Identifying essential information for valid informed consent from egg donors: an international Delphi study
Professor Veerle Provoost, Professor Guido Pennings (Ghent University) and Professor Dominic Stoop (University Hospital Ghent) are supervising a Delphi study conducted by Lara Jacxsens, a PhD researcher in Philosophy and Moral Sciences, and assisted by Lien Lentacker, a master’s student in Science in Health Care Management and Policy.
We, the research team mentioned above, invite you to partake in our Delphi study “Identifying essential information for valid informed consent from egg donors”. The intention is to reach a consensus on what information is relevant and morally necessary in order to obtain valid consent from candidate egg donors.
We believe your experience and your personal views as an experienced egg donor can provide vital input for policy guidance on what information should be provided to egg donors if we want to assure a valid informed consent. Your participation involves three rounds of online surveys. The study ends December 2024, but we expect to complete the survey rounds and thus your participation before the end of March 2024. Note that this is an estimation.
Please find the information about the study below. Feel free to contact us if you have any further query.
We are looking forward to hearing from you and wish to thank you for your time.
With kind regards,
Lien Lentacker
Study objective
We are conducting a Delphi study involving an international panel of experts consisting of fertility specialists, medical ethicists, academics (from both medical sciences and humanities), midwives/registered nurses, psychologists, lawyers and experienced egg donors. By gathering the insights and opinions of this diverse group of experts, we aim to establish an international consensus on what is essential information for candidate egg donors in light of their valid informed consent.
Delphi study methods are widely recognized for their effectiveness in achieving consensus among multidisciplinary groups of experts. Through several (in this case three) rounds of data collection, experts’ opinions are gathered and followed by a presentation of these opinions to the group of experts. This iterative process encourages the experts to either further clarify or reconsider their initial responses based on the feedback received from other experts. Typically, consensus is reached within 2-3 rounds of the Delphi study.
The sponsor of this study is Ghent University.
Why do we ask you to participate?
We are seeking the insights of experts in the fields of reproductive medicine, egg donation, and informed consent. In light of this, we conducted a systematic literature and internet search in which we identified professional experts. The inclusion criterion for the professionals was to have a minimum of two scientific publications from 2015 onwards on the subject using the English terms “egg donation,” “oocyte donation,” “gamete donation,” and/or “informed consent in reproduction”. For the group of experienced egg donors, we collaborate with the community We Are Egg Donors. The inclusion criterion is to have previously donated eggs at least once since 2013. We exclude those who were employed or donated in non-Western countries and/or are not proficient in the English language.
What do we ask from you?
Your participation in this Delphi study involves three rounds of online surveys. In each round, you will be asked to determine what information you find relevant and morally necessary in order to obtain informed consent from a candidate egg donor. Additionally, you will have the opportunity to provide comments and suggestions to further elaborate on your opinions or highlight any important considerations.
Timing
The closing date for completion of the first round is 11 February 2024.
The study ends December 2024, but we expect all three rounds, and thus your participation, to be completed before the end of March 2024. Please note that the latter is an estimation. The amount of time needed for completion of each round will vary for each expert but should range from approximately 30 minutes for the first round, 20 minutes for the second round and 15 minutes for the third round. Please remember that the first round will take the longest, but you can always pause and come back to the survey. You do not need to click on a save-button, the survey saves itself automatically.
Benefits of participating in the study
There are no direct benefits to you as a person. This study aims to determine what information about egg donation is essential for candidate egg donors. Based on these results we can draft policy recommendations and help clinics and organisations in the field of egg donation to design their information material. This way, we want to support the informed consent procedure of women interested in donating.
Compensation
We cannot pay or compensate you for your time or participation, but as a token of appreciation, we offer to list your name as a member of the experts panel in the publication of the study. You can formally opt or opt out of this at the start of the survey.
Protection of privacy
All collected personal data will be pseudonymised. ‘Pseudonymization’ refers to the handling of personal data in a way that makes it impossible to associate the data with a specific individual without using additional information. This additional information is stored separately and is safeguarded by technical and organizational measures to prevent the personal data from being linked to a known or identifiable person (Art. 4 GDPR – Definitions – General Data Protection Regulation (GDPR) (gdpr-info.eu)).
To obtain more substantive information about the study and to exercise your rights, please contact the study team.
