The following is a duplicate of the English consent form text that must be signed to receive a sample collection kit. You can find the original text here: Quaranskin consent (English version), Quaranskin consent (French version)
Subject Information and Consent Form
Version number: 5.0
Title of the study: An international sequencing study on the impact of lockdown policies and changes in hygiene habits due to COVID-19 on the skin microbiome.
Qualified Investigator:
- Dr. Ariel Lindner, PhD
- Dr. Edwin Wintermute, PhD
- Dr. Radoslaw Ejsmont, PhD
Sub-Investigators:
- Amandine Maire,
- Valerie March,
- Nicolas Levrier,
- Nikola Zarevski
- Xavier Olessa-Daragon
- Chetan Kumar Velumurugan
Data Officer: Lionel Deveaux
Deputy Data Officer: Chetan Kumar Velumurugan
Sponsors:
- Centre de Recherches Interdisciplinaires
- Genewiz
- Open Humans Foundation
INTRODUCTION
You are invited to participate in a research project which will look at the changes in the skin microbiome composition due to changes in behavioral habits linked to lockdown policies
resulting from the COVID-19 pandemic that started late 2019.
This form explains the reason for the study, and what it entails. It also warns you about any inconvenience or discomfort that might come with this study. It gives you a description of the different steps to follow to complete your contribution to the study. This information will help you to decide if you want to be part of the study or not, provided you meet the inclusion criteria and are not concerned by the exclusion criteria. This decision is yours to be made and you can cancel your participation in this study at any time by sending an email to paris-bettencourt-2020@cri-paris.org.
This research study is performed in the context of an iGEM (international Genetically Engineered Machine) project that will be presented at the iGEM 2020 competition virtual jamboree.
WHAT IS THE PURPOSE OF THE STUDY?
The skin microbiome is the collection of viruses, bacteria and fungi (also referred to as skin microorganisms) that naturally live on the human skin. The composition of the skin microbiome, meaning the relative abundances of the different skin microorganisms, depends on many factors such as the immunity of the individual, their living environment, genetic background and hygiene habits.
Skin microorganisms can play a role in the development of skin diseases, such as eczema where a correlation between the disease and the overgrowth of a specific skin microorganism has been observed. In addition to that, recent studies show the importance of the interactions between the skin microbiome and our immune system to train the latter to better fight infections of pathogens.
The purpose of this study is to better understand how lockdowns might shape our skin microbiome, and through it, impact our health. We will further search whether there is a
relationship between the skin microbiome composition and confinement-related behavior (such as changes in hygiene habits), in comparison to existing data taken from individuals that did not experience a lockdown (using the Human Microbiome Project database as a reference).
The information generated by this study might be used subsequently to determine which microorganisms seem to be linked with skin diseases or incommodities.
To note that this is not a clinical or medical study, that it is not run by medical doctors or professionals, and that the potential findings are limited to the field of fundamental research in biology.
WHO CAN TAKE PART IN THE STUDY?
To take part in this study, you must:
- be older than or of age of majority (depending on your country jurisdiction);
- be strictly younger than 66 years old;
- be able to provide signed and dated informed consent;
- be willing and able to provide skin microbiome samples, as asked in this study.
You should not take part in this study if you do not meet all requirements.
