use data for this research, patients will help improve the chances of success for couples hoping to conceive a child through IVF.
2) What is the research schedule?
The estimated duration of the research is 5 year(s) from June 2020.
3) If patients participate, how will the data collected for the research be processed?
To perform this study, ImVitro needs the following categories of personal data:
– Medical data related to the couple
– Data specific to the IVF medical procedure
– Data concerning embryo culture
ImVitro collects data in a manner that allows the company to guarantee it will never be able to directly identify patients: the first and last names are replaced by a unique identification code, and the correspondence table is only known by the investigating doctor and, if necessary, the persons acting under his authority.
This data will be transmitted to ImVitro, the study sponsor, or to persons / companies acting on its behalf. They will be processed in Europe under strict security conditions.
These data may also, under conditions ensuring their confidentiality, be transmitted to the French health authorities.
Patient’s data may be used for subsequent research or analyzes complementary to this research in collaboration with private or public partners, in France or abroad, under conditions ensuring their confidentiality and the same level of protection as European legislation.
4) How is this research framed?
ImVitro has taken all measures to conduct this research in accordance with the provisions of the Public Health Code applicable to research not involving humans.
ImVitro has also taken care to comply with the requirements of the MR-004 reference methodology of the National Commission for Informatics and Freedoms.
5) What are patients’ rights?
Patients have the right to object to the reuse of their data for this research within the initial period of 4 weeks provided for this purpose without having to justify their decision. This decision will in no way affect their current or future coverage by clinics.
Patients have the right to access, rectify, oppose and erase their data or limit their processing. These rights can be exercised under the conditions described in articles 15 to 21 of the GDPR. Please note that these rights are not absolute and that ImVitro may rely on exceptions in the course of processing all or part of their request.
In order to comply with the requirements of the MR-004, ImVitro is not able to identify patients directly. We are therefore not in a position to respond directly to requests for the exercise of rights that patients send to us. To exercise their rights, we therefore invite them to contact their investigating doctor. However, for any questions relating to the protection of privacy or the processing of their data, they can contact our DPO at firstname.lastname@example.org.
Pursuant to the provisions of Article L 1111-7 of the Public Health Code, patients can also directly access all of their medical data through the investigating doctor of the clinic who took them in charge.
Finally, patients also have the right to lodge a complaint with the CNIL, the supervisory authority for the protection of personal data.
6) What if patients do not want to participate in the study?
If patients do not want their data to be used for this study, they can request that ImVitro stops using their data in the context of this research by contacting their investigating doctor. The latter can, using a correspondence table in his possession, indicate to ImVitro which data must be processed as part of their request for the exercise of rights, while preserving anonymity.
7) Processing of patients’ personal data
The data and information concerning patients and their IVF attempts that will be used for the study are qualified as “personal data”. Personal data will be subject to “processing”, that is to say, collection and use by ImVitro.
ImVitro, as the promoter of the study, is “responsible for the processing” and guarantees that this processing is carried out in complete safety and in accordance with the local regulations in force, in particular the “Informatique et Libertés” law of 6 January 1978 as amended and to European Regulation No. 2016/679 / EU of April 27, 2016 (the GDPR). To ensure this, ImVitro has appointed a personal data protection officer.
More specifically, the processing implemented pursues the following objectives:
– Main objective: the completion of the research by ImVitro (employees and subcontractors), with the pseudonimysed data described in question n ° 3, and
– Secondary objectives: share this information to patients concerned, take into account refusals to participate in the study and comply with the legal obligations imposed on ImVitro in its role as the study sponsor. For these secondary purposes, directly identifying data (surname, first name, contact details) are used by the clinics only.
The processing is based on:
– the legitimate interest (article 6-1-f of the GDPR) to carry out this research, subject to the exercise of patients’ right of opposition, and
– for health data, the need to process such data for the purposes of scientific research (Article 9.2 (j) of the GDPR).
The data will be accessible by:
– ImVitro staff and any subcontractors;
– the scientific head of research;
– clinics staff involved in research and staff acting under their responsibility or authority;
– And possibly any other person authorized to access it within the limit of the recipients provided for by the reference methodology MR-004 and followed by ImVitro to carry out this research.
They will be kept in an active database for 5 years so as to allow the research to run smoothly.
If patients have any questions about the processing of their personal data as part of this study, they are invited to contact as a priority the investigating doctor of the clinic that took care of them. ImVitro’s data protection officer can answer general questions about data protection, but cannot answer questions specific to their data as they do not have data that directly identifies them, as explained above. If patients contact the ImVitro delegate directly, ImVitro will then have data that directly identifies them. To contact the ImVitro delegate, patients can send patients’ questions by email to email@example.com.