The Data Protection Officer can also provide you with further information on the protection of your personal data if required. Contact details : Hanne Elsen, privacy@ugent.be.
The Belgian supervisory Data Protection Authority responsible for enforcing data protection legislation can be reached via the following contact details:
Data Protection Authority (DPA)
Rue de la Presse 35 – 1000 Brussels
Tel: +32 2 274 48 00
E-mail: contact@apd-gba.be
Website: www.dataprotectionauthority.be
Who has access to my (personal) data?
Only the research team has access to your (personal) data in order to process al data. All your personal data will be pseudonymized to ensure confidentiality and protect your privacy. Pseudonymization is a technique that involves replacing identifiable information with unique identifiers or pseudonyms. This process ensures that the data cannot be directly linked to individuals without additional information that is separately and securely stored. The file containing the link between participant codes and names will be encrypted with a password, only known to PhD researcher Lara Jacxsens.
You as participant will remain anonymous towards other participants. You do not have direct contact with other participants, but only with the research team. However, since Delphi studies work with an iterative process where comments from the first/previous round can be included in a subsequent round as feedback, you may encounter a pseudonymized comment of your own during the second or third round. As we are part of an international participants group, it is possible that your comments may leave the European Economic Area (EEA) when they are sent to other participants as feedback.
Use and sharing of the data
In accordance with the Belgian law of August 22, 2002, relating to the rights of the patient, the General Data Protection Regulation (or GDPR) (EU) 2016/679 of April 27, 2016 and the Belgian law of July 30 2018, on the protection of individuals related to the processing of personal data and on the free movement of such data your privacy will be respected and you will be able to access the data collected about you. Each error can be corrected at your request.
Your other rights (i.e. including the right to restrict the processing of your (personal) data, the right to have your (already collected) data erased in certain circumstances, and the right to lodge a complaint) are also safeguarded.
For more information on the rights you have and how to exercise them, please visit the website of UGhent website (Ghent University privacy statement — Ghent University (ugent.be))
The research data collected in this study may also be useful in answering other research questions. Therefore, there is a possibility that the research data will be shared at a later date for other research. This may lead to reuse of your pseudonymized data for future academic research projects and studies, exclusively in the context of the same or a similar research aim (i.e. fertility research). The reuse of the research data can be done both within the own research team and by external researchers within and outside the EEA. In case your data has to be used in a country outside the EEA, U(Z) Ghent will ascertain whether the country of destination offers an adequate level of protection. If the country to which U(Z) Ghent wishes to transfer data does not offer adequate guarantees, U(Z) Ghent itself will enforce adequate guarantees by means of model agreements, made available by the European Commission, or other accepted measures. The processing of your data is based on consent, as mentioned in GDPR article 6, paragraph 1(a).
Such new studies and re-use of data always need to be submitted to and approved by the ethics committee. To this end, the research data will be made available in a controlled manner (i.e. with restricted access) via the repository Open Science Form (OSF). Repositories are storage spaces designed to store digital and digitized information in the most sustainable manner possible. Only pseudonymised data will be shared with restricted access. If other researchers wish to access the pseudonymized data, we will set up a Data Transfer Agreement. All necessary measures will be taken to guarantee the confidentiality of your personal data as prescribed in the UGent Generic Code of Conduct for handling personal data and confidential information.
If you wish your data not to be used for future research, you can contact the research team or the DPO for this purpose (see contact details under section ‘Protection and privacy’).
The controller of the data is the institution of the principal investigator of the study, Professor Veerle Provoost (Ghent University).
After the study, the data will be stored for at least ten years.
Instructions
In the first round of the survey you will be asked to determine 1) how relevant you find specific items of information, and 2) whether or not you find the information morally necessary in order to obtain valid informed consent from a candidate egg donor. Additionally, you will have the opportunity to provide comments and suggestions to further elaborate on your opinions or highlight any important considerations.
Further instructions will be provided on the survey page.
If you agree to participate, please fill out your email address on the provided website of We Are Egg Donors [add link here] and you will be contacted.
We are looking forward to your participation in what could be the first step in an international consensus on what information is relevant for candidate egg donors and which information is morally necessary in order to obtain a valid informed consent.
Feel free to contact any member of the research team for additional information.