You cannot participate in this study if:
- you have a fever at the sampling time (body temperature greater than 37.8°C);
- you applied on your skin large quantities of commercial probiotics;
- you are currently under antibiotic, antifungal, or antiviral treatments;
- you were under systemic antibiotic, antifungal, or antiviral treatment less than 3 months ago (systemic refers to treatments that would propagate in your whole body, which
includes intravenous, intramuscular or oral administration);
- you were under topical antibiotic, antifungal, antiviral or steroid treatment less than a
week before sampling;
- you’ve recently had or currently have substance abuse issues (e.g. alcohol abuse
defined as more than five 45 mL servings of 80 proof distilled spirits, five 350 mL
servings of beer or five 150 mL servings of wine per day. Or frequent use of any illegal
substances, more than once per week.);
- you have an active infection or acute disease at the time of sampling (acute disease is
defined as the presence of a moderate or severe illness with or without fever, but
occasionally);
- you have cancer or are undergoing cancer treatment;
- you are pregnant or lactating;
- you had an invasive surgical procedure less than a month ago;
- you are immunodeficient;
- you take any kind of medical treatment (both to cure and/or reduce symptoms) for acute
or chronic diseases except for disease/trouble related to the skin (ex : eczema,
psoriasis etc.);
- you were diagnosed with COVID-19 or have had COVID-19-related symptoms (such as
fever, dry cough, tiredness, difficulty breathing or shortness of breath, chest pain or
pressure, loss of speech or movement, loss of taste or smell);
You should not take part in this study if you are concerned by one or more of the above excluding criteria.
Clause: Due to logistical limitations not all willing participants can be included in the study
WHAT DOES THE STUDY INVOLVE?
You will be considered as enrolled in the study when you will have completed your participation form, to which you attached this consent form, dated and signed.
Then you will receive a participation kit by post. The kit includes all the materials necessary for the collection of your skin microbiome (e.g. cotton swab contained in sterile tubes) and the detailed guidelines to perform the collection. You will also receive by email a questionnaire to fill in online and a link allowing you to create an account on the Open Humans platform.
Here are then the steps you will have to follow:
- You will have to click on the link received by email to create an account on the Open Humans platform. An 8-digit identification code will then be assigned to you, you will find this code in your Open Humans account. You will have to keep it for the duration of the study. You will have to annotate it to your samples and also indicate it in the online questionnaire in order to preserve your anonymity.
- You will have to rub swabs on your skin before storing the swabs back in their collection tubes.
- Then you’ll have to send us back the collection tubes by post using the prepaid letter in the kit.
- We will send all tubes collected to an external sequencing company (Genewiz) which will be able to identify the microbial species present in your skin microbiome by reading the bacterial DNA. At the end of the study, the sequencing company will have to destroy
your samples as well as the data they produced. It is also important to note that the DNA that will be read by the sequencing company will not be your DNA but of the
microorganisms (bacteria) that are present on your skin.
- In parallel, you will be asked to answer a survey online to know more about your hygiene habits, how much you are confined, and if you noticed some changes on your skin during the confinement. The questions asked in the questionnaire aim at understanding your hygiene habits, your level of confinement/lockdown and to know about some facts that could impact your skin microbiome that can be important to take into account when analyzing the data. No sociological study will be made from the answers provided.
The identifier code given by the Open Humans platform will be used to link your microbiome data to your answers while preserving your anonymity.
At the end of the study, you will have access to your own microbiome data analyzed. Your microbiome sequencing information, as well as your answers to our questionnaire will be published online and publicly accessible after anonymization/de-identification. It should be noted that sampling or sequencing errors may result in data loss and thus a microbiome profile may not be generated for every participant.
WHAT ARE THE POSSIBLE HARMS OR SIDE EFFECTS?
The collection protocol was tested by the investigators on themselves and should not induce any harm to the participant. The proposed protocol is an adaptation of an established standardised sampling protocol (Manual of Procedures for Human Microbiome Project, Version 12.0 (2010)) for which the sampling protocol was defined as “minimal risk to the study subject”. Rubbing of the skin may cause slight irritation or transient redness at the sampling sites.
WHAT WILL THE STUDY COST?
The costs of the study include material cost for the participation kits, shipping fees of the participation kits, shipping of samples to a sequencing company and sequencing cost. All costs are taken in charge by the organizers of the study. As a participant you won't have to pay anything.
WHO IS FUNDING THIS RESEARCH STUDY?
The Center for Research and Interdisciplinarity (CRI) association is funding the costs of this study.
WHO TO CONTACT IF YOU WANT TO REPORT PROBLEMS OR IF YOU HAVE QUESTIONS?
If you have any questions, troubles in conducting the self-collection of your skin microbiome, or any bad effects on the collection sites on your skin, do not hesitate to contact us at the following address: paris-bettencourt-2020@cri-paris.org
If you have any questions about this study or your rights, please contact Ariel Lindner, PhD at ariel.lindner@cri-paris.org
WHAT ABOUT ANONYMITY?
In the following section, “personal information” refers to information about a person that directly identifies the person, such as the person's name, address or any other identifying information. “study data” refers to study-related information that does not directly identify a person, such as age, sex and skin microbiome data.
The data that we will collect will be pseudonymized to protect your identity.
Pseudonymization is the process by which personal information (that identifies a participant) is being removed from the study data accessible by the investigators. This pseudonymization is done by replacing the name of the participant by a unique identifier code randomly generated and randomly attributed. This ensures that your identity will be unknown to the investigators that will analyze the data and to anyone accessing the study data.
In our study, the pseudonymization will be done as follow:
In your Open Humans account you will find an identification code composed of 8 digits. You’ll have to indicate this number on all your samples and in the questionnaire. By doing so, we will not be able to link the results of the skin microbiome analysis to your identity.
A file linking the identification codes to the participants' personal information will be created and stored on an Open Humans server, inaccessible to the study investigators. A separate file linking the study data to identifier codes will be generated by the investigators on a separate server. These two files won’t be submitted together online. Investigators will not have access to the file linking identification codes to participants' personal information but will only have access to the file linking identification codes to study data.
The way of sending back your samples will also allow anonymization, in the kit you’ll have a prepaid letter (allowing you to send back your sample without paying anything) which won’t let us know the address of the participant.
By signing the consent document for this study, you will give permission for the use of your personal information (to ship the kits), and the uses and the disclosures of your study data that are described in the following Data Privacy Statement:
Data Privacy Statement
If you do not want to allow these uses, you should not participate in this study.
If you agree to participate in the study, your personal information and study data will be maintained, used and shared in the following ways:
- The above-mentioned qualified investigator and sub-investigators will have access to
your study data (but cannot link them to your identity since they won’t have access to the
file linking identifier code and personal information).
- Your study data (which does not identify you), either alone or combined with data from
other studies, might be shared with the INSERM ethics review board overseeing this
study.
- Study data might be published in scientific journals or shared with other researchers as
part of scientific discussions after anonymization/de-identification of the dataset.
- Your study data will be publicly available at the end of the study as part of an
anonymized dataset, to help research in the field of skin microbiome and skin diseases
studies
You will have the right to see and copy your personal information and study data for as long as they are maintained by the investigators on their website. However, the investigators are not legally obliged to maintain the accessibility to this information after the end of the study (31th of October 2020).
You may withdraw your permission and exit the study at any time by providing notice to the Data officer. The investigators would then delete the study data related to you. In addition, you would no longer be able to participate in the study.
If you want to withdraw your permission and exit the study, please send an email to the Data officer at: chetan.velumurugan@cri-paris.org
Subject Information and Consent Form
Signature Page
To take part in this study and to allow the use and disclosure of your personal information and study data for the purposes of the study, you must sign and date this page.
By signing this page, you confirm the following:
- I give permission for my personal information and study data to be maintained,
used and shared as described in this document.
- I have read the Subject Information and Consent Form, and have had time to think about whether or not I want to take part in this study.
- All of my questions about the study or this form were answered to my satisfaction. If I did not understand any of the words in this form, the investigators explained it to me.
- I voluntarily agree to take part in the study, to follow the study procedures, and to provide necessary information to the investigators, as requested.
- I understand that I may freely choose to stop being a part of this study at any time.
- I certify the veracity of my statements regarding my adequation with the inclusion and exclusion criteria of this study.
- I have received a readable copy of the Subject Information and Consent Form.
- I returned my signature page to the investigators by attaching it to my completed participation form.